Initial FDA Approval definition

Initial FDA Approval means the first issuance by the FDA of a written approval that [****]*.
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Initial FDA Approval means, with respect to a Licensed Product, the first Regulatory Approval for such Licensed Product by FDA.
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Examples of Initial FDA Approval in a sentence

  • Twenty Five Million United States Dollars ($25,000,000) shall become payable upon Buyer’s receipt of the Initial FDA Approval, such payment to be made promptly, and in no event later than [****]*, after receipt of such approval.

  • Unless otherwise agreed to by the Parties, Zai covenants that its activities and rights under this Agreement are limited to the Lead Product until such time as the Lead Product receives Initial FDA Approval.

  • Zai covenants not to undertake any activities outside the scope of the license and the foregoing restriction of this Section 2.2. Following the Initial FDA Approval for the Lead Product, Zai may practice the license granted under Section 2.1 for Licensed Products other than the Lead Product.

  • If Zai delivers such notice after Initial FDA Approval, then Zai may Develop an Imipenem Combination; provided, that such Development does not have, in the reasonable opinion of Entasis, a material adverse effect of the Development or Commercialization of a Licensed Product.

  • For clarity, Zai may not Develop an Imipenem Combination without Entasis’s prior written consent prior to Initial FDA Approval of the Licensed Product.

  • If such notice is delivered prior to Initial FDA Approval, then following such notice, the Parties shall negotiate for a period of up to [*] on a Development Plan for such Imipenem Combination.

  • If such notice is delivered prior to Initial FDA Approval, then following such notice, the Parties shall negotiate for a period of up to [********] on a Development Plan for such Imipenem Combination.