Pharmacovigilence. During the Term, each Party shall promptly inform the other Party, and provide appropriate notice to any applicable Regulatory Authorities or other Third Parties in accordance with applicable Laws, after such Party becomes aware of any serious adverse event (as defined by the ICH Harmonized Tripartite Guideline on Clinical Safety Data Management) that is directly or indirectly attributable to the use or application of the Compound or Licensed Products.
Pharmacovigilence. CRO agrees not to enter in to any clinical activity implicating pharmacovigilance obligations for the Product prior to execution of a pharmacovigilance agreement presented by Sponsor.
Pharmacovigilence. Insmed shall deliver written notice to Therapure of any complaints it receives, directly or through an Affiliate or third party, regarding or relating to ARIKACE promptly upon receipt of such complaints by Insmed’s complaint handling unit. Therapure shall cooperate with Insmed in any necessary and appropriate investigation of any such complaint. Upon request by Insmed and at Insmed’s expense, Therapure shall conduct any necessary batch record reviews or other analysis of its Manufacturing operations for ARIKACE. Unless otherwise agreed, Therapure shall complete and deliver its written analysis to Insmed as soon as reasonably practicable, giving due consideration to any potential reporting requirements imposed by Governmental or Regulatory Authorities. Insmed shall be responsible for reporting any and all complaints relating to ARIKACE to any applicable Governmental or Regulatory Authorities requiring the filing of such reports. Such reporting shall be made in compliance with all applicable Laws. Therapure shall give prompt (and in any event within [***]) written notice to Insmed of complaints it receives regarding or relating to ARIKACE and provide such information and documentation to Insmed as is necessary for Insmed to evaluate such complaints with respect to Insmed’s existing inventory and previously distributed ARIKACE. Insmed shall reimburse Therapure for the direct costs it incurs in connection with any investigation or review pursuant to this Section 17.1, unless the circumstances giving rise to the such investigation or review are attributable to the acts or omissions of Therapure.
Pharmacovigilence. KVP shall coordinate adverse event reporting with respect to Evamist with FemPharm as may be agreed from time to time in good faith between KVP and FemPharm.
Pharmacovigilence. 12.1.1 STOCOSIL shall be responsible for worldwide pharmacovigilance and will hold the Global Safety Data Sheet of the Product and Optional Product. STOCOSIL will bear the pharmacovigilance costs.
Pharmacovigilence. MPP shall cause Sublicensees to agree to cooperate with AbbVie in fulfilling any pharmacovigilance reporting responsibilities AbbVie may have under applicable laws and regulations, as specified by Abbvie and as arising out of this agreement; provided, Sublicensee must be responsible for fulfilling all pharmacovigilance activities as per the local regulations and requirements for the Licensed Products in the Territory. If MPP or any Sublicensee becomes aware of any adverse reaction relating to the Licensed Products in connection with this Agreement or a Sublicense Agreement, MPP or the relevant Sublicensee shall inform AbbVie within 24 hours of its becoming aware and cooperate with AbbVie in fulfilling AbbVie's reporting responsibilities under applicable laws and regulations.
Pharmacovigilence. During the Agreement Term, each of the Parties will notify appropriate Regulatory Authorities in accordance with applicable law, and the other Party, promptly after receipt of information with respect to any serious adverse event (as defined by the ICH Harmonized Tripartite Guideline on Clinical Safety Data Management), directly or indirectly attributable to the use or application of any Compound or Licensed Product.
Pharmacovigilence. 12.16.1 GSK shall be responsible for the timely reporting of product quality complaints, adverse events and product safety data related to Product Candidates or Products to the appropriate Regulatory Agency or other health authorities. GSK shall maintain a global adverse event database for Product Candidates and Products. GSK shall respond effectively in a timely manner to all safety issues with respect to a Product Candidate or a Product, and to all requests made by any Regulatory Authority in the Territory.
Pharmacovigilence. During the Agreement Term, each of the Parties will notify appropriate Regulatory Authorities in accordance with applicable law, and the other Party, promptly after *** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment. An unredacted version of this exhibit has been filed separately with the Commission. receipt of information with respect to any serious adverse event (as defined by the ICH Harmonized Tripartite Guideline on Clinical Safety Data Management), directly or indirectly attributable to the use or application of any Compound or Licensed Product.
Pharmacovigilence. At Forest’s expense, Mylan shall continue to perform its obligations under that certain Global Safety Database Agreement by and among Xxxxxxx, Xxxxx and Menarini International Operations Luxembourg, S.A. dated as of May 3, 2005 which is attached hereto as Exhibit B and made a part hereof in accordance with and for the period provided thereunder, provided that Forest’s expense obligations shall be limited to the reimbursement of Mylan’s actual incremental costs of performing such obligations, including out-of-pocket costs and allocations of directly related overheads (but not including general or administrative overheads). Schedule 4.4 sets forth Mylan’s current material costs of complying with its obligations under such agreement. Promptly following the date hereof, Mylan and Forest will develop and agree upon a pharmacovigilance reporting protocol providing for the reporting of adverse events by Forest to Mylan for use in compliance with the provisions of the Global Safety Database Agreement and to provide Forest with access to or timely reports from the database so maintained in a manner permitting Forest’s compliance with all applicable regulatory requirements in the Territory. Pending finalization of such protocol, each of the Parties hereto shall disclose to the other Party all safety reports and other information which they may from time to time receive or obtain whether from sources within or without the Territory with respect to any adverse experiences with respect to the Product. Specifically, all serious adverse events and reactions, whether believed due to the Product or not, will be transmitted to the other Party as promptly as possible and in any event within ten (10) calendar days of first knowledge of the event/reaction except for deaths which will be transmitted within five (5) calendar days. All aggregate reports (e.g., IND annual reports, NDA periodic reports, PSURs etc.) submitted to a Regulatory Authority will be transmitted to the other Party within five (5) calendar days of transmission to the Regulatory Authority. All questions from and responses to a health authority will be transmitted to the other Party within five (5) days of receipt/transmission. To the extent Forest develops or acquires the capacity to manage such global safety database at any time during the Term of this Agreement, upon Forest’s request Mylan will use Commercially Reasonable Efforts in cooperation with Forest to effect a prompt and smooth transition of Mylan’s...
