Notice of Pharmaceutical Side-Effects Sample Clauses

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.
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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.
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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.
Sample 1
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.
Sample 1
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.
Sample 1
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.
Sample 1
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.
Sample 1
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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.
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Notice of Pharmaceutical Side-Effects 
Sample 1

Related to Notice of Pharmaceutical Side-Effects

  • Incident Event and Communications Management a. Incident Management/Notification of Breach - Transfer Agent shall develop, implement and maintain an incident response plan that specifies actions to be taken when Transfer Agent or one of its subcontractors suspects or detects that a party has gained material unauthorized access to Fund Data or systems or applications containing any Fund Data (the “Response Plan”). Such Response Plan shall include the following:

  • Notice of Material Events Promptly upon becoming aware thereof, notice of any other event or circumstances that, in the reasonable judgment of the Borrower, is likely to have a Material Adverse Effect; and

  • Notice of Material Events and Change of Address Borrower will promptly notify each Lender in writing, stating that such notice is being given pursuant to this Agreement, of:

  • Communications Relating to Fund Portfolio Securities The Custodian shall transmit promptly to each Fund all written information (including, without limitation, pendency of calls and maturities of Securities and expirations of rights in connection therewith and notices of exercise of put and call options written by the Fund and the maturity of futures contracts purchased or sold by the Fund) received by the Custodian from issuers of Securities being held for the Fund. With respect to tender or exchange offers, the Custodian shall transmit promptly to each Fund all written information received by the Custodian from issuers of the Securities whose tender or exchange is sought and from the party (or its agents) making the tender or exchange offer. If a Fund desires to take action with respect to any tender offer, exchange offer or any other similar transaction, the Fund shall notify the Custodian at least three Business Days prior to the date of which the Custodian is to take such action.

  • Notice of Material Event The Seller shall promptly inform the Purchaser in writing of the occurrence of any of the following, in each case setting forth the details thereof and what action, if any, the Seller proposes to take with respect thereto:

  • Communications Relating to Portfolio Securities Subject to the provisions of Section 2.3, the Custodian shall transmit promptly to the Fund for each Portfolio all written information (including, without limitation, pendency of calls and maturities of domestic securities and expirations of rights in connection therewith and notices of exercise of call and put options written by the Fund on behalf of the Portfolio and the maturity of futures contracts purchased or sold by the Portfolio) received by the Custodian from issuers of the securities being held for the Portfolio. With respect to tender or exchange offers, the Custodian shall transmit promptly to the Portfolio all written information received by the Custodian from issuers of the securities whose tender or exchange is sought and from the party (or his agents) making the tender or exchange offer. If the Portfolio desires to take action with respect to any tender offer, exchange offer or any other similar transaction, the Portfolio shall notify the Custodian at least three business days prior to the date on which the Custodian is to take such action.

  • Notice of Change of Control Each occasion that any Change of Control shall occur and such notice shall set forth in reasonable detail the particulars of each such occasion.

  • Notice of Material Developments Each Party shall give prompt written notice to the other Parties of: (a) any material variances in any of its representations or warranties contained in Articles 2 or 3 above, as the case may be (the Disclosure Schedule); (b) any breach of any covenant or agreement hereunder by such Party; and (c) any other material development which adversely affects the ability of such Party to consummate the transactions contemplated by this Agreement.

  • Notice of Corporate Events If the Company (i) declares a dividend or any other distribution of cash, securities or other property in respect of its Common Stock, including without limitation any granting of rights or warrants to subscribe for or purchase any capital stock of the Company or any Subsidiary, (ii) authorizes or approves, enters into any agreement contemplating or solicits stockholder approval for any Fundamental Transaction or (iii) authorizes the voluntary dissolution, liquidation or winding up of the affairs of the Company, then the Company shall deliver to the Holder a notice describing the material terms and conditions of such transaction, at least 20 calendar days prior to the applicable record or effective date on which a Person would need to hold Common Stock in order to participate in or vote with respect to such transaction, and the Company will take all steps reasonably necessary in order to insure that the Holder is given the practical opportunity to exercise this Warrant prior to such time so as to participate in or vote with respect to such transaction; provided, however, that the failure to deliver such notice or any defect therein shall not affect the validity of the corporate action required to be described in such notice.

  • Notice of Suits, Adverse Events Furnish Agent with prompt notice of (i) any lapse or other termination of any Consent issued to any Borrower by any Governmental Body or any other Person that is material to the operation of any Borrower's business, (ii) any refusal by any Governmental Body or any other Person to renew or extend any such Consent; and (iii) copies of any periodic or special reports filed by any Borrower with any Governmental Body or Person, if such reports indicate any material change in the business, operations, affairs or condition of any Borrower, or if copies thereof are requested by Lender, and (iv) copies of any material notices and other communications from any Governmental Body or Person which specifically relate to any Borrower.

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