Notice of Pharmaceutical Side-Effects. During the term of this Agreement, the parties shall keep each other promptly and fully informed and will promptly notify appropriate authorities in accordance with applicable law, 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 Compounds, a Development Candidate, Bulk Drug Substance, a Drug Product Candidate, a Drug Product, and any other product for which royalties are payable under this Agreement.
Notice of Pharmaceutical Side-Effects. During the term of this Agreement, the parties shall keep each other and the JSC promptly and fully informed and will promptly notify appropriate authorities in accordance with applicable law, 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 a Compound.
Notice of Pharmaceutical Side-Effects. During the term of this Agreement, the Parties shall keep each other promptly and fully informed and will promptly notify appropriate authorities in accordance with applicable law, 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 P2(Y)2 Product, and any other product for which royalties are payable under this Agreement. PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT; [*] DENOTES OMISSIONS. Agreed and acknowledged as of the Effective Date. PREDIX PHARMACEUTICALS HOLDINGS, INC. By: /s/ XXXXXXX X. XXXXXXXX, MD --------------------------------- Title: President and CEO CYSTIC FIBROSIS FOUNDATION THERAPEUTICS INCORPORATED By: /s/ XXXXXX X. XXXXX ----------------------- Title: President and CEO PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT; [*] DENOTES OMISSIONS. EXHIBIT 2.4 CFTR PROGRAM WORK PLAN [ * * * * * * * * CFTR Program Work Plan contains confidential material and has been omitted in its entirety. * * * * * * * *] PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT; [*] DENOTES OMISSIONS.
Notice of Pharmaceutical Side-Effects. During the term of this Agreement, each of the parties will notify appropriate 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 a Development Candidate, Bulk Drug Substance, a Drug Product Candidate or a Drug Product.
Notice of Pharmaceutical Side-Effects. During the term of this Development License and Commercialization Agreement, Cell Genesys and Novartis will notify appropriate authorities in accordance with applicable Law, and concurrently, promptly after receipt of information with respect to any serious adverse reaction, as defined by the World Health Organization or applicable regulatory authority, directly or indirectly attributable to the use or application of the Option Product.
Notice of Pharmaceutical Side-Effects. The parties shall, during the term of this Agreement, keep each other promptly and fully informed of all of their pharmacological, toxicological and clinical trials, investigations and findings relating to the Bulk Drug Substance, Drug Product Candidates or Drug Products. Each of the parties will notify appropriate authorities in accordance with applicable law, and the other party, promptly after receipt of information with respect to any serious adverse reaction, as defined by the World Health Organization, directly or indirectly attributable to the use or application of Bulk Drug Substance, a Drug Product Candidate or a Drug Product. In such a case, the parties shall meet as soon as possible to define, according to the local regulations in the concerned country, appropriate procedures and actions to address such difficulty. Each party also shall forward to the other party on a regular basis information on adverse reactions and any material difficulty associated with the clinical use, studies, investigations, tests and prescriptions of Drug Product Candidates and Drug Products. The parties will inform each other without delay of any other governmental action which may affect the situation of Bulk Drug Substance, Drug Product Candidates or Drug Products and to furnish each other copies of any relevant documents relating thereto.
Notice of Pharmaceutical Side-Effects. The Parties shall keep each other promptly and fully informed of (a) any serious adverse event(s) (SAEs) (as defined by the International Conference of Harmonisation (ICH) guideline, “Clinical Safety Data Management: Definitions and Standards for expedited reporting E2A” dated 27 October 1994); (b) any follow-up information on an SAE; or (c) any findings from tests in laboratory animals that suggest a significant risk for human subjects including reports of mutagenicity, teratogenicity or carcinogenicity; that occur (i) during the Research Project, (ii) during any further research conducted with respect to the Product after the Research Termination Date, (iii) during clinical trials of the Product or (iv) after the First Commercial Sale of the Product. The Parties shall inform each other in writing within a reasonable period of time, not to exceed thirty (30) days, following receipt of such information and will promptly notify the appropriate authorities in accordance with Applicable Law.
Notice of Pharmaceutical Side-Effects. (i) Marinus and Company will enter into a pharmacovigilance agreement pursuant to which each Party will provide to each other the information necessary to monitor the safety of Licensed Products and to meet in a timely manner, for all countries where either Party has responsibility for the Licensed Products, all regulatory requirements for reporting adverse reactions and adverse events. Prior to the enrollment of the first subject in the first Company Clinical Study in the Territory, the Parties will enter into a pharmacovigilance agreement and quality agreement under usual and customary industry terms. In the event that Company at any time discontinues development of a Licensed Product in the Territory, to the extent permitted under applicable law, Company shall promptly provide to Marinus a copy of all Company Development Data related to that Licensed Product. In order to facilitate data exchange, the Parties will enter into a data agreement within [***] after the Effective Date.
Notice of Pharmaceutical Side-Effects
