NPP Product definition

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.
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NPP Product has the meaning set forth in Section 5.6(j)(1).
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NPP Product means the Product subject to the NPP in its secondary packaging for commercialization in the European Union and/or USA.
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Examples of NPP Product in a sentence

  • In the event PINT decides to Commercialize the Product (excluding the NPP Product) under a trademark other than the Trademark, the Parties agree that PINT shall be the exclusive owner of such trademark created by PINT for the Product.

  • 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.

  • 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.

  • Spectrum will promptly (but in no case more than [***] ([***]) Business Days after its receipt of a purchase order placed pursuant to this section) acknowledge in writing its receipt of such Bulk Product and/or NPP Product purchase order.

  • Spectrum shall include the quantities specified by Topotarget pursuant to subsection (k)(1) above, in the purchase orders Spectrum submits to its Third Party manufacturers of Bulk Product and/or NPP Product.

  • Any purchase orders for Bulk Product and/or NPP Product submitted by Topotarget shall reference this Agreement and shall be governed exclusively by the terms contained herein.

  • Topotarget will arrange for and be responsible for the cost of all freight, insurance charges, taxes, import and export duties, inspection fees and other charges applicable to the transport of Bulk Product, NPP Product or API purchased by Topotarget hereunder.

  • Spectrum acknowledges and consents to distribution and sale of NPP Product by Topotarget in the Topotarget Territory for use in named patient programs.

  • 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.

  • 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.