1.2.                             “ Affiliate ” shall mean any corporation, firm, limited liability company, partnership or other entity which directly or indirectly controls or is controlled by or is under common control with a Party to this Agreement.  For purposes of this Section 1.2, “control” means ownership, directly or indirectly through one or more Affiliates, of fifty percent (50%) or more of the shares of stock entitled to vote for the election of directors, in the case of a corporation, or fifty percent (50%) or more of the equity interests in the case of any other type of legal entity, or status as a general partner in the case of any partnership, or any other arrangement whereby a Party controls or has the right to control the Board of Directors or equivalent governing body or management of a corporation or other entity.

 

1.3.                             “ Agreement ” shall mean this Development and License Agreement between the Parties, dated as of the Effective Date, including any exhibits, schedules or other attachments hereto and incorporated herein, as any of the foregoing may be validly amended from time to time.  In the event of any inconsistency between the terms of this Agreement and the terms of any exhibits, schedules or other attachments incorporated herein, unless the Parties expressly agree otherwise in writing, the terms of this Agreement shall govern.

 

1.4.                             “ Antibody ” shall mean a composition comprising a whole antibody or fragment thereof (whether polyclonal or monoclonal, 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 an antibody or fragment.

 

1.5.                             “[******************]” shall mean any Program Technology that is a structural modification, formulation, method of use, administration or delivery of an [***] [***] or other [***] not [***] to a [***] [***********] .

 

1.6.                             “ [***] Antibody ” shall mean any Antibody that is Controlled by Biogen Idec and that binds with a protein encoded by any gene within the [***] Gene Family.

 

1.7.                             “ Biogen Idec Background Technology ” means any Technology used by Biogen Idec, or provided by Biogen Idec for use, in the Research Program that is useful in the Field and that is (a) Controlled by Biogen Idec as of the Effective Date or (b) Controlled by Biogen Idec and developed or conceived by employees of, or consultants to, Biogen Idec on and after the Effective Date in the conduct of activities outside the Research Program and without the use of any Licensed Technology, Licensed Patent Rights or Joint Program Technology.

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company's application requesting confidential investment under Rule 24b-2 under the Securities Exchange Act of 1934.

 

2

 

1.8.                             “ Biogen Idec Patent Rights ” shall mean all Patent Rights with respect to Biogen Idec Background Technology.

 

1.9.                             “ Biogen Idec Program Technology ” shall mean any Program Technology made solely by employees of, or agents or others obligated to assign inventions to, Biogen Idec or a Biogen Idec Affiliate.

 

1.10.                      “ BLA ” shall mean a biologics license application (as defined in Title 21 of the United States Code of Federal Regulations, as amended from time to time) filed with the FDA seeking Regulatory Approval to market and sell any Licensed Product in the United States for a particular indication within the Field.

 

1.11.                      “ Clinical Materials ” shall mean any MAY Compound and/or [*****] -MAY Conjugates supplied by ImmunoGen to Biogen Idec pursuant to Section 4.3 and/or the Supply Agreement for use in human clinical testing.

 

1.12.                      “ Collaboration Committee ” shall mean the committee with representatives of each Party established as set forth in Section 3.4.

 

1.13.                      “ Combination Product ” shall mean a product containing both a Licensed Product and one or more other active ingredients in addition to the Licensed Product that are not covered by the Licensed Patent Rights or do not incorporate Licensed Technology where the other active ingredients have independent, additive or synergistic diagnostic, prophylactic or therapeutic effect in the disease or indication for which the Combination Product is labeled, whether the Licensed Product and the other active ingredients are together in a physical mixture or packaged and priced together as a single product.

 

1.14.                      “ Commercialization ” or “ Commercialize ” shall mean any and all activities constituting importing, marketing, distributing, offering for sale, selling, making, having made, exporting, having exported and supporting the Licensed Product in the Territory for use in the Field.  Commercialization shall include, but not be limited to, promotion as well as post-approval clinical trial and regulatory activities, including Adverse Drug Experience reporting.  When used as a verb, Commercialize shall mean to engage in Commercialization.

 

1.15.                      “ Confidential Information ” shall mean, with respect to a Party (the “receiving Party”), all information which is disclosed by the other Party (the “disclosing Party”) to the receiving Party hereunder or to any of its employees, consultants, Affiliates or Sublicensees,

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company's application requesting confidential investment under Rule 24b-2 under the Securities Exchange Act of 1934.

 

3

 

except to the extent that the receiving Party can demonstrate by written record or other suitable physical evidence that such information, (a) prior to the disclosure is demonstrably known to the receiving Party or its Affiliates other than by virtue of a prior confidential disclosure to such Party or its Affiliates; (b) as of the date of disclosure is in, or subsequently enters, the public domain, through no fault or omission of the receiving Party; (c) is obtained from a Third Party having a lawful right to make such disclosure free from any obligation of confidentiality to the disclosing Party; or (d) is independently developed by or for the receiving Party without reference to or reliance upon any Confidential Information of the Disclosing Party.  For purposes of clarity, subject to the exceptions in the preceding sentence or as otherwise set forth in this Agreement, (a) any technical or financial information of a disclosing Party disclosed at any meeting of the Collaboration Committee, or disclosed through an audit or other report shall constitute Confidential Information of such disclosing Party, (b) the terms of this Agreement, to the extent not disclosed in a public filing or press release permitted under Section 6 of this Agreement, shall constitute Confidential Information of each Party unless otherwise specified, (c) all know-how and trade secrets disclosed by ImmunoGen to Biogen Idec in connection with the licenses set forth in Section 2.1 of this Agreement shall constitute Confidential Information of ImmunoGen, and (d) all know-how and trade secrets disclosed by Biogen Idec to ImmunoGen in connection with the license set forth in Section 2 of this Agreement shall constitute Confidential Information of Biogen Idec.

 

1.16.                      “ Consumer Price Index or CPI” shall mean the CPI for All Urban Consumers published from time to time by the Bureau of Labor Statistics of the United States Department of Labor.

 

1.17.                      “ Contract Year ” shall mean the period beginning on the Effective Date and ending on December 31, 2004 and each succeeding calendar year thereafter during the Term.

 

1.18.                      “ Control ” or “ Controlled ” shall mean, with respect to any Patent Rights Technology or Proprietary Materials (including, without limitation, any MAY Compound, [***] Antibody or other proprietary biologic material covered under this Agreement), the possession by a Party of the ability to grant a license or sublicense (other than by rights granted in this Agreement) of such Patent Rights or Technology and the rights thereto or to supply such

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company's application requesting confidential investment under Rule 24b-2 under the Securities Exchange Act of 1934.

 

4

 

Proprietary Materials as provided for in this Agreement without violating the terms of any arrangement or agreement between such Party or its Affiliates and any Third Party.

 

1.19.                      “ Cost ” shall mean, with respect to any Preclinical Materials or Clinical Materials manufactured and QC tested by ImmunoGen, ImmunoGen’s fully-burdened costs (including the costs associated with product testing and release activities) of producing and packaging such Preclinical 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 Biogen Idec without modification, the amount paid by ImmunoGen to such Third Party for the same; (b) an allocation of manufacturing overhead costs, 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 activity-based method; (c) any other reasonable 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 allocable to its departments based on space occupied or headcount or another activity-based method, according to GAAP.  Manufacturing overhead costs under the foregoing clause (b) 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 [***] to the [***] (including [******] and [********] ) of [***] -MAY Conjugate at ImmunoGen’s facilities.  Notwithstanding the foregoing, Cost shall not include the cost of purchasing any Dedicated Equipment pursuant to Section 4.4 of this Agreement.

 

1.20.                      “ [***] Gene Family ” shall mean the family of human [***] genes that encode the proteins known as, [*****] or [**************************] ( [***] ) [***] , the polypeptide sequences which are set forth on Schedule C attached hereto, any polynucleotide encoding an amino acid sequence at least [***] % identical to the aforementioned polypeptide sequences.

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company's application requesting confidential investment under Rule 24b-2 under the Securities Exchange Act of 1934.

 

5

 

1.21.                      “ [***] -MAY Conjugate ” shall mean any conjugate of an [***] Antibody with a MAY Compound.

 

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

 

1.23.                      “ Development ” and “ Develop ” shall mean, with respect to any Licensed Product, all activities with respect to such Licensed Product relating to research and development in connection with seeking, obtaining and/or maintaining any Regulatory Approval for such Licensed Product in the Field in the Territory, including without limitation, all pre-clinical research and development activities, test method development and stability testing, toxicology, formulation, process development, manufacturing scale-up, development-stage manufacturing, quality assurance/quality control development and performance, all activities relating to developing the ability to manufacture any Licensed Product or any component thereof (including, without limitation, process development work), and all other activities relating to seeking, obtaining and/or maintaining any Regulatory Approvals from the FDA and/or any Foreign Regulatory Authority and Adverse Drug Experience reporting.

 

1.24.                      “ Drug Approval Application ” shall mean any application for Regulatory Approval (including pricing and reimbursement approvals) required prior to any commercial sale or use of a Licensed Product in any country or jurisdiction in the Territory, including, without limitation, (a) any BLA, NDA or other regulatory application filed with the FDA prior to any commercial sale or use of a Licensed Product in the United States, and (b) any MAA or other equivalent regulatory application filed with any Foreign Regulatory Authority for Regulatory Approval (including pricing and reimbursement approvals) required prior to any commercial sale or use of a Licensed Product in any other country or jurisdiction in the Territory.

 

1.25.                      “ Effective Date ” shall mean the date first written above in the introductory paragraph to this Agreement.

 

1.26.                      “ EMEA ” shall mean the European Medicines Agency and any successor agency or authority thereto.

 

1.27.                      “ FDA ” shall mean the United States Food and Drug Administration and any successor agency or authority thereto.

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company's application requesting confidential investment under Rule 24b-2 under the Securities Exchange Act of 1934.

 

6

 

1.28.                      “ Field ” shall mean all human therapeutic, diagnostic and prophylactic uses.

 

1.29.                      “ First Commercial Sale ” shall mean the date of the first commercial transfer or disposition to a Third Party of a Licensed Product by or on behalf of Biogen Idec or any Affiliate or Sublicensee of Biogen Idec.

 

1.30.                      “ Foreign Regulatory Authority ” shall mean the EMEA and any other applicable supranational, national, federal, state or local regulatory agency, department, bureau or other governmental entity of any country or jurisdiction in the Territory (other than the FDA in the United States), having responsibility in such country or jurisdiction for any Regulatory Approvals of any kind in such country or jurisdiction, and any successor agency or authority thereto.

 

1.31.                      “ Full Time Equivalent ” or “ FTE ” shall mean the equivalent of one person-year of work on the Research Program, consisting of [*****] or [*************] , and which is carried out by employees, contractors or agents of ImmunoGen having the appropriate scientific expertise to conduct such activities.  For the purposes of this Agreement, [***] person [***] be [***] as [***] than [***] [***] in any given year.

 

1.32.                      “ FTE Cost ” shall mean, for any period during the Term of this Agreement, the FTE Rate multiplied by the number of FTEs expended over such period.

 

1.33.                      “ FTE Rate ” shall mean, for the [***] [***] [***] Contract Year commencing on the Effective Date, [***] ; and, for 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.

 

1.34.                      “ GMPs ” shall mean all good manufacturing practices under Title 21 of the United States Code of Federal Regulations, as amended from time to time.

 

1.35.                      “ Gross Sales ” shall mean the gross amount invoiced by Biogen Idec or its Affiliates or Sublicensees for sales of a Licensed Product to Third Parties in the Territory, including sales to distributors.  Note for purposes of clarification, Gross Sales will include Biogen Idec’s revenue from distributors, and not revenue of the distributors themselves.  A sale

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company's application requesting confidential investment under Rule 24b-2 under the Securities Exchange Act of 1934.

 

7

 

or transfer of a Licensed Product by Biogen Idec to one of its Affiliates or Sublicensees shall not be considered a sale to a Third Party for the purpose of this provision but the resale of such Licensed Product by such Affiliate or Sublicensee to a Third Party shall be a sale for such purposes.  In the event the Licensed Product is sold in the form of a Combination Product, Gross Sales will be determined by multiplying actual Gross Sales of such Combination Product by the fraction A/(A + B), where A is the invoice price of the Licensed Product, if sold separately, and B is the invoice price of any other active component or components in the combination, if sold separately, in each case in the same country and in the same class, purity and dosage as in the Combination Product.  If, on a country-by-country basis, the other active component or components in the combination are not sold separately in such country, Gross Sales shall be calculated by multiplying actual Gross Sales of such Combination Product by the fraction A/C where A is the invoice price of the Licensed Product if sold separately, and C is the invoice price of the Combination Product, in each case in the same country and in the same class, purity and dosage as in the Combination Product.  If, on a country-by-country basis, the Licensed Product component of the Combination Product is not sold separately in such country, but the other active component or components are sold separately, Gross Sales shall be calculated by multiplying actual Gross Sales of such Combination Product by the fraction (C-B)/C where B is the invoice price of the other active component or components, if sold separately, and C is the invoice price of the Combination Product, in each case in the same country and in the same class, purity and dosage as in the Combination Product.  If, on a country-by-country basis, neither the Licensed Product nor the other active component or components of the Combination Product is sold separately in such country, Gross Sales, for such Combination Product shall be determined by the Parties in good faith.

 

1.36.                      “ ImmunoGen Materials ” shall mean any Proprietary Materials Controlled by ImmunoGen and used by ImmunoGen, or provided by ImmunoGen for use, in the Research Program.  ImmunoGen Materials shall include, without limitation, any MAY Compound.

 

1.37.                      “ ImmunoGen Program Technology ” shall mean any Program Technology made solely by employees of, or agents or others obligated to assign inventions to, ImmunoGen or an ImmunoGen Affiliate.

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company's application requesting confidential investment under Rule 24b-2 under the Securities Exchange Act of 1934.

 

8

 

1.38.                      “ Improvements ” shall mean, collectively, [********************] , Licensed Technology Improvements, [*************] and MAY Compound Improvements.

 

1.39.                      “ IND ” shall mean an investigational new drug application (as defined in Title 21 of the United States Code of Federal Regulations, as amended from time to time) filed or to be filed with the FDA with regard to any Licensed Product.

 

1.40.                      “ Indemnitees ” and “ Indemnifying Party ” shall have the meanings set forth in Section 9.

 

1.41.                      “ Joint Program Technology ” shall mean any Program Technology made jointly by at least one employee or agent to, or other person obligated to assign inventions to, ImmunoGen or an ImmunoGen Affiliate, and by at least on employee or agent to, or other person obligated to assign inventions to, Biogen Idec or a Biogen Idec Affiliate.

 

1.42.                      “ Licensed Patent Rights ” shall mean any Patent Rights which are Controlled by ImmunoGen or its Affiliates as of the Effective Date or become Controlled by ImmunoGen or its Affiliates during the Term (including without limitation ImmunoGen’s interest in any Improvements Controlled by ImmunoGen or an ImmunoGen Affiliate, and ImmunoGen Program Technology and Joint Program Technology covered by Patent Rights), to the extent necessary or useful to Develop, have Developed, Commercialize, have Commercialized, make, have made, use, have used, sell, have sold, offer for sale, import, have imported, export and have exported any [***] -MAY Conjugate in the Field in the Territory.  Certain Licensed Patent Rights existing as of the Effective Date are set forth in Schedule A attached hereto and incorporated herein by reference.

 

1.43.                      “ Licensed Product ” shall mean any product (a) that incorporates, is comprised of, or is otherwise derived from Licensed Technology, or (b) the Development, Commercialization, manufacture, use, sale, offer for sale, importation or exportation of which would, but for the license granted herein, infringe a Valid Claim of the Licensed Patent Rights.

 

1.44.                      “ Licensed Technology ” shall mean any Technology which is Controlled by ImmunoGen or its Affiliates as of the Effective Date or becomes Controlled by ImmunoGen of its Affiliates during the Term (including without limitation ImmunoGen’s interest in any Improvements Controlled by ImmunoGen or its Affiliates, ImmunoGen Program Technology and Joint Program Technology), which is necessary or useful for the Development,

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company's application requesting confidential investment under Rule 24b-2 under the Securities Exchange Act of 1934.

 

9

 

Commercialization, manufacture, use, sale, offer for sale, import or export of any [***] -MAY Conjugate in the Field in the Territory.

 

1.45.                      “ Licensed Technology Improvements ” shall mean any Technology (including without limitation any Program Technology), other than [*******] [***] , MAY Compound Improvements or [*****] [*****] , conceived or reduced to practice in the course of Development of Licensed Products as a result of the use of Licensed Technology or Licensed Patent Rights or ImmunoGen Materials, that is an enhancement, improvement or modification to the Licensed Technology or to an invention claimed in the Licensed Patent Rights.  Licensed Technology Improvements does not include modifications related to humanization or other structural modifications, formulation, method of use, administration or delivery of an Antibody.

 

1.46.                      “ [*****************] ” shall mean any Program Technology that is an [***] , [***] or [***] to [***] useful for [***] a [***] or [********] , such as a [*******] , to [***] or other [***********] .

 

1.47.                      “ MAA ” shall mean an application filed with the EMEA to market and sell any Licensed Product in the European Union or any country or territory therein for a particular indication within the Field.

 

1.48.                      “ MAY Compound ” shall mean any and all maytansinoid compounds, including, without limitation (a) N ^2’ -deacetyl-N ^2’ -(3-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), and all fragments, variants and derivatives of such maytansinoid compounds.

 

1.49.                      “ MAY Compound Improvements ” shall mean any Technology (including without limitation any Program Technology) conceived or reduced to practice in the course of Development of Licensed Products, that is an enhancement, improvement or modification of a MAY Compound, and any compositions or methods useful for the manufacture of such MAY Compound.

 

1.50.                      “ MTA ” shall mean that certain Material Transfer and Evaluation Agreement between Biogen, Inc. and ImmunoGen dated [***] , [***] , as amended by amendments dated [***] , [***] , [***] , [***] , [***] , [***] and [***] , [***] .

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company's application requesting confidential investment under Rule 24b-2 under the Securities Exchange Act of 1934.

 

10

 

1.51.                      “ NDA ” shall mean a new drug application (as defined in Title 21 of the United States Code of Federal Regulations, as amended from time to time) filed with the FDA seeking Regulatory Approval to market and sell any Licensed Product in the United States for a particular indication within the Field.

 

1.52.                      “ Net Sales ” shall mean Gross Sales of a Licensed Product less applicable Sales Returns and Allowances.

 

1.53.                      “ Patent Rights ” shall mean the rights and interests in and to any and all issued patents and pending patent applications (including inventor’s certificates, applications for inventor’s certificates, statutory invention registrations, applications for statutory invention registrations, utility models, and any foreign equivalents thereof) in any country or jurisdiction in the Territory, including any and all provisionals, non-provisionals, substitutions, continuations, continuations-in-part, divisionals and other continuing applications, supplementary protection certificates, renewals, and all letters patent on any of the foregoing, and any and all reissues, reexaminations, extensions, confirmations, registrations and patents of addition on any of the foregoing.

 

1.54.                      “ Phase II Clinical Trial ” shall mean, as to a particular Licensed Product for a particular indication, a controlled and lawful study in humans of the safety, dose ranging and efficacy of such Licensed Product for such indication, which is prospectively designed to generate sufficient data (if successful) to commence a Pivotal Clinical Trial of such Licensed Product for such indication.

 

1.55.                      “ Pivotal Clinical Trial ” shall mean, as to a particular Licensed Product for a particular indication, a controlled and lawful study in humans of the safety and efficacy of such Licensed Product for such indication, which is prospectively designed to demonstrate statistically whether such Licensed Product is safe and effective for use in such indication in a manner sufficient to file an NDA or BLA to obtain Regulatory Approval to market and sell that Licensed Product in the United States or in any other country in the Territory for the indication under investigation in such study.

 

1.56.                      “ Preclinical Materials ” shall mean any MAY Compound and/or [***] -MAY Conjugates supplied by ImmunoGen to Biogen Idec under Section 4.2 for the purpose of conducting research activities and/or preclinical testing with respect to a Licensed Product.

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company's application requesting confidential investment under Rule 24b-2 under the Securities Exchange Act of 1934.

 

11

 

1.57.                      “ Program Technology ” shall mean any Technology, whether or not patentable, conceived or reduced to practice in the conduct of the Research Program, or during manufacture of Preclinical Material or Clinical Material.

 

1.58.                      “ Proprietary Materials ” shall mean any tangible chemical, biological or physical research materials that are furnished by or on behalf of one Party to the other Party in connection with this Agreement, regardless of whether such materials are specifically designated as proprietary by the transferring Party.

 

1.59.                      “ Regulatory Approval ” shall mean any and all approvals (including pricing and reimbursement approvals), product and establishment licenses, registrations or authorizations of any kind of any Regulatory Authority necessary for the development, pre-clinical and/or human clinical testing, manufacture, quality testing, supply, use, storage, importation, export, transport, marketing and sale of a Licensed Product (or any component thereof) for use in the Field in any country or other jurisdiction in the Territory.

 

1.60.                      “ Regulatory Authority ” shall mean the FDA and/or a Foreign Regulatory Authority.

 

1.61.                      “ Research Plan ” shall mean the written plan describing the research activities to be carried out by each Party pursuant to this Agreement.

 

1.62.                      “ Research Program ” shall mean the research activities in the Field commencing after the Effective Date to be conducted by the Parties pursuant to Section 3.1 of this Agreement and reflected in the Research Plan.

 

1.63.                      “ Sales Returns and Allowances ” shall mean the sum of (a) and (b), where: (a) is a provision, determined by Biogen Idec under U.S. GAAP for sales of Licensed Product in the Territory for (i) trade, cash and quantity discounts on Licensed Product (other than price discounts granted at the time of invoicing and which are already included in the determination of Gross Sales), (ii) credits or allowances given or made for rejection or return of previously sold Licensed Product or for rebates or retroactive price reductions (including Medicare, Medicaid and similar types of rebates and chargebacks), (iii) taxes, duties or other governmental charges levied on or measured by the billing amount for Licensed Product, as adjusted for rebates and refunds (excluding income and franchise taxes), (iv) charges for freight and insurance directly related to the distribution of Licensed Product, to the extent included in Gross Sales, and (v)

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company's application requesting confidential investment under Rule 24b-2 under the Securities Exchange Act of 1934.

 

12

 

credits for allowances given or made for wastage replacement, indigent patient and any other sales programs for Licensed Product to the extent the sale of the Licensed Product was included in Gross Sales and the credit is applied against such Gross Sales; and (b) is a periodic adjustment of the provision determined in (a) to reflect amounts actually incurred by Biogen Idec in the Territory for items (i), (ii), (iii), (iv) and (v) in clause (a).

 

1.64.                      “ Sublicensee ” shall mean any Third Party expressly sublicensed by Biogen Idec in accordance with Section 2.1(a)(ii) of this Agreement.  A Sublicensee shall not include (a) a distributor or other Third Party who purchases Licensed Products for the sole purpose of selling such Licensed Products but not to make, have made or formulate Licensed Product (other than a license to perform final packaging of Licensed Product) or (b) a Third Party who primarily performs sales and/or marketing activities with respect to such Licensed Products.

 

1.65.                      “ Target ” shall mean any antigen with which a particular Antibody interacts, and any fragment, peptide or epitope thereof.

 

1.66.                      “ Technology ” shall mean and include any and all unpatented proprietary ideas, trade secrets, inventions, discoveries, data, results, formulae, designs, specifications, methods, processes, formulations, techniques, know-how, technical information (including, without limitation, structural and functional information), process information, pre-clinical information, clinical information, and any and all proprietary biological, chemical, pharmacological, toxicological, pre-clinical, clinical, assay, control and manufacturing data and materials.

 

1.67.                      “ Term ” shall mean the period commencing on the Effective Date and continuing until the expiration or termination of this Agreement in accordance with the terms hereof.

 

1.68.                      “ Territory ” shall mean all countries and jurisdictions of the world.

 

1.69.                      “ Third Party ”, as to a Party, shall mean any entity other than the Party and its respective Affiliates.

 

1.70.                      “ Third Party Payments ” shall have the meaning set forth in Section 5.3(b).

 

1.71.                      “ Upfront Fee ” shall have the meaning set forth in Section 5.1(a).

 

1.72.                      “ Valid Claim ” shall mean a claim (i) of any issued, unexpired patent within the Licensed Patent Rights that (a) has not been finally cancelled, withdrawn, abandoned or rejected by any administrative agency or other body of competent jurisdiction, or (b) has not been revoked, held invalid, or declared unpatentable or unenforceable in a decision of a court or other

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company's application requesting confidential investment under Rule 24b-2 under the Securities Exchange Act of 1934.

 

13

 

body of competent jurisdiction that is unappealable or unappealed within the time allowed for appeal, or (c) has not been rendered unenforceable through disclaimer or otherwise, or (d) is not lost through an interference proceeding; or (ii) of any patent application within the Licensed Patent Rights that shall not have been (a) cancelled, withdrawn, abandoned, or (b) been pending for more than [***] ( [***] ) years.

 

2.                                       GRANT OF RIGHTS

 

2.1                                License Grants .

 

(a)                                    Commercialization License .

 

(i)                                      License to Biogen Idec .  Subject to the terms and conditions of this Agreement, ImmunoGen hereby grants to Biogen Idec an exclusive, royalty-bearing license, including the right to grant sublicenses as described in Section 2.1(a)(ii) below, under the Licensed Patent Rights and Licensed Technology, to Develop, have Developed, Commercialize, have Commercialized, make, have made, use, have used, sell, have sold, offer for sale, import, have imported, export and have exported Licensed Products in the Field in the Territory.  Biogen Idec shall have the full and unrestricted right to extend the licenses granted under this Section 2.1(a)(i) and elsewhere under this Agreement to its Affiliates.  Biogen Idec shall promptly advise ImmunoGen in writing of any such extension to its Affiliates.  [***] shall be responsible for paying any royalty obligations that ImmunoGen may have to any of its Affiliates or to any Third Party under agreements between ImmunoGen and such Affiliates or Third Parties in effect as of the Effective Date arising from the license grant herein.

 

(ii)                                   Right to Sublicense .  Biogen Idec shall have the right freely to grant sublicenses to all or any portion of its rights under the license rights granted pursuant to Section 2.1(a)(i) hereof to any Third Party; provided , however , that (1) ImmunoGen shall be notified in writing of each such sublicense, (2) any and all sublicenses shall be consistent with the terms and conditions of this Agreement, and (3) Biogen Idec shall remain obligated for the payment to ImmunoGen of all of its payment obligations hereunder, including, without limitation, the payment of any milestones and royalties described in Section 5 hereof.

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company's application requesting confidential investment under Rule 24b-2 under the Securities Exchange Act of 1934.

 

14

 

(b)                                   Research Licenses .

 

(i)                                      Research License to Biogen Idec .  Subject to the terms and conditions of this Agreement, during the Term of this Agreement, ImmunoGen hereby grants to Biogen Idec a fully paid up, non-exclusive, royalty free, worldwide license, without the right to grant sublicenses, under the Licensed Technology and Licensed Patent Rights for the sole purpose of conducting the activities required in the performance of its obligations hereunder as part of the Research Program.

 

(ii)                                   Research License to ImmunoGen .  Subject to the terms and conditions of this Agreement, during the Term of this Agreement, Biogen Idec hereby grants to ImmunoGen a paid-up, non-exclusive, royalty-free, worldwide license, without the right to grant sublicenses, under the Biogen Idec Background Technology and Biogen Idec Patent Rights and Biogen Idec’s interest in any Improvements Controlled by Biogen Idec or its Affiliates, Biogen Idec Program Technology and Joint Program Technology, for the sole purpose of conducting the activities required in the performance of its obligations hereunder as part of the Research Program.

 

2.2                                Retained Rights and Covenants .

 

(a)                                    Retained Rights .  Subject to the other terms of this Agreement (including, without limitation, Sections 2.2(b) and 2.3), ImmunoGen retains the right to use the Licensed Technology and Improvements Controlled by ImmunoGen and practice the Licensed Patent Rights (i) to perform its obligations under this Agreement (including without limitation its obligation to manufacture Preclinical Materials and Clinical Materials in accordance with Section 4 of this Agreement) (ii) to develop, have developed, commercialize, have commercialized, make, have made, use, have used, sell, have sold, offer for sale, import, have imported, export and have exported any product that does not contain a conjugate of a MAY Compound to an Antibody which selectively and specifically binds with a protein encoded by a gene within the [***] Gene Family, and (iii) for any and all uses outside of the Field.

 

(b)                                   Covenants .  Notwithstanding anything to the contrary contained in this Agreement, ImmunoGen hereby agrees during the Term of this Agreement, that it shall not (i) grant to any Third Party any license or other right under any Patent Rights, Improvements or Technology Controlled by ImmunoGen or its Affiliates to develop, have developed, commercialize, have commercialized, make, have made, use, have used, sell, have sold, offer for

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company's application requesting confidential investment under Rule 24b-2 under the Securities Exchange Act of 1934.

 

15

 

sale, import, have imported, export and have exported any product containing a conjugate of a MAY Compound to an Antibody which selectively and specifically binds with a protein encoded by a gene within the [***] Gene Family, or (ii) outside the performance of its obligations under this Agreement, develop, have developed, commercialize, have commercialized, make, have made, use, have used, sell, have sold, offer for sale, import, have imported, export and have exported any products containing a conjugate of a MAY Compound to an Antibody which selectively and specifically binds with a protein encoded by a gene within the [***] Gene Family.

 

2.3                                Improvement Licenses .

 

(a)                                    License to ImmunoGen .  Biogen Idec hereby grants to ImmunoGen a non-exclusive, fully paid, irrevocable, royalty-free license, including, except as set forth below, the right to grant sublicenses, (i) under Biogen Idec’s interest in Improvements Controlled by Biogen Idec or its Affiliates to manufacture Clinical Materials or Preclinical Materials pursuant to the terms of this Agreement, and/or each applicable Supply Agreement, (ii) under Biogen Idec’s interest in [**********] , MAY Compound Improvements, and Licensed Technology Improvements, Controlled by Biogen Idec or its Affiliates, to develop, have developed, commercialize, have commercialized, make, have made, use, sell, have sold, offer for sale, import, have imported, export, and have exported any product that is conjugated to a MAY Compound that is not a conjugate of a MAY Compound to an Antibody which selectively and specifically binds with a protein encoded by a gene within the [***] Gene Family, and (iii) under Biogen Idec’s interest in MAY Compound Improvements and Licensed Technology Improvements Controlled by Biogen Idec or its Affiliates to exploit such MAY Compound Improvements and Licensed Technology Improvements for any and all uses outside of the Field.  The licenses granted under Biogen Idec’s interest in Improvements Controlled by Biogen Idec or its Affiliates are limited to such Improvements only.  Notwithstanding the foregoing, ImmunoGen shall only be permitted to sublicense rights to Improvements granted by Biogen Idec under this Section 2.3(a) to any Third Party which has entered into an agreement with ImmunoGen involving the license to such Third Party of ImmunoGen’s Technology used in the conjugation of maytansine derivatives to binding proteins (“ImmunoGen MAY Technology”)

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company's application requesting confidential investment under Rule 24b-2 under the Securities Exchange Act of 1934.

 

16

 

and which contains Substantially Similar Grant Back Rights (as defined below) (each such Third Party, a “Qualified ImmunoGen MAY Licensee”).  For purposes of this Agreement, “Substantially Similar Grant Back Rights” shall mean the grant by a Qualified ImmunoGen MAY Licensee to ImmunoGen of a non-exclusive license to MAY Improvement Patent Rights (as defined below) with the right to sublicense to all other Qualified ImmunoGen MAY Licensees, the grant by a Qualified ImmunoGen MAY Licensee of a non-exclusive license to MAY Improvement Patent Rights (as defined below) to all other Qualified ImmunoGen MAY Licensees, or the ownership by ImmunoGen of MAY Improvement Patent Rights, which ownership results in ImmunoGen Controlling such MAY Improvement Patent Rights.  For purposes of the foregoing, “MAY Improvement Patent Rights” shall mean Patent Rights which are (a) discovered by (or on behalf of) such Qualified ImmunoGen MAY Licensee through the use of ImmunoGen MAY Technology and (b) which represent an enhancement or improvement to ImmunoGen MAY Technology.  Nothing in this Agreement or the course of dealings between the Parties or usage or custom in the industry or trade shall be construed to confer any other rights or licenses to any other intellectual property Controlled by Biogen Idec or its Affiliates by implication, estoppel or otherwise.

 

(b)                                   Licenses to Biogen Idec .  ImmunoGen hereby grants to Biogen Idec (i) a perpetual, worldwide, non-exclusive, fully paid, irrevocable, royalty-free license, including the right to [*******], under ImmunoGen’s interest in [************] Controlled by ImmunoGen or its Affiliates to develop, have developed, commercialize, have commercialized, make, have made, use, sell, have sold, offer for sale, import, have imported, export and have exported [*****************************] for [***] and [***] and (ii) a [******************] (even as to ImmunoGen) [*******************************] , under ImmunoGen’s interest in [*****] Controlled by ImmunoGen or its Affiliates, to develop, have developed, commercialize, have commercialized, make, have made, use, sell, have sold, offer for sale, import, have imported, export and have exported [********] for [***] and [***] .  The licenses granted under ImmunoGen’s interest in Improvements Controlled by ImmunoGen or its Affiliates are limited to such Improvements only.  Nothing in this Agreement or the course of dealings between the Parties or usage or custom in the industry or trade shall be construed to

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company's application requesting confidential investment under Rule 24b-2 under the Securities Exchange Act of 1934.

 

17

 

confer any other rights or licenses to any other intellectual property Controlled by ImmunoGen or its Affiliates by implication, estoppel or otherwise.

 

2.4                                Right to [************************] .   In accordance with and subject to this Section 2.4, Biogen Idec shall have the right, at any time during the period commencing on the Effective Date and continuing until [***] , [***] (the “ [**********************] ”) to [***] that ImmunoGen [***] into an [****************] on [***************]   to the [***] set forth in this [***] (each, an “ [*********************] ”) with respect to any Antibody (other than an [***] Antibody) and Target (each, a “ [*******] ”) by providing a written notice to ImmunoGen, which notice shall specify in reasonable detail the [*******] that it wishes to be the subject of an [*************] (the “ [*************] ”).  ImmunoGen shall provide a written notice to Biogen Idec within [***] ( [***] ) days of its receipt of any [*************] specifying whether or not it wishes to [***] into an [*************] with respect to the [******] (the “ [**********] ”).  In the event that ImmunoGen indicates in its [*************]   that it [***] to the [***] of an [*************] with respect to the [******] described in the [*************] , the Parties shall negotiate in good faith an [*************] in the form of [*****] with respect to the [*****] .  If in the [*************] , ImmunoGen indicates that it does not wish to [***] into an [*************] with respect to the [*****] described in the [*************] , ImmunoGen shall have no further obligations to Biogen Idec under this Section 2.4 with respect to the [*****] described in the [*************] .  Notwithstanding anything to the contrary set forth in this Agreement, the Parties hereby agree that (a) on and after the expiration of the [****************] , ImmunoGen shall have no further obligations to Biogen Idec under this Section 2.4 and (b) Biogen Idec shall have the right to select and maintain no more than [***] ( [***] ) [*****************************] (in addition to [******] ).

 

3.                                       RESEARCH PROGRAM; DEVELOPMENT AND COMMERCIALIZATION
OF LICENSED PRODUCTS

 

3.1                                Research Program .

 

(a)                                    Implementation of Research Program .  As soon as practicable after the Effective Date, the Parties shall prepare a Research Plan which shall set forth with reasonable specificity the research objectives and tasks to be conducted by the Parties under the Research

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company's application requesting confidential investment under Rule 24b-2 under the Securities Exchange Act of 1934.

 

18

 

Program, which shall be designed to facilitate the selection of the appropriate [***] Antibodies and MAY Compound to be used in preparing the [***] -MAY Conjugate.  Without limiting the foregoing, to the extent that Biogen Idec requests that ImmunoGen manufacture Preclinical Materials and Clinical Materials, ImmunoGen shall, in consultation with Biogen Idec, as part of the Research Program, conduct all process development activities as ImmunoGen determines in its discretion are reasonably necessary to produce the quantities of Preclinical Materials and Clinical Materials so ordered, which process development activities shall be [***] within the [***] of [***] to be [***] by Biogen Idec pursuant to Sections 4.2 and 4.3 of this Agreement, provided that [******] shall have [***] - [***] the [***] for such [******] activities.  The Parties acknowledge and agree that Biogen Idec shall have the final decision making authority with respect to the establishment of, additions to and modifications of the Research Plan, provided that allocation of activities specifically to ImmunoGen under the Research Plan, including any amendments or updates to such activities, shall be subject to ImmunoGen’s prior written consent, which consent shall not be unreasonably withheld.  Each Party agrees that the activities assigned to it in the Research Plan shall be conducted diligently and in good scientific manner in accordance with accepted laboratory practices and in compliance with any and all laws, regulations and bioethical conventions applicable to the jurisdiction in which those activities take place.

 

(b)                                   Collaborative Efforts and Reports .  The Parties agree that the successful execution of the Research Program will require the collaborative use of both Parties’ areas of expertise.  The Parties shall keep the Collaboration Committee and each other fully informed about the status of the Research Program.  Scientists at ImmunoGen and Biogen Idec shall cooperate in the performance of the Research Program and, subject to any confidentiality obligations to Third Parties, shall exchange information and materials in a mutually acceptable secure manner as necessary to carry out the Research Program, but subject to the provisions of Section 6 hereof.  The Parties expect that such exchange of information and materials may involve short-term on-site visits (up to a few weeks) by scientists of each Party to the facilities of the other Party.

 

(c)                                    Additional Obligations of ImmunoGen .  Subject to the other terms of this Agreement, ImmunoGen may, [***] [***] [***] [***] , conduct such additional research

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company's application requesting confidential investment under Rule 24b-2 under the Securities Exchange Act of 1934.

 

19

 

activities that ImmunoGen determines, in its sole discretion are necessary or useful for the Development of Licensed Products.  ImmunoGen shall provide Biogen Idec with all information and materials Controlled by ImmunoGen resulting from such research activities.  Without limiting the generality of the foregoing, at Biogen Idec’s request, ImmunoGen shall from time to time, provide Biogen Idec with technical assistance within ImmunoGen’s area of expertise (or its subcontractors) concerning the Development of Licensed Products, provided that such technical assistance and expertise is within the scope of the Licensed Technology and/or Licensed Patent Rights covered under this Agreement.  Such technical assistance and expertise shall include, but not be limited to, visits by ImmunoGen personnel to Biogen Idec and visits by Biogen Idec personnel to ImmunoGen (or its subcontractors), at Biogen Idec’s expense, at such times and for such periods of time as may be reasonably acceptable to the Parties.

 

(d)                                   Supply of Proprietary Materials .  From time to time during the Research Program, either Party (the “transferring Party”) may supply the other Party (the “recipient Party”) with its Proprietary Materials for use in the Research Program.  In connection therewith, the recipient Party hereby agrees that (i) it shall not use Proprietary Materials for any purpose other than exercising any rights specifically granted to it or reserved by it hereunder; (ii) it shall use the Proprietary Materials only in compliance with all applicable, federal, state, and local laws and regulations; (iii) it shall not transfer any Proprietary Materials to any Third Party without the prior written consent of the transferring Party, except as expressly permitted hereby or by Article 6; (iv) the transferring Party shall retain full ownership of all such Proprietary Materials; and (v) upon the expiration or termination of this Agreement, the recipient Party shall at the instruction of the transferring Party either destroy or return any Proprietary Materials which are not the subject of the grant of a continuing license hereunder.

 

(e)                                    Transition of Services Being Provided by ImmunoGen .  In the event that ImmunoGen fails to carry out its material obligation(s) under Section 3.1(a), 3.2(b) 4.2 or 4.3 of this Agreement, (i) Biogen Idec shall provide ImmunoGen with written notice which shall identify such material obligation(s) and (ii) solely to the extent ImmunoGen fails to remedy such failure on or before [***] ( [***] ) days of receipt of such notice, Biogen Idec may, in addition to other remedies available to it under this Agreement at law and in equity, assume such obligations which ImmunoGen has failed to carry out under such Sections or assign them to a Third Party.

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company's application requesting confidential investment under Rule 24b-2 under the Securities Exchange Act of 1934.

 

20

 

ImmunoGen agrees to reasonably cooperate with Biogen Idec in the transition of its activities under this Section 3.1(e) to Biogen Idec or a Third Party as contemplated by the preceding sentence, such cooperation to include without limitation using commercially reasonable efforts to [**************************] of [********] to permit Biogen Idec or a Third Party to carry out the activities transitioned under this Section 3.1(e).  Upon completion of the transition of activities set forth above, the Parties shall negotiate in good faith an [****************] to any provisions related to [***] and [***] from Biogen Idec to ImmunoGen under this Agreement to [***] for the [***] of such services.

 

3.2                                Development and Commercialization .

 

(a)                                    Responsibility .  Subject to Section 3.3 of this Agreement, on and after the Effective Date, Biogen Idec shall have sole control and authority over the Development and Commercialization of Licensed Products in the Field in the Territory, including, without limitation, (i) research and all pre-clinical Development activities (including the assessment of alternative designs for the [***] -MAY Conjugate, the selection of the final [***] Antibody and MAY Compound to be used in the [***] -MAY Conjugate and the selection of the [***] -MAY Conjugate to be Developed as a Licensed Product, all preclinical and IND-enabling studies, including toxicology testing, any pharmaceutical development work on formulations or process development relating to any such Licensed Product), (ii) all activities related to human clinical trials (including any Phase II Clinical Trials and/or Pivotal Trials), (iii) subject to Section 4 of this Agreement, all activities relating to manufacture and supply of all [***] Antibodies, all MAY Compounds, all [***] -MAY Conjugates and all Licensed Products, to the extent such activities relate to the Development and Commercialization of Licensed Products (including all required process development and scale up work with respect thereto), (iv) all Commercialization, activities relating to any Licensed Product, and (v) all activities relating to any regulatory filings, registrations, applications and Regulatory Approvals relating to any of the foregoing (including any INDs or foreign equivalents, any manufacturing facility validation and/or licensure, any Drug Approval Applications and any

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company's application requesting confidential investment under Rule 24b-2 under the Securities Exchange Act of 1934.

 

21

 

other Regulatory Approvals).  Biogen Idec shall own all Technology arising from any such activities under this Agreement as well as all regulatory filings, registrations, applications and Regulatory Approvals relating to Licensed Products (including any INDs or foreign equivalents, any Drug Approval Applications and any other Regulatory Approvals), and all of the foregoing Technology, filings, registrations, applications and Regulatory Approvals relating to Licensed Products shall be considered Confidential Information solely owned by Biogen Idec.  Notwithstanding the foregoing, ImmunoGen shall own all Technology arising from ImmunoGen’s activities relating to the manufacture and supply of MAY Compounds and Licensed Products to Biogen Idec, and all such Technology shall be considered Confidential Information solely owned by ImmunoGen.  All activities relating to Development and Commercialization of Licensed Products under this Agreement shall be undertaken at Biogen Idec’s sole cost and expense, except as otherwise expressly provided in this Agreement.

 

(b)                                   Licensed Technology and Information – Regulatory Authorities and Manufacturing .  ImmunoGen shall disclose and make available to Biogen Idec in a timely manner all Licensed Technology requested by Biogen Idec for use by Biogen Idec, its Affiliates and Sublicensees in connection with Development and Commercialization activities and filings with Regulatory Authorities including, without limitation, the Licensed Technology relating to the manufacture and supply of MAY Compounds and Licensed Products owned by ImmunoGen under Section 3.2(a) and other Confidential Information and Proprietary Materials of ImmunoGen.  Upon request by Biogen Idec and at Biogen Idec’s expense, ImmunoGen shall transfer to Biogen Idec (and/or a Third Party designated by Biogen Idec) all manufacturing-related Licensed Technology (including without limitation Confidential Information, Proprietary Materials, batch records, assays and SOPs) necessary or useful for Biogen Idec and/or its designee to manufacture and supply Licensed Product and related materials (including without limitation, the MAY Compound and the [***] -MAY Conjugate, Preclinical Materials and Clinical Materials) and ImmunoGen shall use commercially reasonable efforts to ensure that such transfer of Licensed Technology is completed promptly following each such Biogen Idec request.

 

(c)                                    Due Diligence .  Biogen Idec will use commercially reasonable efforts to Develop Licensed Products, and to undertake investigations and actions required to obtain appropriate Regulatory Approvals necessary to market Licensed Products, in the Field and in the Territory and, if approved, to Commercialize Licensed Products, such commercially reasonable efforts to be in accordance with the efforts and resources Biogen Idec would use for a compound

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company's application requesting confidential investment under Rule 24b-2 under the Securities Exchange Act of 1934.

 

22

 

owned by it or to which it has rights, which is of similar market potential at a similar stage in development as the applicable Licensed Product, taking into account the proprietary position of the Licensed Product, the relative potential safety and efficacy of the Licensed Product, the regulatory requirements involved in its Development, Commercialization and Regulatory Approval, the cost of goods and availability of capacity to manufacture and supply the Licensed Product at commercial scale, and other relevant factors including, without limitation, technical, legal, scientific or medical factors.

 

3.3                                Updates and Reports; Notification of Milestones; Exchange of Adverse Drug Experience Information .

 

(a)                                    Updates and Reports .  Biogen Idec shall keep ImmunoGen reasonably informed of the progress of Biogen Idec’s efforts to Develop and Commercialize Licensed Products in the Field in the Territory by providing ImmunoGen with brief written reports no less frequently than on or about December 31 of each year during the Term of this Agreement (other than December 31, 2004) which shall summarize Biogen Idec’s efforts to so Develop and Commercialize Licensed Products hereunder, identify the Drug Approval Applications with respect to any Licensed Product that Biogen Idec and its Affiliates and Sublicensees have filed, sought or obtained in the prior twelve (12)-month period, and any they reasonably expect to make, seek or attempt to obtain in the following twelve (12)-month period.

 

(b)                                   Notification of Milestone Achievement .  Biogen Idec shall provide ImmunoGen with prompt written notice of the occurrence of any event giving rise to an obligation to make a milestone payment to ImmunoGen under Section 5.1(b), which shall in any event be no later than ten (10) business days after the occurrence of such event, and shall provide ImmunoGen with prompt written notice of the occurrence of the First Commercial Sale of any particular Licensed Product.  In the event that, notwithstanding the fact that Biogen Idec has not given any such notice, ImmunoGen believes any such milestone event has occurred, it shall so notify Biogen Idec in writing, and shall provide to Biogen Idec the data and information demonstrating that the conditions for payment have been achieved.  Within ten (10) business days of its receipt of such notice, the Parties shall meet to review the data and information and shall agree in good faith whether or not the conditions for payment have been achieved.

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company's application requesting confidential investment under Rule 24b-2 under the Securities Exchange Act of 1934.

 

23

 

(c)                                    Adverse Drug Experiences .  The Parties agree to negotiate in good faith a safety data exchange agreement within a commercially reasonable period of time before the commencement of a first human clinical trial with Licensed Products, such agreement to cover, among other things, information sharing between the Parties regarding Adverse Drug Experiences relating to Licensed Products; provided , that , the Parties hereby acknowledge and agree that the failure of the Parties to negotiate such agreement foregoing shall in no way limit or otherwise affect the Parties’ respective obligations to provide the other Party with any and all Adverse Drug Experiences in its Control relating to Licensed Products or other MAY Compound-conjugated products as is reasonably necessary to ensure the safe use of MAY Compound-conjugated products by the Parties.

 

(d)                                   Review of Correspondence for Licensed Products .  Biogen Idec shall use reasonable commercial efforts to provide ImmunoGen with at least [***] ( [***] ) days advance notice of any material meeting with the FDA which is for the purpose of obtaining Regulatory Approval for any Licensed Product and Biogen Idec shall provide to ImmunoGen the minutes of any such meeting communicated to or from the Regulatory Authority within [***] ( [***] ) days from the date on which the meeting minutes were submitted to, or received from such Regulatory Agency.

 

(e)                                    Confidential Information .  All information, reports, updates, Adverse Drug Experience, product complaint and other information provided by the disclosing Party to the receiving Party under this Agreement (including under this Section 3.3), shall be considered Confidential Information of the disclosing Party, subject to the terms, exceptions and permitted disclosures of Section 6.

 

3.4                                Collaboration Committee .

 

(a)                                    Mandate and Establishment of Committee .  Promptly after the Effective Date, the Parties shall form a Collaboration Committee to serve as a forum for coordination and communication between the Parties with respect to the Research Program and/or the Development of manufacturing processes applicable to any MAY Compound or Licensed Product covered by this Agreement (including, without limitation, all process science and process development work, formulation work, and quality control/assurance work hereunder), and to assist Biogen Idec in the exercise of its rights to make or have made Licensed Products

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company's application requesting confidential investment under Rule 24b-2 under the Securities Exchange Act of 1934.

 

24

 

under this Agreement.  The Collaboration Committee shall solely serve as a forum for coordination and communication and shall not have any authority to make decisions.  Within a reasonable period of time after the Effective Date, the Parties shall each nominate representatives (which shall be no less than two (2) and no more than five (5) each) for membership on the Collaboration Committee.  Each representative shall be an individual of suitable authority and seniority who has