Product IND definition

Product IND means any IND filed in the Territory related to a Product, whether in existence as of the Effective Date or filed with the FDA during the Term, including any supplements or amendments thereto. The Product INDs as of the Execution Date are set forth on Exhibit 1.141.

Product IND means Depomed’s Investigational New Drug Application filed with the FDA with respect to Product, including all submissions, supplements and amendments thereto.

Product IND means any IND filed in the Territory pertaining to a Product filed during the Term, including any supplements or amendments thereto.

Examples of Product IND in a sentence

• Within [***] days of the Effective Date, unless otherwise agreed by the Parties, Takeda will assign to Licensee all rights, title, and interests in and to each Licensed Product IND filed in the Field in the Licensee Territory, and will transfer to Licensee copies (in electronic or other format) of those Regulatory Materials owned by Takeda or its Affiliates as of the Effective Date that are necessary to assign such Licensed Product INDs to Licensee.

• From the Effective Date, Aptalis shall, at its sole expense, support and maintain all Regulatory Approvals in the Territory (including the Product IND and Product NDA assigned to Aptalis by ProStrakan under Section 5.1 above and any future Regulatory Approvals obtained by Aptalis or its Affiliates for the Product in the Territory), including filing reports or regulatory variations with the applicable Regulatory Authorities (subject to the provisions of Sections 5.4 and 5.6).

• Effective as of the Effective Date, ProStrakan hereby assigns the Product NDA and the Product IND to Aptalis.

• Effective only as of the NDA Transfer Date, Depomed shall, and it hereby does, assign to Santarus all right, title and interest in the Product NDA, subject to the Existing Rights of Reference and any Additional Rights of Reference granted by Depomed during the Pre-Transfer Period, and the Product IND.

• Notwithstanding anything to the contrary in this Agreement, except in connection with the assignment of this Agreement in accordance with Section 17.6, Aptalis shall not be entitled to transfer, assign, encumber (other than in connection with general liens as part of financing arrangements in the ordinary course) or convey such Product NDA and Product IND to any Third Party.

More Definitions of Product IND

Product IND means any IND filed in the Territory pertaining to a Product, including any supplements or amendments thereto.

Product IND means IND number 45,326. * Confidential treatment requested.

Product IND means any IND filed in the Territory related to a Product, whether in existence as of the Effective Date or filed with a Regulatory Authority during the Term, including any supplements or amendments thereto. The Product INDs as of the Effective Date are set forth on Exhibit D.

Product IND means the IND (IND File No. 54,732) submitted to the FDA by Noven on December 12, 1997, seeking approval to develop, test and perform clinical and non-clinical trials of the Product, along with any amendments, correspondence or supplements thereto and incorporated therein.

Product IND means any and all Investigational New Drug Applications filed by GENAERA and relating to the Genaera Product, including but not limited to IND No. 40,454 and IND No. 43,929.

Product IND means any IND(s) for any Product(s), together with all amendments, modifications, supplements and updates thereto. “Product License Agreement” means any agreement pursuant to which Seaport or any of its Controlled Affiliates grants a Third Party (each, a “Product Licensee”) a license (or similar rights) under the Glyph IP to develop and/or commercialize any Product in any country in the Territory, including a license or agreement granting marketing and/or distribution rights with respect to Products to such Third Party; but excluding (i) any agreement pursuant to which Seaport or any of its Controlled Affiliates grants rights to a Third Party to perform development or commercialization activities on behalf of Seaport or its Controlled Affiliates where such persons are compensated at market rates for services rendered, and (ii) any agreement that is entered into as part of, or otherwise results in, a Change of Control. “Product Licensee” has the meaning set forth in the definition of “Product License Agreement”. “PureTech Benefit Arrangement” means any (a) “employee benefit plans,” as defined in Section 3(3) of ERISA, together with plans or arrangements that would be so defined if they were not (i) otherwise exempt from ERISA by Section 3(3) of ERISA or another Section of ERISA or (ii) individually negotiated or applicable only to one individual and (b) any other written or oral benefit arrangement or obligation to provide benefits or compensation for services rendered, in each case within this sentence in respect of any employees, independent contractors, directors, officers or stockholders of PureTech or any Controlled Affiliate, which is sponsored or maintained by PureTech or any Controlled Affiliate or with respect to which PureTech or any Controlled Affiliate has made or is required to make payments, transfers or contributions or has or may have any Liability, directly or through its ERISA Affiliates.

Product IND means the IND application No. 68,279 submitted by Reata to the FDA for clearance to conduct a clinical investigation with Product.