Quality Agreement and Pharmacovigilance Agreement Sample Clauses

Quality Agreement and Pharmacovigilance Agreement. Within (60) days of the Effective Date, the parties will enter into a mutually acceptable Supplier Quality Agreement, attached hereto as Exhibit C and the Pharmacovigilance Agreement, attached hereto as Exhibit D. In the event of any conflict or inconsistency between the provisions of this Agreement and the provisions of any quality and pharmacovigilance agreement, the provisions of this Agreement shall prevail in every case.
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Quality Agreement and Pharmacovigilance Agreement. Following the Closing Date, the Parties shall enter into a Pharmacovigilance Agreement and a Quality Agreement on terms mutually agreeable and in all circumstances on terms generally applicable to the nature of the transactions contemplated therein and in this Agreement.
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Quality Agreement and Pharmacovigilance Agreement. In addition to the execution of the Supply Agreement, the Parties will enter into a Quality Agreement and a Pharmacovigilance Agreement incorporating terms required in the License Agreement and such other terms appropriate for manufacture of Bulk Tablets for commercial distribution (including physician samples) and Clinical Supplies.
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Quality Agreement and Pharmacovigilance Agreement. (a) The Parties have entered into a Quality Agreement, the most recent version dated [**], which shall remain in effect. Any changes requested by PTC shall follow the process set forth in the Quality Agreement. ​ (b) Pharmacovigilance. The Parties agree that PTC shall have primary responsibility for the monitoring of all filing of all required reports concerning the PTC Suspension Product in the Territory throughout its development and commercialization in the Territory. Faes its Affiliates or its Third Party partners shall have primary responsibility for the monitoring of all filing of all required reports concerning the Faes Product in the countries, territories or jurisdictions in which Faes (either directly or indirectly) or its Affiliates or Third Party partners commercialize with respect to, the Faes Product. Specific details regarding the management of information adverse events related to the PTC Suspension Product in the Territory and delineated in the Pharmacovigilance Agreement by the Parties remains in effect, provided, however, that in any event each Party agrees to provide the other Party with such information regarding adverse events with respect to the PTC Suspension Product or the Faes Product, as the case may be, within such time frames as are required by applicable Laws. ​ ​
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Quality Agreement and Pharmacovigilance Agreement. (a) Within [**] Business Days after the Effective Date, the Parties shall do their best efforts to enter into the Quality Agreement. Marathon shall use its best efforts to prepare and circulate the first version of this Quality Agreement (in a reasonable and customary format) within [**] Business Days after the Effective Date. (b) The Parties agree that Marathon shall have primary responsibility for the monitoring of all clinical experiences and filing of all required reports concerning the Marathon Suspension Product in the Territory throughout its development and commercialization in the Territory. Faes (either itself or through a clinical research organization with whom it has contracted), its Affiliates or its Third Party partners shall have primary responsibility for the monitoring of all clinical experiences and filing of all required reports concerning the Faes Product in the countries, territories or jurisdictions in which Faes (either directly or indirectly) or its Affiliates or Third Party partners commercialize, or conduct clinical or other activity with respect to, the Faes Product. The Parties shall cooperate to develop methods and/or procedures for sharing information relating to such clinical experiences in accordance with safety reporting requirements of the respective applicable Governmental Entities and all applicable Laws. Specific details regarding the management of information adverse events related to the clinical development and use of the Marathon Suspension Product in the Territory will be delineated in the Pharmacovigilance Agreement to be entered into by the Parties within [**] Business Days after the Effective Date, provided, however, that in any event each Party agrees to provide the other Party with such information regarding adverse events with respect to the Marathon Suspension Product or the Faes Product, as the case may be, within such time frames as are required by applicable Laws.
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Related to Quality Agreement and Pharmacovigilance Agreement

  • 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.

  • 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

  • Collaboration Agreement The Collaboration Agreement shall not have been terminated in accordance with its terms and shall be in full force and effect.

  • Supply Agreement Seller and Buyer, or their Affiliates, shall have executed the Supply Agreement.

  • Supply Agreements For a period of three years from the consummation of the IPO, Odetics shall not unilaterally terminate or assign its guarantee obligation with respect to any supply agreement pursuant to which it has guaranteed the performance by ATL of ATL's obligations, unless such suppliers have consented to the termination or assignment of such guarantee.

  • Development Agreement As soon as reasonably practicable following the ISO’s selection of a transmission Generator Deactivation Solution, the ISO shall tender to the Developer that proposed the selected transmission Generator Deactivation Solution a draft Development Agreement, with draft appendices completed by the ISO to the extent practicable, for review and completion by the Developer. The draft Development Agreement shall be in the form of the ISO’s Commission-approved Development Agreement for its reliability planning process, which is in Appendix C in Section 31.7 of Attachment Y of the ISO OATT, as amended by the ISO to reflect the Generator Deactivation Process. The ISO and the Developer shall finalize the Development Agreement and appendices as soon as reasonably practicable after the ISO’s tendering of the draft Development Agreement. For purposes of finalizing the Development Agreement, the ISO and Developer shall develop the description and dates for the milestones necessary to develop and construct the selected project by the required in-service date identified in the Generator Deactivation Assessment, including the milestones for obtaining all necessary authorizations. Any milestone that requires action by a Connecting Transmission Owner or Affected System Operator identified pursuant to Attachment P of the ISO OATT to complete must be included as an Advisory Milestone, as that term is defined in the Development Agreement. If the ISO or the Developer determines that negotiations are at an impasse, the ISO may file the Development Agreement in unexecuted form with the Commission on its own, or following the Developer’s request in writing that the agreement be filed unexecuted. If the Development Agreement is executed by both parties, the ISO shall file the agreement with the Commission for its acceptance within ten (10) Business Days after the execution of the Development Agreement by both parties. If the Developer requests that the Development Agreement be filed unexecuted, the ISO shall file the agreement at the Commission within ten (10) Business Days of receipt of the request from the Developer. The ISO will draft, to the extent practicable, the portions of the Development Agreement and appendices that are in dispute and will provide an explanation to the Commission of any matters as to which the parties disagree. The Developer will provide in a separate filing any comments that it has on the unexecuted agreement, including any alternative positions it may have with respect to the disputed provisions. Upon the ISO’s and the Developer’s execution of the Development Agreement or the ISO’s filing of an unexecuted Development Agreement with the Commission, the ISO and the Developer shall perform their respective obligations in accordance with the terms of the Development Agreement that are not in dispute, subject to modification by the Commission. The Connecting Transmission Owner(s) and Affected System Operator(s) that are identified in Attachment P of the ISO OATT in connection with the selected transmission Generator Deactivation Solution shall act in good faith in timely performing their obligations that are required for the Developer to satisfy its obligations under the Development Agreement.

  • Manufacturing and Supply (a) Depomed shall supply Product for use in conducting Depomed’s development activities for Product in the Field and in the Territory as set forth in Exhibit D. (b) During the four-year period beginning on the Effective Date (the “Supply Period”), Depomed shall supply and package (or have supplied and packaged) Product pursuant to this Section 4.8. Depomed will use commercially reasonable efforts to enter into a long-term Product supply agreement with [***] days after the Effective Date (the “Depomed Supply Agreement”) that will be freely assignable to Solvay or its Affiliates, successors or assigns at any time. In addition, Depomed and Solvay will negotiate and enter into a Product supply agreement with business terms substantially similar to the Depomed Supply Agreement concurrently with the execution and delivery by Depomed and [***] of the Depomed Supply Agreement (the “Solvay Supply Agreement”, and, together with the Depomed Supply Agreement, the “Supply Agreements”). The Supply Agreements will, together, contain the following provisions (among others mutually agreeable to the Parties): (i) Under the Solvay Supply Agreement, Depomed will agree to supply Solvay with its requirements of finished, packaged Product during the Supply Period; (ii) All manufacturing and records will be performed and maintained in accordance with specifications, cGMP and Applicable Law; (iii) Depomed will provide reasonable assistance to Solvay in the event Solvay wishes to qualify a backup Product manufacturer; (iv) Depomed shall [***]; (v) Solvay will pay Depomed the following amounts in connection with all activities performed by or on behalf of Depomed associated with Product manufacture and supply (other than activities specified on Exhibit D) (A) [***]% of Depomed’s out-of-pocket costs incurred in connection with such manufacture and supply of Product to Solvay, and (B) a labor charge equal to the FTE Charges for all Depomed employees allocated to the manufacture and supply of Product to Solvay, not to exceed FTE Charges for an aggregate of [***] during any given calendar quarter (and Depomed shall provide to Solvay periodic reports detailing the FTE Charges for which Solvay must pay Depomed hereunder);

  • License Agreement The Trust shall have the non-exclusive right to use the name "Invesco" to designate any current or future series of shares only so long as Invesco Advisers, Inc. serves as investment manager or adviser to the Trust with respect to such series of shares.

  • Cooperation Agreement If a Cooperating Institution is appointed, the Fund shall enter into a Cooperation Agreement with the Cooperating Institution setting forth the terms and conditions of its appointment.

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