Drug Storage and Drug Accountability Sample Clauses

Drug Storage and Drug Accountability. ‌ All unused study drug must be stored in its packaging at controlled room temperature, 15 to 25°C (59 to 77°F) with excursion to 30°C (86°F), in a dry, secure area. Access to drug storage areas should be limited to the investigator and designated staff involved with the study. All used and unused drug must be maintained at the study site and made available for audits by VIVUS personnel or their designee. It should be noted that phentermine, one component of the VI-0521 combination is a Schedule IV controlled substance. The investigator should take all appropriate measures to control access to and dispensing of study drug. The investigator must maintain records documenting the amount, condition, and date of delivery of all study drug received from the sponsor. In addition, all drug dispensed to study subjects during the course of the study must be recorded on the appropriate accountability forms. Subjects must be instructed to return all empty containers and all unused medication in its original packaging, and sites must make an accounting of drug use by each subject. No study drug, used or unused, may be discarded. All used and unused drug must be returned to the sponsor or designated representative upon completion of the study.
Sample 1
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Drug Storage and Drug Accountability. All unused study drug must be stored in its packaging at room temperature in a dry, secure area. Access to drug storage areas should be limited to the investigator and staff involved with the study. All used and unused drug must be maintained at the study site, and made available for audit by VIVUS, Inc. personnel. The investigator must maintain records documenting the amount, condition, and date of delivery of all study drug received from the Sponsor. In addition, all drug dispensed to study subjects during the course of the study must be ***. Subjects must be instructed to *** by each subject. No investigational drug, used or unused, may be discarded. All used and unused drug must be returned to the sponsor or designated representative upon completion of the study.
Sample 1
Drug Storage and Drug Accountability. All unused study drug must be stored in its packaging at room temperature in a dry, secure area. Access to drug storage areas should be limited to the investigator and designated staff involved with the study. All used and unused drug must be maintained at the study site and made available for audits by VIVUS, Inc. personnel or their designee. It should be noted that one component of the study drug combination is a Schedule IV controlled substance. The investigator should take all appropriate measures to control access to and dispensing of study drug. The investigator must maintain records documenting the amount, condition and date of delivery of all study drug received from the sponsor. In addition, all drug dispensed to study subjects during the course of the study must be ***. Subjects must be instructed to *** by each subject. No investigational drug or packaging, used or unused, may be discarded. All packaging and used and unused drug must be returned to the sponsor or designated representative upon completion of the study. *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
Sample 1
Drug Storage and Drug Accountability. All unused study drug must be stored in its packaging at room temperature in a dry, secure area. Access to drug storage areas should be limited to the investigator and designated staff involved with the study. All used and unused drug must be maintained at the study site and made available for audits by VIVUS personnel or their designee. It should be noted that one component of the study drug combination is a Schedule IV controlled substance. The investigator should take all appropriate measures to control access to and dispensing of study drug. The investigator must maintain records documenting the amount, condition and date of delivery of all study drug received from the sponsor. In addition, all drug dispensed to study subjects during the course of the study must be ***. Subjects must be instructed to *** by each subject. No investigational drug or packaging, used or unused, may be discarded. All packaging and used and unused drug must be returned to the sponsor upon completion of the study.
Sample 1

Related to Drug Storage and Drug Accountability

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  • 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, Registration Statement, the Pricing Disclosure Package or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with applicable laws, rules, regulations and policies of the Food and Drug Administration of the U.S. Department of Health and Human Services (the “FDA”) or any committee thereof or of any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board; 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 materially inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Pricing Disclosure Package or the Prospectus; for such studies that have been or are being conducted, the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by foreign government or drug or medical device regulatory agencies, or foreign health care facility Institutional Review Boards; and no investigational new drug application filed by or on behalf of the Company or any of its subsidiaries with the FDA has been terminated or suspended by the FDA, and neither the FDA nor any applicable foreign regulatory agency has commenced, or, to the knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay or suspend, any proposed or ongoing studies conducted or proposed to be conducted by or on behalf of the Company or any of its subsidiaries.

  • FDA and Regulatory Matters Except as set forth in the Prospectus and the Prospectus Supplement, there is no legal or governmental proceeding to which the Company or any of its subsidiaries is a party or of which any property or assets of the Company or any of its subsidiaries or any officer or director of the Company, in their roles as such, or any employee benefit plan sponsored by the Company, is the subject, including any proceeding before the United States Food and Drug Administration of the U.S. Department of Health and Human Services (the “FDA”) or comparable federal, state, local or foreign governmental authorities (it being understood that the interaction between the Company and the FDA and such comparable governmental bodies relating to the clinical development and product approval process shall not be deemed proceedings for purposes of this representation), which is required to be described in the Registration Statement, the Prospectus or the Prospectus Supplement or a document incorporated by reference therein and is not described therein, or which, singularly or in the aggregate, if determined adversely to the Company or any of its subsidiaries, could reasonably be expected to have a Material Adverse Effect; and to the Company’s knowledge after reasonable investigation (“Knowledge”), no such proceedings are threatened by governmental authorities. The Company is in compliance with all applicable federal, state, local and foreign laws, regulations, orders and decrees governing its business as prescribed by the FDA, or any other federal, state or foreign agencies or bodies engaged in the regulation of pharmaceuticals or biohazardous substances or materials, except where noncompliance would not, singly or in the aggregate, have a Material Adverse Effect. All preclinical and clinical studies conducted by or on behalf of the Company to support approval for commercialization of the Company’s products have been conducted by the Company, or to the Company’s Knowledge by third parties, in compliance with all applicable federal, state or foreign laws, rules, orders and regulations, except for such failure or failures to be in compliance as could not reasonably be expected to have, singularly or in the aggregate, a Material Adverse Effect. The Company and each of its subsidiaries possess all licenses, certificates, authorizations and permits issued by, and have made all declarations and filings with, the appropriate local, state, federal or foreign governmental or regulatory agencies or bodies (including, without limitation, those administered by the FDA or by any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA) that are necessary for the ownership or lease of their respective properties or the conduct of their respective businesses as described in the Registration Statement, the Prospectus and the Prospectus Supplement (collectively, the “Governmental Permits”), except where any failures to possess or make the same would not, singularly or in the aggregate, have a Material Adverse Effect. The Company and its subsidiaries are in compliance with all such Governmental Permits and all such Governmental Permits are valid and in full force and effect, except where the noncompliance, validity or failure to be in full force and effect would not, singularly or in the aggregate, have a Material Adverse Effect. Neither the Company nor any subsidiary has received notification of any revocation, modification, suspension, termination or invalidation (or proceedings related thereto) of any such Governmental Permit and to the Knowledge of the Company, no event has occurred that allows or results in, or after notice or lapse of time or both would allow or result in, revocation, modification, suspension, termination or invalidation (or proceedings related thereto) of any such Governmental Permit and the Company has no reason to believe that any such Governmental Permit will not be renewed, except where such revocation, modification, suspension, termination, invalidation or nonrenewal would not, singularly or in the aggregate, have a Material Adverse Effect. The Company and its subsidiaries, and to the Company’s Knowledge, its directors, officers, employees or agents, each in their respective roles with the Company, are and have been in compliance in all material respects with applicable federal, state, local and foreign health care regulatory laws, including without limitation, laws related to fraud and abuse, payment transparency, and privacy and security of protected health information (collectively, “Health Care Laws”). The Company and its subsidiaries have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court, arbitrator or governmental or regulatory authority or third party alleging that the Company, its subsidiaries or its personnel have violated any applicable Health Care Law, nor, to the Company’s Knowledge, has any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action been threatened, which, individually or in the aggregate, might result in any Material Adverse Effect. The studies, tests and preclinical or clinical trials conducted by or on behalf of the Company that are described in the Prospectus and the Prospectus Supplement (the “Company Studies and Trials”) were and, if still pending, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards; the descriptions of the results of the Company Studies and Trials contained or incorporated by reference in the Registration Statement, the Prospectus and the Prospectus Supplement are accurate in all material respects; the Company has no knowledge of any other studies or trials not described in the Prospectus and the Prospectus Supplement, the results of which are inconsistent with or call in question the results described or referred to in the Registration Statement, the Prospectus and the Prospectus Supplement; and the Company has not received any notices or correspondence from the FDA or any foreign, state or local governmental authority exercising comparable authority requiring the termination, suspension or material modification of any Company Studies and Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect and, to the Company’s Knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Prospectus and the Prospectus Supplement, the Company has not granted rights to develop, manufacture, produce, assemble, distribute, license, market or sell its products or product candidates to any other person and is not bound by any agreement that affects the exclusive right of the Company to develop, manufacture, produce, assemble, distribute, license, market or sell its products or product candidates.

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