Common use of Proposal of Additional Studies Clause in Contracts

Proposal of Additional Studies. (i) To the extent that either Party wishes to conduct an Additional Study or related series of Additional Studies of a Collaboration Product ([***]) that is not set forth in the Joint Development Plan and Budget for the applicable Program for the purpose of seeking Regulatory Approval for such Collaboration Product, such Party shall prepare a [***] year rolling Development plan and budget for such Additional Study(ies) and propose such Additional Study(ies) to the JDC. Such proposed Development plan and budget shall identify the applicable Collaboration Product, [***] (an “Additional Study Proposal”). Following receipt of the Additional Study Proposal from the proposing Party, the non-proposing Party shall have [***] days to decide whether or not to co-fund such Additional Study, and if such non-proposing Party elects to so co-fund, then such Additional Study will be considered a “Joint Development Study”, and the Parties shall amend and update the Joint Development Plan and Budget for the applicable Program to include such Additional Study as a Joint Development Study as part of the Joint Development Program. (ii) If the non-proposing Party fails to elect to co-fund a proposed Additional Study within such [***] day period, then (1) with respect to such proposed Additional Study for the PCV Program, [***] (2) with respect to a proposed Additional Study for a Joint SAV Program, [***], may independently conduct such Additional Study (an “Independent Additional Study”) subject to the terms and conditions of this Section 4.4 and in accordance with such Additional Study Proposal (thereafter, an “Independent Additional Study Development Plan”); provided, however, that if (A) the Independent Additional Study would involve a Collaboration Product in combination with a Moderna Agent when Moderna is the non-proposing Party or a Merck Agent [***] when Merck is the non-proposing Party, then [***], or (B) the non-proposing Party reasonably and in good faith believes that [***], then the proposing Party shall [***].