Exchange of Safety Information. The Parties shall, without prejudice to the provisions of Article 10 and subject to their applicable legislation:
Exchange of Safety Information. 11.1 The Parties shall keep each other informed on all reports including publications of adverse events coming to either Party’s knowledge with regard to Perifosine and/or Contract Product, regardless of the origin of such reports.
Exchange of Safety Information. The Parties shall exchange safety information as per ICH guidelines so that each party can meet their regulatory requirements. The parties agree that a detailed agreement with respect to the exchange of safety data is to be entered into separately. Sublicensor shall, at its own cost and expense, assemble, maintain, deploy and make available to Sublicensee a database on any and all information on all serious adverse events including those collected from its existing and future sublicensees, Sublicensee and Panion.
Exchange of Safety Information. If applicable, the Parties shall establish procedures for the exchange and reporting of all adverse events related to the Compound, which shall be governed by a Pharmacovigilance & Safety Exchange Agreement (the “Pharmacovigilance Agreement”). The Parties shall use Commercially Reasonable Efforts to establish such procedures and execute the mentioned Pharmacovigilance Agreement, if applicable, within […***…] from the Effective Date. Once signed, the Pharmacovigilance Agreement will be attached to this Agreement as Schedule 7.5. Each Party shall designate a qualified/appropriate person responsible for pharmacovigilance to ensure proper communication of, and adherence to, the Pharmacovigilance Agreement. Each Party shall be responsible for the collection of adverse event reports for the Compound reported to that Party in their respective development programs. Starting on Effective Date and for so long as the Pharmacovigilance Agreement is not signed all serious adverse events and reactions, whether believed due to the Compound or not, will be transmitted to the other Party as promptly as possible and in any event within […***…] of first knowledge of the event/reaction except for deaths or life-threatening events which will be transmitted within […***…]. Each Party will be responsible to prepare the aggregate reports required to fulfill regulatory requirements for their corresponding activities with the Compound or the Product (e.g., regulatory periodic reports, DSURs etc.). Each Party shall make an effort to promptly obtain any follow-up information to the initial report from the reporter. The Parties shall promptly inform each other of any safety issues in a time and manner sufficient to permit the Parties to comply with their respective legal and regulatory responsibilities.
Exchange of Safety Information. 11.1 This clause 11 applies where the Owner is the Rail Infrastructure Manager for the Private Infrastructure or has contracted an entity other than QR Network to do so.
Exchange of Safety Information. Prior to the execution of the Safety Data Exchange Agreement in accordance with Section 10.2, the Parties shall keep each other informed of all reports (including publications) of adverse events/incidents coming to either Party’s knowledge with regard to Licensed Product, regardless of the origin of such reports. The Parties shall enter into a Safety Data Exchange Agreement (the “SDEA”) within six (6) months after the execution of this Agreement to define and finalize the respective responsibilities of both Parties for the purpose of protecting patients and promoting their well-being in connection with each Party’s Exploitation of the Licensed Product, in the case of Licensor, outside the Territory and inside the Territory but outside the Field, and in the case of Licensee, within the Territory and inside the Field. These responsibilities shall include mutually acceptable guidelines and procedures for the receipt, investigation, recording, communication, and exchange (as between the Parties) of adverse event reports, pregnancy reports, and any other information concerning the safety of any Licensed Product. Such guidelines and procedures shall be in accordance with, and enable the Parties and their respective Affiliates to fulfill, local and international regulatory reporting obligations to government authorities. Furthermore, such agreed procedures shall be consistent with relevant International Council for Harmonization (ICH) guidelines, except where said guidelines may conflict with existing local regulatory safety reporting requirements, in which case local reporting requirements shall prevail. Following the execution of the SDEA, Section 10.1 shall have no further force or effect.
Exchange of Safety Information. 11.1 The Parties shall keep each other informed on all reports including publications of adverse events coming to either Party's knowledge with regard to Contract Products and/or D-63153, regardless of the origin of such reports.
Exchange of Safety Information. Between the Closing and the effectiveness of the Pharmacovigilance Agreement, each of Seller and Buyer agrees to:
Exchange of Safety Information. Each Party shall promptly advise the other Party if it becomes aware of any concerns regarding the safety of C242 when administered to humans.
Exchange of Safety Information. Following the Closing Date and continuing for so long as either Party holds an NDA for the Product and ending on the earlier of (a) the expiration or termination of the Supply Agreement and (b) the effectiveness of the Pharmacovigilance Agreement, each Party hereto agrees to notify the other Party of any information of which such Party becomes aware concerning any adverse events with respect to the Product. Such notice shall be provided in English in the form of a processed CIOMS I or MedWatch within five calendar days of such Party becoming aware of such information where such potential adverse event is serious and associated with the clinical uses, studies, investigations, tests or marketing of the Product. In the case of any other adverse event (non-serious expected or non-serious unexpected adverse event), such notice shall be provided in [***] 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 THE RULES APPLICABLE TO SUCH CONFIDENTIAL TREATMENT REQUEST. English within 10 calendar days of such Party becoming aware of such information or such adverse event is reported to a Party in connection with the clinical uses, studies, investigations, tests or marketing of such Product.
