Shire Product definition

Shire Product means all formulations and dosages of CARBATROL® (carbamazepine) approved by the FDA, but excluding EQUETRO®.
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Shire Product has the meaning given to it in the Promotional Agreement.
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Shire Product means a Collaboration Product to be manufactured hereunder as set forth in Section 2.1.
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Examples of Shire Product in a sentence

  • In the event a specialty pharmacy receives a Product quality and/or performance complaint via a third party e-mail or fax, the product quality and/or performance defect complaint must be sent to Shire Product Quality Complaints at PQC@shire.com or 1-800-828-2088 option 3 within 24 hours.

  • Impax represents and warrants that it and each member of the Sales Force have the necessary, secure and proper environment for the storage of samples of the Shire Product.

  • Except for the warranties, obligations and undertakings of each of the Parties set forth in this Agreement, no warranty, condition, term, undertaking or representation (express or implied, statutory or otherwise) is given by one Party to the other in respect of the Trademark, the Shire Product or the Impax Product; such warranties, conditions, terms, undertakings and representations are to the extent permitted by law expressly excluded.

  • All written communications from Impax to the Sales Force regarding strategy, positioning, safety, efficacy, labeling or promotion for the Shire Product are subject to the prior review and written approval of Shire, which approval shall not be unreasonably withheld, delayed or conditioned.

  • Shire shall use commercially reasonable efforts to maintain the Shire Product on formularies of managed care customers consistent with the inclusion thereon of the Shire Product as of the Effective Date of this Agreement.

  • Shire, at its option, shall replace any damaged or defective Shire Product, or issue a credit in the amount of the purchase price paid by the direct purchasing customer, provided that the Product is returnable and is returned in accordance with the provisions of this policy.

  • Impax shall not, and shall ensure that the Sales Force members shall not, directly or indirectly, make any representations or warranties relating to the Shire Product that conflict, or are inconsistent with the NDA, applicable Law or the FDA approved label for the Shire Product.

  • Notwithstanding the foregoing, the Parties understand and agree that Impax shall not have any right to conduct clinical or non-clinical trials on the Shire Product, or without Shire’s consent, which consent shall not be unreasonably withheld, delayed or conditioned, initiate or participate in symposia, seminars, technical or scientific exhibits or other professional events with respect to the Shire Product.

  • During the Term and for a period of not less than three (3) years thereafter, on twenty-four (24) hours notice from Shire, Impax shall provide, or procure that its Affiliates provide, Shire (or its nominee) access to any records or reports relating to the receipt, storage or distribution of samples of the Shire Product.

  • Notwithstanding anything contained in this Agreement, Shire shall have the sole right to make final decisions relating to any advertising, marketing material or promotion material, brand strategy and messaging relating to the Shire Product.

Related to Shire Product

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

  • 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.

  • 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 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.

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

  • Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other than a chemically synthesized polypeptide, or analogous product, or arsphenamine or any derivative of arsphenamine or any other trivalent organic arsenic compound, applicable to the prevention, treatment, or cure of a disease or condition of human beings.

  • 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.”

  • 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 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.

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

  • Software Product means any COTS which you propose to provide pursuant to the contract.

  • 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 products means all products made from industrial hemp,

  • 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;

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

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

  • Combination Product means any product that comprises a Licensed Compound or Licensed Product sold in conjunction with another active component so as to be a combination product (whether packaged together or in the same therapeutic formulation).

  • 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.

  • 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.

  • 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.

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

  • API means the American Petroleum Institute.

  • 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.

  • Combination Products means any product containing both a pharmaceutically active agent or ingredient which constitutes a Licensed Product and one or more other pharmaceutically active agents or ingredients which do not constitute Licensed Products.

  • Final Product means a product that is not used in producing other products and is built and intended for use outdoors, provided the final product has not deteriorated or has otherwise become a potential source of contaminants.

  • 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.