Examples of Collaboration mRNA Constructs in a sentence
AstraZeneca will have the sole right to conduct all communications with the Regulatory Authorities, including all meetings, conferences and discussions (including advisory committee meetings), with regard to Collaboration mRNA Constructs, Product Candidates, and Products in the Territory.
All applications for Regulatory Approval, the Regulatory Approvals, and other Regulatory Filings (including all INDs) relating to Collaboration mRNA Constructs, Product Candidates, and Products will be the property of AstraZeneca and held in the name of AstraZeneca or its designees.
AstraZeneca will be responsible for preparing and submitting all Regulatory Filings related to Collaboration mRNA Constructs, Product Candidates, and Products, including all applications for Regulatory Approval.
Subject to and in accordance with the terms of this Agreement, during the R&D Term the Parties will [***] undertake Development activities as set forth in R&D Plans with the goal of identifying and Developing Collaboration mRNA Constructs and Product Candidates directed to R&D Program Pathogens, [***] the “R&D Programs”) and (c) [***].
Upon the effective date of any such discontinuance, such TPP shall no longer exist and all [***] under such discontinued TPP [***] will become Discontinued Targets and all Collaboration mRNA Constructs in the Product Candidate Pool for such TPP will become Discontinued mRNA Constructs (to the extent such mRNA Constructs are not within another Product Candidate Pool).
In addition to Section 4, Exhibit A and any Supply Agreement, during the Post-R&D Period Merck may request, and Moderna will supply, reasonable quantities of Collaboration mRNA Constructs for Merck to conduct such assays and Development as necessary to identify and nominate new Product Candidates, provided that the Parties acknowledge and agree that Merck may only request Collaboration mRNA Constructs that were included in a Product Candidate Pool established pursuant to Section 2.9.
For each R&D Program, Moderna shall design [***] Collaboration mRNA Constructs [***], and such Collaboration mRNA Constructs will be Manufactured and supplied by or on behalf of Moderna in accordance with Section 4.1 for use in the applicable R&D Program.
During the Post R&D Period, Collaboration Activities will be directed to the Development of Collaboration mRNA Constructs against specified Target Product Profiles, in each case as determined [***].
At the expiration of the R&D Term, (i) all R&D Programs will become “Discontinued Programs” (ii) all R&D Targets and R&D [***] Targets that are not Locked Targets will become Discontinued Targets and (iii) all Collaboration mRNA Constructs that are not in a Product Candidate Pool will become Discontinued mRNA Constructs.
As set forth in greater detail below in this Section 5, but subject to Sections 5.4, 5.5 and 15.5, [***] will lead and have sole control of, and bear all costs of, all regulatory efforts for Collaboration mRNA Constructs, Product Candidates, Elected Candidates and Products worldwide, including with respect to preparing and filing the relevant Regulatory Filings and all communications (formal and informal) with Regulatory Authorities.