Common use of Efforts to Achieve Milestones Clause in Contracts

Efforts to Achieve Milestones. Until the earlier of (a) the seventh (7th) anniversary of the Closing and (b) the achievement of U.S. Commercial Launch, Parent shall, and shall cause its controlled Affiliates and Ultimate Parent to, use their Commercially Reasonable Efforts to (i) develop and seek FDA Approval for the Product, and (ii) following receipt of FDA Approval for the Product, achieve U.S. Commercial Launch; provided, that the use of Commercially Reasonable Efforts in accordance with this Agreement does not guarantee that Parent will obtain FDA Approval for the Product, achieve U.S. Commercial Launch, or guarantee that Parent will achieve any of the Milestones at all or by a specific date. Notwithstanding anything in this Agreement to the contrary, in no event shall Parent or any of its Affiliates be required to undertake any level of efforts, or employ any level of resources, to (A) conduct, or commit to conduct, any additional clinical, safety or efficacy studies (including any randomized controlled trial) in connection with obtaining regulatory approvals of the Product, (B) achieve any Milestone, (C) seek regulatory approval for, maintain market availability or commercialize, the Product outside the United States or (D) develop, market or commercialize any Product at any time following achievement of U.S. Commercial Launch.

Appears in 3 contracts

Samples: Contingent Value Rights Agreement (Indivior PLC), Contingent Value Rights Agreement (Indivior PLC), Contingent Value Rights Agreement (Indivior PLC)

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Efforts to Achieve Milestones. Until the earlier of (a) the seventh (7th) anniversary of the Closing and (b) the achievement of U.S. Commercial LaunchDecember 31, 2028, Parent shall, and shall cause its controlled Affiliates and Ultimate Parent to, use their Commercially Reasonable Efforts to (i) develop and seek FDA Approval for the Product, and (ii) following receipt of FDA Approval for the Product, achieve U.S. Commercial Launch; provided, that the use of Commercially Reasonable Efforts in accordance with this Agreement does not guarantee that Parent will will—at all or by a specific date—obtain FDA Approval for the Product, achieve U.S. Commercial Launch, or guarantee that Parent will achieve any of the Milestones at all or by a specific dateMilestones. Notwithstanding anything in this Agreement to the contrary, in no event shall contrary herein: (A) neither Parent or nor any of its controlled Affiliates be required to undertake any level shall act in bad faith for purposes of efforts, or employ any level of resources, to (A) conduct, or commit to conduct, any additional clinical, safety or efficacy studies (including any randomized controlled trial) in connection with obtaining regulatory approvals avoiding achievement of the ProductMilestones or the payment of any Milestone Payment, (B) achieve neither Parent nor any Milestone, (C) of its controlled Affiliates shall be required to seek regulatory approval for, maintain market availability or commercialize, commercialize the Product outside the United States States, (C) an increase in the number of randomized patients included in the clinical trials relating to the Product to one hundred twenty, or any other number reasonably determined by Parent, patients shall not be deemed a breach by Parent of its obligations pursuant to this Section 4.3, and (D) developParent shall have the right, market or commercialize any in its reasonable discretion, to determine that the Product at any time following achievement is not commercially viable, and abandon further development and/or commercialization of U.S. Commercial Launchthe Product.

Appears in 2 contracts

Samples: Merger Agreement (Timber Pharmaceuticals, Inc.), Merger Agreement (Timber Pharmaceuticals, Inc.)

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