Examples of Collaboration mRNA Constructs in a sentence
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.
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.
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.
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 [***].
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) [***].
Following the expiration of the R&D Term there will be a Post-R&D Period during which Merck may define up to five (5) Target Product Profiles for which Merck may Develop [***] Product Candidates incorporating Collaboration mRNA Constructs from the Product Candidate Pool for such Target Product Profiles.
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.
Prior to issuing any TPP Notice, Merck will review the most current data and results generated from performance of the applicable R&D Program and will make a good faith determination, based on such data and results, as to which Collaboration mRNA Constructs from such R&D Program should be included in the 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.