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 that facilitates patient access to medications that are not licensed for marketing or are commercially unavailable in the country where a patient is receiving treatment if no suitable alternative is available or exists in such country. Physicians request the medication on behalf of a specific “named” patient.
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Examples of Named Patient Program in a sentence

  • The program involves 40 Phase I, 4 Phase II, and 15 Phase III/IIIb clinical trials as well as a Named Patient Program and an Expanded Access Program.

  • 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).

  • As part of this transaction, Onxeo's current license agreement with Pint Pharma for South America, as well as the contracts with Clinigen plc and iQone for the Named Patient Program in certain European countries, and related agreements, were also transferred to Acrotech.In addition, this new contract transfers certain patents and know-how concerning belinostat to Acrotech.

  • 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.

  • In order to initiate the Named Patient Program (NPP) and progress the clinical development of Bisantrene, the Company is relying on its ability to gain US Food and Drug Administration (FDA) allowance for an Investigational New Drug (IND) application and further to have the FDA agree to the application of the 505(b)(2) route of approval.

  • The EAP aimed at providing insight into Raxone®'s therapeutic potential in a real-world setting and was conducted under the Named Patient Program in the EU and the Investigational New Drugs regulations in the U.S. Enrollment was limited to patients presenting for treatment within 1 year of onset of symptoms.

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

  • In thousand € NOTE 13: OTHER OPERATIONAL INCOME AND CHARGES 13.1 Turnover In thousand €6/30/20196/30/2018Recurring revenue from license agreements1,4251,040Non-recurring revenue from license agreements2781,062Total turnover1,7032,102The recurring revenue comes from direct sales of Beleodaq® in the context of the European Named Patient Program (NPP) and from royalties on sales of Beleodaq® in the United States by partner Acrotech Biopharma.

  • 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.

  • Subject to Article XI of this Agreement, STRD shall be fully responsible for the conduct of the Named Patient Program in Europe in accordance with all applicable laws and regulations and terms and conditions of this Agreement.

Related to Named Patient Program

  • Participating Clinical Laboratory means a Clinical Laboratory which has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Collaborative pharmacy practice agreement means a written and signed

  • Dependent care assistance program or "DCAP" means a benefit plan whereby school employees may pay for certain employment related dependent care with pretax dollars as provided in the salary reduction plan under chapter 41.05 RCW pursuant to 26 U.S.C. Sec. 129 or other sections of the Internal Revenue Code.

  • Program Plan means the tobacco settlement program plan dated February 14, 2001, including exhibits to the program plan, submitted by the authority to the legislative council and the executive council, to provide the state with a secure and stable source of funding for the purposes designated by section 12E.3A and other provisions of this chapter.

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Hospice patient s family" means a hospice patient's immediate family members, including a spouse, brother, sister, child, or parent, and any other relative or individual who has significant personal ties to the patient and who is designated as a member of the patient's family by mutual agreement of the patient, the relative or individual, and the patient's interdisciplinary team.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • 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.

  • Phase 2 Clinical Trial means a human clinical trial, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory other than the United States.

  • AML Program has the meaning ascribed thereto in Schedule 2.1(F)(8) hereof.

  • E-Verify Program above means the employment verification program administered by the United States Department of Homeland Security, the Social Security Administration, or any successor program.

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • Participating Hospice Care Program Provider means a Hospice Care Program Provider that either: (i) has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield to provide services to participants in this benefits program, or; (ii) a Hospice Care Program Provider which has been designated by a Blue Cross and/or Blue Shield Plan as a Participating Provider Option program.

  • Medicaid program means the Kansas program of medical

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

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

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • Medical marijuana product means a product that contains cannabinoids that have been extracted from plant material or the resin therefrom by physical or chemical means and is intended for administration to a licensed patient, including but not limited to concentrates, oils, tinctures, edibles, pills, topical forms, gels, creams, and other derivative forms, except that this term does not include live plant forms.

  • Non-Participating Clinical Laboratory means a Clinical Laboratory which does not have a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan provide services to you at the time services are rendered.

  • 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:

  • Participating Prescription Drug Provider means an independent retail Pharmacy, chain of retail Pharmacies, mail-order Pharmacy or specialty drug Pharmacy which has entered into an agreement to provide pharmaceutical services to participants in the benefit program. A retail Participating Pharmacy may or may not be a select Participating Pharmacy as that term is used in the Vaccinations Obtained Through Participating Pharmacies section.

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Collaborative pharmacy practice means a practice of pharmacy whereby one or

  • Licensed mental health professional or "LMHP" means a physician, licensed clinical psychologist, licensed professional counselor, licensed clinical social worker, licensed substance abuse treatment practitioner, licensed marriage and family therapist, certified psychiatric clinical nurse specialist, licensed behavior analyst, or licensed psychiatric/mental health nurse practitioner.