Common use of Development Tasks Clause in Contracts

Development Tasks. (a) Following the election of a Compound Construct as a Product under Section 3.1, Biogen Idec shall develop an initial HLDP for the Product to address both the Biogen Idec and Sobi Territories for the Product, which HLDP shall be submitted to the JSC for approval. Biogen Idec shall Manufacture, Develop and Finally Develop each Product for the United States and EU markets in accordance with the HLDP. (i) As of the Effective Date, the Parties agree on the HLDP contained herein as Schedule 3.3(a) that addresses both the Biogen Idec and Sobi Territories for the Lead Products. (ii) Each HLDP shall further define the development principles, operational plans and diligence obligations under which Biogen Idec will carry out Manufacturing, Development and Final Development activities and provide a non-binding budget for each Product. Each such HLDP shall address and contain HLDP Principles that include, at a minimum, requirements that: (A) [**] (B) [**] (C) [**] (D) [**]. (iii) [**]. Each updated HLDP shall reference this Agreement but shall not require an amendment to this Agreement. (b) Biogen Idec shall have responsibility for, and shall be free to make, all operational Manufacturing, Development and Final Development decisions consistent with the principles established by the HLDP. Biogen Idec shall take Sobi input from JSC meetings into account and shall have final decision-making authority for all Product Development, Manufacturing and Final Development decisions prior to Sobi’s Opt-In for such Product; provided, that Biogen Idec may not take any action that would conflict with the rights granted Sobi hereunder or conflict with the terms of this Agreement. On a periodic basis prior to Opt-In, but not more frequently than quarterly unless otherwise agreed by the JSC, Biogen Idec will update Sobi as to its progress on a Product-by-Product basis and solicit input from Sobi, particularly on matters pertaining to the Sobi Territory. Any input from Sobi on topics discussed in a JSC meeting shall be communicated by Sobi to Biogen Idec during the same JSC meeting unless a later timeframe for providing such input is agreed to and documented in the minutes of that JSC meeting. (c) Material Operational Changes and changes to the HLDP Principles may be made, only by mutual agreement of the Parties, except to the extent that Biogen Idec, in its reasonable discretion, determines that such Material Operational Change is a necessary condition for FDA and/or EMA Regulatory Approval of any Product or has been mandated by the FDA or EMA. “Material Operational Change” means [**].

Development Tasks. (a) Following Each Party shall use Commercially Reasonable Efforts to perform its respective Development tasks and Phase III Development tasks set forth in the election of a Compound Construct as a Product under Section 3.1, Biogen Idec shall develop an initial HLDP then-current Development Plan for the Product within the estimated time periods set forth for such tasks therein. (b) Attached hereto as Schedule 3.1(b) is a “Preliminary Development Plan” that sets forth the Development that will occur prior to address the JDC’s implementation of a Development Plan and an overview of the further Development of the Product. Within 90 days following the Effective Date, the JDC shall establish a reasonably detailed Development Plan for the Product that shall be consistent with the Preliminary Development Plan. Prior to November 1 of each year, the JDC shall approve a Development Plan covering Development and Phase III Development activities for the Product in the following year. The JDC shall, from time to time, as appropriate based on Development and Phase III Development activities and results to date, amend or modify the then-current Development Plans. Although each Party may contribute effort toward each Development task, overall responsibility for conducting certain activities for the Product is anticipated to be allocated either to Chelsea, with the assistance of Active Biotech, or to Active Biotech, with the assistance of Chelsea, in the manner set forth in the then-current Development Plan. Each Party shall be responsible for its own Phase III Development tasks in such Party’s Territory; provided, that the protocols for Phase III clinical studies shall conform with the patient eligibility criteria, clinical endpoints and other key parameters established by the JDC with the objective that the results of such studies may be used by both Parties. Each Party shall perform its responsibilities under the Biogen Idec Development Plan in accordance with all applicable regulatory requirements, including then-current cGLP, cGCP and Sobi Territories cGMP. Each Party will inform the other Party, in writing, of the draft protocols for such clinical studies for review and input before commencement of any clinical studies. The Party sponsoring a clinical study will consider in good faith all comments provided by the other Party within twenty (20) days of its receipt of such protocols; provided, that, subject to the preceding sentences, the sponsoring Party may determine all final protocols so long as they conform with the Development Plan and the other requirements under this Agreement. (c) Each Party will keep the other Party fully informed about its efforts to Develop the Product, including summaries of all results and data from such development efforts, progress towards meeting all goals and milestones in each Development Plan, significant findings and developments, any reasons for any delays in meeting milestones or timelines in any Development Plan, and any proposed changes thereto. Such disclosures will be made through the JDC, and in a written report provided to other Party at least once semi–annually. Without limiting the generality of the foregoing, such reports will contain the following: (i) summary of development results and data, including progress of initiation of sites and enrollment of patients in clinical trials and any significant events occurring in the clinical development program, including adverse events; (ii) filing of any IND or Regulatory Filing in any jurisdiction; (iii) initiation of any clinical study; and (iv) identification of significant development results and clinical trial progress and Regulatory Approvals. The Parties shall maintain all records, documents, raw data and other Information relating to Development and Phase III Development in sufficient detail and in good scientific manner as will properly reflect all work done and results achieved in the development of the Product. Each Party shall have the right, which shall be exercised in a reasonable manner, to inspect, copy, cross-reference and use in accordance with the licenses granted under Section 7.1 such Information of the other Party for the purpose of carrying out its obligations and exercising its rights under this Agreement. (d) The Parties shall share equally the Development Expenses for the Product, which HLDP shall be submitted except Development Expenses relating to the JSC for approval. Biogen Idec shall Manufacture, Develop and Finally Develop each Product for the United States and EU markets Phase III Development in a Party’s Territory incurred in accordance with the HLDPrelevant Development Plan (including the budgets set forth therein), regardless of which Party is responsible for the performance of one or more of the relevant Development tasks. Each Party shall be responsible for all costs and expenses incurred in conducting its own Phase III Development. (i) As In order to effect a reconciliation of accounts for any calendar quarter with respect to the Effective DateDevelopment activities with respect to a Product, each Party shall provide to the Parties agree on other Party and to the HLDP contained herein as Schedule 3.3(aJDC, within thirty (30) that addresses both days after the Biogen Idec end of such calendar quarter, a quarterly written accounting of and Sobi Territories copies of supporting invoices for the Lead Productsexpenditures, costs and other resources actually devoted by such Party to the applicable Development tasks for such Product (each, a “Quarterly Report”). (ii) Each HLDP shall further define Within thirty (30) days after each Party’s receipt of the development principlesother Party’s Quarterly Report with respect to a calendar quarter, operational plans and diligence obligations under the Party which Biogen Idec will carry out Manufacturing, incurred less Development and Final Development activities and provide a non-binding budget for each Product. Each such HLDP shall address and contain HLDP Principles that include, at a minimum, requirements that: (A) [**] (B) [**] (C) [**] (D) [**]. (iii) [**]. Each updated HLDP shall reference this Agreement but shall not require an amendment to this Agreement. (b) Biogen Idec shall have responsibility for, and shall be free to make, all operational Manufacturing, Development and Final Development decisions consistent with the principles established by the HLDP. Biogen Idec shall take Sobi input from JSC meetings into account and shall have final decision-making authority for all Product Development, Manufacturing and Final Development decisions prior to Sobi’s Opt-In Expenses for such Product; provided, that Biogen Idec may not take any action that would conflict with Product in such calendar quarter than the rights granted Sobi hereunder or conflict with other Party (the terms of this Agreement. On a periodic basis prior to Opt“Over-In, but not more frequently than quarterly unless otherwise agreed by the JSC, Biogen Idec will update Sobi as to its progress on a Product-by-Product basis and solicit input from Sobi, particularly on matters pertaining Paying Party”) shall pay to the Sobi Territory. Any input from Sobi on topics discussed in a JSC meeting shall be communicated by Sobi to Biogen Idec during the same JSC meeting unless a later timeframe for providing Over-Paying Party an amount such input is agreed to and documented in the minutes of that JSC meeting. each Party bears one-half (c50%) Material Operational Changes and changes to the HLDP Principles may be made, only by mutual agreement of the PartiesDevelopment Expenses with respect to such Product in such calendar quarter, except to that Active Biotech shall pay the extent that Biogen Idec, in its reasonable discretion, determines that such Material Operational Change is a necessary condition for FDA and/or EMA Regulatory Approval first $1,000,000 of any Product or has been mandated by the FDA or EMA. “Material Operational Change” means [**]Development Expenses.