Examples of Amended RSV R&D Plan in a sentence
Each Party shall be responsible for performing the activities allocated to such Party under the Amended RSV R&D Plan, which activities will be considered Collaboration Activities.
Any changes to the budget set forth in the Amended RSV R&D Plan, including amounts in connection with the performance of activities that are not included in the Amended RSV R&D Plan or that are not specifically included in the budget set forth therein, shall require review and approval by the JSC, which approval may come in any written form [***].
If RSV Drug Product Manufactured by or on behalf of Moderna using Moderna mRNA API that conformed to the foregoing specifications, quality standards and requirements at the time of such Manufacture, does not conform to the applicable specifications, quality standards and requirements set forth in the Amended RSV R&D Plan due to an error or deficiency with respect to [***], Moderna will, [***], provided that [***]; provided, however, that [***].
Notwithstanding anything in Sections 2 or 3.2 or elsewhere in the Agreement to the contrary, any modifications or amendments to the Amended RSV R&D Plan that relate to the Moderna RSV Lead Activities will be submitted to the JSC for review and approval, [***].
Notwithstanding anything in Section 5 or elsewhere in the Agreement to the contrary, but subject to Sections 2.3 and 2.4 of this Third Amendment, the Parties acknowledge and agree that during the Moderna Lead Period, Moderna will have primary responsibility for preparing and maintaining all Regulatory Filings with respect to the RSV IND and RSV Phase I Study, and conducting the RSV Phase I Study, in each case in accordance with this Third Amendment and the Amended RSV R&D Plan.
Merck agrees to pay Moderna for the Manufacture of RSV Drug Product in accordance with the amounts and schedules set forth in the Amended RSV R&D Plan and applicable Statement of Work.
If Moderna mRNA API contained within the RSV Drug Product Manufactured by or on behalf of Moderna does not conform to the specifications, quality standards and requirements set forth in the Amended RSV R&D Plan and applicable Statements of Work, Moderna will, [***].
Moderna shall invoice Merck in accordance with the Amended RSV R&D Plan and applicable Statement of Work and Merck shall pay the undisputed portion of such invoice within [***] days of receipt of same.
The R&D Plan for the RSV R&D Program existing immediately prior to the Third Amendment Effective Date is hereby replaced in its entirety with the Amended RSV R&D Plan.
Any dispute within the JSC with respect to such proposed modification or amendment to the Amended RSV R&D Plan [***] that is not settled by the Parties within [***] days following submission to the JSC for review shall be referred to the Executive Officers (or their designees, which designee is required to have decision-making authority on behalf of such Party), who will attempt in good faith to resolve such dispute by negotiation and consultation for a [***] day period following such referral.