Elected Candidate Notice definition

Elected Candidate Notice has the meaning set forth in Section 2.10(a).
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Examples of Elected Candidate Notice in a sentence

  • If Merck issues an Elected Candidate Notice during the R&D Term, but Xxxxx has not, prior to the issuance of such Elected Candidate Notice, established a TPP with respect to such Elected Candidate, then along with such Elected Candidate Notice, Merck will provide Moderna with a TPP Notice with respect to such Elected Candidate.

  • At least [***] during each consecutive [***] period from the date of the Elected Candidate Notice until the first Regulatory Approval for Product, within [***] of Moderna’s written request, the Parties will meet in person at a U.S. site of Merck for Merck to provide Moderna with an update on the Development of a Product by Merck and its Affiliates and Sublicensees.

  • Upon Moderna’s receipt of the Elected Candidate Notice, such designated Product Candidate will be an Elected Candidate.

  • Upon Moderna’s receipt of the Elected Candidate Notice (and TPP Notice, if applicable), such designated Product Candidate will be an Elected Candidate.

  • For the avoidance of doubt, a separate Elected Candidate Notice is required for each of the five (5) possible designations of Elected Candidates, and following the designation of the fifth (5th) Elected Candidate, Xxxxx shall no longer have the right to designate any additional Elected Candidates hereunder.

Related to Elected Candidate Notice

  • 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.

  • Election Period means the period immediately preceding the beginning of each Plan Year established by the Administrator, such period to be applied on a uniform and nondiscriminatory basis for all Employees and Participants. However, an Employee's initial Election Period shall be determined pursuant to Section 5.1.

  • 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. [***]

  • 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).