NPP Product definition

NPP Product has the meaning set forth in Section 5.6(j)(1).
Sample 1Sample 2
NPP Product means the labeled, packaged and released vials of the Product meeting the specifications and requirements of the NDA for the Product. Spectrum acknowledges and consents to distribution and sale of NPP Product by Topotarget in the Topotarget Territory for use in named patient programs.
Sample 1Sample 2
NPP Product means the Product subject to the NPP in its secondary packaging for commercialization in the European Union and/or USA.
Sample 1

Examples of NPP Product in a sentence

  • In the event a shipment of API, NPP Product or Bulk Product is Non-Conforming in accordance with the Quality Agreement, and Spectrum or its Affiliates or a Third Party manufacturer is responsible for such Non-Conformance, Spectrum will conduct an investigation of the causes of such Non-Conformance, report the findings of such investigation to Topotarget, and use its Commercially Reasonable Efforts to implement remedial measures as appropriate.

  • Topotarget will be responsible for the export or re-export of Bulk Product, NPP Product or API from the country of delivery, and will comply with all applicable Laws and regulations relating to the export or re-export of Bulk Product, NPP Product or API, including the prohibition against unlawful transshipments.

  • Where Bulk Product, NPP Product or API are destined for export or re-export from the country of delivery, Topotarget agrees and accepts that it shall act as the exporter of record, and warrants that as the exporter of record, it will duly authorize and retain an agent who will act on its behalf, assuming all attendant responsibilities associated with the export or re-export, including obtaining any necessary export licenses.

  • Topotarget shall have the right, at reasonable intervals, as circumstances require, and on reasonable written prior notice (which notice shall be waived if circumstances warrant), to inspect Spectrum’s (to the extent applicable), or jointly inspect with Spectrum those sections of the Third Party manufacturer’s, manufacturing, packaging, laboratory and warehousing facilities utilized in the manufacture, packaging, storage, testing, shipping or receiving of API, NPP Product and/or Bulk Products.

  • Topotarget may from time to time request that Spectrum supply Product (including API, NPP Product and Bulk Product) outside of the forecast and Firm Order process specified in Sections 5.6(k) through (m) from Spectrum’s available stock.

  • Spectrum shall carry out its responsibilities hereunder, and shall use its Commercially Reasonable Efforts to cause the Third Party Manufacturers to carry out their responsibilities relating to the API, NPP Product and Bulk Product, in conformance with cGMPs, and any other Applicable Laws.

  • Spectrum shall provide Topotarget all API, NPP Product and Bulk Product-specific written communications or notices of inspection received from any Regulatory Authority no later than[***] ([***]) Business Days after such communications or notices are received by Spectrum.

  • If Topotarget does not provide such notice within such [***] ([***]) calendar day period then such Bulk Product or NPP Product shall be considered accepted and Topotarget shall not have a right to reject it except with respect to a latent defect which existed at the time of delivery and was not reasonably discoverable at the time of delivery and for which Spectrum still has the right, under its agreement with the relevant Third Party manufacture, to reject such Bulk Product or NPP Product.

  • Spectrum shall provide Topotarget with copies of all Regulatory Approvals for the API, NPP Product and Bulk Product and on an annual basis, Spectrum shall provide Topotarget with its anticipated schedule of material Regulatory Authority filings for the next [***] ([***]) calendar years.

  • Spectrum (itself or through its designee) will manufacture, test and supply Topotarget’s orders for the Bulk Product, NPP Product and API, in accordance with the terms hereof.

Related to NPP Product

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

  • 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.

  • 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.”

  • 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.

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

  • 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.

  • 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.

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

  • 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.

  • 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.

  • Hemp products means all products made from industrial hemp,

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

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

  • 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:

  • 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.

  • End product means those articles, materials, and supplies to be acquired under the contract for public use.

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

  • 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;

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

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

  • Roll-on product means any antiperspirant or deodorant that dispenses active ingredients by rolling a wetted ball or wetted cylinder on the affected area.

  • Edible cannabis product means cannabis product that is intended to be used, in whole or in part, for human consumption, including, but not limited to, chewing gum, but excluding products set forth in Division 15 (commencing with Section 32501) of the Food and Agricultural Code. An edible cannabis product is not considered food, as defined by Section 109935 of the Health and Safety Code, or a drug, as defined by Section 109925 of the Health and Safety Code.

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

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

  • SAP Products means Software, Documentation, SAP Materials, Services, Subscription Services, Cloud Services and Maintenance Services. “SAP SDK” means SAP software development kit that includes tools such as APIs, source code, redistributable files and instructions. “Services” means SAP’s then-current services offered under and described in detail in the applicable SAP PartnerEdge Model.