Joint Development Plans Sample Clauses
Joint Development Plans. (i) Within (x) [***] days after the Merck Participation Election Date for the PCV Program, or (y) subject to the last sentence of this Section 4.3(c)(i), [***] days after the date of the Merck Participation Election Notice for a given Joint SAV Program, the Parties shall agree on the Collaboration Activities of the Parties with respect to the applicable Joint Development Program and set forth such activities and a [***] year rolling budget therefor (such budget to be on a study-by-study or activity-by-activity basis) in a joint development plan (each, a “Joint Development Plan and Budget”), the initial draft of which shall be prepared by [***]. The purpose of the Joint Development Plan and Budget for the applicable Program is to set forth the specific Development activities to be performed by the Parties in support of such Joint Development Program, [***]. Each Joint Development Plan and Budget for the applicable Program shall set forth activities that are similar in nature to those contained in the applicable POC Plan. Notwithstanding anything herein to the contrary, if the Parties fail to mutually agree on a Joint Development Plan and Budget for a given Joint SAV Program within [***] days after the date of the Merck Participation Election Notice for such Joint SAV Program, then Moderna shall deliver written notice (together with an invoice) to Merck that the SAV Participation Election Payment for such Joint SAV Program is due and either (1) Merck may pay the SAV Participation Election Payment for such Joint SAV Program within [***] Business Days after receipt of such notice, and the Parties will continue to diligently work to mutually agree on a Joint Development Plan and Budget for such Joint SAV Program, or (2) if Merck does not make such payment under clause (1), then [***].
(ii) Either Party may propose at any meeting of the JDC amendments to the Joint Development Plan and Budget for the applicable Program; provided, however, if such amendments involve an Additional Study or series of related Additional Studies, the inclusion of such Additional Study(ies) shall be in accordance with Section 4.4. Notwithstanding the foregoing, at a minimum, no later than [***] days prior to the start of a Calendar Year, the Parties shall propose an updated budget for any ongoing studies or activities under the then-current Joint Development Plan and Budget for the applicable Joint Development Program for the upcoming Calendar Year for the JDC’s review and JSC’s approv...
Joint Development Plans. The Joint Development Plans, when mutually agreed upon in writing and signed by the Parties, form part of this Agreement and shall have full force and effect as if expressly set out in the body of this Agreement, and reference to this Agreement shall include the attached Joint Development Plans. If any conflict arises between any term, condition or provision of a Joint Development Plan and any term, condition or provision of this Agreement, the applicable term, condition or provision of this Agreement shall prevail.
Joint Development Plans. Pursuant to Section 4.4(a), the Working Group designated by JDRC shall in good faith discuss and prepare the Joint Development Plan covering Approved Clinical Study(ies) for review by JDRC.
(i) Once Joint Development Plan prepared by the Working Group is approved at JDRC, the Parties shall initiate the Approved Clinical Study(ies) in accordance with the Joint Development Plan.
(ii) In the event that the JDRC is unable to agree upon a Joint Development Plan for such Approved Clinical Study within sixty (60) days after the applicable Joint Study Proposal has been approved by the JDRC, each Party shall be free to carry out such Approved Clinical Study(ies) at its own expense independently upon notice to the other Party, and subject to the terms of Sections 2.1 and 4.4(c).
(iii) The JDRC shall review the Joint Development Plan on an ongoing basis from time-to-time as needed. The JDRC may make adjustments to the then-current Joint Development Plan from time-to-time as it deems appropriate.
Joint Development Plans. If a Joint Development Plan is approved by all members of the JDC, then each Party will use Commercially Reasonable Efforts to conduct those Development activities allocated to such Party under and in accordance with the Joint Development Plan and the applicable Joint Development Budget.
Joint Development Plans. Each Joint Development Plan shall include a comprehensive overall plan, including Clinical Studies anticipated to be conducted to satisfy applicable regulatory requirements for obtaining Regulatory Approval for [***]. The Lead Party shall allocate responsibility for each Development activity in the Joint Development Plan, including Clinical Studies, to one of the Parties in good faith, taking into consideration each Party’s capabilities and available resources. The terms of, and activities set forth in, the Joint Development Plan shall at all times be designed to be in compliance with all applicable Laws and the Parties’ Applicable Internal Policies (as described in Section 3.11). The Parties expect that [***].
Joint Development Plans. Promptly upon designation of a Jointly Funded Clinical Combination and or a Joint Development Radioconjugate, the Parties will meet (through the JDC) to prepare (or in the case of a Jointly Funded Clinical Combination, update as necessary the applicable Clinical Development Plan) and submit to the JSC for approval a detailed development plan setting forth all Development activities to be conducted with respect to such Jointly Funded Clinical Combination and or a Joint Development Radioconjugate (each a “Joint Development Plan”). In addition, each Joint Development Plan shall also include a reasonably detailed budget of the costs and expenses (including FTE Costs) for the activities to be conducted pursuant to such plan (the “Joint Development Budget”) on an activity-by-activity or study-by-study basis, as appropriate.
(a) The Parties intend, and each Joint Development Plan will reflect that AstraZeneca will sponsor and operationally run all clinical trials conducted under each Joint Development Plan.
(b) The JDC will periodically (or at the request of one of the Parties) review each then-current Joint Development Plan, and if the JDC determines an amendment is needed to a then-current Joint Development Plan, the JDC will collaborate to prepare an amendment to such then-current Joint Development Plan, for review, comment and approval by the JSC. Such amended Joint Development Plan will reflect any changes (including additions) to the applicable Joint Development Budget. Once approved by the JSC, such amended Joint Development Plan will become effective and supersede the previous Joint Development Plan as of the date of such approval.
Joint Development Plans. Nycomed shall be responsible for implementing and overseeing any Joint Development Plans prepared by the Joint Development Committee relating to the [*] Process and the Parties shall each be responsible for fifty percent (50%) of the costs and expenses of implementing any such Joint Development Plans. If NPS does not agree to any such Joint Development Plans, then NPS may elect not to participate and shall not be obligated to pay any costs or expenses associated with such Joint Development Plan. In the event of such an election not to participate by NPS, each Party may pursue its own Development relating to the [*] Process and shall be responsible for its own costs and expenses incurred in connection therewith. Thereafter, if either Party desires to utilize any Improvements Developed solely by the other Party (the “Developing Party”) relating to the [*] Process, such Party shall be offered the rights to such Improvements by reimbursing the Developing Party an amount equal to [*] of the Developing Party’s costs incurred after the Effective Date to Develop such Improvements plus interest on such amount equal to an annual compound rate of [*] of such amount beginning on the date the Developing Party began incurring costs for such Developing such Improvements up to the date of payment.
Joint Development Plans. If the Parties agree to jointly Develop any Indications on a global basis, the Parties shall consider the specific sales potential and regulatory requirements on an Indication-by-Indication and Country-by-Country basis in designing any studies and in selecting the primary investigators, the key opinion leader and the trial centers used to Develop such Indication in such Country; provided that any such Joint Development Plans may not adversely affect the commercial potential of Product outside the Territory. Each Party shall be responsible for fifty percent (50%) of all costs and expenses associated with such joint Development of any Indication. If Nycomed desires to change any Joint Development Plan previously agreed by the Parties and NPS does not agree to such change, then NPS may elect not to participate in such Joint Development Plan and shall not be obligated to pay any costs or expenses associated with such Joint Development Plan; provided, however, that any such changes to a Joint Development Plan may not adversely affect the commercial potential of Product outside the Territory. In the event of such an election not to participate by NPS, NPS may subsequently opt-in to such Development Plan in accordance with Section 4.2(g).
Joint Development Plans