Common use of Pharmacovigilance Clause in Contracts

Pharmacovigilance. Syndax shall be the global safety database holder and shall be responsible for all aspects of pharmacovigilance of the Product. Syndax (or its designee) shall be responsible for the collection, review, assessment, tracking and filing of information related to adverse events associated with the Product in the countries outside the Territory as well as, to the *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. extent required under Applicable Law, compiling and communicating to Regulatory Authorities outside the Territory. KHK shall reasonably cooperate with and assist Syndax upon request as required by Syndax in order to comply with Syndax’s regulatory obligations with respect to the Product outside of the Territory. KHK shall be responsible for the collection, review, assessment, tracking and filing of information related to adverse events associated with the Product in the Field in the Territory. Not later than the date of the first IND submission in the Territory or such earlier date required by Applicable Law with respect to the Parties’ activities hereunder, the Parties shall enter into a separate, written pharmacovigilance agreement (the “PV Agreement”) containing the specific terms, conditions and obligations of the Parties with respect to the collection, reporting and monitoring of all adverse events, risk management activities and other relevant drug safety matters with respect to Products during the Term. The PV Agreement shall ensure that adverse event and other safety information is exchanged according to a schedule that will permit each Party (and its designees or licensees) to comply with Applicable Law and regulatory requirements in their respective markets.

Pharmacovigilance. Syndax shall be the global safety database holder and shall be responsible for all aspects of pharmacovigilance of the Product. Syndax (or its designee) shall be responsible for the collection, review, assessment, tracking and filing of information related to adverse events associated with the Product in the countries outside the Territory as well as, to the *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. extent required under Applicable Law, compiling and communicating to Regulatory Authorities outside the Territory. KHK shall reasonably cooperate with and assist Syndax upon request as required by Syndax in order to comply with Syndax’s regulatory obligations with respect to the Product outside of the Territory. KHK shall be responsible for the collection, review, assessment, tracking and filing of information related to adverse events associated with the Product in the Field in the Territory. Not In no event later than twelve (12) months after the date of the first IND submission in the Territory or such earlier date required by Applicable Law with respect to the Parties’ activities hereunderEffective Date, the Parties shall enter into a separate, written pharmacovigilance agreement concerning all matters relating to the pharmacovigilance and the exchange of all relevant Information that relates to the safety of each Product worldwide and especially all adverse events and which will provide that (a) Distributor will liaise with Coherus’ pharmacovigilance provider for its reporting obligations[***], (b) Distributor shall be responsible for reporting all adverse drug reaction experiences required to be reported to the “PV Agreement”) containing appropriate Regulatory Authorities in the specific termscountries in the Territory in which such Product is being Commercialized, conditions and obligations in accordance with the Applicable Laws of the Parties relevant countries and Regulatory Authorities in coordination with Coherus and with the review and final approval by Coherus of any such reporting; and (c) Coherus, its Affiliates or licensees or sublicensees shall be responsible for submitting all regulatory filings, including without limitation any post-marketing reports of adverse drug experiences, relating to such Product required to be reported to the appropriate regulatory authorities outside of the Territory in accordance with the Applicable Laws of the relevant countries. Each Party shall have the right to share any and all information received from the other Party under this Section 3.7 (and/or such pharmacovigilance agreement) with its Affiliates and licensees and sublicensees, including without limitation, permitted Sublicensees. Coherus shall review from time to time Distributor’s pharmacovigilance policies and procedures. Subject to the requirements of Section 11.3 (Termination for Material Breach) including the requirement of providing written notice and the entitlement of a cure period, in the event that [***] rate of reported serious adverse events within a country within the Territory for a Product compared to [***], Coherus shall have the right to terminate all rights granted to Distributor under this Agreement with respect to such Product in such country, and Section 11.6 (Consequences of Termination) shall apply with respect to such Product in such country. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the collection, reporting and monitoring of all adverse events, risk management activities and other relevant drug safety matters with respect to Products during the Term. The PV Agreement shall ensure that adverse event and other safety information is exchanged according to a schedule that will permit each Party (and its designees or licensees) to comply with Applicable Law and regulatory requirements in their respective marketsomitted portions.

Pharmacovigilance. Syndax POZEN shall be not have any safety data reporting obligations with respect to the global safety database holder and Licensed Products except that if POZEN conducts any human clinical study of any Licensed Product outside the Territory, POZEN shall be responsible for all aspects of pharmacovigilance provide to Licensee a copy of the Productsafety data from such human clinical studies within a reasonable timeframe after POZEN completes the relevant safety data reports required by Applicable Law. Syndax (In the event that POZEN or its designee) shall be responsible for the collection, review, assessment, tracking and filing of information related to adverse events associated with the Affiliates Commercialize any Licensed Product in the countries outside the Territory as well as(solely on POZEN’s or such Affiliates’ own behalf, and not through any Third Party licensee), the Parties agree to negotiate in good faith a pharmacovigilance agreement on standard and customary terms. In the event that POZEN (i) grants any Third Party not acting on behalf of POZEN the right to conduct human clinical studies using any Licensed Product, or (ii) licenses rights to any Third Party to Develop or Commercialize Licensed Products outside the Territory, POZEN shall notify Licensee in writing of such grant of rights and the identity of such Third Party and POZEN shall use Commercially Reasonable Efforts to secure such Third Party’s agreement (a) to enter into a pharmacovigilance agreement with Licensee with respect to the *** INDICATES MATERIAL THAT WAS OMITTED reporting of adverse events for Licensed Product and containing other customary terms and conditions within ninety (90) days of POZEN granting such rights to such Third Party, and (b) for the disclosure to Licensee of the pharmacovigilance contact person at such Third Party promptly upon POZEN granting such rights to such Third Party. POZEN shall report adverse events in accordance with POZEN’s responsibilities under this Section 11.1 to Licensee at the following address: Sanofi US Attn: Vice President US Drug Safety, Sanofi US Xxxxxxxxxxx, XX 00000 Tel: (000) 000-0000 Fax: (000) 000-0000 XXXXxxxxxxx@xxxxxx.xxx THIS EXHIBIT HAS BEEN REDACTED AND FOR WHICH IS THE SUBJECT OF A CONFIDENTIAL TREATMENT WAS REQUESTEDREQUEST. ALL SUCH OMITTED REDACTED MATERIAL WAS IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. extent required under Applicable Law, compiling and communicating to Regulatory Authorities outside the Territory. KHK shall reasonably cooperate with and assist Syndax upon request as required by Syndax in order to comply with Syndax’s regulatory obligations with respect to the Product outside of the Territory. KHK shall be responsible for the collection, review, assessment, tracking and filing of information related to adverse events associated with the Product in the Field in the Territory. Not later than the date of the first IND submission in the Territory or such earlier date required by Applicable Law with respect to the Parties’ activities hereunder, the Parties shall enter into a separate, written pharmacovigilance agreement (the “PV Agreement”) containing the specific terms, conditions and obligations of the Parties with respect to the collection, reporting and monitoring of all adverse events, risk management activities and other relevant drug safety matters with respect to Products during the Term. The PV Agreement shall ensure that adverse event and other safety information is exchanged according to a schedule that will permit each Party (and its designees or licensees) to comply with Applicable Law and regulatory requirements in their respective marketsCOMMISSION.

Pharmacovigilance. Syndax shall be the global safety database holder and shall be responsible for all aspects of pharmacovigilance of the Product. Syndax (or its designee) shall be responsible for the collection, review, assessment, tracking and filing of information related to adverse events associated with the Product in the countries outside the Territory as well as, to the No later than [*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933*] prior to (a) [***] or (b) [***], AS AMENDED. extent required under Applicable Law, compiling the Parties will negotiate in good faith and communicating to Regulatory Authorities outside finalize the Territory. KHK shall reasonably cooperate with and assist Syndax upon request as required by Syndax in order to comply with Syndax’s regulatory obligations actions that the Parties will employ with respect to the Product outside Licensed Products to protect patients and promote their well-being in a written pharmacovigilance agreement (the “Pharmacovigilance Agreement”). These responsibilities will include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between the Parties) of Adverse Event reports and any other information concerning the Territorysafety of any Licensed Product, including recall and withdrawal responsibilities, processes, and procedures. KHK shall Such guidelines and procedures will be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under applicable Law. Furthermore, such agreed procedure will be consistent with relevant ICH guidelines, except where such guidelines may conflict with existing local regulatory reporting safety reporting requirements, in which case local reporting requirement will prevail. Lian will be responsible for the collectionreporting quality complaints, reviewAdverse Events, assessment, tracking and filing of information safety data related to adverse events associated with the Product Licensed Products in the Field to applicable Regulatory Authorities in the Territory, as well as responding to safety issues and to all requests of Regulatory Authorities relating to Licensed Products in the Field in the Territory. Not later than Lyra will be responsible for reporting quality complaints, Adverse Events, and safety data related to Licensed Product to applicable Regulatory Authorities outside the date Territory, as well as responding to safety issues and to all requests of Regulatory Authorities relating to Licensed Product outside the first IND submission in the Territory or such earlier date required Territory. The Pharmacovigilance Agreement will also provide for a worldwide safety database to be maintained by Applicable Law with respect Lyra at its sole cost and expense, which worldwide safety database will be accessible by Lian and its Affiliates, Sublicensees, and contractors to the Parties’ activities hereunderfull extent necessary for Lian to exercise its rights under this Agreement, the Parties shall enter into a separatecomply with its obligations under this Agreement, written pharmacovigilance agreement (the “PV Agreement”) containing the specific terms, conditions and comply with all applicable Law. Each Party will comply with its respective obligations of the Parties with respect to the collection, reporting under such Pharmacovigilance Agreement and monitoring of all adverse events, risk management activities will cause its Affiliates and other relevant drug safety matters with respect to Products during the Term. The PV Agreement shall ensure that adverse event Sublicensees and other safety information is exchanged according to a schedule that will permit each Party (and its designees or licensees) contractors to comply with Applicable Law and regulatory requirements in their respective marketssuch obligations.

Pharmacovigilance. Syndax Orexigen and Takeda entered into a pharmacovigilance agreement effective as of September 10, 2014 (as may be amended by the Parties in accordance with its terms, the “Pharmacovigilance Agreement”) concerning all matters relating to management and exchange of safety information on terms no less stringent than those required by ICH guidelines. Takeda shall be responsible, at its own expense, for the establishment and maintenance of the global safety database holder for Products in all Indications in the Territory. Each Party shall cooperate (at its sole cost and expense), and shall cause its Affiliates, licensees, and sublicensees to cooperate, in implementing a pharmacovigilance mutual alert process with respect to the Products and to comply with all applicable Laws. Generally, (a) prior to transfer of the Regulatory Filings as set forth in Section 3.4.2, Orexigen shall be responsible for submitting all aspects required IND safety reports contemplated by 21 C.F.R. 312.32, and post-marketing reports of pharmacovigilance adverse drug experiences contemplated by 21 C.F.R. 314.80, or the foreign equivalent in the Territory, relating to Products to the appropriate Regulatory Authorities in the Territory, in accordance with applicable Laws; (b) following transfer of the Product. Syndax (or its designee) Regulatory Filings as set forth in Section 3.4.2, and with respect to any other Regulatory Filings, Takeda shall be responsible for reporting all adverse drug reaction experiences required to be reported to the collectionappropriate Regulatory Authorities in the Territory in which such Product is being Developed or Commercialized, reviewin accordance with Laws; and (c) Orexigen, assessmentits Affiliates or licensees or sublicensees shall be responsible for submitting all regulatory filings, tracking including any post-marketing reports of adverse drug experiences, relating to Products and filing required to be reported to the appropriate regulatory authorities outside of information related to adverse events associated the Territory, in accordance with the Product in Laws of the countries outside relevant countries. Orexigen shall have the Territory as well asright to share any and all information received from Takeda under this Section 3.6, to or the *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933Pharmacovigilance Agreement, AS AMENDED. extent required under Applicable Law, compiling with Orexigen’s Affiliates and communicating to Regulatory Authorities licensees and sublicensees outside the Territory. KHK Takeda shall reasonably cooperate have the right to share any and all information received from Orexigen under this Section 3.6 or the Pharmacovigilance Agreement with Takeda’s Affiliates and assist Syndax upon request as required by Syndax in order to comply with Syndax’s regulatory obligations with respect to the Product outside of the Territory. KHK shall be responsible for the collection, review, assessment, tracking and filing of information related to adverse events associated with the Product in the Field Sublicensees in the Territory. Not later than The JSC shall review from time to time Takeda’s and Orexigen’s pharmacovigilance policies and procedures. The Pharmacovigilance Agreement identifies the date responsibilities of each Party regarding the first IND submission in information to be exchanged and the Territory or timeframes for such earlier date required by Applicable Law with respect to the Parties’ activities hereunderexchange, the Parties shall enter into a separateregulatory reporting, written pharmacovigilance agreement (the “PV Agreement”) containing the specific terms, conditions and obligations of the Parties with respect to the collection, reporting and monitoring of all adverse eventsliterature review, risk management activities management, and other relevant drug safety matters with respect to Products during the Termlabeling. The PV Agreement shall ensure that adverse event and other safety information is exchanged according to a schedule that will permit each Party (and its designees or licensees) to comply with Applicable Law and regulatory requirements in their respective markets.FINAL VERSION

Pharmacovigilance. Syndax shall Notwithstanding Section 4.2(g) of the Agreement, Alexza will be relieved of its responsibility for maintaining the global safety database holder for the Product until the Product obtains regulatory approval outside of the Territory and outside the U.S. For clarification, Xxxxxx will remain responsible, at its own expense, for maintaining the safety database and for pharmacovigilance for the Product in the Territory. Promptly after the Fourth [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Amendment Effective Date, the Parties shall amend any existing pharmacovigilance and safety data exchange agreements between them to be consistent with the following, such amendments to be effective upon the transfer of MAA Approval pursuant to Section 3.1(a) of this Fourth Amendment unless otherwise required by Regulatory Authority requirements: (a) Xxxxxx shall be responsible for all aspects of designating to the EMA and other applicable Regulatory Authorities in the Territory a qualified person responsible for pharmacovigilance of (QPPV) for the Product. Syndax , (or its designeeb) Xxxxxx shall be responsible for the collectionpharmacovigilance system Master file for the EMA and other applicable Regulatory Authorities in the Territory for the Product, review(c) Xxxxxx shall be responsible for processing periodic safety update reporting and case reporting with respect to the EMA and other applicable Regulatory Authorities in the Territory and (d) Xxxxxx shall enter into pharmacovigilance agreements with Alexza’s U.S. licensee (in addition to its continuing pharmacovigilance agreement with Alexza) not later than September 1, assessment2015, tracking for the purposes of exchange of pharmacovigilance information in their respective territories, provided that until entry into such agreement with the U.S. licensee, Xxxxxx shall communicate to Alexza all safety reports and filing of information Serious Adverse Events related to adverse events associated with the Product in the countries outside the Territory as well as, and Alexza shall keep Xxxxxx informed about safety reports and Serious Adverse Events related to the *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. extent required under Applicable Law, compiling and communicating to Regulatory Authorities Product outside the Territory. KHK shall reasonably cooperate with and assist Syndax upon request as required by Syndax in order The transition process from Alexza to comply with SyndaxXxxxxx will begin immediately following Alexza’s regulatory obligations with respect to the Product outside submission of the Territory. KHK shall be responsible for the collection, review, assessment, tracking and filing of information related MAA transfer application to adverse events associated with the Product in the Field in the Territory. Not later than the date of the first IND submission in the Territory or such earlier date required by Applicable Law with respect to the Parties’ activities hereunder, the Parties shall enter into a separate, written pharmacovigilance agreement (the “PV Agreement”) containing the specific terms, conditions and obligations of the Parties with respect to the collection, reporting and monitoring of all adverse events, risk management activities and other relevant drug safety matters with respect to Products during the Term. The PV Agreement shall ensure that adverse event and other safety information is exchanged according to a schedule that will permit each Party (and its designees or licensees) to comply with Applicable Law and regulatory requirements in their respective marketsEMA.

Pharmacovigilance. Syndax Within ninety (90) days after the Effective Date, the Parties shall define and finalize the actions that the Parties shall employ with respect to the Licensed Compounds and Licensed Products to protect patients and promote their well-being in a written pharmacovigilance agreement (the “Pharmacovigilance Agreement”). 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 Product. Such guidelines and procedures shall be in accordance with, and enable the global Parties to fulfill, local and national regulatory reporting obligations under Applicable Laws. Furthermore, such agreed procedure shall be consistent with relevant ICH guidelines, except where said guidelines may conflict with existing local regulatory reporting safety database holder and reporting requirements, in which case local reporting requirement shall prevail. Each Party shall be responsible for all aspects of pharmacovigilance of the Product. Syndax (or its designee) shall be responsible for the collectionreporting quality complaints, review, assessment, tracking adverse events and filing of information safety data related to adverse events associated with the a Licensed Product to applicable Regulatory Authorities in its Territory, as well as responding to safety issues and to all requests of Regulatory Authorities relating to a Licensed Product in the countries outside the Territory as well as, its Territory. The Pharmacovigilance Agreement shall also provide for a worldwide safety database to the be maintained by TESARO at its cost. Each Party hereby agrees to comply with its respective obligations under such Pharmacovigilance Agreement and to cause its Affiliates and permitted sublicensees to comply with such obligations. [*** *] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 19331934, AS AMENDED. extent required under Applicable Law, compiling and communicating to Regulatory Authorities outside the Territory. KHK shall reasonably cooperate with and assist Syndax upon request as required by Syndax in order to comply with Syndax’s regulatory obligations with respect to the Product outside of the Territory. KHK shall be responsible for the collection, review, assessment, tracking and filing of information related to adverse events associated with the Product in the Field in the Territory. Not later than the date of the first IND submission in the Territory or such earlier date required by Applicable Law with respect to the Parties’ activities hereunder, the Parties shall enter into a separate, written pharmacovigilance agreement (the “PV Agreement”) containing the specific terms, conditions and obligations of the Parties with respect to the collection, reporting and monitoring of all adverse events, risk management activities and other relevant drug safety matters with respect to Products during the Term. The PV Agreement shall ensure that adverse event and other safety information is exchanged according to a schedule that will permit each Party (and its designees or licensees) to comply with Applicable Law and regulatory requirements in their respective markets.

Pharmacovigilance. Syndax Within ninety (90) days after the Effective Date, the Parties shall be define and finalize the global safety database holder actions that the Parties shall employ with respect to the Licensed Compounds and Licensed Products to protect patients and promote their well-being in a written pharmacovigilance agreement (the “Pharmacovigilance Agreement”). These responsibilities shall be responsible for all aspects of pharmacovigilance of the Product. Syndax (or its designee) shall be responsible include mutually acceptable guidelines and procedures for the collectionreceipt, review, assessment, tracking and filing of information related to adverse events associated with the Product in the countries outside the Territory as well as, to the [*** *] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 19331934, AS AMENDED. extent required 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 Product. Such guidelines and procedures shall be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under Applicable LawLaws. Furthermore, compiling and communicating to Regulatory Authorities outside the Territorysuch agreed procedure shall be consistent with relevant ICH guidelines, except where said guidelines may conflict with existing local regulatory reporting safety reporting requirements, in which case local reporting requirement shall prevail. KHK shall reasonably cooperate with and assist Syndax upon request as required by Syndax in order to comply with Syndax’s regulatory obligations with respect to the Product outside of the Territory. KHK Each Party shall be responsible for the collectionreporting quality complaints, review, assessment, tracking adverse events and filing of information safety data related to adverse events associated with the a Licensed Product to applicable Regulatory Authorities in its Territory, as well as responding to safety issues and to all requests of Regulatory Authorities relating to a Licensed Product in the Field in the its Territory. Not later than the date of the first IND submission in the Territory or such earlier date required by Applicable Law with respect to the Parties’ activities hereunder, the Parties shall enter into a separate, written pharmacovigilance agreement (the “PV Agreement”) containing the specific terms, conditions and obligations of the Parties with respect to the collection, reporting and monitoring of all adverse events, risk management activities and other relevant drug safety matters with respect to Products during the Term. The PV Pharmacovigilance Agreement shall ensure that adverse event and other also provide for a worldwide safety information is exchanged according database to a schedule that will permit each be maintained by TESARO at its cost. Each Party (and its designees or licensees) hereby agrees to comply with Applicable Law its respective obligations under such Pharmacovigilance Agreement and regulatory requirements in their respective marketsto cause its Affiliates and permitted sublicensees to comply with such obligations.

Pharmacovigilance. Syndax shall be Subject to the global safety database holder and shall be responsible for all aspects terms of pharmacovigilance this Agreement, as needed, within three (3) months after the Execution Date, or notification to the Pharmacovigilance Departments of the Product. Syndax (or its designee) shall be responsible for the collection, review, assessment, tracking and filing of information related to adverse events associated with the Product in the countries outside the Territory as well as, to the *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. extent required under Applicable Law, compiling and communicating to Regulatory Authorities outside the Territory. KHK shall reasonably cooperate with and assist Syndax upon request as required by Syndax in order to comply with Syndax’s regulatory obligations with respect to the Product outside of the Territory. KHK shall be responsible for the collection, review, assessment, tracking and filing of information related to adverse events associated with the Product in the Field in the Territory. Not later than the date of the first IND submission in the Territory or such earlier date required by Applicable Law with respect to the Parties’ activities hereunderexecution date, the Parties (under the guidance of their respective Pharmacovigilance Departments, or equivalent thereof) shall enter into 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 or Licensed Product. 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 or Licensed Product. 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 separate, written pharmacovigilance agreement between the Parties (hereafter referred to as the “PV Pharmacovigilance Agreement”), the party responsible for Pharmacovigilance prior to execution of this Agreement shall have sole Pharmacovigilance responsibility for the Licensed Compound or Licensed Product 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. Any regulatory commitments relating to BMS’ prior development activities regarding the Licensed program in the Partner Territory prior to the Effective Date will remain the responsibility of BMS, and promptly after the Effective Date, BMS shall provide ZAI with pharmacovigilance data that is set forth in the Pharmacovigilance Agreement for the Licensed Product(s) containing obtained prior to the specific termsEffective Date. [*] = Certain confidential information contained in this document, conditions marked by brackets, has been omitted and obligations filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Parties with respect to the collectionSecurities Act of 1933, reporting and monitoring of all adverse events, risk management activities and other relevant drug safety matters with respect to Products during the Term. The PV Agreement shall ensure that adverse event and other safety information is exchanged according to a schedule that will permit each Party (and its designees or licensees) to comply with Applicable Law and regulatory requirements in their respective marketsas amended.

Pharmacovigilance. Syndax shall be Pfizer, as the global safety database holder and of the Product Approval, shall be responsible for all aspects the collection, review, assessment, tracking and filing of pharmacovigilance information related to adverse events associated with the Product in the Field in the Territory (whether or not Product Approval has been achieved), in each case in accordance with applicable Law and this Agreement (and Pfizer shall ensure that, in the Development and Commercialization of the Product, it will record, investigate, summarize, notify, report and review all adverse events in accordance with applicable Law). Syndax Auxilium (or its designee) shall be responsible for the collection, review, assessment, tracking and filing of information related to adverse events associated with the Product in the countries outside the Territory as well as, Territory. The safety units from each of the Parties shall meet and agree upon a written pharmacovigilance agreement for exchanging adverse event and other safety information relating to the *Product prior to Pfizer’s first clinical activity or prior to the first Regulatory Approval in the Territory (whichever is first); provided that Pfizer shall be responsible for maintaining the global safety database for the Product. Such written pharmacovigilance agreement shall ensure that adverse event and other safety ** INDICATES MATERIAL THAT WAS CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDEDA CONFIDENTIAL TREATMENT REQUEST. extent required under Applicable Law, compiling and communicating to Regulatory Authorities outside the Territory. KHK shall reasonably cooperate with and assist Syndax upon request as required by Syndax in order to comply with Syndax’s regulatory obligations with respect to the Product outside of the Territory. KHK shall be responsible for the collection, review, assessment, tracking and filing of information related to adverse events associated with the Product in the Field in the Territory. Not later than the date of the first IND submission in the Territory or such earlier date required by Applicable Law with respect to the Parties’ activities hereunder, the Parties shall enter into a separate, written pharmacovigilance agreement (the “PV Agreement”) containing the specific terms, conditions and obligations of the Parties with respect to the collection, reporting and monitoring of all adverse events, risk management activities and other relevant drug safety matters with respect to Products during the Term. The PV Agreement shall ensure that adverse event and other safety information is exchanged according to a schedule that will permit each Party (and its designees sublicensees or licenseesdesignees) to comply with Applicable Law applicable Laws and regulatory requirements in their respective markets.

Pharmacovigilance. Syndax Wyeth shall be solely responsible for all of the following in the Territory: 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 holder database; all interactions with relevant Regulatory Authorities and investigators; periodic submissions; risk management; safety monitoring, signal detection and safety measures (e.g., clinical holds and restriction on distribution). ADLS shall be solely responsible for all aspects of pharmacovigilance of the Product. Syndax (or its designee) shall be responsible for the collection, review, assessment, tracking and filing of information related to adverse events associated with the Product in the countries 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 well asrequired; 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 (e.g., clinical holds and restriction on distribution). Notwithstanding the foregoing and until such time as a pharmacovigilance agreement is executed as provided in Section 4.8.4, to the *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. extent required under Applicable Law, compiling and communicating to Regulatory Authorities outside the Territory. KHK shall reasonably cooperate with and assist Syndax upon request as required by Syndax in order to comply with Syndax’s regulatory obligations with respect either Party has or receives any information regarding any adverse experience which may be related to the Product outside use of the Territory. KHK shall be responsible for the collection, review, assessment, tracking Compounds and filing of information related to adverse events associated with the Product in the Field in the Territory. Not later than the date of the first IND submission in the Territory or such earlier date required by Applicable Law with respect to the Parties’ activities hereunderProducts, the Parties shall enter into a separate, written pharmacovigilance agreement (promptly forward such information as follows: · Fatal or life-threatening serious adverse events/adverse drug reactions judged by either the “PV Agreement”) containing the specific terms, conditions and obligations of the Parties with respect investigator or sponsor to be reasonably related to the collectionCompounds, reporting and monitoring of all Products or protocol shall be transmitted to the other Party within two (2) calendar 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, risk management activities Products or [***] Confidential Treatment Requested Confidential portion omitted and filed separately with the Commission protocol shall be transmitted to the other relevant drug safety matters with respect Party within five (5) calendar days from the date received by the receiving Party. If to Products during the Term. The PV Agreement shall ensure that adverse event and other safety information is exchanged according Wyeth: Facsimile: 000-000-0000 or Overnight courier to: Global Safety Surveillance Epidemiology & Labeling Wyeth Research GSSEL Triage Unit Dock E 000 Xxxxxx Xxxx Xxxxxxxxxxxx, XX 00000 If to a schedule that will permit each Party (and its designees ADLS: Facsimile: 000-000-0000 or licensees) to comply with Applicable Law and regulatory requirements in their respective markets.Overnight courier to: Advanced Life Sciences Holdings, Inc. 0000 Xxxxx Xxxx Xxxxxxxxx, XX 00000 Attn: Director of Regulatory Affairs

Pharmacovigilance. Syndax shall be Subject to the global safety database holder and terms of this Section 5.6.1, each Party shall be responsible for all aspects its respective pharmacovigilance obligations under Applicable Laws. Licensee, as the intended beneficiary under this Agreement of pharmacovigilance the privileges of ownership of the Product Approvals in the Field in the Territory, shall be responsible for the collection, review, assessment, tracking and filing of information related to adverse events associated with the Product in the Territory (whether or not Product Approval has been achieved), in each case in accordance with Applicable Laws and this Agreement (and Licensee shall ensure that, in the Development and Commercialization of the Product, it will record, investigate, summarize, notify, report and review all adverse events in accordance with Applicable Laws, including, for clarity, laws relating to adverse event reporting in both the U.S. and the Territory). Syndax Amarin (or its designee) shall be responsible for the collection, review, assessment, tracking and filing of information related to adverse events associated with the Product in the countries outside the Territory as well as, to the *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. extent required under Applicable Law, compiling and communicating to Regulatory Authorities outside the Territory. KHK The safety units from each of the Parties shall reasonably cooperate with meet and assist Syndax agree upon request as required by Syndax in order to comply with Syndax’s regulatory obligations with respect a written pharmacovigilance agreement for exchanging adverse event and other safety information relating to the Product outside of the Territory. KHK shall be responsible for the collection, review, assessment, tracking and filing of information related prior to adverse events associated with the Product in the Field in the Territory. Not later than the date of Licensee’s first clinical activity or prior to the first IND submission Regulatory Approval in the Territory or such earlier date required by Applicable Law with respect to the Parties’ activities hereunder, the Parties shall enter into a separate, (whichever is first). Such written pharmacovigilance agreement (the “PV Agreement”) containing the specific terms, conditions and obligations of the Parties with respect to the collection, reporting and monitoring of all adverse events, risk management activities and other relevant drug safety matters with respect to Products during the Term. The PV Agreement shall ensure that adverse event associated with the Product and other safety information is exchanged according to a schedule that will permit each Party (and its designees or licenseesor, solely with respect to Amarin, its sublicensees) to comply with Applicable Law Laws and regulatory requirements in their respective markets.

Pharmacovigilance. Syndax Arena or its Arena ex-Territory Distributors shall be responsible, at its own expense, for all required safety reporting with respect to each Product in each country outside of the Territory. Promptly after the 2nd Amendment Effective Date, (a) Arena shall cooperate towards the orderly transfer to Eisai, or the establishment by Eisai, of the global safety database holder for the Product, and thereafter, Eisai shall be responsible at its expense for all aspects maintaining the global safety database and (b) the Parties shall amend and restate the PV Agreement to address the exchange of pharmacovigilance of the Product. Syndax (or its designee) shall be responsible for the collection, review, assessment, tracking and filing of safety information related to adverse events associated with the Product in the countries outside the Territory as well as, to the *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. extent required under Applicable Law, compiling and communicating to Regulatory Authorities outside the Territory. KHK shall reasonably cooperate with and assist Syndax upon request as required by Syndax in order to comply with Syndax’s regulatory obligations with respect to the Product outside of in the Territory (including with respect to Arena’s current and future ex-Territory Distributors). As between the Parties, the Party holding the relevant IND will be responsible for all safety reporting for clinical development (unless otherwise agreed to by the Parties) in the Territory and will assume all such expenses associated with safety reporting in the Territory. KHK Eisai (or its designated Affiliate or Sub-distributor) will be responsible for all safety reporting relating to Commercialization of the Product in the Territory and will assume all such expenses associated with safety reporting in the Territory. Eisai shall be responsible for ensuring compliance by its Affiliates or Sub-distributors with respect to pharmacovilgilance responsibilities under the collection, review, assessment, tracking PV Agreement and filing of information related to adverse events associated with the Product Applicable Law in the Field applicable countries in the Territory. Not later than Arena shall be responsible for ensuring compliance by Arena ex-Territory Distributors with respect to pharmacovigilance responsibilities under the date of the first IND submission PV Agreement and Applicable Law in the ex-Territory or such earlier date required by Applicable Law countries, including safety reporting requirements. Each Party shall cooperate and shall cause its Affiliates (and, in the case of Arena, shall cause the Arena ex-Territory Distributors, and in the case of Eisai, shall cause the Sub-distributors) to cooperate in implementing a pharmacovigilance mutual alert process with respect to the Parties’ Products. Arena and Eisai shall each have the right to subcontract any such activities hereunderto a Third Party. Further, the PV Agreement shall provide: (a) a Joint Product Safety Committee (the “JPSC”) will be established by the Parties as a JDC Subcommittee with representatives from Eisai and Arena (including pharmacovigilance, regulatory, medical affairs and legal representatives); (b) the JPSC shall seek to act by consensus whenever possible, with Eisai representatives having final decision-making authority; (c) Arena shall have the right to have its or its Affiliate’s personnel interact on a regular basis with Eisai’s operational safety team for the Products; (d) Arena shall have the right to maintain an informational database with a copy of all global safety reports; (e) Eisai will generate aggregate reports and for those reports to be submitted to ex-Territory countries provide Arena a reasonable amount of time to review and comment on such reports (and the Parties shall enter into a separateseek to reach conclusions by consensus, written pharmacovigilance agreement (the “PV Agreement”) containing the specific terms, conditions and obligations of the Parties with respect to the collection, reporting and monitoring of all adverse events, risk management activities and other relevant drug safety matters with respect to Products during the Term. The PV Agreement shall ensure that adverse event and other safety information is exchanged according to a schedule that will permit each Party (and its designees or licensees) to comply with Applicable Law and regulatory requirements in their respective markets.Eisai having final decision-

Pharmacovigilance. Syndax shall be the global safety database holder and shall be responsible for all aspects of pharmacovigilance of the Product. Syndax (or its designee) Incyte shall be responsible for the collection, review, assessment, tracking and filing of information related to adverse events associated with the Product Licensed Products in the countries outside Incyte Territory (whether or not Product Approval has been achieved), in each case in accordance with applicable Laws and this Agreement (and Incyte shall ensure that, in the Territory as well as, to the *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. extent required under Applicable Law, compiling Development and communicating to Regulatory Authorities outside the Territory. KHK shall reasonably cooperate with and assist Syndax upon request as required by Syndax in order to comply with Syndax’s regulatory obligations with respect to the Product outside Commercialization of the TerritoryLicensed Products, it will record, investigate, summarize, notify, report and review all adverse events in accordance with applicable Laws). KHK Hengrui shall be responsible for the collection, review, assessment, tracking and filing of information related to adverse events associated with the Product Licensed Products in the Field Hengrui Territory (whether or not Product Approval has been achieved), in each case in accordance with applicable Laws and this Agreement (and Hengrui shall ensure that, in the TerritoryDevelopment and Commercialization of the Licensed Products, it will record, investigate, summarize, notify, report and review all adverse events in accordance with applicable Laws). Not later than Each Party shall keep the date other Party informed of any SAE, SUSAR, or pregnancy report occurring in subjects exposed to the Licensed Products, whether through commercial use or Development Activity, according to timelines defined in a written pharmacovigilance agreement. The safety representatives from each of the Parties shall meet and agree upon a written pharmacovigilance agreement for exchanging adverse event and other safety information relating to the Licensed Products within [**] prior to the anticipated first dosing of the first IND submission patient in the Territory or such earlier date required by Applicable Law with respect to first Clinical Trial performed under this Agreement. [**] of establishing and maintaining the Parties’ activities hereunder, global safety database for the Parties shall enter into a separate, Licensed Products. Such written pharmacovigilance agreement (the “PV Agreement”) containing the specific terms, conditions and obligations of the Parties with respect to the collection, reporting and monitoring of all adverse events, risk management activities and other relevant drug safety matters with respect to Products during the Term. The PV Agreement shall ensure that all adverse event and other safety information is exchanged according to a schedule that will permit each Party (and its designees Affiliates, sublicensees or licenseessubcontractors) to comply with Applicable Law applicable Laws and regulatory requirements in their respective marketsTerritory, including reporting any safety data provided by the other Party to the Regulatory Authorities in such Party’s Territory.

Pharmacovigilance. Syndax As soon as possible, but no later than [***], Orexigen and Takeda shall enter into a pharmacovigilance agreement concerning all matters relating to management and exchange of safety information on terms no less stringent than those required by ICH guidelines. Takeda shall be responsible, at its own expense, for the *** 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. establishment and maintenance of the global safety database holder for Products in all Indications in the Territory. Each Party shall cooperate (at its sole cost and expense), and shall cause its Affiliates, licensees and sublicensees to cooperate, in implementing a pharmacovigilance mutual alert process with respect to the Products and to comply with all applicable Laws. Generally, (a) prior to transfer of the Regulatory Filings as set forth in Section 3.4.2, Orexigen shall be responsible for submitting all aspects required IND safety reports contemplated by 21 C.F.R. 312.32, and post-marketing reports of pharmacovigilance adverse drug experiences contemplated by 21 C.F.R. 314.80, or the foreign equivalent in the Territory, relating to Products to the appropriate Regulatory Authorities in the United States, in accordance with applicable Laws; (b) following transfer of the Product. Syndax (or its designee) Regulatory Filings as set forth in Section 3.4.2, and with respect to any other Regulatory Filings, Takeda shall be responsible for reporting all adverse drug reaction experiences required to be reported to the collection, review, assessment, tracking and filing of information related to adverse events associated with the Product appropriate Regulatory Authorities in the countries outside in the Territory as well asin which such Product is being Developed or Commercialized, in accordance with the Laws of the relevant countries; and (c) Orexigen, its Affiliates or licensees or sublicensees shall be responsible for submitting all regulatory filings, including any post-marketing reports of adverse drug experiences, relating to Products and required to be reported to the *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTEDappropriate regulatory authorities outside of the Territory, in accordance with the Laws of the relevant countries. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933Orexigen shall have the right to share any and all information received from Takeda under this Section 3.6, AS AMENDED. extent required under Applicable Lawor the pharmacovigilance agreement entered into between the Parties, compiling with Orexigen’s Affiliates and communicating to Regulatory Authorities licensees and sublicensees outside the Territory. KHK Takeda shall reasonably cooperate have the right to share any and all information received from Orexigen under this Section 3.6 or such pharmacovigilance agreement with Takeda’s Affiliates and assist Syndax upon request as required by Syndax in order to comply with Syndax’s regulatory obligations with respect to the Product outside of the Territory. KHK shall be responsible for the collection, review, assessment, tracking and filing of information related to adverse events associated with the Product in the Field Sublicensees in the Territory. Not later than the date of the first IND submission in the Territory or such earlier date required by Applicable Law with respect The JSC shall review from time to the Parties’ activities hereunder, the Parties shall enter into a separate, written time Takeda’s and Orexigen’s pharmacovigilance policies and procedures. The pharmacovigilance agreement (shall identify the “PV Agreement”) containing responsibilities of each Party regarding the specific termsinformation to be exchanged and the timeframes for such exchange, conditions and obligations of the Parties with respect to the collectionregulatory reporting, reporting and monitoring of all adverse eventsliterature review, risk management activities management, and other relevant drug safety matters with respect to Products during the Term. The PV Agreement shall ensure that adverse event and other safety information is exchanged according to a schedule that will permit each Party (and its designees or licensees) to comply with Applicable Law and regulatory requirements in their respective marketslabeling.

Pharmacovigilance. Syndax shall be 5.4.1 Within [*] after the global safety database holder and shall be responsible for all aspects of pharmacovigilance of the Product. Syndax (or its designee) shall be responsible for the collection, review, assessment, tracking and filing of information related to adverse events associated with the Product in the countries outside the Territory as well as, to the *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. extent required under Applicable Law, compiling and communicating to Regulatory Authorities outside the Territory. KHK shall reasonably cooperate with and assist Syndax upon request as required by Syndax in order to comply with Syndax’s regulatory obligations with respect to the Product outside of the Territory. KHK shall be responsible for the collection, review, assessment, tracking and filing of information related to adverse events associated with the Product in the Field in the Territory. Not later than the date of the first IND submission in the Territory or such earlier date required by Applicable Law with respect to the Parties’ activities hereunderEffective Date, the Parties shall parties agree to negotiate in good faith and enter into a separate, written pharmacovigilance agreement (the “PV Agreement”) containing ), which shall include mutually acceptable procedures governing the specific termscollection, conditions investigation, reporting, and obligations exchange of information concerning adverse drug reactions/experiences, pregnancy reports and any other information concerning the safety of the Parties Product, sufficient to permit each party to comply with its regulatory and other legal obligations within the applicable timeframes, shall be in accordance with U.S., EU and ICH guidelines, and shall be consistent with the “Pharmacovigilance Agreement” (as such term is to be defined in the Mundipharma Agreement); provided, however, that at Cidara’s request, the parties shall cooperate in good faith with each other and with Mundipharma to make Melinta a party to the Pharmacovigilance Agreement in which case all references in this Agreement to the PV Agreement shall be deemed to refer to such “Pharmacovigilance Agreement.” The PV Agreement shall specify that each party shall be responsible for monitoring all clinical experiences with respect to Product in the course of Development activities of which such party is the regulatory sponsor. The parties’ respective responsibilities regarding the following shall also be set forth in the PV Agreement: (a) filing all required reports with respect thereto (including quality complaints, adverse events and safety data); and (b) responding to safety issues and to all associated requests of Regulatory Authorities relating to Product in the Territory; provided that Cidara shall be responsible for all monitoring and reporting obligations in respect of the Lead Indication Trials. Prior to the Transfer Date, Cidara shall be responsible for the costs it incurs in complying with its monitoring and reporting obligations under the PV Agreement and in reporting relevant information to Melinta with respect to the collection, Current Product for the Lead Indications. Melinta shall be responsible for the costs it incurs in complying with its monitoring obligations under the PV Agreement and in reporting and monitoring of all adverse events, risk management activities and other relevant drug safety matters information to Cidara with respect to Products during the Termany other Product or indications. The Following the Transfer Date, Melinta shall be responsible for the costs it incurs in complying with its monitoring obligations under the PV Agreement shall ensure that adverse event and other safety in reporting relevant information is exchanged according to a schedule that will permit each Party (and its designees or licensees) Cidara with respect to comply with Applicable Law and regulatory requirements in their respective marketsthe Current Product for the Lead Indications.

Pharmacovigilance. Syndax shall be Subject to the global safety database holder and terms of this Section 5.6.1, each Party shall be responsible for all aspects of its respective pharmacovigilance obligations for the Product under Applicable Laws. Licensee, as the intended beneficiary under this Agreement of the Productprivileges of ownership of the Product Approvals for the Product in the Territory for the Field, (or its designee) shall be responsible for the collection of information relating to Safety Data or Serious Adverse Events associated with the Product in the Territory for the Field and for forwarding such information to Amarin, who shall be responsible for reviewing, assessment, tracking and filing of such information (whether or not Product Approval has been achieved), in each case in accordance with Applicable Laws and this Agreement. Syndax Amarin (or its designee) shall be responsible for the collection, review, assessment, tracking and filing of information related to adverse events Safety Data or Serious Adverse Events associated with the Product in the countries outside the Territory as well asTerritory, to the *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. extent required under Applicable Law, compiling and communicating to Regulatory Authorities outside the Territory. KHK shall reasonably cooperate with and assist Syndax upon request as required by Syndax in order to comply with Syndax’s regulatory obligations with respect to the Product outside of the Territory. KHK Licensee (or its designee) shall be responsible for filing with the collection, review, assessment, tracking and filing of applicable Regulatory Authorities information related to adverse events Safety Data or Serious Adverse Events associated with the Product in the Field in Territory for the TerritoryField. Not later than the date The safety units from each of the Parties shall meet and agree upon a written pharmacovigilance agreement for exchanging Safety Data and Serious Adverse Events and other safety information relating to the Product prior to Licensee’s first IND submission clinical activity or prior to the first Regulatory Approval in the Territory or such earlier date required by Applicable Law with respect to the Parties’ activities hereunder, the Parties shall enter into a separate, (whichever is first). Such written pharmacovigilance agreement (the “PV Agreement”) containing the specific terms, conditions and obligations of the Parties with respect to the collection, reporting and monitoring of all adverse events, risk management activities and other relevant drug safety matters with respect to Products during the Term. The PV Agreement shall ensure that adverse event Safety Data and Serious Adverse Events associated with the Product and other safety information is exchanged according to a schedule that will permit each Party (and its designees or licenseesor, solely with respect to Amarin, its (sub)licensees) to comply with Applicable Law Laws and regulatory requirements in their respective markets.

Pharmacovigilance. Syndax Within ninety (90) days after the Effective Date, the Parties shall be define and finalize the global safety database holder and actions that the Parties shall be responsible for all aspects of pharmacovigilance of the Product. Syndax (or its designee) shall be responsible for the collection, review, assessment, tracking and filing of information related to adverse events associated employ with the Product in the countries outside the Territory as well as, respect to the [*** *] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 19331934, AS AMENDED. extent required under Applicable Law, compiling Licensed Compounds and communicating Licensed Products to Regulatory Authorities outside the Territory. KHK shall reasonably cooperate with protect patients and assist Syndax upon request as required by Syndax promote their well-being in order to comply with Syndax’s regulatory obligations with respect to the Product outside of the Territory. KHK shall be responsible for the collection, review, assessment, tracking and filing of information related to adverse events associated with the Product in the Field in the Territory. Not later than the date of the first IND submission in the Territory or such earlier date required by Applicable Law with respect to the Parties’ activities hereunder, the Parties shall enter into a separate, written pharmacovigilance agreement (the “PV Pharmacovigilance Agreement”). These responsibilities shall include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between the Parties) containing of adverse event reports, pregnancy reports, and any other information concerning the specific termssafety of any Licensed Product. Such guidelines and procedures shall be in accordance with, conditions and obligations of enable the Parties to fulfill, local and national regulatory reporting obligations under Applicable Laws. Furthermore, such agreed procedure shall be consistent with respect relevant ICH guidelines, except where said guidelines may conflict with existing local regulatory reporting safety reporting requirements, in which case local reporting requirement shall prevail. Each Party shall be responsible for reporting quality complaints, adverse events and safety data related to the collectiona Licensed Product to applicable Regulatory Authorities in its Territory, reporting as well as responding to safety issues and monitoring to all requests of all adverse events, risk management activities and other relevant drug safety matters with respect Regulatory Authorities relating to Products during the Terma Licensed Product in its Territory. The PV Pharmacovigilance Agreement shall ensure that adverse event and other also provide for a worldwide safety information is exchanged according database to a schedule that will permit each be maintained by TESARO at its cost. Each Party (and its designees or licensees) hereby agrees to comply with Applicable Law its respective obligations under such Pharmacovigilance Agreement and regulatory requirements in their respective marketsto cause its Affiliates and permitted sublicensees to comply with such obligations.

Pharmacovigilance. Syndax Sobi shall be responsible for the collection, review, assessment, tracking and filing of information related to adverse events associated with the Bulk Product or Finished Product (solely for purposes of this Section 5.5, references to “Finished Product” shall not include the specific concentrations of Product and diluent referenced in Unit of Product) in the Field in the Territory (whether or not Product Approval has been achieved), in each case in accordance with Laws and this Agreement (and Sobi shall ensure that, in the Development of the Bulk Product, if any, and Commercialization of the Finished Product, it will record, investigate, summarize, notify, report and review all adverse events in accordance with Laws). Auxilium is responsible for maintaining the global safety database holder for the Bulk Product and shall be responsible for all aspects of pharmacovigilance of the Product. Syndax Finished Product and as such Auxilium (or its designee) shall be responsible for the collection, review, assessment, tracking and filing of information related to adverse events associated with the Bulk Product or Finished Product in the countries outside the Territory as well as, Territory. Auxilium and Sobi will coordinate such that Sobi has reasonable and necessary access to such global safety database. The safety units from each of the Parties shall meet and agree upon a written pharmacovigilance agreement for exchanging adverse event and other safety information relating to the *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTEDBulk Product and Finished Product. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. extent required under Applicable Law, compiling and communicating A pharmacovigilance agreement for the period of transition of such responsibilities to Regulatory Authorities outside the Territory. KHK shall reasonably cooperate with and assist Syndax upon request as required by Syndax in order to comply with Syndax’s regulatory obligations with respect to the Product outside of the Territory. KHK Sobi shall be responsible for the collection, review, assessment, tracking and filing of information related to adverse events associated with the Product entered into as promptly as possible but in the Field in the Territory. Not no event later than thirty (30) days from the date of this Agreement, and a final pharmacovigilance agreement shall be entered into by the first IND submission in the Territory or such earlier date required by Applicable Law with respect Parties prior to the Parties’ activities hereunder, date that Sobi becomes the Parties shall enter into a separate, holder of the MAA. Such written pharmacovigilance agreement (the “PV Agreement”) containing the specific terms, conditions and obligations of the Parties with respect to the collection, reporting and monitoring of all adverse events, risk management activities and other relevant drug safety matters with respect to Products during the Term. The PV Agreement agreements shall ensure that adverse event and other safety information is exchanged according to a schedule that will permit each Party (and its designees or licenseessublicensees) to comply with Applicable Law applicable Laws and regulatory requirements in their respective markets.

Pharmacovigilance. Syndax shall be Actelion, as the global safety database holder and of the Product Approvals, shall be responsible for all aspects the collection, review, assessment, tracking and filing of pharmacovigilance information related to adverse events associated with the Bulk Product or Finished Product (solely for purposes of this Section 5.5, references to “Finished Product” shall not include the specific concentrations of Product and diluent referenced in Unit of Product) in the Field in the Territory (whether or not Product Approval has been achieved), in each case in accordance with Laws and this Agreement (and Actelion shall ensure that, in the Development of the Bulk Product and Commercialization of the Finished Product, it will record, investigate, summarize, notify, report and review all adverse events in accordance with Laws). Syndax Auxilium (or its designee) shall be responsible for the collection, review, assessment, tracking and filing of information related to adverse events associated with the Bulk Product or Finished Product in the countries outside the Territory as well as, Territory. The safety units from each of the Parties shall meet and agree upon a written pharmacovigilance agreement for exchanging adverse event and other safety information relating to the *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. extent required under Applicable Law, compiling Bulk Product and communicating Finished Product prior to Regulatory Authorities outside the Territory. KHK shall reasonably cooperate with and assist Syndax upon request as required by Syndax in order to comply with SyndaxActelion’s regulatory obligations with respect first clinical activity or prior to the Product outside of the Territory. KHK shall be responsible for the collection, review, assessment, tracking and filing of information related to adverse events associated with the Product in the Field in the Territory. Not later than the date of the first IND submission Regulatory Approval in the Territory or such earlier date required by Applicable Law with respect to the Parties’ activities hereunder, the Parties shall enter into a separate, (whichever is first). Such written pharmacovigilance agreement (the “PV Agreement”) containing the specific terms, conditions and obligations of the Parties with respect to the collection, reporting and monitoring of all adverse events, risk management activities and other relevant drug safety matters with respect to Products during the Term. The PV Agreement shall ensure that adverse event and other safety information is exchanged according to a schedule that will permit each Party (and its designees or licenseessublicensees) to comply with Applicable Law applicable Laws and regulatory requirements in their respective markets.

Pharmacovigilance. Syndax shall be Subject to the global safety database holder and terms of this Section 5.6.1, each Party shall be responsible for all aspects its respective pharmacovigilance obligations under Applicable Laws. Licensee, as the intended beneficiary under this Agreement of pharmacovigilance the privileges of ownership of the Regulatory Approvals in the Field in the Territory, shall be responsible for the collection, review, assessment, tracking and filing of information related to adverse events associated with the Product in the Territory (whether or not Regulatory Approval has been achieved), in each case in accordance with Applicable Laws and this Agreement (and Licensee shall ensure that, in the Development and Commercialization of the Product, it will record, investigate, summarize, notify, report and review all adverse events in accordance with Applicable Laws, including, for clarity, laws relating to adverse event reporting in the Territory). Syndax VBL (or its designee) shall be responsible for the collection, review, assessment, tracking and filing of information related to adverse events associated with the Product in the countries outside the Territory as well as, to the *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. extent required under Applicable Law, compiling and communicating to Regulatory Authorities outside the Territory. KHK The safety units from each of the Parties shall reasonably cooperate with meet and assist Syndax agree upon request as required by Syndax in order to comply with Syndax’s regulatory obligations with respect a written pharmacovigilance agreement for exchanging adverse event and other safety information relating to the Product outside of promptly following the Territory. KHK shall be responsible for the collectionEffective Date, reviewand in any event, assessment, tracking and filing of information related prior to adverse events associated with the Product in the Field in the Territory. Not later than the date of Licensee’s first clinical activity or prior to the first IND submission Regulatory Approval in the Territory or such earlier date required by Applicable Law with respect to the Parties’ activities hereunder, the Parties shall enter into a separate, (whichever is first). Such written pharmacovigilance agreement (the “PV Agreement”) containing the specific terms, conditions and obligations of the Parties with respect to the collection, reporting and monitoring of all adverse events, risk management activities and other relevant drug safety matters with respect to Products during the Term. The PV Agreement shall ensure that adverse event associated with the Product and other safety information is exchanged according to a schedule that will permit each Party (and its designees or licenseesits sublicensees) to comply with Applicable Law Laws and regulatory requirements in their respective markets. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,AS AMENDED.

Pharmacovigilance. Syndax Subject to the terms of this Agreement, NovaDel and BioAlliance (under the guidance of their respective pharmacovigilance departments, or equivalent thereof) shall define and finalize the responsibilities the parties shall employ to protect patients who receive Licensed Product and promote their well-being in a separate Safety Data Exchange Agreement (“SDEA”), and NovaDel will use Commercially Reasonable Efforts to have its other licensees of Licensed Product agree to be parties to the SDEA. These responsibilities shall include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication and exchange (as between the parties) of safety information such as Adverse Events, pregnancy exposure, lack of efficacy, misuse/abuse; and any other information concerning the safety of the Licensed Product. Such guidelines and procedures will be in accordance with, and enable the parties to fulfill, local and international regulatory reporting obligations to Regulatory Authorities. Furthermore, such agreed procedures shall be the global consistent with relevant FDA and International Council for Harmonization (ICH) guidelines, except where said guidelines may conflict with existing local regulatory safety database holder and reporting requirements, in which case local reporting requirements shall prevail. The SDEA shall provide that: (i) BioAlliance shall be responsible for all aspects of pharmacovigilance of activities regarding the Product. Syndax (or its designee) shall be responsible for the collection, review, assessment, tracking and filing of information related to adverse events associated with the Licensed Product in the countries outside the Territory as well asTerritory, including signal detection, medical surveillance, risk management, global medical literature review and monitoring, Adverse Event reporting and responses to the *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. extent required under Applicable Law, compiling and communicating to Regulatory Authorities outside the Territory. KHK shall reasonably cooperate with and assist Syndax upon request as required by Syndax in order to comply with Syndax’s regulatory obligations with respect to the Product outside of the Territory. KHK shall be responsible for the collection, review, assessment, tracking and filing of information related to adverse events associated with the Product authority requests or enquiries; (ii) in the Field event NovaDel receives safety information regarding the Licensed Product, or information regarding any safety-related regulatory request or inquiry, NovaDel shall notify BioAlliance as soon as practicable, but, in any event, not later than five (5) business days after it receives such safety information, regulatory authority request or query; and (iii) in the Territory. Not event BioAlliance receives safety information regarding the Licensed Product, or information regarding any safety-related regulatory request or inquiry, BioAlliance shall notify NovaDel as soon as practicable, but, in any event, not later than the date of the first IND submission in the Territory five (5) business days after it receives such safety information, regulatory authority request or such earlier date required by Applicable Law with respect to the Parties’ activities hereunder, the Parties shall enter into a separate, written pharmacovigilance agreement (the “PV Agreement”) containing the specific terms, conditions and obligations of the Parties with respect to the collection, reporting and monitoring of all adverse events, risk management activities and other relevant drug safety matters with respect to Products during the Term. The PV Agreement shall ensure that adverse event and other safety information is exchanged according to a schedule that will permit each Party (and its designees or licensees) to comply with Applicable Law and regulatory requirements in their respective marketsquery.

Pharmacovigilance. Syndax shall be Pfizer, as the global safety database holder and of the Product Approval, shall be responsible for all aspects the collection, review, assessment, tracking and filing of pharmacovigilance information related to adverse events associated with the Product in the Field in the Territory (whether or not Product Approval has been achieved), in each case in accordance with applicable Law and this Agreement (and Pfizer shall ensure that, in the Development and Commercialization of the Product, it will record, investigate, summarize, notify, report and review all adverse events in accordance with applicable Law). Syndax Auxilium (or its designee) shall be responsible for the collection, review, assessment, tracking and filing of information related to adverse events associated with the Product in the countries outside the Territory as well as, to the *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. extent required under Applicable Law, compiling and communicating to Regulatory Authorities outside the Territory. KHK The safety units from each of the Parties shall reasonably cooperate with meet and assist Syndax agree upon request as required by Syndax in order to comply with Syndax’s regulatory obligations with respect a written pharmacovigilance agreement for exchanging adverse event and other safety information relating to the Product outside of prior to Pfizer’s first clinical activity or prior to the Territory. KHK first Regulatory Approval in the Territory (whichever is first); provided that Pfizer shall be responsible for maintaining the collection, review, assessment, tracking and filing of information related to adverse events associated with global safety database for the Product in the Field in the TerritoryProduct. Not later than the date of the first IND submission in the Territory or such earlier date required by Applicable Law with respect to the Parties’ activities hereunder, the Parties shall enter into a separate, Such written pharmacovigilance agreement (the “PV Agreement”) containing the specific terms, conditions and obligations of the Parties with respect to the collection, reporting and monitoring of all adverse events, risk management activities and other relevant drug safety matters with respect to Products during the Term. The PV Agreement shall ensure that adverse event and other safety information is exchanged according to a schedule that will permit each Party (and its designees sublicensees or licenseesdesignees) to comply with Applicable Law applicable Laws and regulatory requirements in their respective markets. ** CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

Pharmacovigilance. Syndax shall be the global safety database holder Newsoara and its Affiliates shall be responsible for submitting all aspects required Clinical Trial reports and post-marketing reports of pharmacovigilance adverse drug experiences relating to the Product to the appropriate Regulatory Authorities in the Territory in accordance with Applicable Laws and Guidelines in the Territory and requirements of Regulatory Authorities in the ProductTerritory. Syndax (or Newsoara and its designee) Affiliates shall be responsible for reporting all adverse drug reaction experiences required to be reported to the collection, review, assessment, tracking and filing of information related to adverse events associated with appropriate Regulatory Authorities in the Territory in which the Product is being Developed for the Initial Indication or any Additional Indication or Commercialized, in accordance with Applicable Laws and Guidelines in the countries outside Territory. LBS shall provide to Newsoara, without additional charge, adequate information to support Newsoara’s reporting obligations in the Territory as well asTerritory. Newsoara shall provide to LBS, without additional charge, adequate information to the *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933support LBS’s, AS AMENDED. extent required under Applicable Lawits Affiliates’, compiling licensees’ and communicating to Regulatory Authorities sublicensees’ reporting obligations outside the Territory. KHK shall reasonably cooperate with and assist Syndax upon request as required by Syndax in order to comply with Syndax’s regulatory obligations with respect to the Product outside of the Territory. KHK LBS, its Affiliates or licensees or sublicensees shall be responsible for submitting all Regulatory Filings, including any post-marketing reports of adverse drug experiences, relating to the collection, review, assessment, tracking and filing Product required to be reported to the appropriate Regulatory Authorities outside of information related to adverse events associated the Territory in accordance with the Product in Applicable Laws and Guidelines of the Field in relevant countries outside the Territory. Not later than LBS shall have the date of right to share any and all information received from Newsoara under this Section 7.3 or under Section 7.4 or Section 7.5 and/or any pharmacovigilance agreement between the first IND submission in Parties with LBS’s Affiliates, licensees and sublicensees outside the Territory or such earlier date required by Applicable Law with respect to Territory. Within a reasonable period after the Parties’ activities hereunderEffective Date, the Parties shall will enter into a separate, written pharmacovigilance agreement (the “PV Agreement”) containing the specific on customary terms, conditions and obligations of the Parties with respect to the collection, reporting and monitoring of all adverse events, risk management activities and other relevant drug safety matters with respect to Products during the Term. The PV Agreement shall ensure that adverse event and other safety information is exchanged according to a schedule that will permit each Party (and its designees or licensees) to comply with Applicable Law and regulatory requirements in their respective markets.***Certain Confidential Information Omitted

Pharmacovigilance. Syndax shall be the global safety database holder and shall be responsible for all aspects of pharmacovigilance of the Product. Syndax (or its designee) shall be responsible for The Parties undertake to co-operate in the collection, review, assessment, tracking and filing of information related to adverse events Adverse Events and Adverse Drug Reactions associated with the Product and, in the countries outside case of Nycomed, other products incorporating the Territory as well asCompound for use in fields other than the Field, in accordance with US 21 CFR 312.32, 314.80 and the Pharmacovigilance Standard Operating Procedure (SOP) ("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 *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTEDsale of any Product) and will be attached as Schedule 12.4 to this Agreement. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933Without limitation, AS AMENDEDthe 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. extent required under Applicable Law, compiling Information regarding serious (as defined in Schedule 12.4) Adverse Events and communicating to Regulatory Authorities outside the Territory. KHK serious Adverse Drug Reactions (whether expected or unexpected) of which a Party becomes aware shall reasonably cooperate with and assist Syndax upon request as required by Syndax in order to comply with Syndax’s regulatory obligations with respect be transmitted to the Product outside of impacted Party without undue delay within the Territorytime periods specified in Schedule 12.4. KHK Nycomed shall be responsible for the collection, review, assessment, tracking and filing of information related to adverse events associated with maintaining a global safety database for the Product 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 routine maintenance. Sepracor shall be responsible for AE and ADR processing, expedited, and periodic reporting of AEs and ADRs to the Regulatory Authorities in the Field accordance with all applicable AE regulatory reporting requirements in the Territory. Not later than the date of the first IND submission , and Nycomed shall be responsible for such activities in the Territory or such earlier date ROW, both at their cost and expense. Nycomed shall provide summary reports of adverse events at regular intervals consistent with the intervals required by Applicable Law with respect to the Parties’ activities hereunder, the Parties shall enter into a separate, written pharmacovigilance agreement under international reporting requirements for period reporting (the “PV Agreement”) containing the specific terms, conditions U.S. Periodic Reporting requirements and obligations of the Parties with respect to the collection, reporting and monitoring of all adverse events, risk management activities and other relevant drug safety matters with respect to Products during the Term. The PV Agreement shall ensure that adverse event and other safety information is exchanged according to a schedule that will permit each Party (and its designees or licensees) to comply with Applicable Law and regulatory Periodic Safety Reporting requirements in their respective marketsthe EU), and at other times, upon reasonable written request by Sepracor, such summary reports to be set up in accordance with Periodic Safety Reporting requirements in the EU.