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. 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 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 disqualification proceedings by any regulato...
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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.

  • Random Drug Testing All employees covered by this Agreement shall be subject to random drug testing in accordance with Appendix D.

  • Clinical 1.1 Provides comprehensive evidence based nursing care and individual case management to a specific group of patients/clients including assessment, intervention and evaluation. 1.2 Undertakes clinical shifts at the direction of senior staff and the Nursing Director including participation on the on-call/after-hours/weekend roster if required. 1.3 Responsible and accountable for patient safety and quality of care through planning, coordinating, performing, facilitating, and evaluating the delivery of patient care relating to a particular group of patients, clients or staff in the practice setting. 1.4 Monitors, reviews and reports upon the standard of nursing practice to ensure that colleagues are working within the scope of nursing practice, following appropriate clinical pathways, policies, procedures and adopting a risk management approach in patient care delivery. 1.5 Participates in xxxx rounds/case conferences as appropriate. 1.6 Educates patients/carers in post discharge management and organises discharge summaries/referrals to other services, as appropriate. 1.7 Supports and liaises with patients, carers, colleagues, medical, nursing, allied health, support staff, external agencies and the private sector to provide coordinated multidisciplinary care. 1.8 Completes clinical documentation and undertakes other administrative/management tasks as required. 1.9 Participates in departmental and other meetings as required to meet organisational and service objectives. 1.10 Develops and seeks to implement change utilising expert clinical knowledge through research and evidence based best practice. 1.11 Monitors and maintains availability of consumable stock. 1.12 Complies with and demonstrates a positive commitment to Regulations, Acts and Policies relevant to nursing including the Code of Ethics for Nurses in Australia, the Code of Conduct for Nurses in Australia, the National Competency Standards for the Registered Nurse and the Poisons Act 2014 and Medicines and Poisons Regulations 2016. 1.13 Promotes and participates in team building and decision making. 1.14 Responsible for the clinical supervision of nurses at Level 1 and/or Enrolled Nurses/ Assistants in Nursing under their supervision.

  • Drug Testing (A) The state and the PBA agree to drug testing of employees in accordance with section 112.0455, F.S., the Drug-Free Workplace Act. (B) All classes covered by this Agreement are designated special risk classes for drug testing purposes. Special risk means employees who are required as a condition of employment to be certified under Chapter 633 or Chapter 943, F.S. (C) An employee shall have the right to grieve any disciplinary action taken under section 112.0455, the Drug-Free Workplace Act, subject to the limitations on the grievability of disciplinary actions in Article 10. If an employee is not disciplined but is denied a demotion, reassignment, or promotion as a result of a positive confirmed drug test, the employee shall have the right to grieve such action in accordance with Article 6.

  • Trials The Ship shall run the following test and trials: (1) Harbour Acceptance Tests, including setting to work of the various equipment;

  • Product Testing No later than [**] prior to a scheduled Delivery ARIAD US shall send to ARIAD SWISSCO the Delivery Documents for review. Following such review, unless within [**] of receipt of the Delivery Documents ARIAD SWISSCO gives written notice of rejection of the Product to be delivered, stating the reasons for such rejection, the Delivery shall proceed, and both Parties shall organize the same. Upon arrival at ARIAD SWISSCO nominated site it shall visually inspect the shipment of the Product to identify any damage to the external packaging. ARIAD SWISSCO may reject any shipment (or portion thereof) of the Product that is damaged by providing to ARIAD US reasonable evidence of damage within [**] after Delivery of such Product. If ARIAD SWISSCO does not so reject any shipment (or portion thereof) of the Product within [**] of Delivery of such Product, ARIAD SWISSCO shall be deemed to have accepted such shipment of the Product; provided, however, that in the case of the Product having any Latent Defect, ARIAD SWISSCO shall notify ARIAD US promptly once it becomes aware that a Product contains a Latent Defect and subsequently may reject such Product by giving written notice to ARIAD US of ARIAD SWISSCO’s rejection of such Product and shipping a representative sample of such Product or other evidence of Non-Conformance to ARIAD US within [**] after becoming aware of such Latent Defect, which notice shall include a description of the Latent Defect.

  • Clinical Data and Regulatory Compliance The preclinical tests and clinical trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement 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; 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 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”); 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 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, regulations and policies of the Regulatory Agencies.

  • 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.

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