Pharmacovigilance Responsibilities Sample Clauses

Pharmacovigilance Responsibilities. The Parties shall enter into a mutually agreeable safety data exchange agreement no later than [***] ([***]) days following the Effective Date.
Sample 1Sample 2Sample 3See All (4)
AutoNDA by SimpleDocs
Pharmacovigilance Responsibilities. (a) Prior to the transfer of the initial NDA to Partner: (i) Partner shall be responsible, at its sole cost and expense, for all pharmacovigilance activities associated with the EAP for the Product in the Partner Territory, including filing all reports required to be filed in order to maintain any Regulatory Approvals granted in connection with the EAP for the Product in the Partner Territory (including, reporting of adverse events/adverse drug experiences, product quality complaints and safety data relating to the EAP for the Product in the Partner Territory). Partner shall promptly notify Bioprojet with respect to any material changes or material issues that may arise in connection with any Regulatory Approvals for the EAP for the Product in the Partner Territory. Partner shall ensure that its Affiliates and Sublicensees comply with such reporting obligations; and (ii) Bioprojet shall be responsible, at its sole cost and expense, for all pharmacovigilance activities associated with the Product in the Partner Territory (other than the pharmacovigilance activities for which Partner is responsible pursuant to Section 4.4(a)(i)), including filing all reports required to be filed in order to maintain any Regulatory Approvals granted for the Product in the Partner Territory (including, reporting of adverse events/adverse drug experiences, product quality complaints and safety data relating to the Product in the Partner Territory). Bioprojet shall promptly notify Partner with respect to any material changes or material issues that may arise in connection with any Regulatory Approvals for the Product, in the Partner Territory. Bioprojet shall ensure that its Affiliates and Sublicensees comply with such reporting obligations. (b) Effective from and after the transfer of the initial NDA to Partner, Partner shall be responsible, at its sole cost and expense, for all pharmacovigilance activities associated with the Product in the Partner Territory, including filing all reports required to be filed in order to maintain any Regulatory Approvals granted for the Product in the Partner Territory (including, reporting of adverse events/adverse drug experiences, product quality complaints and safety data relating to the Product in the Partner Territory). Partner shall promptly notify Bioprojet with respect to any material changes or material issues that may arise in connection with any Regulatory Approvals for the Product, in the Partner Territory. Partner shall ensure tha...
Sample 1Sample 2
Pharmacovigilance Responsibilities. (a) Licensee shall be responsible, [***] for all pharmacovigilance activities associated with the Products in the Field in the Territory, including filing all reports required to be filed in order to maintain any Regulatory Approvals. Licensee shall ensure that its Affiliates and Sublicensees comply with such reporting obligations. Licensee shall promptly notify Licensor with respect to any material changes or material issues that may arise with respect to the Product in the Field. (b) The Parties shall endeavor to cooperate with each other and to enable each other to fulfil their respective pharmacovigilance obligations. (c) Licensee shall notify Licensor about any change on the RSI (Reference Safety Information) no later than [***] from the effective change by email to [***]. (d) If a safety signal is detected and validated, Licensee shall notify Licensor about the validated signal including any emerging safety issues (which means safety signals that could have a significant impact on the benefit-risk balance for a medicinal product and/or have implications for public health and require immediate action) no later than [***] after validation by Licensee with the supportive documents by email to [***]. (e) The receiving Party shall acknowledge receipt for each information received within [***]. (f) For avoidance of doubt, the Parties are strictly prohibited from using data disclosed pursuant to this Section 4.5 for any purpose other than fulfilling their pharmacovigilance obligations.
Sample 1
Pharmacovigilance Responsibilities. Subject to the terms of this Agreement, and within three (3) months after the Effective Date of this Agreement, BMS and Medarex (under the guidance of their respective Pharmacovigilance Departments, or equivalent thereof) shall define and finalize the responsibilities the Parties shall employ to protect patients and promote their well-being. 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 Product, as well as the Lead Agents. Such guidelines and procedures shall be in accordance with, and enable the Parties and their Affiliates to fulfill, local and international regulatory reporting obligations to government authorities. Furthermore, such agreed procedures shall be consistent with relevant International Council for Harmonisation (ICH) guidelines, except where said guidelines may conflict with existing local regulatory safety reporting requirements, in which case local reporting requirements shall prevail. Until such guidelines and procedures are set forth in an agreement between the Parties, (hereafter referred to as the “Safety Data Exchange Agreement”), the terms of subsections 3.11.1 - 3.11.4 shall apply. Following the execution of the Safety Data Exchange Agreement, subsections 3.11.1 - 3.11.4 shall have no further force or effect.
Sample 1
Pharmacovigilance Responsibilities. (a) Pursuant to its marketing authorization, in accordance with the requirements of appropriate regulatory authorities, each Party is responsible for: (i) preparing and reporting expedited and periodic safety data from all sources; (ii) obtaining follow-up information from the reporter as needed for regulatory purposes or medical understanding of the case; and (iii) responding to regulatory adverse event inquiries; where appropriate. (b) Each Party will exchange, with the other company, a confidential copy of their periodic safety updates/periodic reports at the same time that they are distributed to regulatory authorities. (c) Each Party shall notify the other promptly regarding any new or significant safety signal identified at any time. The Parties shall collaborate as needed on any future action deemed appropriate. (d) Each Party will inform the other of any regulatory inquiries involving safety issues as soon as possible. In the event of a product recall for safety reasons, or where there is potential impact on the other company, or a withdrawal, or a suspension of license, or issue involving significant changes to the labeling of any Product, this notification should be made to the other company within 24 hours of receipt of the regulatory communication. Where appropriate, the parties will collaborate in providing a response, specifically including (but not limited to) providing each other with access to data from the parties’ adverse experience databases (including the Lilly global safety database) as needed to respond to such inquiries. If no collaboration is deemed necessary, the outcome of the inquiries will still be promptly notified to the other party. (e) The Parties will each make available to the other party data from their respective adverse experience databases (including the Lilly global safety database) as needed to prepare Annual Adverse Drug Reaction (ADR) Reports and Product Safety Update/Periodic Reports (PSUR) or equivalent reports. In the event that either Party intends to dispose of such databases or portions of such databases, that Party will give the other Party prior notice and a reasonable opportunity to copy or transfer the affected data.
Sample 1

Related to Pharmacovigilance Responsibilities

  • Licensee’s Responsibilities Licensee will be responsible for any and all damage to or relocation of existing facilities. Further, Licensee shall reimburse the City for all costs of replacing or repairing any property of the City, or of others, that is damaged by or on behalf of Licensee as a result of activities under this Agreement.

  • Specific Responsibilities Without limiting the responsibilities of the Manager, the Manager will: 1. Maintain office facilities (which may be in the offices of the Manager or a corporate affiliate but shall be in such location as the Trust reasonably determines). 2. Furnish statistical and research data, clerical services and stationery and office supplies. 3. Compile data for, prepare for execution by the Fund and file all the Fund’s federal and state tax returns and required tax filings other than those required by this Agreement to be made by the Fund’s custodian and transfer agent. 4. Prepare compliance filings pursuant to state securities laws with the advice of the Trust’s counsel. 5. Prepare the Trust’s Annual and Semi-Annual Reports to Shareholders and amendments to its Registration Statements (on Form N-1A or any replacement therefor). 6. Compile data for, prepare and file timely Notices to the SEC required pursuant to Rule 24f-2 under the 1940 Act. 7. Determine the daily pricing of the portfolio securities and computation of the net asset value and the net income of Fund in accordance with the Prospectus, resolutions of the Trust’s Board of Trustees, and the procedures set forth in EXHIBIT A: NET ASSET VALUE CALCULATIONS. 8. Keep and maintain the financial accounts and records of the Fund and provide the Trust with certain reports, as needed or requested by the Fund. 9. Provide officers for the Trust as requested by the Trust’s Board of Trustees. 10. Perform fund accounting services for the Fund as set forth in EXHIBIT B: FUND ACCOUNTING FUNCTIONS. 11. Generally assist in all aspects of the operations of the Fund.

  • Licensee Responsibilities Licensee is responsible for Licensee’s Users’ compliance with this Agreement. Licensee is responsible for all of Licensee’s uses and accounts. Licensee will be responsible for maintaining the security of Licensee’s accounts, passwords and files. Licensee and Users cannot share Licensee’s accounts or passwords or allow any third party to use Licensee’s accounts or passwords. Licensee will exercise reasonable precautions to prevent unauthorized use of the Software.

  • Client’s Responsibilities (a) Client agrees to advise Consultant regarding Client's Project requirements and to provide all relevant information, surveys, data and previous reports accessible to Client which Consultant may reasonably require. (b) Client shall designate a Project Representative to whom all communications from Consultant shall be directed and who shall have limited administrative authority on behalf of Client to receive and transmit information and make decisions with respect to the Project. Said representative shall not, however, have authority to bind Client as to matters of governmental policy or fiscal policy, nor to contract for additions or obligations exceeding a value which is the lesser of $5000 or 5% of the maximum contract price. (c) Client shall examine all documents presented by Consultant, and render decisions pertaining thereto within a reasonable time. The Client's approval of any drawings, specifications, reports, documents or other materials or product furnished hereunder shall not in any way relieve Consultant of responsibility for the professional adequacy of its work. (d) Client shall perform its obligations and render decisions within a reasonable time under the circumstances presented. Based upon the nature of Client and its requirements, a period of 14 days shall be presumed reasonable for any decision not involving policy decision or significant financial impact, when all information reasonably necessary for Client to responsibly render a decision has been furnished. A period of 46 days shall be presumed reasonable for Client to act with respect to any matter involving policy or significant financial impact. The above periods of presumed reasonableness shall be extended where information reasonably required is not within the custody or control of Client but must be procured from others.

  • Joint Responsibilities The relationship between SAE ITC, the Activities and its Members shall be, and at all times, advisory only, and no party shall have the authority to enter into any contract or commitment in the name of, or on behalf of, any other party. Nothing in this Agreement shall be construed to confer upon either party the status of employee, agent, partner, joint venturer or legal representative of the other, it being intended by all parties to remain independent legal entities solely responsible for its own actions.

  • Regulatory Responsibilities 6.6.1 From and after the Closing, subject to the terms of the Transition Services Agreement and except as required by a Party to comply with applicable Law or to exercise its rights and obligations hereunder or under any other Ancillary Agreement, Purchaser shall have the sole right and responsibility for preparing, obtaining and maintaining all Regulatory Approvals necessary for the Product Business, and for conducting communications with Governmental Authorities of competent jurisdiction, for Seller Products. Without limitation of the foregoing, promptly following the Closing, Purchaser shall obtain such FDA approvals as are necessary for Purchaser’s own Product labeling and shall comply with such FDA approvals upon receipt thereof. 6.6.2 Subject to the terms of the Transition Services Agreement from and after the Closing, Seller shall support Purchaser, as may be reasonably necessary and practicable, at Purchaser’s cost and expense, in preparing, obtaining and maintaining all Regulatory Approvals for the Seller Products, including providing necessary documents or other materials required by applicable Law for Purchaser to obtain or maintain such Regulatory Approvals, in each case, in accordance with the terms and conditions of this Agreement. 6.6.3 Except to the extent otherwise provided in the Transition Services Agreement, from and after the Closing, Seller shall provide Purchaser with (i) copies of all written or electronic correspondence relating to any Seller Product received by Seller, its Affiliates, licensees, sublicensees or distributors from, or submitted by Seller, its Affiliates, licensees, sublicensees or distributors to, Regulatory Authorities; and (ii) copies of all meeting minutes and other similar summaries of all meetings, conferences and discussions held by Seller with Regulatory Authorities to the extent relating to any Seller Product, including copies of all contact reports produced by Seller and its Affiliates, licensees, sublicensees and distributors, in each case ((i) and (ii)), within ten (10) Business Days after Seller’s receipt, submission or production of the foregoing, as applicable. To the extent applicable, Seller shall provide Purchaser a draft of any written response thereto reasonably in advance (in light of the prevailing circumstances) of submitting such response to the applicable Regulatory Authorities.

  • Monitoring Responsibilities The Custodian shall furnish annually to the Fund, during the month of June, information concerning the foreign sub-custodians employed by the Custodian. Such information shall be similar in kind and scope to that furnished to the Fund in connection with the initial approval of this Contract. In addition, the Custodian will promptly inform the Fund in the event that the Custodian learns of a material adverse change in the financial condition of a foreign sub-custodian or any material loss of the assets of the Fund or in the case of any foreign sub-custodian not the subject of an exemptive order from the Securities and Exchange Commission is notified by such foreign sub-custodian that there appears to be a substantial likelihood that its shareholders' equity will decline below $200 million (U.S. dollars or the equivalent thereof) or that its shareholders' equity has declined below $200 million (in each case computed in accordance with generally accepted U.S. accounting principles).

  • Vendor Responsibilities Note: NO EXCEPTIONS OR REVISIONS WILL BE CONSIDERED IN C-M, O-S, V-W. Indemnification

  • COUNTY’S RESPONSIBILITIES A. A County program liaison will monitor the submission of all correspondence required in this Agreement, including, but not limited to: 1. Quarterly Treatment Reports; 2. Financial reports such as annual budgets, cost allocation plans, and cost reports; 3. Incident reports; 4. Outcome data; 5. Monthly XXXXX Reports 6. Other requested reports B. A County program liaison may visit Contractor during the contract term. The visits shall be for the purpose of reviewing any aspect of Contractor’s program operations. The visit may include, but is not limited to: 1. Review all pertinent participant records. 2. Conduct appropriate interviews/discussions with participants served by Contractor. 3. Review and monitor all correspondence and reports submitted by Contractor related to Contractor’s services provided under this Agreement. 4. Meet with appropriate program management and operations staff. 5. Conduct site visit(s) to Contractor’s program(s) at least once during the term of the Agreement to review all aspects of program operations. Site visit(s) may include a review of Contractor’s programmatic and fiscal documentation related to required reports on services specified in the Exhibits. a. Provide a written site review report documenting areas of compliance and any necessary corrective action(s) required. 6. A County program liaison may attend an organized activity of a selected component or selected components of Contractor’s program(s) at least once during the contract term. C. AODS will conduct periodic mandatory treatment provider meetings with representatives of all contracted service providers and appropriate staff. D. Provide ongoing technical assistance as needed. E. AODS shall act as intermediary on behalf of each contracted alcohol and drug service provider in the submission of the California Outcomes Measurement System (CalOMS) data submissions to the State of California. I. GENERAL ADMINISTRATIVE REQUIREMENTS A. Attend each of the following meetings: 1. Contractor shall attend periodic mandatory meetings; and 2. Drug and Alcohol Information System for You (DAISY) User Group meeting. 3. Other meetings as required by the County B. Contractor shall acknowledge the San Mateo County Alcohol and Other Drug Services (AODS) and/or the County of San Mateo as a funding source on newly developed promotional materials. C. Subcontracting requirements: 1. Pursuant to paragraph 12 of the body of this Agreement, Contractor may subcontract for provision of services described in this Agreement with written approval of the Director of the Human Services Agency or her designee. If Contractor subcontracts for any services under this Agreement, Contractor will guarantee that any and all subcontractors have and maintain the same level of insurance coverage required of the Contractor under this Agreement. Contractor and County will be listed as additional insured on all applicable insurance of subcontractor.

  • Reporting Responsibilities The IRA Owner agrees to provide the Custodian with information necessary for the Custodian to prepare any reports required under Code Sections 408(i), 408A(d)(3)(D), and Regulations Sections 1.408-5 and 1.408-6. The Custodian agrees to submit reports to the IRS and the IRA Owner (or Beneficiary(ies) upon the IRA Owner’s death) as prescribed by the IRS and such additional reports as the Custodian may choose to deliver. The Custodian shall furnish annual calendar-year reports concerning the status of the IRA and such information concerning required minimum distributions as is prescribed by the Commissioner of the IRS.

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