Product INDs definition

Product INDs means the INDs for the Product as set forth on Annex 3.
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Product INDs has the meaning set forth in Section 3.4.
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Product INDs means Depomed’s Investigational New Drug Applications filed with the FDA with respect to Products set forth on Schedule 1.158, including all supplements and amendments thereto.
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Examples of Product INDs in a sentence

  • Promptly after such transfer, Ultragenyx shall take all steps necessary to transfer ownership of all such Product INDs and Product Regulatory Approvals in the Takeda Territory to Takeda, including, if applicable, submitting to the PMDA a letter or other necessary documentation (with a copy to Takeda) notifying the PMDA of the transfer of such ownership.

  • 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.

  • Without limiting Section 4.3.1 (Licensed Product INDs), the transfer to Licensee of all Assigned Regulatory Materials will be accomplished in accordance with the timing and the process set forth in the Transition Plan.

  • Licensee will bear [***] in connection with the transfer and assignment of all Assigned Regulatory Materials, and any other copies of Regulatory Materials provided to Licensee pursuant to Section 4.3.1 (Licensed Product INDs) through Section 4.3.3 (Other Regulatory Materials).

  • Takeda shall promptly notify Myovant if Myovant is required pursuant to Applicable Law to make any changes to the TAK-385 Licensed Product INDs related to the appointment of a Third Party to Manufacture of the Drug Substance or Drug Product.

  • Myovant shall, and shall ensure that its Affiliates, Sublicensees and Subcontractors: (a) comply with the requirements and restrictions of any Permits and other Applicable Laws applicable to the use of the Drug Substance or Drug Product in accordance with the License Agreement; (b) use the Drug Substance or Drug Product in compliance with Applicable Laws and the TAK-385 Licensed Product INDs; and (c) comply with Myovant’s obligations under this Agreement.

  • Takeda shall supply the Drug Substance and Drug Product that conforms to GMPs, Applicable Laws and the TAK-385 Licensed Product INDs. Takeda shall be entitled, at its cost and expense, to modify the Specifications, Manufacturing, and testing processes, in each case, employed with regard to the Manufacture of the Drug Substance or Drug Product from time to time, subject to approval, solely to the extent required by Applicable Laws or Regulatory Authorities.

  • All Product INDs for any Clinical Trials conducted by Licensee in Japan with respect to the Licensee Japan Development Activities shall be owned by, and shall be the sole property and held in the name of Licensee or its designee (the “Licensee Japan INDs”), but may be transferred to Takeda pursuant to Section 6.1(c).

  • All Product INDs are in full force and effect and there are no facts that would constitute a material default or noncompliance under the Product IND.

  • Emisphere shall have the right to cross file and reference data from Product INDs or NDAs with respect to obtaining Regulatory Approval for Program Carriers for other drugs.


More Definitions of Product INDs

Product INDs means the INDs set forth on Annex 1.1(f). “Product NDAs” means the NDAs set forth on Annex 1.1(g).
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Product INDs shall have the meaning set forth in the recitals.
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Product INDs means the INDs set forth on Annex 1.1(f).
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Product INDs has the meaning assigned to such term in Section 5.9.
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Related to Product INDs

  • Product Inventory means all inventory owned as of the Closing by Seller or any Affiliate thereof of finished Product that is in conformance with the Specifications and has an expiration date of October 1, 2016 or later, regardless of whether such inventory is held at a location or facility of Seller or any Affiliate (or of any other Person on behalf of Seller or any Affiliate, including in any of Seller’s warehouses, manufacturers, suppliers, distributors or consignees) or in transit to or from Seller or any Affiliate (or any such other Person).

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

  • Covered Product The consumer product that You purchased concurrently with and is covered by this Agreement.

  • Covered Products means Your Applications, Libraries, Passes, Safari Extensions, Safari Push Notifications, and/or FPS implementations developed under this Agreement.

  • Designated country end product means a WTO GPA country end product, a Free Trade Agreement country end product, a least developed country end product, or a Caribbean Basin country end product.