Clinical Test definition

Clinical Test means: any clinical trial, test and/or whatsoever analysis which is required by the Laws, necessary and/or useful for obtaining from FDA and/or any further competent authority of the TERRITORY the approval to the placement on the market and the REGISTRATION of the PRODUCTS in the TERRITORY;
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Clinical Test means: any clinical trial, test and/or whatsoever analysis which is required by the LAWS: (i) for obtaining from FDA IDE approval for ▇▇.▇▇ as commenced under the PRIOR AGREEMENT, (ii) for responding to FDA’s letter dated November 15, 2006 regarding the 510(k) submission for CHROMIS Deep and responding to the FDA regarding the 510(k) submission for SKIPPER Deep (the “510(k) Responses”), and/or (iii) for continuing valid registration of the PRODUCTS in the TERRITORY;
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Clinical Test means a well-controlled clinical study conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug. 1.36 "RESEARCH PLAN" shall mean individually and collectively a DRUG RESEARCH PLAN, PROTEIN RESEARCH PLAN and ANTIBODY RESEARCH PLAN. 9
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Examples of Clinical Test in a sentence

  • At the Closing, each Shareholder shall sell, transfer, convey, assign and deliver to Love Group its Lovego Holdings Shares free and clear of all Liens in exchange for the Love Group Stock listed on Annex A opposite such Shareholder’s name.

  • The JDT shall develop mutually agreeable budgets and schedules which will establish the maximum amount of Development Costs (such amount is referred to herein as the "Development Cost Limit") to be expended in developing the Clinical Test Inhaler and the Inhaler to the point of completion of an application for Section 510(k) Premarket Notification Clearance ("510(k) Clearance") for the Inhaler.

  • All capital expenditures necessary to manufacture and supply the Clinical Test Inhalers and the Inhalers pursuant to this Agreement shall be the sole responsibility of AeroGen.

  • AeroGen shall use commercially reasonable efforts to develop the Clinical Test Inhaler, in accordance with the specifications set [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.

  • AeroGen shall use all quantities of filled Ampoule or Tobramycin Solution so supplied by PathoGenesis pursuant to this Agreement exclusively for the development and related testing of the Clinical Test Inhaler and the Inhaler.

  • AeroGen shall provide to PathoGenesis the Clinical Test Inhaler for clinical testing (in quantities and in accordance with the schedule set forth in Exhibit B and the specifications in Exhibit A).

  • In the event PathoGenesis intends to utilize the Clinical Test Inhaler, Inhaler, Adapter, Ampoule or any other [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.

  • PathoGenesis shall have a period of [*] from the date of receipt of the shipment of Clinical Test Inhaler(s) to test for quality of the shipment and to accept or reject such shipment.

  • AeroGen shall undertake commercially reasonable efforts to correct such defect, and supply PathoGenesis with a replacement shipment of Clinical Test Inhalers acceptable to PathoGenesis, within a reasonable time and in view of the timelines set forth in Exhibit B.

  • AeroGen shall use commercially reasonable efforts to provide PathoGenesis with the samples of the Clinical Test Inhaler for examination, testing and comment in the amounts and according to the schedule set forth in Exhibit B.


More Definitions of Clinical Test

Clinical Test means a well-controlled clinical study conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug. 1.19 "RESEARCH PLAN" shall mean a plan for research and development of an EXCLUSIVE SP PRODUCT in the FIELD which includes, at a minimum, scientific data, research and development efforts, research and development milestones, and is sufficient to reasonably monitor diligence of research/development of such EXCLUSIVE SP PRODUCT. A representative example of such a plan is shown in Appendix A. 1.20 "RESEARCH TERM" shall mean the INITIAL RESEARCH TERM and the EXTENDED TERM, if any. 1.21 "SOFTWARE" shall mean software (together with the source code therefor and maintenance files and "Documentation" as defined below) designed and developed by HGS prior to or during the INITIAL RESEARCH TERM for analysis of ▇▇▇▇▇▇▇▇ ▇▇▇▇ with respect to human DNA and expression products thereof, including, without limitation, the specific software modules set forth in the attached Appendix B. "Documentation" shall include all operating and user manuals, training materials guides, listings, specifications and other material used with the SOFTWARE. 1.22 "SP PATENT(s)" shall mean all patents and patent applications to the extent that they claim SP TECHNOLOGY, which are or become owned by SP or to which SP otherwise has, now or in the future, the right to grant licenses. Included within the definition of SP PATENTS are all continuations, continuations-in-part, divisions, patents of addition, reissues, 6
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Related to Clinical Test

  • 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.

  • 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.

  • Drug test means a test designed to detect the illegal use of a controlled substance.

  • Drug use test means a scientifically substantiated method to test for the presence of illegal or performance-enhancing drugs or the metabolites thereof in a person’s urine.

  • 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.