Existing INDs definition

Existing INDs means the IND(s) referenced on Schedule 1.25 and related to the Licensed Product, all of which are controlled by ▇▇▇▇▇▇▇ or its Affiliate on the Effective Date. For clarity, notwithstanding the definition of IND provided in Section 1.36 below, Existing IND(s) shall not include any IND filed with any regulatory authority other than the FDA.
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Existing INDs means the INDs for CDZ173 filed with the FDA with IND numbers [***].
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Existing INDs has the meaning set forth in Section 4.6(b).
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Examples of Existing INDs in a sentence

  • As partial consideration for the exclusive licenses set forth in Section 4.1 and 4.2, the obligation of assignment of the Existing IND(s) to PPD provided in Section 2.2, and the obligation of the provision of GMP API and CTM to PPD by ▇▇▇▇▇▇▇ pursuant to Section 3.1, PPD shall pay a one-time, nonrefundable, upfront payment of three million five hundred thousand dollars ($3,500,000) to ▇▇▇▇▇▇▇, within ten (10) business days after the Effective Date.

  • Prior to the assignment and transfer of the Existing INDs: (a) [***]; and (b) [***].

  • The Adolescent Study will be conducted under the Existing INDs in the United States or under new INDs in Israel (“Adolescent Study Territory”) which will be amended by the Parties’ mutual written agreement and in accordance with the Adolescent Study Protocol.

  • If this Agreement expires pursuant to Section 7.1(b) as a result of Medgenics’ exercise of the Option during the Option Period, Medgenics will retain title to the Existing INDs and all amendments or supplements thereto submitted to FDA by or on behalf of Medgenics pursuant to the License Agreement (as defined below).

  • Prior to the assignment and transfer of the Existing INDs: (a) [ * ] and (b) [ * ].

  • Pursuant to the Original CDOA, KKC transferred and assigned to Aevi all of KKC’s and its Affiliates’ rights in and to IND #(***) and IND #(***) (the “Existing INDs”) and delivered to the United States Food and Drug Administration or a successor agency in the United States with responsibilities comparable to those of the United States Food and Drug Administration (“FDA”) the letter required by 21 CFR Part 314.72 notifying FDA of the transfer of the Existing INDs to Aevi.

  • If this Agreement expires or terminates other than as a result of the exercise of the Option prior to the expiration of the Option Period, Medgenics will transfer and assign to KHK or KHK’s designee the Existing INDs and all amendments or supplements thereto submitted to FDA by or on behalf of Medgenics within ***** after such expiration or termination of this Agreement.

  • The Signal Finding Study will be conducted under the Existing INDs. Medgenics will act as the sponsor of the Signal Finding Study and conduct the Signal Finding Study subject to and in accordance with the terms and conditions of this Agreement, the Study Protocol and all Applicable Law, including but not limited to applicable Good Clinical Practices and Good Laboratory Practices.

  • Subject to the timelines set forth in Section 4.2.2 below for the transfer of the Existing INDs [***] the Effective Date, XenoPort will make available to Reckitt [***].

  • No later than ***** after the CDOA Effective Date, KHK will deliver to the United States Food and Drug Administration or a successor agency in the United States with responsibilities comparable to those of the United States Food and Drug Administration (“FDA”) the letter required by 21 CFR Part 314.72 notifying FDA of the transfer of the Existing INDs to Medgenics.

Related to Existing INDs

  • Existing Indentures means (1) the Indenture dated as of November 22, 2002, among the Issuer, the guarantors named therein and The Bank of New York Mellon (as successor to J.P. Morgan Trust Company, National Association), as trustee, as amended and supplemented by the First Supplemental Indenture through the Twenty-Second Supplemental Indenture and as may be further amended and supplemented, (2) the Indenture dated as of April 20, 2009, among the Issuer, the guarantors named therein and The Bank of New York Mellon, as trustee, as amended and supplemented by the First Supplemental Indenture through the Fourth Supplemental Indenture, the resolutions dated as of April 20, 2009 authorizing the 8.910% Senior Notes due 2017 and the resolutions dated as of September 22, 2009 authorizing the 6.750% Senior Notes due 2019, and as may be further amended and supplemented, (3) the Indenture dated as of February 7, 2012, among the Issuer, the guarantors named therein and The Bank of New

  • Existing Indenture means the Indenture dated as of June 30, 1998 among General Partner, Prologis and U.S. Bank National Association (as successor in interest to State Street Bank and Trust Company of California, N.A.), as Trustee.

  • Existing Indebtedness Agreements shall have the meaning provided in Section 5.05.

  • Existing uses means those uses actually attained in a water body on or after November 28, 1975, whether or not they are included in the water quality standards.

  • Existing Indebtedness means all Indebtedness of the Company and its Subsidiaries (other than Indebtedness under the Credit Agreement) in existence on the date of this Indenture, until such amounts are repaid.