Common use of Pharmacovigilance Clause in Contracts

Pharmacovigilance. (a) GW shall be responsible for maintaining the global safety database for each Product and for monitoring the overall safety of the Product, including signal detection. (b) Novartis shall be responsible for pharmacovigilance activities with respect to Products in the Territory, including collecting and processing safety data and reporting to the Regulatory Authorities as required under applicable Laws. (c) Within six (6) months following the Effective Date (or such longer period as may be agreed between the Parties), the Parties shall agree upon and implement a procedure for the mutual exchange, receipt, record, communication and investigation of adverse event reports and safety or other information associated with the Products covered by this Section 6.5. Details of the operating procedure respecting such adverse event reports and safety information exchange shall be the subject of a mutually-agreed written pharmacovigilance agreement (“Pharmacovigilance Agreement”) between the Parties which shall be entered into within such six (6) month period (or such longer period as may be agreed between the Parties). (d) Each Party agrees that the other may audit its pharmacovigilance systems/operations or contracted pharmacovigilance activities at reasonable intervals to ensure that the elements set forth in the Pharmacovigilance Agreement are being met. The Parties will discuss and agree in good faith on how such audits will be conducted (including with respect to audit plan, duration of audit, audit report and corrective actions). Each Party’s routine audit will be scheduled no more frequently than once every two (2) years, with a minimum of 90 days notice. All such audits shall be reasonable in scope, limited to the Product, and shall take place during normal business hours. The audited Party will correct (and/or ensure if Affiliates and Sublicensees correct) any audit observations in a timely manner and communicate its corrective actions to the other Party. (e) Notwithstanding paragraph (d) above, in the case of a serious suspected breach of compliance with the Pharmacovigilance Agreement, a directed audit may be performed by either Party, or an independent Third Party, upon thirty (30) days written notice to the auditee, without further need for agreement between the Parties. (f) The Parties shall allow foreign and local Regulatory Authorities in the Territory to inspect their pharmacovigilance operations as it is necessary for Novartis to obtain and maintain Regulatory Approvals for the Products in countries in the Territory. Each Party shall provide the other with written notice (at the time of the notification) of any inspection addressing Product-specific pharmacovigilance and allow a representative from the other Party to attend and participate in such inspections. The inspected Party shall communicate urgent or critical issues affecting the other Party’s pharmacovigilance activities within fourteen (14) Business Days of receipt of documented findings cited during a Regulatory Authority inspection. Once corrective actions are determined, the inspected Party will provide a summary of the relevant inspection findings, with associated corrective actions, where the other Party is impacted.

Pharmacovigilance. (a) GW shall be responsible The Parties will cooperate with regard to the reporting and handling of safety information involving the Licensed Products in accordance with the applicable regulatory Laws on pharmacovigilance and clinical safety, with Eureka being responsible, at its cost, for maintaining the a global safety database for each Product database, and for monitoring the overall safety of the ProductLicensee being responsible, including signal detection. (b) Novartis shall be responsible at its cost, for pharmacovigilance activities with respect to Products reporting in the Licensee Territory, including collecting and processing safety data and reporting to the Regulatory Authorities as required under applicable Laws. (c) . Within six (6) months 120 days following the Effective Date (or as such longer period as may be agreed between extended by mutual written agreement of the Parties, but within such time to ensure that all regulatory requirements are met), the Parties shall agree upon will negotiate in good faith and implement enter into a procedure for pharmacovigilance agreement related to the mutual exchangeLicensed Products, receipt, record, communication and investigation of adverse event reports and safety or other information associated with which will define the Products covered by this Section 6.5. Details pharmacovigilance responsibilities of the operating procedure respecting such adverse event reports Parties and include safety data exchange procedures governing the exchange of information exchange shall be affecting the subject of a mutually-agreed written pharmacovigilance agreement Licensed Products (e.g., Adverse Events, Serious Adverse Events, emerging safety issues) to enable each Party to comply with all Laws related to the Licensed Products (the “Pharmacovigilance Agreement”) between the Parties which shall be entered into within such six (6) month period (or such longer period as may be agreed between the Parties). (d) Each Party agrees that the other may audit its pharmacovigilance systems/operations or contracted pharmacovigilance activities at reasonable intervals to ensure that the elements set forth in the Pharmacovigilance Agreement are being met. The Parties will discuss and agree in good faith on how such audits will be conducted (including with respect to audit plan, duration of audit, audit report and corrective actions). Each Party’s routine audit will be scheduled no more frequently than once every two (2) years, with a minimum of 90 days notice. All such audits shall be reasonable in scope, limited to Without limiting the Product, and shall take place during normal business hours. The audited Party will correct (and/or ensure if Affiliates and Sublicensees correct) any audit observations in a timely manner and communicate its corrective actions to the other Party. (e) Notwithstanding paragraph (d) above, in the case of a serious suspected breach of compliance with foregoing or anything under the Pharmacovigilance Agreement, a directed audit may be performed unless otherwise mutually agreed by either Partythe Parties, or an independent Third Partyduring the Term, upon thirty each Party shall, and shall cause its Affiliates, licensees and sublicensees to, (30a) days written notice disclose to the auditeeother Party all information relating to Serious Adverse Events from any clinical use of any Licensed Product in its respective Territory for storage into its global safety database, without further need for agreement between the Parties. (fb) The Parties shall allow foreign and local Regulatory Authorities in the Territory to inspect their pharmacovigilance operations as it is necessary for Novartis to obtain and maintain Regulatory Approvals for the Products in countries in the Territory. Each Party shall on at least a monthly basis, provide the other Party with written notice an update of all safety data (at including all Serious Adverse Events) with respect to the time of the notificationLicensed Product in its respective Territory, (c) of any inspection addressing Product-specific pharmacovigilance and allow a representative from notify the other Party to attend within five Business Days of any identified safety signals, (d) notify the other Party within two Business Days of any emerging safety issues, and participate in such inspections. The inspected Party shall communicate urgent or critical issues affecting (e) upon the other Party’s request, provide to such other Party any pharmacovigilance activities or clinical safety data within fourteen (14) five Business Days of receipt of documented findings cited during a Regulatory Authority inspection. Once corrective actions are determined, the inspected Party will provide a summary of the relevant inspection findings, with associated corrective actions, where the other Party is impactedsuch request.

Pharmacovigilance. (a) GW shall be responsible for maintaining Until the global safety database for each Product and for monitoring the overall safety end of the ProductService Period set forth in item 8 in the Work Order (such period, as the same may be modified in a Change Order or terminated by the Company pursuant to Section 7.2.1, the “PV Service Period”), Seller shall bear responsibility for pharmacovigilance relating to the Compound and Products, including signal detection. (b) Novartis shall be responsible for pharmacovigilance activities with respect to Products in the Territory, including collecting timely reporting of all adverse drug reactions/experiences and processing aggregate safety data and reporting relating to the Regulatory Authorities as required under applicable Laws. (c) Within six (6) months following Compound. As part of the Effective Date (or such longer period as may be agreed between Services, Seller shall communicate with the Parties)Company regarding Product pharmacovigilance matters and, in furtherance thereof, the Parties shall agree upon enter into a separate agreement setting forth the pharmacovigilance responsibilities and implement a procedure procedures for the mutual exchange, receipt, record, communication and investigation of adverse event reports and safety or other information associated with the Products covered by this Section 6.5. Details of the operating procedure respecting such adverse event reports and safety information exchange shall to be carried out by the subject of a mutually-agreed written pharmacovigilance agreement Parties (the “Pharmacovigilance Agreement”) between ). The Pharmacovigilance Agreement shall contain guidelines and procedures for the Parties which receipt, investigation, recording, communication, and exchange of reports of adverse drug reactions/experiences, safety data and other information concerning the safety of Product or the Compound (“Safety Information”), and shall be entered into within in all events include such six (6) month period (or such longer period terms as may be agreed between the Parties). (d) Each Party agrees that the other may audit its pharmacovigilance systems/operations or contracted pharmacovigilance activities at reasonable intervals are necessary to ensure that the elements set forth Parties comply with Applicable Laws and meet the reporting requirements of any applicable Governmental Entity. Without limiting the foregoing, prior to execution of the Pharmacovigilance Agreement, Seller shall instruct Quintiles, Inc. to copy the Company’s Transition Manager on all communications transmitting Safety Information to Seller, and in the Pharmacovigilance Agreement are being met. The Parties will discuss and agree event Seller receives any Safety Information that meets the criteria for a Serious, Suspected Adverse Drug Reaction (as defined in good faith on how ICH E2A) in a communication to which the Company is not copied, Seller shall send the source documents including such audits will be conducted Safety Information that were transmitted by Quintiles, Inc. to the Company, or other mutually agreed format, via email or fax as soon as possible, but, in any event, not later than One (including with respect 1) Business Day after Seller receives such Safety Information, and, in the event Seller receives any information concerning any investigation, inquiry or other action by any Governmental Entity concerning the safety of the Compound or Product, Seller shall send such information to audit planthe Company via email or fax as soon as possible, duration of auditbut in any event, audit report and corrective actions). Each Party’s routine audit will be scheduled no more frequently later than once every two (2) yearsdays after Seller receives notice of such investigation, with a minimum of 90 days noticeinquiry or other action. All As soon as reasonably practicable after the PV Service Period or such audits earlier time as may be requested in writing by the Company, Seller shall take all actions as reasonably may be reasonable in scope, limited required to effectuate the transfer to the ProductCompany of all Safety Information, and shall take place during normal business hours. The audited Party will correct (and/or ensure if Affiliates and Sublicensees correct) any audit observations in a timely manner and communicate its corrective actions including the portion of Seller’s global safety database that pertains to the other PartyCompound and the Products. (e) Notwithstanding paragraph (d) above, in the case of a serious suspected breach of compliance with the Pharmacovigilance Agreement, a directed audit may be performed by either Party, or an independent Third Party, upon thirty (30) days written notice to the auditee, without further need for agreement between the Parties. (f) The Parties shall allow foreign and local Regulatory Authorities in the Territory to inspect their pharmacovigilance operations as it is necessary for Novartis to obtain and maintain Regulatory Approvals for the Products in countries in the Territory. Each Party shall provide the other with written notice (at the time of the notification) of any inspection addressing Product-specific pharmacovigilance and allow a representative from the other Party to attend and participate in such inspections. The inspected Party shall communicate urgent or critical issues affecting the other Party’s pharmacovigilance activities within fourteen (14) Business Days of receipt of documented findings cited during a Regulatory Authority inspection. Once corrective actions are determined, the inspected Party will provide a summary of the relevant inspection findings, with associated corrective actions, where the other Party is impacted.

Pharmacovigilance. The Parties undertake to co-operate in the collection, review, assessment, tracking and filing of information related to Adverse Events and Adverse Drug Reactions associated with the Product and, in the case of Nycomed, other products incorporating the Compound for use in fields other than the Field, in accordance with US 21 CFR 312.32, 314.80 and the Pharmacovigilance Standard Operating Procedure (aSOP) GW ("Ciclesonide Pre- and Post Marketing Surveillance Standard Operating Procedures (SOP)") and a Pharmacovigilance Exchange Agreement (PVEA) the definitive terms of which will be agreed by the parties within ninety (90) days of the Effective Date (and in any event, prior to the sale of any Product) and will be attached as Schedule 12.4 to this Agreement. Without limitation, the Parties agree to promptly communicate to each other all information that comes to their attention pertaining to Adverse Events and Adverse Drug Reactions or side effects developing in persons who have been administered the Product. Information regarding serious (as defined in Schedule 12.4) Adverse Events and serious Adverse Drug Reactions (whether expected or unexpected) of which a Party becomes aware shall be transmitted to the impacted Party without undue delay within the time periods specified in Schedule 12.4. Nycomed shall be responsible for maintaining the a global safety database for each the Product and consistent with industry practices, to which Sepracor shall have access at all times during the Term, except during such limited times that the database is offline for monitoring the overall safety of the Product, including signal detection. (b) Novartis routine maintenance. Sepracor shall be responsible for pharmacovigilance activities AE and ADR processing, expedited, and periodic reporting of AEs and ADRs to the Regulatory Authorities in accordance with respect to Products all applicable AE regulatory reporting requirements in the Territory, including collecting and processing safety data Nycomed shall be responsible for such activities in the ROW, both at their cost and reporting to expense. Nycomed shall provide summary reports of adverse events at regular intervals consistent with the Regulatory Authorities as intervals required under applicable Laws. international reporting requirements for period reporting (c) Within six (6) months following U.S. Periodic Reporting requirements and Periodic Safety Reporting requirements in the Effective Date (or such longer period as may be agreed between the PartiesEU), the Parties shall agree and at other times, upon and implement a procedure for the mutual exchangereasonable written request by Sepracor, receipt, record, communication and investigation of adverse event such summary reports and safety or other information associated to be set up in accordance with the Products covered by this Section 6.5. Details of the operating procedure respecting such adverse event reports and safety information exchange shall be the subject of a mutually-agreed written pharmacovigilance agreement (“Pharmacovigilance Agreement”) between the Parties which shall be entered into within such six (6) month period (or such longer period as may be agreed between the Parties). (d) Each Party agrees that the other may audit its pharmacovigilance systems/operations or contracted pharmacovigilance activities at reasonable intervals to ensure that the elements set forth Periodic Safety Reporting requirements in the Pharmacovigilance Agreement are being met. The Parties will discuss and agree in good faith on how such audits will be conducted (including with respect to audit plan, duration of audit, audit report and corrective actions). Each Party’s routine audit will be scheduled no more frequently than once every two (2) years, with a minimum of 90 days notice. All such audits shall be reasonable in scope, limited to the Product, and shall take place during normal business hours. The audited Party will correct (and/or ensure if Affiliates and Sublicensees correct) any audit observations in a timely manner and communicate its corrective actions to the other PartyEU. (e) Notwithstanding paragraph (d) above, in the case of a serious suspected breach of compliance with the Pharmacovigilance Agreement, a directed audit may be performed by either Party, or an independent Third Party, upon thirty (30) days written notice to the auditee, without further need for agreement between the Parties. (f) The Parties shall allow foreign and local Regulatory Authorities in the Territory to inspect their pharmacovigilance operations as it is necessary for Novartis to obtain and maintain Regulatory Approvals for the Products in countries in the Territory. Each Party shall provide the other with written notice (at the time of the notification) of any inspection addressing Product-specific pharmacovigilance and allow a representative from the other Party to attend and participate in such inspections. The inspected Party shall communicate urgent or critical issues affecting the other Party’s pharmacovigilance activities within fourteen (14) Business Days of receipt of documented findings cited during a Regulatory Authority inspection. Once corrective actions are determined, the inspected Party will provide a summary of the relevant inspection findings, with associated corrective actions, where the other Party is impacted.

Pharmacovigilance. (a) GW shall be responsible for maintaining the global safety database for each Product and for monitoring the overall safety Within a reasonable amount of the Producttime, including signal detection. (b) Novartis shall be responsible for pharmacovigilance activities with respect not to Products in the Territory, including collecting and processing safety data and reporting to the Regulatory Authorities as required under applicable Laws. (c) Within exceed six (6) months following from the Effective Date (or such longer period as may be agreed between the Parties)Date, the Parties shall agree upon and implement a procedure for the mutual exchange, receipt, record, communication and investigation exchange of adverse event reports and safety or other information associated with the Products covered by this Section 6.5Products. Details The details of the operating procedure respecting such adverse event reports and safety information procedures relating to the exchange shall be the subject of a mutually-agreed upon written pharmacovigilance agreement (the “Pharmacovigilance Agreement”) ). Such Pharmacovigilance Agreement shall govern the collaboration between the Parties which enabling each to comply with its respective obligations under applicable laws, regulations and guidelines with regard to adverse event data collection, analysis and reporting. (b) It is further acknowledged and agreed that if the Parties enter into a Co-Detailing Agreement pursuant to the provisions set forth in Section 7.2(e) above, any such Co-Detailing Agreement shall specify that Array shall promptly report to Novartis any adverse events related to the use of the Product in conformity with the adverse event reporting procedures established by Novartis. In addition, each party shall promptly notify the other of any complaint relating to the Product received by Array. (c) The Parties shall promptly inform each other (via their respective appointed pharmacovigilance representatives) of any new safety information, including without limitation, suspected serious adverse reactions (whether unexpected or not), clinical trial reports and/or ad interim analyses results and the timely notification of trial completion in accordance with all applicable law and regulations governing safety reporting, including relevant timelines. For clarity, in the event the Parties have executed a Pharmacovigilance Agreement, all relevant safety findings (both clinical and pre-clinical) should be entered into within such six (6) month period (or such longer period as may be agreed between included in periodic reports per the Parties)detailed Pharmacovigilance Agreement and regulatory requirements. (d) Each Party agrees The Parties shall promptly inform each other (via their respective appointed pharmacovigilance representatives) of any safety issues and/or actions planned or taken for reasons of patient safety, including documentation such as Dear Doctor Letters and any changes to the safety profile of the Product, as documented in the current product label or investigator brochure in accordance with applicable law and regulations governing safety reporting, including relevant timelines, as may be further detailed in a separate pharmacovigilance agreement. (e) The Parties agree that within ninety (90) days following the other may audit Effective Date, Array will transition to Novartis its global database and following such transition, Novartis will hold the global database, be primarily responsible for authoring of the Periodic Safety Update Report and be responsible for the Core Data Sheet and Investigator Brochure. (f) The Parties agree that its pharmacovigilance systems/operations or contracted pharmacovigilance activities will be audited at reasonable intervals to ensure that the elements set forth in the Pharmacovigilance Agreement are being metfulfilled for the appropriate product. The Both Parties will discuss and agree in good faith on how such audits an audit will be conducted (including with respect to audit plan, duration of audit, audit report and corrective actions). Each Party’s routine audit will be scheduled no more frequently than once every two (2) years, with a minimum of 90 ninety (90) days notice. All such audits shall Audits must be reasonable in scope, limited scope and in relationship to the Product, Product and shall must take place during normal business hours. The audited Party Parties will correct (and/or ensure if Affiliates and Sublicensees correct) any audit observations in a timely manner and communicate its corrective those actions to the other Party. (eg) Notwithstanding paragraph (d) above, Each Party shall provide the other with a notice in the case event of a serious suspected breach of compliance with the Pharmacovigilance Agreement. Within thirty (30) days following receipt of notice of such notice by a Party hereto, a directed audit may will be performed by either Party, the other party or an independent Third Party, upon thirty (30) days written notice to the auditee, without further need for agreement between the Parties. (fh) The Parties shall allow foreign and local Regulatory Authorities in the Territory health authorities to inspect their pharmacovigilance operations as it is necessary for Novartis either Party to obtain and maintain Regulatory Approvals for the Products in countries registration in the Territorycountries where the Product is marketed. Each Party shall provide the other with written notice (at the time of the notification) of any inspection addressing Product-specific pharmacovigilance and allow a A representative from the other Party to attend and may participate in such inspections. The inspected Party Parties shall communicate urgent or critical issues affecting the other Party’s Parties pharmacovigilance activities within fourteen (14) Business Days of receipt of documented findings cited during a Regulatory Authority health authority inspection. Once corrective actions are determined, the inspected Party will provide a summary of the relevant inspection findings, findings with associated corrective actions, actions where the other Party is impacted.

Pharmacovigilance. (a) GW Wyeth shall be solely responsible for maintaining the global safety database for each Product and for monitoring the overall safety all of the Product, including signal detection. (b) Novartis shall be responsible for pharmacovigilance activities with respect to Products following in the Territory, including collecting : adverse experience reports; literature review and processing associated reports; adverse experience follow-up reports; preparation and submission of all safety data and reporting reports to the Regulatory Authorities as required under applicable Laws. required; maintaining information regarding Compounds and Products for inclusion in the global safety database; all interactions with relevant Regulatory Authorities and investigators; periodic submissions; risk management; safety monitoring, signal detection and safety measures (c) Within six e.g., clinical holds and restriction on distribution). ADLS shall be solely responsible for all of the following outside the Territory or in connection with its clinical studies: adverse experience reports; literature review and associated reports; adverse experience follow-up reports; preparation and submission of all safety reports to the Regulatory Authorities as required; maintaining information regarding Compounds and Products for inclusion in the global safety database; all interactions with relevant Regulatory Authorities and investigators; periodic submissions; risk management; safety monitoring, signal detection and safety measures (6) months following e.g., clinical holds and restriction on distribution). Notwithstanding the Effective Date (foregoing and until such time as a pharmacovigilance agreement is executed as provided in Section 4.8.4, to the extent either Party has or such longer period as receives any information regarding any adverse experience which may be agreed between related to the Parties)use of the Compounds and Products, the Parties shall agree upon and implement a procedure for promptly forward such information as follows: · Fatal or life-threatening serious adverse events/adverse drug reactions judged by either the mutual exchangeinvestigator or sponsor to be reasonably related to the Compounds, receipt, record, communication and investigation of adverse event reports and safety Products or other information associated with the Products covered by this Section 6.5. Details of the operating procedure respecting such adverse event reports and safety information exchange protocol shall be the subject of a mutually-agreed written pharmacovigilance agreement (“Pharmacovigilance Agreement”) between the Parties which shall be entered into within such six (6) month period (or such longer period as may be agreed between the Parties). (d) Each Party agrees that transmitted to the other may audit its pharmacovigilance systems/operations or contracted pharmacovigilance activities at reasonable intervals to ensure that the elements set forth in the Pharmacovigilance Agreement are being met. The Parties will discuss and agree in good faith on how such audits will be conducted (including with respect to audit plan, duration of audit, audit report and corrective actions). Each Party’s routine audit will be scheduled no more frequently than once every Party within two (2) yearscalendar days from the date received by the receiving Party. · All other serious adverse events/adverse drug reactions not fatal or life-threatening but judged by either the investigator or sponsor to be reasonably related to the Compounds, Products or [***] Confidential Treatment Requested Confidential portion omitted and filed separately with a minimum of 90 days notice. All such audits the Commission protocol shall be reasonable in scope, limited to the Product, and shall take place during normal business hours. The audited Party will correct (and/or ensure if Affiliates and Sublicensees correct) any audit observations in a timely manner and communicate its corrective actions transmitted to the other Party. Party within five (e5) Notwithstanding paragraph (d) above, in the case of a serious suspected breach of compliance with the Pharmacovigilance Agreement, a directed audit may be performed by either Party, or an independent Third Party, upon thirty (30) calendar days written notice to the auditee, without further need for agreement between the Parties. (f) The Parties shall allow foreign and local Regulatory Authorities in the Territory to inspect their pharmacovigilance operations as it is necessary for Novartis to obtain and maintain Regulatory Approvals for the Products in countries in the Territory. Each Party shall provide the other with written notice (at the time of the notification) of any inspection addressing Product-specific pharmacovigilance and allow a representative from the other Party date received by the receiving Party. If to attend and participate in such inspections. The inspected Party shall communicate urgent or critical issues affecting the other Party’s pharmacovigilance activities within fourteen (14) Business Days Wyeth: Facsimile: ▇▇▇-▇▇▇-▇▇▇▇ Overnight courier to: Global Safety Surveillance Epidemiology & Labeling Wyeth Research GSSEL Triage Unit Dock E ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇ If to ADLS: Facsimile: ▇▇▇-▇▇▇-▇▇▇▇ Overnight courier to: Advanced Life Sciences Holdings, Inc. ▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇ Attn: Director of receipt of documented findings cited during a Regulatory Authority inspection. Once corrective actions are determined, the inspected Party will provide a summary of the relevant inspection findings, with associated corrective actions, where the other Party is impacted.Affairs