COLLABORATIVE DEVELOPMENT AND LICENSE AGREEMENT

List of Schedules

Schedule 1   Calculation of Net Income

Schedule 2   Licensed Patent Rights

Schedule 3   Material Terms to be Included in Supply Agreement

This COLLABORATIVE DEVELOPMENT AND LICENSE AGREEMENT (this “Agreement”) is entered into as of July 7, 2006 (the “Effective Date”), by and between ImmunoGen, Inc., a Massachusetts corporation with its principal place of business at 128 Sidney Street, Cambridge, Massachusetts, USA 02139 (“ImmunoGen”) and Biotest AG, a corporation organized under the laws of Germany having an address of Landsteinerstraße 5, D-63303 Dreieich, Germany (“Biotest”). Each of Biotest and ImmunoGen is sometimes referred to individually herein as a “Party” and collectively as the “Parties.”

WHEREAS, Biotest Controls certain Technology and/or Proprietary Materials related to its proprietary [***] Antibodies (as defined below); and

WHEREAS, ImmunoGen Controls certain Technology and/or Proprietary Materials related to or otherwise useful in the conjugation of maytansine derivatives to binding proteins; and

WHEREAS, ImmunoGen and Biotest desire to enter into a collaboration for the purpose of Developing and Commercializing Licensed Products derived from the conjugation of Biotest’s proprietary [***] Antibodies with ImmunoGen’s maytansine derivatives.

NOW, THEREFORE, in consideration of the mutual covenants contained herein, and for other good and valuable consideration, the Parties hereto, intending to be legally bound, 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.

1.1    “ Adverse Event ” means any untoward medical occurrence in a human clinical trial subject or in a patient who is administered a Licensed Product, whether or not having a causal relationship with such Licensed Product, including, without limitation, any unfavorable and unintended sign (including for example, any abnormal laboratory findings of clinical concern), symptom or disease temporarily associated with the use of such Licensed Product.

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

1.3    “ Annual Net Sales ” means the aggregate Net Sales during a particular Calendar Year.

1.4   “ Antibody ” means a composition comprising a whole antibody or fragment thereof (whether polyclonal or monoclonal, human, humanized, chimeric or murine, or derived from another relevant species, multiple or single chain, recombinant, transgenic animal derived or naturally occurring, and any constructs thereof) or having been derived from nucleotide sequences encoding, or amino acid sequences of, such antibody or fragment.

1.5   “ Anti-[***] Antibody ” means any Antibody (including without limitation the BT-062 Antibody) that is Controlled by Biotest and that targets the [***] Antigen.

1.6   “ Anti-[***] Antibody-MAY Conjugate ” means any conjugate of an Anti-[***] Antibody with a MAY Compound.

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, national securities exchanges or securities listing organizations that may be in effect from time to time during the Term and applicable to a particular activity hereunder.

1.8   “ Audited Party ” means the Party that is the subject of an audit by the other Party under Sections 5.1.4, 5.2.2, 6.2.1 or 6.4.3.

1.9   “ Auditing Party ” means the Party that is conducting an audit of the other Party under Sections 5.1.4, 5.2.2, 6.2.1 or 6.4.3.

1.11  “ Biotest Co-Promotion Percentage ” means fifty percent (50%) of the Annual Net Income.

1.12   “ Biotest Decision ” means the following decisions which, in the event of deadlock, will be decided by a Biotest member of the JSC: (a) with respect to each Licensed Product that is not a Co-Developed Product, the determination of the indication(s), other than as defined in the initial Development Plan, for which such Licensed Product shall be used, and (b) all decisions with respect to the Development and Commercialization of Co-Developed Products outside the Co-Development Territory.  

1.13   “ Biotest Materials ” means any Proprietary Materials Controlled by Biotest and used by Biotest, or provided by Biotest for use, in the Research Program and/or the Development of Licensed Products. For purposes of clarity, Biotest Material shall include, without limitation, the BT-062 Antibody.

1.14   “ Biotest Patent Rights ” means any Patent Rights containing one or more claims that cover Biotest Technology. For purposes of clarity, Biotest Patent Rights include Biotest’s fifty percent (50%) interest in the [***] Conjugate Patent Rights.

1.15   “ Biotest Product ” means any Licensed Product that is not a Co-Developed Product .

1.16   “ Biotest Program Technology ” means any Program Invention conceived or first reduced to practice by employees of, or consultants to, Biotest, alone or jointly with Third Parties, without the use in any respect of any ImmunoGen Technology, ImmunoGen Materials or Joint Technology.

1.17   “ Biotest Technology ” means, collectively, Biotest Background Technology and Biotest Program Technology.

1.18   “ Biotest Territory ” means all countries of the world other than the Co-Development Territory.

1.19   “ BT-062 Antibody ” means the chimeric Antibody targeting the [***] Antigen Controlled by Biotest.

1.20   “ Calendar Quarter ” means the period beginning on the Effective Date and ending on the last day of the calendar quarter in which the Effective Date falls, and thereafter each successive period of three (3) consecutive calendar months ending on March 31, June 30, September 30 or December 31.

1.21   “ Calendar Year ” means each successive period of twelve (12) months commencing on January 1 and ending on December 31.

1.22   “ [***] Antigen ” means the transmembrane [***] [***] [***] [***] antigen (aka [***]), having the Swiss-Prot primary accession number [***].

1.23   “ [***] Conjugate Patent Rights ” means the Patent Rights that relate to United States Patent Application [***] entitled [***].

1.24   “ Clinical Materials ”   shall mean any MAY Compound or Licensed Product supplied by ImmunoGen to Biotest pursuant to Section 4.5.2(b)(iii) and/or the terms of a Supply Agreement for any use, including for use in any Clinical Trials other than Pivotal Clinical Trials. For the purpose of clarity, Clinical Material shall not comprise unconjugated Antibody.

1.25   “ Clinical Trial Notification” or “CTN ” means the notification submitted to the Japanese Ministry of Health, Labor and Welfare prior to the Initiation of a Clinical Trial in Japan.

1.26   “ Co-Developed Product ” means any Licensed Product with respect to which ImmunoGen has exercised a Co-Development Option as described in Section 5.1.1. For purposes of clarity, Co-Developed Products include Early Stage Co-Developed Products and Late Stage Co-Developed Products.

1.27   “ Co-Development Costs ” means the reasonable Out-of-Pocket Costs and internal costs incurred by a Party (or for its account by an Affiliate or a Third Party) on and after the exercise by ImmunoGen of the applicable Co-Development Option that are generally consistent with the respective activities allocated to such Party in the Co-Development Plan and/or Co-Development Marketing and Sales Plan and, in any case, are specifically attributable to the Development of a Co-Developed Product in the Co-Development Territory. For purposes of this definition (a) Out-of-Pocket Costs relate to the costs attributable to specific external Development activities, and/or Commercialization related to pre-commercial marketing activities, applicable to a Co-Developed Product, including, without limitation (i) all filing fees required for, and other costs associated with, any Regulatory Filings and Drug Approval Applications and (ii) all Third Party Required Payments; (b) internal costs means all direct labor costs to the extent attributable to the Development of a Co-Developed Product in accordance with the Co-Development Plan and/or Co-Development Marketing and Sales Plan, including, without limitation, any employees of a Party that perform project management and other activities attributable to such Development, all as calculated on the basis of an annual rate equal to the Party’s specific FTE Rate; and (c) the reasonable Out-of-Pocket Costs and internal costs of manufacturing or obtaining Co-Developed Products in final dosage form for use in the activities in clause (a) shall be included in the definition of Co-Development Costs. For the avoidance of doubt, Co-Development Costs (a) shall include the costs incurred by either Party in conducting clinical trials with respect to a Co-Developed Product, other than costs incurred with respect to Shared Clinical Trials as defined in 1.128(b), which shall be allocated between the Parties in accordance with Section 5.1.4 and Pivotal MAY Compound Process Development Costs, which shall be paid by Biotest in accordance with Section 5.1.5; and (b) shall not include (i) milestone payments made by Biotest to ImmunoGen pursuant to Section 6.3.1, and (ii) any Co-Development Option Exercise Fee to be paid by ImmunoGen pursuant to Section 5.1.1.  

1.28   “ Co-Development Manufacturing Plan ” means, with respect to each Co-Developed Product, the written plan for the manufacture of such Co-Developed Product in the Co-Development Territory prepared by the JDC which shall include, without limitation, expected manufacturing scale-up, formulation and filling activities to be conducted by each Party, as well as a budget and proposed timelines for such activities, as such plan may be amended or updated.

1.29   “ Co-Development Marketing and Sales Plan ” means, with respect to each Co-Developed Product, the written plan for the Commercialization of such Co-Developed Product in the Co-Development Territory prepared by the JMC which shall include, without limitation, (a) a regulatory and Commercialization strategy with proposed timelines and sales forecasts that are, in each case, applicable to such Co-Developed Product and (b) a co-promotion plan which shall describe the Co-Promotion activities to be conducted by each Party in the Co-Development Territory, a budget and proposed timelines, as such plan may be amended or updated.

1.30   “ Co-Development Option Exercise Dates ” means, collectively, the Early Stage Option Commencement Date and the Late Stage Option Commencement Date.

1.31   “ Co-Development Plan ” means, with respect to each Co-Developed Product, the written plan describing the joint Development activities to be carried out by both Parties over each Contract Year commencing with the date of exercise of the Co-Development Option in

accordance with Section 5.1.1 for each Co-Developed Product, broken down by Calendar Quarters, and which shall contain, inter   alia , (a) the specific Development objectives, projected 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; (d) an estimate of the expected Co-Development Costs to be incurred over such period; (e) the expected Regulatory Filings to be required and prepared, and the expected timetable to budget for making such Regulatory Filings; (f) the manufacturing strategy, budget and proposed timelines for manufacturing scale-up, formulation, filling and/or shipping for each such Licensed Product, MAY Compound and Linker; and (g) a Co-Development clinical development plan. The Co-Development Plan shall be set forth in a written document jointly prepared by the Parties and approved by the JDC. Each amendment and/or update to the Co-Development Plan shall be set forth in a written document prepared by the Parties and approved by the JDC, shall specifically state that it is an amendment, modification or update to the Co-Development Plan and shall be attached to the minutes of the meeting of the JDC at which such amendment, modification or updated is approved by the JDC. Without limiting the nature or frequency of any other amendments or updates of the Co-Development Plan that may be approved by the JDC, the Co-Development Plan shall be updated   at least once prior to the end of each Contract Year to describe the Co-Development activities to be carried out by each Party during the next Contract Year pursuant to this Agreement.

1.32   “ Co-Development Territory ” means, with respect to each Co-Developed Product, the United States of America and its territories and possessions.

1.33   “ Collaboration ” means the association of ImmunoGen and Biotest established pursuant to this Agreement for the purpose of Developing and Commercializing Licensed Products in the Field in the Territory.

1.34   “ Combination Product ” means any Biotest Product that contains both a pharmaceutically active agent or ingredient that constitutes a Biotest Product and one or more   other pharmaceutically active agents or ingredients that do not constitute a Biotest Product.

1.35   “ Commercialization ” or “ Commercialize ” means any and all activities directed to the commercialization of a Licensed Product, including but not limited to, pre-launch and post-launch marketing, manufacturing for commercial sale, promoting, Detailing, distributing, offering to sell, having sold, selling, importing, having imported, exporting and having exported a Licensed Product for sale, conducting additional post-approval human clinical studies in the approved indication (but not pre-clinical studies) and interacting with Regulatory Authorities regarding the foregoing. When used as a verb, “Commercializing” means to engage in Commercialization and “Commercialized” has a corresponding meaning.

1.36   “ Commercialization Regulatory Approval ” means, with respect to any Licensed Product, (a) an NDA or (b) the equivalent of an NDA required by Applicable Laws in any country or region in the Territory outside of the United States to sell such Licensed Product for use in the Field in such country or region.

1.37   “ Commercially Reasonable Efforts ” means with respect to the Development and Commercialization of a particular Licensed Product and/or Co-Developed Product by

Biotest and/or ImmunoGen, as applicable, the efforts and resources (i) as provided by this Agreement, including, without limitation, the Research Plan, the Development Plan, the Manufacturing Plan, the Co-Development Marketing and Sales Plan and the Co-Development Manufacturing Plan, and (ii) typically used by the respective Party in the development of its other product candidates or the commercialization of its other products, which are of similar commercial potential and at a similar stage in their development or product life, as applicable, taking into account the competitiveness of the applicable marketplace, the regulatory structure involved, the profitability of the applicable products, the scientific, technical, development and regulatory requirements, obstacles and risks, and other similar factors. For the avoidance of doubt, for the purpose of determining Commercially Reasonable Efforts for a particular Licensed Product and/or Co-Developed Product, the fact that a Party is entitled to a greater share of profits with respect to a product other than a Licensed Product compared to the profit share to which it is entitled according to this Agreement with respect to such Licensed Product and/or Co-Developed Product shall not be taken into account.

1.38   “ Completion ” means, with respect to a clinical trial, the date on which all material data reasonably expected to be derived therefrom has been generated and the study report with respect thereto has been finalized and received by ImmunoGen.

1.39   “ Confidential Information ” means (a) with respect to ImmunoGen, all tangible embodiments of ImmunoGen Technology, (b) with respect to Biotest, all tangible embodiments of Biotest Technology and (c) with respect to each Party, (i) all tangible embodiments of Joint Technology and (ii) all information, Technology and Proprietary Materials disclosed or provided by or on behalf of such Party (the “disclosing Party”) pursuant to this Agreement or the Existing Agreements to the other Party (the “receiving Party”) or to any of the receiving Party’s employees, consultants, Affiliates or sublicensees; provided that none of the foregoing shall be Confidential Information if: (A) as of the date of disclosure, it is known to the receiving Party or its Affiliates, as demonstrated by credible written documentation, other than by virtue of a prior confidential disclosure to such receiving Party or its Affiliates; (B) as of the date of disclosure it is in the public domain, or it subsequently enters the public domain through no fault, in relation to the disclosing Party, of the receiving Party or its Affiliates; (C) it is obtained by the receiving Party from a Third Party having a lawful right to make such disclosure free from any obligation of confidentiality to the disclosing Party; or (D) it is independently developed by or for the receiving Party without reference to or use of any Confidential Information of the disclosing Party as demonstrated by credible written documentation. For purposes of clarity, (i) any scientific, technical or financial information of a disclosing Party disclosed at any meeting of any of the committees or teams established pursuant to the Agreement or disclosed through an audit report prepared pursuant to this Agreement shall constitute Confidential Information of the disclosing Party and (ii) the terms of this Agreement shall constitute Confidential Information of each Party.

1.40   “ Contract Quarter ” means (a) the period beginning on the Effective Date and ending on the last day of the third full calendar month after the Effective Date and (b) each succeeding three (3) month period thereafter.

1.41   “ Contract Year ” means (a) with respect to the first Contract Year, the period beginning on the Effective Date and ending on December 31, 2006 and (b) with respect to the second and each subsequent Contract Year, the Calendar Year.

1.42   “ Control ” or “ Controlled ” means (a) with respect to Technology (other than Proprietary Materials) or Patent Rights, the possession by a Party of the right to grant a license or sublicense to such Technology or Patent Rights as provided herein without the payment of additional consideration to, and without violating the terms of any agreement or arrangement with, any Third Party and (b) with respect to Proprietary Materials, the possession by a Party of the right to supply such Proprietary Materials to the other Party as provided herein without the payment of additional consideration to, and without violating the terms of any agreement or arrangement with, any Third Party.

1.43   “ Co-Promotion ” or “ Co-Promote ” means the employment by the Parties of sales representatives to jointly Detail a Co-Developed Product in the Co-Development Territory under the same Licensed Product Trademark and brand using the same Advertising, a coordinated Co-Development Marketing and Sales Plan and an integrated sales force consisting of Representatives of both Biotest and ImmunoGen.

1.44   “ Co-Promotion Percentage ” means, collectively, the Biotest Co-Promotion Percentage and the ImmunoGen Co-Promotion Percentage.

1.45   “ Dedicated Equipment ” shall mean any equipment, instrument or machinery used by ImmunoGen exclusively in the manufacturing of Preclinical Materials or Clinical Materials.

1.46   “ Derived ” means obtained, developed, created, synthesized, designed, derived or resulting from, based upon, containing, incorporating or otherwise generated from (whether directly or indirectly, or in whole or in part).

1.47   “ Designated Senior Officer ” means, with respect to a Party, the senior officer designated by such Party to have final decision-making authority over Disputed Matters which, absent unusual circumstances, shall be the President or Chief Executive Officer of such Party.

1.48   “ Detail ” means, with respect to a Co-Developed Product, an interactive, live, face-to-face contact of a Representative within the Co-Development Territory with a medical professional with prescribing authority or other individuals or entities that have a significant impact or influence on prescribing decisions, in an effort to increase physician prescribing preferences of such Co-Developed Product for its approved uses within the Co-Development Territory, which shall involve (a) a primary product presentation (i.e., a Detail in which the Co-Developed Product is given an important emphasis) or (b) a secondary product presentation (i.e., a non-primary product presentation; provided, however, the emphasis is not less than that placed upon other products presented), in each case as measured by generally accepted industry standards. When used as a verb, “Detailing” means performing Details. When used as an adjective, “Detailing” means of or related to performing Details.

1.49   “ Development ” or “ Develop ” means, with respect to each Licensed Product, all non-clinical and clinical activities required to obtain Regulatory Approval of such Licensed

Product in accordance with this Agreement on and after the Effective Date and up to the obtaining of Commercialization Regulatory Approval of such Licensed Product. For purposes of clarity, these activities include, without limitation, the determination of the indication(s) for which each Licensed Product shall be used, test method development and stability testing, regulatory toxicology and pharmacology, formulation, process development, manufacturing, manufacturing scale-up, development-stage manufacturing, statistical analysis and report writing, and clinical trial design and operations. When used as a verb, “Developing” means to engage in Development and “Developed” has a corresponding meaning.

1.50   “ Development Plan ” means the written plan describing the Development activities to be carried out over each Contract Year to be prepared jointly by the Parties and approved by the JDC in accordance with Section 4.1.1 for each Licensed Product, broken down by Calendar Quarters, and which shall contain, inter   alia , (a) the specific Development objectives, projected 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; (d) an estimate of the expected Development costs to be incurred over such period; (e) the expected Regulatory Filings and Drug Approval Applications to be required and prepared, and the expected timetable for making such Regulatory Filing and Drug Approval Applications; and (f) the manufacturing strategy, budget and proposed timelines for manufacturing scale-up, formulation, filling and/or shipping for each such Licensed Product. The initial Development Plan shall contain all activities until December 31, 2007. Each amendment and/or update to the Development Plan shall be set forth in a written document jointly prepared by the Parties and approved by the JDC, shall specifically state that it is an amendment, modification or update to the Development Plan and shall be attached to the minutes of the meeting of the JDC at which such amendment, modification or update is approved by the JDC. Without limiting the nature or frequency of any other amendments or updates of the Development Plan that may be approved by the JDC, the Development Plan shall be updated at least once prior to the end of each Contract Year to describe the Development activities to be carried out by each Party during the next Contract Year pursuant to this Agreement.

1.51   “ Drug Approval Application ” means, with respect to a Licensed Product in a particular country or region, an application for Commercialization Regulatory Approval for such Licensed Product in such country or region, including without limitation: (a) an NDA or sNDA; (b) a counterpart of an NDA or sNDA in any country or region in the Territory; and (c) all supplements and amendments to any of the foregoing.

1.52   “ Early Stage Co-Development Licensed Product ” means any Licensed Product that becomes a Co-Developed Product pursuant to the exercise by ImmunoGen of the Early Stage Co-Development Option.

1.53   “ Early Stage Co-Development Option ” means any Co-Development Option that may be exercised by ImmunoGen during the Early Stage Option Exercise Period.

1.54   “ Early Stage Option Commencement Date ” means, with respect to each Licensed Product, the date of Completion of [***] [***] [***] [***] [***] [***] with respect to that Licensed Product.

1.55   “ ECB ” means the European Central Bank.

1.56   “ EMEA ” means the European Medicines Evaluation Agency, or any successor thereto, which coordinates the scientific review of human pharmaceutical products under the centralized licensing procedures of the European Community.

1.57   “ EU ” means the European Union.

1.58   “ Existing Agreements ” means the Confidentiality Agreement by and between the Parties dated as of [***] [***] [***] and the Material Transfer and Evaluation Agreement by and between the Parties dated as of [***] [***] [***], and the First Amendment thereto, dated as of [***] [***] [***].

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

1.60   “ FDCA ” means the United States Federal Food, Drug, and Cosmetic Act, as amended.

1.61   “ Field ” means all human therapeutic, prophylactic and diagnostic uses.

1.62   “ First Commercial Sale ” means, with respect to a Licensed Product in any country in the Territory, the first sale, transfer or disposition for value, for end use or for consumption of such Licensed Product to a Third Party in such country.

1.63   “ First Interim Analysis ” means, with respect to a clinical trial, the date on which the data from such clinical trial has undergone an interim analysis and such interim analysis has been finalized by Biotest and received by ImmunoGen.

1.64   “ Force Majeure ” means any occurrence beyond the reasonable control of a Party that (a) prevents or substantially interferes with the performance by such Party of any of its obligations hereunder and (b) occurs by reason of any act of God, flood, fire, explosion, earthquake, strike, lockout, labor dispute, casualty or accident, or war, revolution, civil commotion, act of terrorism, blockage or embargo, or any injunction, law, order, proclamation, regulation, ordinance, demand or requirement of any government or of any subdivision, authority or representative of any such government.

1.65   “ FTE ” means a full time person dedicated to the Research Program and/or dedicated to the Development of Licensed Products as described in any Development Plan, or in the case of less than a full-time dedicated person, a full-time, equivalent person year pro rata temporis, based on a total of at least [***] hours or [***] [***] weeks per year of work, on or directly related to the Research Program and/or dedicated to the Development of Licensed Products as described in any Development Plan, measured, with respect to ImmunoGen, in accordance with ImmunoGen’s time allocation practices from time to time or, with respect to Biotest’s FTEs (if applicable), in accordance with Biotest's time allocation practices from time to time. For purposes of clarity, FTEs shall not include any sales representatives employed by a Party.

1.66   “ FTE Cost ” means, for any Calendar Quarter, the FTE Rate multiplied by the applicable number of FTEs used during such Calendar Quarter.

1.67   “ FTE Rate ” means, in each case pro rata temporis, with respect to any ImmunoGen Activities to be performed by ImmunoGen prior to its exercise of a Co-Development Option (a) during the first Contract Year, the portion of [***] [***] [***] [***] Dollars (US $[***]) corresponding to such part of the Calendar Year that is covered by the first Contract Year; and, (b) during each Contract Year thereafter, the result obtained by multiplying $[***] by the sum of (1+CPI) where CPI is a fraction, the numerator of which is the difference between the Consumer Price Index as of the last month of the immediately preceding Contract Year and the Consumer Price Index as of the month immediately preceding the Effective Date and the denominator of which is the Consumer Price Index as of the month immediately preceding the Effective Date. For purposes of clarity, the FTE rates applicable to ImmunoGen Activities and applicable to activities undertaken by Biotest, both conducted after the exercise by ImmunoGen of the Co-Development Option will be determined by the JFC.

1.68   “ GAAP ” means United States generally accepted accounting principles, consistently applied.

1.69   “ GCP ” means the then current Good Clinical Practice standards promulgated or endorsed by the FDA or in the case of foreign jurisdictions, comparable regulatory standards promulgated or endorsed by the applicable Regulatory Authority, including those procedures expressed or implied in the Regulatory Filings.

1.70   “ GLP ”  means the then current Good Laboratory Practice standards promulgated or endorsed by the FDA or in the case of foreign jurisdictions, comparable regulatory standards promulgated or endorsed by the applicable Regulatory Authority, e.g., the EMEA, including those procedures expressed or implied in the Regulatory Filings.

1.71   “ GMP ” means the then current Good Manufacturing Practice standards promulgated or endorsed by the FDA or in the case of foreign jurisdictions, comparable regulatory standards promulgated or endorsed by the applicable Regulatory Authority, e.g., the EMEA, including those procedures expressed or implied in the Regulatory Filings.

1.72   “ Hatch-Waxman Act ” means the Drug Price Competition and Patent Term Restoration Act of 1984, as amended.

1.73   “ ICC ” means the International Chamber of Commerce.

1.74   “ ImmunoGen Activities ” means those activities associated with the Research Program and/or associated with the Development of Licensed Products as described in the Research Plan or any Development Plan that are, in either case, to be undertaken by ImmunoGen.

1.75   “ ImmunoGen Background Technology ” means any Technology used by ImmunoGen, or provided by ImmunoGen for use, in the Research Program and/or the Development of Licensed Products   that is useful in the Field and that is (a) Controlled by ImmunoGen as of the Effective Date or (b) developed or conceived or first reduced to practice

by employees of, or consultants to, ImmunoGen after the Effective Date other than in the conduct of ImmunoGen Activities and without the use in any respect of any Biotest Technology or Biotest Materials or any Program Inventions.

1.76   “ ImmunoGen Co-Promotion Percentage ” means fifty percent (50%) of the Annual Net Income.

1.77   “ ImmunoGen Decision ” means the following decisions which, in the event of deadlock, will be decided by an ImmunoGen member of the JSC: the selection of Third Party manufacturers to manufacture Preclinical Materials and Clinical Materials following the request by Biotest pursuant to Section 4.5.2(b).

1.78   “ ImmunoGen Materials ” means any Proprietary Materials Controlled by ImmunoGen and used by ImmunoGen, or provided by ImmunoGen for use, in the Research Program and/or the Development of Licensed Products. For purposes of clarity, ImmunoGen Materials shall include all MAY Compounds and Linkers.

1.79   “ ImmunoGen Patent Rights ” means any Patent Rights that contain one or more claims that cover ImmunoGen Technology. For purposes of clarity, ImmunoGen Patent Rights include Licensed Patent Rights and ImmunoGen’s fifty percent (50%) interest in the [***] Conjugate Patent Rights.

1.80   “ ImmunoGen Program Technology ” means any Program Invention conceived or first reduced to practice by employees of, or consultants to, ImmunoGen, alone or jointly with any Third Party, without the use in any respect of any Biotest Technology, Biotest Materials or Joint Technology.

1.81   “ ImmunoGen Technology ” means, collectively, ImmunoGen Background Technology and ImmunoGen Program Technology.

1.82   “ Improvement ” means any enhancement, improvement or modification to the Licensed Technology or the Licensed Patent Rights.

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

1.84   “ Initiation ” means, with respect to a human clinical trial, the first date that a subject is dosed in such clinical trial.

1.85   “ Joint Development Committee ” or “ JDC ” means the Joint Development Committee of ImmunoGen and Biotest representatives established pursuant to Section 2.2 to oversee the conduct and progress of the Research Program and the Development of Licensed Products.

1.86   “ Joint Finance Committee ” or “ JFC ” means the Joint Finance Committee of ImmunoGen and Biotest representatives established pursuant to Section 2.4 to oversee the allocation between the Parties of Co-Development Costs and Net Income Payments with respect to Co-Developed Products.

1.87   “ Joint Marketing Committee ” or “ JMC ” means the committee of ImmunoGen and Biotest representatives established pursuant to Section 2.5 to coordinate the Commercialization activities of Co-Developed Products within the Co-Development Territory.

1.88   “ Joint Patent Rights ” means Patent Rights that contain one or more claims that cover Joint Technology. For purposes of clarity, Joint Patent Rights shall not include [***] Conjugate Patent Rights.

1.89   “ Joint Steering Committee ” or “ JSC ” means the Joint Steering Committee of ImmunoGen and Biotest representatives established pursuant to Section 2.1 to oversee the overall conduct and progress of the Development and Commercialization of Licensed Products.

1.90   “ Joint Technology ” means any Program Invention (a) conceived or first reduced to practice jointly by employees of, or consultants to, Biotest and employees of, or consultants to, ImmunoGen or (b) conceived or first reduced to practice by employees of, or consultants to, one Party with the use in any respect of any Technology, Patent Rights or Proprietary Materials of the other Party.

1.91   “ Late Stage Co-Development Licensed Product ” means any Licensed Product that becomes a Co-Developed Product pursuant to the exercise by ImmunoGen of the Late Stage Co-Development Option.

1.92   “ Late Stage Co - Development Option ” means any Co-Development Option that may be exercised by ImmunoGen during the Late Stage Option Exercise Period.

1.93   “ Late Stage Option Commencement Date ” means, with respect to each Licensed Product, the date of Completion of [***] [***] [***] [***] [***] [***] for the first indication in the first country where such clinical trials are performed with respect to that Licensed Product.

1.94   “ Licensed Patent Rights ” means any Patent Rights that are Controlled by ImmunoGen as of the Effective Date (including ImmunoGen Patent Rights and ImmunoGen’s interest in Joint Patent Rights) to the extent necessary to use, Develop, have Developed, make, have made, Commercialize and have Commercialized any Licensed Product. For purposes of clarity, (a) all Licensed Patent Rights existing as of the Effective Date are described on Schedule 2 attached hereto and (b) any Patent Rights that become Controlled by ImmunoGen during the Term of this Agreement that ImmunoGen reasonably believes are necessary and/or useful for the research, Development and Commercialization of Licensed Products in the Field (“New Patent Rights”) shall be presented to Biotest by ImmunoGen and Biotest shall have the right to decide within sixty (60) days following the presentation whether or not to add the New Patent Rights to Licensed Patent Rights on Schedule 2 . 

1.95   “ Licensed Product ” means any product that contains, is comprised of, or otherwise Derived from, an Anti-[***] Antibody-MAY Conjugate.

1.96   “ Licensed Product Trademark ” means (a) any trademark or trade name, whether or not registered, or any trademark application, renewal, extension or modification thereto, in the Territory, or any trade dress and packaging, that is applied to or used with Licensed Products by Biotest and (b) all goodwill associated therewith, and any promotional materials relating thereto.

1.97   “ Licensed Technology ” means any ImmunoGen Technology or Joint Technology that (a) relates to the MAY Compound and/or Linker portion of any Licensed Product and (b) is necessary for Biotest to exercise the licenses granted to it pursuant to Sections 8.1.1 and 8.2.1.

1.98   “ Linker ” means any chemical entity utilized to attach a MAY Compound to an Anti-[***] Antibody, including but not limited to SMCC, SPP, SPDB, CPD, PEG-containing chemical entities.

1.99   “ MAA ” means an application filed with the EMEA, or through the mutual recognition procedures in the European Union, for Regulatory Approval to Commercialize a Licensed Product as a medicinal product in the European Union, or in any country or territory therein.

1.100   “ Manufacturing Cost ” means, with respect to any Preclinical Materials or Clinical Materials manufactured by ImmunoGen, ImmunoGen’s fully-burdened costs (including the costs associated with product testing and release activities) of producing and packaging such Preclinical Materials or Clinical Materials, including the sum of the following components: (a) direct costs, including (1) materials directly used in producing and packaging such Preclinical Materials or Clinical Materials and (2) with respect to any Preclinical Materials or Clinical Materials obtained by ImmunoGen from a Third Party and supplied to Biotest without modification, the amount paid by ImmunoGen to such Third Party for the same; (b) manufacturing overhead costs attributable to the cost of goods under the foregoing clause (a) (1), including manufacturing and quality labor and manufacturing and quality supervisory services, operating and administrative costs of the manufacturing and quality departments and occupancy costs which are allocable to company departments based on space occupied or headcount  or another reasonable activity-based method; for the purpose of clarity, any cost allocation shall be (i) in any case applied in accordance with GAAP, and (ii) applied consistently by ImmunoGen in relation to all other Third Parties for which ImmunoGen manufactures comparable materials; (c) any other reasonable and customary Out-of-Pocket Costs borne by ImmunoGen for the testing, transport, customs clearance, duty, insurance and/or storage of such Preclinical Materials or Clinical Materials; and (d) ImmunoGen’s general and administrative costs, including purchasing, human resources, payroll, information system and accounting, which are directly attributable or reasonably allocable to company departments based on space occupied or headcount. Manufacturing overhead costs under the foregoing clause (b) and general and administrative costs under the foregoing clause (d) are allocable to each batch of Preclinical Material and/or Clinical Material produced based upon the [***] of [***], or any portion of a [***], that a Manufacturing [***] is [***] for the [***] (including [***] [***] and [***]) of Preclinical

Materials or Clinical Materials, as the use may be, at ImmunoGen’s facilities. Notwithstanding the foregoing, Manufacturing Cost shall not include the cost of purchasing any Dedicated Equipment pursuant to Section 4.5.2(c).

1.101   “ Manufacturing Plan ” means, subject to 4.1.3, with respect to each Licensed Product, the written plan for the manufacture of such Licensed Product in the Territory prepared by the JDC or the JMC which shall include, without limitation, expected manufacturing scale-up, formulation, and filling activities to be conducted for each Licensed Product as well as a budget and proposed timelines for such activities, as such plan may be amended or updated.

1.102   “ Material Use ” means, with respect to Shared Clinical Trial Data, (a) the inclusion of such Shared Clinical Data in a core report of an NDA filed by a Party (as evidenced by (i) the use of a bridging study to utilize such Shared Clinical Data, (ii) the elimination for the need to [***] such Shared Clinical Data through a clinical trial within such Party's respective geographic territory, or (iii) such other reference use of such Shared Clinical Data consistent with clauses (i)-(ii) above), or (b) the use of such Shared Clinical Data by a Party in a manner substantially similar to that contained in a full Clinical Study Report (CSR), as described in ICH Harmonized Guideline E3 (Structure and Content of Clinical Study Reports), and including the appendices specified in Section 16 of such guideline that are applicable to such Party’s NDA. For purposes of clarity, it shall not be deemed to be a Material Use of clinical data if such clinical data is used only to support an NDA filing.

1.103   “ MAY Compound ” means any and all maytansinoid compounds and any and all derivatives of any such maytansinoid compounds, to the extent, in any case, Controlled by ImmunoGen, including without limitation, (a) N ^2′ -deacetyl-N ^2′ -(c-mercapto-1 oxopropyl)-maytansine (CAS No. 139504-50-0) commonly referred to as DM1); (b) N ^2′ -deacetyl-N ^2′- (4-mercapto-1-oxopentyl)-maytansine (commonly referred as DM3); and (c) N ^2′ -deacetyl-N ^2′ -(4-mercapto-4-methyl-1-oxopentyl)-maytansine (commonly referred as DM4).

1.104   “ NDA ” means a New Drug Application, as defined in the FDCA and applicable regulations promulgated thereunder, or any successor application or procedure required to sell a Licensed Product in the United States.

1.105   “ Net Sales ” means the gross amount billed or invoiced by a Party (a “Selling Party”) or any of its Affiliates or Sublicensees to Third Parties throughout the Territory for sales or other dispositions or transfers for value of Licensed Products (including, without limitation, Third Party distributors and wholesalers), less (a) allowances for normal and customary trade, quantity and cash discounts actually allowed and taken, (b) transportation, insurance and postage charges, if prepaid by such Selling Party or any Affiliate of such Selling Party and included on any such party’s bill or invoice as a separate item, (c) credits, rebates, returns (including, without limitation, wholesaler and retailer returns) pursuant to agreements (including, without limitation, managed care agreements) or government regulations, to the extent actually allowed, and (d) sales, use and other consumption taxes, including VAT, similarly incurred to the extent stated on the invoice as a separate item. In addition, Net Sales are subject to the following:

(i)   If such Selling Party or any of its Affiliates or Sublicensees effects a sale, disposition or other transfer of a Licensed Product to a customer in a particular country other

than on customary commercial terms or as part of a package of Licensed Products and services, the Net Sales of such Licensed Product to such customer shall be deemed to be the “fair market value” of such Licensed Product. For purposes of this subsection (i), “fair market value” shall mean the value that would have been derived had such Licensed Product been sold as a separate Licensed Product to another customer in the country concerned on customary commercial terms.

(ii)   In the case of pharmacy incentive programs, hospital performance incentive program chargebacks, disease management programs, similar programs or discounts on “bundles” that include Licensed Products, all discounts and the like shall be allocated among the products in such bundles on the basis on which such discounts and the like were actually granted or, if such basis cannot be determined, in proportion to the respective list prices of such products.

(iii)   For purposes of clarity, the use of any Licensed Product in clinical trials, pre-clinical studies or other research or development activities, shall not give rise to any Net Sales. In addition, use of any Licensed Product in a compassionate use program shall not give rise to any deemed sale for purposes of this definition unless such Selling Party or its Affiliates or Sublicensees bills such program for such Licensed Product at a price which exceeds [***] [***] [***] percent ([***]%) of such Selling Party’s fully-burdened cost to supply such Licensed Product.

1.106   “Out-of-Pocket Costs ” means the reasonable, direct, documented and specifically identifiable expenses paid by a Party to any Third Party.

1.107   “ Patent Rights ” means the rights and interests in and to issued patents and pending patent applications (which, for purposes of this Agreement, include certificates of invention, applications for certificates of invention and priority rights) in any country or region, including all provisional applications, substitutions, continuations, continuations-in-part, divisions, renewals, all letters patent granted thereon, and all reissues, reexaminations and extensions thereof, and all foreign counterparts of any of the foregoing.

1.108   “ Person ” means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, 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.

1.109   “ Phase I Clinical Trial ” means a human clinical trial conducted in a country or countries that generally provides, with respect to that country, for the first introduction into humans of a Licensed Product with the purpose of assessing its safety, tolerability, toxicity, metabolism, absorption, elimination or other pharmacological action as more fully defin ed in 21 C.F.R. 312.21(a).

1.110   “ Phase II Clinical Trial ” means a human clinical trial conducted in a country or countries in patients with a particular disease or condition with the purpose of further assessing safety and tolerability of a Licensed Product and providing an indication of its efficacy for such disease or condition, as more fully defined in 21 C.F.R. 312.21(b).  

1.111   Phase IIb Clinical Trial ” means, as to a particular Licensed Product and indication, the portion of a Phase II Clinical Trial designed to generate sufficient data (if successful) to commence a Phase III Clinical Trial of such Licensed Product for such indication.

1.112   “ Phase III Clinical Trial ” means a pivotal human clinical trial conducted in a country or countries in patients with a particular disease or condition with the purpose of establishing the safety and tolerability of a Licensed Product and confirming or establishing its efficacy for such disease or condition as a basis for obtaining Regulatory Approval of such Licensed Product, as more fully defined in 21 C.F.R. 312.21(c).  

1.113   “ Pivotal MAY Compound Process Development Costs ” means the reasonable costs incurred by ImmunoGen after the Effective Date (both before and after the exercise of the Co-Development Option) in the conduct of process development activities for pivotal MAY Compounds, provided that such costs (i) are related to activities described in the Pivotal MAY Compound Process Development Plan, and (ii) have been approved by the Biotest members on the JDC, which approval shall not be unreasonably withheld, conditioned or delayed, provided that withholding, conditioning or delaying of the approval by Biotest for cost reasons would not be deemed to be unreasonable.

1.114   “ Pivotal MAY Compound Process Development Percentage ” means a portion of the Pivotal MAY Compound Process Development Costs calculated by dividing the aggregate amount of Pivotal MAY Compound Process Development Costs incurred by ImmunoGen by the [***] [***] [***], [***] [***] [***] [***], at the date the allocation of such Pivotal MAY Compound Process Development Costs is being determined, [***] [***] [***] or [***] that [***] [***] [***] that are used in [***] [***] [***] or [***] [***] and [***] and are [***] using the [***] developed in the conduct of such pivotal process development activities.  

1.115   “ Preclinical Materials ” means any MAY Compound, Linker and/or Licensed Product supplied by ImmunoGen to Biotest in accordance with Section 4.5.2(b)(ii) for the purpose of conducting preclinical testing with respect to a Licensed Product. For the purpose of clarity, Preclinical Material shall not include unconjugated Antibody.

1.116   “ Program Invention ” means any Technology (including, without limitation, any new and useful process, method of manufacture or composition of matter) that is conceived or first reduced to practice (actively or constructively) in the conduct of the Research Program and/or the Development of Licensed Products.

1.117   “ Proprietary Materials ” means tangible chemical, biological or physical materials that are furnished by or on behalf of one Party to the other Party in connection with this Agreement, whether or not specifically designated as proprietary by the transferring Party.

1.118   “ Regulatory Approval ” means, with respect to any country or region in the Territory, any approval (including, without limitation, any pricing approval), product and establishment license, registration or authorization of any Regulatory Authority required for the manufacture, use, storage, importation, export, transport, clinical testing or sale of a Licensed Product for use in the Field in such country or region.

1.120   “ Regulatory Filings ” means, collectively, (a) all INDs, NDAs, establishment license applications, drug master files, applications for designation of a Licensed Product as an “Orphan Product(s)” under the Orphan Drug Act, for “Fast Track” status under Section 506 of the FDCA (21 U.S.C. § 356) or for a Special Protocol Assessment under Section 505(b)(4)(B) and (C) of the FDCA (21 U.S.C. § 355(b)(4)(B)) or all other similar filings (including, without limitation, any counterparts of any of the foregoing in any country region in the Territory, e.g. a CTN) as may be required by any Regulatory Authority for the Development or Commercialization of a Licensed Product; (b) all supplements and amendments to any of the foregoing; and (c) all data contained in, and correspondence relating to, any of the foregoing.

1.121   “ Research Materials ” means any MAY Compound, Linker and/or Licensed Product supplied by ImmunoGen to Biotest in accordance with Section 3.3(b)(ii) for the purpose of conducting research activities under the Research Program with respect to a Licensed Product.

1.122   “ Research Plan ” means the written plan describing the research activities to be carried out by each Party during each Contract Year during the Research Program term in conducting the Research Program pursuant to this Agreement, as such written plan may be amended, modified or updated. Such Research Plan shall also comprise, inter   alia , (a) the specific objectives, projected 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 FTEs covering ImmunoGen Activities associated with the Research Program. The initial Research Plan shall be prepared jointly by the Parties at the latest fourteen (14) days from the Effective Date and shall describe the research activities (including basic process development) to be carried out by each Party during the first Contract Year and shall, in combination with the initial Development Plan, contain all activities until December 31st, 2007. Each amendment, modification and update to the Research Plan shall be set forth in a written document prepared by, or at the direction of, the JDC and approved by the JDC, shall specifically state that it is an amendment, modification or update to the Research Plan and shall be attached to the minutes of the meeting of the JDC at which such amendment, modification or update was approved by the JDC. Without limiting the nature or frequency of any other amendments, modifications or updates of the Research Plan that may be approved by the JDC, the Research Plan shall be updated at least once prior to the end of each Contract Year to describe the research activities to be carried out by each Party during the next Contract Year during the Research Program term in conducting the Research Program pursuant to this Agreement.

1.125   “ Royalty-Bearing Territory ” means (a) with respect to Co-Developed Products, all countries within the Biotest Territory and (b) with respect to Biotest Products, all countries within the Territory.

1.126   “ Royalty Term ” means, with respect to each Royalty-Bearing Product in each country in the Royalty-Bearing Territory, the period beginning on the date of First Commercial Sale of such Royalty-Bearing Product in such country and continuing on a country-by-country basis until the later of (a) the expiration of the last to expire Valid Claim in such country that covers such Royalty-Bearing Product or its use, method of delivery or manufacture or (b) twelve (12) years from the date of the First Commercial Sale of such Royalty-Bearing Product in such country.

1.127   " Serious Adverse Event " means an Adverse Event occurring at any dose of a drug that (a) results in death or poses a threat to life; (b) requires or prolongs hospitalization; (c) results in a persistent and/or significant disability or incapacity; (d) is medically significant; or (e) results in a congenital anomaly or birth defect.

1.128   “ Shared Clinical Trial ” means (a) any non-U.S. clinical trial conducted by or on behalf of a Party outside the Co-Development Territory, the results of which are included in the Regulatory Filings for a Co-Developed Product in the Co-Development Territory and therefore [***] conducting a similar clinical trial for Regulatory Filings for a Co-Developed Product in the Co-Development Territory; and (b) any clinical trial conducted by or on behalf of the Parties for a Co-Developed Product in the Co-Development Territory, the results of which are included in the Regulatory Filings outside the Co-Development Territory and therefore [***] conducting a similar clinical trial outside the Co-Development Territory.

1.129   “ Shared Clinical Trial Costs ” means the aggregate amount of Out-of-Pocket Costs and internal costs incurred by either Party (or for its account by an Affiliate or a Third Party) that are specifically attributable to the conduct of a Shared Clinical Trial.

1.130   “ Shared Clinical Trial Cost-Sharing Percentage ” means, with respect to any Shared Clinical Trial, (a) if Biotest uses the results of such Shared Clinical Trial according to 1.128(b), and such Shared Clinical Trial enables Biotest to [***] conducting a similar clinical trial outside the Co-Development Territory, [***] percent ([***]%) for Biotest and [***] percent ([***]%) for ImmunoGen; and (b) if ImmunoGen and Biotest jointly use the results of such Shared Clinical Trial according to 1.128(a), and such Shared Clinical Trial enables ImmunoGen and Biotest to [***] conducting a similar clinical trial in the Co-Development Territory, [***] percent ([***]%) for ImmunoGen and [***] percent ([***]%) for Biotest. If data is only supportive then no adjustment of the 50:50 cost sharing will be necessary.

1.131   “ Shared Clinical Trial Data ” means all data, results and information produced in the conduct of a Shared Clinical Trial.

1.133   “ Sublicensee ” means any Third Party (other than an Affiliate) to which Biotest grants a sublicense in accordance with Section 8.3.

1.134   “ Technology ” means, collectively, all ideas, inventions, discoveries, improvements, trade secrets and proprietary methods, whether or not patentable, including without limitation: (a) methods of production or use of, and structural and functional information pertaining to, chemical and/or biological compounds and (b) data, formulae, designs, specifications, formulations, processes, process information, techniques, know-how and results (including any negative results), pre-clinical information, clinical information, and any and all proprietary biological, chemical, pharmacological, toxicological, pre-clinical, clinical, assay, control and manufacturing data and materials.

1.136   “ Third Party ” means any party other than Biotest and ImmunoGen and their respective Affiliates.

1.137   “ Third Party Required Payments ” means all royalty payments paid to any Third Party in any country in the Co-Development Territory in order to obtain a license to an issued patent or patents in the absence of which the portion of the Co-Developed Product consisting of the Licensed Technology or Licensed Patent Rights would not legally be developed, manufactured or sold in such country.

1.138   “ Unanimous Decision ” means any of the following decisions requiring the unanimous approval of all members of the JSC, the JDC and/or the JMC, as the case may be: (a) any determination as to whether a milestone has been achieved under Section 6.3.1 of this Agreement for which a milestone payment is payable; (b) any decision that relates to the Co-Development or Co-Promotion of a Co-Developed Product (including without limitation any decision with respect to the manufacture of such Co-Developed Product within the Co-Development Territory) in the Co-Development Territory; (c) any decision that results, or would reasonably be expected to result, in an increase in the amount of Co-Development Costs payable by a Party pursuant to Section 5.1 of more than   [***] [***] percent ([***]%) in any Calendar Year as compared to the amount of Co-Development Costs forecasted in the then current Co-Development Plan for that Calendar Year for any reason (including, without limitation, as a result of a change in the number of patients, number of sites, duration of the study or the number of studies); (d) the initial allocation of Detailing responsibilities between the Parties with respect to a Co-Developed Product; (e) any disputed matter which, in accordance with the terms of this Agreement, is referred to the JSC by the JDC, the JFC or the JMC; and (f) with respect to each Licensed Product that is a Co-Developed Product, the determination of the indication(s) for which such Co-Developed Product shall be used in the Co-Development Territory.

1.139   “ Valid Claim ” means any claim of an issued unexpired patent or a pending patent application within the Licensed Patent Rights that (a) has not been finally cancelled, withdrawn, abandoned or rejected by ImmunoGen and/or any administrative agency or other

body of competent jurisdiction, (b) has not been revoked, held invalid, or declared unpatentable or unenforceable in a decision of a court or other body of competent jurisdiction that is unappealable or unappealed within the time allowed for appeal, (c) has not been rendered unenforceable through disclaimer or otherwise, and (d) is not lost through an interference proceeding; provided, however, that (i) a claim contained in a pending patent application shall, if and to the extent such claim is not issued on or before [***] ([***]) years from the date of filing of the subject application, shall cease to constitute a Valid Claim and (ii) if a claim that ceases to be a Valid Claim by reason of subsection (i) above subsequently issues, such claim shall once again be deemed to be a Valid Claim for purposes of this Agreement.

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

2.   ADMINISTRATION OF THE COLLABORATION

2.1.1   Establishment . ImmunoGen and Biotest hereby establish the Joint Steering Committee. The JSC shall have and perform the responsibilities set forth in Section 2.1.4.

2.1.2   Membership . Each of ImmunoGen and Biotest shall designate an equal (not less than two (2)) number of representatives to the JSC (which may be employees of, or consultants to, such Party). Unless otherwise agreed by the Parties, one of Biotest’s representatives shall be designated as the Chairman of the JSC. Each Party shall have the right at any time to substitute individuals, on a permanent or temporary basis, for any of its previously designated representatives to the JSC by giving written notice to the other Party.

2.1.3   Meetings .

(a)   Schedule of Meetings; Agenda . The JSC shall establish a schedule of times for regular meetings, taking into account, without limitation, the planning needs of the Research Program and the responsibilities of the JSC. In addition, special meetings may be convened by any member of the JSC upon thirty (30) days (or, if such meeting is proposed to be conducted by teleconference, upon ten (10) days) written notice to the other members; provided that (i) notice of any such special meeting may be waived at any time, either before or after such meeting and (ii) attendance of any member at a special meeting shall constitute a valid waiver of notice from such member. Regular and special meetings of the JSC may be held in person or by teleconference or videoconference; provided that meetings held in person shall alternate between the respective offices of the Parties in Cambridge, Massachusetts and Dreieich, Germany or such other locations mutually agreeable to the JSC members. The Chairman shall have the responsibility for preparing and circulating to each JSC member an agenda for each JSC meeting not later than one (1) week prior to such meeting.

(b)   Quorum; Voting; Decisions . At each JSC meeting, (i) the presence in person of at least   one (1) member designated by each Party shall constitute a quorum and (ii) each member who is present shall have one vote on all matters before the JSC at such meeting. All decisions of the JSC, other than Unanimous Decisions, Biotest Decisions and ImmunoGen Decisions, shall be made by majority vote; provided, that, any member designated by a Party shall have the right to cast the votes of any of such Party’s members on the JSC who are absent

from the meeting. Alternatively, the JSC may act by written consent signed by at least one (1) member   designated by each Party. All decisions of the JSC that involve Unanimous Decisions shall be made by vote of all members of the JSC. Whenever any action by the JSC is called for hereunder during a time period in which the JSC is not scheduled to meet, the Chairman shall cause the JSC to take the action in the requested time period by calling a special meeting or by circulating a written consent. Representatives of each Party or of its Affiliates who are not members of the JSC (including, without limitation, the Patent Coordinators) may attend JSC meetings as non-voting observers. In the event that the JSC is unable to resolve any matter before it, such matter shall be resolved in accordance with Section 2.1.6.

(c)   Minutes . The JSC shall keep minutes of its meetings that record all decisions and all actions recommended or taken in reasonable detail. Drafts of the minutes shall be prepared and circulated to the members of the JSC within a reasonable time after the meeting, not to exceed ten (10) business days, and the Parties shall alternate responsibility for the preparation and circulation of draft minutes. Each member of the JSC shall have the opportunity to provide comments on the draft minutes. Draft minutes shall be approved, disapproved and revised as soon as practicable. Upon approval, final minutes of each meeting shall be circulated to the members of the JSC by the Chairman.

(d)   Expenses . ImmunoGen and Biotest shall each bear all expenses of their respective JSC representatives related to their participation on the JSC and attendance at JSC meetings.

2.1.4   Responsibilities . Without limiting the generality of the foregoing, the JSC shall have the following responsibilities:

(a)   overseeing the JDC’s performance of its responsibilities, the JFC’s performance of its responsibilities and the JMC’s performance of its responsibilities;

(b)   reviewing data, reports or other information submitted to it by the JDC, JMC and JFC from time to time;

(c)   resolving all JDC, JMC or JFC matters that are referred to the JSC for resolution;

(d)   making such other decisions as may be delegated to the JSC pursuant to this Agreement or by mutual written agreement of the Parties after the Effective Date; and

(e)   the JSC will meet in accordance with Section 2.1.3 for the purpose of (i) serving as a forum for Biotest and/or ImmunoGen, as applicable, to update each other as to Development and Commercialization progress with respect to Licensed Products, including monitoring the progress of the Development of each Licensed Product in accordance with the Development Plan and the Commercialization of each Co-Developed Product in accordance with the applicable Co-Development Marketing and Sales Plan and reviewing each annual update to each Co-Development Marketing and Sales Plan; and (ii) resolving any matters that require a Unanimous Decision. At each such meeting of the JSC the members of Biotest on the JSC shall provide an update as to Biotest’s general strategy for the Development and Commercialization of each Licensed Product in the Field to the extent applicable. In the event ImmunoGen exercises a Co-Development Option, the members of Biotest and ImmunoGen on the JSC shall provide (i) an

update as to the Co-Promotion strategy for the Development and Commercialization of each Co-Developed Product in the Field set forth in the Co-Development Plan and/or Co-Development Marketing and Sales Plan (ii) an update concerning the anticipated timelines on a region-by-region basis for the Development of each Co-Developed Product and Regulatory Filings with respect thereto in the Field in the Territory, (iii) an update concerning the anticipated timelines on a region-by-region basis for the commercial launch of each Co-Developed Product and (iv) sales forecast guidance for each Co-Developed Product in the Field in the Territory; provided, that, in proving such update, the members of Biotest on the JSC shall be entitled to omit discussion of Confidential Information of Biotest that Biotest reasonably determines to be materially sensitive. If there is a material change in such timelines or guidance after any such meeting, Biotest will endeavor to notify ImmunoGen thereof through the convenience of a special meeting of the JSC.

2.1.5   Interests of the Parties . Notwithstanding any other provisions of this Agreement, all decisions made and all actions taken by the JSC shall be made or taken in the best interest of the Collaboration.

2.1.6   Dispute Resolution . The JSC members shall use reasonable efforts to reach agreement on any and all matters. In the event that, despite such reasonable efforts, agreement on a particular matter cannot be reached by the JSC within ten (10) days after the JSC first meets to consider such matter or such later date as may be mutually agreed to by the Parties (each such matter, a “Disputed Matter”), then, if the Disputed Matter does not involve a Unanimous Decision, a Biotest Decision or an ImmunoGen Decision, the Chairman of the JSC shall have the right to make the final decision on such Disputed Matter, but shall only exercise such right in good faith after full consideration of the positions of both Parties. Notwithstanding the foregoing, (a) if the Disputed Matter involves an ImmunoGen Decision, one of the ImmunoGen members of the JSC shall have the right to make the final decision on such Disputed Matter, but shall only exercise such right in good faith after full consideration of the positions of both Parties, (b) if the Disputed Matter involves a Biotest Decision, one of the Biotest members of the JSC shall have the right to make the final decision on such Disputed Matter, but shall only exercise such right in good faith after full consideration of the positions of both Parties, and (c) if the Disputed Matter involves a Unanimous Decision, the Disputed Matter shall be referred to the Designated Senior Officer of each Party, who shall promptly initiate discussions in good faith to resolve the Disputed Matter. If the Disputed Matter is not resolved by such Designated Senior Officers within the first to occur of (i) ten (10) days after the date the Designated Senior Officers first met to consider such Disputed Matter or such later date as may be mutually agreed to by the Parties or (ii) thirty (30) days after the date the JSC first met to consider such Disputed Matter or such later date as may be mutually acceptable to the Parties, the Disputed Matter shall be resolved in accordance with Section 14.1. In addition, if the Disputed Matter involves determining whether a patent application should be filed with respect to a Program Invention and/or the jurisdictions in which it will be filed, subject to Section 10.1.4, the Party whose Program Invention is involved shall have the right to make the final decision on such Disputed Matter.

2.2.2   Membership . Each of ImmunoGen and Biotest shall designate an equal (not less than two (2)) number of representatives to the JDC (which may be employees of, or consultants to, such Party). Unless otherwise agreed by the Parties, one of Biotest’s representatives shall be designated by Biotest as the Chairman of the JDC. Each Party shall have the right at any time to substitute individuals, on a permanent or temporary basis, for any of its previously designated representatives to the JDC by giving written notice to the other Party.

2.2.3   Meetings .

(a)   Schedule of Meetings; Agenda . The JDC shall establish a schedule of times for regular quarterly meetings, taking into account, without limitation, the planning needs of the Research Program and the responsibilities of the JDC. In addition, special meetings may be convened by any member of the JDC upon thirty (30) days (or, if such meeting is proposed to be conducted by teleconference, upon ten (10) days) written notice to the other members; provided that (i) notice of any such special meeting may be waived at any time, either before or after such meeting and (ii) attendance of any member at a special meeting shall constitute a valid waiver of notice from such member. In no event shall the JDC meet less frequently than four (4) times in each Calendar Year. Regular and special meetings of the JDC may be held in person or by teleconference or videoconference; provided that meetings held in person shall alternate between the respective offices of the Parties in Cambridge, Massachusetts and Dreieich, Germany or such other locations mutually agreeable to the JDC members. The Chairman shall have the responsibility for preparing and circulating to each JDC member an agenda for each JDC meeting not later than one (1) week prior to such meeting.

(b)   Quorum; Voting; Decisions . At each JDC meeting, (i) the presence in person of at least   one (1) member designated by each Party shall constitute a quorum and (ii) each member who is present shall have one vote on all matters before the JDC at such meeting. All decisions of the JDC, other than Unanimous Decisions, Biotest Decisions and ImmunoGen Decisions, shall be made by majority vote; provided, that, any member designated by a Party shall have the right to cast the votes of any of such Party’s members on the JDC who are absent from the meeting. Alternatively, the JDC may act by written consent signed by at least one (1) member   designated by each Party. All decisions of the JDC that involve Unanimous Decisions shall be made by vote of all members of the JDC. Whenever any action by the JDC is called for hereunder during a time period in which the JDC is not scheduled to meet, the Chairman shall cause the JDC to take the action in the requested time period by calling a special meeting or by circulating a written consent. Representatives of each Party or of its Affiliates who are not members of the JDC (including, without limitation, the Patent Coordinators) may attend JDC meetings as non-voting observers. In the event that the JDC is unable to resolve any matter before it, such matter shall be resolved in accordance with Section 2.2.6.

(c)   Minutes . The JDC shall keep minutes of its meetings that record all decisions and all actions recommended or taken in reasonable detail. Drafts of the minutes shall be prepared and circulated to the members of the JDC within a reasonable time after the meeting, not to exceed [***] ([***]) business days, and the Parties shall alternate responsibility for the preparation and circulation of draft minutes. Each member of the JDC shall have the opportunity to provide comments on the draft minutes. Draft minutes shall be approved, disapproved and revised as necessary at the next JDC meeting. Upon approval, final minutes of each meeting shall be circulated to the members of the JDC by the Chairman.

(d)   Expenses . ImmunoGen and Biotest shall each bear all expenses of their respective JDC representatives related to their participation on the JDC and attendance at JDC meetings.

2.2.4   Responsibilities . The JDC shall be responsible for overseeing the conduct and progress of the Research Program and the Development of Licensed Products. Without limiting the generality of the foregoing, during the Research Program term, the JDC shall have the following responsibilities:

2.2.5   Interests of the Parties . Notwithstanding any other provisions of this Agreement, all decisions made and all actions taken by the JDC shall be made or taken in the best interest of the Collaboration.

2.2.6   Dispute Resolution . The JDC members shall use reasonable efforts to reach agreement on any and all matters. The JDC shall be operated by consensus; provided, that, prior to ImmunoGen’s exercise of a Co-Development Option in the event that, despite such reasonable efforts, agreement on a particular matter cannot be reached by the JDC, the judgment of the Biotest Chairman shall be determinative. Provided that ImmunoGen has exercised a Co-Development Option, in the event that, despite such reasonable efforts, agreement on a particular matter regarding the Co-Developed Product in the Co-Development Territory cannot be reached by the JDC within ten (10) days after the JDC first meets to consider such matter, then the matter shall be referred to the JSC for resolution pursuant to Section 2.1.6. With respect to the Development of Biotest Products in the Territory and/or Co-Developed Products outside the Co-Development Territory, the judgment of the Biotest Chairman shall be determinative.

2.3.1   Appointment . Each Party shall appoint a person who shall oversee contact between the Parties for all matters related to the research and Development of Licensed Products between meetings of the JDC and the JSC (each, an “Alliance Manager”). The Alliance Managers shall have the right to attend all meetings of the JSC, JDC, the JFC and the JMC, as the case may be, as non-voting participants and may bring to the attention of the JSC, JDC, the JFC and the JMC, as the case may be, any matters or issues either of them reasonably believes should be discussed and shall have such other responsibilities as the Parties may mutually agree in writing. Each Party may replace its Alliance Manager at any time by notice in writing to the other Party.

2.3.2   Responsibilities . The Alliance Managers shall have the responsibility of creating and maintaining a constructive work environment within the JSC, JDC, the JFC and the JMC, as the case may be, and between the Parties for all matters related to the Collaboration. Without limiting the generality of the foregoing, such Alliance Managers shall:

(a)   identify and bring to the attention of the JSC, as applicable, any disputes arising between the Parties related to the Collaboration 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;

(b)   provide a single point of communication for seeking consensus within the Parties’ respective organizations and between the Parties with respect to the Collaboration;

(c)   plan and coordinate cooperative efforts and internal and external communications between the Parties with respect to the Collaboration; and

(d)   take such steps as may be required to ensure that meetings of the JSC, JDC, the JFC and the JMC, as the case may be, occur as set forth in the 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.

2.4.1   Establishment . As soon as practicable following the exercise by ImmunoGen of a Co-Development Option with respect to a Co-Developed Product in accordance with Section 5.1.1, ImmunoGen and Biotest will establish the Joint Finance Committee. The JFC shall have and perform the responsibilities set forth in Section 2.4.4.

2.4.2   Membership . Each Party shall designate, in its sole discretion, up to two (2) members to the JFC (which member may be an employee of, or consultant to, such Party). Each Party shall have the right at any time to substitute any individual, on a permanent or temporary basis, for its previously designated representative to the JFC by giving written notice to the other Party.

2.4.3   Meetings .

  (a)   Schedule of Meetings . The JFC shall establish a schedule of times for regular meetings, taking into account, without limitation, the need to review Co-Development Costs incurred by the Parties and the Net Income received with respect to Co-Developed Products. Meetings of the JFC may be held in person or by teleconference or videoconference; provided that meetings held in person shall alternate between the respective offices of the Parties.

(b)   Voting; Decisions . At each JFC meeting, (i) the presence in person of at least   one (1) member designated by each Party shall constitute a quorum and (ii) each member who is present shall have one vote on all matters before the JFC at such meeting. All decisions of the JFC related to Co-Developed Products in the Co-Development Territory shall be made by majority vote; provided, that, any member designated by a Party shall have the right to cast the votes of any of such Party’s members on the JFC who are absent from the meeting. Alternatively, the JFC may act by written consent signed by at least one (1) member   designated by each Party. In the event that the JFC is unable to resolve any matter before it, such matter shall be referred to the JSC to be resolved in accordance with Section 2.1.6.

(c)   Minutes . The JFC shall keep minutes of its meetings that record all decisions and all actions recommended or taken in reasonable detail. Drafts of the minutes shall be prepared and circulated to the members of the JFC within a reasonable time after the meeting, not to exceed [***] ([***]) business days, and the Parties shall alternate responsibility for the preparation and circulation of draft minutes. Each member of the JFC shall have the opportunity to provide comments on the draft minutes. The minutes shall be approved, disapproved and revised as necessary at the next JFC meeting.

(d)   Expenses . ImmunoGen and Biotest shall each bear all expenses of their respective JFC members related to their participation on the JFC and attendance at JFC meetings.

2.4.4   Responsibilities . The JFC shall be responsible for (a) monitoring the activities of, and reconciling issues between, the Parties with respect to the Parties’ respective share of Co-Development Costs, Co-Promotion costs and Net Income with respect to Co-Developed Products in the Co-Development Territory and the Co-Promotion Percentage, (b) preparing ongoing rolling forecasts for each Calendar Quarter with respect to all Co-Development Costs and Net Income of Co-Developed Products in the Co-Development Territory, (c) determining the FTE rate applicable to the performance by ImmunoGen of ImmunoGen’s activities and by Biotest of Biotest’s activities after the exercise of a Co-Development Option and/or with respect to Representatives used by the Parties in Co-Promoting each Co-Developed Product; and (d) making such other decisions as may be delegated to the JFC by mutual agreement of the Parties after the Effective Date.

2.5.1   Establishment . As soon as practicable following the exercise by ImmunoGen of a Co-Development Option with respect to a Co-Developed Product in accordance with Section 5.1.1, ImmunoGen and Biotest shall establish the Joint Marketing Committee which shall have and perform the responsibilities set forth in Section 2.5.4.

2.5.2   Membership . Each Party shall designate, in its sole discretion, not less than two (2) members to the JMC (which members may be employees or consultants of such Party). Unless otherwise agreed by the Parties, one of Biotest’s designees shall be designated by Biotest as the Chairman. Each Party shall have the right at any time to substitute individuals, on a permanent or temporary basis, for any of its previously designated representatives to the JMC by giving written notice to the other Party.

2.5.3   Meetings .

(a)   Schedule of Meetings; Agenda . The JMC shall establish a schedule of times for regular meetings, taking into account, without limitation, the planning needs for the Co-Developed Products and its responsibilities. If formed, in no event shall the JMC meet less frequently than four (4) times per Calendar Year. Regular and special meetings of the JMC may be held in person or by teleconference or videoconference; provided, that, meetings held in person shall alternate between the respective offices of the Parties. The Chairman shall prepare and circulate to each JMC member an agenda for each JMC meeting not later than one (1) week prior to each meeting.

(b)   Quorum; Voting; Decisions . At each JMC meeting, (i) the presence in person of at least one (1) member designated by each Party shall constitute a quorum and (ii) each member designated by each Party who is present shall have one vote on all matters before the JMC at such meeting. All decisions of the JMC other than Unanimous Decisions, Biotest Decisions and ImmunoGen Decisions shall be made by majority vote; provided, that, any member designated by a Party shall have the right to cast the votes of any of such Party’s members on the JMC who are absent from the meeting. Alternatively, the JMC may act by written consent signed by at least one (1) member designated by each Party. All decisions of the JMC that involve Unanimous Decisions shall be made by vote of all members of the JMC. Whenever any action by the JMC is called for hereunder during a time period in which the JMC is not scheduled to meet, the Chairman shall cause the JMC to take the action in the requested time period by calling a special meeting or by circulating a written consent. Representatives of each Party or of its Affiliates who are not members of the JMC may attend JMC meetings as non-voting observers.

(c)   Expenses . ImmunoGen and Biotest shall bear all the expenses of their respective JMC members related to their participation on the JMC and attendance at JMC meetings.

2.5.4   Responsibilities . The JMC shall be responsible for overseeing the Co-Promotion of Co-Developed Products in the Co-Development Territory. Without limiting the generality of the foregoing, the JMC shall have the following responsibilities:

(a)   preparing or directing the preparation of a Co-Development Marketing and Sales Plan containing a Co-Promotion Plan and a brand plan for each Co-Developed Product in the Co-Development Territory, such Plan to include allocation of responsibilities for Commercialization activities;

(b)   reviewing and approving all Additional Co-Promotion Activities to be conducted by either Party pursuant to Section 5.7;

(c)   preparing short-term and long-term sales forecasts for Co-Developed Products in the Co-Development Territory;

(d)   presenting sales forecasts and the results of all Co-Promotion efforts in the Co-Development Territory to the JSC as needed, but no less often than four (4) times per Calendar Year;

(e)   coordinating the Detailing efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products;

(f)   overseeing all recalls, market withdrawals and any other corrective actions related to Co-Developed Products in the Co-Development Territory;

(g)   receiving and providing to the Parties sales reports pertaining to Co-Developed Products in the Co-Development Territory;

(h)   consulting the Parties in the selection of Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Development Territory; and

(i)   performing such activities as may be delegated to the JMC pursuant to this Agreement, or by mutual written agreement of the Parties after the Effective Date.

2.5.5   Dispute Resolution . The JMC members shall use reasonable efforts to reach agreement on any and all matters. In the event that, despite such reasonable efforts, agreement on a particular matter cannot be reached by the JMC within ten (10) days after the JMC first meets to consider such matter, then the matter shall be referred to the JSC for resolution pursuant to Section 2.1.6.

3.   RESEARCH PROGRAM

3.1   Objectives of the Research Program . The objective of the Research Program shall be the identification of one or more Licensed Products suitable for further Development and Commercialization. 

3.2   Research Plan . The JDC shall create a Research Plan to, among other things, enable selection of the best Anti-[***] Antibody-MAY Conjugate for further Development and to conduct initial research activities with respect to such conjugate, including basic process development, prior to the initiation of formal Development activities. For each Contract Year during the conduct of the Research Program commencing with the second Contract Year, the Research Plan shall be amended and updated by the Parties, which amendments and updates shall be submitted to and approved by the JDC in accordance with Section 2.2.4. Each such amendment shall: (a) set forth (i) the research objectives and activities to be performed for the Contract Year covered by the update with reasonable specificity; (ii) the Party that shall be responsible for performing such activities; (iii) a timeline for such activities; and (iv) with respect to ImmunoGen Activities, the number of FTEs estimated to be required to perform such ImmunoGen Activities; and (b) be consistent with the terms of this Agreement.

3.3   Conduct of Research Program . In consultation with the JDC and in accordance with the objectives of the Research Program, each Party shall be primarily responsible for those tasks and obligations in connection with the Research Program that are assigned to it pursuant to this Section 3.3 and in the Research Plan. Without limiting the foregoing, the Parties hereby agree as follows:

(a)   Biotest Activities Under Research Program . Subject to ImmunoGen’s obligations to conduct ImmunoGen Activities and/or to supply Research Materials pursuant to Section 3.3(b)(ii) and Preclinical Materials and Clinical Materials in accordance with Section 4.5.2, Biotest shall have the sole right and responsibility for all aspects related to the research and early stage Development of Licensed Products, including without limitation (i) making all strategic and tactical decisions with respect thereto; (ii) assessing alternative product designs; (iii) the selection of the Antibody, Linker and MAY Compound to be used in each Licensed Product; (iv) the conduct of, at its sole cost and expense, all preclinical and IND-enabling studies (including toxicology testing) with respect to any Licensed Product so selected.

(b)   ImmunoGen Activities under the Research Program .

(i)   In General . Notwithstanding anything to the contrary in Section 3.3(a), ImmunoGen will undertake (A) any ImmunoGen Activities set forth in the Research Plan, subject to the payment by Biotest of the consideration set forth in Section 6.2 and (B) any other basic research activities that ImmunoGen determines, in its sole discretion and [***] [***] [***] [***], are necessary in order to successfully apply ImmunoGen Technology to the research of Licensed Products.

(ii)   Supply of Research Materials . Upon Biotest’s written request, ImmunoGen will supply Biotest with such quantities of Research Materials as may be reasonably required by Biotest in order to conduct research relating to Licensed Products. To the extent that Biotest requests that ImmunoGen provide such Research Materials, Biotest shall order all

amounts of Research Materials, and ImmunoGen shall deliver all such ordered amounts, in accordance with advance ordering timeframes and delivery timeframes and specifications to be agreed upon by the Parties. ImmunoGen shall use commercially reasonable efforts to deliver to Biotest such amounts of Research Materials as are ordered by Biotest in accordance with the foregoing (including such agreed upon timeframes) in a timely manner. ImmunoGen’s price to supply Research Materials to Biotest shall equal ImmunoGen’s cost of materials plus its manufacturing costs [***] [***] [***] [***] [***].

3.4   Diligence . Each Party shall use commercially reasonable efforts to perform its respective obligations under the Research Program in accordance with the Research Plan and shall commit such resources as are specified in the Research Plan as may be necessary to conduct its activities set forth therein in a timely fashion. Without limiting the foregoing, Biotest and ImmunoGen shall commit such scientific resources, including, but not limited to consultants, facilities, equipment, and Proprietary Materials, as are necessary and commercially reasonable to achieve the objectives of the Research Program.

3.5   Compliance . Each Party shall perform its obligations under the Research Plan in good scientific manner and in compliance in all material respects with all Applicable Laws; provided that, for purposes of clarity, (a) with respect to each activity performed under the Research Plan that will or could reasonably be expected to be submitted to a Regulatory Authority in support of a Regulatory Filing in the United States, the Party performing such activity shall comply in all material respects with the regulations and guidance of the FDA that constitute Good Laboratory Practice or Good Manufacturing Practice , in each case as applicable;  (b) to the extent Biotest wishes ImmunoGen to comply with the regulations or guidance of any Regulatory Authority outside the United States (including any International Conference on Harmonization (ICH) guidance), Biotest shall provide ImmunoGen with written notice which shall identify such regulations or guidance, and ImmunoGen shall confirm in writing whether it agrees to comply with same within [***] ([***]) business days of its receipt of such notice; and (c) to the extent Biotest wishes ImmunoGen to comply with the regulations or guidance of any Regulatory Authority outside the United States (including any ICH guidance) and ImmunoGen agrees to comply with such regulations or guidance, ImmunoGen agrees to be inspected after prior written notice by Biotest and competent foreign Regulatory Authority to allow for a Regulatory Filing outside the United States. Each Party shall be solely responsible for paying the salaries and benefits of its employees and consultants conducting its activities under the Research Plan.

3.5.1   Cooperation . Scientists at ImmunoGen and Biotest shall cooperate in the performance of the Research Program and, subject to the terms of this Agreement and any confidentiality obligations to Third Parties, shall exchange such data, information and materials as is reasonably necessary for the other Party to perform its obligations under the Research Plan.

3.6   Records .

3.6.1   Record Keeping .

(a)   Records . Each Party shall maintain records of its activities under the Research Program in sufficient detail, in good scientific manner and otherwise in a manner that reflects all work done and results achieved in the performance of the Research Program.

(b)   Record Keeping Policies . Without limiting the generality of Section 3.6.1(a), each Party agrees to maintain a policy that requires its employees and consultants to record and maintain all data and information developed during the Research Program in a manner designed to enable the Parties to use such records to establish the earliest date of invention or reduction to practice. At a minimum, the policy shall require such individuals to record such data and information by them in standard laboratory notebooks that are dated and corroborated by non-inventors on a regular, contemporaneous basis.

3.7   Reports . At each meeting of the JDC, the Parties shall update the JDC as to such Party’s efforts under the Research Program and shall present to the JDC all data and results generated from such efforts. The JDC may decide, from time to time, to cause the Research Plan to be updated to reflect changes in the research activities performed by each Party under the Research Plan.   

3.8   Supply of Proprietary Materials . From time to time during the Term, either Party (the “transferring Party”) may supply the other Party (the “recipient Party”) with Proprietary Materials of the transferring Party for use in the Research Program. In connection therewith, each recipient Party hereby agrees that (a) it shall not use such Proprietary Materials for any purpose other than exercising its rights or performing its obligations hereunder; (b) it shall use such Proprietary Materials only in compliance with all Applicable Laws; (c) it shall not transfer any such Proprietary Materials to any Third Party without the prior written consent of the transferring Party, except as expressly permitted hereby or as otherwise permitted under the Existing Agreements; (d) the recipient Party shall not acquire any right, title or interest in or to such Proprietary Materials as a result of such supply by the transferring Party; (e) the recipient Party shall, if and as instructed by the Party, either destroy or return any such Proprietary Materials that are not the subject of the grant of a continuing license hereunder; and (f) to the extent ImmunoGen is the transferring Party, upon Biotest’s request, ImmunoGen shall provide Biotest with supply safety data sheets and instructions for use, waste management, transportation, packaging and labeling of ImmunoGen Materials.

4.1.1   Development Plans . Until the exercise of a Co-Development Option for a Licensed Product, Biotest will be solely responsible for conducting the Development of Licensed Products. As soon as practicable after the identification in the Research Program of each Licensed Product for further Development, the Parties shall jointly prepare and submit to the

JDC for approval a Development Plan covering the activities to be carried out over each Contract Year which shall: (a) set forth (i) the Development objectives and activities to be performed for each Contract Year period covered by the Development Plan with reasonable specificity, broken down by Calendar Quarters, (ii) the Party that shall be responsible for performing such activities, and (iii) a timeline for such activities; and (b) be consistent with the other terms of this Agreement. ImmunoGen will undertake the ImmunoGen Activities set forth in the Development Plan, subject to the payment by Biotest of the consideration set forth in Section 6.2. The Parties shall discuss at meetings of the JDC the scope of, and the expenditures for, any process development activities planned by either Party after the Effective Date for pivotal MAY Compounds, which discussions shall be included in the minutes of the applicable JDC meeting (the portion of such minutes, the “Pivotal MAY Compound Process Development Plan”), taking into account Pivotal MAY Compound Process Development activities of Third Parties, covering the activities to be carried out over each Contract Year including: (a) the process development objectives and activities to be performed for each Contract Year period with reasonable specificity, broken down by Calendar Quarters, (b) the Party that shall be responsible for performing such activities, and (c) a timeline for such activities . The Pivotal MAY Compound Process Development Plan shall include the Pivotal MAY Compound Process Development Costs approved by the JDC as provided in Section 1.113.  

4.1.2   Marketing and Sales Plans .   Until such time as ImmunoGen has exercised a Co-Development Option, (a) Biotest shall be solely responsible for all activities and associated costs related to the worldwide marketing and sales of Licensed Products and (b) decisions regarding marketing and sales will be made solely by Biotest.

4.1.3   Manufacturing Plan . Biotest shall be solely responsible for the manufacture of Biotest Products in the Territory and Co-Developed Products in the Biotest Territory. The Parties shall prepare and provide to the JDC for its review and approval a Manufacturing Plan that specifies which manufacturer of MAY Compounds and Anti-[***] Antibody-MAY Conjugates are to be used for Biotest Products and/or Co-Developed Products and/or Preclinical Materials and/or Clinical Materials, which Manufacturing Plan shall be updated by the Parties and reviewed and approved by the JDC each Contract Year during the Term following the JDC’s approval of the initial Manufacturing Plan. Each update to the Manufacturing Plan shall: (a) set forth (i) the manufacturing scale-up, formulation and filling requirements for each Biotest Product and/or Co-Developed Product to be performed for the Contract Year covered by the Manufacturing Plan with reasonable specificity, (ii) a timeline and budget for such activities, (iii) the objectives and activities to be performed for each Contract Year period covered by the Manufacturing Plan with reasonable specificity, (iv) the Party that shall be responsible for performing such activities, (v) the estimated expenses covering the activities associated with the Manufacturing Plan; and (b) be consistent with the other terms of this Agreement. The JDC members shall use reasonable efforts to reach agreement on manufacturing issues. In the event that, despite such reasonable efforts, agreement on a particular matter cannot be reached by the JDC, the judgment of the Biotest Chairman shall be determinative. If the JDC requests that ImmunoGen manufacture Preclinical Materials and/or Clinical Materials, then the judgment of the ImmunoGen representatives on the JDC shall be determinative.

4.2   Biotest Products . Subject to Section 5,   Biotest shall have the sole right and responsibility, at its sole cost and expense, for all aspects of the Development and Commercialization of Biotest Products in accordance with the applicable Development Plan in the Field in the Territory, including, without limitation, the conduct of (a) all activities relating to the manufacture and supply of Biotest Products in the Territory, and (b) all marketing, promotion, sales, distribution, import and export activities (including securing reimbursement, sales and marketing and conducting any post-marketing trials or databases and post-marketing safety surveillance) with respect to Biotest Products in the Territory. Without limiting the generality of the foregoing, Biotest shall have the sole right and responsibility, at its sole expense, (a) for the conduct of: (i) all activities related to human clinical trials (including, to the extent conducted, Phase IV clinical trials); (ii) all activities relating to the

4.3   Commercialization Diligence . Biotest shall use Commercially Reasonable Efforts during the Term to Develop and to Commercialize Biotest Products in the Field and in the Territory. Without limiting the foregoing, Biotest shall, itself or through one or more Sublicensees, seek Regulatory Approvals for, and Commercialize, each Biotest Product in such countries of the Territory that Biotest, in its commercially reasonable judgment, deems appropriate. If ImmunoGen at any time reasonably believes that Biotest is not meeting its diligence obligations pursuant to this Section 4.3, ImmunoGen may give, in the form of detailed reasons, written notice to Biotest requesting written justification, in the form of detailed reasons, that would support the proposition that Biotest is meeting such diligence obligations. In such event, Biotest shall provide such written justification to ImmunoGen within thirty (30) days after such notice is given. In the event that Biotest does not reasonably justify that it is meeting its diligence obligations pursuant to this Section 4.3 within such thirty (30) day period, then, to the extent such failure to meet its diligence obligations constitutes a material breach of this Agreement, ImmunoGen shall have the right, in its sole discretion, to exercise its rights under Section 11.2.1 or any or all other rights or remedies