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

  • 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.

  • 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.

  • 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.

  • 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.

  • 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).

  • 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.

  • 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.

  • Licensee shall have the sole right and responsibility, and shall exercise Commercially Reasonable Efforts, to prepare, obtain, and maintain, as applicable, the Regulatory Materials in the Territory, including the Product INDs and other submissions, and to conduct communications with the relevant Regulatory Authorities, related to or needed for the Commercialization of Product in the Field in the Territory.

  • Product INDs in any jurisdiction outside the United States shall be closed or transferred to Buyer on a country-by-country basis as specified in the transition plan.

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

  • Product Inventory means all inventory of the Product owned by Seller or its Affiliates as of the Closing, including raw materials, work-in-process, bulk form drug and finished Product.

  • 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.

  • Product means any deliverable under the Contract, which may include commodities, services, technology or software.

  • Milk product or "dairy product" means cottage cheese, dry curd cottage cheese, reduced fat cottage cheese, lowfat cottage cheese, cream, light cream, light whipping cream, heavy cream, heavy whipping cream, whipped cream, whipped light cream, sour cream, acidified sour cream, cultured sour cream, half-and-half, sour half-and-half, acidified sour half-and-half, cultured sour half-and-half, reconstituted or recombined milk and milk products, concentrated milk, concentrated milk products, skim milk, lowfat milk, frozen milk concentrate, flavored milk, eggnog, buttermilk, cultured milk, cultured lowfat milk, cultured skim milk, yogurt, lowfat yogurt, nonfat yogurt, acidified milk, acidified lowfat milk, acidified skim milk, low-sodium milk, low-sodium lowfat milk, low-sodium skim milk, lactose-reduced milk, lactose-reduced lowfat milk, lactose-reduced skim milk, aseptically processed and packaged milk, milk products with added safe and suitable microbial organisms, and any other milk product made by the addition or subtraction of milkfat or addition of safe and suitable optional ingredients for protein, vitamin, or mineral fortification. Unless a product is considered a milk product under this subdivision, milk product does not include dietary products, infant formula, ice cream or other desserts, cheese, or butter. Milk products include the following:

  • Tobacco product manufacturer means an entity that after the date of enactment of this Act directly (and not exclusively through any affiliate):

  • Nicotine product means a product that contains nicotine and is not any of the following:

  • Licensed Product means a product or part of a product in the Licensed Field of Use: (A) the making, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent; or (B) which is made with, uses or incorporates any Technology.

  • WTO GPA country end product means an article that—

  • Product Patents means any and all United States patents and patent applications, all divisionals, continuations, continuations-in-part, re-issues, extensions or foreign counterparts thereof, now or hereafter owned or controlled ("controlled" being used in the sense of having the right to grant licenses thereunder) by PERIMMUNE, covering the manufacture, use, sale, offer for sale and/or importation of the Product, including but not limited to, the U.S. Patent No. 5,407,912 attached hereto as Exhibit B.

  • New Product means the Synology-branded hardware product and Synology-branded accessories contained in the original packaging Customer bought from an authorized Synology distributor or reseller. You may see our “New Product” at Product Support Status.

  • Product Manufacturer means the entity that assembles the component parts to manufacture the final Product;

  • U.S. Territory means American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, the Commonwealth of Puerto Rico, or the U.S. Virgin Islands.

  • Existing Product means any formulation of the same product category and form sold, supplied, manufactured, or offered for sale in California prior to the following dates, or any subsequently introduced identical formulation:

  • Finished Product means a cannabis product in its final form to be sold at a retail premises.

  • Generic Product means a product which (a) contains as its active pharmaceutical ingredient a compound that is (or is substantially the same as) the Licensed Compound, and (b) has been placed on the market pursuant to a validly granted marketing authorization.

  • Licensed Compounds means: (a) Research Program Active Compounds; (b) Novartis Active Compounds; (c) salts, hydrates, solvates, esters, metabolites, intermediates, stereoisomers and polymorphs of Research Program Active Compounds or Novartis Active Compounds; and (d) prodrugs of Research Program Active Compounds or Novartis Active Compounds (any of the foregoing, a “Licensed Compound”).

  • Hemp product means the same as that term is defined in § 3.2-4112.

  • Licensed Compound means [***].

  • Territory means worldwide.

  • Competing Product means [***].

  • Aerosol Product means a pressurized spray system that dispenses product ingredients by means of a propellant contained in a product or a product's container, or by means of a mechanically induced force. “Aerosol Product” does not include “Pump Spray.”

  • Royalty Product means, either (a) an Alnylam Royalty Product, or (b) an Inex Royalty Product.

  • New Products means any product which is not an Enhanced Product or 2 Existing Product but which is substantially similar to an Existing Product with respect to design and function and possesses reasonable performance improvements. If Company desires to purchase an Enhanced or New Product(s) from Supplier, Company shall so notify Supplier and provide Supplier the opportunity to manufacture such Enhanced or New Product(s), subject to the following conditions and procedures.