Clinical Safety Reporting; Pharmacovigilance Sample Clauses

Clinical Safety Reporting; Pharmacovigilance. Prior to the Option Exercise Date, as between the Parties, Xencor shall be responsible for the timely reporting of all adverse drug events and safety data relating to the Compound and Products and similar matters to the appropriate Regulatory Authorities. Subsequent to the Option Exercise Date, as between the Parties, Amgen shall be responsible for the reporting of all new adverse drug events in compliance with the required timeframes in the Territory and safety data that arise or occur with respect to activities conducted by Amgen after such Option Exercise Date. Amgen shall also be responsible for the reporting of all new information related to previously reported adverse drug events by Xencor that are have not been resolved prior to the Option Exercise Date, other than such reporting required to be undertaken by Xencor under Applicable Law. In connection with the foregoing, upon request by either Party on or after the Option Exercise Date, the Parties shall promptly enter into a reasonable pharmacovigilance agreement concerning such operating procedures and related obligations to enable each Party to comply with Applicable Laws regarding adverse event and safety reporting.
Sample 1Sample 2Sample 3See All (4)
AutoNDA by SimpleDocs
Clinical Safety Reporting; Pharmacovigilance. With respect to any Adverse Drug Reaction, IND safety report or similar obligation to report to any Regulatory Authority relating to any safety issue with respect to Licensed Products in the Field, Alcon shall be responsible for and shall establish operating procedures to report to the appropriate Regulatory Authority(ies) all such matters in accordance with applicable laws, rules and regulations. Such operating procedures shall include any measures necessary for each Party to fully comply with such laws, rules and regulations. Such operating procedures and any material revisions to them shall be provided to the Coordination Committee for review and comment. The Parties agree to implement prior to the initiation of the first clinical trial for a Licensed Product in the Field, a separate agreement setting forth the responsibilities and procedures for clinical safety information exchange and reporting. In addition, the Parties agree to implement prior to the first launch of a Licensed Product in the Field, a separate agreement setting forth the pharmacovigilance responsibilities and procedures for safety information exchange and reporting. Such agreements shall include provisions requiring each Party promptly communicate to the other Party any correspondence related to the safety of Licensed Products in the Field to or from any Regulatory Authority. Such agreements shall also include coordination of reporting and correspondence related to safety matters with respect to products incorporating Development Compounds for applications outside of the Field. Without limiting the foregoing, the strategy and content of all responses to any questions from any such Regulatory Authority related to such matters received by either Party shall be subject to review and comment by the Coordination Committee (to the extent practical given the time-frames involved).
Sample 1Sample 2
Clinical Safety Reporting; Pharmacovigilance. With respect to any Adverse Drug Reaction, IND safety report or similar obligation to report to any Regulatory Authority relating to any safety issue with respect to Collaboration Products in the Field, Galderma shall be responsible for and shall establish operating procedures to report to the appropriate Regulatory Authority(ies) in the Galderma Territory and NovaBay shall be responsible for and shall establish operating procedures to report to the appropriate Regulatory Authority(ies) in the NovaBay Territory, in each case all in accordance with applicable Law and in close coordination with the other Party. Such operating procedures shall include any measures necessary for each Party to fully comply with such Laws and establish Galderma as responsible for establishing and maintaining the world-wide database for reporting for Collaboration Products in the Field. Such operating procedures and any material revisions to them shall be provided to the Coordination Committee for review and comment. The Parties agree to implement prior to the initiation of the first clinical trial for a Collaboration Product in the Field, a separate agreement setting forth the responsibilities and procedures for clinical safety information exchange and reporting. In addition, the Parties agree to implement prior to the first commercial sale of a Collaboration Product in the Field in the Galderma Territory or NovaBay Territory, a separate agreement setting forth the pharmacovigilance responsibilities and procedures for safety information exchange and reporting. Such agreements shall include provisions requiring each Party promptly communicate to the other Party any correspondence related to the safety of Collaboration Products in the Field to or from any Regulatory Authority. Such agreements shall also include coordination of reporting and correspondence related to safety matters with respect to products incorporating Multiple-Field Compounds for applications outside of the Field. Without limiting the foregoing, the strategy and content of all responses to any questions from any such Regulatory Authority related to such matters received by either Party shall be subject to review and comment by the Coordination Committee (to the extent practical given the time-frames involved).
Sample 1Sample 2
Clinical Safety Reporting; Pharmacovigilance. The Parties agree that Coroando shall be responsible for the establishment of the global safety database for the Licensed Products in the Territory and the monitoring of all clinical experiences and submission of all required reports throughout clinical Development and Commercialization of the Licensed Products in the Territory, and that Licensor shall have primary responsibility for the monitoring of all clinical experiences and submission of all required reports concerning the Licensed Products outside the Territory. In each Party’s respective territory, such Party will be obligated, as part of their monitoring of all clinical experiences, to obtain follow-up information on any incomplete safety reports generated throughout the non-clinical and clinical Development and Commercialization of the Licensed Products. The Parties hereby agree to report to each other all Adverse Events and/or Serious Adverse Events with respect to the Licensed Products (whether occurring in any clinical trial conducted with regard to the Licensed Products or in connection with the commercialization of the Licensed Products in any country), within timeframes consistent with its reporting obligations under applicable Laws and in any event, if either Party is actively conducting a clinical trial under its own IND or commercializing the Licensed Products, then the other Party shall report such events no later than three (3) business days for Serious Adverse Event, and quarterly for Adverse Events, which report shall, in each case, include the circumstances and nature of such Serious Adverse Event or Adverse Event as required for reporting under applicable Laws. In addition, to the extent requested by either Party, the other Party shall promptly provide to the requesting Party any other information or materials that the requesting Party may require to provide to any Regulatory Authority with respect to any such Adverse Event or Serious Adverse Event. All disclosures made under this Section 4.5 shall be deemed Confidential Information of the disclosing Party; provided, that, the Party receiving such disclosures may, upon written notice to the disclosing Party, report the occurrence, circumstances and nature of such Adverse Event and/or Serious Adverse Event to any Regulatory Authority solely insofar as such reporting is required to comply with applicable Laws. For purposes of this section: “Adverse Event” means any untoward medical occurrence in a human clinical trial subject or in a...
Sample 1Sample 2
Clinical Safety Reporting; Pharmacovigilance. Within ninety (90) days after the Effective Date, the Parties shall discuss in good faith and enter into a pharmacovigilance and adverse event reporting agreement setting forth the worldwide pharmacovigilance procedures for the Parties Portions herein identified by [ * ] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. with respect to the Licensed Products, and shall include customary terms and conditions governing safety data sharing, adverse events reporting and prescription events monitoring sufficient to permit Eagle, Cephalon, and their respective Affiliates and (sub)licensees to comply with their respective legal obligations, including in accordance with applicable Law inside and outside of the Territory (the “Pharmacovigilance Agreement”). The Pharmacovigilance Agreement will provide for Cephalon’s support of Eagle with respect to such pharmacovigilance matters. Eagle will be solely responsible for establishing and will establish appropriate operating and other procedures reasonably sufficient to report to the appropriate Regulatory Authority(ies) all adverse event reports, safety reports and similar matters in accordance with the Pharmacovigilance Agreement.
Sample 1
Clinical Safety Reporting; Pharmacovigilance. With respect to any Adverse Drug Reaction, IND safety report or similar obligation to report to any Regulatory
Sample 1
Clinical Safety Reporting; Pharmacovigilance. At all times subsequent to the Amgen Option Effective Date, Amgen shall be solely responsible for establishing *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. and shall establish operating and other procedures reasonably sufficient to report to the appropriate Regulatory Authority(ies) all adverse event reports, safety reports and similar matters, unless otherwise determined by the JDC in accordance with the Laws in the Territory (and CK outside the Territory). Promptly following the Amgen Option Effective Date, the safety personnel of Amgen and CK will develop and agree upon safety data exchange procedures governing the coordination of collection, investigation, reporting, and exchange of information concerning adverse events with respect to Compounds (including with respect to pregnancies), product quality and product complaints involving adverse events with respect to Compounds, sufficient to permit each Party, its Affiliates and licensees to comply with their legal obligations, including to the extent applicable, those obligations contained in FDA regulations. Each Party shall further provide the other Party any assistance reasonably requested by the other Party in connection with safety reporting and fulfilling its obligations to Regulatory Authorities with respect thereto, and the requesting Party shall reimburse the other Party [***] costs incurred in connection therewith.
Sample 1
AutoNDA by SimpleDocs
Clinical Safety Reporting; Pharmacovigilance. The Parties shall establish reasonable processes and procedures for tracking, reporting, and otherwise addressing adverse events and reactions, safety issues, IND safety reports and similar obligation that each Party may have to any Regulatory Authority or otherwise under applicable law relating to any Collaboration Product. Such operating procedures and any material revisions to them, shall be reasonably coordinated between the Parties across jurisdictions.
Sample 1
Clinical Safety Reporting; Pharmacovigilance 
Sample 1

Related to Clinical Safety Reporting; Pharmacovigilance

  • Pharmacovigilance Licensee shall maintain until the termination of this Agreement (or, as applicable, until the rights and obligations intended to survive termination of this Agreement have been fulfilled) pharmacovigilance and risk management systems, procedures and documentation needed to perform and comply with its regulatory obligations and its related obligations under this Agreement. Licensee shall ensure that it will comply with all Applicable Law regarding Licensed Product in the Territory, including, without limitation, those laws and regulations relating to risk management, drug safety and pharmacovigilance. If Licensee becomes aware of any adverse reaction relating to Licenced Product in connection with this Agreement, Licensee shall inform MPP and Pfizer within twenty-four (24) hours of its becoming aware and cooperate with Pfizer in fulfilling Pfizer’s reporting responsibilities under Applicable Law. Licensee will be responsible for fulfilling all pharmacovigilance activities pursuant to the local regulations and requirements for the Licenced Products in the Territory and provide MPP and Pfizer with a report containing information regarding all such activities. Such report shall be provided annually, on February 1 of each year, and otherwise on reasonable request by MPP or Pfizer to both MPP and Pfizer’s pharmacovigilance contact as may be designated by Pfizer from time to time. Licensee shall notify MPP and Pfizer forthwith of the receipt of an enquiry from an Agency in the Territory relating to Licensed Product that concerns any safety issue. If Licensee becomes aware of any action that may be, will be or has been taken by an Agency for a safety reason connected with Licensed Product, it shall immediately, and in any event no later than twenty-four

  • Commercialization Reports Throughout the term of this Agreement and during the Sell-Off Period, and within thirty (30) days of December 31st of each year, Company will deliver to University written reports of Company’s and Sublicensees’ efforts and plans to develop and commercialize the innovations covered by the Licensed Rights and to make and sell Licensed Products. Company will have no obligation to prepare commercialization reports in years where (a) Company delivers to University a written Sales Report with active sales, and (b) Company has fulfilled all Performance Milestones. In relation to each of the Performance Milestones each commercialization report will include sufficient information to demonstrate achievement of those Performance Milestones and will set out timeframes and plans for achieving those Performance Milestones which have not yet been met.

  • Clinical Data and Regulatory Compliance The preclinical tests and clinical trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, Registration Statement, the Pricing Disclosure Package or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with applicable laws, rules, regulations and policies of the Food and Drug Administration of the U.S. Department of Health and Human Services (the “FDA”) or any committee thereof or of any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are materially inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Pricing Disclosure Package or the Prospectus; for such studies that have been or are being conducted, the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by foreign government or drug or medical device regulatory agencies, or foreign health care facility Institutional Review Boards; and no investigational new drug application filed by or on behalf of the Company or any of its subsidiaries with the FDA has been terminated or suspended by the FDA, and neither the FDA nor any applicable foreign regulatory agency has commenced, or, to the knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay or suspend, any proposed or ongoing studies conducted or proposed to be conducted by or on behalf of the Company or any of its subsidiaries.

  • Tests and Preclinical and Clinical Trials The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder (collectively, “FFDCA”); the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the General Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, the Company is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, neither the Company nor any Subsidiary has received any notices or correspondence from the FDA or any Governmental Entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

  • Pharmacovigilance Agreement Within [***] after the Effective Date, BMS and the Company (under the guidance of their respective Pharmacovigilance Departments, or equivalent thereof) shall define and finalize the responsibilities the Parties shall employ to protect patients and promote their well-being in connection with the use of the Licensed Compound(s) until such time that all pharmacovigilance responsibilities have transferred from BMS to Company. These responsibilities shall include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between the Parties) of adverse event reports, pregnancy reports, and any other information concerning the safety of any Licensed Compound(s). Such guidelines and procedures shall be in accordance with, and enable the Parties and their 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. Until such guidelines and procedures are set forth in a written agreement between the Parties (hereafter referred to as the “Pharmacovigilance Agreement”), the Party responsible for pharmacovigilance prior to execution of this Agreement shall have sole Pharmacovigilance responsibility for the Licensed Compound(s) subject to all applicable regulations and guidelines. In the event that this Agreement is terminated, the Parties agree to implement the necessary procedures and practices to ensure that any outstanding pharmacovigilance reporting obligations are fulfilled. Certain information marked as [***] has been excluded from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

  • Clinical Data The descriptions of the results of any studies and tests conducted by or on behalf of, or sponsored by, the Company or its subsidiaries, or in which the Company has participated, that are described in the Disclosure Package and the Prospectus, or the results of which are referred to in the Disclosure Package and the Prospectus do not contain any misstatement of material fact or omit to state a material fact necessary to make such statements not misleading. The Company has no knowledge of any studies or tests not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Disclosure Package or Prospectus.

  • Adverse Event Reporting Both Parties acknowledge the obligation to comply with the Protocol and / or applicable regulations governing the collection and reporting of adverse events of which they may become aware during the course of the Clinical Trial. Both Parties agree to fulfil and ensure that their Agents fulfil regulatory requirements with respect to the reporting of adverse events.

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

  • Development Reports Beginning six months after Effective Date and ending on the date of first commercial sale of a Licensed Product in the United States, LICENSEE shall report to Cornell progress covering LICENSEE's (and Affiliate's and Sublicensee's) activities and efforts in the development of rights granted to LICENSEE under this Agreement for the preceding six months. The report shall include, but not be limited to, activities and efforts to develop and test all Licensed Products and obtain governmental approvals necessary for marketing the same. Such semi-annual reports shall be due within sixty days (60) of the reporting period and shall use the form as provided herein as Appendix C.

Time is Money Join Law Insider Premium to draft better contracts faster.