Licensed Product IND definition

Licensed Product IND means any IND filed related to a Licensed Product, whether in existence as of the Effective Date or filed by a Party with a Regulatory Authority during the Term, including any supplements or amendments thereto. The Licensed Product INDs as of the Effective Date are set forth on Schedule 1.78(a) (TAK-385 Licensed Product INDs) and Schedule 1.78(b) (TAK-448 Licensed Product INDs).
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Licensed Product IND means any IND filed related to a Licensed Product, whether in existence as of the Effective Date or filed by a Party with a Regulatory Authority during the Term, including any supplements or amendments thereto. The Licensed Product INDs as of the Effective Date are set forth on Schedule 1.78(a) (TAK-385 Licensed Product INDs) of the License Agreement. [See License Agreement Section 1.78]
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Licensed Product IND means the IND filed related to the Licensed Product in existence as of the Effective Date.
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Examples of Licensed 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.

  • Licensor shall cooperate with and provide assistance to Licensee with respect to communications with the FDA and with responding to all requests for information from, and with making all required filings with, the FDA in respect of the Licensed Products, including the Licensed Product IND (as defined below).

  • In addition, Licensor shall provide to Licensee all data and information necessary for Licensee to comply with all requirements and obligations to the FDA with respect to the maintenance of the Licensed Product IND.

  • Licensee shall cooperate with and provide reasonable assistance to Licensor, at Licensor’s expense, with respect to transfer of all Licensed Patent Rights and the Licensed Product IND to Licensor.

  • Promptly upon the request of Regeneron, Sanofi or its Affiliate shall submit a letter of authorization to FDA or the applicable Regulatory Authority (and take such actions or make such other filings) in order to permit any ANG2 Licensed Product IND, BLA, Registration Filing and/or Approval to be incorporated by reference in such Excluded Ocular ANG2 Product regulatory filings.

  • Subject to the terms of this Agreement, Licensee shall be the sole and exclusive owner of (a) the Licensed Product IND; (b) the Development IP and (c) any and all Improvements or other derivatives of the Licensed Patent Rights or Licensed Technology, and all Patent Rights or other Intellectual Property Rights therein.

  • Section 8.1, in order to enable Licensee to exercise its rights in the Licensed Patent Rights and Licensed Technology, Licensor will promptly provide to Licensee all necessary cooperation and assistance reasonably requested by Licensee in connection with transferring any Licensed Patent Rights, Licensed Technology and the Licensed Product IND.

  • As the result of and effective as of such Transfer, GEHC will act as the sponsor of the Licensed Product IND for the Licensed Product in the Territory, and will take over from LMI all responsibilities of sponsors as defined under the FD&C Act, other FDA regulations, and all other Applicable Laws, including pharmacovigilance responsibilities.

  • Such exchange shall include summaries of information relating to material Development activities of each Party, including all Clinical Trials of the Licensed Product, IND and Regulatory Approval Application filings for all Indications for the Licensed Product.

  • LMI will take all steps reasonably necessary to effect the Transfer, including submitting to each applicable Regulatory Authority within *** after the Effective Date a letter or other necessary documentation (with a copy to GEHC) notifying such Regulatory Authority of the transfer of such ownership of the Licensed Product IND.


More Definitions of Licensed Product IND

Licensed Product IND means any IND filed related to a Licensed Product, whether in existence as of the Effective Date or filed by a Party with a Regulatory Authority during the Term, including any supplements or amendments thereto. The Licensed Product INDs as of the Effective Date are set forth on Schedule 1.78(a) (TAK-385 Licensed Product INDs) of the License Agreement. [See License Agreement
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Related to Licensed Product IND

  • 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.

  • Licensed producer means an agent, broker, or reinsurance intermediary licensed pursuant to the applicable provision of the insurance law of any jurisdiction.

  • Licensed Products means tangible materials which, in the course of manufacture, use, sale, or importation, would be within the scope of one or more claims of the Licensed Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.

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

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

  • Licensed Territory means worldwide.

  • 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”).

  • Licensed Compound means [***].

  • 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.

  • 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 Field means [***].

  • Diagnostic Product means any test or assay for diagnosing or detecting a disease, disorder, medical condition, or symptom.

  • Hemp products means all products made from industrial hemp,

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether

  • Licensed Fields of Use means the fields of use identified in Appendix B.

  • Bundled Product means Product sold together with any other product(s) or service(s) at a single unit price, whether packaged together or separately, and which other product(s) or service(s) have material independent value from Product itself.

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

  • Licensed Services means all functions performed by the Licensed System.

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

  • Therapeutic Product means a health product categorised as a therapeutic product in the First Schedule to the Act;

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

  • Licensed Field of Use means all fields.

  • 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.

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

  • Licensed Program means the executable processing programs of licensed information, which is composed of various modules in the Licensed Software package provided by the Licensor.