Clinical Requirements definition

Clinical Requirements means the quantities of the Product, Placebo and Diluent required for the conduct of pre-clinical studies and/or Clinical Studies of Product in the Field pursuant to a Development Plan.
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Clinical Requirements means the amount of BC Parenteral Meloxicam or Finished Meloxicam to be provided by Alkermes to Recro and its Sublicensees in accordance with Section 3.4 of this Agreement for the conduct of clinical studies of Finished Meloxicam.
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Clinical Requirements means those quantities of a Product reasonably required by a Party for the conduct of preclinical and clinical studies of such Product in that Party's Territory. The term Clinical Requirements as used herein with respect to a Party shall also include the Clinical Requirements of that Party's licensees, if any.
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Examples of Clinical Requirements in a sentence

  • These policies are determined by the Clinical Requirements Committee and may change throughout the year; it is the responsibility of the student to maintain compliance.

  • CONTRACTOR accepts such engagement, on the General Terms and Conditions hereinafter specified in this Agreement, the Additional Provisions attached hereto, and the following described exhibits, all of which are incorporated into this Agreement by this reference: Exhibit A: Scope of Services and Clinical Requirements Exhibit A, Attachment 1: Y.

  • The LPN-BSN Online Preceptor Handbook and Clinical Requirements document is updated annually and can be found on the EMSON Website.

  • Clinical Requirements At orientation, all students will receive a Clinic Handbook with general clinical requirements.

  • That preceptor must also be recognized in their jurisdiction of practice, and that jurisdiction must recognize the CPM credential for legal practice.The attached NARM and Southwest Tech Midwife Program Clinical Requirements document fully explains all aspects of the clinical training portion of the Direct Entry Midwife Program and requirements for graduation.

  • Clinical times will be posted as soon as possible each semester to allow time to adjust family and work schedules.Dress Code and Clinical Requirements UNIFORM: Only school mandated tops and pants will be acceptable.

  • At the end of each clinical posting, Clinical Log Book (Procedural Competencies/Skills) (Appendix-3a and 3b) and Clinical Requirements (Appendix-4) has to be signed by the preceptor/faculty every fortnight.

  • Unless Recro directs otherwise, the provision of the CMC Development Services, and the supply of the Clinical Requirements and the Requirements will continue until such time as the Parties reach agreement on any issue subject to resolution pursuant to Section 2.1(e); provided, however, that neither Party will have any obligation to incur any costs, or to perform any related activities, if such costs would be in dispute if incurred.

  • GENENTECH shall not favor the supply of its own clinical requirements of a Product to it or its other licensees over ROCHE's Clinical Requirements.

  • In addition, as set forth in the Quality Agreements and unless otherwise elected by Recro, Alkermes will only provide Finished Meloxicam for the first Batch that is part of the Clinical Requirements.


More Definitions of Clinical Requirements

Clinical Requirements means such quantities of any Anti-IgE Product as are required by Novartis, Genentech and/or Tanox for the conduct of preclinical and clinical studies in order to obtain Approval of that Anti-IgE Product with respect to a particular Regulatory Jurisdiction, quantities of any Anti-IgE Product which are required by Novartis, Genentech or Tanox for submission to a Public Authority in accordance with this Agreement (or any Ancillary Agreement) in connection with any Approval Application or Approval in any Regulatory Jurisdiction and quantities of any Anti-IgE Product which are required by Novartis, Genentech or Tanox for any post-marketing clinical trial or Phase IV clinical trial intended to support expanded labeling or required to satisfy requirements of a Public Authority in connection with any Approval or Pricing Approval.
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Clinical Requirements means the quantities of Finished Product and Placebo needed for the conduct of pre-clinical and/or clinical studies (including any post-marketing clinical studies, regardless of how they are accounted for in Exhibit B to the Collaboration Agreement) of the Licensed Product in the Territory.
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Clinical Requirements means all quantities of SCH 619734 (Rolapitant) as are required by the Acquirer of the Rolapitant Product Assets for the conduct of preclinical, clinical studies, and/or Clinical Trials for the purposes of obtaining any and all Applications and/or Product Approvals in the United States for the use of Products containing SCH 619734 (Rolapitant) for CINV and/or PONV.
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Clinical Requirements means the quantities of Kits which are needed by SCHERING and its sublicensees (if any) for the conduct of preclinical and clinical studies of Licensed Product throughout the Licensed Territory.
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Clinical Requirements means the quantities of a Drug Candidate or Product which are required by a Party for the conduct of preclinical and clinical studies of that Drug Candidate or Product by that Party. The term Clinical Requirements as used herein with respect to a Party shall also include the Clinical Requirements of that Party's permitted licensees, if any.
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Clinical Requirements means the amount of Polymer Product needed by Amylin, Amylin Parent and Collaboration Partner for the conduct of clinical studies of Exenatide LAR pursuant to the Development and License Agreement.
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Related to Clinical Requirements

  • Technical Requirements means the Technical Requirements in Section VII of the tendering documents.

  • Applicable Technical Requirements and Standards means those certain technical requirements and standards applicable to interconnections of generation and/or transmission facilities with the facilities of an Interconnected Transmission Owner or, as the case may be and to the extent applicable, of an Electric Distributor, as published by Transmission Provider in a PJM Manual provided, however, that, with respect to any generation facilities with maximum generating capacity of 2 MW or less (synchronous) or 5 MW or less (inverter-based) for which the Interconnection Customer executes a Construction Service Agreement or Interconnection Service Agreement on or after March 19, 2005, “Applicable Technical Requirements and Standards” shall refer to the “PJM Small Generator Interconnection Applicable Technical Requirements and Standards.” All Applicable Technical Requirements and Standards shall be publicly available through postings on Transmission Provider’s internet website.

  • MREL Requirements means the laws, regulations, requirements, guidelines, rules, standards and policies relating to minimum requirements for own funds and eligible liabilities applicable to the Issuer and/or the Group, from time to time, (including any applicable transitional or grandfathering provisions), including, without limitation to the generality of the foregoing, any delegated or implementing acts (such as regulatory technical standards) adopted by the European Commission and any regulations, requirements, guidelines, rules, standards and policies relating to minimum requirements for own funds and eligible liabilities adopted by the Federal Republic of Germany or the Republic of Italy, a relevant resolution authority or the European Banking Authority from time to time (whether or not such requirements, guidelines or policies are applied generally or specifically to the Issuer and/or the Group), as any of the preceding laws, regulations, requirements, guidelines, rules, standards, policies or interpretations may be amended, supplemented, superseded or replaced from time to time.

  • Operational requirements means the need to ensure that the Agency is to be operated as effectively, efficiently and economically as possible.

  • MREL Requirement means the minimum requirement for own funds and eligible liabilities which is or, as the case may be, will be applicable to the Issuer;

  • Regulatory Capital Requirements means any applicable capital resources requirement or applicable overall financial adequacy rule required by the Relevant Regulator, as such requirements or rule are in force from time to time;

  • Capital Requirements means, as to any person, any matter, directly or indirectly, (i) regarding capital adequacy, capital ratios, capital requirements, the calculation of such person’s capital or similar matters, or (ii) affecting the amount of capital required to be obtained or maintained by such person or any person controlling such person (including any direct or indirect holding company), or the manner in which such person or any person controlling such person (including any direct or indirect holding company), allocates capital to any of its contingent liabilities (including letters of credit), advances, acceptances, commitments, assets or liabilities.

  • Safety Requirements means Prudent Electrical Practices, CPUC General Order No. 167, Contractor Safety Program Requirements, and all applicable requirements of Law, PG&E, the Utility Distribution Company, the Transmission Provider, Governmental Approvals, the CAISO, CARB, NERC and WECC.

  • Program Requirements means certain minimum program entry requirements as well as ongoing program requirements, to be fulfilled by Partner, some of which are general PartnerEdge requirements, some of which are specific for the “Sell Engagement” and some of which are specific for the different “Cloud” Product Families, including, without limitation payment of the Program Fee(s), meeting certain minimum annual revenue requirements, upholding a Sell Authorization for at least one “Cloud” Product Family and other requirements as set out in detail in the PartnerEdge Program Guide and the RSPI.

  • Storage Injection Requirements means all volumes required by the Seller for injection into underground storage, including cushion gas, and for liquification, including fuel used for injection and in liquification plants, or for such other storage projects that may be developed expressly for the protection of supply to high priority users.

  • Requirements of Environmental Law means all requirements imposed by any law (including for example and without limitation The Resource Conservation and Recovery Act and The Comprehensive Environmental Response, Compensation, and Liability Act), rule, regulation, or order of any federal, state or local executive, legislative, judicial, regulatory or administrative agency, board or authority in effect at the applicable time which relate to (i) noise; (ii) pollution, protection or clean-up of the air, surface water, ground water or land; (iii) solid, gaseous or liquid waste generation, treatment, storage, disposal or transportation; (iv) exposure to Hazardous Substances; (v) the safety or health of employees or (vi) regulation of the manufacture, processing, distribution in commerce, use, discharge or storage of Hazardous Substances.

  • Web Site Accessibility Standards/Specifications means standards contained in Title 1 Texas Administrative Code Chapter 206.

  • Environmental, Health, and Safety Requirements means all federal, state, local and foreign statutes, regulations, and ordinances concerning public health and safety, worker health and safety, and pollution or protection of the environment, including without limitation all those relating to the presence, use, production, generation, handling, transportation, treatment, storage, disposal, distribution, labeling, testing, processing, discharge, release, threatened release, control, or cleanup of any hazardous materials, substances or wastes, as such requirements are enacted and in effect on or prior to the Closing Date.

  • Environmental, Health or Safety Requirements of Law means all Requirements of Law derived from or relating to foreign, federal, state and local laws or regulations relating to or addressing pollution or protection of the environment, or protection of worker health or safety, including, but not limited to, the Comprehensive Environmental Response, Compensation and Liability Act, 42 U.S.C. § 9601 et seq., the Occupational Safety and Health Act of 1970, 29 U.S.C. § 651 et seq., and the Resource Conservation and Recovery Act of 1976, 42 U.S.C. § 6901 et seq., in each case including any amendments thereto, any successor statutes, and any regulations or guidance promulgated thereunder, and any state or local equivalent thereof.

  • Pretreatment requirements means any substantive or procedural requirement related to pretreatment, other than a pretreatment standard, imposed on an industrial user.

  • OHS Requirements means all Laws applicable to the Supply and related to occupational health or safety, and all of the City Policies that relate to occupational health or safety, and includes without limitation the WCA;

  • Federal safety requirements means applicable provisions of 49 U.S.C. § 30101 et seq. and all

  • cGMP means current Good Manufacturing Practices as specified in the United States Code of Federal Regulations, ICH Guideline Q7A, or equivalent laws, rules, or regulations of an applicable Regulatory Authority at the time of manufacture.

  • Web Site Accessibility Standards/Specifications means standards contained in Title 1 Texas Administrative Code Chapter 206.

  • Environmental Requirements means all Laws and requirements relating to human, health, safety or protection of the environment or to emissions, discharges, releases or threatened releases of pollutants, contaminants, or Hazardous Materials in the environment (including, without limitation, ambient air, surface water, ground water, land surface or subsurface strata), or otherwise relating to the treatment, storage, disposal, transport or handling of any Hazardous Materials.

  • Accessibility Standards means accessibility standards and specifications for Texas agency and institution of higher education websites and EIR set forth in 1 TAC Chapter 206 and/or Chapter 213.

  • Design requirements means the written description of the infrastructure facility to be procured pursuant to this article, including:

  • Environmental and Safety Requirements means all federal, state, local and foreign statutes, regulations, ordinances and similar provisions having the force or effect of law, all judicial and administrative orders and determinations, all contractual obligations and all common law concerning public health and safety, worker health and safety and pollution or protection of the environment, including all such standards of conduct and bases of obligations relating to the presence, use, production, generation, handling, transport, treatment, storage, disposal, distribution, labeling, testing, processing, discharge, release, threatened release, control, or cleanup of any hazardous materials, substances or wastes, chemical substances or mixtures, pesticides, pollutants, contaminants, toxic chemicals, petroleum products or by-products, asbestos, polychlorinated biphenyls (or PCBs), noise or radiation.

  • Environmental Requirement means any Environmental Law, agreement or restriction, as the same now exists or may be changed or amended or come into effect in the future, which pertains to any Hazardous Material or the environment including ground or air or water or noise pollution or contamination, and underground or aboveground tanks.

  • Governmental Requirements means all judgments, orders, writs, injunctions, decrees, awards, laws, ordinances, statutes, regulations, rules, franchises, permits, certificates, licenses, authorizations and the like and any other requirements of any government or any commission, board, court, agency, instrumentality or political subdivision thereof.

  • Maintenance Requirements shall have the meaning set forth in Clause 14.2;