Exchange of Safety Information. The Parties shall, without prejudice to the provisions of Article 10 and subject to their applicable legislation:
(a) provide each other, on request and in a timely manner, information available to their technical agents related to accidents, serious incidents or occurrences in relation to civil aeronautical products, services or activities covered by the Annexes to this Agreement; and
(b) exchange other safety information as the technical agents may decide.
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 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.
11.2 Each Party will report all serious adverse events with a reasonable suspicion of causal relationship (suspected adverse drug reactions) occurring in clinical trials under the use of the Contract Products to the other Party within ten (10) business days after they come to the attention of that Party. In the event of fatal or life-threatening situations related to the Contract Products, adverse events will be reported to the other Party within five (5) business days after they come to the attention of that Party. Details of an exchange of safety information will be agreed separately between the Parties after the Effective Date, which agreement should adhere to the standards required by the appropriate regulatory agencies.
11.3 Each Party is responsible for submitting its own Periodic Safety Update Reports in accordance with the applicable guidelines including the "Notice to Marketing Authorization Holders: Pharmacovigilance Guidelines" and the ICH E2C Guidelines "Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs" and will provide a copy of each such Periodic Safety Update Report to the other Party. When data received from the other Party might contribute meaningfully to the safety analysis and influence any proposed or effected changes in the reporting marketing authorization holder's product information, these data should be included, with source indicated and discussed in the Periodic Safety Update Reports.
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.
11.2 Each Party will report all serious adverse events with a reasonable suspicion of causal relationship (suspected adverse drug reactions) occurring in clinical trials under the use of the Contract Product to the other Party within five (5) days after they come to the attention of that Party. In the event of fatal or life-threatening situations, adverse events will be reported to the other Party within twenty four (24) hours after they come to the attention of that Party by facsimile or email message or by telephone.
11.3 Each Party is responsible for submitting its own Periodic Safety Update Reports in accordance with the applicable guidelines including the “Notice to Marketing Authorization Holders: Pharmacovigilance Guidelines” and the ICH E2C Guidelines “Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs” and will provide a copy of each such Periodic Safety Update Report to the other Party. When data received from the other Party might contribute meaningfully to the safety analysis and influence any proposed or effected changes in the reporting marketing authorization holder’s product information, these data should be included, with source indicated and discussed in the Periodic Safety Update Reports.
Exchange of Safety Information. Between the Closing and the effectiveness of the Pharmacovigilance Agreement, each of Seller and Buyer agrees to:
(a) promptly exchange all relevant information in its possession that relates to the safety of the Product or the Authorized Generic Product;
(b) promptly exchange all significant medical and technical inquiries received in relation to the Product or the Authorized Generic Product, in each case both inside and outside the Territory; and
(c) use reasonable efforts to remove from any of the information exchanged pursuant to Section 5.7.2(a) or Section 5.7.2(b), any personal information that is not legally required to be recorded for drug safety purposes.
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 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.
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. 12.1 Senetek will be responsible for co-ordinating and managing global pharmacovigilance in respect of the Product and the Delivery System.
12.2 Each Party will keep the other Party informed in relation to all reports including, but not limited to, publications of adverse events coming to that Party’s knowledge with regard to safety of the Product and/or the Delivery System, regardless of the origin of such reports.
12.3 Each Party will report to the other all and any Serious Adverse Events in respect of the Product and/or the Delivery System, whether in relation to clinical trials or otherwise, within three (3) days of such event coming to that Party’s knowledge or attention.
12.4 Senetek will procure that each of its licensees and sub-licensees from time to time reports to Plethora all and any Serious Adverse Events in respect of the Product and/or the Delivery System, whether in relation to clinical trials or otherwise, within three (3) days of such event coming to that licensee’s or sub-licensee’s knowledge or attention. Senetek will notify Plethora within fourteen (14) days following the appointment of each licensee or sub-licensee from time to time and will provide contact details of the responsible person (from time to time) for pharmacovigilance within such licensee or sub-licensee. Thereafter Plethora will report to the said responsible person all and any Serious Adverse Events in respect of the Product and/or the Delivery System, whether in relation to clinical trials or otherwise, within three (3) days of such event coming to Plethora’s knowledge or attention.
12.5 Each Party will submit, and Senetek will procure that its other licensees and sub-licensees submit, appropriate Periodic Safety Update Reports in respect of each country or territory in which it holds a marketing authorisation or it is conducting clinical trials in accordance with the applicable guidelines, including but not limited to the “Notice to Marketing Authorization Holders: Pharmacovigilance Guidelines”, the ICH E2C Guidelines “Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs” and the relevant FDA guidelines (all as the same may be updated, revised or reissued from time to time) and will provide a copy of each such Periodic Safety Update Report to the other Party and all other Senetek licensees or sub-licensees.
