Supplement Approval definition

Supplement Approval means FDA’s approval of a filing intended to be made by BDSI to the FDA pursuant to 21 U.S.C. §314.70(b)(1) with respect to the proposed commercial manufacture of the Current Product by *** which, upon such approval, would permit the sale of Current Product manufactured by *** for human therapeutic use in the Territory under the Current Product NDA (such filing, the “Supplemental Filing”).
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Supplement Approval means FDA’s approval of a filing intended to be made by BDSI to the FDA pursuant to 21 U.S.C. §314.70(b)(1) with respect to the proposed commercial manufacture of the Current Product by *** which, upon such approval, would permit the sale of Current Product manufactured by
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Supplement Approval means FDA’s approval of a filing intended to be made by BDSI to the FDA pursuant to 21
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Examples of Supplement Approval in a sentence

  • BDSI shall assign the *** Agreement to Collegium as soon as reasonably possible following Supplement Approval and assignment to Collegium of the Current Product NDA, all Governmental Approvals and all other Regulatory Filings related thereto in the Territory.

  • BDSI shall use Commercially Reasonable Efforts to obtain Supplement Approval as soon as reasonably possible following the Effective Date and, in any event, BDSI shall use Commercially Reasonable Efforts to make the supplemental filing contemplated by the definition of “Supplement Approval” to the FDA by December 31, 2016 (such filing, the “Supplement”).

  • The agreement between CVWD and MWD dated December 19, 1989 and entitled Agreement to Supplement Approval Agreement.

  • IID and MWD have entered into an Agreement for the Implementation of a Water Conservation Program and Use of Conserved Water dated December 22, 1988 (1988 Agreement); IID, MWD, PVID and CVWD have entered into a related Approval Agreement, dated December 19, 1989 (1989 Approval Agreement); and MWD and CVWD have entered into an Agreement to Supplement Approval Agreement, dated December 19, 1989 (1989 Supplemental Agreement).

  • Subject to the terms of this Agreement, and without affecting ownership or title to any BDSI Know-How contained or referenced therein, BDSI shall, promptly following receipt of Supplement Approval of the Current Product, assign to Collegium all of BDSI’s rights in and to the Current Product NDA, Governmental Approvals and all other Regulatory Filings related thereto in the Territory *** Confidential Information has been omitted and filed separately with the Securities and Exchange Commission.

  • The Agreement to Supplement Approval Agreement between MWD and CVWD dated December 19, 1989 shall be amended as set forth in the Amendment to Agreement to Supplement Approval Agreement, which amendment is attached hereto as Exhibit A.

  • Collegium shall use Commercially Reasonable Efforts to comply with and, upon Supplement Approval, maintain all Governmental Approvals in the Territory, including but not limited to the Current Product NDA, and, subject to the remainder of this Section 2.02, Develop Licensed Products in the Territory.

  • Q-Med shall prepare and submit on behalf of the Purchaser a PMA Application for obtaining issuance of a duplicate PMA Approval (based on the procedures described in Section 6.3 above) with respect to Restylane Fine Lines(TM) promptly upon receipt of the final Milestone Payment or the original PMA Approval or PMA Supplement Approval for Restylane Fine Lines(TM), whichever is later.

  • Collegium shall use Commercially Reasonable Efforts to comply with and, upon Supplement Approval, maintain all Governmental Approvals in the Territory, including but not limited to the *** Confidential Information has been omitted and filed separately with the Securities and Exchange Commission.

  • Subject to the terms of this Agreement, and without affecting ownership or title to any BDSI Know-How contained or referenced therein, BDSI shall, promptly following receipt of Supplement Approval of the Current Product, assign to Collegium all of BDSI’s rights in and to the Current Product NDA, Governmental Approvals and all other Regulatory Filings related thereto in the Territory and transfer to Collegium a copy of BDSI’s safety database concerning the Licensed Product in the Territory.