GDNF Product definition

GDNF Product means any Gene Therapy product capable of delivering GDNF or the gene encoding GDNF, or in either case any fragment of GDNF that has Functional Activity.
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Examples of GDNF Product in a sentence

  • The Parties acknowledge that developing and seeking Regulatory Approvals for a GDNF Product may include sequential implementation of clinical trials and intervals between clinical trials for data interpretation and clinical program planning and approval.

  • The Parties shall work together in good faith for a period of [**] days to transfer to Amgen any GDNF Product developed by AMT prior to the date of such termination, including by transferring Regulatory Filings related to the program and manufacturing of GDNF Products.

  • Upon the first approval of an NDA with respect to a GDNF Product achieved by AMT and/or its Affiliates (the “Approval Milestone”), AMT shall promptly (and, in any event, no later than [**] days) notify Amgen in writing of such occurrence and the amount received, and Amgen will invoice AMT for a one-time payment in the amount of the greater of (a) ten million US Dollars (US$10,000,000) and (b) [**]% of any milestone payments received by AMT from Third Parties in respect of the Approval Milestone.

  • Amgen shall have [**] Business Days from receipt of such notice to request from AMT a data package containing such information as Amgen may reasonably request and as may be available regarding such GDNF Product (the “Data Package”).

  • Amgen acknowledges that in determining whether AMT has met its requirement to use Reasonably Diligent Efforts in accordance with Section 5.1 (Use of Reasonably Diligent Efforts) reference will be made to the totality of AMT’s activities with respect to all GDNF Product(s) (if, in AMT’s sole discretion, it decides to develop more than one GDNF Product) in all countries, not on a country-by-country basis.

  • AMT, itself or through one or more Third Party contract manufacturers designated by it that have appropriate expertise and are suitably qualified, including holding the requisite permits and having been subject to or available for appropriate audits and inspections by the relevant regulatory bodiesis solely responsible for the manufacture and supply of requirements of GDNF Products (including any GDNF used in a GDNF Product).

  • For a period of [**] days after the termination of this Agreement under either Section 8.2 (Termination by AMT) or 8.3 (Termination by Amgen), AMT, its Affiliates and Sublicensees shall have the right to sell off any stock of GDNF Product on hand or in-process and provide services relating to GDNF Products, and the provisions of Section 4.2 (Revenue Sharing) and the payment provisions of this Agreement shall apply to such sales.

  • AMT shall notify Amgen in writing within [**] Business Days after Completion of the first Phase 2 Clinical Trial (whether a stand-alone clinical trial or in combination with another clinical trial, i.e., a phase 1/2 clinical trial or phase 2/3 clinical trial) for the first GDNF Product.

  • If any GDNF Product Exploited by or under the authority of AMT becomes the subject of a Third Party’s claim or assertion of infringement of a patent relating to the manufacture, use, sale, offer for sale or importation of such GDNF Product, the Party first having notice of the claim or assertion shall promptly notify the other Party, and the Parties shall promptly confer to consider the claim or assertion and the appropriate course of action.

  • Without limiting the foregoing, Amgen hereby acknowledges that AMTretains the right to Exploit, and authorize (by license or otherwise) Third Parties to Exploit, any product other than a GDNF Product even if such product is covered by a claim within the AMT Licensed Patent Rights.

Related to GDNF Product

  • Licensed Product means a product, method or service in the Licensed Field of Use, the making, having made, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent.

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

  • Spray buff product means a product designed to restore a worn floor finish in conjunction with a floor buffing machine and special pad.

  • 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.

  • 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 any pharmaceutical product that (i) is sold by a Third Party that is not an Affiliate or licensee of Buyer and (ii) (a) contains the same active pharmaceutical ingredient as the Product or (b) is categorized by the applicable Governmental Entity in a country to be therapeutically equivalent to, or interchangeable with, the Product, such that the pharmaceutical product may be substituted for the Product at the point of dispensing without any intervention by the prescribing physician in such country.

  • Licensed producer means a person or entity licensed to produce medical cannabis.

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

  • Licensed Compound means [***].

  • 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.

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

  • complex product means a product which is composed of multiple components which can be replaced permitting disassembly and re-assembly of the product.

  • 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.

  • Licensed Compounds means any EZH2 Compound(s) that is:

  • Cannabis product means cannabis that has undergone a process whereby the plant material has been transformed into a concentrate, including, but not limited to, concentrated cannabis, or an edible or topical product containing cannabis or concentrated cannabis and other ingredients.

  • Biosimilar Product means, with respect to a Licensed Product in any country, any biosimilar product sold by a Third Party not authorized by or on behalf of Celgene, its Affiliates or Sublicensees, (a) that is a biosimilar biological product, as defined in 21 USC 379j-51 (or any successor or replacement thereof), a similar biological medicinal product, as defined in Annex I to Directive 2001/83/EC (or any successor or replacement thereof), or any similar biosimilar or generic product under the Laws of any country or jurisdiction, or (b) regarding which Regulatory Approval is obtained by referencing Regulatory Data of such Licensed Product.

  • Licensed System means, collectively:

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

  • Marihuana-infused product means a topical formulation, tincture, beverage, edible substance, or similar product containing marihuana and other ingredients and that is intended for human consumption.

  • Terminated Product has the meaning set forth in Section 13.5.

  • 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.”

  • Hemp products means all products made from industrial hemp,

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

  • Tobacco product means any substance containing tobacco leaf, including but not limited to, cigarettes, cigars, pipe tobacco, hookah tobacco, snuff, chewing tobacco, dipping tobacco, bidis, blunts, clove cigarettes, or any other preparation of tobacco; and any product or formulation of matter containing biologically active amounts of nicotine that is manufactured, sold, offered for sale, or otherwise distributed with the expectation that the product or matter will be introduced into the human body by inhalation; but does not include any cessation product specifically approved by the U.S. Food and Drug Administration for use in treating nicotine or tobacco dependence.

  • Licensed Service means a service provided using Licensed Products or Licensed Methods, including, without limitation, any such service provided in the form of contract research or other research performed by Licensee on behalf of a third party.

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;