Preclinical Testing and Clinical Trials Sample Clauses

Preclinical Testing and Clinical Trials. The human clinical trials, animal studies and other preclinical tests conducted by the Company or any of its Subsidiaries or in which the Company or any of its Subsidiaries has participated, and such studies and tests conducted on behalf of the Company or any of its Subsidiaries, were and, if still pending, are being conducted in all material respects in accordance with experimental protocols, informed consents, procedures and controls generally used by qualified experts in the preclinical or clinical study of products comparable to those being developed by the Company or any of its Subsidiaries. None of the Company, its Subsidiaries or any agent or representative of the Company or any of its Subsidiaries has received any notices or correspondence from the FDA or any other governmental agency requiring the termination, suspension or modification (other than such modifications as are normal in the regulatory process) of any animal studies, preclinical tests or clinical trials conducted by or on behalf of the Company or any of its Subsidiaries or in which the Company or any of its Subsidiaries has participated. To the Company's knowledge, no clinical investigator acting for the Company has been or is now, or is threatened to become, the subject of any disbarment or disqualification proceedings by any regulatory agency.
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Preclinical Testing and Clinical Trials. To the knowledge of the Transferor, the preclinical tests and clinical trials related to the Programs and the Product Candidates were and, if still pending, are being conducted in all material respects in accordance with protocols filed with the appropriate regulatory authorities for each such clinical trial or human trial, as the case may be, and, to the knowledge of the Transferor, in compliance in all material respects with all applicable Laws, rules and regulations, including all public health and safety provisions of state law and regulations, Permits, governmental licenses, registrations, approvals, concessions, franchises, authorizations, Orders, injunctions and decrees. To the knowledge of the Transferor, all Product Candidates used in the conduct of clinical trials through the Execution Date have been manufactured in compliance in all material respect with cGMPs. To the knowledge of the Transferor, each regulatory filing made with respect to the Product Candidates (including the INDs therefor) were, at the time of filing, true, complete and accurate in all material respects. No serious adverse event information has come to the attention of the Transferor relating to the clinical trials for the Product Candidates. To the knowledge of the Transferor, the development of the Product Candidates has been conducted in compliance in all material respects with all applicable Laws, and the Transferor has not received any written notice which has, or reasonably should have, led it to believe that any of the INDs for same are not currently in good standing with the FDA. The Transferor has no knowledge of any other studies or tests the results of which are inconsistent with or otherwise call into question the results of such preclinical tests and clinical trials. The Transferor has not received any written notices or other correspondence from the FDA or any other Governmental Authority requiring the termination, suspension or modification of any clinical trials related to the Programs. Notwithstanding the foregoing, the Acquirer acknowledges that the Transferor has had no involvement in the conduct of the preclinical and clinical trials related to the Programs and the Product Candidates, the preparation of any regulatory filings made in connection therewith, or the manufacture of any Product Candidate.
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Preclinical Testing and Clinical Trials. The human clinical trials, animal studies and other preclinical tests conducted by the Company or in which the Company has participated, and such studies and tests conducted on behalf of the Company, were and, if still pending, are being conducted in all material respects in accordance with experimental protocols, informed consents, procedures and controls generally used by qualified experts in the preclinical or clinical study of products comparable to those being developed by the Company. Neither the Company, nor any agent or representative of the Company nor, to the Knowledge of the Company, any of its licensees and IP Assignees, has received any notices or correspondence from the Food and Drug Administration ("FDA") or any other Governmental Authority requiring the termination, suspension or modification (other than such modifications as are normal in the regulatory process) of any animal studies, preclinical tests or clinical trials conducted by or on behalf of the Company or, to the Knowledge of the Company, such licensees and IP Assignees, or in which the Company or, to the Knowledge of the Company, such licensees and IP Assignees, have participated. To the Company's Knowledge, no clinical investigator acting for the Company has been or is now, or is threatened to become, the subject of any disbarment or disqualification proceedings by any regulatory agency.
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Preclinical Testing and Clinical Trials. The Millennium --------------------------------------- Disclosure Schedule sets forth all human clinical trials conducted prior to the date of this Agreement by Millennium or any of its Subsidiaries, on behalf of Millennium or any of its Subsidiaries, or in which Millennium or any of its Subsidiaries has participated, with respect to the Phase II Products (including any such trials which are still pending). The human clinical trials, animal studies and other preclinical tests relating to the Phase II Products conducted by Millennium or any of its Subsidiaries or in which Millennium or any of its Subsidiaries has participated, and such studies and tests conducted on behalf of Millennium or any of its Subsidiaries, were and, if still pending, are being conducted in accordance with (A) experimental protocols, informed consents, procedures and controls generally used by qualified experts in the preclinical or clinical study of products comparable to the Phase II Products, and (B) all applicable laws and regulations, including but not limited to, 21 CFR part 50 (informed consent), part 56 (institutional review boards), part 58 (good laboratory practices), part 812 (investigational device exemptions), and all other applicable laws and regulations, except for any noncompliances which, individually or in the aggregate, are not reasonably likely to have a Millennium Material Adverse Effect. None of Millennium, its Subsidiaries or the contract research organization overseeing or assisting Millennium in administering any clinical or preclinical trial or investigator-sponsored trials on behalf of Millennium or its Subsidiaries has received any notices or correspondence from the FDA or any other governmental agency, and no any agent or representative of Millennium or any of its Subsidiaries has received any written notices or correspondence from the FDA or any other governmental agency, requiring the delay, termination, suspension or modification (other than such modifications as are normal in the regulatory process) of any animal studies, preclinical tests or clinical trials conducted by or on behalf of Millennium or any of its Subsidiaries relating to the Phase II Products or in which Millennium or any of its Subsidiaries has participated relating to the Phase II Products. No clinical investigator acting for Millennium or any of its Subsidiaries with respect to the Phase II Products has been or is now, or is threatened to become, the subject of any disbarment or disq...
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Preclinical Testing and Clinical Trials. To Seller’s knowledge, the human clinical trials, animal studies and other preclinical tests conducted by Seller or in which Seller has participated, and such studies and tests conducted on behalf of Seller, with respect to the Business were and, if still pending, are being conducted in accordance with experimental protocols, informed consents, procedures and controls generally used by qualified experts in the preclinical or clinical study of comparable products. Neither Seller nor any agent or representative of Seller has received any written notice or correspondence from the FDA or any other Governmental Entity requiring the termination, suspension or modification (other than such modifications as are normal in the regulatory process) of any animal studies, preclinical tests or clinical trials conducted by or on behalf of Seller or in which Seller has participated with respect to the Business. To Seller’s knowledge, no clinical investigator acting for Seller with respect to the Business has been or is now, or is threatened to become, the subject of any disbarment or disqualification proceedings by any Governmental Entity.
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Preclinical Testing and Clinical Trials. The Seller Disclosure Schedule sets forth all human clinical trials relating to the Assets conducted by the Seller, on behalf of the Seller, or in which the Seller has participated. The human clinical trials, animal studies and other preclinical tests relating to the Assets conducted by the Seller or in which the Seller has participated, and such trials, studies and tests conducted on behalf of the Seller, were and, if still pending, are being conducted in accordance with experimental protocols, informed consents, procedures and controls generally used by qualified experts in the preclinical or clinical study of products comparable to those being developed by the Seller. None of the Seller or any contract research organization overseeing or assisting the Seller in administering any clinical or preclinical trial or investigator-sponsored trial on behalf of the Seller has received any notices or correspondence from the Federal Food and Drug Administration (the “FDA”) or any other governmental agency, and no other agent or representative of the Seller has received any written notices or correspondence from the FDA or any other governmental agency, requiring the delay, termination, suspension or modification (other than such modifications as are normal in the regulatory process) of any animal studies, preclinical tests or clinical trials relating to the Assets conducted by or on behalf of the Seller or in which the Seller has participated.
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Preclinical Testing and Clinical Trials. SECTION 3.15 of the Company Disclosure Schedule sets forth all human clinical trials conducted by the Company, on behalf of the Company, or in which the Company has participated (the "COMPANY ONGOING CLINICAL PROGRAMS"). To the Company's knowledge, the Company Ongoing Clinical Programs were and, if still pending, are being conducted in accordance with applicable laws and regulations, including but not limited to, 21 CFR part 50 (informed consent), part 56 (institutional review boards), part 58 (good laboratory practices), part 812 (investigational device exemptions), and all other applicable laws and regulations, except where the failure to be so conducted would individually or in the aggregate reasonably be expected to have a Company Material Adverse Effect. Since January 1, 2000, neither the Company, nor any agent or representative of the Company, has received any written notices or correspondence from the United States Food and Drug Administration or any other governmental agency requiring the 31 delay, termination, suspension or modification of any clinical trials conducted by or on behalf of the Company or in which the Company has participated, or any disqualification of testing facilities used by the Company. To the Company's knowledge, no clinical investigator acting for the Company has been, is or is threatened to become, the subject of any disbarment or disqualification proceedings by any regulatory agency or has been terminated or threatened to be terminated from any such investigation.
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Related to Preclinical Testing and Clinical Trials

  • Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to the U.S. Food and Drug Administration (the “FDA”) or other comparable government entities, 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, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes reasonably call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies 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.

  • 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.

  • 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.

  • Product Testing Upon request, Customer shall provide Operator a laboratory report for each Product delivery by Customer or Customer’s supplier. Operator will not be obligated to receive Contaminated Product for throughput through the Pipelines, nor will Operator be obligated to accept Product that fails to meet the applicable quality specifications for the Berths under the BAUTA and any Terminal Service Orders issued thereunder.

  • Clinical Data and Regulatory Compliance The preclinical tests and clinical trials conducted by the Company, and to the knowledge of the Company, the preclinical tests and clinical trials conducted on behalf of or sponsored by the Company, 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 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 and all applicable laws and regulations, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, and 312; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, 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 Prospectuses or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such Permits 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 would not, individually or in the aggregate, reasonably be expected 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 would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

  • Development Program A. Development Activities to be Undertaken (Please break activities into subunits with the date of completion of major milestones)

  • Commercialization Reports After the First Commercial Sale of a Licensed Product anywhere in the Territory, LICENSEE shall submit to Cornell semi-annual reports on or before each February 28 and August 31 of each year. Each report shall cover LICENSEE’s (and each Affiliate’s and Sublicensee’s) most recently completed calendar half-year and shall show:

  • Research Program The term “Research Program” shall mean the research program to be undertaken by TSRI under the direction and control of the Principal Investigator as expressly set forth on Exhibit A hereto.

  • Development Plan As defined in Section 3.2(a).

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