Pharmacovigilance and Safety Data Sample Clauses

Pharmacovigilance and Safety Data. ADCT shall establish and maintain, at ADCT’s sole cost and expense, a global drug safety database for the Products. Subject to Section 6.2.4, MTPC shall have the right to access from such global drug safety database all Safety Data necessary for MTPC to comply with all Applicable Laws in the MTPC Territory. MTPC may establish and maintain, at MTPC’s sole cost and expense, a local drug safety database for the Products in the MTPC Territory; provided that all data therein shall also be provided to ADCT for inclusion in the global drug safety database. Each Party will be responsible, at its sole cost and expense, for: (a) collecting all pharmacovigilance and other Safety Data for the Products in its respective Territory as required by Applicable Laws; (b) reporting any such pharmacovigilance and other Safety Data, including Adverse Events in its respective Territory, to the applicable Regulatory Authorities in its respective Territory, as appropriate to be in compliance with all Applicable Laws, and (c) with respect to MTPC, reporting Safety Data to ADCT in XML files (or CIOMS format) (in English) for entry into the global safety database. Each Party expressly acknowledges that the other Party may provide information it receives pursuant to this Section 6.5.1 to appropriate Regulatory Authorities within its respective Territory by itself or through any of its Affiliates or Sublicensees engaged in Development and Commercialization activities of the Products in its respective Territory.
Sample 1
AutoNDA by SimpleDocs
Pharmacovigilance and Safety Data. As between the Parties, DRL shall establish, hold and maintain (at DRL’s sole cost and expense) a global safety database for Final Product with respect to information on adverse events concerning Final Product, as and to the extent required by Applicable Laws. Each Party shall collect all information necessary to comply with its pharmacovigilance responsibilities with respect to Final Product, including, as applicable, any adverse drug experiences taking place from pre-clinical or clinical laboratory, animal toxicology and pharmacology studies conducted by such Party, and clinical studies sponsored by such Party in the Territory, and from such Party’s commercial experiences in the Territory. Such global safety database shall be maintained by DRL [***]. Coya shall forward to DRL all adverse drug event reports received from lay persons or health care professionals relating to the Commercialization of Final Product in the Coya Retained Territory. Prior to the first commercial sale of Final Product, the Parties shall enter into a pharmacovigilance agreement allocating responsibilities for pharmacovigilance (including safety data exchange) consistent with this Section 5.5 (the “Pharmacovigilance Agreement”). Each Party shall maintain pharmacovigilance infrastructure as required to fulfill its responsibilities under this Agreement and the Pharmacovigilance Agreement.
Sample 1
Pharmacovigilance and Safety Data. Each Party shall be responsible for managing pharmacovigilance related to the Final Product in its respective territory. Each Party shall forward to the other Party all adverse drug event reports received from lay persons or health care professionals relating to Final Product in the other Party’s territory. Prior to the first commercial sale of Final Product, the Parties shall enter into a pharmacovigilance agreement allocating responsibilities for pharmacovigilance (including safety data exchange) consistent with this Section (the “Pharmacovigilance Agreement”). Each Party shall maintain pharmacovigilance infrastructure as required to fulfill its responsibilities under this Agreement and the Pharmacovigilance Agreement.
Sample 1
Pharmacovigilance and Safety Data. ADCT shall establish and maintain, at ADCT’s sole cost and expense, a global drug safety database for the Products. Consistent with Section 5.3.6 (Safety Data Exception), Sobi shall have the right to access from such global drug safety database all Safety Data necessary for Sobi and its Affiliates and its and their Sublicensees to comply with all Applicable Laws in the Sobi Territory. Sobi may, and will to the extent required by Applicable Laws, establish and maintain, at Sobi’s sole cost and expense, its own drug safety database for the Products; provided that all data therein shall also be provided to ADCT for inclusion in the global drug safety database. Each Party will be responsible, at its sole cost and expense, for: (a) collecting all pharmacovigilance and other Safety Data for the Products in its respective Territory as required by Applicable Laws; (b) reporting any such pharmacovigilance and other Safety Data, including Adverse Events, in its respective Territory, to the applicable Regulatory Authorities in its respective Territory, as appropriate to be in compliance with all Applicable Laws, (c) with respect to Sobi, reporting Safety Data to ADCT in XML files (or CIOMS or E2B format) (in English) for entry into the global safety database, and (d) with respect to ADCT, reporting Safety Data to Sobi in XML files (or CIOMS or E2B format) (in English) for entry into Sobi’s safety database. Each Party expressly acknowledges that the other Party may provide information it receives pursuant to this Section 6.6.1 (Pharmacovigilance and Safety Data) to appropriate Regulatory Authorities within its respective Territory itself or through any of its Affiliates or Sublicensees engaged in Development and Commercialization activities of the Products in its respective Territory.
Sample 1
Pharmacovigilance and Safety Data. Forty Seven shall establish and maintain, at Forty Seven’s sole cost and expense, a global drug safety database for the Products. Ono shall have the right to access from such global drug safety database all Safety Data necessary for Ono to comply with all Applicable Laws in the Ono Territory. Ono may establish and maintain, at Ono’s sole cost and expense, a local drug safety database for the Products in the Ono Territory. Each Party will be responsible, at its sole cost and expense, for: (a) collecting all pharmacovigilance and other Safety Data for the Products in its respective Territory as required by Applicable Laws; and (b) reporting any such pharmacovigilance and other Safety Data, including Adverse Events in its respective Territory, to the applicable Regulatory Authorities in its respective Territory, as appropriate to be in compliance with all Applicable Laws, including reporting Safety Data to the other Party in XML files (or CIOMS format) (in English) for entry into the global safety database. Each Party expressly acknowledges that the other Party may provide information it receives pursuant to this Section 5.5 to appropriate Regulatory Authorities within its respective Territory by itself or through any of its Affiliates, Sublicensees and Forty Seven Partners engaged in Development and Commercialization activities of the Products in its respective Territory.
Sample 1

Related to Pharmacovigilance and Safety Data

  • Pharmacovigilance Licensee shall maintain until the termination of this Agreement (or, as applicable, until the rights and obligations intended to survive termination of this Agreement have been fulfilled) pharmacovigilance and risk management systems, procedures and documentation needed to perform and comply with its regulatory obligations and its related obligations under this Agreement. Licensee shall ensure that it will comply with all Applicable Law regarding Licensed Product in the Territory, including, without limitation, those laws and regulations relating to risk management, drug safety and pharmacovigilance. If Licensee becomes aware of any adverse reaction relating to Licenced Product in connection with this Agreement, Licensee shall inform MPP and Pfizer within twenty-four (24) hours of its becoming aware and cooperate with Pfizer in fulfilling Pfizer’s reporting responsibilities under Applicable Law. Licensee will be responsible for fulfilling all pharmacovigilance activities pursuant to the local regulations and requirements for the Licenced Products in the Territory and provide MPP and Pfizer with a report containing information regarding all such activities. Such report shall be provided annually, on February 1 of each year, and otherwise on reasonable request by MPP or Pfizer to both MPP and Pfizer’s pharmacovigilance contact as may be designated by Pfizer from time to time. Licensee shall notify MPP and Pfizer forthwith of the receipt of an enquiry from an Agency in the Territory relating to Licensed Product that concerns any safety issue. If Licensee becomes aware of any action that may be, will be or has been taken by an Agency for a safety reason connected with Licensed Product, it shall immediately, and in any event no later than twenty-four

  • Pharmacovigilance Agreement Subject to the terms of this Agreement, and at a date to be determined by the JDC, Facet and Trubion shall define and finalize the actions the Parties shall employ to protect patients and promote their well-being in a written agreement (hereinafter referred to as the “Pharmacovigilance Agreement”). These responsibilities shall include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between the Parties) of adverse event reports, pregnancy reports, and any other information concerning the safety of any Collaboration Product. Such guidelines and procedures shall be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations to Governmental Authorities. Furthermore, such agreed procedures shall be consistent with relevant ICH guidelines, except where said guidelines may conflict with existing local regulatory safety reporting requirements, in which case local reporting requirements shall prevail. The Pharmacovigilance Agreement will provide for a worldwide safety database to be maintained by the Party appointed by the JDC. Each Party hereby agrees to comply with its respective obligations under such Pharmacovigilance Agreement (as the Parties may agree to modify it from time to time) and to cause its Affiliates and permitted sublicensees to comply with such obligations.

  • Quality Agreement Concurrently with execution of this Agreement, the Parties will enter into an agreement that details the quality assurance obligations of each Party with respect to the Manufacture and supply of Supplied Products under this Agreement (the “Quality Agreement”). Each Party shall perform its obligations under the Quality Agreement in accordance with the terms and conditions thereof. In the event of a conflict between the terms of the Quality Agreement and the terms of this Agreement, the provisions of the Quality Agreement shall govern.

  • Research Use Reporting To assure adherence to NIH GDS Policy, the PI agrees to provide annual Progress Updates as part of the annual Project Renewal or Project Close-out processes, prior to the expiration of the one (1) year data access period. The PI who is seeking Renewal or Close-out of a project agree to complete the appropriate online forms and provide specific information such as how the data have been used, including publications or presentations that resulted from the use of the requested dataset(s), a summary of any plans for future research use (if the PI is seeking renewal), any violations of the terms of access described within this Agreement and the implemented remediation, and information on any downstream intellectual property generated from the data. The PI also may include general comments regarding suggestions for improving the data access process in general. Information provided in the progress updates helps NIH evaluate program activities and may be considered by the NIH GDS governance committees as part of NIH’s effort to provide ongoing stewardship of data sharing activities subject to the NIH GDS Policy.

  • 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.

  • 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.

  • Protocols Each party hereby agrees that the inclusion of additional protocols may be required to make this Agreement specific. All such protocols shall be negotiated, determined and agreed upon by both parties hereto.

  • Health and Safety Plan Consultant shall prepare and submit a Health and Safety Plan (“HASP”) for the portion of Consultant’s work that will involve field work, assessments, or investigations of certain Project elements. The HASP shall describe how Consultant plans to complete field work, assessments, and/or investigations at the RWF. Consultant’s HASP must comply with the CIP HASP and shall be updated as new conditions are encountered.

  • Function of Joint Health and Safety Committee All incidents involving aggression or violence shall be brought to the attention of the Joint Health and Safety Committee. The Employer agrees that the Joint Health and Safety Committee shall concern itself with all matters relating to violence to staff.

  • Joint Health and Safety Committee (a) The Employer and the Union agree that they mutually desire to maintain standards of occupational health and safety in the organization, in order to prevent accidents, injury and illness. The parties agree to promote health and safety throughout the organization. The employer shall provide orientation and training in health and safety to new and current employees on an ongoing basis, and employees shall attend required health and safety training sessions. (b) Recognizing its responsibilities under the applicable legislation, the Employer agrees to accept as a member of its Joint Health and Safety Committee, at least one representative from the bargaining unit. The number of committee members will be no less than that determined by legislation and the bargaining unit will be entitled to the same membership as any other employee group on the committees. The Union shall notify the employer of their representatives. (c) Such Committee shall identify potential dangers and hazards, institute means of improving health and safety programs, and recommend actions to be taken to improve conditions related to occupational health and safety. (d) The Employer agrees to cooperate reasonably in providing necessary information to enable the Committee to fulfill its functions. The Committee shall respect the confidentiality of the information. (e) The Union agrees to endeavour to obtain the full cooperation of its membership in the observation of all safety rules and practices. (f) Meetings shall be held every third month or more frequently at the call of either co-chair, if required. The Committee shall keep Minutes of all meetings and make the Minutes available for review. (g) All time spent by a member of the Joint Health and Safety Committee attending meetings of the Committee and carrying out the members duties, shall be deemed to be time worked for which the member shall be paid by the Employer at the member's applicable rate of pay, and the member shall be entitled to such time from the member's work as necessary for those duties. (h) The employer shall take every precaution reasonable in the circumstances for the protection of a worker. [Occupational Health and Safety Act, s. 25

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!