Named Patient Supply definition

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, 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.
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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.
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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.
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Examples of Named Patient Supply in a sentence

  • Halte Besar BSD – Halte Al-Azhar – Halte Pemasaran BSD – Jl. Serpong Raya – Tol Tangerang Kebon Jeruk – Jl. Tomang Raya – Jl. Kyai Caringin – Jl. Balikpapan – Jl. Suryo Pranoto – Halte Busway Harmoni Jl. Juanda – Jl. Juanda – Halte Pasar Baru (Gedung Kesenian Jakarta) – Jl. Veteran – Halte Harmoni lampu merah Suryo Pranoto – Jl. Tomang Raya – Tol Jakarta Tangerang 55Tel.

  • Trouble Regarding Coin-operated Parking "Signage" on the Rise - Overview of InquiriesTrouble reported to local consumer centers across Japan regarding coin-operated parking signage has been increasing year by year.

  • 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.

  • 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.

  • Whereas Acorda and/or Biogen Idec may receive requests for Named Patient Supply of the Product in the Territory.

  • More recent work has been conducted by Spinneken and Swan (2009a,b) for wavemakers operated in force-control mode.

  • Whereas Biogen Idec and Acorda agree that Biogen Idec is responsible for such requests and Named Patient Supply.

  • 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.

  • 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.

  • Whereas Acorda and/or Biogen Idec receives requests for Named Patient Supply of the Product in the Territory.


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.
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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;
Sample 1
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 ”).”
Sample 1
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”).”
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Related to Named Patient Supply

  • Medical equipment supplier means any person, as defined in § 1-230, engaged in the delivery to the ultimate consumer, pursuant to the lawful order of a practitioner, of hypodermic syringes and needles, medicinal oxygen, Schedule VI controlled devices, those Schedule VI controlled substances with no medicinal properties that are used for the operation and cleaning of medical equipment, solutions for peritoneal dialysis, and sterile water or saline for irrigation.

  • Replacement Supplier means any third party provider of Replacement Services appointed by or at the direction of the Customer from time to time or where the Customer is providing Replacement Services for its own account, shall also include the Customer;

  • Third Party Supplier means a third party manufacturer and/or licensor of Products.

  • Relevant Supplier shall have the meaning set out in Clause 7.1;

  • Covered Government support contractor means a contractor (other than a litigation support contractor covered by 252.204-7014) under a contract, the primary purpose of which is to furnish independent and impartial advice or technical assistance directly to the Government in support of the Government’s management and oversight of a program or effort (rather than to directly furnish an end item or service to accomplish a program or effort), provided that the contractor—

  • Gene Therapy means the introduction of a nucleic acid sequence encoding a protein intended for or otherwise conferring therapeutic benefit into a person for therapeutic purposes (i) by in vivo introduction for incorporation into cells of such person, or (ii) by ex vivo introduction into cells for transfer into a person.

  • Tobacco product manufacturer means an entity that after the date of enactment of this Act directly (and not exclusively through any affiliate):

  • Contract Manufacturer means a company that produces goods under contract for another company under the label or brand name of that company.

  • Permanent Supportive Housing means voluntary, flexible supports to help individuals with psychiatric disabilities choose, get, and keep housing that is decent, safe, affordable, and integrated into the community. Tenants have access to an array of services that help them keep their housing, such as case management, assistance with daily activities, conflict resolution, and crisis response consistent with evidence-based practice standards published by the Substance Abuse and Mental Health Services Administration.

  • Product Manufacturer means the entity that assembles the component parts to manufacture the final Product;

  • Security Agreement Supplement has the meaning specified in the Security Agreement.

  • Clinical Supply Agreement has the meaning set forth in Section 4.2.

  • Third Party Vendor means any person or entity that provides SaaS, third party software and/or related intellectual property. “Work” means any additional work the Customer requests Singtel to perform in relation to the Service.

  • Routine patient care costs means Covered Medical Expenses which are typically provided absent a clinical trial and not otherwise excluded under the Policy. Routine patient care costs do not include:

  • Red Hat Products means Software, Services, Subscriptions and other Red Hat branded offerings made available by Red Hat.

  • Self Supply LSE means a Load Serving Entity in one or more Mitigated Capacity Zones that operates under a long-standing business model to meet more than fifty percent of its Load obligations through its own generation and that is (i) a municipally owned electric system that was created by an act of one or more local governments pursuant to the laws of the State of New York to own or control distribution facilities and/or provide electric service, (ii) a cooperatively owned electric system that was created by an act of one or more local governments pursuant to the laws of State of New York or otherwise created pursuant to the Rural Electric Cooperative Law of New York to own or control distribution facilities and/or provide electric service, (iii) a “Single Customer Entity,” or (iv) a “Vertically Integrated Utility.” A Self Supply LSE cannot be an entity that is a public authority or corporate municipal instrumentality created by the State of New York (including a subsidiary of such an authority or instrumentality) that owns or operates generation or transmission and that is authorized to produce, transmit or distribute electricity for the benefit of the public unless it meets the criteria provided in section (i), (ii), or (iii) of this definition. For purposes of this definition only: “Vertically Integrated Utility” means a utility that owns generation, includes such generation in a non-bypassable charge in its regulated rates, earns a regulated return on its investment in such generation, and that as of the date of its request for a Self Supply Exemption, has not divested more than seventy-five percent of its generation assets owned on May 20, 1996; and “Single Customer Entity” means an LSE that serves at retail only customers that are under common control with such LSE, where such control means holding 51% or more of the voting securities or voting interests of the LSE and all its retail customers.

  • Third Party Licensor means the relevant licensor of any Third Party Data or any Third Party Trade Xxxx;

  • mixed supply means two or more individual supplies of goods or services, or any combination thereof, made in conjunction with each other by a taxable person for a single price where such supply does not constitute a composite supply.

  • Third Party(ies) means a person or entity who or which is neither a Party nor an Affiliate of a Party.

  • Pharmacist preceptor or “preceptor” means a pharmacist licensed to practice pharmacy whose license is current and in good standing. Preceptors shall meet the conditions and requirements of rule 657—4.9(155A). No pharmacist shall serve as a preceptor while the pharmacist’s license to practice pharmacy is the subject of disciplinary sanction by a pharmacist licensing authority.

  • Third Party Contractor as used in the Student Data Protection Act and “Operator” as used in COPPA. De-Identified Information (DII): De-Identification refers to the process by which the Contractor removes or obscures any Personally Identifiable Information (“PII”) from Education Records in a way that removes or minimizes the risk of disclosure of the identity of the individual and information about them.

  • IP Security Agreement Supplement has the meaning specified in the Security Agreement.

  • Qualifying patient means a person who:

  • Approved Product means any water fitting, plumbing product, material or component which is the subject of an existing WRAS Approval;

  • Contractor/Supplier means the person or company whose tender is accepted by the Purchaser and shall be deemed to include the Contractor’s successors, heirs, executors, administrators, representatives and assigns approved by the Purchaser.

  • Qualified patient means a competent adult who is a resident of this State and who has satisfied the requirements of this Act in order to obtain a prescription for medication that the qualified patient may self-administer to end the qualified patient's life in a humane and dignified manner.[PL 2019, c. 271, §4 (NEW).]