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 Xxxxxxx 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

  • El Actuario debiera revelar en el Reporte estos hechos, al tercero que definió los supuestos y metodología, y las razones por las que un tercero, en lugar del Actuario, establecio dichos supuestos y metodología.▪ No fue posible para el Actuario juzgar qué tan apropiados son la metodología o supuestos, sin tener que desarrollar un monto substancial de Trabajo adicional al Trabajo encomendado, o el Actuario no estaba calificado para juzgar que tan apropiados eran los supuestos.

  • 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.

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

  • 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.

  • Thereafter, Pharming shall have sole responsibility to maintain the Existing INDs and any other IND related to the Licensed Compound or Licensed Products, and shall be responsible for all future communications with the relevant Regulatory Authorities regarding the Transferred Regulatory Filings and any and all subsequent Regulatory Filings relating to the Licensed Compound or Licensed Products under the Transferred Regulatory Filings or otherwise.

  • 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.

  • 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 [ * ].

  • 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 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) [ * ].

Related to Existing INDs

  • Existing Indentures means (a) the Indenture with respect to the Target Company’s 1.5% Convertible Senior Notes due 2017, dated as of August 25, 2010, by and between the Target Company and The Bank of New York Mellon Trust Company, N.A. and (b) the Indenture with respect to the Target Company’s 0.5% Convertible Senior Notes due 2020, dated as of October 29, 2013, by and between the Target Company and The Bank of New York Mellon Trust Company, N.A. (each as amended, restated, supplemented or otherwise modified from time to time prior to the date hereof).

  • 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 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.

  • Existing Plan means the Amended and Restated Novatel Wireless, Inc. 2000 Stock Incentive Plan.

  • Existing Agreements has the meaning as set forth in Section 3.2 hereof.

  • Existing Facility Agreement has the meaning specified therefor in the recitals hereto.

  • Existing Agreement has the meaning set forth in the recitals.

  • Existing use means a use actually attained in a surface water of the state on or after November 28, 1975, whether or not it is a designated use.

  • Permitted Existing Indebtedness means the Indebtedness of the Company and its Subsidiaries identified as such on Schedule 1.1.1 to this Agreement.

  • Existing Credit Agreements has the meaning set forth in the recitals hereto.

  • Existing structure means any structure that is installed or approved for installation at the time a wireless services provider or wireless infrastructure provider provides notice to a locality or the Department of an agreement with the owner of the structure to co-locate equipment on that structure. "Existing structure" includes any structure that is currently supporting, designed to support, or capable of supporting the attachment of wireless facilities, including towers, buildings, utility poles, light poles, flag poles, signs, and water towers.

  • existing industrial building means a building used for or in connection with,

  • Existing Leases means those leases, license agreements and occupancy agreements identified on Schedule 2.1.3, as the same may be amended or modified from time to time in accordance with the terms of this Agreement.

  • Existing Facility means a facility in existence on any given date, newly constructed or altered.

  • Existing Contracts means the existing licenses and contracts given by the Railway Administration / Authority, in relation to commercial establishments, as existing on Station Development Land, as on the date of the Agreement, and as further set out in the Schedules, which shall, for avoidance of doubt, exclude any licenses and/ or contracts in relation to any Excluded Activities and/or Railway Operational Activities;

  • Company IP Agreements means all licenses, sublicenses, consent to use agreements, settlements, coexistence agreements, covenants not to xxx, permissions and other Contracts (including any right to receive or obligation to pay royalties or any other consideration), whether written or oral, relating to Intellectual Property to which the Company is a party, beneficiary or otherwise bound.

  • Existing Financing means the financing arrangements that provided for a security interest granted by Company in the Aircraft and that were outstanding on August 3, 2020.

  • Original Agreement has the meaning set forth in the recitals.

  • Existing Loan Agreement has the meaning set forth in the recitals to this Agreement.

  • Material Contracts has the meaning set forth in Section 3.09(a).

  • Existing Credit Facilities means (a) the 364-Day Credit Agreement dated as of February 28, 2012 among TMCC, TMFNL, TFSUK, TLG, TCPR, TCCI and TKG, the lenders party thereto, BNP Paribas, as administrative agent, swing line agent and swing line lender, Citibank, N.A., as syndication agent and swing line lender, Bank of America, N.A., as syndication agent and swing line lender, The Bank of Tokyo-Mitsubishi UFJ, Ltd., as syndication agent, and JPMorgan Chase Bank, N.A., as documentation agent, (b) the Three Year Credit Agreement dated as of March 1, 2011, as amended by Amendment No. 1 dated as of February 28, 2012, among TMCC, TMFNL, TFSUK, TLG, TCPR, TCCI and TKG, the lenders party thereto, BNP Paribas, as administrative agent, swing line agent and swing line lender, Citibank, N.A., as syndication agent and swing line lender, Bank of America, N.A., as syndication agent and swing line lender, The Bank of Tokyo-Mitsubishi UFJ, Ltd., as syndication agent, and JPMorgan Chase Bank, N.A., as documentation agent, and (c) the Five Year Credit Agreement dated as of March 1, 2011, as amended by Amendment No. 1 dated as of February 28, 2012, among TMCC, TMFNL, TFSUK, TLG, TCPR, TCCI and TKG, the lenders party thereto, BNP Paribas, as administrative agent, swing line agent and swing line lender, Citibank, N.A., as syndication agent and swing line lender, Bank of America, N.A., as syndication agent and swing line lender, The Bank of Tokyo-Mitsubishi UFJ, Ltd., as syndication agent, and JPMorgan Chase Bank, N.A., as documentation agent.

  • Existing Lease shall have the meaning assigned thereto in Section 10.7.

  • Prior Agreements Has the meaning given such term in the recitals to this Agreement.

  • Existing Credit Agreement as defined in the recitals hereto.