Joint Development Plan. All Development of the Memantine-Donepezil FDC Products for Commercialization in the Territory in the Field shall be conducted in accordance with the Development Plan [*]. The Development Plan shall set forth the activities to be performed by each Party with respect to the Development of the Memantine-Donepezil FDC Products for Commercialization in the Territory in the Field. The Development Plan may be amended by the JDC from time to time in good faith and as reasonably necessary or useful for the Development of the Memantine-Donepezil FDC Products; provided that the JDC shall not [*] except [*] and the JDC shall not [*]. In the event that the Development Plan does not specify which Party shall be responsible for a particular Development activity, the JDC shall assign the activity to one of the Parties. Each Party shall act in a manner consistent with the Development Plan and with the Regulatory Plan. Forest shall, [*] in connection with the Development [*] = 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 406 of the Securities Act of 1933, as amended. activities assigned to Adamas in the Development Plan, which Development activities shall include activities assigned to Adamas under a certain letter agreement between Adamas and Forest, dated [*] (the “Letter Agreement”). The following shall apply to Adamas’ activities under such Letter Agreement: (i) until [*] the cessation of any ongoing activities under the Letter Agreement, Adamas shall continue to conduct such activities; (ii) such activities are deemed to be conducted under the Development Plan and subject to the foregoing reimbursement by Forest to Adamas; and (iii) such reimbursed amounts shall consist of: (A) the amounts consistent with the budget set forth in the Letter Agreement; (B) the amounts incurred by or on account of Adamas [*] with respect to such activities; and (C) the amounts incurred by Adamas for its FTEs and consultants as required to support the activities set forth in subsection (A) and/or (B) above; provided, however, that any amounts in (B) or (C) shall be only for activities specifically requested by Forest, and the Parties shall cooperate in good faith to agree on a written budget therefor within [*] Business Days after the Effective Date. If Adamas is assigned any activities other than those set forth in the Letter Agreement, the Parties shall ...
Joint Development Plan. Beginning on the Effective Date, the Parties shall jointly Develop the Lead Product in accordance with the pre-clinical and clinical development plan attached to this Agreement as Exhibit 2.3.1.(a), as may be supplemented and amended from time to time by the Joint Steering Committee, as described in Section 2.2.2.(a) (“Joint Development Plan”). The Joint Development Plan shall set forth the research and Development activities to be conducted by the Parties in order to achieve Marketing Approval from [***] for the Lead Product and will describe the scope, the budget and the activities to be performed by both Parties, among other items. The Parties acknowledge and agree that the initial Joint Development Plan attached as Exhibit 2.3.1.(a) as of the Effective Date will set forth those Development activities to be conducted by the Parties through first-in-man trial and reasonably in advance of (but at least [***] prior to) the expected completion of such Development activities under the initial Joint Development Plan, the Parties (through the JSC as contemplated in this Agreement) shall update and amend such initial Joint Development Plan to comply with the requirements of the immediately preceding sentence.
Joint Development Plan. Starting on the Effective Date, each Party shall be responsible for its Agreed Percentage of the Shared Costs for the Lead Product, as set forth in the budget associated with the then current Joint Development Plan (“Joint Development Budget”) as included in Exhibit 2.3.1.(a). Each Party shall be responsible for any other costs such Party incurs in connection with the Development of the Lead Product.
Joint Development Plan. (i) Following Sobi’s exercise of its Opt-In Right with respect to that Product, all Development, Post Opt-In Development and Final Development activities (including those designated as Additional Agreed Activities) for a Product, as well as further medical and development activities for such Product, shall be governed by the Joint Development Plan for such Product. Any Continuing HLDP Activities will be incorporated into the Joint Development Plan. For clarity, each Joint Development Plan shall specify all of the medical and development activities of each Party, whether to be conducted individually or jointly by the Parties, and shall specify which, if any, of such medical and development activities are Additional Agreed Activities.
(ii) Biogen Idec shall prepare the first Joint Development Plan prior to Sobi’s exercise of its Opt-In Right. Prior to [**] of each year, the JMDC shall update and the JSC shall approve the Joint Development Plan for each Product. The JMDC may, from time to time, amend or modify the then-current Joint Development Plan. Each Joint Development Plan shall contain sufficient details for each Party to conduct its typical budgeting activities. Notwithstanding anything to the contrary in this Agreement, any Joint Development Plan prepared by Biogen Idec prior to Opt-In shall not be binding on Sobi to conduct any activities, or be responsible for any portion of any costs incurred, after the exercise of its Opt-In Right for a Product, except to the extent such Joint Development Plan is confirmed by the JMDC or JSC after Opt-In.
Joint Development Plan. The Parties shall carry out their respective obligations with respect to the Joint Development Activities as set forth in each agreed upon Joint Development Plan, each of which shall be attached hereto as Exhibit C and incorporated herein upon execution by the Parties. For so long as a Joint Development Plan is in place, the Parties shall work with one another to carry out their respective Joint Development Activities thereunder and seek to maximize the value for the Parties in connection therewith, subject to the exclusivity provisions in Section 3.3. The Parties shall at all times during the Term cooperate and collaborate in good faith with respect to the Joint Development Activities and the implementation and execution of the Joint Development Plan. In the event of any conflict or ambiguity between a term or condition of the body of this Agreement and a term or condition of the Joint Development Plan, the applicable term or condition of the body of this Agreement shall control unless the applicable term or condition of the Joint Development Plan expressly states that it shall control over a specific term or condition of the body of this Agreement.
Joint Development Plan. The Parties shall mutually agree upon the joint plan for Development of the Shared Product for the U.S. (the “Joint Development Plan”) promptly following the applicable Notice of Exercise, which plan shall include the target Indications and patient populations, corresponding Development activities to be performed by each Party, anticipated timelines, clinical supply forecasts, and the budget of Shared Development Costs. The Joint Development Plan may be amended or updated from time to time by mutual agreement of the Parties through the JDC, including any amendments or updates to any anticipated timelines or to the then-current budget.
Joint Development Plan. Promptly following the exercise by Xxxxxx of its Option in respect of a China Licensed Target, the Parties shall develop and agree to a plan for the conduct of the Development activities to be undertaken by each Party in the further Development of China Licensed Compounds and China Licensed Products directed to such China Licensed Target (such activities, “Joint Development Activities” and such plan the “Joint Development Plan”) and the Joint Development Plan shall assign responsibility for the Joint Development Activities (including any regulatory activities) between the Parties.
Joint Development Plan. (i) Without limiting Apollomics’ obligations under Section 4.1(i), Apollomics shall use Commercially Reasonable Efforts to perform the activities assigned to it and set forth in the initial Joint Development Plan (and any updated Joint Development Plan) upon the terms and conditions set forth in this Agreement. The initial Joint Development Plan is attached hereto as Schedule 4.2. Apollomics shall allocate sufficient time, effort, equipment and facilities and use personnel with sufficient skills and experience as are required to perform the activities allocated to Apollomics set forth in the Joint Development Plan. Apollomics shall be entitled to utilize the service of Third Party contractors to perform its Joint Development Plan activities, provided that Apollomics shall remain responsible for the performance of its contractors hereunder. Apollomics shall ensure that its and its contractors’ activities under the Joint Development Plan are conducted in accordance with applicable Law and the existing protocols. Apollomics shall remain at all times fully responsible for obtaining all necessary approvals and clearances, including IRB approvals, INDs and other regulatory approvals, customs clearances and patient informed consent forms necessary for the conduct of such activities under the Joint Development Plan.
(ii) Edison shall be responsible for and shall use Commercially Reasonable Efforts to perform the activities assigned to it and set forth in the initial Joint Development Plan (and any updated Joint Development Plan) upon the terms and conditions set forth in this Agreement. Such activities shall include designing and conducting the Initial Clinical Trial, and filing all regulatory materials and interacting with Regulatory Authorities associated with such Initial Clinical Trial. Edison shall also conduct such activities that the Parties agree in advance, at Apollomics’ expense, reasonably necessary to support the Development of the Licensed Products in the Licensed Field and Licensed Territory.
(iii) All Development and regulatory obligations provided in the Joint Development Plan shall be subject to JSC review and approval.
Joint Development Plan. (a) Promptly following the License Effective Date (but in any event within [**] following the License Effective Date), the JDC (in consultation with the Financial Working Group and the JMC, as applicable) shall prepare, discuss and agree on a written development plan with respect to the Shared Global Development Activities to be conducted by the Parties during the Development Term (such plan, as approved by the JSC pursuant to this Section 5.2.2 (Joint Development Plan), the “Joint Development Plan”). Except for Independent Registration Studies, neither Party may (itself or with or through any of its Affiliates or any Third Party) conduct any Shared Global Development Activities except as set forth in the Joint Development Plan.
(b) The Joint Development Plan will include: (i) the Shared Global Development Activities to be performed by the Parties with respect to the Licensed Compound and Licensed Products in the Territory (provided that (A) [**], (B) unless otherwise mutually agreed by the Parties via the JSC, Mersana shall be responsible for the conduct of any ongoing Clinical Trials that were being conducted under the Initial Development Plan prior to the License Effective Date and will continue to be conducted under the Joint Development Plan, (C) unless otherwise mutually agreed by the Parties via the JSC, it is expected that GSK will [**], and (D) unless otherwise mutually agreed by the Parties via the JSC, Mersana will [**]; (ii) the estimated timelines for the performance and completion of, and any applicable success criteria -49- or endpoints with respect to, the Shared Global Development Activities; (iii) the regulatory strategy for obtaining and maintaining Regulatory Approval for Licensed Products in the U.S. and European Union; and (iv) (A) activities required for the Manufacture and supply of the Licensed Compound, Licensed Products (or components thereof), comparator compounds, other therapeutically active compounds for Combination Studies or placebos, in each case, as required for the conduct of the Shared Global Development Activities and (B) any CMC Development activities for the Licensed Compound or Licensed Products (provided that the JDC shall consult with the JMC with respect any Manufacturing or supply components of the Joint Development Plan).
(c) In addition, the Joint Development Plan shall also include, subject to Section 5.2.4 (Shared Development Costs), (i) a corresponding binding budget for [**] period [**], which budget shall...
Joint Development Plan. The “Joint Development Plan” or “JDP” agreed to by the Parties sets forth the Development Program including on a calendar year-by-calendar year basis through final Regulatory Approval in the EU and the U.S.: (i) the development, scientific, medical, regulatory and other activities including Clinical Trials, Non-Clinical studies, Dosage Form Development, manufacturing process development, scale-up and validation, CMC, ICH registration batches, pre-approval inspections and preparation, pharmaceutical development including quality control and stability and manufacturing qualification under this Agreement for the development of the Product through Regulatory Approval in both the U.S. and the EU; (ii) the estimated budget for each development activity, and estimated over-all budget for performance of all development activities under the JDP (“JDP Budget”); (iii) target Product profiles; (iv) timelines and (v) subject to Section 4.3, the allocation of the respective responsibilities of DURECT and NYCOMED regarding development activities. The JDP shall be updated by and reviewed by the JDC at least once [* * *] by a date no later than [* * *] so as to cover any other amendments, and each amendment shall be approved by the JEC.
