Product Candidate Pool definition

Product Candidate Pool means, with respect to a Target Product Profile, all Collaboration mRNA Constructs that are [***].
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Examples of Product Candidate Pool in a sentence

  • 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).

  • 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.

  • On a TPP-by-TPP basis from time to time during the Post-R&D Period, Merck may elect to establish a Product Candidate comprised by Collaboration mRNA Constructs from the associated Product Candidate Pool by issuing a written notice to Moderna (a “Product Candidate Notice”).

  • 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.

  • 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.

  • 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 [***].

Related to Product Candidate Pool

  • Product Candidate means any pharmaceutical product developed, manufactured and/or tested by or on behalf of the Company that has not received a Regulatory Authorization for commercial distribution other than in connection with pre-clinical or clinical trials.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • New Product means the Synology-branded hardware product and Synology-branded accessories contained in the original packaging Customer bought from an authorized Synology distributor or reseller. You may see our “New Product” at Product Support Status.