RSV IND Filing. Moderna will be responsible for preparing and submitting the RSV IND, and the RSV IND will be the property of Moderna and held in the name of Moderna; provided, however, prior to making such submission with the TGA (or any other applicable Regulatory Authority), Moderna shall submit to the JSC a draft of the RSV IND and any [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED correspondence pertaining to such RSV IND to be submitted therewith to the TGA (or any other applicable Regulatory Authority). Through the JSC, Moderna will consult with Merck with respect to such submission [***]. Any dispute within the JSC with respect to such proposed submission 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. If, despite such efforts, agreement cannot be reached by the Executive Officers within such [***] day period, then [***].
Appears in 5 contracts
Samples: Collaboration and License Agreement, Collaboration and License Agreement (Moderna, Inc.), Collaboration and License Agreement (Moderna, Inc.)
