ImmunoGen, Inc.
IMMUNOGEN INC (Form: 10-Q, Received: 05/08/2015 13:43:21)

Table of Contents

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

x       QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended March 31, 2015

 

OR

 

o          TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from            to            

 

Commission file number 0-17999

 

ImmunoGen, Inc.

 

Massachusetts

 

04-2726691

(State or other jurisdiction of incorporation or
organization)

 

(I.R.S. Employer Identification No.)

 

830 Winter Street, Waltham, MA 02451

(Address of principal executive offices, including zip code)

 

(781) 895-0600

(Registrant’s telephone number, including area code)

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.   x Yes  o No

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Website, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).  x Yes   o No

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):

 

Large accelerated filer x

 

Accelerated filer o

 

 

 

Non-accelerated filer o
(Do not check if a smaller reporting company)

 

Smaller reporting company o

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).  o Yes   x   No

 

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.

 

Shares of common stock, par value $.01 per share:  86,185,057 shares outstanding as of April 30, 2015.

 

 

 



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IMMUNOGEN, INC.

FORM 10-Q

FOR THE QUARTER ENDED MARCH 31, 2015

TABLE OF CONTENTS

 

Item

 

 

 

Page Number

 

 

 

 

 

 

 

Part I

 

 

1.

 

Financial Statements (Unaudited):

 

 

 

 

 

 

 

1a.

 

Consolidated Balance Sheets as of March 31, 2015 and June 30, 2014

 

2

 

 

 

 

 

1b.

 

Consolidated Statements of Operations and Comprehensive Loss for the three and nine months ended March 31, 2015 and 2014

 

3

 

 

 

 

 

1c.

 

Consolidated Statements of Cash Flows for the nine months ended March 31, 2015 and 2014

 

4

 

 

 

 

 

1d.

 

Notes to Consolidated Financial Statements

 

5

 

 

 

 

 

2.

 

Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

23

 

 

 

 

 

3.

 

Quantitative and Qualitative Disclosures about Market Risk

 

36

 

 

 

 

 

4.

 

Controls and Procedures

 

36

 

 

 

 

 

 

 

Part II

 

 

 

 

 

 

 

1A.

 

Risk Factors

 

37

 

 

 

 

 

6.

 

Exhibits

 

38

 

 

 

 

 

 

 

Signatures

 

39

 

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Table of Contents

 

ITEM 1.  Financial Statements

 

IMMUNOGEN, INC.

CONSOLIDATED BALANCE SHEETS

(UNAUDITED)

In thousands, except per share amounts

 

 

 

March 31,
2015

 

June 30,
2014

 

ASSETS

 

 

 

 

 

Cash and cash equivalents

 

$

111,827

 

$

142,261

 

Accounts receivable

 

754

 

1,896

 

Unbilled revenue

 

536

 

1,329

 

Inventory

 

2,702

 

2,950

 

Prepaid and other current assets

 

3,309

 

2,320

 

Total current assets

 

119,128

 

150,756

 

 

 

 

 

 

 

Property and equipment, net of accumulated depreciation

 

14,631

 

14,349

 

Other assets

 

43

 

213

 

 

 

 

 

 

 

Total assets

 

$

133,802

 

$

165,318

 

LIABILITIES AND SHAREHOLDERS’ EQUITY

 

 

 

 

 

Accounts payable

 

$

6,322

 

$

4,819

 

Accrued compensation

 

7,171

 

6,865

 

Other accrued liabilities

 

7,693

 

6,668

 

Current portion of deferred lease incentive

 

646

 

528

 

Current portion of deferred revenue

 

980

 

2,374

 

Total current liabilities

 

22,812

 

21,254

 

 

 

 

 

 

 

Deferred lease incentive, net of current portion

 

6,462

 

5,679

 

Deferred revenue, net of current portion

 

40,917

 

58,969

 

Other long-term liabilities

 

3,941

 

3,717

 

Total liabilities

 

74,132

 

89,619

 

Commitments and contingencies (Note E)

 

 

 

 

 

Shareholders’ equity:

 

 

 

 

 

Preferred stock, $0.01 par value; authorized 5,000 shares; no shares issued and outstanding

 

 

 

Common stock, $0.01 par value; authorized 150,000 shares; issued and outstanding 86,134 and 85,903 shares as of March 31, 2015 and June 30, 2014, respectively

 

861

 

859

 

Additional paid-in capital

 

737,205

 

722,971

 

Accumulated deficit

 

(678,396

)

(648,131

)

Total shareholders’ equity

 

59,670

 

75,699

 

Total liabilities and shareholders’ equity

 

$

133,802

 

$

165,318

 

 

The accompanying notes are an integral part of the consolidated financial statements.

 

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IMMUNOGEN, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(UNAUDITED)

In thousands, except per share amounts

 

 

 

Three Months Ended
March 31,

 

Nine Months Ended
March 31,

 

 

 

2015

 

2014

 

2015

 

2014

 

 

 

 

 

 

 

 

 

 

 

Revenues:

 

 

 

 

 

 

 

 

 

License and milestone fees

 

$

5,078

 

$

305

 

$

52,729

 

$

39,150

 

Royalty revenue

 

5,099

 

2,558

 

13,890

 

6,946

 

Research and development support

 

532

 

1,948

 

2,140

 

5,860

 

Clinical materials revenue

 

718

 

2,064

 

4,171

 

2,197

 

 

 

 

 

 

 

 

 

 

 

Total revenues

 

11,427

 

6,875

 

72,930

 

54,153

 

 

 

 

 

 

 

 

 

 

 

Operating Expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

25,666

 

38,280

 

81,331

 

81,171

 

General and administrative

 

7,000

 

6,040

 

20,967

 

18,013

 

 

 

 

 

 

 

 

 

 

 

Total operating expenses

 

32,666

 

44,320

 

102,298

 

99,184

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

(21,239

)

(37,445

)

(29,368

)

(45,031

)

 

 

 

 

 

 

 

 

 

 

Other (expense) income, net

 

(379

)

(7

)

(897

)

166

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(21,618

)

$

(37,452

)

$

(30,265

)

$

(44,865

)

 

 

 

 

 

 

 

 

 

 

Basic and diluted net loss per common share

 

$

(0.25

)

$

(0.44

)

$

(0.35

)

$

(0.53

)

 

 

 

 

 

 

 

 

 

 

Basic and diluted weighted average common shares outstanding

 

86,080

 

85,684

 

85,962

 

85,375

 

Total comprehensive loss

 

$

(21,618

)

$

(37,452

)

$

(30,265

)

$

(44,865

)

 

The accompanying notes are an integral part of the consolidated financial statements.

 

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IMMUNOGEN, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(UNAUDITED)

In thousands, except per share amounts

 

 

 

Nine Months ended March 31,

 

 

 

2015

 

2014

 

 

 

 

 

 

 

Cash flows from operating activities:

 

 

 

 

 

Net loss

 

$

(30,265

)

$

(44,865

)

Adjustments to reconcile net loss to net cash used for operating activities:

 

 

 

 

 

Depreciation and amortization

 

4,231

 

3,428

 

(Gain) loss on sale/disposal of fixed assets

 

(7

)

20

 

Gain on forward contracts

 

 

(2

)

Non-cash licensing fee

 

 

12,830

 

Stock and deferred share unit compensation

 

12,804

 

12,395

 

Deferred rent

 

161

 

92

 

Changes in operating assets and liabilities:

 

 

 

 

 

Accounts receivable

 

1,142

 

(36

)

Unbilled revenue

 

793

 

134

 

Inventory

 

248

 

(1,781

)

Prepaid and other current assets

 

(467

)

(613

)

Other assets

 

170

 

(113

)

Accounts payable

 

1,503

 

245

 

Accrued compensation

 

306

 

243

 

Other accrued liabilities

 

639

 

(84

)

Deferred revenue, net of non-cash upfront license payment

 

(19,446

)

(16,849

)

Proceeds from landlord for tenant improvements

 

1,350

 

227

 

Net cash used for operating activities

 

(26,838

)

(34,729

)

 

 

 

 

 

 

Cash flows from investing activities:

 

 

 

 

 

Purchases of property and equipment

 

(4,506

)

(4,711

)

Payments for transaction costs related to sale of future royalties

 

(522

)

 

Payments from settlement of forward contracts

 

 

(1

)

Net cash used for investing activities

 

(5,028

)

(4,712

)

 

 

 

 

 

 

Cash flows from financing activities:

 

 

 

 

 

Proceeds from stock options exercised

 

1,432

 

8,557

 

Net cash provided by financing activities

 

1,432

 

8,557

 

 

 

 

 

 

 

Net change in cash and cash equivalents

 

(30,434

)

(30,884

)

 

 

 

 

 

 

Cash and cash equivalents, beginning balance

 

142,261

 

194,960

 

 

 

 

 

 

 

Cash and cash equivalents, ending balance

 

$

111,827

 

$

164,076

 

 

The accompanying notes are an integral part of the consolidated financial statements.

 

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IMMUNOGEN, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

March 31, 2015

 

A.                                     Summary of Significant Accounting Policies

 

Basis of Presentation

 

The accompanying unaudited consolidated financial statements at March 31, 2015 and June 30, 2014 and for the three and nine months ended March 31, 2015 and 2014 include the accounts of ImmunoGen, Inc., or the Company, and its wholly owned subsidiaries, ImmunoGen Securities Corp., ImmunoGen Europe Limited and Hurricane, LLC. The consolidated financial statements include all of the adjustments, consisting only of normal recurring adjustments, which management considers necessary for a fair presentation of the Company’s financial position in accordance with accounting principles generally accepted in the U.S. for interim financial information. Certain information and footnote disclosures normally included in the Company’s annual financial statements have been condensed or omitted. The preparation of interim financial statements requires the use of management’s estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the interim financial statements and the reported amounts of revenues and expenditures during the reported periods. The results of the interim periods are not necessarily indicative of the results for the entire year. Accordingly, the interim financial statements should be read in conjunction with the audited financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended June 30, 2014.

 

Subsequent Events

 

The Company has evaluated all events or transactions that occurred after March 31, 2015 up through the date the Company issued these financial statements. In March 2015, the Company entered into a royalty purchase agreement with Immunity Royalty Holdings, L.P., which closed on April 3, 2015, pursuant to which Immunity Royalty Holdings purchased the Company’s right to receive 100% of the royalty payments on commercial sales of Kadcyla ®  arising under our License Agreement with Genentech, Inc. dated as of May 2, 2000, as amended, until Immunity Royalty Holdings has received aggregate Kadcyla royalties equal to $235 million or $260 million, depending on when the aggregate Kadcyla royalties received by Immunity Royalty Holdings reach a specified milestone.  Once the applicable threshold is met, if ever, the Company will thereafter receive 85% and Immunity Royalty Holdings will receive 15% of the Kadcyla royalties for the remaining royalty term.  At consummation of the transaction in April 2015, the Company received cash proceeds of $200 million.  The Company expects to record these cash proceeds as a deferred royalty obligation liability which will be amortized over the expected royalty recovery period.  As part of this transaction, the Company incurred approximately $5.7 million in transaction costs.  The Company did not have any other material recognizable or unrecognizable subsequent events during this period.

 

Revenue Recognition

 

The Company enters into licensing and development agreements with collaborative partners for the development of monoclonal antibody-based anticancer therapeutics. The terms of these agreements contain multiple deliverables which may include (i) licenses, or options to obtain licenses, to the Company’s antibody-drug conjugate, or ADC, technology, (ii) rights to future technological improvements, (iii) research activities to be performed on behalf of the collaborative partner, (iv) delivery of cytotoxic agents and (v) the manufacture of preclinical or clinical materials for the collaborative partner. Payments to the Company under these agreements may include upfront fees, option fees, exercise fees, payments for research activities, payments for the manufacture of preclinical or clinical materials, payments based upon the achievement of certain milestones and royalties on product sales. The Company follows the provisions of the Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) Topic 605-25, “Revenue Recognition—Multiple-Element Arrangements,” and ASC Topic 605-28, “Revenue Recognition—Milestone Method,” in accounting for these agreements. In order to account for these agreements, the Company must identify the deliverables included within the agreement and evaluate which deliverables represent separate units of accounting based on if certain criteria are met, including whether the delivered element has stand-alone value to the collaborator. The consideration received is allocated among the separate units of accounting, and the applicable revenue recognition criteria are applied to each of the separate units.

 

At March 31, 2015, the Company had the following two types of agreements with the parties identified below:

 

·                   Development and commercialization licenses, which provide the party with the right to use the Company’s ADC technology and/or certain other intellectual property to develop compounds to a specified antigen target:

 

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Amgen (four exclusive single-target licenses(1))

 

Bayer HealthCare (one exclusive single-target license)

 

Biotest (one exclusive single-target license)

 

Lilly (three exclusive single-target licenses)

 

Novartis (five exclusive single-target licenses and one license to two related targets: one target on an exclusive basis and the second target on a non-exclusive basis)

 

Roche, through its Genentech unit (five exclusive single-target licenses)

 

Sanofi (one exclusive single-target license and one exclusive license to multiple individual targets)

 

·                   Research license/option agreement for a defined period of time to secure development and commercialization licenses to use the Company’s ADC technology to develop anticancer compounds to specified targets on established terms (referred to herein as right-to-test agreements):

 

Sanofi

 

CytomX

 

Takeda, through its wholly owned subsidiary, Millennium Pharmaceuticals, Inc.

 

There are no performance, cancellation, termination or refund provisions in any of the arrangements that contain material financial consequences to the Company.

 

Development and Commercialization Licenses

 

The deliverables under a development and commercialization license agreement generally include the license to the Company’s ADC technology with respect to a specified antigen target, and may also include deliverables related to rights to future technological improvements, research activities to be performed on behalf of the collaborative partner and the manufacture of preclinical or clinical materials for the collaborative partner.

 

Generally, development and commercialization licenses contain non-refundable terms for payments and, depending on the terms of the agreement, provide that the Company will (i) at the collaborator’s request, provide research services at negotiated prices which are generally consistent with what other third parties would charge, (ii) at the collaborator’s request, manufacture and provide to it preclinical and clinical materials or deliver cytotoxic agents at negotiated prices which are generally consistent with what other third parties would charge, (iii) earn payments upon the achievement of certain milestones and (iv) earn royalty payments, generally until the later of the last applicable patent expiration or 10 to 12 years after product launch. In the case of Kadcyla, however, the royalty term, on a country-by-country basis, is 10 years after product launch, which may be extended an additional two years, for a maximum royalty term of 12 years, depending on patent protection as of the end of the initial 10-year royalty term. Royalty rates may vary over the royalty term depending on the Company’s intellectual property rights and/or the presence of comparable competing products. The Company may provide technical assistance and share any technology improvements with its collaborators during the term of the collaboration agreements. The Company does not directly control when or whether any collaborator will request research or manufacturing services, achieve milestones or become liable for royalty payments. As a result, the Company cannot predict when or if it will recognize revenues in connection with any of the foregoing.

 

In determining the units of accounting, management evaluates whether the license has stand-alone value from the undelivered elements to the collaborative partner based on the consideration of the relevant facts and circumstances for each arrangement. Factors considered in this determination include the research capabilities of the partner and the availability of ADC technology research expertise in the general marketplace. If the Company concludes that the license has stand-alone value and therefore will be accounted for as a separate unit of accounting, the Company then determines the estimated selling prices of the license and all other units of accounting based on market conditions, similar arrangements entered into by third parties, and entity-specific factors such as the terms

 


(1)  Amgen has sublicensed one of its exclusive single-target licenses to Oxford BioTherapeutics Ltd.

 

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of the Company’s previous collaborative agreements, recent preclinical and clinical testing results of therapeutic products that use the Company’s ADC technology, the Company’s pricing practices and pricing objectives, the likelihood that technological improvements will be made, and, if made, will be used by the Company’s collaborators and the nature of the research services to be performed on behalf of its collaborators and market rates for similar services.

 

Upfront payments on development and commercialization licenses are deferred if facts and circumstances dictate that the license does not have stand-alone value. Prior to the adoption of Accounting Standards Update (ASU) No. 2009-13, “Revenue Arrangements with Multiple Deliverables” on July 1, 2010, the Company determined that its licenses lacked stand-alone value and were combined with other elements of the arrangement and any amounts associated with the license were deferred and amortized over a certain period, which the Company refers to as the Company’s period of substantial involvement. The determination of the length of the period over which to defer revenue is subject to judgment and estimation and can have an impact on the amount of revenue recognized in a given period. Historically the Company’s involvement with the development of a collaborator’s product candidate has been significant at the early stages of development, and lessens as it progresses into clinical trials. Also, as a drug candidate gets closer to commencing pivotal testing the Company’s collaborators have sought an alternative site to manufacture their products, as the Company’s facility does not produce pivotal or commercial drug product. Accordingly, the Company generally estimates this period of substantial involvement to begin at the inception of the collaboration agreement and conclude at the end of non-pivotal Phase II testing. The Company believes this period of substantial involvement is, depending on the nature of the license, on average six and one-half years. Quarterly, the Company reassesses its periods of substantial involvement over which the Company amortizes its upfront license fees and makes adjustments as appropriate. In the event a collaborator elects to discontinue development of a specific product candidate under a development and commercialization license, but retains its right to use the Company’s technology to develop an alternative product candidate to the same target or a target substitute, the Company would cease amortization of any remaining portion of the upfront fee until there is substantial preclinical activity on another product candidate and its remaining period of substantial involvement can be estimated. In the event that a development and commercialization license were to be terminated, the Company would recognize as revenue any portion of the upfront fee that had not previously been recorded as revenue, but was classified as deferred revenue, at the date of such termination.

 

Subsequent to the adoption of ASU No. 2009-13, the Company determined that its research licenses lack stand-alone value and are considered for aggregation with the other elements of the arrangement and accounted for as one unit of accounting.

 

Upfront payments on development and commercialization licenses may be recognized upon delivery of the license if facts and circumstances dictate that the license has stand-alone value from the undelivered elements, which generally include rights to future technological improvements, research services, delivery of cytotoxic agents and the manufacture of preclinical and clinical materials.

 

The Company recognizes revenue related to research services that represent separate units of accounting as they are performed, as long as there is persuasive evidence of an arrangement, the fee is fixed or determinable, and collection of the related receivable is probable. The Company recognizes revenue related to the rights to future technological improvements over the estimated term of the applicable license.

 

The Company may also provide cytotoxic agents to its collaborators or produce preclinical and clinical materials at negotiated prices which are generally consistent with what other third parties would charge. The Company recognizes revenue on cytotoxic agents and on preclinical and clinical materials when the materials have passed all quality testing required for collaborator acceptance and title and risk of loss have transferred to the collaborator. Arrangement consideration allocated to the manufacture of preclinical and clinical materials in a multiple-deliverable arrangement is below the Company’s full cost, and the Company’s full cost is not expected to ever be below its contract selling prices for its existing collaborations. During the nine months ended March 31, 2015 and 2014, the difference between the Company’s full cost to manufacture preclinical and clinical materials on behalf of its collaborators as compared to total amounts received from collaborators for the manufacture of preclinical and clinical materials was $8.7 million and $1.6 million, respectively. The majority of the Company’s costs to produce these preclinical and clinical materials are fixed and then allocated to each batch based on the number of batches produced during the period. Therefore, the Company’s costs to produce these materials are significantly impacted by the number of batches produced during the period. The volume of preclinical and clinical materials the Company produces is directly related to the number of clinical trials the Company and its collaborators are preparing for or currently have underway, the speed of enrollment in those trials, the dosage schedule of each clinical trial and the time period such trials last. Accordingly, the volume of preclinical and clinical materials produced, and therefore the Company’s per-batch costs to manufacture these preclinical and clinical materials, may vary significantly from period to period.

 

The Company may also produce research material for potential collaborators under material transfer agreements. Additionally, the Company performs research activities, including developing antibody specific conjugation processes, on behalf of its collaborators and potential collaborators during the early evaluation and preclinical testing stages of drug development. The Company

 

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records amounts received for research materials produced or services performed as a component of research and development support revenue. The Company also develops conjugation processes for materials for later-stage testing and commercialization for certain collaborators. The Company is compensated at negotiated rates and may receive milestone payments for developing these processes which are recorded as a component of research and development support revenue.

 

The Company’s development and commercialization license agreements have milestone payments which for reporting purposes are aggregated into three categories: (i) development milestones, (ii) regulatory milestones, and (iii) sales milestones. Development milestones are typically payable when a product candidate initiates or advances into different clinical trial phases. Regulatory milestones are typically payable upon submission for marketing approval with the U.S. Food and Drug Administration, or FDA, or other countries’ regulatory authorities or on receipt of actual marketing approvals for the compound or for additional indications. Sales milestones are typically payable when annual sales reach certain levels.

 

At the inception of each agreement that includes milestone payments, the Company evaluates whether each milestone is substantive and at risk to both parties on the basis of the contingent nature of the milestone. This evaluation includes an assessment of whether (a) the consideration is commensurate with either (1) the entity’s performance to achieve the milestone, or (2) the enhancement of the value of the delivered item(s) as a result of a specific outcome resulting from the entity’s performance to achieve the milestone, (b) the consideration relates solely to past performance and (c) the consideration is reasonable relative to all of the deliverables and payment terms within the arrangement. The Company evaluates factors such as the scientific, regulatory, commercial and other risks that must be overcome to achieve the respective milestone, the level of effort and investment required to achieve the respective milestone and whether the milestone consideration is reasonable relative to all deliverables and payment terms in the arrangement in making this assessment.

 

Non-refundable development and regulatory milestones that are expected to be achieved as a result of the Company’s efforts during the period of substantial involvement are considered substantive and are recognized as revenue upon the achievement of the milestone, assuming all other revenue recognition criteria are met. Milestones that are not considered substantive because we do not contribute effort to the achievement of such milestones are generally achieved after the period of substantial involvement and are recognized as revenue upon achievement of the milestone, as there are no undelivered elements remaining and no continuing performance obligations, assuming all other revenue recognition criteria are met.

 

Under the Company’s development and commercialization license agreements, the Company receives royalty payments based upon its licensees’ net sales of covered products. Generally, under these agreements the Company is to receive royalty reports and payments from its licensees approximately one quarter in arrears, that is, generally in the third month of the quarter after the licensee has sold the royalty-bearing product or products. The Company recognizes royalty revenues when it can reliably estimate such amounts and collectability is reasonably assured. As such, the Company generally recognizes royalty revenues in the quarter reported to the Company by its licensees, or one quarter following the quarter in which sales by the Company’s licensees occurred.

 

Right-to-Test Agreements

 

The Company’s right-to-test agreements provide collaborators the right to (a) test the Company’s ADC technology for a defined period of time through a research, or right-to-test, license, (b) take a defined number of options, for a defined period of time, to specified targets and (c) upon exercise an option, secure or “take” a license to develop and commercialize products for the specified targets on established terms. Under these agreements, fees may be due to the Company (i) at the inception of the arrangement (referred to as “upfront” fees or payments), (ii) upon taking an option with respect to a specific target (referred to as option fees or payments earned, if any, when the option is “taken”), (iii) upon the exercise of a previously taken option to acquire a development and commercialization license(s) (referred to as exercise fees or payments earned, if any, when the development and commercialization license is “taken”), or (iv) some combination of all of these fees.

 

The accounting for right-to-test agreements is dependent on the nature of the options granted to the collaborative partner. Options are considered substantive if, at the inception of a right-to-test agreement, the Company is at risk as to whether the collaborative partner will choose to exercise the options to secure development and commercialization licenses. Factors that are considered in evaluating whether options are substantive include the overall objective of the arrangement, the benefit the collaborator might obtain from the agreement without exercising the options, the cost to exercise the options relative to the total upfront consideration, and the additional financial commitments or economic penalties imposed on the collaborator as a result of exercising the options.

 

For right-to-test agreements where the options to secure development and commercialization licenses to the Company’s ADC technology are considered substantive, the Company does not consider the development and commercialization licenses to be a deliverable at the inception of the agreement. For those right-to-test agreements entered into prior to the adoption of ASU No. 2009-13

 

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where the options to secure development and commercialization licenses are considered substantive, the Company has deferred the upfront payments received and recognizes this revenue over the period during which the collaborator could elect to take options for development and commercialization licenses. These periods are specific to each collaboration agreement. If a collaborator takes an option to acquire a development and commercialization license under these agreements, any substantive option fee is deferred and recognized over the life of the option, generally 12 to 18 months. If a collaborator exercises an option and takes a development and commercialization license to a specific target, the Company attributes the exercise fee to the development and commercialization license. Upon exercise of an option to acquire a development and commercialization license, the Company would also attribute any remaining deferred option fee to the development and commercialization license and apply the multiple-element revenue recognition criteria to the development and commercialization license and any other deliverables to determine the appropriate revenue recognition, which will be consistent with the Company’s accounting policy for upfront payments on single-target licenses. In the event a right-to-test agreement were to be terminated, the Company would recognize as revenue any portion of the upfront fee that had not previously been recorded as revenue, but was classified as deferred revenue, at the date of such termination. None of the Company’s right-to-test agreements entered into subsequent to the adoption of ASU No. 2009-13 has been determined to contain substantive options.

 

For right-to-test agreements where the options to secure development and commercialization licenses to the Company’s ADC technology are not considered substantive, the Company considers the development and commercialization licenses to be a deliverable at the inception of the agreement and applies the multiple-element revenue recognition criteria to determine the appropriate revenue recognition. None of the Company’s right-to-test agreements entered into prior to the adoption of ASU No. 2009-13 has been determined to contain non-substantive options.

 

The Company does not directly control when or if any collaborator will exercise its options for development and commercialization licenses. As a result, the Company cannot predict when or if it will recognize revenues in connection with any of the foregoing.

 

Fair Value of Financial Instruments

 

Fair value is defined under ASC Topic 820, “Fair Value Measurements and Disclosures,” as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date.  Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs.  The standard describes a fair value hierarchy to measure fair value which is based on three levels of inputs, of which the first two are considered observable and the last unobservable, as follows:

 

·                            Level 1 - Quoted prices in active markets for identical assets or liabilities.

 

·                            Level 2 - Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.

 

·                            Level 3 - Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

 

As of March 31, 2015, the Company held certain assets that are required to be measured at fair value on a recurring basis.  The following table represents the fair value hierarchy for the Company’s financial assets measured at fair value on a recurring basis as of March 31, 2015 (in thousands):

 

 

 

Fair Value Measurements at March 31, 2015 Using

 

 

 

 

 

Quoted Prices in
Active Markets for
Identical Assets

 

Significant Other
Observable Inputs

 

Significant
Unobservable
Inputs

 

 

 

Total

 

(Level 1)

 

(Level 2)

 

(Level 3)

 

Cash and cash equivalents

 

$

111,827

 

$

111,827

 

$

 

$

 

 

As of June 30, 2014, the Company held certain assets that are required to be measured at fair value on a recurring basis. The following table represents the fair value hierarchy for the Company’s financial assets measured at fair value on a recurring basis as of June 30, 2014 (in thousands):

 

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Fair Value Measurements at June 30, 2014 Using

 

 

 

 

 

Quoted Prices in
Active Markets for
Identical Assets

 

Significant Other
Observable Inputs

 

Significant
Unobservable
Inputs

 

 

 

Total

 

(Level 1)

 

(Level 2)

 

(Level 3)

 

Cash, cash equivalents and restricted cash

 

$

142,261

 

$

142,261

 

$

 

$

 

 

The fair value of the Company’s cash equivalents is based primarily on quoted prices from active markets.

 

Unbilled Revenue

 

The majority of the Company’s unbilled revenue at March 31, 2015 and June 30, 2014 represents research funding earned prior to those dates based on actual resources utilized under the Company’s agreements with various collaborators.

 

Inventory

 

Inventory costs relate to clinical trial materials being manufactured for sale to the Company’s collaborators. Inventory is stated at the lower of cost or market as determined on a first-in, first-out (FIFO) basis.

 

Inventory at March 31, 2015 and June 30, 2014 is summarized below (in thousands):

 

 

 

March 31,
2015

 

June 30,
2014

 

 

 

 

 

 

 

Raw materials

 

$

353

 

$

437

 

Work in process

 

2,349

 

2,513

 

 

 

 

 

 

 

Total

 

$

2,702

 

$

2,950

 

 

Raw materials inventory consists entirely of DM1 and DM4, proprietary cell-killing agents the Company developed as part of its ADC technology. The Company considers more than a twelve month supply of raw materials that is not supported by firm, fixed orders and/or projections from its collaborators to be excess and establishes a reserve to reduce to zero the value of any such excess raw material inventory with a corresponding charge to research and development expense. In accordance with this policy, the Company recorded $434,000 and $236,000 of expense related to excess inventory during the nine-month periods ended March 31, 2015 and 2014, respectively. The Company recorded $42,000 and $32,000 of expense related to excess inventory during the three-month periods ended March 31, 2015 and 2014, respectively.

 

Work in process inventory consists of conjugate manufactured for sale to the Company’s collaborators to be used in preclinical and clinical studies.  All conjugate is made to order at the request of the collaborators and subject to the terms and conditions of respective supply agreements.  As such, no reserve for work in process inventory is required.

 

Computation of Net Loss per Common Share

 

Basic and diluted net loss per share is calculated based upon the weighted average number of common shares outstanding during the period. During periods of income, participating securities are allocated a proportional share of income determined by dividing total weighted average participating securities by the sum of the total weighted average common shares and participating securities (the “two-class method”). Shares of the Company’s restricted stock participate in any dividends declared by the Company and are therefore considered to be participating securities. Participating securities have the effect of diluting both basic and diluted earnings per share during periods of income. During periods of loss, no loss is allocated to participating securities since they have no contractual obligation to share in the losses of the Company. The impact of applying the two-class method was not material.  Diluted (loss) income per share is computed after giving consideration to the dilutive effect of stock options that are outstanding during the period, except where such non-participating securities would be anti-dilutive. Securities which were considered anti-dilutive and which could potentially dilute basic earnings per share in the future were as follows:

 

 

 

March 31,

 

 

 

2015

 

2014

 

Options outstanding to purchase common stock and unvested restricted stock

 

10,158

 

8,605

 

 

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Stock-Based Compensation

 

As of March 31, 2015, the Company is authorized to grant future awards under one employee share-based compensation plan, which is the ImmunoGen, Inc. 2006 Employee, Director and Consultant Equity Incentive Plan, or the 2006 Plan. At the annual meeting of shareholders on November 11, 2014, an amendment to the 2006 Plan was approved and an additional 5,500,000 shares were authorized for issuance under this plan.  As amended, the 2006 Plan provides for the issuance of Stock Grants, the grant of Options and the grant of Stock-Based Awards for up to 17,500,000 shares of the Company’s common stock, as well as 1,676,599 shares of common stock which represent awards granted under the previous stock option plan, the ImmunoGen, Inc. Restated Stock Option Plan, or the Former Plan, that were forfeited, expired or were cancelled without delivery of shares of common stock or which resulted in the forfeiture of shares of common stock back to the Company between November 11, 2006 and June 30, 2014. Option awards are granted with an exercise price equal to the market price of the Company’s stock at the date of grant. Options vest at various periods of up to four years and may be exercised within ten years of the date of grant.

 

The stock-based awards are accounted for under ASC Topic 718, “Compensation—Stock Compensation.” Pursuant to Topic 718, the estimated grant date fair value of awards is charged to the statement of operations and comprehensive loss over the requisite service period, which is the vesting period. Such amounts have been reduced by an estimate of forfeitures of all unvested awards. The fair value of each stock option is estimated on the date of grant using the Black-Scholes option-pricing model with the assumptions noted in the following table. As the Company has not paid dividends since inception, nor does it expect to pay any dividends for the foreseeable future, the expected dividend yield assumption is zero. Expected volatility is based exclusively on historical volatility data of the Company’s stock. The expected term of stock options granted is based exclusively on historical data and represents the period of time that stock options granted are expected to be outstanding. The expected term is calculated for and applied to one group of stock options as the Company does not expect substantially different exercise or post-vesting termination behavior among its option recipients. The risk-free rate of the stock options is based on the U.S. Treasury rate in effect at the time of grant for the expected term of the stock options.

 

 

 

Three Months Ended
March 31,

 

Nine Months Ended
 March 31,

 

 

 

2015

 

2014

 

2015

 

2014

 

Dividend

 

None

 

None

 

None

 

None

 

Volatility

 

60.76%

 

60.44%

 

60.46%

 

60.44%

 

Risk-free interest rate

 

1.67%

 

1.94%

 

1.86%

 

1.74%

 

Expected life (years)

 

6.3

 

6.3

 

6.3

 

6.3

 

 

Using the Black-Scholes option-pricing model, the weighted average grant date fair values of options granted during the three months ended March 31, 2015 and 2014 were $3.83 and $9.52 per share, respectively, and $6.06 and $10.54 per share for options granted during the nine months ended March 31, 2015 and 2014, respectively.

 

Stock compensation expense related to stock options and restricted stock awards granted under the 2006 Plan was $3.6 million and $12.5 million during the three and nine months ended March 31, 2015, respectively, compared to stock compensation expense of $3.7 million and $12.1 million for the three and nine months ended March 31, 2014, respectively. As of March 31, 2015, the estimated fair value of unvested employee awards was $22.3 million, net of estimated forfeitures. The weighted-average remaining vesting period for these awards is approximately two years.

 

During the nine months ended March 31, 2015, holders of options issued under the Company’s equity plans exercised their rights to acquire an aggregate of approximately 205,000 shares of common stock at prices ranging from $3.19 to $9.88 per share.  The total proceeds to the Company from these option exercises were approximately $1.4 million.

 

Financial Instruments and Concentration of Credit Risk

 

The Company’s cash equivalents consist of money market funds with underlying investments primarily being U.S. Government-issued securities and high quality, short-term commercial paper. All of the Company’s cash and cash equivalents are maintained with three financial institutions in the U.S.  The Company uses a Euro-denominated bank account to manage the foreign currency exposures that exist as part of our ongoing business operations. Our foreign currency risk management strategy is principally designed to mitigate the future potential financial impact of changes in the value of transactions, anticipated transactions and balances denominated in foreign currency, resulting from changes in foreign currency exchange rates.

 

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Segment Information

 

During the nine months ended March 31, 2015, the Company continued to operate in one operating segment which is the business of discovery of monoclonal antibody-based anticancer therapeutics.

 

The percentages of revenues recognized from significant customers of the Company in the three and nine months ended March 31, 2015 and 2014 are included in the following table:

 

 

 

Three Months Ended
March 31,

 

Nine Months Ended
 March 31,

 

Collaborative Partner:

 

2015

 

2014

 

2015

 

2014

 

Biotest

 

9%

 

13%

 

4%

 

3%

 

Lilly

 

1%

 

15%

 

24%

 

18%

 

Novartis

 

44%

 

22%

 

44%

 

40%

 

Roche

 

45%

 

37%

 

19%

 

31%

 

 

There were no other customers of the Company with significant revenues in the three and nine months ended March 31, 2015 and 2014.

 

Recent Accounting Pronouncements

 

In May 2014, the FASB issued Accounting Standards Update 2014-9, Revenue from Contracts with Customers (Topic 606), to clarify the principles for recognizing revenue. This update provides a comprehensive new revenue recognition model that requires revenue to be recognized in a manner to depict the transfer of goods or services to a customer at an amount that reflects the consideration expected to be received in exchange for those goods or services. This guidance is effective for annual reporting beginning after December 15, 2016, including interim periods within the year of adoption, and allows for either full retrospective or modified retrospective application, with early adoption not permitted. Accordingly, the standard is effective for the Company on July 1, 2017. The Company is currently evaluating the adoption method it will apply and the impact that this guidance will have on its consolidated financial statements and related disclosures.

 

In August 2014, the FASB issued Accounting Standards Update 2014-15, Presentation of Financial Statements-Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern. This new standard gives a company’s management the final responsibilities to decide whether there’s substantial doubt about the company’s ability to continue as a going concern and to provide related footnote disclosures. The standard provides guidance to management, with principles and definitions that are intended to reduce diversity in the timing and content of disclosures that companies commonly provide in their footnotes. Under the new standard, management must decide whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the company’s ability to continue as a going concern within one year after the date that the financial statements are issued, or within one year after the date that the financial statements are available to be issued when applicable. This guidance is effective for annual reporting beginning after December 15, 2016, including interim periods within the year of adoption, with early application permitted. Accordingly, the standard is effective for the Company on July 1, 2017. The adoption of this guidance is not expected to have a material impact on the Company’s consolidated financial statements.

 

In April 2015, the FASB issued Accounting Standards Update 2015-03,  Interest-Imputation of Interest (Subtopic 835-30): Simplifying the Presentation of Debt Issuance Costs. To simplify presentation of debt issuance costs, this new standard requires that debt issuance costs related to a recognized debt liability be presented in the balance sheet as a direct deduction from the carrying amount of that debt liability, consistent with debt discounts.  The recognition and measurement guidance for debt issuance costs are not affected by this update.  This guidance is effective for annual reporting beginning after December 15, 2015, including interim periods within the year of adoption, and calls for retrospective application, with early application permitted. Accordingly, the standard is effective for the Company on July 1, 2016. The Company is currently evaluating the impact that this guidance will have on the Company’s consolidated financial statements.

 

B.                                     Collaborative Agreements

 

Roche

 

In May 2000, the Company granted Genentech, now a unit of Roche, an exclusive license to use the Company’s maytansinoid ADC technology with antibodies, such as trastuzumab, or other proteins that target HER2. Under the terms of this agreement, Roche has exclusive worldwide rights to develop and commercialize maytansinoid ADC compounds targeting HER2. The ADC marketed by Roche as Kadcyla was developed under this agreement. Roche is responsible for the manufacturing, product

 

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development and marketing of Kadcyla and any other products resulting from the agreement. The Company received a $2 million non-refundable upfront payment from Roche upon execution of the agreement. The Company is also entitled to receive up to a total of $44 million in milestone payments, plus royalties on the commercial sales of Kadcyla or any other resulting products. Total milestones are categorized as follows: development milestones—$13.5 million; and regulatory milestones—$30.5 million. Through March 31, 2015, the Company has received and recognized $13.5 million and $20.5 million in development and regulatory milestone payments, respectively, related to Kadcyla, including two $5 million regulatory milestone payments in connection with marketing approval of Kadcyla in Japan and in the EU. Based on an evaluation of the effort contributed to the achievement of these milestones, the Company determined these milestones were not substantive. In consideration that there were no undelivered elements remaining, no continuing performance obligations and all other revenue recognition criteria had been met, the Company recognized the $10 million non-refundable payments as revenue upon achievement of the milestones, which is included in license and milestone fees for the nine months ended March 31, 2014. The next potential milestone the Company will be entitled to receive will be a $5 million regulatory milestone for marketing approval of Kadcyla for a first extended indication as defined in the agreement. Based on an evaluation of the effort contributed towards the achievement of this future milestone, the Company determined this milestone is not substantive.

 

The Company receives royalty reports and payments related to sales of Kadcyla from Roche one quarter in arrears. In accordance with the Company’s revenue recognition policy, $5.1 million of royalties on net sales of Kadcyla for the three-month period ended December 31, 2014 were recorded and included in royalty revenue for the three months ended March 31, 2015 and $13.9 million of royalties on net sales of Kadcyla for the nine-month period ended December 31, 2014 were included in royalty revenue for the nine months ended March 31, 2015 compared to $2.6 million of royalties on net sales of Kadcyla for the three-month period ended December 31, 2013 which is included in royalty revenue for the three months ended March 31, 2014 and $6.9 million of royalties on net sales of Kadcyla for the nine-month period ended December 31, 2013 which is included in royalty revenue for the nine months ended March 31, 2014.

 

Amgen

 

Under a now-expired right-to-test agreement, in September 2009, November 2009 and December 2012, Amgen took three exclusive development and commercialization licenses, for which the Company received an exercise fee of $1 million for each license taken. In May 2013, Amgen took one non-exclusive development and commercialization license, for which the Company received an exercise fee of $500,000. In October 2013, the non-exclusive license was amended and converted to an exclusive license, for which Amgen paid an additional $500,000 fee to the Company. Amgen has sublicensed its rights under this license to Oxford BioTherapeutics Ltd. For each development and commercialization license taken, the Company is entitled to receive up to a total of $34 million in milestone payments, plus royalties on the commercial sales of any resulting products. The total milestones per license are categorized as follows: development milestones—$9 million; regulatory milestones—$20 million; and sales milestones—$5 million. Amgen (or its sublicensee(s)) is responsible for the manufacturing, product development and marketing of any products resulting from these development and commercialization licenses.

 

Since a deliverable to the original right-to-test agreement was determined to be materially modified at the time the non-exclusive license was converted to exclusive in October 2013, the Company accounted for the multiple-element agreement in accordance with ACS 605-25 (as amended by ASU No. 2009-13). As a result, all of the deferred revenue recorded on the date of the modification and the new consideration received as part of the modification was allocated to all of the remaining deliverables at the time of amendment of the right-to-test agreement based on the estimated selling price of each element. The remaining amount represents consideration for previously delivered elements and was recognized upon the execution of the modification.

 

The outstanding licenses, including the exclusive license delivered upon the signing of the amendment, contain the rights to future technological improvements as well as options to purchase materials and research and development services. The Company concluded that additional materials and research and development services would be paid at a contractual price equal to the estimated selling price based estimated prices that would be charged by third parties for similar services. The estimated selling price of the right to technological improvements is the Company’s best estimate of selling price and was determined by estimating the probability that technological improvements will be made and the probability that such technological improvements made will be used by Amgen. In estimating these probabilities, we considered factors such as the technology that is the subject of the development and commercialization licenses, our history of making technological improvements, and when such improvements, if any, were likely to occur relative to the stage of development of any product candidates pursuant to the development and commercialization licenses. The Company’s estimate of probability considered the likely period of time that any improvements would be utilized, which was estimated to be ten years following delivery of a commercialization and development license. The value of any technological improvements made available after this ten year period was considered to be de minimis due to the significant additional costs that would be incurred to incorporate such technology into any existing product candidates. The estimate of probability was multiplied by the estimated

 

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selling price of the development and commercialization licenses and the resulting cash flow was discounted at a rate of 13%, representing the Company’s estimate of its cost of capital at the time of amendment of the right-to-test agreement.

 

The $430,000 determined to be the estimated selling price of the future technological improvements is being recognized as revenue ratably over the period the Company is obligated to make available any technological improvements, which is equivalent to the estimated term of the agreement. The Company estimates the term of a development and commercialization license to be approximately 25 years, which reflects management’s estimate of the time necessary to develop and commercialize products pursuant to the license plus the estimated royalty term. The Company reassesses the estimated term at the end of each reporting period.

 

After accounting for the undelivered elements at the estimated selling price, the Company had $2.2 million of remaining allocable consideration which was determined to represent consideration for the previously delivered elements, including the exclusive license that was delivered upon the execution of the modification. This amount was recorded as revenue and is included in license and milestone fees for the nine months ended March 31, 2014.

 

In November 2011, the IND applications to the FDA for two compounds, AMG 595 and AMG 172, developed under the 2009 development and commercialization licenses became effective, which triggered two $1 million milestone payments to the Company. The next potential milestone the Company will be entitled to receive for each of these compounds under the 2009 development and commercialization licenses will be a development milestone for the first dosing of a patient in a Phase II clinical trial, which will result in a $3 million payment being due. The next potential milestones the Company will be entitled to receive under the December 2012 and May 2013 development and commercialization licenses will be a $1 million development milestone for an IND becoming effective. At the time of execution of each of these development and commercialization licenses, there was significant uncertainty as to whether these milestones would be achieved. In consideration of this, as well as the Company’s past involvement in the research and manufacturing of these product candidates, these milestones were deemed substantive.

 

Sanofi

 

In July 2003, the Company entered into a broad collaboration agreement with Sanofi (formerly Aventis) to discover, develop and commercialize antibody-based products. The collaboration agreement provides Sanofi with worldwide development and commercialization rights to new antibody-based products directed to targets that are included in the collaboration, including the exclusive right to use the Company’s maytansinoid ADC technology in the creation of products developed to these targets. The product candidates (targets) as of March 31, 2015 in the collaboration include SAR650984 (CD38), SAR566658 (CA6), SAR408701 (CEACAM5) and one earlier-stage compound.

 

The Company is entitled to receive milestone payments potentially totaling $21.5 million, per target, plus royalties on the commercial sales of any resulting products. The total milestones are categorized as follows: development milestones—$7.5 million; and regulatory milestones—$14 million. Through March 31, 2015, the Company has received and recognized an aggregate of $20.5 million in milestone payments for compounds covered under this agreement now or in the past, including a $3 million development milestone related to initiation of a Phase IIb clinical trial (as defined in the agreement) for SAR650984 and a $1 million development milestone related to initiation of a Phase I clinical trial for SAR408701which are included in license and milestone fee revenue for the nine months ended March 31, 2015. The next potential milestone the Company will be entitled to receive for each of SAR566658 and SAR408701 will be a development milestone for initiation of a Phase IIb clinical trial (as defined in the agreement), which will result in each case in a $3 million payment being due. The next potential milestone the Company will be entitled to receive with respect to SAR650984 will be a development milestone for initiation of a Phase III clinical trial, which will result in a $3 million payment being due. The next potential milestone the Company will be entitled to receive for the unidentified target will be a development milestone for commencement of a Phase I clinical trial, which will result in a $1 million payment being due. At the time of execution of this agreement, there was significant uncertainty as to whether these milestones would be achieved. In consideration of this, as well as the Company’s past involvement in the research and manufacturing of these product candidates, these milestones were deemed substantive.

 

In December 2006, the Company entered into a right-to-test agreement with Sanofi. The agreement provides Sanofi with the right to (a) test the Company’s maytansinoid ADC technology with Sanofi’s antibodies to targets under a right-to-test, or research, license, (b) take exclusive options, with certain restrictions, to specified targets for specified option periods and (c) upon exercise of those options, take exclusive licenses to use the Company’s maytansinoid ADC technology to develop and commercialize products directed to the specified targets on terms agreed upon at the inception of the right-to-test agreement. Sanofi no longer has the right to take additional options under the agreement, although multiple outstanding options remain in effect for the remainder of their respective option periods. For each development and commercialization license taken, the Company is entitled to receive an exercise fee of $2 million and up to a total of $30 million in milestone payments, plus royalties on the commercial sales of any resulting products. The total milestones are categorized as follows: development milestones—$10 million; and regulatory milestones—

 

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$20 million. Sanofi is responsible for the manufacturing, product development and marketing of any products resulting from the agreement.

 

In December 2013, Sanofi took its first exclusive development and commercialization license under the right-to-test agreement, for which the Company received an exercise fee of $2 million and was recognizing this amount as revenue ratably over the Company’s estimated period of its substantial involvement. The Company had previously estimated this development period would conclude at the end of non-pivotal Phase II testing.  During the current period, the Company determined it will not be substantially involved in the development and commercialization of the product based on Sanofi’s current plans to develop and manufacture the product without the assistance of the Company. As a result of this determination, the Company recognized the balance of the upfront exercise fee during the first quarter of fiscal 2015.  This change in estimate results in an increase to license and milestone fees of $1.6 million for the nine months ended March 31, 2015 compared to amounts that would have been recognized pursuant to the Company’s previous estimate.  The next payment the Company could receive would either be a $2 million development milestone payment with the initiation of a Phase I clinical trial under the first development and commercialization license taken, or a $2 million exercise fee for the execution of a second license. At the time of execution of this agreement, there was significant uncertainty as to whether the milestone related to initiation of a Phase I clinical trial under the first development and commercialization license would be achieved. In consideration of this, as well as the Company’s expected involvement in the research and manufacturing of these product candidates, this milestone was deemed substantive.

 

Novartis

 

Novartis had the right to take six exclusive development and commercialization licenses under a right-to-test agreement established in October 2010, and took these licenses prior to the expiration of the agreement in October 2014. The Company received a $45 million upfront payment in connection with the execution of the right-to-test agreement in 2010, and for each development and commercialization license taken for a specific target, the Company received an exercise fee of $1 million and is entitled to receive up to a total of $199.5 million in milestone payments, plus royalties on the commercial sales of any resulting products. The total milestones are categorized as follows: development milestones—$22.5 million; regulatory milestones—$77 million; and sales milestones—$100 million. The initial three-year term of the right-to-test agreement was extended by Novartis in October 2013 for an additional one-year period by payment of a $5 million fee to the Company. The Company also is entitled to receive payments for research and development activities performed on behalf of Novartis. Novartis is responsible for the manufacturing, product development and marketing of any products resulting from this agreement.

 

In March 2013, the Company and Novartis amended the right-to-test agreement so that Novartis could take a license to develop and commercialize products directed at two undisclosed, related targets, one target licensed on an exclusive basis and the other target initially licensed on a non-exclusive basis. The target licensed on a non-exclusive basis may no longer be converted to an exclusive target due to the expiration of the right-to-test agreement. The Company received a $3.5 million fee in connection with the execution of the amendment to the agreement. The Company may be required to credit this fee against future milestone payments if Novartis discontinues the development of a specified product under certain circumstances.

 

In connection with the amendment, in March 2013, Novartis took the license referenced above under the right-to-test agreement, as amended, enabling it to develop and commercialize products directed at the two targets. The Company received a $1 million upfront fee with the execution of this license. Additionally, the execution of this license provides the Company the opportunity to receive milestone payments totaling $199.5 million (development milestones—$22.5 million; regulatory milestones—$77 million; and sales milestones—$100 million) or $238 million (development milestones—$22.5 million; regulatory milestones—$115.5 million; and sales milestones—$100 million), depending on the composition of any resulting products.

 

In October 2013 and November 2013, Novartis took its second and third exclusive licenses to single targets, and in October 2014, took three remaining exclusive licenses, each triggering a $1 million payment to the Company and the opportunity to receive milestone payments totaling $199.5 million, as outlined above, plus royalties on the commercial sales of any resulting products. In January 2015, Novartis initiated Phase I, first-in-human clinical testing of its cKit-targeting ADC product candidate, LOP628, triggering a $5 million development milestone payment to the Company. The next payment the Company could receive would be either a $7.5 million development milestone for commencement of a Phase II clinical trial under this license or a $5 million development milestone for commencement of a Phase I clinical trial under any of its other five licenses. At the time of execution of these agreements, there was significant uncertainty as to whether these milestones would be achieved. In consideration of this, as well as the Company’s past involvement in the research and manufacturing of these product candidates, these milestones were deemed substantive. Additionally, the Company is entitled to receive royalties on product sales, if any.

 

In accordance with ACS 605-25 (as amended by ASU No. 2009-13), the Company identified all of the deliverables at the inception of the right-to-test agreement and subsequently when amended. The significant deliverables were determined to be the

 

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right-to-test, or research, license, the development and commercialization licenses, rights to future technological improvements, and the research services. The options to obtain development and commercialization licenses in the right-to-test agreement were determined not to be substantive and, as a result, the exclusive development and commercialization licenses were considered deliverables at the inception of the right-to-test agreement. Factors that were considered in determining the options were not substantive included (i) the overall objective of the agreement was for Novartis to obtain development and commercialization licenses, (ii) the size of the exercise fee of $1 million for each development and commercialization license obtained is not significant relative to the $45 million upfront payment that was due at the inception of the right-to-test agreement, (iii) the limited economic benefit that Novartis could obtain from the right-to-test agreement unless it exercised its options to obtain development and commercialization licenses, and (iv) the lack of economic penalties as a result of exercising the options.

 

The Company has determined that the research license together with the development and commercialization licenses represent one unit of accounting as the research license does not have stand-alone value from the development and commercialization licenses due to the lack of transferability of the research license and the limited economic benefit Novartis would derive if they did not obtain any development and commercialization licenses. The Company has also determined that this unit of accounting does have stand-alone value from the rights to future technological improvements and the research services. The rights to future technological improvements and the research services are considered separate units of accounting as each of these was determined to have stand-alone value. The rights to future technological improvements have stand-alone value as Novartis would be able to use those items for their intended purpose without the undelivered elements. The research services have stand-alone value as similar services are sold separately by other vendors.

 

The estimated selling prices for the development and commercialization licenses are the Company’s best estimate of selling price and were determined based on market conditions, similar arrangements entered into by third parties, including the Company’s understanding of pricing terms offered by its competitors for single-target development and commercialization licenses that utilize ADC technology, and entity-specific factors such as the pricing terms of the Company’s previous single-target development and commercialization licenses, recent preclinical and clinical testing results of therapeutic products that use the Company’s ADC technology, and the Company’s pricing practices and pricing objectives. The estimated selling price of the right to technological improvements is the Company’s best estimate of selling price and was determined by estimating the probability that technological improvements will be made and the probability that such technological improvements made will be used by Novartis. In estimating these probabilities, we considered factors such as the technology that is the subject of the development and commercialization licenses, our history of making technological improvements, and when such improvements, if any, were likely to occur relative to the stage of development of any product candidates pursuant to the development and commercialization licenses. The Company’s estimate of probability considered the likely period of time that any improvements would be utilized, which was estimated to be ten years following delivery of a commercialization and development license. The value of any technological improvements made available after this ten year period was considered to be de minimis due to the significant additional costs that would be incurred to incorporate such technology into any existing product candidates. The estimate of probability was multiplied by the estimated selling price of the development and commercialization licenses and the resulting cash flow was discounted at a rate of 16%, representing the Company’s estimate of its cost of capital at the time. The estimated selling price of the research services was based on third-party evidence given the nature of the research services to be performed for Novartis and market rates for similar services.

 

Upon payment of the extension fee in October 2013, the total arrangement consideration of $60.2 million (which comprises the $45 million upfront payment, the amendment fee of $3.5 million, the $5 million extension fee, the exercise fee for each license, and the expected fees for the research services to be provided under the remainder of the arrangement) was reallocated to the deliverables based on the relative selling price method as follows: $55 million to the delivered and undelivered development and commercialization licenses; $4.5 million to the rights to future technological improvements; and $710,000 to the research services. The Company recorded $17.2 million of the $55 million of the arrangement consideration outlined above for the two development and commercialization licenses taken by Novartis in October 2013 and November 2013, which is included in license and milestone fee revenue for the nine months ended March 31, 2014, and $25.7 million for the three development and commercialization licenses taken in October 2014, which is included in license and milestone fee revenue for the nine months ended March 31, 2015.  The Company also recorded a cumulative catch-up of $1 million for the license delivered in March 2013 and the delivered portion of the license covering future technological improvements, which is included in license and milestone fee revenue for the nine months ended March 31, 2014.

 

Since execution of the first development and commercialization license taken in March 2013, the amount of the total arrangement consideration allocated to future technological improvements is being recognized as revenue ratably over the period the Company is obligated to make available any technological improvements, which is equivalent to the estimated term of the agreement. The Company estimates the term of a development and commercialization license to be approximately 25 years, which reflects management’s estimate of the time necessary to develop and commercialize products pursuant to the license plus the estimated royalty

 

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term. The Company reassesses the estimated term at the end of each reporting period. The Company will recognize research services revenue as the related services are delivered.

 

Lilly

 

Eli Lilly and Company (Lilly) had the right to take three exclusive development and commercialization licenses under a right-to-test agreement established in December 2011, and took these licenses prior to the expiration of the agreement in December 2014. The Company received a $20 million upfront payment in connection with the execution of the right-to-test agreement in 2011.  Under the terms of this right-to-test agreement, the first license had no associated exercise fee, and the second and third licenses each had a $2 million exercise fee. The first development and commercialization license was taken in August 2013 and the agreement was amended in December 2013 to provide Lilly with an extension provision and retrospectively include a $2 million exercise fee for the first license in lieu of the fee due for either the second or third license. The second and third licenses were taken in December 2014, with one including the $2 million exercise fee and the other not. Under the two licenses with the $2 million exercise fee, the Company is entitled to receive up to a total of $199 million in milestone payments, plus royalties on the commercial sales of any resulting products.  Under the license taken in December 2014 without the exercise fee, the Company is entitled to receive up to a total of $200.5 million in milestone payments, plus royalties on the commercial sales of any resulting products. The total milestones are categorized as follows: development milestones—$29 million for the two development and commercialization licenses with the $2 million exercise fee, and $30.5 million for the one development and commercialization license with no exercise fee; regulatory milestones—$70 million in all cases; and sales milestones—$100 million in all cases. The next payment the Company could receive would be a $5 million development milestone payment with the initiation of a Phase I clinical trial under any of these three development and commercialization licenses taken. At the time of execution of this agreement, there was significant uncertainty as to whether these milestones related to initiation of a Phase I clinical trial under the development and commercialization licenses would be achieved. In consideration of this, as well as the Company’s expected involvement in the research and manufacturing of these product candidates, these milestones were deemed substantive. The Company also is entitled to receive payments for delivery of cytotoxic agents to Lilly and research and development activities performed on behalf of Lilly. Lilly is responsible for the manufacturing, product development and marketing of any products resulting from this collaboration.

 

In accordance with ASC 605-25 (as amended by ASU No. 2009-13), the Company identified all of the deliverables at the inception of the right-to-test agreement. The significant deliverables were determined to be the right-to-test, or research, license, the exclusive development and commercialization licenses, rights to future technological improvements, delivery of cytotoxic agents and the research services. The options to obtain development and commercialization licenses in the right-to-test agreement were determined not to be substantive and, as a result, the exclusive development and commercialization licenses were considered deliverables at the inception of the right-to-test agreement. Factors that were considered in determining the options were not substantive included (i) the overall objective of the agreement was for Lilly to obtain development and commercialization licenses, (ii) the size of the exercise fees of $2 million for each development and commercialization license taken beyond the first license is not significant relative to the $20 million upfront payment that was due at the inception of the right-to-test agreement, (iii) the limited economic benefit that Lilly could obtain from the right-to-test agreement unless it exercised its options to obtain development and commercialization licenses, and (iv) the lack of economic penalties as a result of exercising the options.

 

The Company has determined that the research license together with the development and commercialization licenses represent one unit of accounting as the research license does not have stand-alone value from the development and commercialization licenses due to the lack of transferability of the research license and the limited economic benefit Lilly would derive if they did not obtain any development and commercialization licenses. The Company has also determined that this unit of accounting has stand-alone value from the rights to future technological improvements, the delivery of cytotoxic agents and the research services. The rights to future technological improvements, delivery of cytotoxic agents and the research services are considered separate units of accounting as each of these was determined to have stand-alone value. The rights to future technological improvements have stand-alone value as Lilly would be able to use those items for their intended purpose without the undelivered elements. The research services and cytotoxic agents have stand-alone value as similar services and products are sold separately by other vendors.

 

The estimated selling prices for the development and commercialization licenses are the Company’s best estimate of selling price and were determined based on market conditions, similar arrangements entered into by third parties, including pricing terms offered by our competitors for single-target development and commercialization licenses that utilize antibody-drug conjugate technology, and entity-specific factors such as the pricing terms of the Company’s previous single-target development and commercialization licenses, recent preclinical and clinical testing results of therapeutic products that use the Company’s ADC technology, and the Company’s pricing practices and pricing objectives. The estimated selling price of the rights to technological improvements is the Company’s best estimate of selling price and was determined by estimating the probability that technological improvements will be made, and the probability that technological improvements made will be used by Lilly. In estimating these probabilities, we considered factors such as the technology that is the subject of the development and commercialization licenses, our

 

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history of making technological improvements, and when such improvements, if any, were likely to occur relative to the stage of development of any product candidates pursuant to the development and commercialization licenses. The company’s estimate of probability considered the likely period of time that any improvements would be utilized, which was estimated to be ten years following delivery of a commercialization and development license. The value of any technological improvements made available after this ten year period was considered to be de minimis due to the significant additional costs that would be incurred to incorporate such technology into any existing product candidates. The estimate of probability was multiplied by the estimated selling price of the development and commercialization licenses and the resulting cash flow was discounted at a rate of 16%, representing the Company’s estimate of its cost of capital at the time. The estimated selling price of the cytotoxic agent was based on third-party evidence given market rates for the manufacture of such cytotoxic agents. The estimated selling price of the research services was based on third-party evidence given the nature of the research services to be performed for Lilly and market rates for similar services.

 

The total arrangement consideration of $28.2 million (which comprises the $20 million upfront payment, the exercise fee, if any, for each license, the expected fees for the research services to be provided and the cytotoxic agent to be delivered under the arrangement) was allocated to the deliverables based on the relative selling price method as follows: $23.5 million to the development and commercialization licenses; $0.6 million to the rights to future technological improvements, $0.8 million to the sale of cytotoxic agent; and $3.3 million to the research services. Upon execution of the development and commercialization license taken by Lilly in August 2013, the Company recorded $7.8 million of the $23.5 million of the arrangement consideration outlined above, which is included in license and milestone fee revenue for the nine-month period ended March 31, 2014. With this first development and commercialization license taken, the amount of the total arrangement consideration allocated to future technological improvements will commence to be recognized as revenue ratably over the period the Company is obligated to make available any technological improvements, which is the equivalent to the estimated term of the license. The Company estimates the term of a development and commercialization license to be approximately 25 years, which reflects management’s estimate of the time necessary to develop and commercialize therapeutic products pursuant to the license plus the estimated royalty term. The Company will reassess the estimated term at each subsequent reporting period. Upon execution of two development and commercialization licenses taken by Lilly in December 2014, the Company recognized as license revenue the remaining $15.6 million of arrangement consideration allocated to the development and commercialization licenses, which is included in license and milestone fee revenue for the nine-month period ended March 31, 2015. The Company will recognize research services revenue and revenue from the delivery of cytotoxic agents as the related services and cytotoxic agents are delivered.

 

CytomX

 

In January 2014, the Company entered into a reciprocal right-to-test agreement with CytomX Therapeutics, Inc. (CytomX). The agreement provides CytomX with the right to test the Company’s ADC technology with CytomX Probodies to create Probody-drug conjugates (PDCs) directed to a specified number of targets under a right-to-test, or research, license, and to subsequently take an exclusive, worldwide license to use the Company’s ADC technology to develop and commercialize PDCs directed to the specified targets on terms agreed upon at the inception of the right-to- test agreement. The Company received no upfront cash payment in connection with the execution of the right-to-test agreement. Instead, the Company received reciprocal rights to CytomX’s Probody technology whereby the Company was provided the right to test CytomX’s Probody technology to create PDCs directed to a specified number of targets and to subsequently take exclusive, worldwide licenses to develop and commercialize PDCs directed to the specified targets on terms agreed upon at the inception of the right-to-test agreement. The terms of the right-to-test agreement require the Company and CytomX to each take its respective development and commercialization licenses by the end of the term of the research licenses. In addition, both the Company and CytomX are required to perform specific research activities under the right-to-test agreement on behalf of the other party for no monetary consideration.

 

With respect to the development and commercialization license that may be taken by CytomX, the Company is entitled to receive up to a total of $160 million in milestone payments plus royalties on the commercial sales of any resulting product. The total milestones are categorized as follows: development milestones—$10 million; regulatory milestones—$50 million; and sales milestones—$100 million. Assuming no annual maintenance fee is payable as described below, the next payment the Company could receive would be a $1 million development milestone payment with commencement of a Phase I clinical trial. At the time of execution of the right-to-test agreement, there was significant uncertainty as to whether the milestone related to the Phase I clinical trial would be achieved. In consideration of this, as well as the Company’s expected involvement in the research and manufacturing of any product candidate, this milestone was deemed substantive. CytomX is responsible for the manufacturing, product development and marketing of any PDC resulting from the development and commercialization license taken by CytomX under this collaboration.

 

With respect to any development and commercialization license that may be taken by the Company, the Company will potentially be required to pay up to a total of $80 million in milestone payments per license, plus royalties on the commercial sales of any resulting product. The total milestones per license are categorized as follows: development milestones—$7 million; regulatory milestones—$23 million; and sales milestones—$50 million. Assuming no annual maintenance fee is payable as described below, the

 

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next payment the Company could be required to make is a $1 million development milestone payment with commencement of a Phase I clinical trial. The Company is responsible for the manufacturing, product development and marketing of any PDC resulting from any development and commercialization license taken by the Company under this collaboration.

 

In addition, each party may be liable to pay annual maintenance fees to the other party if the licensed PDC product candidate covered under each development and commercialization license has not progressed to a specified stage of development within a specified time frame.

 

The arrangement was accounted for based on the fair value of the items exchanged. The items to be delivered to CytomX under the arrangement are accounted for under the Company’s revenue recognition policy. The items to be received from CytomX are recorded as research and development expenses as incurred.

 

In accordance with ASC 605-25 (as amended by ASU No. 2009-13), the Company identified all of the deliverables at the inception of the right- to-test agreement. The significant deliverables were determined to be the right-to-test, or research, license, the exclusive development and commercialization license, rights to future technological improvements, and the research services. The research license in the right-to-test agreement was determined not to be substantive and, as a result, the exclusive development and commercialization license was considered a deliverable at the inception of the right-to-test agreement. Factors that were considered in determining the research license was not substantive included (i) the overall objective of the agreement is for CytomX to obtain a development and commercialization license, (ii) there are no exercise fees payable upon taking the development and commercialization license, (iii) the limited economic benefit that CytomX could obtain from the right-to-test agreement unless CytomX was able to take the development and commercialization license, and (iv) the lack of economic penalties as a result of taking the license.

 

The Company has determined that the research license from the Company to CytomX together with the development and commercialization license from the Company to CytomX represent one unit of accounting as the research license does not have stand-alone value from the development and commercialization license due to the lack of transferability of the research license and the limited economic benefit CytomX would derive if they did not obtain any development and commercialization license. The Company has also determined that this unit of accounting has stand-alone value from the rights to future technological improvements and the research services. The rights to future technological improvements and the research services are considered separate units of accounting as each of these was determined to have stand-alone value. The rights to future technological improvements have stand-alone value as CytomX would be able to use those items for their intended purpose without the undelivered elements. The research services have stand-alone value as similar services are sold separately by other vendors.

 

The estimated selling price for the development and commercialization license is the Company’s best estimate of selling price and was determined based on market conditions, similar arrangements entered into by third parties, including pricing terms offered by the Company’s competitors for single-target development and commercialization licenses that utilize antibody-drug conjugate technology, and entity-specific factors such as the pricing terms of the Company’s previous single-target development and commercialization licenses, recent preclinical and clinical testing results of therapeutic products that use the Company’s ADC technology, and the Company’s pricing practices and pricing objectives. In order to determine the best estimate of selling price, the Company determined the overall value of a license by calculating a risk- adjusted net present value of a recent, comparable transaction the Company entered into with another collaborator. This overall value was then decreased by risk-adjusting the net present value of the contingent consideration (the milestones and royalties) payable by CytomX under the development and commercialization license. This amount represents the value that a third party would be willing to pay as an upfront payment for this license to the Company’s technology.

 

The estimated selling price of the rights to technological improvements is the Company’s best estimate of selling price and was determined by estimating the probability that technological improvements will be made, and the probability that technological improvements made will be used by CytomX. In estimating these probabilities, the Company considered factors such as the technology that is the subject of the development and commercialization license, the Company’s history of making technological improvements, and when such improvements, if any, were likely to occur relative to the stage of development of the product candidate pursuant to the development and commercialization license. The Company’s estimate of probability considered the likely period of time that any improvements would be utilized, which was estimated to be ten years following delivery of the commercialization and development license. The value of any technological improvements made available after this ten year period was considered to be de minimis due to the significant additional costs that would be incurred to incorporate such technology into any existing product candidate. The estimate of probability was multiplied by the estimated selling price of the development and commercialization license and the resulting cash flow was discounted at a rate of 13%, representing the Company’s estimate of its cost of capital at the time.

 

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The estimated selling price of the research services was based on third-party evidence given the nature of the research services to be performed for CytomX and market rates for similar services.

 

The total allocable consideration of $13.1 million (which comprises the $13.0 million that a third party would be willing to pay as an upfront payment for this license to the Company’s technology plus $140,000 for the fair value of fees for the research services to be provided) was allocated to the deliverables based on the relative selling price method as follows: $12.7 million to the development and commercialization license; $350,000 to the rights to future technological improvements and $140,000 to the research services. The Company will recognize as license revenue the amount of the total allocable consideration allocated to the development and commercialization license when the development and commercialization license is delivered to CytomX. At the time the license is taken, the amount of the total allocable consideration allocated to future technological improvements will commence to be recognized as revenue ratably over the period the Company is obligated to make available any technological improvements, which is the equivalent to the estimated term of the license. The Company estimates the term of a development and commercialization license to be approximately 25 years, which reflects management’s estimate of the time necessary to develop and commercialize therapeutic products pursuant to the license plus the estimated royalty term. The Company will be required to reassess the estimated term at each subsequent reporting period. The Company does not control when CytomX will take the development and commercialization license. As a result, the Company cannot predict when it will recognize the related license revenue except that it will be within the term of the research license. The Company will recognize research services revenue as the related services are delivered.

 

No license fee revenue has been recognized related to this agreement through March 31, 2015 as the research license was not considered to be substantive and the development and commercialization license had not been delivered at this time. Accordingly, $13.0 million of allocated arrangement consideration is included in long-term deferred revenue at March 31, 2015.

 

The $13.1 million of total allocable consideration to be accounted for as revenue described above is also the amount that was used to account for the expense of the licenses and research services the Company received or will receive from CytomX. Based on an estimate of the research services that CytomX will be providing to the Company for no monetary consideration, $310,000 was allocated to such services and will be expensed over the period the services are provided. The balance of $12.8 million pertains to technology rights received which was recorded as research and development expense for the three and nine months ended March 31, 2014 upon execution of the research agreement.

 

Takeda

 

In March 2015, the Company entered into a right-to-test agreement with Takeda Pharmaceutical Company Limited (Takeda) through its wholly owned subsidiary, Millennium Pharmaceuticals, Inc.  The agreement provides Takeda with the right to (a) take exclusive options, with certain restrictions, to individual targets selected by Takeda for specified option periods, (b) test the Company’s antibody-drug conjugate (ADC) technology with Takeda’s antibodies directed to the targets optioned under a right-to-test, or research, license, and (c)  take exclusive licenses to use the Company’s ADC technology to develop and commercialize products to targets optioned for up to two individual targets on terms specified in the right-to-test agreement.  Takeda must exercise its options for the development and commercialization licenses by the end of the three-year term of the right-to-test agreement, after which any then outstanding options will lapse.  Takeda has the right to extend the three-year right-to-test period for one additional year by payment to the Company of $4 million.  Alternatively, Takeda has the right to expand the scope of the right-to-test agreement by payment to the Company of $8 million.  If Takeda opts to expand the scope of the right-to-test agreement, it will be entitled to take additional exclusive options, one of which may be exercised for an additional development and commercialization license, and the right-to test period will be extended until the fifth anniversary of the effective date of the right-to-test agreement.  Takeda is responsible for the manufacturing, product development and marketing of any products resulting from this collaboration.

 

The Company received a $20 million upfront payment in connection with the execution of the right-to-test agreement and, for each development and commercialization license taken, is entitled to receive up to a total of $210 million in milestone payments, plus royalties on the commercial sales of any resulting products. The total milestones are categorized as follows: development milestones—$30 million; regulatory milestones—$85 million; and sales milestones—$95 million. The first potential milestone the Company will be entitled to receive will be a $5 million development milestone payment with the initiation of a Phase I clinical trial under the first development and commercialization license taken. At the time of execution of this agreement, there was significant uncertainty as to whether the milestone related to initiation of a Phase I clinical trial under the first development and commercialization license would be achieved. In consideration of this, as well as the Company’s expected involvement in the research and manufacturing of these product candidates, this milestone was deemed substantive. The Company also is entitled to receive payments for delivery of cytotoxic agents to Takeda and research and development activities performed on behalf of Takeda.

 

In accordance with ASC 605-25 (as amended by ASU No. 2009-13), the Company identified all of the deliverables at the inception of the right- to-test agreement. The significant deliverables were determined to be the right-to-test, or research, license, the

 

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two exclusive development and commercialization licenses, rights to future technological improvements, the development and commercialization license contained in the option to expand the agreement and the research services. The options to obtain two development and commercialization licenses in the right-to-test agreement were determined not to be substantive and, as a result, the exclusive development and commercialization licenses were considered deliverables at the inception of the right-to-test agreement. Factors that were considered in determining the options were not substantive included (i) the overall objective of the agreement was for Takeda to obtain development and commercialization licenses, (ii) no additional consideration required for each development and commercialization license taken beyond the $20 million upfront payment that was due at the inception of the right-to-test agreement, (iii) the limited economic benefit that Takeda could obtain from the right-to-test agreement unless it exercised its options to obtain development and commercialization licenses, and (iv) the lack of economic penalties as a result of exercising the options.

 

The option to expand the scope of the right-to-test agreement and obtain, among other deliverables, a third development and commercialization license was not determined to be substantive and, as a result, the third development and commercialization license was considered a deliverable at the inception of the right-to-test agreement. Factors that were considered in determining this option was not substantive included (i) the overall objective of the agreement was for Takeda to obtain development and commercialization licenses and (ii) the relative size of the $8 million option payment in exchange for this third development and commercialization license and two year extension of the right-to-test period when compared to the $20 million upfront payment in exchange for, among other deliverables, two development and commercialization licenses and the separate ability to extend the right-to-test period for one year in exchange for a $4 million payment.

 

The Company has determined that the research license together with the development and commercialization licenses represent one unit of accounting as the research license does not have stand-alone value from the development and commercialization licenses due to the lack of transferability of the research license and the limited economic benefit Takeda would derive if they did not obtain any development and commercialization licenses. The Company has also determined that this unit of accounting has stand-alone value from the rights to future technological improvements, the license contained in the option to expand the agreement and the research services. The license contained in the option to expand the agreement has stand-alone value as it would result in an additional license with which Takeda would derive economic benefit. The rights to future technological improvements have stand-alone value as Takeda would be able to use those items for their intended purpose without the undelivered elements. The research services have stand-alone value as similar services are sold separately by other vendors.

 

The estimated selling prices for the development and commercialization licenses are the Company’s best estimate of selling price and were determined based on market conditions, similar arrangements entered into by third parties, including pricing terms offered by our competitors for single-target development and commercialization licenses that utilize antibody-drug conjugate technology, and entity-specific factors such as the pricing terms of the Company’s previous single-target development and commercialization licenses, recent preclinical and clinical testing results of therapeutic products that use the Company’s ADC technology, and the Company’s pricing practices and pricing objectives. The estimated selling price of the rights to technological improvements is the Company’s best estimate of selling price and was determined by estimating the probability that technological improvements will be made, and the probability that technological improvements made will be used by Takeda. In estimating these probabilities, we considered factors such as the technology that is the subject of the development and commercialization licenses, our history of making technological improvements, and when such improvements, if any, were likely to occur relative to the stage of development of any product candidates pursuant to the development and commercialization licenses. The Company’s estimate of probability considered the likely period of time that any improvements would be utilized, which was estimated to be ten years following delivery of a commercialization and development license. The value of any technological improvements made available after this ten year period was considered to be de minimis due to the significant additional costs that would be incurred to incorporate such technology into any existing product candidates. The estimate of probability was multiplied by the estimated selling price of the development and commercialization licenses and the resulting cash flow was discounted at a rate of 13%, representing the Company’s estimate of its cost of capital at the time. The estimated selling price of the research services was based on third-party evidence given the nature of the research services to be performed for Takeda and market rates for similar services.

 

The total arrangement consideration of $31.4 million (which comprises the $20 million upfront payment, the $8 million payment to expand the agreement and the expected fees for the research services to be provided) was allocated to the deliverables based on the relative selling price method. The Company will recognize as license revenue an equal amount of the total arrangement consideration allocated to the development and commercialization licenses as each individual license is delivered to Takeda upon Takeda’s exercise of its options to such licenses. At the time the first development and commercialization license is taken, the amount of the total arrangement consideration allocated to future technological improvements will commence to be recognized as revenue ratably over the period the Company is obligated to make available any technological improvements, which is the equivalent to the estimated term of the license. The Company estimates the term of a development and commercialization license to be approximately 25 years, which reflects management’s estimate of the time

 

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necessary to develop and commercialize therapeutic products pursuant to the license plus the estimated royalty term. The Company will reassess the estimated term at each subsequent reporting period. The Company does not control when Takeda will exercise its options for development and commercialization licenses. As a result, the Company cannot predict when it will recognize the related license revenue except that it will be within the term of the research license. The Company will recognize research services revenue as the related services are delivered.

 

For additional information related to these agreements, as well as the Company’s other significant collaborative agreements, please read Note C, Agreements to our consolidated financial statements included within the Company’s 2014 Form 10-K.

 

C.                       Capital Stock

 

2001 Non-Employee Director Stock Plan

 

During the three and nine months ended March 31, 2015, the Company recorded approximately $18,000 and $(19,000) in expense and expense reduction, respectively, related to stock units outstanding under the Company’s 2001 Non-Employee Director Stock Plan, or the 2001 Plan, compared to $2,000 and $(11,000) in expense and expense reduction recorded during the three and nine months ended March 31, 2014. The value of the stock units are classified as a liability and adjusted to market value at each reporting period as the redemption amount of stock units for this plan will be paid in cash.  No stock units have been issued under the 2001 Plan subsequent to June 30, 2004.

 

Compensation Policy for Non-Employee Directors

 

On November 12, 2013, the Board amended the Compensation Policy for Non-Employee Directors to make certain changes to the compensation of its non-employee directors, including an increase in the fees paid in cash to the non-employee directors. Under the terms of the amended policy , the redemption amount of deferred share units issued will continue to be paid in shares of common stock of the Company on the date a director ceases to be a member of the Board. Annual retainers vest quarterly over approximately one year from the date of grant, contingent upon the individual remaining a director of ImmunoGen as of each vesting date.  The number of deferred share units awarded is now fixed per the plan on the date of the award and is no longer based on the market price of the Company’s common stock on the date of the award. All unvested deferred stock awards will automatically vest immediately prior to the occurrence of a change of control.

 

In addition to the deferred share units, the Non-Employee Directors are now also entitled to receive a fixed number of stock options instead of a fixed grant date fair value of options, determined using the Black-Scholes option pricing model measured on the date of grant, which would be the date of the annual meeting of shareholders.  These options vest quarterly over approximately one year from the date of grant.  Any new directors will receive a pro-rated award, depending on their date of election to the Board.  The directors received a total of 80,000, 80,000 and 41,805 stock options for the nine-month period ended March 31, 2015, and fiscal years 2014 and 2013, respectively, and the related compensation expense for the three and nine months ended March 31, 2015 and 2014 is included in the amounts discussed in the “Stock-Based Compensation” section of footnote A above.

 

During the three and nine months ended March 31, 2015, the Company recorded approximately $93,000 and $329,000 in compensation expense, respectively, related to deferred share units issued and outstanding under the Company’s Compensation Policy for Non-Employee Directors, compared to $118,000 and $315,000 in compensation expense recorded during the three and nine months ended March 31, 2014.

 

D.                     Cash and Cash Equivalents

 

As of March 31, 2015 and June 30, 2014, the Company held $111.8 million and $142.3 million, respectively, in cash and money market funds consisting principally of U.S. Government-issued securities and high quality, short-term commercial paper which were classified as cash and cash equivalents.

 

E.                       Commitments and Contingencies

 

Leases

 

Effective July 27, 2007, the Company entered into a lease agreement with Intercontinental Fund III for the rental of approximately 89,000 square feet of laboratory and office space at 830 Winter Street, Waltham, MA through March 2020. The Company uses this space for its corporate headquarters and other operations. In December 2013, the Company modified its lease agreement at 830 Winter Street, Waltham, MA to include approximately 19,000 square feet of additional office space through 2020, concurrent with the remainder of the original lease term. As part of the lease amendment, the Company received a construction

 

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allowance of approximately $746,000 to build out office space to the Company’s specifications. The Company obtained physical control of the additional space to begin construction in January 2014. In April, 2014, the Company again modified its lease agreement at this site to extend the lease to 2026. The Company may extend the lease for two additional terms of five years. As part of this lease amendment, the Company received a construction allowance of approximately $1.1 million to build out office space to the Company’s specifications. The Company is required to pay certain operating expenses for the leased premises subject to escalation charges for certain expense increases over a base amount. The Company entered into a sublease in December 2009 for 14,100 square feet of this space in Waltham through January 2015; however, the Company and the sublessee agreed to end the lease term effective December 31, 2014.

 

Effective April 2012, the Company entered into a sublease agreement for the rental of 7,310 square feet of laboratory and office space at 830 Winter Street, Waltham, MA from Histogenics Corporation, the term of which expires in May 2015.  The Company is required to pay certain operating expenses for the leased premises subject to escalation charges for certain expense increases over a base amount.

 

The Company also leases manufacturing and office space at 333 Providence Highway, Norwood, MA under an agreement through 2018 with an option to extend the lease for an additional term of five years. The Company is required to pay certain operating expenses for the leased premises subject to escalation charges for certain expense increases over a base amount.

 

Effective April 2013, the Company entered into a lease agreement with River Ridge Limited Partnership for the rental of 7,507 square feet of additional office space at 100 River Ridge Drive, Norwood, MA. The initial term of the lease is for five years and two months commencing in July 2013 with an option for the Company to extend the lease for an additional term of five years. The Company is required to pay certain operating expenses for the leased premises subject to escalation charges for certain expense increases over a base amount. The Company entered into a sublease in December 2014 for this space, effective January 2015 through July 2018.

 

The minimum rental commitments for the Company’s facilities, including real estate taxes and other expenses, for the next five fiscal years and thereafter under the non-cancelable operating lease agreements discussed above are as follows (in thousands):

 

2015 (three months remaining)

 

$

1,781

 

2016

 

6,926

 

2017

 

6,942

 

2018

 

7,048

 

2019

 

6,237

 

Thereafter

 

43,900

 

Total minimum lease payments

 

$

72,834

 

Total minimum rental payments from sublease

 

(395

)

Total minimum lease payments, net

 

$

72,439

 

 

There are no obligations under capital leases as of March 31, 2015, as all of the capital leases were single payment obligations which have all been made.

 

Collaborations

 

The Company is contractually obligated to make potential future success-based development, regulatory or sales milestone payments in conjunction with certain collaborative agreements. These payments are contingent upon the occurrence of certain future events and, given the nature of these events, it is unclear when, if ever, the Company may be required to pay such amounts. Further, the timing of any future payment is not reasonably estimable. As of March 31, 2015, the maximum amount that may be payable in the future under the Company’s current collaborative agreements is $162 million, $1.4 million of which is reimbursable by a third party under a separate agreement.

 

ITEM 2.   Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

OVERVIEW

 

Since our inception, we have been principally engaged in the development of novel, antibody-drug conjugates, or ADCs, for the treatment of cancer using our expertise in cancer biology, monoclonal antibodies, highly potent cytotoxic, or cell-killing, agents, and the design of linkers that enable these agents to remain stably attached to the antibodies while in the blood stream and released in

 

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their fully active form after delivery to a cancer cell. An anticancer compound made using our ADC technology consists of a monoclonal antibody that binds specifically to an antigen target found on the surface of cancer cells with one of our proprietary cell-killing agents attached to the antibody using one of our engineered linkers. Its antibody component enables an ADC compound to bind specifically to cancer cells that express its target antigen, the highly potent cytotoxic agent serves to kill the cancer cell, and the engineered linker controls the release and activation of the cytotoxic agent inside the cancer cell. With some ADC compounds, the antibody component also has anticancer activity of its own. Our ADC technology is designed to enable the creation of highly effective, well-tolerated anticancer products. All of the ADC compounds currently in clinical testing contain either DM1 or DM4 as the cytotoxic agent. Both DM1 and DM4, collectively DMx, are our proprietary derivatives of a cytotoxic agent called maytansine. We also have developed agents we call IGNs, one of which, DGN462, is used in our preclinical compound IMGN779.

 

We use our proprietary ADC technology in conjunction with our in-house antibody expertise to develop our own anticancer product candidates. We also enter into agreements that enable companies to use our ADC technology to develop and commercialize product candidates to specified targets. Under the terms of our agreements, we are generally entitled to upfront fees, milestone payments, and royalties on any commercial product sales. In addition, under certain agreements we are compensated for research and development activities performed at our collaborative partner’s request at negotiated prices which are generally consistent with what other third parties would charge. We are compensated to manufacture preclinical and clinical materials and deliver cytotoxic agent material at negotiated prices which are generally consistent with what other third parties would charge. Currently, our partners include Amgen, Bayer HealthCare, Biotest, Lilly, Novartis, Roche, Sanofi and Takeda. We also have a research agreement with CytomX Therapeutics that allows each company to develop probody-drug conjugates against a specified number of cancer targets using CytomX’s Probody antibody masking technology with our payload agents and engineered linkers. We expect that substantially all of our revenue for the foreseeable future will result from payments under our collaborative arrangements. Details for all of our significant agreements can be found in our 2014 Annual Report on Form 10-K

 

Roche —In May 2000, we granted Genentech, now a unit of Roche, an exclusive license to use our maytansinoid ADC technology with antibodies, such as trastuzumab, or other proteins that target HER2. Under the terms of this agreement, Roche has exclusive worldwide rights to develop and commercialize maytansinoid ADC compounds targeting HER2. In February 2013, the US FDA granted marketing approval to the HER2-targeting ADC compound, Kadcyla.  Roche received marketing approval for Kadcyla in Japan and in the EU in September 2013 and November 2013, respectively, and with each event, we received a $5 million regulatory milestone payment. Roche is responsible for the manufacturing, product development and marketing of Kadcyla and any other products resulting from the agreement. We received a $2 million non-refundable upfront payment from Roche upon execution of the agreement. We are also entitled to receive up to a total of $44 million in milestone payments, plus royalties on the commercial sales of Kadcyla and any other resulting products. Total milestones are categorized as follows: development milestones—$13.5 million; and regulatory milestones—$30.5 million. Through March 31, 2015, we have received and recognized $13.5 million and $20.5 million in development and regulatory milestone payments, respectively, related to Kadcyla. Included in license and milestone fees for the nine months ended March 31, 2014 is $10 million of milestone payments for marketing approval of Kadcyla in the EU and Japan.

 

We receive royalty reports and payments related to sales of Kadcyla from Roche one quarter in arrears. In accordance with our revenue recognition policy, $5.1 million of royalties on net sales of Kadcyla for the three-month period ended December 31, 2014 were recorded and included in royalty revenue for the three months ended March 31, 2015 and $13.9 million of royalties on net sales of Kadcyla for the nine-month period ended December 31, 2014 were included in royalty revenue for the nine months ended March 31, 2015 compared to $2.6 million of royalties on net sales of Kadcyla for the three-month period ended December 31, 2013 which is included in royalty revenue for the three months ended March 31, 2014 and $6.9 million of royalties on net sales of Kadcyla for the nine-month period ended December 31, 2013 which is included in royalty revenue for the nine months ended March 31, 2014.

 

Amgen — Under a now-expired right-to-test agreement entered into with Amgen in December 2000, in September 2009, November 2009 and December 2012, Amgen took three exclusive development and commercialization licenses, for which we received an exercise fee of $1 million for each license taken. In May 2013, Amgen took one non-exclusive development and commercialization license, for which we received an exercise fee of $500,000. In October 2013, the non-exclusive license was amended and converted to an exclusive license, for which Amgen paid an additional $500,000 fee to us.  For each of these development and commercialization license taken, we are entitled to receive up to a total of $34 million in milestone payments, plus royalties on the commercial sales of any resulting products. The total milestones per exclusive development and commercialization license are categorized as follows: development milestones—$9 million; regulatory milestones—$20 million; and sales milestones—$5 million.

 

Since a deliverable to the original right-to-test agreement was determined to be materially modified at the time the non-exclusive license was converted to exclusive in October 2013, we accounted for the multiple-element agreement in accordance with ACS 605-25 (as amended by ASU No. 2009-13).  As a result, all of the deferred revenue recorded on the date of the modification and the new consideration received as part of the modification was allocated to all of the remaining deliverables at the time of amendment

 

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of the right-to-test agreement based on the estimated selling price of each element.  The remaining amount represents consideration for previously delivered elements and was recognized upon the execution of the modification.

 

The outstanding licenses, including the exclusive license delivered upon the signing of the amendment, contain the rights to future technological improvements as well as options to purchase materials and research and development services. We concluded that additional materials and research and development services would be paid at a contractual price equal to the estimated selling price based estimated prices that would be charged by third parties for similar services.  The estimated selling price of the right to technological improvements is the Company’s best estimate of selling price and was determined by estimating the probability that technological improvements will be made and the probability that such technological improvements made will be used by Amgen. The $430,000 determined to be the estimated selling price of the future technological improvements is being recognized as revenue ratably over the period we are obligated to make available any technological improvements, which is equivalent to the estimated term of the agreement, or 25 years. After accounting for the undelivered elements at the estimated selling price, we had $2.2 million of remaining allocable consideration which was determined to represent consideration for the previously delivered elements, including the exclusive license that was delivered upon the execution of the modification.  This amount was recorded as revenue and is included in license and milestone fees for the nine months ended March 31, 2014.

 

Sanofi — In July 2003, we entered into a broad collaboration agreement with Sanofi (formerly Aventis) to discover, develop and commercialize antibody-based products. The collaboration agreement provides Sanofi with worldwide development and commercialization rights to new antibody-based products directed to targets that are included in the collaboration, including the exclusive right to use our maytansinoid ADC technology in the creation of products developed to these targets. The product candidates (targets) as of March 31, 2015 in the collaboration include SAR650984 (CD38), SAR566658 (CA6), SAR408701 (CEACAM5) and one earlier-stage compound that has yet to be disclosed.

 

We are entitled to receive milestone payments potentially totaling $21.5 million, per target, payments, plus royalties on the commercial sales of any resulting products. The total milestones are categorized as follows: development milestones—$7.5 million; and regulatory milestones—$14 million. Through March 31, 2015, the Company has received and recognized an aggregate of $20.5 million in milestone payments for compounds covered under this agreement now or in the past, including a $3 million development milestone related to initiation of a Phase IIb clinical trial (as defined in the agreement) for SAR650984 and a $1 million development milestone related to initiation of a Phase I clinical trial for SAR408701 which are included in license and milestone fee revenue for the nine months ended March 31, 2015.

 

In December 2006, we entered into a right-to-test agreement with Sanofi. The agreement provides Sanofi with the right to (a) test our maytansinoid ADC technology with Sanofi’s antibodies to targets under a right-to-test, or research, license, (b) take exclusive options, with certain restrictions, to specified targets for specified option periods and (c) upon exercise of those options, take exclusive licenses to use the Company’s maytansinoid ADC technology to develop and commercialize products directed to the specified targets on terms agreed upon at the inception of the right-to-test agreement. Sanofi no longer has the right to take additional options under the agreement, although multiple outstanding options remain in effect for the remainder of their respective option periods. For each development and commercialization license taken, we are entitled to receive an exercise fee of $2 million and up to a total of $30 million in milestone payments, plus royalties on the commercial sales of any resulting products. The total milestones are categorized as follows: development milestones—$10 million; and regulatory milestones—$20 million.

 

In December 2013, Sanofi took its first exclusive development and commercialization license under the right-to-test agreement, for which we received an exercise fee of $2 million and was recognizing this amount as revenue ratably over our estimated period of its substantial involvement. We had previously estimated this development period would conclude at the end of non-pivotal Phase II testing.  During the first quarter of fiscal 2015, we determined we will not be substantially involved in the development and commercialization of the product based on Sanofi’s current plans to develop and manufacture the product without our assistance. As a result of this determination, we recognized the balance of the upfront exercise fee during the current period.  This change in estimate results in an increase to license and milestone fees of $1.6 million for the nine months ended March 31, 2015 compared to amounts that would have been recognized pursuant to our previous estimate.

 

Novartis —Under a now-expired right-to-test agreement, Novartis has taken six exclusive development and commercialization licenses. We received a $45 million upfront payment in connection with the execution of the right-to-test agreement, and for each development and commercialization license for a specific target, we received an exercise fee of $1 million and are entitled to receive up to a total of $199.5 million in milestone payments, plus royalties on the commercial sales of any resulting products. The initial three-year term of the right-to-test agreement was extended by Novartis in October 2013 for an additional one-year period by payment of a $5 million fee to us. The total milestones are categorized as follows: development milestones—$22.5 million; regulatory milestones—$77 million; and sales milestones—$100 million. In January 2015, Novartis

 

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initiated Phase I, first-in-human clinical testing of its product candidate, LOP628, triggering a $5 million development milestone payment to us.

 

In accordance with our revenue recognition policy, we recorded $17.2 million of revenue for the two development and commercialization licenses taken by Novartis in October 2013 and November 2013, which is included in license and milestone fee revenue for the nine months ended March 31, 2014, and $25.7 million for the three development and commercialization licenses taken in October 2014, which is included in license and milestone fee revenue for the nine months ended March 31, 2015.  We also recorded a cumulative catch-up of $1 million for the license delivered in March 2013 and the delivered portion of the license covering future technological improvements, which is included in license and milestone fee revenue for the three and nine months ended March 31, 2014.

 

Lilly — Under a now-expired right-to-test agreement executed in December 2011, Lilly has taken three exclusive development and commercialization licenses. We received a $20 million upfront payment in connection with the execution of the right-to-test agreement, and for the first development and commercialization license taken in August 2013 and amended in December 2013, we received an exercise fee in the amount of $2 million and are entitled to receive up to a total of $199 million in milestone payments, plus royalties on the commercial sales of any resulting products. The second and third exclusive licenses were taken in December 2014, one of which we received an exercise fee in the amount of $2 million and are entitled to receive up to a total of $199 million in milestone payments, plus royalties on the commercial sales of any resulting products.  For the third license taken in December 2014, for which we did not receive an exercise fee of $2 million, we are entitled to receive up to a total of $200.5 million in milestone payments, plus royalties on the commercial sales of any resulting products. The total milestones are categorized as follows: development milestones—$29 million for the two development and commercialization licenses with the $2 million exercise fee, and $30.5 million for the one development and commercialization license with no exercise fee; regulatory milestones—$70 million in all cases; and sales milestones—$100 million in all cases.

 

In accordance with our revenue recognition policy, upon execution of the development and commercialization license taken by Lilly in August 2013, we recorded $7.8 million of revenue which is included in license and milestone fee revenue for the nine months ended March 31, 2014. Upon execution of two development and commercialization licenses taken by Lilly in December 2014, we recorded $15.6 million of revenue which is included in license and milestone fee revenue for the nine months ended March 31, 2015.

 

CytomX —In January 2014, we entered into a reciprocal right-to-test agreement with CytomX. The agreement provides CytomX with the right to test our ADC technology with CytomX Probodies to create Probody-drug conjugates (PDCs) directed to a specified number of targets under a right-to-test, or research, license, and to subsequently take an exclusive, worldwide license to use our ADC technology to develop and commercialize PDCs directed to the specified targets on terms agreed upon at the inception of the right to test agreement.  We received no upfront cash payment in connection with the execution of the right to test agreement.  Instead, we received reciprocal rights to CytomX’s Probody technology whereby we were provided the right to test CytomX’s Probody technology to create PDCs directed to a specified number of targets and to subsequently take exclusive licenses to develop and commercialize PDCs directed to the specified targets on terms agreed upon at the inception of the right to test agreement. The terms of the right to test agreement require us and CytomX to take our respective development and commercialization licenses by the end of the term of the research licenses.  In addition, both we and CytomX are required to perform specific research activities under the right-to-test agreement on behalf of the other party for no monetary consideration.

 

With respect to the development and commercialization license that may be taken by CytomX, we are entitled to receive up to a total of $160 million in milestone payments plus royalties on the commercial sales of any resulting product. The total milestones are categorized as follows: development milestones—$10 million; regulatory milestones—$50 million; and sales milestones—$100 million.

 

With respect to any development and commercialization license that may be taken by us, we will potentially be required to pay up to a total of $80 million in milestone payments per license, plus royalties on the commercial sales of any resulting product. The total milestones per license are categorized as follows: development milestones—$7 million; regulatory milestones—$23 million; and sales milestones—$50 million.

 

The total allocable consideration of $13.1 million (which comprises the $13.0 million that a third party would be willing to pay as an upfront payment for this license to our technology plus $140,000 for the fair value of fees for the research services to be provided) was allocated to the deliverables based on the relative selling price method as follows: $12.7 million to the development and commercialization license; $350,000 to the rights to future technological improvements and $140,000 million to the research services. No license fee revenue has been recognized related to this agreement through March 31, 2015 as the research license was not considered to be substantive and the development and commercialization license had not been delivered. We do not control when, or if, CytomX will exercise its options for development and commercialization licenses.  As a result, we cannot predict when we will

 

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recognize license fee revenue except that it will be within the term of the research license. Accordingly, $13.0 million of allocated arrangement consideration is included in long term deferred revenue at March 31, 2015.

 

The $13.1 million of total allocable consideration to be accounted for as revenue noted above is also the amount that was used to account for the expense of the licenses and research services we received or will receive from CytomX.  Based on an estimate of the research services that CytomX will be providing to us for no monetary consideration, $310,000 was allocated to such services and will be expensed over the period the services are provided.  The balance of $12.8 million pertains to technology rights received which was recorded as research and development expense for the three and nine months ended March 31, 2014 upon execution of the research agreement.

 

Takeda — In March 2015, we entered into a right-to-test agreement with Takeda Pharmaceutical Company Limited through its wholly owned subsidiary, Millennium Pharmaceuticals, Inc.  The agreement provides Takeda with the right to (a) take exclusive options, with certain restrictions, to individual targets selected by Takeda for specified option periods, (b) test our antibody-drug conjugate (ADC) technology with Takeda’s antibodies directed to the targets optioned under a right-to-test, or research, license, and (c)  take exclusive licenses to use our ADC technology to develop and commercialize products to targets optioned for up to two individual targets on terms specified in the right-to-test agreement.  Takeda must exercise its options for the development and commercialization licenses by the end of the three-year term of the right-to-test agreement, after which any then outstanding options will lapse.  Takeda has the right to extend the three-year right-to-test period for one additional year by payment to us of $4 million.  Alternatively, Takeda has the right to expand the scope of the right-to-test agreement by payment to us of $8 million.  If Takeda opts to expand the scope of the right-to-test agreement, it will be entitled to take additional exclusive options, one of which may be exercised for an additional development and commercialization license, and the right-to test period will be extended until the fifth anniversary of the effective date of the right-to-test agreement.  Takeda is responsible for the manufacturing, product development and marketing of any products resulting from this collaboration.

 

We received a $20 million upfront payment in connection with the execution of the right-to-test agreement and, for each development and commercialization license taken, are entitled to receive up to a total of $210 million in milestone payments, plus royalties on the commercial sales of any resulting products. The total milestones are categorized as follows: development milestones—$30 million; regulatory milestones—$85 million; and sales milestones—$95 million. We also are entitled to receive payments for delivery of cytotoxic agents to Takeda and research and development activities performed on behalf of Takeda.

 

The total arrangement consideration of $31.4 million (which comprises the $20 million upfront payment, the $8 million payment to expand the agreement and the expected fees for the research services to be provided) was allocated to the deliverables based on the relative selling price method. We will recognize as license revenue an equal amount of the total arrangement consideration allocated to the development and commercialization licenses as each individual license is delivered to Takeda upon Takeda’s exercise of its options to such licenses. At the time the first development and commercialization license is taken, the amount of the total arrangement consideration allocated to future technological improvements will commence to be recognized as revenue ratably over the period we are obligated to make available any technological improvements, which is the equivalent to the estimated term of the license. We estimate the term of a development and commercialization license to be approximately 25 years, which reflects management’s estimate of the time necessary to develop and commercialize therapeutic products pursuant to the license plus the estimated royalty term. We will reassess the estimated term at each subsequent reporting period. We do not control when Takeda will exercise its options for development and commercialization licenses. As a result, we cannot predict when it will recognize the related license revenue except that it will be within the term of the research license. We will recognize research services revenue as the related services are delivered.

 

To date, we have not generated revenues from commercial sales of internal products and we expect to incur significant operating losses for the foreseeable future. As of March 31, 2015, we had approximately $111.8 million in cash and cash equivalents compared to $142.3 million in cash and cash equivalents as of June 30, 2014.  In April 2015, pursuant to a royalty purchase agreement, we received cash proceeds of approximately $194.3 million, net of transaction fees.

 

We anticipate that future cash expenditures will be partially offset by collaboration-derived proceeds, including milestone payments and upfront fees. Accordingly, period-to-period operational results may fluctuate dramatically based upon the timing of receipt of the proceeds. We believe that our established collaborative agreements, while subject to specified milestone achievements, will provide funding to assist us in meeting obligations under our collaborative agreements while also assisting in providing funding for the development of internal product candidates and technologies. However, we can give no assurances that such collaborative agreement funding will, in fact, be realized in the time frames we expect, or at all. Should we or our partners not meet some or all of the terms and conditions of our various collaboration agreements, we may be required to secure alternative financing arrangements, find additional partners and/or defer or limit some or all of our research, development and/or clinical projects. However, we cannot

 

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provide assurance that any such opportunities presented by additional partners or alternative financing arrangements will be entirely available to us, if at all.

 

Critical Accounting Policies

 

We prepare our consolidated financial statements in accordance with accounting principles generally accepted in the U.S. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and related disclosure of contingent assets and liabilities. On an on-going basis, we evaluate our estimates, including those related to our collaborative agreements, clinical trial accruals, inventory and stock-based compensation. We base our estimates on historical experience and various other assumptions that we believe to be reasonable under the circumstances. Actual results may differ from these estimates.

 

There were no significant changes to our critical accounting policies from those disclosed in our Annual Report on Form 10-K for the fiscal year ended June 30, 2014.

 

RESULTS OF OPERATIONS

 

Comparison of Three Months ended March 31, 2015 and 2014

 

Revenues

 

Our total revenues for the three months ended March 31, 2015 and 2014 were $11.4 million and $6.9 million, respectively. The $4.5 million increase in revenues in the three months ended March 31, 2015 from the same period in the prior year is attributable to an increase in license and milestone fees and royalty revenue, partially offset by a decrease in research and development support revenue and clinical materials revenue, all of which are discussed below.

 

Revenues from license and milestone fees for the three months ended March 31, 2015 increased $4.8 million to $5.1 million from $305,000 in the same period ended March 31, 2014. Included in license and milestone fees for the three months ended March 31, 2015 is a $5 million development milestone achieved under a license agreement with Novartis.  The amount of license and milestone fees we earn is directly related to the number of our collaborators, the collaborators’ advancement of the product candidates, and the overall success in the clinical trials of the product candidates. As such, the amount of license and milestone fees may vary significantly from quarter to quarter and year to year.  Total revenue from license and milestone fees recognized from each of our collaborative partners in the three-month periods ended March 31, 2015 and 2014 is included in the following table (in thousands):

 

 

 

Three Months Ended March 31,

 

License and Milestone Fees

 

2015

 

2014

 

Collaborative Partner:

 

 

 

 

 

Amgen

 

$

4

 

$

4

 

Biotest

 

7

 

6

 

Lilly

 

6

 

6

 

Novartis

 

5,045

 

45

 

Sanofi

 

16

 

244

 

Total

 

$

5,078

 

$

305

 

 

Deferred revenue of $41.9 million as of March 31, 2015 primarily represents consideration received from our collaborators pursuant to our license agreements, which we have yet to earn pursuant to our revenue recognition policy. Included within this amount is a $20 million upfront payment received from Takeda during the current quarter and $13 million of non-cash consideration recorded in connection with our arrangement with CytomX during fiscal 2014.

 

Kadcyla is an ADC marketed product resulting from one of our development and commercialization licenses with Roche, through its Genentech unit. We receive royalty reports and payments related to sales of Kadcyla from Roche one quarter in arrears. In accordance with our revenue recognition policy, $5.1 million of royalties on net sales of Kadcyla for the three-month period ended December 31, 2014 were recorded and included in royalty revenue for the three months ended March 31, 2015 and $2.6 million of royalties on net sales of Kadcyla for the three-month period ended December 31, 2013 is included in royalty revenue for the three months ended March 31, 2014. We expect royalty revenue to increase in future periods as the underlying net sales of Kadcyla increase.

 

In April 2015, we consummated a royalty purchase transaction — see Liquidity and Capital Resources below for further details.

 

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Research and development support revenue was $532,000 for the three months ended March 31, 2015 compared with $1.9 million for the three months ended March 31, 2014. These amounts primarily represent research funding earned based on actual resources utilized under our agreements with our collaborators shown in the table below. Also included in research and development support revenue are fees for developing antibody-specific conjugation processes on behalf of our collaborators and potential collaborators during the early evaluation and preclinical testing stages of drug development. The amount of research and development support revenue we earn is directly related to the number of our collaborators and potential collaborators, the stage of development of our collaborators’ product candidates and the resources our collaborators allocate to the development effort. As such, the amount of research and development support revenue may vary widely from quarter to quarter and year to year. Total revenue recognized from research and development support from each of our collaborative partners in the three-month periods ended March 31, 2015 and 2014 is included in the following table (in thousands):

 

 

 

Three Months Ended March 31,

 

Research and Development Support

 

2015

 

2014

 

Collaborative Partner:

 

 

 

 

 

Amgen

 

$

59

 

$

97

 

Biotest

 

278

 

137

 

Lilly

 

137

 

987

 

Novartis

 

20

 

706

 

Takeda

 

12

 

 

Other

 

26

 

21

 

Total

 

$

532

 

$

1,948

 

 

Clinical materials revenue was $718,000 for the three months ended March 31, 2015 compared with $2.1 million for the three months ended March 31, 2014. We are compensated at negotiated prices which are generally consistent with what other third-parties would charge. The amount of clinical materials revenue we earn, and the related cost of clinical materials charged to research and development expense, is directly related to the number of clinical trials our collaborators who use us to manufacture clinical materials are preparing or have underway, the speed of enrollment in those trials, the dosage schedule of each clinical trial and the time period, if any, during which patients in the trial receive clinical benefit from the clinical materials, and the demand our collaborators have for clinical-grade material for process development and analytical purposes. As such, the amount of clinical materials revenue and the related cost of clinical materials charged to research and development expense may vary significantly from quarter to quarter and year to year.

 

Research and Development Expenses

 

Our research and development expenses relate to (i) research to evaluate new targets and to develop and evaluate new antibodies, linkers and cytotoxic agents, (ii) preclinical testing of our own and, in certain instances, our collaborators’ product candidates, and the cost of our own clinical trials, (iii) development related to clinical and commercial manufacturing processes and (iv) manufacturing operations which also includes raw materials.

 

Research and development expense for the three months ended March 31, 2015 decreased $12.6 million to $25.7 million from $38.3 million for the three months ended March 31, 2014. During the three-month period ended March 31, 2014, we recorded a $12.8 million non-cash charge to research and development expense for technology rights obtained under the collaboration agreement executed with CytomX in January 2014. A more detailed discussion of research and development expense in the period follows.

 

We are unable to accurately estimate which potential product candidates, if any, will eventually move into our internal preclinical research program. We are unable to reliably estimate the costs to develop these products as a result of the uncertainties related to discovery research efforts as well as preclinical and clinical testing. Our decision to move a product candidate into the clinical development phase is predicated upon the results of preclinical tests. We cannot accurately predict which, if any, of the discovery stage product candidates will advance from preclinical testing and move into our internal clinical development program. The clinical trial and regulatory approval processes for our product candidates that have advanced or that we intend to advance to clinical testing are lengthy, expensive and uncertain in both timing and outcome. As a result, the pace and timing of the clinical development of our product candidates is highly uncertain and may not ever result in approved products. Completion dates and development costs will vary significantly for each product candidate and are difficult to predict. A variety of factors, many of which are outside our control, could cause or contribute to the prevention or delay of the successful completion of our clinical trials, or delay or prevent our obtaining necessary regulatory approvals. The costs to take a product through clinical trials are dependent upon, among other factors, the clinical indications, the timing, size and design of each clinical trial, the number of patients enrolled in each trial, and the speed at which patients are enrolled and treated. Product candidates may be found to be ineffective or to cause unacceptable side

 

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effects during clinical trials, may take longer to progress through clinical trials than anticipated, may fail to receive necessary regulatory approvals or may prove impractical to manufacture in commercial quantities at reasonable cost or with acceptable quality.

 

The lengthy process of securing FDA approvals for new drugs requires the expenditure of substantial resources. Any failure by us to obtain, or any delay in obtaining, regulatory approvals, would materially adversely affect our product development efforts and our business overall. Accordingly, we cannot currently estimate, with any degree of certainty, the amount of time or money that we will be required to expend in the future on our product candidates prior to their regulatory approval, if such approval is ever granted. As a result of these uncertainties surrounding the timing and outcome of our clinical trials, we are currently unable to estimate when, if ever, our product candidates that have advanced into clinical testing will generate revenues and cash flows.

 

We do not track our research and development costs by project. Since we use our research and development resources across multiple research and development projects, we manage our research and development expenses within each of the categories listed in the following table and described in more detail below (in thousands):

 

 

 

Three Months Ended March 31,

 

Research and Development Expense

 

2015

 

2014

 

Research

 

$

5,721

 

$

17,281

 

Preclinical and Clinical Testing

 

9,941

 

8,887

 

Process and Product Development

 

2,138

 

2,113

 

Manufacturing Operations

 

7,866

 

9,999

 

Total Research and Development Expense

 

$

25,666

 

$

38,280

 

 

Research :    Research includes expenses primarily associated with activities to identify and evaluate new targets and to develop and evaluate new antibodies, linkers and cytotoxic agents for our products and in support of our collaborators. Such expenses primarily include personnel, contract services, research licensing fees, facilities and lab supplies. Research expenses for the three months ended March 31, 2015 decreased $11.6 million compared to the three months ended March 31, 2014. This decrease is principally due to a $12.8 million non-cash charge recorded for technology rights obtained under the collaboration agreement executed with CytomX in January 2014, partially offset by an increase in salaries and related expenses, an increase in recruiting costs and an increase in facility-related expenses. We expect research expenses for fiscal 2015 to be significantly lower than fiscal 2014 due to the $12.8 million non-cash charge recorded in the prior-year. No similar charges are expected to be incurred during fiscal 2015.

 

Preclinical and Clinical Testing :  Preclinical and clinical testing includes expenses related to preclinical testing of our own and, in certain instances, our collaborators’ product candidates, regulatory activities, and the cost of our own clinical trials. Such expenses include personnel, patient enrollment at our clinical testing sites, consultant fees, contract services, and facility expenses. Preclinical and clinical testing expenses for the three months ended March 31, 2015 increased $1 million to $9.9 million compared to $8.9 million for the three months ended March 31, 2014. This increase is primarily the result of an increase in contract service expense driven primarily by increased study activities related to IMGN853 and IMGN779 and an increase in facility-related expenses.  Partially offsetting these increases, clinical trial costs decreased due primarily to decreased costs incurred related to the IMGN901 007 study, partially offset by increased costs related to the IMGN853 study during the current period. We expect preclinical and clinical testing expenses for fiscal 2015 to be significantly higher than fiscal 2014 due to increased activities to advance our wholly owned product candidates.

 

Process and Product Development :   Process and product development expenses include costs for development of clinical and commercial manufacturing processes for our own and collaborator compounds. Such expenses include the costs of personnel, contract services and facility expenses. For the three months ended March 31, 2015, total development expenses increased $25,000 compared to the three months ended March 31, 2014. We expect process and product development expenses for fiscal 2015 to be marginally higher than fiscal 2014.

 

Manufacturing Operations: Manufacturing operations expense includes costs to manufacture preclinical and clinical materials for our own and our collaborator’s product candidates, and quality control and quality assurance activities and costs to support the operation and maintenance of our conjugate manufacturing facility. Such expenses include personnel, raw materials for our and our collaborators’ preclinical studies and clinical trials, development costs with contract manufacturing organizations, manufacturing supplies, and facilities expense. For the three months ended March 31, 2015, manufacturing operations expense decreased $2.1 million to $7.9 million compared to $10.0 million in the same period last year. The decrease in the three months ended March 31, 2015 as compared to the three months ended March 31, 2014  is primarily the result of (i) a decrease in cost of clinical materials revenue charged to research and development expense due to timing of orders of such clinical materials from our partners; (ii) a decrease in antibody development and supply expense driven primarily by timing of clinical drug supply for our IMGN853

 

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program; and (iii) an increase in costs capitalized into inventory due to a greater number of manufactured batches of conjugated materials on behalf of our collaborators.  Partially offsetting these decreases, development and supply costs related to our cytotoxic agent, DGN462, increased during the current period. We expect manufacturing operations expense for fiscal 2015 to be significantly higher than fiscal 2014 due primarily to increased activities to advance our wholly owned product candidates.

 

General and Administrative Expenses

 

General and administrative expenses for the three months ended March 31, 2015 increased $960,000 compared to the same period last year. This increase is primarily due to increases in patent expenses, and to a lesser extent, salaries and related expenses. We expect general and administrative expenses for fiscal 2015 to be higher than fiscal 2014 due primarily to increased salaries and related expenses and patent activities.

 

Other (Expense) Income, net

 

Other (expense) income, net for the three months ended March 31, 2015 and 2014 is included in the following table (in thousands):

 

 

 

Three Months Ended March 31,

 

Other (Expense) Income, net

 

2015

 

2014

 

Interest Income

 

$

14

 

$

12

 

Other (Expense) Income, net

 

(393

)

(19

)

Total Other (Expense) Income, net

 

$

(379

)

$

(7

)

 

The change in other (expense) income, net is primarily due to an increase in foreign currency exchange losses related to obligations with non-U.S. dollar-based suppliers and euros held by the Company to manage the foreign currency exposures related to these obligations. We incurred $393,000 and $19,000 in foreign currency exchange losses during the three months ended March 31, 2015 and 2014, respectively.

 

Comparison of Nine Months ended March 31, 2015 and 2014

 

Revenues

 

Our total revenues for the nine months ended March 31, 2015 and 2014 were $72.9 million and $54.2 million, respectively. The $18.7 million increase in revenues in the nine months ended March 31, 2015 from the same period in the prior year is attributable to an increase in license and milestone fees, royalty revenue and clinical materials revenue, partially offset by a decrease in research and development support revenue, all of which are discussed below.

 

Revenues from license and milestone fees for the nine months ended March 31, 2015 increased $13.5 million to $52.7 million from $39.2 million in the same period ended March 31, 2014. Included in license and milestone fees for the nine months ended March 31, 2015 is $15.6 million of license revenue earned upon the execution of two development and commercialization licenses by Lilly, $25.7 million of license revenue earned upon the execution of three development and commercialization licenses by Novartis, a $5 million development milestone achieved under one of the development and commercialization licenses with Novartis and $4 million in development milestones achieved under our collaboration agreement with Sanofi.  Also, during the current period, we made a change in estimate to our period of substantial involvement as it relates to an exclusive license with Sanofi which resulted in an increase to license and milestone fees of $1.6 million for the current period compared to amounts that would have been recognized pursuant to the Company’s previous estimate.  Additionally, during the current period, Janssen Biotech terminated its exclusive development and commercialization license with us, and as a result, we recognized the remaining $241,000 of the $1 million upfront fee received upon execution of the license which had been previously deferred.  Included in license and milestone fees for the nine months ended March 31, 2014 is $7.8 million of license revenue earned upon the execution of a development and commercialization license by Lilly, two $5 million regulatory milestones achieved under our collaboration agreement with Roche, $18.2 million of license revenue earned upon the execution of two development and commercialization licenses and a one-year extension of the original term of the multi-target agreement by Novartis and $2.2 million of revenue from Amgen related to a modification of an existing arrangement.  The amount of license and milestone fees we earn is directly related to the number of our collaborators, the collaborators’ advancement of the product candidates, and the overall success in the clinical trials of the product candidates. As such, the amount of license and milestone fees may vary significantly from quarter to quarter and year to year.  Total revenue from license and milestone fees recognized from each of our collaborative partners in the nine-month periods ended March 31, 2015 and 2014 is included in the following table (in thousands):

 

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Nine Months Ended March 31,

 

License and Milestone Fees

 

2015

 

2014

 

Collaborative Partner:

 

 

 

 

 

Amgen

 

$

13

 

$

2,347

 

Biotest

 

19

 

19

 

Janssen

 

241

 

 

Lilly

 

15,639

 

7,824

 

Novartis

 

30,869

 

18,307

 

Sanofi

 

5,948

 

653

 

Roche

 

 

10,000

 

Total

 

$

52,729

 

$

39,150

 

 

Kadcyla is an ADC marketed product resulting from one of our development and commercialization licenses with Roche, through its Genentech unit. We receive royalty reports and payments related to sales of Kadcyla from Roche one quarter in arrears. In accordance with our revenue recognition policy, $13.9 million of royalties on net sales of Kadcyla for the nine-month period ended December 31, 2014 were recorded and included in royalty revenue for the nine months ended March 31, 2015 and $6.9 million of royalties on net sales of Kadcyla for the nine-month period ended December 31, 2013 is included in royalty revenue for the nine months ended March 31, 2014. We expect royalty revenue to increase in future periods as the underlying net sales of Kadcyla increase.

 

In April 2015, we consummated a royalty purchase transaction— see Liquidity and Capital Resources below for further details.

 

Research and development support revenue was $2.1 million for the nine months ended March 31, 2015 compared with $5.9 million for the nine months ended March 31, 2014. These amounts primarily represent research funding earned based on actual resources utilized under our agreements with our collaborators shown in the table below. Also included in research and development support revenue are fees for developing antibody-specific conjugation processes on behalf of our collaborators and potential collaborators during the early evaluation and preclinical testing stages of drug development. The amount of research and development support revenue we earn is directly related to the number of our collaborators and potential collaborators, the stage of development of our collaborators’ product candidates and the resources our collaborators allocate to the development effort. As such, the amount of research and development support revenue may vary widely from quarter to quarter and year to year. Total revenue recognized from research and development support from each of our collaborative partners in the nine-month periods ended March 31, 2015 and 2014 is included in the following table (in thousands):

 

 

 

Nine Months Ended March 31,

 

Research and Development Support

 

2015

 

2014

 

Collaborative Partner:

 

 

 

 

 

Amgen

 

$

97

 

$

367

 

Biotest

 

458

 

601

 

Lilly

 

1,010

 

2,127

 

Novartis

 

476

 

2,731

 

Takeda

 

12

 

 

 

Other

 

87

 

34

 

Total

 

$

2,140

 

$

5,860

 

 

Clinical materials revenue was $4.2 million for the nine months ended March 31, 2015 compared with $2.2 million for the nine months ended March 31, 2014. We are compensated at negotiated prices which are generally consistent with what other third-parties would charge. The amount of clinical materials revenue we earn, and the related cost of clinical materials charged to research and development expense, is directly related to the number of clinical trials our collaborators who use us to manufacture clinical materials are preparing or have underway, the speed of enrollment in those trials, the dosage schedule of each clinical trial and the time period, if any, during which patients in the trial receive clinical benefit from the clinical materials, and the demand our collaborators have for clinical-grade material for process development and analytical purposes. As such, the amount of clinical materials revenue and the related cost of clinical materials charged to research and development expense may vary significantly from quarter to quarter and year to year.

 

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Research and Development Expenses

 

Research and development expense for the nine months ended March 31, 2015 increased $160,000 to $81.3 million from $81.2 million for the nine months ended March 31, 2014. During the nine-month period ended March 31, 2014, we recorded a $12.8 million non-cash charge to research and development expense for technology rights obtained under the collaboration agreement executed with CytomX in January 2014. Principally offsetting this decrease were the following increases in expense: (i) increased third-party costs related to the advancement of our internal products; (ii) an increase in cost of clinical materials revenue due to timing of orders of such clinical materials from our partners; (iii) an increase in facility-related expenses due primarily to additional laboratory and office space occupied in July 2014 and increased depreciation and amortization related to major capital equipment and improvements; and (iv) salaries and related expenses increased due primarily to increased incentive compensation.  A more detailed discussion of research and development expense in the period follows.

 

We are unable to accurately estimate which potential product candidates, if any, will eventually move into our internal preclinical research program. We are unable to reliably estimate the costs to develop these products as a result of the uncertainties related to discovery research efforts as well as preclinical and clinical testing. Our decision to move a product candidate into the clinical development phase is predicated upon the results of preclinical tests. We cannot accurately predict which, if any, of the discovery stage product candidates will advance from preclinical testing and move into our internal clinical development program. The clinical trial and regulatory approval processes for our product candidates that have advanced or that we intend to advance to clinical testing are lengthy, expensive and uncertain in both timing and outcome. As a result, the pace and timing of the clinical development of our product candidates is highly uncertain and may not ever result in approved products. Completion dates and development costs will vary significantly for each product candidate and are difficult to predict. A variety of factors, many of which are outside our control, could cause or contribute to the prevention or delay of the successful completion of our clinical trials, or delay or prevent our obtaining necessary regulatory approvals. The costs to take a product through clinical trials are dependent upon, among other factors, the clinical indications, the timing, size and design of each clinical trial, the number of patients enrolled in each trial, and the speed at which patients are enrolled and treated. Product candidates may be found to be ineffective or to cause unacceptable side effects during clinical trials, may take longer to progress through clinical trials than anticipated, may fail to receive necessary regulatory approvals or may prove impractical to manufacture in commercial quantities at reasonable cost or with acceptable quality.

 

The lengthy process of securing FDA approvals for new drugs requires the expenditure of substantial resources. Any failure by us to obtain, or any delay in obtaining, regulatory approvals, would materially adversely affect our product development efforts and our business overall. Accordingly, we cannot currently estimate, with any degree of certainty, the amount of time or money that we will be required to expend in the future on our product candidates prior to their regulatory approval, if such approval is ever granted. As a result of these uncertainties surrounding the timing and outcome of our clinical trials, we are currently unable to estimate when, if ever, our product candidates that have advanced into clinical testing will generate revenues and cash flows.

 

We do not track our research and development costs by project. Since we use our research and development resources across multiple research and development projects, we manage our research and development expenses within each of the categories listed in the following table and described in more detail below (in thousands):

 

 

 

Nine Months Ended March 31,

 

Research and Development Expense

 

2015

 

2014

 

Research

 

$

15,313

 

$

25,983

 

Preclinical and Clinical Testing

 

31,157

 

24,819

 

Process and Product Development

 

6,382

 

6,113

 

Manufacturing Operations

 

28,479

 

24,256

 

Total Research and Development Expense

 

$

81,331

 

$

81,171

 

 

Research :    Research includes expenses primarily associated with activities to identify and evaluate new targets and to develop and evaluate new antibodies, linkers and cytotoxic agents for our products and in support of our collaborators. Such expenses primarily include personnel, contract services, research licensing fees, facilities and lab supplies. Research expenses for the nine months ended March 31, 2015 decreased $10.7 million compared to the nine months ended March 31, 2014. This decrease is principally due to a $12.8 million non-cash charge recorded for technology rights obtained under the collaboration agreement executed with CytomX in January 2014, partially offset by an increase in salaries and related expenses, an increase in facility-related expenses and an increase in contract service expense. We expect research expenses for fiscal 2015 to be significantly lower than fiscal 2014 due to the $12.8 million non-cash charge recorded in the prior-year. No similar charges are expected to be incurred during fiscal 2015.

 

Preclinical and Clinical Testing :  Preclinical and clinical testing includes expenses related to preclinical testing of our own and, in certain instances, our collaborators’ product candidates, regulatory activities, and the cost of our own clinical trials. Such expenses include personnel, patient enrollment at our clinical testing sites, consultant fees, contract services, and facility expenses.

 

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Preclinical and clinical testing expenses for the nine months ended March 31, 2015 increased $6.4 million to $31.2 million compared to $24.8 million for the nine months ended March 31, 2014. This increase is primarily the result of higher salaries and related expenses, an increase in facility-related expenses, and an increase in contract service expense driven primarily by increased study activities related to IMGN853 and IMGN289. We expect preclinical and clinical testing expenses for fiscal 2015 to be significantly higher than fiscal 2014 due to increased activities to advance our wholly owned product candidates.

 

Process and Product Development :   Process and product development expenses include costs for development of clinical and commercial manufacturing processes for our own and collaborator compounds. Such expenses include the costs of personnel, contract services and facility expenses. For the nine months ended March 31, 2015, total development expenses increased $269,000 compared to the nine months ended March 31, 2014. This increase is primarily the result of an increase in facility-related expenses. We expect process and product development expenses for fiscal 2015 to be marginally higher than fiscal 2014.

 

Manufacturing Operations: Manufacturing operations expense includes costs to manufacture preclinical and clinical materials for our own and our collaborator’s product candidates, and quality control and quality assurance activities and costs to support the operation and maintenance of our conjugate manufacturing facility. Such expenses include personnel, raw materials for our and our collaborators’ preclinical studies and clinical trials, development costs with contract manufacturing organizations, manufacturing supplies, and facilities expense. For the nine months ended March 31, 2015, manufacturing operations expense increased $4.2 million to $28.5 million compared to $24.3 million in the same period last year. The increase in the nine months ended March 31, 2015 as compared to the nine months ended March 31, 2014 is primarily the result of i) an increase in cost of clinical materials revenue charged to research and development expense due to timing of orders of such clinical materials from our partners; (ii) an increase in contract service expense driven by increased fill/finish activities, increased cytotoxic agent activities and developing third-party conjugation capabilities for our internal products; and (iii) an increase in salaries and related expenses driven by increased personnel and increased incentive compensation. Partially offsetting these increases, antibody development and supply expense decreased driven primarily by timing of clinical drug supply for our IMGN853 program.  We expect manufacturing operations expense for fiscal 2015 to be significantly higher than fiscal 2014 due primarily to increased activities to advance our wholly owned product candidates.

 

General and Administrative Expenses

 

General and administrative expenses for the nine months ended March 31, 2015 increased $3.0 million to $21.0 million compared to $18.0 million in the same period last year. This increase is primarily due to increases in patent expenses and salaries and related expenses. We expect general and administrative expenses for fiscal 2015 to be higher than fiscal 2014 due primarily to increased salaries and related expenses and patent activities.

 

Other (Expense) Income, net

 

Other (expense) income, net for the nine months ended March 31, 2015 and 2014 is included in the following table (in thousands):

 

 

 

Nine Months Ended March 31,

 

Other (Expense) Income, net

 

2015

 

2014

 

Interest Income

 

$

36

 

$

33

 

Other (Expense) Income, net

 

(933

)

133

 

Total Other (Expense) Income, net

 

$

(897

)

$

166

 

 

The change in other (expense) income, net is primarily due to an increase in foreign currency exchange losses related to obligations with non-U.S. dollar-based suppliers and euros held by the Company to manage the foreign currency exposures related to these obligations. We incurred $(940,000) and $130,000 in foreign currency exchange (losses) and gains during the nine months ended March 31, 2015 and 2014, respectively.

 

LIQUIDITY AND CAPITAL RESOURCES

 

 

 

As of

 

 

 

March 31,

 

June 30,

 

 

 

2015

 

2014

 

 

 

(In thousands)

 

Cash and cash equivalents

 

$

111,827

 

$

142,261

 

Working capital

 

96,316

 

129,502

 

Shareholders’ equity

 

59,670

 

75,699

 

 

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Table of Contents

 

 

 

Nine Months Ended March 31,

 

 

 

2015

 

2014

 

 

 

(In thousands)

 

Cash used for operating activities

 

$

(27,360

)

$

(34,729

)

Cash used for investing activities

 

(4,506

)

(4,712

)

Cash provided by financing activities

 

1,432

 

8,557

 

 

Cash Flows

 

We require cash to fund our operating expenses, including the advancement of our own clinical programs, and to make capital expenditures. Historically, we have funded our cash requirements primarily through equity financings in public markets and payments from our collaborators, including license fees, milestones, research funding and more recently, royalties. As of March 31, 2015, we had approximately $111.8 million in cash and cash equivalents. Net cash used for operations was $27.4 million and $34.7 million for the nine months ended March 31, 2015 and 2014, respectively. The principal use of cash for operating activities for both periods presented was to fund our net loss.

 

Net cash used for investing activities was $4.5 million and $4.7 million for the nine months ended March 31, 2015 and 2014, respectively, and represents cash outflows for capital expenditures, primarily for the purchase of new equipment and leasehold improvements.

 

Net cash provided by financing activities was $1.4 million and $8.6 million for the nine months ended March 31, 2015 and 2014, respectively, which represents proceeds from the exercise of approximately 205,000 and 1.0 million stock options, respectively.

 

In March 2015, we entered into a royalty purchase agreement with Immunity Royalty Holdings, L.P., which closed on April 3, 2015, pursuant to which Immunity Royalty Holdings purchased our right to receive 100% of the royalty payments on commercial sales of Kadcyla ®  arising under our License Agreement with Genentech, Inc. dated as of May 2, 2000, as amended, until Immunity Royalty Holdings has received aggregate Kadcyla royalties equal to $235 million or $260 million, depending on when the aggregate Kadcyla royalties received by Immunity Royalty Holdings reach a specified milestone.  Once the applicable threshold is met, if ever, we will thereafter receive 85% and Immunity Royalty Holdings will receive 15% of the Kadcyla royalties for the remaining royalty term.  At consummation of the transaction in April 2015, we received gross cash proceeds of $200 million.  The Company expects to record these cash proceeds as a deferred royalty obligation liability which will be amortized over the expected royalty recovery period.  As part of this transaction, the Company incurred approximately $5.7 million in transaction costs.

 

We anticipate that our current capital resources and expected future collaborator payments under existing collaborations will enable us to meet our operational expenses and capital expenditures partway through fiscal year 2017. However, we cannot provide assurance that such future collaborative agreement funding will, in fact, be received. Should we or our partners not meet some or all of the terms and conditions of our various collaboration agreements, we may be required to pursue additional strategic partners, secure alternative financing arrangements, and/or defer or limit some or all of our research, development and/or clinical projects.

 

Contractual Obligations

 

There have been no material changes to our contractual obligations during the current period from those disclosed in our Annual Report on Form 10-K for the fiscal year ended June 30, 2014.

 

Recent Accounting Pronouncements

 

In May 2014, the FASB issued Accounting Standards Update 2014-9, Revenue from Contracts with Customers (Topic 606), to clarify the principles for recognizing revenue. This update provides a comprehensive new revenue recognition model that requires revenue to be recognized in a manner to depict the transfer of goods or services to a customer at an amount that reflects the consideration expected to be received in exchange for those goods or services. This guidance is effective for annual reporting beginning after December 15, 2016, including interim periods within the year of adoption, and allows for either full retrospective or modified retrospective application, with early adoption not permitted. Accordingly, the standard is effective for us on July 1, 2017. We are currently evaluating the adoption method we will apply and the impact that this guidance will have on our financial statements and related disclosures.

 

In August 2014, the FASB issued Accounting Standards Update 2014-15, Presentation of Financial Statements-Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern. This new standard

 

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gives a company’s management the final responsibilities to decide whether there’s substantial doubt about the company’s ability to continue as a going concern and to provide related footnote disclosures. The standard provides guidance to management, with principles and definitions that are intended to reduce diversity in the timing and content of disclosures that companies commonly provide in their footnotes. Under the new standard, management must decide whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the company’s ability to continue as a going concern within one year after the date that the financial statements are issued, or within one year after the date that the financial statements are available to be issued when applicable. This guidance is effective for annual reporting beginning after December 15, 2016, including interim periods within the year of adoption, with early application permitted. Accordingly, the standard is effective for us on July 1, 2017. The adoption of this guidance is not expected to have a material impact on our consolidated financial statements.

 

In April 2015, the FASB issued Accounting Standards Update 2015-03,  Interest-Imputation of Interest (Subtopic 835-30): Simplifying the Presentation of Debt Issuance Costs. To simplify presentation of debt issuance costs, this new standard requires that debt issuance costs related to a recognized debt liability be presented in the balance sheet as a direct deduction from the carrying amount of that debt liability, consistent with debt discounts.  The recognition and measurement guidance for debt issuance costs are not affected by this update.  This guidance is effective for annual reporting beginning after December 15, 2015, including interim periods within the year of adoption, and calls for retrospective application, with early application permitted. Accordingly, the standard is effective for us on July 1, 2016. We are currently evaluating the impact that this guidance will have on our consolidated financial statements.

 

Forward-Looking Statements

 

This quarterly report includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to analyses and other information which are based on forecasts of future results and estimates of amounts that are not yet determinable. These statements also relate to our future prospects, developments and business strategies.

 

These forward-looking statements can be identified by their use of terms and phrases, such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “will” and other similar terms and phrases, including references to assumptions. They may also use words such as “will,” “would,” “should,” “could” or “may”. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from those contemplated by our forward-looking statements. These known and unknown risks, uncertainties and other factors are described in detail in the “Risk Factors” section and in other sections of this Annual Report on Form 10-K for the year ended June 30, 2014. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

 

Kadcyla ®  is a registered trademark of Genentech, Inc., a member of the Roche Group.

Probody™ is a trademark of CytomX Therapeutics, Inc.

 

OFF-BALANCE SHEET ARRANGEMENTS

 

None.

 

ITEM 3.                         Quantitative and Qualitative Disclosure about Market Risk

 

Our market risks, and the ways we manage them, are summarized in Part II, Item 7A, “Quantitative and Qualitative Disclosures About Market Risk” of our Annual Report on Form 10-K for the fiscal year ended June 30, 2014. Since then there have been no material changes to our market risks or to our management of such risks.

 

ITEM 4.                         Controls and Procedures

 

(a)         Disclosure Controls and Procedures

 

The Company’s management, with the participation of its principal executive officer and principal financial officer, has evaluated the effectiveness of the Company’s disclosure controls and procedures (as defined in Rules 13a-15(e) or 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) as of the end of the period covered by this Quarterly Report on Form 10-Q. Based on such evaluation, the Company’s principal executive officer and principal financial officer have concluded that, as of the end of such period, the Company’s disclosure controls and procedures were adequate and effective.

 

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(b)          Changes in Internal Controls

 

There have not been any changes in the Company’s internal control over financial reporting (as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended March 31, 2015 that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.

 

PART II. OTHER INFORMATION

 

ITEM 1A.                Risk Factors

 

You should carefully review and consider the information regarding certain factors that could materially affect our business, financial condition or future results set forth under Item 1A. (Risk Factors) in our Annual Report on Form 10-K for the fiscal year ended June 30, 2014. There have been no material changes from the factors disclosed in our 2014 Annual Report on Form 10-K, although we may disclose changes to such factors or disclose additional factors from time to time in our future filings with the Securities and Exchange Commission.

 

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ITEM 6.                         Exhibits

 

Exhibit No.

 

Description

10.1*

 

Multi-Target Agreement dated as of March 20, 2015 by and between the Registrant and Millennium Pharmaceuticals, Inc.

10.2*

 

Royalty Purchase Agreement dated as of March 24, 2015 by and among the Registrant, Hurricane, LLC and Immunity Royalty Holdings, L.P.

31.1

 

Certification of Principal Executive Officer under Section 302 of the Sarbanes-Oxley Act of 2002.

31.2

 

Certification of Principal Financial Officer under Section 302 of the Sarbanes-Oxley Act of 2002.

32†

 

Certifications of Principal Executive Officer and Principal Financial Officer under Section 906 of the Sarbanes-Oxley Act of 2002.

101.INS

 

XBRL Instance Document

101.SCH

 

XBRL Taxonomy Extension Schema

101.CAL

 

XBRL Taxonomy Extension Calculation Linkbase

101.DEF

 

XBRL Taxonomy Extension Definition Linkbase

101.LAB

 

XBRL Taxonomy Extension Label Linkbase

101.PRE

 

XBRL Taxonomy Extension Presentation Linkbase

 


*                                          Portions of this Exhibit were omitted, as indicated by [***], and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment.

                                         Furnished, not filed.

 

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SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

 

 

ImmunoGen, Inc.

 

 

Date: May 8, 2015

By:

/s/ Daniel M. Junius

 

 

Daniel M. Junius

 

 

President, Chief Executive Officer (Principal Executive Officer)

 

 

 

Date: May 8, 2015

By:

/s/ David B. Johnston

 

 

David B. Johnston

 

 

Executive Vice President, Chief Financial Officer (Principal Financial and Accounting Officer)

 

39


Exhibit 10.1

 

CONFIDENTIAL TREATMENT REQUESTED

 

MULTI-TARGET AGREEMENT

 

This Multi-Target Agreement (this Agreement ) is made effective as of the date of the last signature below (the Effective Date ) by and between ImmunoGen, Inc. , a Massachusetts corporation ( ImmunoGen ), with its principal place of business at 830 Winter Street, Waltham, Massachusetts 02451, and Millennium Pharmaceuticals, Inc. , a Delaware corporation ( Millennium ) and a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, with its principal place of business at 40 Landsdowne Street, Cambridge, Massachusetts 02139.  ImmunoGen and Millennium are sometimes each hereinafter referred to individually as a Party and collectively as the Parties .”

 

WHEREAS, Millennium is the owner of or otherwise controls certain rights in Technology relating to certain Antibodies directed to specified Targets and the conjugation of Antibodies with payloads; and

 

WHEREAS, ImmunoGen is the owner of or otherwise controls certain rights in Technology relating to or otherwise useful in the conjugation of Cytotoxic Compounds to Antibodies; and

 

WHEREAS, pursuant to the terms and conditions set forth herein, Millennium desires to have access to ImmunoGen’s Technology (and associated Patent Rights) for research, discovery and development of ADCs to specified Targets, and ImmunoGen desires to give Millennium such access.

 

NOW, THEREFORE, in consideration of the mutual covenants contained herein, and for other good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, the Parties hereby agree as follows:

 

1.                                       DEFINITIONS

 

Whenever used in this Agreement with an initial capital letter, the terms defined in this Section 1 shall have the meanings specified.

 

ImmunoGen/Millennium Confidential

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 



 

CONFIDENTIAL TREATMENT REQUESTED

 

1.1                                ADC means any compound that incorporates, is comprised of, or is otherwise derived from, a conjugate of an Antibody with a Cytotoxic Compound.

 

1.2                                ADC Platform Improvements means any enhancement, improvement or modification [***] or [***]or otherwise [***] or [***] (each an Improvement ) to the Licensed Intellectual Property that is (a) an Improvement to the [***] of or [***] of [***], (b) an Improvement to [***] for [***] (including, for example, [***] or [***] that create improvements in the [***] of such [***], (c) an Improvement to the [***] of or [***] for [***], (d) an Improvement to any of the [***] for [***] or [***] any [***] or [***], or (e) an Improvement to the [***] of any [***].

 

1.3                                Adverse Event means the development of an undesirable medical condition or the deterioration of a pre-existing medical condition in a patient or clinical investigation subject following or during exposure to a pharmaceutical product or investigational drug, whether or not considered causally related to such product or drug, the exacerbation of any pre-existing condition(s) occurring during the use of such product or drug, or any other adverse experience or adverse drug experience described in the FDA’s Investigational New Drug safety reporting and regulatory approval post-marketing reporting regulations, 21 C.F.R. §§ 312.32 and 314.80, respectively, and any applicable corresponding regulations outside the United States.  For purposes of this Agreement, (a) “undesirable medical condition” shall include symptoms ( e.g ., nausea, chest pain), signs ( e.g. , tachycardia, enlarged liver) or the abnormal results of an investigation ( e.g ., laboratory findings, electrocardiogram), including unfavorable side effects, toxicity, injury, overdose or sensitivity reactions and (b) the failure of a product to exhibit its expected pharmacologic/biologic effect in a clinical study is not considered an Adverse Event.

 

1.4                                Affiliate means, with respect to any Person, any other Person that, directly or indirectly, through one or more Affiliates, controls or is controlled by or is under common control with such Person.  For purposes of this definition, “control” means (a) ownership of fifty percent (50%) or more of the shares of stock entitled to vote for the election of directors, in the case of a corporation, or fifty percent (50%) or more of the equity interests in the case of any other type of legal entity, (b) status as a general partner in the case of any partnership, or (c) any other arrangement whereby a Person controls or has the right to control the board of directors or

 

ImmunoGen/Millennium Confidential

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

2



 

CONFIDENTIAL TREATMENT REQUESTED

 

equivalent governing body or management of another Person.  A Person shall be deemed an Affiliate only so long as it satisfies the foregoing definition.

 

1.5                                Ancillary Agreements means each License Agreement and any additional agreement that may be entered into from time to time by and between the Parties relating to the subject matter hereof, including any services agreement, supply agreement, manufacturing agreement or safety data exchange agreement.

 

1.6                                Antibody means (a) a polypeptide that Targets one (1) or more antigen(s), which polypeptide comprises: (i) one or more immunoglobulin variable domains; or (ii) fragments, variants, modifications or derivatives of such immunoglobulin variable domains irrespective of origin or source, including but not limited to antigen binding portions including Fab, Fab’, F(ab’)2, fragment of a variable domain (Fv), diabody and CDR fragments, single chain antibodies (scFv), chimeric antibodies, monospecific antibodies, bispecific antibodies, multi-specific antibodies, diabodies and other polypeptides, any of which contain at least a portion of an immunoglobulin that is sufficient to confer specific antigen binding to the polypeptide; and (iii) in each case (i) and (ii) above, humanized or fully human versions thereof or (b) any other [***] or [***] (including [***] and [***] or [***]) that [***].

 

1.7                                Applicable Laws means all federal, state, local, national and supra-national laws, statutes, rules and regulations, including any rules, regulations, guidelines or requirements of Regulatory Authorities, securities regulatory authorities, national securities exchanges or securities listing organizations that may be in effect from time to time and applicable to a particular activity hereunder.

 

1.8                                Business Day means any day other than a Saturday, Sunday or other day on which banking institutions in Boston, Massachusetts or Osaka, Japan are required to be closed or are actually closed with legal authorization.

 

1.9                                Calendar Quarter means, with respect to the first such Calendar Quarter during the Term, the period beginning on the Effective Date and ending on the last day of the calendar quarter within which the Effective Date falls, and thereafter each successive period of three (3) consecutive months during the Term ending on March 31, June 30, September 30 and

 

ImmunoGen/Millennium Confidential

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

3



 

CONFIDENTIAL TREATMENT REQUESTED

 

December 31; except that the last Calendar Quarter during the Term shall end upon the expiration of the Term in accordance with Section 8 hereof.

 

1.10                         Calendar Year means, with respect to the first such Calendar Year during the Term, the period beginning on the Effective Date and ending on December 31 of the calendar year within which the Effective Date falls, and thereafter each successive period of twelve (12) consecutive months during the Term commencing on January 1 and ending on December 31; except that the last Calendar Year during the Term shall end upon the expiration of the Term in accordance with Section 8 hereof.

 

1.11                         Change of Control means any of the following events: (a) any Third Party becomes the beneficial owner, directly or indirectly, of more than fifty percent (50%) of the Total Voting Power of all Voting Securities of ImmunoGen then outstanding, as a result of a single transaction or a series of related transactions; (b) ImmunoGen consolidates with or merges into a Third Party, or any such Third Party consolidates with or merges into ImmunoGen, in either event pursuant to a transaction in which more than fifty percent (50%) of the Total Voting Power of all Voting Securities of the surviving entity then outstanding is not held by the parties holding at least fifty percent (50%) of the Total Voting Power of all Voting Securities of ImmunoGen outstanding immediately prior to such consolidation or merger; or (c) ImmunoGen conveys, transfers or leases all or substantially all of its assets to a Third Party.

 

1.12                         Confidential Information means (a) with respect to ImmunoGen, (i) all tangible embodiments of the Licensed Technology that are disclosed by or on behalf of ImmunoGen or its Affiliates to Millennium or its Affiliates (other than Product Technology and [***] ADC Platform Improvements, in each case regardless of ownership, and Joint ADC Platform Improvements) and (ii) the identification by ImmunoGen of any Proposed Target as an Excluded Target; (b) with respect to Millennium, (i) the identification by Millennium of any Proposed Targets, the identity of Program Targets, any Holding Option Exercise Notice, any written notice by which Millennium exercises any Reserve Option and the grant by ImmunoGen of any Holding Option or Reserve Option hereunder and (ii) any Product Technology and any [***] ADC Platform Improvements, in each case regardless of ownership; and (c) with respect to each Party, any Joint ADC Platform Improvements (other than Joint [***] ADC Platform

 

ImmunoGen/Millennium Confidential

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

4



 

CONFIDENTIAL TREATMENT REQUESTED

 

Improvements) and, except as provided above, all information and Technology which is disclosed by or on behalf of such Party (in such capacity, the Disclosing Party ) or its Affiliates to the other Party (in such capacity, the Receiving Party ) or its Affiliates hereunder or to any of the Receiving Party’s or its Affiliates’ employees, consultants or subcontractors (collectively, Representatives ), except (A) with respect to clauses (a), (b)(i) and (c) above, to the extent that the Receiving Party can demonstrate by contemporaneous written record or other suitable physical evidence that such tangible embodiment or information, (1) as of the date of disclosure is known to the Receiving Party or its Affiliates other than by virtue of a prior confidential disclosure by or on behalf of the Disclosing Party or its Affiliates to the Receiving Party or its Affiliates; (2) is obtained by the Receiving Party or its Affiliates from a Third Party without breach of any duty and without restriction on disclosure to or from the Disclosing Party; or (3) is independently developed by or for the Receiving Party or its Affiliates without benefit of, reference to or reliance upon any Confidential Information of the Disclosing Party, and (B) with respect to clauses (a), (b) and (c) above, to the extent the Receiving Party can demonstrate by contemporaneous written record or other suitable physical evidence that such tangible embodiment or information as of the date of disclosure is in, or subsequently enters, the public domain through no fault or omission of the Receiving Party or its Affiliates or their respective Representatives.

 

1.13                         Confidentiality Agreement means that certain Confidential Disclosure Agreement effective February 26, 2014 by and between ImmunoGen and Millennium, as amended.

 

1.14                         Control or Controlled means, with respect to any Patent Rights, Technology or Proprietary Materials, the possession by a Party of the ability to grant a license or sublicense of such Patent Rights or Technology and the rights thereto or to supply such Proprietary Materials as contemplated in this Agreement without violating the terms of any arrangement or agreement between such Party or its Affiliates and any Third Party.

 

1.15                         Cytotoxic Compound means MAY Compounds and IGN Compounds.

 

1.16                         [***] means [***] published from time to time by the [***].

 

ImmunoGen/Millennium Confidential

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

5



 

CONFIDENTIAL TREATMENT REQUESTED

 

1.17                         Excluded Target means any Target as to which, as of the date of the applicable Holding Option Request, (a) ImmunoGen or any Affiliate of ImmunoGen is [***], (b) ImmunoGen has [***], or is [***], an [***] or [***] to a [***] under any [***] or [***] by [***] that are necessary or useful for the development, manufacture, use or sale of any compound or product that is [***] to [***], and the [***] of such [***] or [***] from [***] the [***] to [***] and [***] as contemplated by an [***], were it to be [***] (a [***]), (c) ImmunoGen has [***] with a [***] that is in effect as of [***], that [***] ImmunoGen from [***] on the terms and conditions of this Agreement, or (d) [***] has retained any [***] under the terms of the [***].  For purposes of clarity, an Excluded Target as defined in clause (b) above shall include [***], even if the scope of such [***] is [***].  A Target shall be deemed an Excluded Target [***]. For clarity, as of the Effective Date, neither of the [***] Targets (as defined in the [***] Agreement) is an Excluded Target.

 

1.18                         FDA means the United States Food and Drug Administration and any successor agency or authority thereto.

 

1.19                         FDCA means the United States Food, Drug, and Cosmetic Act, as amended (21 U.S.C. § 301  et seq. ), and the rules and regulations promulgated thereunder.

 

1.20                         Field means all uses, including pharmaceutical, therapeutic, prophylactic and diagnostic uses for humans and animals.

 

1.21                         FTE means a full time equivalent person year (consisting of a total of 1,800 hours per year) of scientific or technical work on or directly related to the provision of the ImmunoGen Activities.

 

1.22                         FTE Cost means, for any period during the Term, the FTE Rate multiplied by the number of FTEs expended over such period.

 

1.23                         FTE Rate means, for the [***]; provided that such rate shall be [***], with each [***], with the [***], to correspond with the [***] in the [***] over the [***]; provided, however, that in no event shall the FTE Rate for any [***] be [***].  For the avoidance of doubt, such rate includes (a) all salaries, wages, bonuses, benefits, management fees, profit sharing, stock option grants and FICA costs and other similar costs, meals and entertainment, training, recruiting, relocation, travel expenses, operating supplies and equipment and other disposable

 

ImmunoGen/Millennium Confidential

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

6



 

CONFIDENTIAL TREATMENT REQUESTED

 

goods to the extent required for the performance of the applicable services and (b) overhead costs associated with such FTE and the performance of its activities hereunder.  The reported actual time spent shall be substantiated by a time tracking system consistently applied.

 

1.24                         [***] shall mean [***], or such [***] as may be agreed by the Parties in writing from time to time.

 

1.25                         GLP means all good laboratory practices under Title 21 of the United States Code of Federal Regulations, as amended from time to time.

 

1.26                         Holding Option Grant Date means, with respect to a Proposed Target that is not an Excluded Target, the date of disclosure to ImmunoGen of the identity of the Proposed Target specified in a [***] Response.

 

1.27                         Holding Option Target means any Proposed Target that becomes the subject of a Holding Option granted by ImmunoGen pursuant to Section 3.1(a) hereof.  A Target ceases to be a Holding Option Target once (a) it has been designated as a Reserve Option Target in accordance with Section 3.1(b) hereof, or (b) the applicable Holding Option Period has expired without the Holding Option Target having been designated as a Reserve Option Target.

 

1.28                         IGN Compound means any and all [***], whether produced from a botanical source, natural fermentation, chemical synthesis or otherwise, including, without limitation, all analogs, variants, fragments or derivatives of any of the foregoing, in each case owned or Controlled by ImmunoGen.

 

1.29                         ImmunoGen Activities means those activities associated with the conduct of the Research Program as described in the Research Plan that are undertaken by or on behalf of ImmunoGen or its Affiliates.

 

1.30                         ImmunoGen ADC Platform Improvements means any ADC Platform Improvement (other than Joint ADC Platform Improvements), including ImmunoGen [***] ADC Platform Improvements, the inventors of which (alone or with others) include one or more employees of, or others obligated to assign inventions to, ImmunoGen or any of its Affiliates or [***].

 

1.31                         ImmunoGen In-License means any agreement between ImmunoGen or any of its Affiliates, on the one hand, and a Third Party, on the other hand, pursuant to which

 

ImmunoGen/Millennium Confidential

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

7



 

CONFIDENTIAL TREATMENT REQUESTED

 

ImmunoGen or such Affiliate has obtained any rights or interest in or to any Patent Rights or Technology included within the Licensed Intellectual Property.

 

1.32                         ImmunoGen Internal Program means a bona fide internal research, development or commercialization program undertaken by ImmunoGen with respect to a Target, with respect to which, as of the date of [***] from the [***] of a [***] for such Target (the Receipt Date ), an Antibody Targeting such Target, whether or not conjugated to a cytotoxic or cytostatic agent (which may or may not be a Cytotoxic Compound) has been generated by or on behalf of ImmunoGen (an ImmunoGen Internal Product Candidate ), and ImmunoGen owns or has otherwise acquired rights to use such ImmunoGen Internal Product Candidate in the research or development of [***] or [***] for use in the Field and further provided that (a) as of the Receipt Date, ImmunoGen or an Affiliate of ImmunoGen had commenced process development activities in connection with a [***] of such ImmunoGen Internal Product Candidate or (b) as of the Receipt Date, ImmunoGen is conducting research and preclinical studies [***] or [***] in any [***] of such ImmunoGen Internal Program Candidate in a sustained manner consistent with ImmunoGen’s other internal programs at similar stages of research and development.  Notwithstanding the foregoing, if ImmunoGen or an Affiliate of ImmunoGen entered into a Third Party license pursuant to which ImmunoGen or such Affiliate has in-licensed Patent Rights from a Third Party covering the [***] or [***] of an [***], then ImmunoGen shall be deemed to be pursuing an ImmunoGen Internal Program with respect to the Target to which such Antibody is Targeted for the [***]-month period immediately following the effective date of such Third Party license, without any additional activities required on the part of ImmunoGen.

 

1.33                         ImmunoGen [***] ADC Platform Improvements means any [***] ADC Platform Improvement (other than Joint [***] ADC Platform Improvements) the inventors of which (alone or with others) include one or more employees of, or others obligated to assign inventions to, ImmunoGen or any of its Affiliates or [***].

 

1.34                         ImmunoGen Product Technology means any Product Technology (other than Joint Product Technology) the inventors of which (alone or with others) include one or more

 

ImmunoGen/Millennium Confidential

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

8



 

CONFIDENTIAL TREATMENT REQUESTED

 

employees of, or others obligated to assign inventions to, ImmunoGen or any of its Affiliates or [***].

 

1.35                         ImmunoGen Proprietary Antibody Rights means all Technology (and associated Patent Rights) owned or Controlled by ImmunoGen during the Term solely to the extent they constitute or claim the [***] or [***] of an Antibody (in [***] or [***]) that was generated or in-licensed by ImmunoGen other than under this Agreement or any Ancillary Agreement, whether or not patentable (an ImmunoGen Proprietary Antibody ), but only to the extent such Technology (and associated Patent Rights) [***] the ImmunoGen Proprietary Antibody and [***] such Technology (and associated Patent Rights) covers [***] (in [***] or [***]).  For purposes of clarity, “ImmunoGen Proprietary Antibody Rights” does not include any [***] that relates to [***] or any [***] made under or in connection with [***] or any Patent Rights claiming such [***] or [***].

 

1.36                         IND means (a) an Investigational New Drug Application (as defined in the FDCA and regulations promulgated thereunder) or any successor application or procedure required to initiate clinical testing of an ADC in humans in the United States; (b) a counterpart to an Investigational New Drug Application that is required in any other country or region in the Territory before beginning clinical testing of an ADC in humans in such country or region; and (c) all supplements and amendments to any of the foregoing.

 

1.37                         Independent Patent Counsel means an outside patent counsel reasonably acceptable to both Parties who (and whose firm) is not at the time of the dispute, and was not at any time during the [***]-year period preceding the dispute, performing legal services of any nature for either of the Parties or their respective Affiliates and which did not, at any time, employ either of the Parties’ chief patent counsels (or equivalent thereof).  Any outside counsel agreed to by the Parties to be an Independent Patent Counsel shall be deemed independent regardless of whether it satisfies this definition. Each Party shall be entitled to rely on such Independent Patent Counsel’s representation as to whether it satisfies the above requirements, and neither Party shall be in breach of this Agreement if, notwithstanding such representation, an Independent Patent Counsel selected by the Parties does not satisfy the above requirements.

 

ImmunoGen/Millennium Confidential

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

9



 

CONFIDENTIAL TREATMENT REQUESTED

 

1.38                         Joint ADC Platform Improvements means ADC Platform Improvements, including Joint [***]ADC Platform Improvements, the inventors of which include both (a) one or more employees of, or others obligated to assign inventions to, ImmunoGen or any Affiliate of ImmunoGen, and (b) one or more employees of, or others obligated to assign inventions to, Millennium or any Affiliate of Millennium.

 

1.39                         Joint [***] ADC Platform Improvements means [***] ADC Platform Improvements the inventors of which include both (a) one or more employees of, or others obligated to assign inventions to, ImmunoGen or any Affiliate of ImmunoGen, and (b) one or more employees of, or others obligated to assign inventions to, Millennium or any Affiliate of Millennium.

 

1.40                         Joint Product Technology means any Product Technology the inventors of which include both (a) one or more employees of, or other persons obligated to assign inventions to, ImmunoGen or any Affiliate of ImmunoGen, and (b) one or more employees of, or other persons obligated to assign inventions to, Millennium or any Affiliate of Millennium.

 

1.41                         License Agreement means a written license agreement executed by the Parties pursuant to Section 3.2(a) hereof in the form set forth in Schedule A attached hereto.

 

1.42                         Licensed Intellectual Property means, collectively, the Licensed Patent Rights and the Licensed Technology.

 

1.43                         Licensed Patent Rights means any Patent Rights that are owned or Controlled by ImmunoGen or any of its Affiliates as of the Effective Date or become owned or Controlled by ImmunoGen or any of its Affiliates during the Term (including ImmunoGen’s interest in any Patent Rights claiming Joint Product Technology and Joint ADC Platform Improvements) that are necessary or useful for Millennium to conduct the Millennium Activities; provided, however, that Licensed Patent Rights shall expressly exclude any [***] solely to the extent that [***].

 

1.44                         Licensed Product has the meaning ascribed to such term in the License Agreement were such agreement to be effective with respect to any particular Licensed Target.

 

1.45                         [***] ADC Platform Improvements means any ADC Platform Improvements that are incorporated into any [***] (or any constituent or precursor thereof) or otherwise used in connection therewith, or are used in any method of making, releasing or characterizing any such

 

ImmunoGen/Millennium Confidential

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

10



 

CONFIDENTIAL TREATMENT REQUESTED

 

[***] (or any [***] or [***] thereof), in connection with the Research Program, unless [***] can [***] to [***] at or prior to the time the [***] that such ADC Platform Improvement would have [***] to [***].  Anything contained in this Agreement to the contrary notwithstanding, [***] ADC Platform Improvement included within the Licensed Intellectual Property shall be deemed to be an [***], but not a [***] ADC Platform Improvement, if it is incorporated into an [***] that does not, by the end of [***], become a [***], and such ADC Platform Improvement would not otherwise qualify as a [***] ADC Platform Improvement under any of the [***].

 

1.46                         Licensed Target means a Target that has become the subject of an Exclusive License.

 

1.47                         Licensed Technology means any and all Technology that is owned or Controlled by ImmunoGen or any of its Affiliates as of the Effective Date or becomes owned or Controlled by ImmunoGen or any of its Affiliates during the Term (including ImmunoGen’s interest in any Joint Product Technology and Joint ADC Platform Improvements) that is necessary or useful for Millennium to conduct the Millennium Activities; provided, however, that Licensed Technology shall expressly exclude any ImmunoGen Proprietary Antibody Rights.

 

1.48                         Linker means any compound or composition owned or Controlled by ImmunoGen or any of its Affiliates that is useful for linking a cytotoxic or cytostatic moiety, including, without limitation, a Cytotoxic Compound, and a cell-binding moiety, including, without limitation, an Antibody, together to form a conjugate of the cytotoxic or cytostatic moiety with the cell-binding moiety.

 

1.49                         Major Countries means any of [***] and [***].

 

1.50                         MAY Compound means any and all maytansinoid compounds (including, without limitation, maytansinol, ansamitocins, DM1 and DM4), whether produced by a botanical source, natural fermentation, chemical synthesis or otherwise, and shall include, without limitation, all variants, fragments or derivatives of any of the foregoing, in each case owned or Controlled by ImmunoGen or any of its Affiliates.

 

1.51                         Millennium Activities means those activities associated with the conduct of the Research Program as described in the Research Plan that are undertaken by Millennium or its Affiliates or by Permitted Third Party Service Providers.

 

ImmunoGen/Millennium Confidential

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

11



 

CONFIDENTIAL TREATMENT REQUESTED

 

1.52                         Millennium ADC Platform Improvement means any ADC Platform Improvement (other than Joint ADC Platform Improvements), including Millennium [***] ADC Platform Improvements, the inventors of which (alone or with others) include one or more employees of, or others obligated to assign inventions to, Millennium or any of its Affiliates, or, to the extent Millennium has obtained rights therefrom pursuant to Section 2.2 hereof, any Permitted Third Party Service Providers.

 

1.53                         Millennium Antibody means any Antibody owned or controlled by Millennium or its Affiliates.

 

1.54                         Millennium [***] ADC Platform Improvements means any [***] ADC Platform Improvement other than ImmunoGen [***]ADC Platform Improvements and Joint [***] ADC Platform Improvements.

 

1.55                         Millennium Product Technology means any Product Technology other than ImmunoGen Product Technology and Joint Product Technology.

 

1.56                         [***] means any [***] or [***], other than an [***] or a [***], that may be [***] to an [***] to [***] an [***] and that is (a) owned by [***] and first conceived and reduced to practice by [***] prior the [***] or [***] of [***] or (b) acquired or in-licensed from [***] by [***] and [***] by [***] prior to the [***] or [***] of [***].

 

1.57                         Patent Rights means the rights and interests in and to any and all issued patents and pending patent applications (including inventor’s certificates, applications for inventor’s certificates, statutory invention registrations, applications for statutory invention registrations, utility models and any foreign counterparts thereof) in any country or jurisdiction in the Territory, including any and all provisionals, non-provisionals, substitutions, continuations, continuations-in-part, divisionals and other continuing applications, extensions or restorations by existing or future extension or restoration mechanisms, including patent term extension, supplementary protection certificates or the equivalent, renewals, and all letters patent on any of the foregoing, and any and all reissues, reexaminations, extensions, confirmations, registrations and patents of addition on any of the foregoing.

 

1.58                         Person means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust,

 

ImmunoGen/Millennium Confidential

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

joint stock company, trust, incorporated association, joint venture or similar entity or organization, including a government or political subdivision, department or agency of a government.

 

1.59                         Product Technology means any Technology (other than ADC Platform Improvements) conceived or first reduced to practice or otherwise made or generated in connection with the Research Program.

 

1.60                         Program Targets means, collectively, Holding Option Targets, Reserve Option Targets and Licensed Targets.

 

1.61                         Proposed Target has the meaning in Section 3.1(a) hereof.

 

1.62                         Proprietary Materials means any tangible chemical, biological or other research materials that are furnished by or on behalf of one Party to the other Party in connection with this Agreement, regardless of whether such materials are specifically designated as proprietary by the transferring Party.  Any mutant, derivative, progeny or improvement made to or from a Party’s Proprietary Materials shall be considered to be that Party’s Proprietary Materials.  Without limiting the generality of the foregoing, any [***] furnished by ImmunoGen to Millennium or any of its Affiliates (or any Permitted Third Party Service Providers on behalf of Millennium), including, without limitation, any samples, cultures or cell banks derived directly or indirectly from any mutant, derivative, progeny or improvement thereof (collectively, the [***]), shall be deemed to be ImmunoGen’s Proprietary Materials and included within the Licensed Technology.  Without prejudice to any of ImmunoGen’s intellectual property rights in and to MAY Compounds, any tangible MAY Compounds manufactured by or for Millennium or any of its Affiliates or Permitted Third Party Service Providers using the [***] as a precursor in connection with the Research Program shall not be deemed to be ImmunoGen’s Proprietary Materials for purposes of this Agreement.

 

1.63                         Regulatory Authority means the FDA or any counterpart to the FDA outside the United States, or other national, supra-national, regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity with authority over the distribution, importation, exportation, manufacture, production, use, storage, transport, clinical testing or sale of an ADC.

 

ImmunoGen/Millennium Confidential

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

1.64                         Research Plan means the written plan describing the research activities to be carried out by each Party during each Calendar Year during the Term in conducting the Research Program pursuant to this Agreement, as such written plan may be amended, modified or updated.  Such Research Plan, and any modification, amendment or update thereto, shall set forth, inter alia, (a) the specific objectives, projected achievement milestones, resource allocation requirements and activities to be performed over such period; (b) the Party responsible for such activities; (c) a timeline for such activities; and (d) the estimated FTE Cost for the ImmunoGen Activities to be performed over such period.

 

1.65                         Research Program means, subject to the limitations set forth in Sections 2.1 and 2.2 hereof, any and all research and preclinical studies in vitro and in vivo in any non-human species of any ADC Targeting Holding Option Targets or Reserve Option Targets and the manufacture of ADC solely for use in such research and preclinical studies.  The purpose of the Research Program will be to identify, develop and evaluate ADCs for possible development and commercialization under an Exclusive License.  Notwithstanding the foregoing, the Research Program shall not include GLP toxicology studies, which require an Exclusive License as to the particular ADC.

 

1.66                         Reserve Option means an exclusive option granted by ImmunoGen to obtain an Exclusive License in the Territory under the Licensed Intellectual Property as defined in the License Agreement with respect to the applicable Reserve Option Target in accordance with Section 3.2 hereof.

 

1.67                         Reserve Option Target means a Target that becomes the subject of a Reserve Option in accordance with Section 3.1(b) hereof.  A Target ceases to be a Reserve Option Target once (a) it has become the subject of an Exclusive License in accordance with Section 3.2(a) hereof, or (b) the applicable Reserve Option has been terminated in accordance with Section 3.2(c) hereof.

 

1.68                         Restricted Period means the period commencing on the Effective Date and ending on the [***] anniversary of the Effective Date.

 

1.69                         Sanofi Collaboration Agreement means that certain Collaboration and License Agreement dated as of July 30, 2003 by and between ImmunoGen and sanofi-aventis

 

ImmunoGen/Millennium Confidential

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

U.S. LLC ( Sanofi ), as successor-in-interest to Aventis Pharmaceuticals, Inc., as the same may have been amended prior to the Effective Date.

 

1.70                         “[***] Agreement means that certain [***] Agreement dated as of July 18, 2014 by and between ImmunoGen and Millennium, as the same may be amended from time to time.

 

1.71                         Target means, when used as a noun, an antigen described by [***].

 

1.72                         Target ,” “ Targeting or Targeted means, when used as a verb to describe the relationship between a molecule and a Target, that the molecule’s primary intended mechanism of action functions such that it specifically binds to the Target (or a portion thereof).

 

1.73                         Technical Transfer Materials means ImmunoGen information (including, without limitation, technical transfer reports) and materials as provided by ImmunoGen to its licensees of Technology and Patent Rights for the purpose of [***],[***] and [***] with respect to ADCs, Cytotoxic Compounds and Linkers, as applicable, including: (a) [***] and general properties; (b) an example of an ADC [***], including [***] and [***]; (c) an [***] for [***] and [***] and [***] of [***]; (d) information [***] and [***] (e) an [***] of [***]; (f) technical reports based on [***] for ADCs against Program Targets developed by ImmunoGen in connection with the ImmunoGen Activities; (g) a list of [***] and [***] and [***] for [***] ADCs; and (h) any and all relevant [***] and [***] and [***], including, without limitation, [***] and [***] and [***] relating to the ADCs generated pursuant to the [***].

 

1.74                         Technology means, collectively, all inventions, discoveries, improvements, trade secrets and proprietary methods or materials, whether or not patentable, including, without limitation, macromolecular sequences, data, formulations, processes, techniques, know-how and results (including negative results).

 

1.75                         Territory means all countries and jurisdictions of the world.

 

1.76                         Third Party means any Person other than ImmunoGen, Millennium and their respective Affiliates.

 

ImmunoGen/Millennium Confidential

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

1.77                         Third Party Expert Services Agreement means that certain Services Agreement effective as of May 28, 2014 by and among ImmunoGen, Millennium and [***], as the same may be amended from time to time.

 

1.78                         Total Voting Power means at any time the total combined voting power in the general election of directors of ImmunoGen of all the Voting Securities then outstanding.

 

1.79                         Voting Securities means, at any time, shares of any class of capital stock of ImmunoGen which are then entitled to vote generally in the election of directors of ImmunoGen.

 

Additional Definitions .   In addition, each of the following definitions shall have the respective meanings set forth in the section of the Agreement indicated below:

 

Definition

 

Section

Agreement

 

Recitals

Alliance Managers

 

4.1(a)

[***]

 

[***]

Covered Results

 

6.3

Disclosing Party

 

1.12

Disclosure Letter

 

9.1

Dispute

 

11.12

Effective Date

 

Recitals

Exclusive License

 

3.2(a)

Exclusive License Effective Date

 

3.2(a)

Expired Holding Option

 

3.1(d)

[***] Response

 

3.1(a)

Holding Option

 

3.1(a)

Holding Option Exercise Notice

 

3.1(b)

Holding Option Period

 

3.1(b)

Holding Option Request

 

3.1(a)

Holding Option Response

 

3.1(a)

ImmunoGen

 

Recitals

 

ImmunoGen/Millennium Confidential

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

ImmunoGen Indemnitees

 

10.1(a)

ImmunoGen Internal Product Candidate

 

1.31

[***]

 

[***]

ImmunoGen Proprietary Antibody

 

1.34

[***]

 

[***]

Improvement

 

1.2

Indemnified Party

 

10.2

Indemnifying Party

 

10.2

Initial Term

 

8.1(a)

JRC

 

4.2(a)

Knowledge

 

9.1

Losses

 

10.1(a)

Material Breach

 

8.2(b)

Millennium

 

Recitals

Millennium Indemnitees

 

10.1(b)

Millennium [***] Patents

 

7.7

Panel

 

11.12(b)(ii)

Party/Parties

 

Recitals

Patent Committee

 

7.1(d)

Patent-Related Filings

 

7.2(c)

Permitted Third Party Service Providers

 

2.2

Proposed Sublicensee

 

2.3

Receipt Date

 

1.31

Receiving Party

 

1.12

Representatives

 

1.12

Research Extension Term

 

8.1(c)

Research Program Expansion Fee

 

5.3(a)

Research Program Expansion Term

 

8.1(b)

 

ImmunoGen/Millennium Confidential

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

Research Term Extension Fee

 

5.3(b)

Reserve Option Grant Date

 

3.1(b)

Reserve Option Period

 

3.2(a)

Restricted Data

 

7.2(g)

Restricted Party

 

11.15

Rolling Forecast

 

4.3(b)

Sanofi

 

1.68

[***]

 

[***]

Term

 

8.1(d)

Terminated Reserve Option

 

3.2(c)

Third Party Claims

 

10.1(a)

[***]

 

[***]

[***]

 

[***]

Upfront Fee

 

5.1

 

2.                                       GRANT OF RIGHTS

 

2.1                                Research License .   Subject to the terms and conditions of this Agreement, during the Term, ImmunoGen and its Affiliates hereby grant to Millennium and its Affiliates a fully paid-up, non-transferable (except as expressly permitted in this Agreement), royalty-free, worldwide, exclusive (but only as to Program Targets so long as they remain Program Targets) license, without the right to grant sublicenses (except to Permitted Third Party Service Providers), under the Licensed Intellectual Property for the sole purpose of conducting the Millennium Activities.  Anything contained in this Agreement to the contrary notwithstanding, Millennium shall not, directly or through a Permitted Third Party Service Provider, [***] relating to or for use in connection with [***] of an [***] for which Millennium [***] in accordance with [***].

 

2.2                                Permitted Third Party Service Providers .   Millennium and its Affiliates shall have the right, without ImmunoGen’s permission or consent but subject to the conditions set forth herein, to engage one or more Third Parties ( Permitted Third Party Service Providers )

 

ImmunoGen/Millennium Confidential

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

as subcontractors to perform designated functions in connection with the Millennium Activities (including transferring or disclosing Licensed Technology and ImmunoGen’s Proprietary Materials as may be necessary or useful for such Permitted Third Party Service Provider to perform such designated functions); provided that (a) Millennium shall [***] and (b) Millennium shall [***] cause each such Permitted Third Party Service Provider [***].  The obligations of Millennium and its Affiliates set forth in clause (b) above shall not apply to [***] conceived or first reduced to practice by a Permitted Third Party Service Provider that incorporate or constitute enhancements, improvements or modifications to [***].

 

2.3                                Millennium ADC Platform Improvement License to ImmunoGen .   Millennium, on behalf of itself and its Affiliates, hereby grants to ImmunoGen a non-exclusive, fully paid, irrevocable, royalty-free, worldwide license, [***], under Millennium’s rights in and to any Patent Rights solely to the extent that they claim any Millennium ADC Platform Improvements (other than Millennium [***] ADC Platform Improvements): (a) to manufacture ADCs and Cytotoxic Compounds solely in connection with the conduct of the ImmunoGen Activities; (b) to research, develop, make, have made, use, sell, offer for sale, import or otherwise commercialize any [***] (excluding any [***] that Targets (i) either a Holding Option Target or a Reserve Option Target while the applicable Holding Option or Reserve Option is outstanding or (ii) a Licensed Target (A) while the exclusive license granted under the applicable License Agreement remains in effect [***] and (B) [***]; and (c) to otherwise exploit such Patent Rights for any and all uses [***].  ImmunoGen’s ability to grant sublicenses under the preceding sentence shall be effective in any given case only if ImmunoGen’s sublicensee (a Proposed Sublicensee ) [***], provided, however, that for purposes of this sentence the term [***] shall mean [***].

 

2.4                                [***] .   If ImmunoGen determines, in its sole discretion, to [***], then ImmunoGen shall [***].

 

2.5                                License to Millennium [***] Patents .   In consideration of the assignment of the Millennium [***] Patents by Millennium and its Affiliates to ImmunoGen pursuant to Section 7.7 hereof, ImmunoGen and its Affiliates hereby grant to Millennium and its Affiliates a perpetual, irrevocable, freely transferable, fully paid-up, royalty-free, worldwide, non-exclusive

 

ImmunoGen/Millennium Confidential

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

license, with the right to grant sublicenses through multiple tiers of sublicensees, under the Millennium [***] Patents for any and all purposes.

 

2.6                                No Implied Licenses .   Except as expressly set forth herein, neither Party grants to the other Party or its Affiliates any rights or licenses to any intellectual or other proprietary property owned or Controlled by that Party or its Affiliates.

 

3.                                       HOLDING OPTIONS; RESERVE OPTIONS; EXCLUSIVE LICENSES

 

3.1                                Holding Options .

 

(a)                                   Holding Option Request and Grant .  As of the Effective Date, without any further action by either Party or [***], Millennium shall be deemed to have submitted [***] Holding Option Requests identifying the [***] Targets (as defined in the [***] Agreement) as Proposed Targets, such [***] Targets shall not be deemed to be Excluded Targets and shall be designated as Holding Option Targets subject to Holding Options, and the Holding Option Grant Date with respect to such Holding Option shall be the Effective Date.  Subject to the limitations set forth in Section 3.1(d) hereof, Millennium may from time to time during the Term provide confidential written notice to [***] proposing a Target (the “ Proposed Target ”) to be designated as a Holding Option Target, which Target shall be identified by its common designation(s) and unique UniProtKB/Swiss Prot accession number.  Concurrent with such notice, Millennium shall provide written notice to ImmunoGen that it has proposed a Target to be designated as a Holding Option Target, without identifying the Proposed Target to ImmunoGen.  Within [***] Business Days following any such notice by Millennium to ImmunoGen, ImmunoGen shall provide [***].  Following [***] from ImmunoGen, [***] in writing (the “[***] Response ”) whether the Proposed Target is an Excluded Target.  If the Proposed Target is an Excluded Target, [***] shall not [***] in the [***] Response or otherwise disclose to [***], and Millennium shall not have exhausted any of its rights to designate Holding Option Targets hereunder.  If the Proposed Target is not an Excluded Target, [***] shall [***] in the [***] Response to [***] (the “ Holding Option Request ”).  Within [***] Business Days of ImmunoGen’s receipt of the [***] Response, ImmunoGen shall deliver to Millennium a written response (the “ Holding Option Response ”) indicating whether or not the Proposed Target [***]

 

ImmunoGen/Millennium Confidential

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

an Excluded Target [***].  If the Proposed Target [***] an Excluded Target [***], the Proposed Target shall not become a Holding Option Target and Millennium shall not have exhausted any of its rights to designate Holding Option Targets hereunder.  If ImmunoGen timely provides a Holding Option Response to Millennium indicating that the Proposed Target specified in the Holding Option Request is not an Excluded Target or if ImmunoGen fails to timely provide a Holding Option Response as required by this Section 3.1(a), then, subject to Section 3.4(a) hereof: (i) ImmunoGen shall and does hereby automatically grant to Millennium an exclusive option (each such option a “ Holding Option ”) to obtain a Reserve Option, with respect to the Holding Option Target specified in the Holding Option Request; (ii) the Proposed Target shall be deemed to be a Holding Option Target for purposes of this Agreement; and (iii) for the duration of the Holding Option Period, ImmunoGen shall not [***].  Notwithstanding anything to the contrary contained herein, the Parties may mutually agree in writing to [***] set forth in this Section 3.1(a) with an [***].  If any Excluded Target with respect to which Millennium has delivered a Holding Option Request ceases to be an Excluded Target during the Term, then ImmunoGen will promptly notify Millennium thereof and subject to notice, availability and the limitations pursuant to this Section 3.1, Millennium shall have the right to submit a Holding Option Request with respect to such Target.  [***]

 

(b)                                  Exercise of Holding Options; Grant of Reserve Options .  Subject to the limitations set forth in Section 3.2(b) hereof, Millennium shall have the right to exercise a Holding Option at any time during the period commencing on the Holding Option Grant Date and continuing for a period of [***] months thereafter (the Holding Option Period ); provided, however that no Holding Option Period shall extend beyond the expiration of the Term.  Millennium shall exercise a Holding Option by delivering a confidential written notice of exercise thereof (the Holding Option Exercise Notice ), which notice shall specify the Holding Option Target.  Upon ImmunoGen’s receipt of a Holding Option Exercise Notice (the Reserve Option Grant Date ), (i) a Reserve Option shall be deemed to have been automatically granted, (ii) the applicable Holding Option Target shall be deemed to be a Reserve Option Target for purposes of this Agreement and (iii) for the duration of the Reserve Option Period, ImmunoGen shall not [***].

 

ImmunoGen/Millennium Confidential

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

(c)                                   Number of Holding Options .  Millennium may take up to a total of [***] Holding Options during the Term (inclusive of the [***] Holding Options with respect to the Standstill Targets); provided, however, upon timely exercise of Millennium’s option to expand the Research Program in accordance with Section 3.6 hereof, Millennium shall be entitled to take up to [***] additional Holding Options (for an aggregate total of no more than [***] Holding Options) during the Term.  If a Holding Option expires without being exercised for any reason, such Expired Holding Option shall nevertheless continue to count against the aggregate number of Holding Options available to Millennium under this Section 3.1.

 

(d)                                                          Expiration of Holding Options .  If Millennium fails to exercise any Holding Option prior to the expiration of the applicable Holding Option Period (each, an Expired Holding Option ), then ImmunoGen shall have the right to [***] with respect to a [***]; provided, however, that Millennium may submit another Holding Option Request with respect to the Target covered by such Expired Holding Option subject to notice, availability and the limitations pursuant to this Section 3.1 hereof; provided, however, if Millennium submits such Holding Option Request with respect to a Holding Option Target prior to the expiration of the applicable Holding Option Period, then such Holding Option Target shall not become an Expired Holding Option and a new Holding Option Period will start for such Holding Option Target commencing at the end of the prior Holding Option Period.

 

3.2                                Reserve Options; Grant of Exclusive Licenses .

 

(a)                                  Exercise of Reserve Options .  Subject to the limitations set forth in Section  3.3 hereof, Millennium shall have the right to exercise a Reserve Option at any time during the period commencing on the Reserve Option Grant Date and continuing until [***], subject to earlier termination in accordance with Section 3.2(c) hereof (the Reserve Option Period ).  Millennium shall exercise a Reserve Option by delivering confidential written notice of exercise thereof to ImmunoGen, which notice shall specify the Reserve Option Target.  Upon delivery of the written notice of exercise of a Reserve Option as provided in this Section 3.2(a), and subject to Section 3.4(b) hereof, (i) the Licensed Intellectual Property [***] shall be automatically exclusively (even as to ImmunoGen) licensed to Millennium with respect to such single Reserve Option Target specified in such notice to Millennium on the terms and subject to

 

ImmunoGen/Millennium Confidential

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

22



 

CONFIDENTIAL TREATMENT REQUESTED

 

the conditions set forth in the relevant License Agreement were such agreement to be effective with respect to such Reserve Option Target (each an Exclusive License ), and (ii) such Exclusive License shall be effective as of the date of ImmunoGen’s receipt of Millennium’s notice of exercise of the Reserve Option with respect to the Reserve Option Target that is the subject of the Exclusive License (the Exclusive License Effective Date ).  ImmunoGen shall deliver to Millennium, within [***] Business Days following the applicable Exclusive License Effective Date, a License Agreement executed on behalf of ImmunoGen in which ImmunoGen has (A) inserted the name and unique UniProtKB/Swiss Prot accession number of the applicable Licensed Target in Schedule A of the License Agreement; and (B) inserted the Exclusive License Effective Date into the License Agreement as the effective date of the Exclusive License. ImmunoGen shall not make any changes to the form of license agreement attached hereto as Schedule A except as provided in the preceding sentence or as otherwise agreed in writing by the Parties.  For the avoidance of doubt, in the event of any failure by ImmunoGen to deliver a copy of the License Agreement as described above, ImmunoGen shall be deemed to have granted to Millennium the rights with respect to the Exclusive License consistent with the License Agreement as of the Exclusive License Effective Date without any further action by ImmunoGen.  The Parties shall each use its best efforts to cause each License Agreement to be executed by such Party as promptly as practicable following the applicable Exclusive License Effective Date.

 

(b)                                  Number of Reserve Options Millennium shall have the right to [***] outstanding, unexercised Reserve Options [***] during the Term; provided, however, upon timely exercise of Millennium’s option to expand the Research Program in accordance with Section 3.6 hereof, Millennium shall be entitled to [***] additional outstanding, unexercised Reserve Option for a total of [***] during the Term; provided, further, that the aggregate number of unexercised Reserve Options that Millennium shall have the right to maintain at any given time shall [***] so that the [***].

 

(c)                                   Termination of Reserve Options .  Millennium may terminate any outstanding Reserve Option with respect to a particular Reserve Option Target at any time during the Reserve Option Period, effective immediately upon Millennium’s providing written notice of

 

ImmunoGen/Millennium Confidential

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

23



 

CONFIDENTIAL TREATMENT REQUESTED

 

termination to ImmunoGen, which notice shall identify the Reserve Option Target to be terminated (each, a Terminated Reserve Option ), and thereafter Millennium shall have the right to exercise a Holding Option with respect to another Holding Option Target in lieu of such Terminated Reserve Option pursuant to Section 3.1(b) hereof.  Upon termination of a Reserve Option with respect to a particular Reserve Option Target as provided in this Section 3.2(c), the Parties shall have the same rights set forth in Section 3.1(d) hereof with respect to the Target subject to such Terminated Reserve Option as if the Terminated Reserve Option were an Expired Holding Option.

 

3.3                                Number of Exclusive Licenses .   Anything contained in this Agreement to the contrary notwithstanding, Millennium may take Exclusive Licenses to up to a total of [***] Reserve Option Targets during the Term; provided, however, that upon timely exercise of Millennium’s option to expand the Research Term in accordance with Section 3.6 hereof, Millennium shall be entitled to take an Exclusive License to [***] additional Reserve Option Target (for an aggregate total of no more than [***] Reserve Option Targets) during the Term.  Subject to Section 3.4 hereof, if an Exclusive License is terminated at any time for any reason, such terminated Exclusive License shall nevertheless continue to be counted against the aggregate number of Exclusive Licenses available to Millennium under this Section 3.3.

 

3.4                                Rescission of [***] Exercise of Reserve Option .

 

(a)                                   [***]

 

(b)                                  Rescission of Exercise of Reserve Option .  Anything contained in this Agreement to the contrary notwithstanding, if, in connection with Millennium’s exercise of any Reserve Option, ImmunoGen delivers a Disclosure Letter in connection with the execution and delivery of the applicable License Agreement within [***] Business Days after ImmunoGen’s receipt of the applicable Reserve Option exercise notice, then Millennium shall be entitled to rescind the exercise of such Reserve Option by delivering written notice of such rescission to ImmunoGen within [***] Business Days after Millennium’s receipt of the Disclosure Letter.  Any failure by ImmunoGen to deliver a Disclosure Letter to Millennium within the applicable [***]-Business Day period described above shall be deemed a waiver of ImmunoGen’s right to qualify its representations and warranties in the applicable License Agreement by any

 

ImmunoGen/Millennium Confidential

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

24



 

CONFIDENTIAL TREATMENT REQUESTED

 

information that ImmunoGen may have intended to include in such Disclosure Letter.  If ImmunoGen delivers a Disclosure Letter on a timely basis, then any failure by Millennium to deliver a rescission notice to ImmunoGen within the applicable [***]-Business Day period described above shall be deemed a waiver of Millennium’s right to rescind the exercise of such Reserve Option pursuant to this Section 3.4(b), and ImmunoGen’s representations and warranties in the applicable License Agreement shall be qualified by any information contained in such Disclosure Letter.  If a Reserve Option is rescinded pursuant to this Section 3.4(b), (i) the Exclusive License relating to such Reserve Option shall not be counted against the aggregate number of Exclusive Licenses available to Millennium under Section 3.3 hereof, (ii) the Reserve Option shall remain outstanding in accordance with its original terms and (iii) Millennium shall have the right to exercise any other Reserve Option for another Target as provided herein; provided, however, that anything in this Agreement to the contrary notwithstanding, if the Reserve Option Period would have expired at any time within the period beginning on the date that Millennium exercises the Reserve Option and ending on the [***] Business Day after Millennium’s delivery of the rescission notice to ImmunoGen, Millennium shall have the right to (A) exercise a Reserve Option for a different Reserve Option Target (excluding any Reserve Option Target that was the subject of a previous rescission) within [***] Business Days (or such longer period as may be mutually agreed to in writing by the Parties) after Millennium’s delivery of the rescission notice to ImmunoGen, and (B) to exercise any Holding Option pursuant to Section 3.1(b) hereof or terminate any Reserve Option and substitute another Holding Option Target pursuant to Section 3.2(c) hereof during such period.

 

3.5                                Excluded Target Verification .   Subject to the other terms of this Section 3.5, at the request of Millennium (which request may not be given more than [***] Business Days after a Proposed Target has been identified by [***] ImmunoGen in a Holding Option Response), at any time during normal business hours within [***] Business Days of ImmunoGen’s delivery to Millennium of written acknowledgement of ImmunoGen’s receipt of such request, ImmunoGen shall permit an independent law firm [***] to inspect (during regular business hours) the relevant records upon which ImmunoGen based its determination that such Proposed Target was an Excluded Target at the time of ImmunoGen’s receipt of [***] or a Holding Option Request that

 

ImmunoGen/Millennium Confidential

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

is the subject of a Holding Option Response indicating that the Proposed Target is an Excluded Target.  Before permitting such law firm to have access to such records, ImmunoGen may require such law firm to enter into a confidentiality agreement (in form and substance reasonably acceptable to both Parties) as to any confidential information that is to be provided to such law firm while conducting the verification contemplated hereby.  The law firm shall be instructed to provide both Parties with a written report stating its conclusion as to whether ImmunoGen’s determination that a Proposed Target was an Excluded Target was correct within [***] days after the completion of its inspection.  Such law firm may not reveal to Millennium any other information learned in the course of such examination, including, without limitation, the basis for ImmunoGen’s determination.  Millennium agrees to treat all information disclosed to it in accordance with this Section 3.5 as ImmunoGen’s Confidential Information, except to the extent necessary for Millennium to enforce its rights under this Agreement.  If the law firm’s report concludes that ImmunoGen’s determination was correct, Millennium shall be responsible for paying all fees and expenses invoiced by the law firm.  If the law firm’s report concludes that ImmunoGen’s determination was incorrect, (a) Millennium shall automatically be deemed to have delivered another Holding Option Request for such Proposed Target as of the date of such determination and (b) ImmunoGen shall be responsible for paying all reasonable fees and expenses invoiced by the law firm.

 

3.6                                Expansion of the Research Program .   If this Agreement has not been terminated in accordance with Section 8.2 hereof (other than termination by Millennium in accordance with Section 8.2(b) hereof) on or before the [***] anniversary of the Effective Date, and Millennium has not theretofor exercised its option to extend the Research Term in accordance with Section 8.1(c) hereof, Millennium may expand the scope of the Research Program by providing written notice to ImmunoGen and paying the Research Program Expansion Fee in accordance with Section 5.3(a) hereof at any time on or prior to the [***] anniversary of the Effective Date.  Upon timely exercise of Millennium’s option to expand the Research Program in accordance with this Section 3.6, (a) the Term shall be extended as set forth in Section 8.1(b) hereof and (b) the number of Holding Options, Reserve Options and Exclusive

 

ImmunoGen/Millennium Confidential

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

Licenses available to Millennium under this Agreement shall be increased as set forth in Sections 3.1(c), 3.2(b) and 3.3 hereof.

 

4.                                       RESEARCH PROGRAM

 

4.1                                Alliance Management .

 

(a)                                  Appointment of Alliance Managers .  Promptly after the Effective Date, the Parties shall each appoint an individual who shall oversee contact between the Parties for all matters related to this Agreement and the Parties’ respective activities hereunder (the Alliance Managers ).  The Alliance Managers may, but are not required to be, members of the JRC, but in all events the Alliance Managers shall have the right to attend all meetings of the JRC and may bring to the attention of the JRC any matters or issues either of them reasonably believes should be discussed by such committee.  Each Party shall bear its own costs and expenses, including travel and lodging, in connection with the activities of its Alliance Manager hereunder.  Each Party may replace its Alliance Manager at any time by written notice to the other Party.

 

(b)                                  Responsibilities .  The Alliance Managers shall have the responsibility of creating and maintaining a constructive work environment between the Parties for all matters related to this Agreement and the Parties’ respective activities hereunder.  Without limiting the generality of the foregoing, the Alliance Managers shall:

 

(i)                                      identify and bring to the attention of their respective managements any disputes arising between the Parties related to this Agreement or the Parties’ respective activities hereunder in a timely manner, including, without limitation, any asserted occurrence of a Material Breach by a Party, and function as the point of first referral in the resolution of each dispute;

 

(ii)                                   provide a single point of communication between the Parties with respect to this Agreement and the Parties’ respective activities hereunder;

 

(iii)                                plan and coordinate efforts and external communications by or between the Parties with respect to this Agreement and the Parties’ respective activities hereunder;

 

ImmunoGen/Millennium Confidential

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

(iv)                               take such steps as may be required to ensure that meetings of the JRC occur as set forth in this Agreement, that procedures are followed with respect to such meetings (including, without limitation, the giving of proper notice and the preparation and approval of minutes) and that relevant action items resulting from such meetings are appropriately carried out or otherwise addressed; and

 

(v)                                  undertake such other responsibilities as the Parties may mutually agree in writing.

 

4.2                                Joint Research Committee .

 

(a)                                  Mandate and Establishment of Committee .  Promptly after the Effective Date, the Parties shall form a joint research committee (the JRC ) to serve as a forum for coordination and communication between the Parties with respect to the Research Program.  Within [***] days after the Effective Date, the Parties shall each nominate for membership on the JRC an equal number of representatives (which shall be no less than two (2) or more than five (5) each), each with the requisite expertise and seniority to enable such person to make decisions on behalf of the Parties with respect to the issues falling within the jurisdiction of the JRC.  Each Party may change its representative(s) as it deems appropriate by written notice to the other Party.  From time to time the JRC may establish one or more sub-teams comprised of an equal number of representatives of both Parties to undertake specific responsibilities of the JRC, which sub-teams shall be governed in the same manner and subject to the relevant requirements set forth herein for the JRC.

 

(b)                                  Chair of Committee; Meetings .  The chair of the JRC shall be one of the Millennium representatives on the JRC, as designated by Millennium.  The JRC shall meet on a quarterly basis or other schedule agreed upon by the Parties, unless the Parties mutually agree in advance of any scheduled meeting that there is no need for such meeting.  In such instance, the next JRC meeting shall also be scheduled as agreed upon by the Parties.  Millennium may request additional ad hoc meetings at a mutually agreeable times. The location of meetings of the JRC shall alternate between ImmunoGen’s offices and Millennium’s offic