Named Patient Program definition

Named Patient Program means a compassionate use, named patient use, or similar program for the supply of the Product in the Field in the Territory prior to obtainment of Registrations, to the extent permitted by and in accordance with Applicable Laws.
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Named Patient Program means a program established to provide a specific named patient with the Licensed Product in the Field prior to Regulatory Approval of such Licensed Product in such country outside the Territory, under strict conditions, including serious or life-threatening disease, no satisfactory alternative treatment options, written request from the patient’s treating physician, compliance with all Applicable Laws and ethical guidelines.
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Examples of Named Patient Program in a sentence

  • Upon Merus filing for any regulatory approval for a Licensed Product in any country outside the Territory, Merus may, upon [*] notice to Company, require Company to discontinue the Named Patient Program in any country outside the Territory, except for any patient then on treatment as of the time of notice.

  • For clarity, the foregoing license for the Named Patient Program includes the right for Company to supply Licensed Products outside the Territory, solely for the purposes of such Named Patient Program.

  • Any sales of the Licensed Product made pursuant to a Named Patient Program shall be considered for the purposes of calculating milestones, Net Sales and royalties (including determining the applicable royalty rate) due to Merus under Article 6.

  • The Royalty Payments with respect to Named Patient Program outside the Territory shall be payable on a country-by-country basis until the termination of such Named Patient Program in such country in accordance with Section 5.7.3.

  • Within [*] after the end of each Calendar Quarter during which Licensed Product has been sold, Company shall deliver to Merus, a written report, on a Licensed Product-by-Licensed Product and country-by-country (for any Named Patient Program outside the Territory) basis, of the gross sales and Net Sales of each Licensed Product subject to Royalty Payments for such Calendar Quarter, and a calculation of the applicable Royalty Payments for each Licensed Product.

  • Dyax and STRD agree that STRD may initiate a Named Patient Program in Europe only.

  • EpiCept will terminate on a country by country basis when and as requested by MEDA the IDIS Named Patient Program conducted under agreements and other arrangements between EpiCept and IDIS Ltd.

  • Participation in programs where Insmed provides product free of charge, such as compassionate or early access programs, must comply with the Compassionate Use/Emergency Named Patient Program (CUENPP) for an Insmed Investigational Product SOP.

  • Product supplied by STRD for use in the Named Patient Program in Europe may be used in any indication for which it has been prescribed within the angioedema field (including without limitation hereditary angioedema, acquired angioedema, drug-induced angioedema and/or idiopathic angioedema).

  • Dyax shall provide STRD with all reasonable support required by the terms of this Agreement in connection with the conduct of the Named Patient Program in Europe (whether conducted by STRD or its designee).

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