Named Patient Supply definition

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Named Patient Supply means means the supply of an unlicensed product which does not have a Regulatory Approval in the applicable country of the Territory (but does have a Regulatory Approval in another country outside of the Territory) and is supplied to meet the special needs of a specific patient or patients under the order of a medical practitioner or any other person lawfully permitted to prescribe such product to a specific patient or patients in the Territory or relevant part of it. In certain countries of the Territory this supply may include the supply of larger quantities of the product subject to applicable laws, including without limitation local regulation and import permissions.

Named Patient Supply means the supply of Product to Purchasers, whether paid for or free of charge, on behalf of a specific Patient or Patients in the Territory, under such procedures as may exist or be adopted by regulatory authorities in the Territory that permit use and purchase of the Product in the Territory.

Examples of Named Patient Supply in a sentence

Following the Opt-In for a Lead Product and receipt of FDA’s approval of the Regulatory Filing for such Lead Product, if either Party receives a request from a medical practitioner for Named Patient Supply in the Sobi Territory for such Lead Product, such Party shall notify the other Party.
Whereas Biogen Idec and Acorda agree that Biogen Idec is responsible for such requests and Named Patient Supply.
Biogen Idec shall be free to make Named Patient Supply in any country in the Biogen Idec Territory of any Product approved by, and bearing an approved label of, any other country in the Biogen Idec Territory.
Whereas Acorda and/or Biogen Idec receives requests for Named Patient Supply of the Product in the Territory.
Biogen Idec shall have the right to terminate each Named Patient Supply program, including the supply therefor, upon written notice to Sobi if Biogen Idec believes, in its reasonable discretion, that such Named Patient Supply program is not compliant with applicable laws or regulations or has, or is likely to have, a material adverse effect on the Commercialization activities for the Lead Product anywhere in the Biogen Idec Territory.
Whereas Acorda and/or Biogen Idec may receive requests for Named Patient Supply of the Product in the Territory.
For clarity, following EMA approval of the Regulatory Filing of any Product, Sobi shall be free to make Named Patient Supply in any country in the Sobi Territory of such Product approved by, and bearing an approved label of, any other country in the Sobi Territory.
Biogen Idec shall supply the Lead Products for such use in accordance with terms of the applicable CSAs. If Biogen Idec changes the manufacturing process for a Lead Product that is being supplied to Sobi for Named Patient Supply, or if the CPP is otherwise modified, Biogen Idec shall provide written notice to Sobi reasonably in advance, and Sobi shall be responsible for ensuring that any further Named Patient Supply of such Lead Product comply with applicable laws and regulations.
Sobi shall be responsible for compliance with all applicable laws and regulations in connection with the conduct of such Named Patient Supply, including any applicable laws of the United States and the subject country.
Sobi shall, to the extent legally permitted, be responsible for all interactions and applications with the relevant Regulatory Authorities in connection with such Named Patient Supply.

More Definitions of Named Patient Supply

Named Patient Supply means that a Licensed Product is sold for use by an individual patient, based on the decision of a physicians’ commission and imported pursuant to a special import license before any Regulatory Approval is obtained to cover such patient, if allowed under Applicable Laws and the Parties’ policies, procedures and practices.

Named Patient Supply means the lawful placing on the market or distribution by way of wholesale dealing of a Relevant Medical Product for which no Marketing Authorisation is in force in the part of the Territory or where no such licensed product is available in the part of the Territory in which such Relevant Medicinal Product is placed on the market or distributed by way of wholesale dealing at the time of such placing on the market or distribution;

Named Patient Supply means the sale or other supply of a Product in a given country in the Territory prior to receipt of Regulatory Approval of such Product in such country and in accordance with the applicable laws of that country, directly or through an entity that is qualified to distribute unregistered pharmaceutical products in that country, (a) on a “named-patient” basis to meet the special needs of particular patients under the order of, and at the specific request of, a medical practitioner; or (b) in the case solely of Kuwait, Oman, Qatar, the Kingdom of Saudi Arabia, and the United Arab Emirates, pursuant to an appropriate request from a health care provider, pharmacy or governmental agency to treat a specific patient or group of patients and in accordance with regulatory practices that allow import and use of a Product based on such Product having obtained Regulatory Approval in another country (in this case the United States or a country within the EMA Centralized Authorization Countries), including under so called “Doctor Specific Patient Requests” or “DSPR”; provided, however, in all cases of clauses (a) and (b) above, solely with respect to previously treated patients (“ PTPs ”).”