Clinical Trial Reporting Sample Clauses

Clinical Trial Reporting. Each Party agrees that (i) each Clinical Trial conducted with respect to a Galapagos Product or an Optioned Product that is required to be posted pursuant to Applicable Law or applicable industry codes, including the PhRMA Code, on xxxxxxxxxxxxxx.xxx or any other similar registry shall be so posted, and (ii) all results of such Clinical Trials that are necessary for obtaining a Regulatory Approval for a Galapagos Product or an Optioned Product shall be posted on xxxxxxxxxxxxxx.xxx and on any other registry with requirements consistent with the registration and publication guidelines of the International Committee of Medical Journal Editors, to the extent required. The Party responsible for conducting any Clinical Trial shall be responsible for the activities described in the preceding sentence with respect to such Clinical Trial.
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Clinical Trial Reporting. Each Party agrees that (a) each Clinical Trial conducted pursuant to a Development Plan, as applicable, that is required to be posted pursuant to Applicable Law or applicable industry codes, including the PhRMA Code, on xxxxxxxxxxxxxx.xxx or any other similar registry shall be so posted, and (b) all results of such Clinical Trials that are necessary for obtaining a Regulatory Approval for a Licensed Product or Gilead Combination Product in the Territory shall be posted on xxxxxxxxxxxxxxxxxxxx.xxx and on any other registry with requirements consistent with the registration and publication guidelines of the International Committee of Medical Journal Editors, to the extent required. All data and Information generated under such Clinical Trial posted on xxxxxxxxxxxxx.xxx, xxxxxxxxxxxxxxxxxxxx.xxx or any other registry pursuant to this Section 3.6 shall be subject to Section 12.4(b) as if such posting were a Publication.
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Clinical Trial Reporting. Each Party agrees that (a) each Clinical Trial conducted pursuant to the Joint Development Plan that is required to be posted pursuant to Applicable Law or applicable industry codes, including the PhRMA Code, on xxxxxxxxxxxxxx.xxx or any other similar registry shall be so posted, and (b) all results of such Clinical Trials that are necessary for obtaining a Regulatory Approval for a Licensed Product in the Territory shall be posted on xxxxxxxxxxxxxxxxxxxx.xxx and on any other registry with requirements consistent with the registration and publication guidelines of the International Committee of Medical Journal Editors, to the extent required. All data and information posted on xxxxxxxxxxxxx.xxx, xxxxxxxxxxxxxxxxxxxx.xxx or any other registry pursuant to this Section 3.8 shall be subject to prior review and authorization pursuant to Section 12.5 as if such posting were a publication.
Sample 1
Clinical Trial Reporting. Each Party agrees that (a) each Clinical Trial that is required to be posted pursuant to Applicable Law or with respect to Bayer, applicable industry codes (including the PhRMA Code or the EFPIA, JPMA or IFPMA code), on xx.xxx, on xxxxxxxxxxxxxx.xxx or any other similar registry shall be so posted, and (b) all results of such Clinical Trials that are necessary pursuant to Applicable Law or industry commitments accepted by such Party shall be posted on any registry with requirements consistent with the registration and publication guidelines of the International Committee of Medical Journal Editors (“ICMJE”), to the extent required. All data and information posted on xxxxxxxxxxxxx.xxx or any other registry pursuant to this Section 3.5 shall be subject to prior review of the other Party. If no comments in compliance with Applicable Law, industry commitments and ICMJE requirements are received within [***] after the other Party’s receipt of the proposed disclosure, the requesting Party shall be free to make such disclosure.
Sample 1
Clinical Trial Reporting. In the event that CHOP manufactures Project Deliverables for human clinical studies, Customer shall provide CHOP, upon execution of this Agreement, and on or around July 15 annually thereafter when requested by CVC, the name of any clinical trials in which the Project Deliverables manufactured hereunder will be used or are being used, the number of patients that Customer anticipates will be treated with the Project Deliverables provided hereunder in the upcoming year, and the number of patients that Customer has treated during the prior year. CHOP will maintain such information as confidential information only to be disclosed to CHOPs insurance underwriter and as may required by law.
Sample 1
Clinical Trial Reporting. In the event that CHOP manufactures Project Deliverables for human clinical studies, Customer shall provide CHOP, upon execution of this Agreement, and on June 30 annually thereafter, the name of any clinical trials in which the product manufactured hereunder will be used, the number of patients that Customer anticipates will be treated with the product provided hereunder in the upcoming year, and the number of patients that Customer has treated during the prior year.
Sample 1
Clinical Trial Reporting. Each Party agrees that (i) each Clinical Trial conducted with respect to an Arcus Product or an Optioned Product that is required to be posted pursuant to Applicable Law or applicable industry codes, including the PhRMA Code, on cxxxxxxxxxxxxx.xxx or any other similar registry shall be so posted by the Party sponsoring the Clinical Trial, and (ii) all results of such Clinical Trials that are necessary for obtaining a Regulatory Approval for an Arcus Product or an Optioned Product shall be posted by the Party sponsoring the Clinical Trial on cxxxxxxxxxxxxx.xxx and on any other registry with requirements consistent with the registration and publication guidelines of the International Committee of Medical Journal Editors, to the extent required. The Party responsible for conducting any Clinical Trial shall be responsible for the activities described in the preceding sentence with respect to such Clinical Trial.
Sample 1
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Clinical Trial Reporting. Each Party agrees that (i) each Clinical Trial conducted with respect to an Assembly Product that is required to be posted pursuant to Applicable Law or applicable industry codes, including the PhRMA Code, on xxxxxxxxxxxxxx.xxx or any other similar registry shall be so posted by [***] and (ii) all results of such Clinical Trials that are necessary for obtaining a Regulatory Approval for an Assembly Product shall be posted by Assembly on xxxxxxxxxxxxxx.xxx and on any other registry with requirements consistent with the registration and publication guidelines of the International Committee of Medical Journal Editors, to the extent required. [***] shall be responsible for the activities described in the preceding sentence with respect to such Clinical Trial.
Sample 1

Related to Clinical Trial Reporting

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

  • Tests and Preclinical and Clinical Trials The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder (collectively, “FFDCA”); the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the General Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, the Company is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, neither the Company nor any Subsidiary has received any notices or correspondence from the FDA or any Governmental Entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

  • Regulatory Reporting Ultimus agrees to provide reports to the federal and applicable state authorities, including the SEC, and to the Funds’ Auditors. Applicable state authorities are those governmental agencies located in states in which the Fund is registered to sell shares.

  • Clinical Data and Regulatory Compliance The preclinical tests and clinical trials conducted or sponsored by the Company (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the trade, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect; neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules and regulations of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

  • Adverse Event Reporting Both Parties acknowledge the obligation to comply with the Protocol and / or applicable regulations governing the collection and reporting of adverse events of which they may become aware during the course of the Clinical Trial. Both Parties agree to fulfil and ensure that their Agents fulfil regulatory requirements with respect to the reporting of adverse events.

  • Commercialization Reports Throughout the term of this Agreement and during the Sell-Off Period, and within thirty (30) days of December 31st of each year, Company will deliver to University written reports of Company’s and Sublicensees’ efforts and plans to develop and commercialize the innovations covered by the Licensed Rights and to make and sell Licensed Products. Company will have no obligation to prepare commercialization reports in years where (a) Company delivers to University a written Sales Report with active sales, and (b) Company has fulfilled all Performance Milestones. In relation to each of the Performance Milestones each commercialization report will include sufficient information to demonstrate achievement of those Performance Milestones and will set out timeframes and plans for achieving those Performance Milestones which have not yet been met.

  • Information for Regulatory Compliance Each of the Company and the Depositary shall provide to the other, as promptly as practicable, information from its records or otherwise available to it that is reasonably requested by the other to permit the other to comply with applicable law or requirements of governmental or regulatory authorities.

  • Regulatory Compliance a. Monitor compliance with the 1940 Act requirements, including:

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