Common use of Adverse Experiences Clause in Contracts

Adverse Experiences. (a) The Parties shall use their established operating procedures to report Adverse Experiences to the FDA in accordance with applicable laws. Such operating procedures shall include any measures necessary for each Party to fully comply with such laws as apply to such Party. In any event, each Party shall notify the other Party within [*] of any Serious Adverse Experience (as set forth in 21 CFR 314.80). The agreed procedures will be reviewed jointly on a regular basis or when there is a change in regulations governing Adverse Experience reporting. Valera shall be responsible for the timely filing with the FDA of all Adverse Experience reports, provided, that nothing herein shall be construed as restricting Indevus’ ability to take action that it deems, based upon the advice of counsel, to be required by applicable law. Valera shall promptly provide to Indevus copies of all such reports, analyses, summaries and all submissions to the FDA or other governmental agency. (b) Valera’s central safety department will use its existing toll-free phone number for patients, physicians and others to report Adverse Experiences. The costs of such reporting and of all services provided in connection with Adverse Experiences hereunder shall be borne by Valera. Valera will timely collect information about the Adverse Experiences, initiate and conduct reasonably required investigations, determine if physical or other testing of Product appears to be reasonably required, determine the nature of the Adverse Experience based on data and reports it has obtained, and issue any reports, analyses, or summaries of its activities as may be required by applicable laws, including, without limitation, preparing and filing with the FDA on a timely basis such reports as are necessary and appropriate. Copies of all such reports, including reports filed by Valera with the FDA, will be promptly provided to Indevus.

Adverse Experiences. (a) 10.1 The Parties Development Committee shall use their established establish operating procedures to report Adverse Experiences to the FDA in accordance with applicable lawsLaws; provided that, subject to Section 4.2(a), prior to the NDA Transfer Date, Indevus shall be responsible for the timely filing with the FDA of all Adverse Experience reports in the United States and after the NDA Transfer Date, Esprit shall be responsible for the timely filing with the FDA of all Adverse Experience reports in the United States. Such operating procedures shall provide for the exchange of safety information between the Parties sufficient to enable each Party to comply with its legal obligations to report to the FDA, include any measures necessary for each Party to fully comply with such laws as apply Laws applicable to such Party. In any event, each Each Party shall notify promptly provide the other Party within [*] with copies of all such reports, analyses, summaries and all submissions to the FDA or any Serious other governmental agency. The Adverse Experience (as procedures utilized in the preparation and filing of such reports will incorporate the provisions set forth in 21 CFR 314.80)Section 10.2. The Parties agree to implement, or update any pharmacovigilance agreement in effect as of the Effective Date between the Parties, as applicable, concerning responsibilities and case exchange. The agreed procedures will be reviewed jointly on a regular basis or when there is a change in regulations governing Adverse Experience reporting. Valera shall be responsible for the timely filing with the FDA of all Adverse Experience reports, provided, that nothing herein shall be construed as restricting Indevus’ ability to take action that it deems, based upon the advice of counsel, to be required by applicable law. Valera shall promptly provide to Indevus copies of all such reports, analyses, summaries and all submissions to the FDA or other governmental agency. (b) Valera10.2 Esprit’s central safety department will use its existing has established and shall continue to maintain a toll-free phone number for patients, physicians and others to report Adverse Experiences. The costs of such reporting and of all services provided by any Third Party contractor in connection with Adverse Experiences hereunder shall be borne by ValeraEsprit. Valera As of the Effective Date, the Parties anticipate that Esprit or a Third Party contractor will timely collect reasonable information about the Adverse Experiences, initiate and conduct reasonably required investigations, determine interact with Indevus if physical or other testing of a Product appears to be reasonably required, determine the nature of the Adverse Experience based on data and reports it has obtained, and issue any reports, analyses, analyses or summaries of its activities as may be required by applicable lawsLaw, including, without limitationprior to the NDA Transfer Date, preparing and filing with the FDA providing to Indevus on a timely basis such reports as reports, which, in form and substance, are necessary and appropriateappropriate for Indevus to file such periodic reports on a timely basis with the FDA. Copies of all such reports, including reports filed by Valera Indevus with the FDA, will be promptly provided to Esprit. 10.3 All safety related reports and correspondence shall be addressed to, for Esprit, ▇▇▇▇▇▇ ▇▇▇▇▇▇▇; or to such other safety representative as may be designated by Esprit., and for Indevus: Senior Vice President, Clinical Development and Medical Affairs, Indevus Pharmaceuticals, Inc., ▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇ (facsimile number ▇▇▇-▇▇▇-▇▇▇▇; telephone number ▇▇▇-▇▇▇-▇▇▇▇), or such other safety representative as may be designated by Esprit for Esprit or by Indevus for Indevus. 10.4 Notwithstanding anything in this Article 10 to the contrary, prior to the NDA Transfer Date, Indevus shall have the right, at its own cost and expense, to conduct any investigations required under Law(s), and, subject to Section 4.2, to communicate with the FDA regarding the results of those investigations, regarding Products and Product quality; provided, however, that upon Indevus’ request, Esprit shall provide reasonable assistance and cooperation in connection with any such investigations at Indevus’ cost and expense.

Adverse Experiences. (a) 10.1 The Parties Development Committee shall use their established establish operating procedures to report Adverse Experiences to the FDA in accordance with applicable lawsLaws. Such operating procedures shall include any measures necessary for each Party to fully comply with such laws Laws as apply to such Party. The Parties agree to implement, no later than thirty (30) days prior to the Launch Date, a separate agreement concerning responsibilities and case exchange. In any event, each Party shall notify the other Party within [*] twenty-four (24) hours of any Serious Adverse Experience (as set forth in 21 CFR 314.80)Experience. The agreed procedures will be reviewed jointly on a regular basis or when there is a change in regulations governing Adverse Experience reporting. Valera Indevus shall be responsible for the timely filing with the FDA of all Adverse Experience reports, provided, that nothing herein shall be construed as restricting Indevus’ ability to take action that it deems, based upon . The Adverse Experience procedures utilized in the advice preparation and filing of counsel, to be required by applicable lawsuch reports will incorporate the provisions set forth in Section 10.2. Valera Indevus shall promptly provide to Indevus copies of all such reports, analyses, summaries and all submissions to the FDA or other governmental agencyagency to Odyssey. (b) Valera10.2 Odyssey’s central safety department will use its existing shall establish and maintain a toll-free phone number for patients, physicians and others to report Adverse ExperiencesExperiences to a Third Party contractor. The costs of such reporting and of all services provided by such Third Party contractor in connection with Adverse Experiences hereunder shall be borne by ValeraOdyssey. Valera As of the Effective Date, the Parties anticipate that such Third Party contractor will timely collect reasonable information about the Adverse Experiences, initiate and conduct reasonably required investigations, determine interact with Indevus if physical or other testing of Product appears to be reasonably required, determine the nature of the Adverse Experience based on data and reports it has obtained, and issue any reports, analyses, or summaries of its activities as may be required by applicable lawsLaws and Indevus, including, without limitation, preparing and filing with the FDA providing to Indevus on a timely basis such reports as which, in form and substance, are necessary and appropriateappropriate for Indevus to file such periodic reports on a timely basis with the FDA. Copies of all such reports, including reports filed by Valera Indevus with the FDA, will be promptly provided to Odyssey. 10.3 All safety related reports and correspondence shall be addressed to, for Odyssey: Safety Director, Odyssey Pharmaceuticals, Inc. (fax number ▇▇▇-▇▇▇-▇▇▇▇; telephone number ▇▇▇-▇▇▇-▇▇▇▇), and for Indevus: Executive Vice President, Research and Development, Indevus Pharmaceuticals, Inc., ▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇ (facsimile number ▇▇▇-▇▇▇-▇▇▇▇; telephone number ▇▇▇-▇▇▇-▇▇▇▇), or such other safety representative as may be designated by Odyssey for Odyssey or by Indevus for Indevus. 10.4 A representative of each Party shall be entitled to attend in person or by telephone conference, and to receive on a timely basis any written minutes of, any internal safety review meetings relating to Product held by the other Party or by the other Party’s Affiliate. Each Party shall provide the other Party with reasonable advance notice of the date, time and location of such meetings. 10.5 In the event Odyssey shall desire to appoint a Third Party contractor to collect and report Adverse Experiences, Odyssey shall notify Indevus of such contractor in writing and Indevus shall have the right to review and consent to such contractor. The Parties shall have the right to audit any such Third Party Contractor. 10.6 Notwithstanding anything in this Article 10 to the contrary, Indevus shall have the right to conduct any investigations required under Law(s), and to communicate with the FDA regarding the results of those investigations, regarding Product and Product quality; provided, however, that upon Indevus’s request, Odyssey shall provide reasonable assistance and cooperation in connection with any such investigations.

Adverse Experiences. (a) 10.1 The Parties Development Committee shall use their established establish operating procedures to report Adverse Experiences to the FDA in accordance with applicable lawsLaws; provided that, subject to Section 4.2(a), prior to the NDA Transfer Date, Indevus shall be responsible for the timely filing with the FDA of all Adverse Experience reports in the United States and after the NDA Transfer Date, Esprit shall be responsible for the timely filing with the FDA of all Adverse Experience reports in the United States. Such operating procedures shall provide for the exchange of safety information between the Parties sufficient to enable each Party to comply with its legal obligations to report to the FDA, include any measures necessary for each Party to fully comply with such laws as apply Laws applicable to such Party. In any event, each Each Party shall notify promptly provide the other Party within [*] with copies of all such reports, analyses, summaries and all submissions to the FDA or any Serious other governmental agency. The Adverse Experience (as procedures utilized in the preparation and filing of such reports will incorporate the provisions set forth in 21 CFR 314.80)Section 10.2. The Parties agree to implement, or update any pharmacovigilance agreement in effect as of the Effective Date between the Parties, as applicable, concerning responsibilities and case exchange. The agreed procedures will be reviewed jointly on a regular basis or when there is a change in regulations governing Adverse Experience reporting. Valera shall be responsible for the timely filing with the FDA of all Adverse Experience reports, provided, that nothing herein shall be construed as restricting Indevus’ ability to take action that it deems, based upon the advice of counsel, to be required by applicable law. Valera shall promptly provide to Indevus copies of all such reports, analyses, summaries and all submissions to the FDA or other governmental agency. (b) Valera10.2 Esprit’s central safety department will use its existing has established and shall continue to maintain a toll-free phone number for patients, physicians and others to report Adverse Experiences. The costs of such reporting and of all services provided by any Third Party contractor in connection with Adverse Experiences hereunder shall be borne by ValeraEsprit. Valera As of the Effective Date, the Parties anticipate that Esprit or a Third Party contractor will timely collect reasonable information about the Adverse Experiences, initiate and conduct reasonably required investigations, determine interact with Indevus if physical or other testing of a Product appears to be reasonably required, determine the nature of the Adverse Experience based on data and reports it has obtained, and issue any reports, analyses, analyses or summaries of its activities as may be required by applicable lawsLaw, including, without limitationprior to the NDA Transfer Date, preparing and filing with the FDA providing to Indevus on a timely basis such reports as reports, which, in form and substance, are necessary and appropriateappropriate for Indevus to file such periodic reports on a timely basis with the FDA. Copies of all such reports, including reports filed by Valera Indevus with the FDA, will be promptly provided to Esprit. 10.3 All safety related reports and correspondence shall be addressed to, for Esprit, S▇▇▇▇▇ ▇▇▇▇▇▇▇; or to such other safety representative as may be designated by Esprit., and for Indevus.: Senior Vice President, Clinical Development and Medical Affairs, Indevus