Sponsor Drug definition

Sponsor Drug means the Sponsor’s product that is being studied in the Trial. If the Sponsor’s product is being studied in the Trial in combination with another product, “Sponsor Drug” shall mean the combination.
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Sponsor Drug means the Sponsor’s product that is being studied in the Trial. If the Sponsor’s product is being studied in the Trial in combination with another product, “Sponsor’s Drug” shall mean the combination. „Lék zadavatele“ znamená produkt zadavatele, který bude zkoumán v klinickém hodnocení. Pokud je přípravek zadavatele v klinickém hodnocení zkoumán v kombinaci s jiným přípravkem, „Lék zadavatele“ označuje tuto kombinaci. “Sponsor Indemnitees” shall have the meaning set forth in Article 16.1. „Odškodňované osoby zadavatele“ má stejný význam jako v článku 16.1. “SUKL” means State Institute for Drug Control. „SUKL“ znamená Státní ústav pro kontrolu léčiv. “Trial” shall mean the multi-center clinical trial to be performed in accordance with the Protocol. „Klinické hodnocení“ znamená multicentrické klinické hodnocení prováděné v souladu s protokolem. “Trial Data” shall include, without limitation, CRFs (or their equivalent) or electronic data records, as well as any other documents or materials created for the Trial and required to be submitted to Sponsor or the CRO or any other third party vendor instructed by Sponsor, such as X-ray, MRI, or other types of medical images, ECG, EEG, or other types of tracings or printouts, or data summaries. „Data klinického hodnocení“ zahrnují mimo jiné CRF (či jejich ekvivalent) nebo elektronické záznamy dat, jakož i veškeré další dokumenty či materiály vytvořené pro hodnocení, a u nichž je požadováno, aby byly předloženy zadavateli nebo CRO nebo jakémukoli dodavateli třetí strany instruovaným zadavatelem, jako jsou rentgenové snímky, snímky magnetické rezonance nebo jiné typy lékařských snímků, EKG, EEG či jiné typy sledování či výtisků nebo souhrny dat. “Trial Subject” shall mean a patient participating in the Trial. „Subjekt klinického hodnocení“ znamená pacienta účastnícího se klinického hodnocení.
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Sponsor Drug means the Sponsor’s product that is being studied in the Trial. If the Sponsor’s product is being studied in the Trial in combination with another product, “Sponsor Drug” shall mean the combination. 1.20 “Sponsor Indemnitees” shall have the meaning set forth in Section 0 . 1.21 “Trial” shall mean the multi-center clinical trial to be performed in accordance with the Protocol. kombinácii s R-CHOP v porovnaní s R-CHOP samostatne u predtým neliečených stredne- vysoko a vysoko rizikových pacientov s novo diagnostikovaným difúznym veľkobunečným B- lymfómom (DLBCL)“ a každý protokol spoločnosti, ktorý neskôr písomne vypracuje a schváli Zadávateľ a podpíše HS, a ktorý sa realizuje súbežne so všetkými alebo rovnakými Subjektmi Skúšania, vrátane všetkých dodatkov vyššie uvedených dokumentov. Aby sa predišlo pochybnostiam, Protokol sa pokladá za finálny dokument po jeho podpise Zadávateľom a HS a schválení príslušnou nezávislou EK. Potom sa môžu dodatky k Protokolu vypracovať len pod vedením Zadávateľa a po následnom schválení nezávislej EK. 1.15 „Záznamy” znamenajú Záznamy skúšania o Subjektoch skúšania, čo zahŕňa kópie všetkých Údajov skúšania Inštitúcie a HS, ako aj všetky súvisiace zdrojové dokumenty. 1.16 „Zástupca” má význam, aký sa uvádza v Článku 24.2. 1.17 „Údaje výskumu” majú význam, aký sa uvádza v Článku 10.4. 1.18 „Údaje o vzorkách” majú význam, aký sa uvádza v Článku 13.3. 1.19 „Produkt Zadávateľa“ znamená produkt Zadávateľa, ktorý sa v Skúšaní skúma. Ak sa Produkt Zadávateľa skúma v Skúšaní v kombinácii s iným produktom, „Produkt zadávateľa“ znamená ich kombináciu. 1.20 „Odškodnené osoby Zadávateľa” majú význam, aký sa uvádza v Článku 19.1. 1.21 „Skúšanie” znamená multicentrické klinické skúšanie, ktoré sa má realizovať v súlade s Protokolom.
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Examples of Sponsor Drug in a sentence

  • Any other use of Sponsor Drug or Comparator Drug constitutes a material breach of this Agreement.

  • Sponsor grants Institution and Principal Investigator no express or implied intellectual property rights in the Sponsor Drug or in any methods of making or using the Sponsor Drug.

  • Institution and Principal Investigator will use Sponsor Drug or Comparator Drug only as specified in the Protocol.

  • Sponsor does not object to publication by Institution or Principal Investigator of the results of the Trial based on information collected or generated by Institution and Principal Investigator, whether or not the results are favorable to the Sponsor Drug.

  • The Parties agree that CRO expressly disclaims any and all liability whatsoever in connection with the Sponsor Drug or the Protocol except to the extent that such liability arises from CRO’s negligent act, omission or willful misconduct.

  • Institution will return and/or destroy any unused Sponsor Drug or Comparator Drug, as applicable, at Sponsor’s expense.

  • Company agrees to perform in a diligent, efficient, competent and skillful manner commensurate with the highest standards of the profession, and to otherwise perform as is necessary to undertake the Services required by this Agreement, including the requirements set forth in the Certification of Sponsor Drug Free Workplace Exhibit “C”.

  • Institution and Principal Investigator will adhere to Applicable Law requiring careful custody and dispensing of Sponsor Drug or Comparator Drug, as well as appropriate documentation of such activities.

  • Sponsor grants Institution no express or implied intellectual property rights in the Sponsor Drug or in any methods of making or using the Sponsor Drug.

  • Institution and Principal Investigator will not charge a Trial Subject or third-party payer for Sponsor Drug or Comparator Drug or for any services reimbursed by Sponsor or its designee under this Agreement.


More Definitions of Sponsor Drug

Sponsor Drug means the Sponsor’s product that is being studied in the Trial. If the Sponsor’s product is being studied in the Trial in combination with another product, “Sponsor Drug” shall mean the combination. 1.19 “Sponsor Indemnitees” shall have the meaning set forth in Section 0 . 1.20 “Trial” shall mean the multi-center clinical trial to be performed in accordance with the Protocol. 1.21 “Trial Data” shall include, without limitation, Research Data, CRFs (or their equivalent) or electronic data records, as well as any other documents or materials created for the Trial and required to be submitted to Sponsor or the CRO or any other third party vendor instructed by Sponsor, such as X-ray, MRI, or other types of medical images, ECG, EEG, or other types of tracings or printouts, or data summaries. 1.22 “Trial Subject” shall mean a patient participating in the Trial. 2 PI, Sub-Investigators and Research Staff 2.1 PI is an employee of Institution and shall be responsible for the direction of the Trial in accordance with Applicable Law, the Protocol, Sponsor’s instructions, IEC approval and Institution’s applicable policies. Institution may not appoint any other person as PI without Sponsor’s prior written approval. PI shall provide Sponsor and/or CRO with a written statement about his/her possible economic or other interests in connection with the performance of the Trial and Trial preparations (financial disclosure) upon the Effective Date. If PI is unable to perform the duties required under this Agreement, Institution and PI shall promptly notify the Sponsor in writing. If a replacement acceptable to the Sponsor is not available, this Agreement may be terminated as provided in Section 20.1.e) of this Agreement. 1.18 „Produkt Zadávateľa“ znamená produkt Zadávateľa, ktorý sa v Skúšaní skúma. Ak sa Produkt Zadávateľa skúma v Skúšaní v kombinácii s iným produktom, „Produkt zadávateľa“ znamená ich kombináciu. 1.19 „Odškodnené osoby Zadávateľa” majú význam, aký sa uvádza v Článku 19.1. 1.20 „Skúšanie” znamená multicentrické klinické skúšanie, ktoré sa má realizovať v súlade s Protokolom. 1.21 „Údaje skúšania” zahŕňajú bez obmedzenia Údaje výskumu, CRF (alebo ich ekvivalent) alebo elektronické záznamy údajov, ako aj iné dokumenty alebo materiály, ktoré sa vypracujú pre účely Skúšania, a ktoré xx xxxxx predložiť Zadávateľovi alebo CRO alebo inému poskytovateľovi služieb tretej strany, ktorého riadi Zadávateľ, ako xx xxxxxxx, MR alebo iné druhy snímkovania, EKG, EEG alebo in...
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Related to Sponsor Drug

  • controlled drug means an article or substance prescribed under a regulation to be a controlled drug.

  • Approved clinical trial means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or Condition and is described in any of the following:

  • Phase IV Clinical Trial means a product support clinical trial of a Product commenced after receipt of Regulatory Approval in the country where such trial is conducted. A Phase IV Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies, and investigator-sponsored clinical trials studying Product that are approved by BMS and that otherwise fit the foregoing definition.

  • Generic Drug means any Prescription Drug approved by the FDA that has the same bio-equivalency as a specific Brand Name Drug.

  • Phase 4 Clinical Trial means a Clinical Study in any country which is conducted after Regulatory Approval of a product has been obtained from an appropriate Regulatory Authority, consisting of trials conducted voluntarily for enhancing marketing or scientific knowledge of an approved indication and trials conducted due to request or requirement of a Regulatory Authority.

  • Diagnostic x-ray system means an x-ray system designed for irradiation of any part of the human or animal body for the purpose of diagnosis or visualization.

  • 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.

  • Phase I Clinical Trial means a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • 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.

  • Covered drug means any prescription drug that:

  • New drug means: (i) any drug, except a new animal drug or an animal feed bearing or containing

  • Relevant Electric Retail Regulatory Authority means an entity that has jurisdiction over and establishes prices and policies for competition for providers of retail electric service to end- customers, such as the city council for a municipal utility, the governing board of a cooperative utility, the state public utility commission or any other such entity.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Pivotal Clinical Trial means a pivotal human clinical trial of a Licensed Product with a defined dose or a set of defined doses of such Licensed Product designed to ascertain efficacy and safety of such Licensed Product for the purpose of enabling the preparation and submission of an MAA to the competent Regulatory Authorities in a country of the Territory, as further defined in 21 C.F.R. § 312.21(c) for the U.S., as amended from time to time, or the corresponding foreign regulations.

  • Narcotic drug means any of the following, whether produced directly or indirectly by extraction from substances of vegetable origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis:

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

  • Analytical x-ray system means a group of components utilizing x-rays to determine the elemental composition or to examine the microstructure of materials.

  • Regulatory asset means an asset recorded on the books of an

  • 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.

  • 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.

  • low protein modified food product means a food product that is specially formulated to have less than one gram of protein per serving and is intended to be used under the direction of a Practitioner for the dietary treatment of an inherited metabolic disease, but does not include a natural food that is naturally low in protein; and

  • Therapeutically equivalent drug products means drug products that contain the same active ingredients and are identical in strength or concentration, dosage form, and route of administration and that are classified as being therapeutically equivalent by the U.S. Food and Drug Administration pursuant to the definition of "therapeutically equivalent drug products" set forth in the most recent edition of the Approved Drug Products with Therapeutic Equivalence Evaluations, otherwise known as the "Orange Book."

  • Phase III Clinical Trial means a large, controlled or uncontrolled Clinical Study that would satisfy the requirements of 21 CFR 312.21(c), intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.

  • Clinical Trial means a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.

  • 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.