Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Exhibit 10.37 COLLABORATIVE RESEARCH, DEVELOPMENT AND
COMMERCIALIZATION AGREEMENT This COLLABORATIVE RESEARCH, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT (the " Agreement" ), effective as of January 30, 2006 (the " Effective Date" ) is made by and between Pharmion Corporation, a corporation organized under the laws of the State of Delaware, USA, with a place of business at 2525-28 th Street, Suite 200, Boulder, Colorado, 803301, USA (" Pharmion Corporation" ) and Pharmion GmbH, a wholly-owned subsidiary of Pharmion Corporation registered in Switzerland having its principle place of business at Aeschenvorstadt 71, 4051 Basel, Switzerland (" Pharmion GmbH" and, collectively with Pharmion Corporation, " Pharmion" ) on the one hand and MethylGene Inc., a corporation organized under the laws of Quebec, Canada, with its principal place of business at 7220 Frederick-Banting, Suite 200, Montreal, Que9bec H4S 2A1, Canada (" MG" ). Each of Pharmion and MG shall be referred to as a " Party" and, together, as the " Parties ." BACKGROUND A. MG has developed certain proprietary technology related to small molecule HDAC Inhibitors (as defined below), which may be useful for developing pharmaceutical products for the treatment and prophylaxis of cancer in humans. B. Pharmion possesses pharmaceutical development and commercialization capabilities. C. MG has identified certain novel, proprietary HDAC Inhibitors, including the Compound designated as MGCD0103, which MG is pursuing as potential development candidates for cancer. D. MG and Pharmion desire to collaborate to pursue potential commercial development in the cancer field of one or more HDAC Inhibitors, discovered by MG prior to the Effective Date, and discover and potentially commercialize additional HDAC Inhibitors as potential development compounds for cancer, all on the terms and conditions set forth herein. E. In addition, MG desires to grant to Pharmion, and Pharmion desires to obtain, a license from MG of HDAC Inhibitors for use in the Territory (as defined below) in the Field (as defined below), on the terms and conditions set forth herein. NOW THEREFORE, for and in consideration of the covenants, conditions, and undertakings hereinafter set forth, it is agreed by and between the Parties as follows: ARTICLE 1
DEFINITIONS 1.1 " Actions" shall have the meaning set forth in Section 17.5.
- 1 -
1.2 " Additional Clinical Candidate(s)" shall mean a Selected Compound with respect to which IND enabling studies have been completed pursuant to the Collaboration, other than the Initial Clinical Candidate. 1.3 " Additional Partner" shall mean each Third Party who is granted by MG, directly or indirectly, a right to market or commercialize Compounds and/or Products outside the Territory, other than a Non-Cancer Partner or an Opt-out Non-Cancer Partner. It is understood that, for purposes of this definition, " a right to market or commercialize" shall include an option to acquire such rights. As of the Effective Date, the sole Additional Partner is Taiho. 1.4 " Affiliate" shall mean, in the case of a subject entity, another entity which controls, is controlled by or is under common control with the subject entity. For purposes of this definition only, " control" shall mean beneficial ownership (direct or indirect) of at least fifty percent (50%) of the shares of the subject entity entitled to vote in the election of directors (or, in the case of an entity that is not a corporation, in the election of the corresponding managing authority). 1.5 " Agreement" shall have the meaning set forth in the Preamble. 1.6 " Audited Party" and " Auditing Party" shall have the meanings set forth in Section 12.5.1. 1.7 " Cancer Compound" shall have the meaning set forth in Section 11.7.1. 1.8 " Cancer HDAC Research" shall mean Research conducted by or under authority of MG that is not conducted as part of Non-Cancer HDAC Research. 1.9 " Cancer Royalty" shall have the meaning set forth in Section 11.7.1. 1.10 " Change of Control" shall mean with respect to a Party, (a) a merger, consolidation, share exchange or other similar transaction involving such Party and any Third Party which results in the holders of the outstanding voting securities of such Party immediately prior to such merger, consolidation, share exchange or other similar transaction ceasing to hold more than fifty percent (50%) of the combined voting power of the surviving, purchasing or continuing entity immediately after such merger, consolidation, share exchange or other similar transaction, (b) any transaction or series of related transactions in which any " person" , as such term is used in Sections 13(d) and 14(d) of the Securities Exchange Act of 1934, as amended (the " Exchange Act" ), together with any of such person' s " affiliates" or " associates" , as such terms are used in the Exchange Act, becomes the beneficial owner of fifty percent (50%) or more of the combined voting power of the outstanding securities of a Party, or (c) the sale or other transfer to a Third Party of all or substantially all of a Party' s assets. [***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
- 2 -
1.11 " Clinical Studies" shall mean the Preclinical Studies, as well as those certain clinical trials of a Compound and/or Product in the Territory in the Field, as set forth in the Development Plans established in accordance with Article 4 below. 1.12 " Collaboration" shall mean the Research, the Development and the Commercialization conducted pursuant to this Agreement. 1.13 " Collaboration Term" shall have the meaning set forth in Section 20.1. 1.14 " Commercialization Costs" shall mean, with respect to a Product Co-Promoted in North America, the variable costs and fixed costs properly incurred by each Party with respect to work performed by the Parties and their subcontractors in connection with the conduct of the applicable Commercialization Plan for such Product, and in accordance with the budget contained therein, including (a) the Fully Absorbed Cost of Goods for batches of such Product sold, (b) marketing, distribution and sales expenses attributable to a Product, including costs incurred in connection with commercial launch, market research, post-approval marketing studies, advertising, producing Product Promotional Materials, sponsoring seminars and symposia (including continuing medical education sponsored by the Marketing Party), sales training meetings and seminars specific to the Product, reimbursement and other patient support services, distribution costs, product liability insurance, transportation expenses including insurance (but only to the extent not charged to customers), inventory losses (except to the extent caused by the gross negligence or willful misconduct of a Party), allocated based upon the proportion of such expenses directly attributable to such Product or the activities of the Parties in connection with the conduct of the Commercialization Plan, (c) to the extent not included in the Fully Absorbed Cost of Goods of a Product, license fees, milestone payments and other amounts required to be paid to Third Parties in consideration for rights required to conduct activities under the applicable Commercialization Plan as agreed to pursuant to this Agreement, allocated based on the proportion of such costs directly attributable to such Product, (d) costs associated with Prosecution and enforcement of Licensed Patents in North America pursuant to Sections 17.4 and 17.6 covering any Co-Promoted Products and defense of Third Party intellectual property claims in North America pursuant to Section 17.5 incurred after the Marketing Approval of such Product, and (e) post-Marketing Approval regulatory expenses directly related to the Product, including costs to maintain such Marketing Approval (including user fees paid after Marketing Approval), medical and safety activities, adverse event reporting, market withdrawals, field adjustments or recalls. For purposes of this paragraph and to the extent agreed upon by the JSC and included in the applicable Commercialization Plan, " variable costs" shall be deemed to be the cost of labor (calculated on a full-time equivalent basis) and other material resources directly consumed in the execution of the applicable Commercialization Plan and " fixed costs" shall be deemed to be the fixed costs directly related to the execution of the applicable Commercialization Plan, allocated based upon the proportion of such costs directly attributable to support of the applicable Commercialization Plan or by such other method of cost allocation as may be approved by the JSC. A Party' s internal costs associated with efforts of sales representatives shall be allocated to Commercialization Costs based on reasonable metrics established by the JSC prior to obtaining Marketing Approval of a Product. Except as otherwise provided in this Agreement, all cost determinations made hereunder shall be made in accordance with GAAP. [***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
- 3 -
1.15 " Commercialization Plan" shall mean, with respect to a Product, the comprehensive plan and budget for such Product, as more fully described in Section 5.4 and approved by the JSC in accordance Sections 3.1 and 5.4.2. 1.16 " Commercialization Program" shall mean, with respect to a Product, the program for the Commercialization of such Product, as more fully described in Section 5.4 and the applicable Commercialization Plan. 1.17 " Commercialization" shall mean any and all activities directed to marketing, promoting, distributing, offering for sale and selling a Product, importing a Product for sale and manufacturing a Product for sale. 1.18 " Commercially Reasonable and Diligent Efforts" shall mean the carrying out of obligations in a diligent and sustained manner using efforts reasonably necessary or appropriate to actively develop a product in an expeditious manner, taking into consideration the countries in question and the market potential for such product. " Market potential" for a product shall be fairly determined in good faith and without limitation may be based upon the market size, labeled indication, price, competition, patent rights, product liability issues and general marketing parameters. Without limiting the foregoing, Commercially Reasonable and Diligent Efforts requires that the applicable party: (a) promptly assign responsibility for such obligations to specific employee(s) who are held accountable for progress and monitor such progress on an on-going basis, (b) set and consistently seek to achieve specific meaningful objectives for carrying out such obligations, and (c) consistently make and implement decisions and allocate the full complement of resources necessary or appropriate to advance progress with respect to such objectives in accordance with the foregoing, in each case in a manner similar to other high priority drug development programs. 1.19 " Complaint" shall mean any oral or written communication of dissatisfaction regarding the identity, quality, durability, reliability or performance of a Product. Examples include, but are not limited to appearance, low fills, foreign materials, foreign product, defective packaging or defective labeling. 1.20 " Compounds" shall mean all HDAC Inhibitors identified, synthesized, discovered or acquired (collectively, " Discovered" ) by or under authority of MG or its Affiliates: (a) prior to the Effective Date, or (b) during the Research Term, or (c) any time during the term of this Agreement after the Research Term, if Discovered in connection with Cancer HDAC Research, or (d) any time during the term of this Agreement prior to [***] after completion of the last Cancer HDAC Research, if Discovered pursuant to Non-Cancer HDAC Research; provided that in each case such HDAC Inhibitors are used or useful in the Field. With respect to each Compound, such Compound shall include all salts, esters, hydrates, solvates, polymorphs, free base, isomers, prodrugs, metabolites, conjugated forms and/or liposomal or other formulations thereof, and other compositions consisting of such Compound non-covalently bounded with other moieties. In the event that MG or its Affiliate has entered or enters into an agreement with a Third Party (including an Additional Partner or Non-Cancer Partner) in connection with Research or prior to the end of the time periods, each as described in clauses (a) through (d) above, Compounds shall [***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
- 4 -
include HDAC Inhibitors Discovered by or under authority of such Third Party during the term of its right to conduct Research granted by MG, but shall exclude those compounds that were identified or being developed by such Third Party, as an inhibitor that directly inhibits the activity of HDAC enzymes or that has therapeutic effect through the inhibition of HDAC enzymes, prior to the time an agreement was first entered into with MG or its Affiliate. For clarity, it is understood that as used herein, the term " Discovered" shall be deemed to include HDAC Inhibitors covered by a patent application filed during the particular period, it being understood that the set of HDAC Inhibitors covered by a patent or patent application shall not be deemed a single Compound for purposes of defining Selected Compounds and Non-Cancer Selected Compounds below, solely because they are covered by such patent application. 1.21 " Compound Disclosure Date" shall mean ninety (90) days after the Compound Registration Date with respect to any Compound. 1.22 " Compound Registration Date" shall mean, with respect to all Compounds, the date such Compound is Registered in the MG Compound Registry, which shall be no later than thirty (30) days after the date such Compound is first synthesized or acquired by or on behalf of MG or its Affiliates, a Non-Cancer Partner or its Affiliates, any Additional Partner or its Affiliates or Pharmion or its Affiliates, as the case may be. 1.23 " Confidential Information" shall have the meaning set forth in Section 16.1. 1.24 " Contracted Research Work" shall mean the research work conducted by or under authority of MG which is funded, in whole or in part, by Pharmion under this Agreement, including without limitation all Research conducted under the Research Plan. 1.25 " Controlling Party" shall have the meaning set forth in Section 17.5. 1.26 " Co-Promote" or " Co-Promoted" or " Co-Promoting" or " Co-Promotion" shall mean to promote jointly a Product in North America through Pharmion and MG and their respective sales forces under both Parties' trade names (in accordance with Section 5.5.2), unless otherwise agreed. 1.27 " Cost of Goods" shall mean, with respect to units of a Compound or Product to be supplied to a Party hereunder: (a) those costs of the supplying party associated with the manufacture of such units that would normally be included as inventoriable costs of such units in accordance with GAAP, and would include raw materials (including normal scrap) and actual direct labor costs and a proper allocation of overhead, subject to Section 11.3 below ( i.e. , with respect to Third Party royalties), and would exclude excess capacity, unusable raw materials, cost of capital and other costs not normally included as inventoriable costs as set forth above; or (b) if the units are purchased from a Third Party that is not an Affiliate, the purchase price thereof. Notwithstanding the foregoing, royalties paid by the manufacturing party with respect to patent rights for generic manufacturing processes used in such manufacture, but that are not primarily used for nor primarily related to Compounds, Products and/or HDAC, shall not be treated as a Third Party royalties subject to Section 11.3 below, for purposes of Section 1.27(a). [***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
- 5 -
1.28 " Data" shall mean, collectively, Research Data, Preclinical and Clinical Data and Manufacturing Data. 1.29 " Detail" shall mean an interactive face-to-face contact of a sales representative, who is fully equipped with, and knowledgeable of, applicable Product Promotional Materials and Product labeling, with a physician or other medical professional licensed to prescribe drugs or other healthcare professional that has a significant impact or influence on prescribing decisions, in which relevant characteristics of the Product are described by the sales representative in a fair and balanced manner consistent with the requirements of this Agreement and applicable laws and regulations, and in a manner that is customary in the industry for the purpose of promoting a prescription pharmaceutical product. Details shall be accounted for in accordance with the Marketing Party' s internal methodology for recording such activity as approved by the JSC. 1.30 " Development" shall mean the Preclinical Development and the clinical development of each Compound selected by the JSC for Clinical Studies; such activities shall include, among others, test method development and stability testing, toxicology, formulation, process development, including process automation, manufacturing scale-up, development-stage manufacturing and QC/QA. 1.31 " Development Costs" with respect to a Product shall mean the variable costs and fixed costs incurred after the Effective Date by a Party pursuant to the conduct of activities covered by this Agreement and in accordance with the relevant approved Development Plan (including the budget contained therein), for the development of such Product, including (a) direct, out-of-pocket external costs, including clinical grants, clinical laboratory fees, formulation costs and the cost of studies conducted and services provided by contract research organizations for clinical development and IND enabling studies and individuals, consultants, toxicology contractors, and manufacturers necessary or useful for the purpose of obtaining Marketing Approvals for such Product, (b) costs incurred in connection with process development and pre-clinical and clinical Product supply as set forth in the relevant approved Development Plan for such Product, including the efforts of Pharmion and MG to develop and document process methods and procedures for the manufacture of such Product, manufacturing process improvements, scale-up, manufacturing site qualification, supply chain management and storage and the Fully Absorbed Cost of Goods for batches of such Product manufactured and supplied for use in Clinical Studies, (c) costs for preparing, submitting, reviewing or developing data or information for the purpose of submissions to any Regulatory Authority, including submission of applications to obtain Marketing Approvals for such Product (including user fees paid prior to Marketing Approval), (d) to the extent not otherwise included in Fully Absorbed Cost of Goods of a Product, license fees and other amounts paid to a Third Party pursuant to a Third Party agreement in consideration for rights necessary to conduct activities under the Development Plans as approved by the JSC and (e) costs associated with Prosecution and enforcement of Licensed Patents in North America pursuant to Sections 17.4 and 17.6 and defense of Third Party intellectual property claims in North America pursuant to Sections 17.5 to the extent not included in Commercialization Costs. For purposes of this definition and to the extent agreed upon by the JSC and included in the applicable Development Plan, " variable costs" means the cost of labor (calculated on a full-time equivalent basis) and other material resources directly [***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
- 6 -
consumed in the conduct of and in accordance with the Development Plans; and " fixed costs" means the fixed costs directly related to the conduct of activities under the Development Plans, allocated based upon the proportion of such costs directly attributable to the support or performance of activities under the Development Plans or by such other method of cost allocation as may be approved by the JSC. Except as otherwise provided in this Agreement, all cost determinations made hereunder shall be made in accordance with GAAP. 1.32 " Development Plans" shall mean the plans and budgets for Development, as described in Article 4. 1.33 " Distributor" shall mean a Third Party in one or more countries in the Territory that (a) purchases a Product in finished form or in bulk form (to be packaged or labeled by such Third Party in accordance with applicable law) from Pharmion, its Sublicensees or their Affiliates for such country(ies) for a price which in no event is less than seventy-five percent (75%) of the average selling price of such Product in countries that are member states of the European Union within the Territory, (b) assumes responsibility from Pharmion for all or a portion of the Commercialization of such Product in such country(ies) and (c) sells such Product in such country(ies). The countries in which Pharmion has engaged a Distributor as of the Effective Date are identified in Exhibit 1.33. 1.34 " DMF" shall mean the Drug Master File filed with the FDA or such corresponding files in other countries or regulatory jurisdictions of the Territory, in each case, with respect to a Product for use within the Field. 1.35 " Effective Date" shall have the meaning set forth in the Preamble. 1.36 " EMEA" shall mean the European Medicines Agency and any successor agency thereto. 1.37 " Enforcement Action" shall have the meaning set forth in Section 17.6. 1.38 " Exempt Patent Licensees" shall have the meaning set forth in Section 8.3.3(a). 1.39 " FDA" shall mean the U.S. Food and Drug Administration, or any successor agency. 1.40 " Field" shall mean the therapeutic or prophylactic treatment of cancer in humans (including neoplasia and other pre-cancerous conditions, including myelodysplasia syndrome) using a Compound or Product. 1.41 " Full Time Equivalent" or " FTE" shall mean one (1) full-time research scientist, or in the case of less than a full-time dedicated research scientist, a full-time, equivalent person year of activities under the Research Plan. The term " research scientists" means personnel of MG assigned to conduct research, scientific and/or technical activities under the Research Plan and having qualifications reasonably approved by the JSC. [***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
- 7 -
1.42 " Fully Absorbed Cost of Goods" with respect to units of a Product shall mean (a) the variable costs and fixed costs incurred by a Party associated with the manufacture (inclusive of finishing processes including filling, packaging, labeling and/or other preparation) quality assurance, quality control and other testing, storage and shipping of batches of such units of such Product or (b) if such units or components of a Product are not manufactured by the Parties, the amounts paid to the vendor plus costs associated with acquisition from such vendor plus the other variable costs and fixed costs incurred by a Party associated with any finishing processes conducted by such Party, including filling, packaging, labeling and QA/QC testing. For purposes of this definition, " variable costs" means the cost of labor (calculated on a full-time equivalent basis), raw materials, scrap, obsolescence, supplies and other resources directly consumed in the manufacture, quality assurance, quality control and other testing, storage and shipping of batches of such Product, and " fixed costs" means the cost of facilities, utilities, insurance (including any product liability insurance or accrual for self-insurance), facility and equipment depreciation and other fixed costs directly related to the manufacture, quality assurance, quality control and other testing, storage and shipping of batches of such Product, as well as amounts paid to Third Parties under a Third Party agreement (subject to Section 11.3 below), as a result of the manufacture, use or sale of such units of Products. Fixed costs shall be allocated to such units of Product based upon the proportion of such costs directly attributable to support of the manufacturing, quality assurance, quality control and other testing, storage and shipping processes for such Product. If a facility is used to manufacture Products and has the capacity to manufacture products for other programs of either Pharmion or MG, fixed costs shall be allocated in proportion to the actual use of such facility for the manufacture of Products and the capacity to manufacture products for such other programs. For the avoidance of doubt, no idle capacity of a manufacturing facility, or a proportionate use thereof, shall be included in Fully Absorbed Cost of Goods except, in the case of a facility dedicated solely to the manufacture of Products, it shall be included to the extent the JSC determines in good faith that such facility is appropriately sized. Fully Absorbed Cost of Goods shall exclude all costs otherwise reimbursed pursuant to this Agreement. All cost determinations made hereunder shall be made in accordance with GAAP. Notwithstanding the foregoing, royalties paid by the manufacturing party with respect to patent rights for generic manufacturing processes used in such manufacture, but that are not primarily used for nor primarily related to Compounds, Products and/or HDAC, shall not be treated as a Third Party royalties subject to Section 11.3 below, for purposes of Section 1.42(a). 1.43 The " FTE Rate" for Research conducted by MG hereunder shall be Two Hundred and Fifty Thousand Dollars (US $250,000) per FTE (consisting of at least a total of eighteen hundred (1,800) hours per calendar year, or such other number as may be agreed by the JSC) for work directly related to the Research or any other activities contemplated under the Research Plan. No additional payment shall be made with respect to any person who works more than eighteen hundred (1,800) hours per calendar year and any person who devotes less than eighteen hundred (1,800) hours per calendar year shall be treated as an FTE on a pro-rata basis based upon the actual number of hours worked divided by eighteen hundred (1,800). Each Party acknowledges that the foregoing FTE rate has been set to include all salary, employee benefits, materials and other expenses, including support staff and overhead for or associated with an FTE. [***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
- 8 -
1.44 " GAAP" shall mean United States generally accepted accounting principles, consistently applied. 1.45 " Generic Competition" shall have the meaning set forth in Section 11.5.1. 1.46 " Global Development Committee" shall have the meaning set forth in Section 3.2. 1.47 " HDAC" shall mean histone deacetylase and shall include without limitation any one of a family of enzymes that remove acetyl groups from amino groups of lysine residues at the N-terminus of a histone, including but not limited to HDAC1, HDAC2, HDAC3, HDAC4, HDAC5, HDAC6, HDAC7, HDAC8, HDAC9, HDAC10, HDAC11, SIRT1, SIRT2, SIRT3, SIRT4, SIRT5, SIRT6, SIRT7, and any histone deacetylase as described or referenced in MG' s patent application WO2003024448A2, or the articles Nature Reviews, Drug Discovery, 1, 287-299 (2002) or J. Biol. Chem., 277, 25748-55 (2002). 1.48 " HDAC Assay" shall mean the evaluation in vitro of a compound' s dose dependent inhibition of at least one (1) isolated, partially purified, recombinant human HDAC enzyme from any HDAC Class I or HDAC Class II enzyme families. 1.49 " HDAC Inhibitors" means Small Molecules that directly inhibit HDAC enzymatic activity or which have therapeutic effect through the inhibition of HDAC enzymes. The Parties hereby agree that such inhibition must be with an IC50 value less than or equal to [***] towards at least one o ...
*End of Preview*
Click the 'Add to Cart' button to download the complete and formatted agreement.