Common use of Adverse Event Reporting Clause in Contracts

Adverse Event Reporting. 9.1 Each Party shall provide to the other Party all information of which it becomes aware (including without limitation, as to SymBio, information provided by its Sublicensees, and in the case of Onconova, information provided by its Licensees) relating to the occurrence of any serious adverse event or any adverse event in connection with the Goods, and shall forward to the other Party information concerning any and all charges, complaints or claims reportable to any Regulatory Authority relating to the Goods that may come to the attention of a Party or its Sublicensees or Licensees (as applicable). 9.2 Details regarding the adverse event reporting and recall procedures shall be set out in a pharmacovigilance agreement or a separate agreement which shall be negotiated and entered into by and between Onconova and SymBio separately within ** after the Effective Date. 9.3 In the event that: (i) SymBio determines that an event, incident, or circumstance has occurred which may result in the need for a recall, market withdrawal or other removal of the Licensed Product or any lot or lots thereof from the market in the Licensed Territory, or Onconova determines that an event, incident, or circumstance that could reasonably adversely affect the Licensed Product in the Licensed Territory has occurred which is reasonably likely to result in the need for a recall, market withdrawal or other removal of the Licensed Product, or any lot or lots thereof from the market; (ii) either Party becomes aware that a Regulatory Authority is threatening or has initiated an action to remove the Licensed Product from the market in the Licensed Territory or, if such event could reasonably adversely affect the Licensed Product in the Licensed Territory, any Regulatory Authority is threatening or has initiated an action to remove the Licensed Product from the market; or (iii) either Party is required by any Regulatory Authority to distribute a “Dear Doctor” letter or its equivalent regarding use of the Licensed Product in the Licensed Territory or, if such event could reasonably adversely affect Licensed Product in the Licensed Territory, any Regulatory Authority has required distribution of a “Dear Doctor” letter or its equivalent regarding use of the Licensed Product, it shall promptly advise the other Party in writing with respect thereto, and shall provide to the other Party copies of all relevant correspondence, notices, and the like in the possession or Control of such Party. In such event, SymBio shall have the sole authority to determine if a recall or other removal of the Licensed Product is required in the Licensed Territory, and shall be responsible for conducting any such recall or other removal of the Licensed Product in the Licensed Territory, whether voluntary or involuntary, or taking such other remedial action required by applicable Laws in the Licensed Territory. At SymBio’s request, Onconova shall assist SymBio, at SymBio’s expense, with respect to any such recall or remedial action, and shall provide SymBio with all information that SymBio may request in connection with its dealings with a Regulatory Authority in connection with such recall or remedial action. For avoidance of doubt, Onconova shall have the sole authority to determine if a recall or other removal of the Licensed Product is required outside of the Licensed Territory. 9.4 The Joint Committee will coordinate the maintenance of safety databases and the preparation of global safety reports.

Adverse Event Reporting. 9.1 (a) Licensor shall be responsible for complying with all Legal Requirements governing adverse events both inside and outside the Territory that occur prior to the transfer of NDA to Licensee, and Licensor's responsibilities shall thereafter continue outside the Territory. Licensor shall submit copies of reports of adverse events to Licensee simultaneously with submission to the applicable Regulatory Authorities, and, following, transfer of the NDA to Licensee, Licensee shall submit copies of adverse events to Licensor simultaneously with submission to the applicable Regulatory Authorities in the Territory. Licensee shall be responsible for complying with all Legal Requirements governing adverse events in the Territory that occur after the transfer of the NDA to Licensee. Each Party shall provide notify the other in a timely manner and in any event within forty eight (48) hours of receiving any notice from a Regulatory Authority, independent review committee, data safety monitoring board or another similar Clinical Trial or post-marketing monitoring body alleging concern regarding a patient safety issue or other material information relevant to the other Party all safety or efficacy of Product. (b) As will be more fully set forth in the Safety Agreement and agreed to pursuant to Section 7.11(d), Licensor shall be responsible at its own cost for establishing and maintaining a global safety database for the Product based on procedures and guidelines so agreed by the Parties for the operation of such database. (c) If during the Product’s Development or Commercialization, the Product becomes subject to adverse effects or information of the type referred to in the last sentence of Section 7.11(a) is received, in each case which it becomes aware (including without limitationLicensee, as in good faith, reasonably believes would seriously impact the long-term viability of Product in the Territory, Licensee shall determine whether or not there exists such serious impact on the long-term viability of such Product and, what if anything, the Parties should do to SymBioaddress the matter. If Licensee, information provided by upon consideration of the relevant facts and in its Sublicenseessole discretion, determines that the Parties are unable to successfully address and resolve the safety issue, Licensee shall provide written notice to Licensor of such determination, which notice shall set forth the reasons therefor, and in the case of Onconova, information provided by Licensee may terminate its Licensees) relating to the occurrence of any serious adverse event or any adverse event in connection with the Goods, rights and shall forward to the other Party information concerning any and all charges, complaints or claims reportable to any Regulatory Authority relating to the Goods that may come to the attention of a Party or its Sublicensees or Licensees (as applicable)obligations under this Agreement upon written notice. 9.2 Details regarding the adverse event reporting and recall procedures shall be set out in a pharmacovigilance agreement or a separate agreement which shall be negotiated and entered into by and between Onconova and SymBio separately within ** after (d) As promptly as practicable following the Effective Date. 9.3 , but in no event later than one hundred eighty (180) days thereafter, Licensee and Licensor will develop and agree upon safety data exchange procedures in a separate and detailed safety agreement (the “Safety Agreement”). Such agreement will describe the coordination of collection, investigation, reporting, and exchange of information concerning adverse events or any other safety problem of any significance, and product quality and product complaints involving adverse events, sufficient to permit each Party, its Affiliates, licensees or sublicensees to comply with its legal obligations. The safety data exchange procedures will be promptly updated if required by changes in Legal Requirements. In the event thatof any conflict or inconsistency between this Agreement and the Safety Agreement with respect to: (i) SymBio determines that an eventsafety-related matters, incident, or circumstance has occurred which may result in the need for a recall, market withdrawal or other removal of the Licensed Product or any lot or lots thereof from the market in the Licensed Territory, or Onconova determines that an event, incident, or circumstance that could reasonably adversely affect the Licensed Product in the Licensed Territory has occurred which is reasonably likely to result in the need for a recall, market withdrawal or other removal of the Licensed Product, or any lot or lots thereof from the marketSafety Agreement shall prevail; and (ii) either Party becomes aware that a Regulatory Authority is threatening or has initiated an action to remove the Licensed Product from the market in the Licensed Territory orany other matter, if such event could reasonably adversely affect the Licensed Product in the Licensed Territory, any Regulatory Authority is threatening or has initiated an action to remove the Licensed Product from the market; or (iii) either Party is required by any Regulatory Authority to distribute a “Dear Doctor” letter or its equivalent regarding use of the Licensed Product in the Licensed Territory or, if such event could reasonably adversely affect Licensed Product in the Licensed Territory, any Regulatory Authority has required distribution of a “Dear Doctor” letter or its equivalent regarding use of the Licensed Product, it this Agreement shall promptly advise the other Party in writing with respect thereto, and shall provide to the other Party copies of all relevant correspondence, notices, and the like in the possession or Control of such Party. In such event, SymBio shall have the sole authority to determine if a recall or other removal of the Licensed Product is required in the Licensed Territory, and shall be responsible for conducting any such recall or other removal of the Licensed Product in the Licensed Territory, whether voluntary or involuntary, or taking such other remedial action required by applicable Laws in the Licensed Territory. At SymBio’s request, Onconova shall assist SymBio, at SymBio’s expense, with respect to any such recall or remedial action, and shall provide SymBio with all information that SymBio may request in connection with its dealings with a Regulatory Authority in connection with such recall or remedial action. For avoidance of doubt, Onconova shall have the sole authority to determine if a recall or other removal of the Licensed Product is required outside of the Licensed Territoryprevail. 9.4 The Joint Committee will coordinate the maintenance of safety databases and the preparation of global safety reports.

Adverse Event Reporting. 9.1 (a) Each Party agrees to comply with any and all Laws that are applicable to it as of the Effective Date and thereafter during the Term relating to Licensed Product safety data collection and reporting (and, if applicable, recalls). Each Party shall provide annually to the other Party all information a listing of which it becomes aware (including without limitationeach serious untoward medical occurrence in a patient or subject who is administered a Licensed Product and shall, should such other Party expressly so request, provide such other Party with additional detail as to SymBio, information provided by its Sublicensees, and in the case such ones of Onconova, information provided by its Licenseessuch occurrences as such other Party may designate. (b) relating to the occurrence of any serious adverse event or any adverse event in connection with the GoodsEach Party shall adhere, and shall forward require that its Affiliates, Sublicensees, Contract Manufacturers, co-marketers and distributors adhere, to all requirements of applicable law and regulations that relate to the investigation and reporting of any CEA Licensed Product Adverse Event, including without limitation an unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease, whether or not considered Captisol or CEA Licensed Product­ related, which occurs or worsens following administration of Captisol or a CEA Licensed Product. Each Party shall provide the other with copies of all relevant reports it obtains (either directly or through any Sublicensee or licensee) of any CEA Licensed Product Adverse Event which is serious (e.g., any such CEA Licensed Product Adverse Event that results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in disability, congenital anomaly or is medically important (i.e., may require other medical or surgical intervention to prevent other serious criteria from occurring)) which such Party information concerning has reason to believe are associated with Captisol within 14 days following (a) submission of any and all charges, complaints or claims reportable to any Regulatory Authority relating such report to the Goods that may come FDA or an equivalent foreign Governmental Body, or (b) receipt from such Party’s Sublicensee, licensee, co-marketer or distributor of any such report to the FDA or an equivalent foreign Governmental Body. Seelos shall also advise CyDex regarding any proposed labeling, Application supplements or registration dossier changes affecting Captisol arising from CEA Licensed Product Adverse Event reports. Reports from Seelos shall be delivered to the attention of Chief Scientific Officer, CyDex, with a Party or its Sublicensees or Licensees (as applicable). 9.2 Details regarding copy to Chief Executive Officer, CyDex, at the adverse event reporting and recall procedures address set forth in Section 13.7. Reports from CyDex shall be delivered to the attention of Chief Operating Officer, Seelos, with a copy to Chief Executive Officer, Seelos, at the address set out forth in a pharmacovigilance agreement or a separate agreement which Section 13.7. The Parties shall be negotiated and entered into by and between Onconova and SymBio separately within ** after the Effective Date. 9.3 In the event that: (i) SymBio determines that an event, incident, or circumstance has occurred which may result in the need for a recall, market withdrawal or other removal mutually cooperate with regard to investigation of the any such serious CEA Licensed Product Adverse Event, whether experienced by Seelos, CyDex or any lot other Affiliate, Sublicensee, sublicensee, co-marketer or lots thereof from the market in the Licensed Territory, distributor of CyDex or Onconova determines that an event, incident, or circumstance that could reasonably adversely affect the Licensed Product in the Licensed Territory has occurred which is reasonably likely to result in the need for a recall, market withdrawal or other removal of the Licensed Product, or any lot or lots thereof from the market; (ii) either Party becomes aware that a Regulatory Authority is threatening or has initiated an action to remove the Licensed Product from the market in the Licensed Territory or, if such event could reasonably adversely affect the Licensed Product in the Licensed Territory, any Regulatory Authority is threatening or has initiated an action to remove the Licensed Product from the market; or (iii) either Party is required by any Regulatory Authority to distribute a “Dear Doctor” letter or its equivalent regarding use of the Licensed Product in the Licensed Territory or, if such event could reasonably adversely affect Licensed Product in the Licensed Territory, any Regulatory Authority has required distribution of a “Dear Doctor” letter or its equivalent regarding use of the Licensed Product, it shall promptly advise the other Party in writing with respect thereto, and shall provide to the other Party copies of all relevant correspondence, notices, and the like in the possession or Control of such Party. In such event, SymBio shall have the sole authority to determine if a recall or other removal of the Licensed Product is required in the Licensed Territory, and shall be responsible for conducting any such recall or other removal of the Licensed Product in the Licensed Territory, whether voluntary or involuntary, or taking such other remedial action required by applicable Laws in the Licensed Territory. At SymBio’s request, Onconova shall assist SymBio, at SymBio’s expense, with respect to any such recall or remedial action, and shall provide SymBio with all information that SymBio may request in connection with its dealings with a Regulatory Authority in connection with such recall or remedial action. For avoidance of doubt, Onconova shall have the sole authority to determine if a recall or other removal of the Licensed Product is required outside of the Licensed TerritorySeelos. 9.4 The Joint Committee will coordinate the maintenance of safety databases and the preparation of global safety reports.

Adverse Event Reporting. 9.1 Each Party shall provide to the other Party all information of which it becomes aware (including without limitation, as to SymBio, information provided by its Sublicensees, and in the case of Onconova, information provided by its Licensees) relating to the occurrence of any serious adverse event or any adverse event in connection with the Goods, and shall forward to the other Party information concerning any and all charges, complaints or claims reportable to any Regulatory Authority relating to the Goods that may come to the attention of a Party or its Sublicensees or Licensees (as applicable). 9.2 Details regarding the adverse event reporting and recall procedures shall be set out in a pharmacovigilance agreement or a separate agreement which shall be negotiated and entered into by and between Onconova and SymBio separately within ** after the Effective Date. 9.3 In the event that: (i) SymBio determines that an event, incident, or circumstance has occurred which may result in the need for a recall, market withdrawal or other removal of the Licensed Product or any lot or lots thereof from the market in the Licensed Territory, or Onconova determines that an event, incident, or circumstance that could reasonably adversely affect the Licensed Product in the Licensed Territory has occurred which is reasonably likely to result in the need for a recall, market withdrawal or other removal of the Licensed Product, or any lot or lots thereof from the market; (ii) either Party becomes aware that a Regulatory Authority is threatening or has initiated an action to remove the Licensed Product from the market in the Licensed Territory or, if such event could reasonably adversely affect the Licensed Product in the Licensed Territory, any Regulatory Authority is threatening or has initiated an action to remove the Licensed Product from the market; or (iii) either Party is required by any Regulatory Authority to distribute a “Dear Doctor” letter or its equivalent regarding use of the Licensed Product in the Licensed Territory or, if such event could reasonably adversely affect Licensed Product in the Licensed Territory, any Regulatory Authority has required distribution of a “Dear Doctor” letter or its equivalent regarding use of the Licensed Product, it shall promptly advise the other Party in writing with respect thereto, and shall provide to the other Party copies of all relevant correspondence, notices, and the like in the possession or Control of such Party. In such event, SymBio shall have the sole authority to determine if a recall or other removal of the Licensed Product is required in the Licensed Territory, and Licensee shall be responsible for conducting reporting Adverse Events in the Field in the Territory to the FDA pursuant to Applicable Law and shall provide a copy of any such recall or other removal expedited reports to Licensor within five (5) days of Licensee's becoming aware of any Adverse Event requiring filing of any such report. Licensor shall be responsible for reporting Adverse Events outside the Licensed Product Field in the Licensed TerritoryTerritory and outside the Territory to the applicable Regulatory Authorities pursuant to Applicable Law and shall provide a copy of any such expedited reports to Licensee within five (5) days of Licensor's becoming aware of any Adverse Event requiring filing of any such report. Without limitation of Section 5.6, whether voluntary each Party shall provide each other with copies of any aggregate periodic reports or involuntarysafety related submissions, or taking such other remedial action required by applicable Laws in the Licensed Territory. At SymBio’s request, Onconova shall assist SymBio, at SymBio’s expenseeach case, with respect to any Licensed Products, to Regulatory Authorities at the time of submission thereof to such recall or remedial action, and Regulatory Authorities. Licensor shall provide SymBio Licensee with all information that SymBio may request in its possession from preclinical and animal toxicology studies necessary for Licensee to comply with its pharmacovigilance responsibilities in the Territory. Each Party shall bear its own costs incurred in connection with its dealings receiving, recording, reviewing, communicating, reporting and responding to Adverse Events. An "ADVERSE EVENT" or "AE" shall mean any untoward medical occurrence in a patient who has been administered a Licensed Product, where the untoward medical occurrence is temporally associated with the use of such Licensed Product, whether or not considered related to such Licensed Product. An AE includes any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of a Regulatory Authority in connection with such recall or remedial actionLicensed Product. For avoidance a marketed Licensed Product, an Adverse Event also includes (a) any failure to produce expected benefits (i.e. lack of doubtefficacy), Onconova shall have the sole authority to determine if a recall and (b) any Adverse Event associated with circumstances of abuse or other removal of the Licensed Product is required outside of the Licensed Territorymisuse. 9.4 The Joint Committee will coordinate the maintenance of safety databases and the preparation of global safety reports.

Adverse Event Reporting. 9.1 (a) Toyama and Cempra, respectively, shall be responsible for complying with all Applicable Laws governing Adverse Events in the Field in (i) the Territory or (ii) Cempra Territory, respectively, which occur after the Effective Date. Each Party shall provide submit copies (with English translations) of reports of such Adverse Events to the other Party all information of which it becomes aware (including without limitation, as to SymBio, information provided by its Sublicensees, and in the case of Onconova, information provided by its Licensees) relating no later than simultaneously with submission to the occurrence of any serious adverse event applicable Regulatory Authorities, provided that, with respect to Adverse Events occurring with respect to Licensed Products for, or any adverse event countries in connection which, Cempra has granted rights to a Third Party with the Goodsrespect thereto, Cempra shall provide such reports to Toyama promptly following Cempra’s receipt thereof. Toyama and Cempra, respectively, shall forward to notify the other Party information concerning any and all charges, complaints or claims reportable to any Regulatory Authority relating to the Goods that may come to the attention of a Party or its Sublicensees or Licensees (as applicable). 9.2 Details regarding the adverse event reporting and recall procedures shall be set out in a pharmacovigilance agreement or a separate agreement which shall be negotiated timely manner and entered into by and between Onconova and SymBio separately in any event within ** after no less than seven (7) Calendar Days of receiving any Serious Adverse Event reports from any human clinical trial of any Licensed Product performed in the Effective Date. 9.3 In the event that: Field in (i) SymBio determines that an eventthe Territory or (ii) Cempra Territory, incidentrespectively, notice from a Regulatory Authority, independent review committee, data safety monitoring board or circumstance has occurred which may result in the need for another similar clinical trial or post-marketing monitoring body alleging significant concern regarding a recall, market withdrawal patient safety issue or other removal material information relevant to the safety or efficacy of the Licensed Product or any lot or lots thereof from the market in the Licensed Territory, or Onconova determines that an event, incident, or circumstance that could reasonably adversely affect the Licensed Product in the Licensed Territory has occurred which is reasonably likely Field. (b) Cempra (or an Affiliate or licensee thereof) shall be responsible for establishing and maintaining a global safety database with respect to result in the need for a recall, market withdrawal or other removal of the Licensed Product, including in accordance with Applicable Laws in Cempra Territory, as shall be further detailed in the Safety Agreement. (c) If during a Licensed Product’s Development or any lot or lots thereof from Commercialization in the market; (ii) either Party becomes aware that a Regulatory Authority is threatening or has initiated an action to remove the Field, such Licensed Product from becomes subject to Adverse Effects or information of the market type referred to in the Licensed Territory orlast sentence of Section 5.2(a) is received, if such event could in each case which either Party, in good faith, reasonably adversely affect believes would seriously impact the long-term viability of a Licensed Product in the Licensed TerritoryField, any Regulatory Authority is threatening or has initiated an action to remove the Licensed Product from the market; or (iii) either Party is required by any Regulatory Authority to distribute a “Dear Doctor” letter may determine whether or its equivalent regarding use not there exists such serious impact on the long-term viability of the such Licensed Product in the Licensed Territory or, if such event could reasonably adversely affect Licensed Product in the Licensed Territory, any Regulatory Authority has required distribution of a “Dear Doctor” letter or its equivalent regarding use of the Licensed Product, it shall promptly advise the other Party in writing with respect thereto, Field and shall provide recommend to the other Party copies of all relevant correspondenceJDC or Joint Commercialization Committee (the “JCC”), noticesas applicable, and what if anything, should be done to address the like in the possession or Control of such Party. In such event, SymBio shall have the sole authority to determine if a recall or other removal of the Licensed Product is required in the Licensed Territory, and shall be responsible for conducting any such recall or other removal of the Licensed Product in the Licensed Territory, whether voluntary or involuntary, or taking such other remedial action required by applicable Laws in the Licensed Territory. At SymBio’s request, Onconova shall assist SymBio, at SymBio’s expense, with respect to any such recall or remedial action, and shall provide SymBio with all information that SymBio may request in connection with its dealings with a Regulatory Authority in connection with such recall or remedial action. For avoidance of doubt, Onconova shall have the sole authority to determine if a recall or other removal of the Licensed Product is required outside of the Licensed Territorymatter. 9.4 The Joint Committee will coordinate the maintenance of safety databases and the preparation of global safety reports.

Adverse Event Reporting. 9.1 (a) Endo shall be responsible for complying with all Regulatory Requirements and other legal requirements governing adverse events in the Territory that occur after the Effective Date. BDSI shall notify Endo on a timely basis of any adverse events occurring at or reported by any Clinical Trial location at which BDSI is responsible for performing BDSI Trials or Supportive Trials or may be conducting the Existing Clinical Trials. Endo shall submit copies of reports of adverse events to BDSI simultaneously with submission to the applicable Regulatory Authorities. Each Party shall provide to notify the other Party all information of which it becomes aware (including without limitation, as to SymBio, information provided by its Sublicensees, in a timely manner and in the case any event within *** of Onconova, information provided by its Licensees) relating to the occurrence of receiving any serious adverse event reports from Clinical Trials that each Party is monitoring, notice from a Regulatory Authority, independent review committee, data safety monitoring board or any adverse event in connection with the Goods, and shall forward another similar clinical trial or post-marketing monitoring body alleging significant concern regarding a patient safety issue or other material information relevant to the other Party information concerning any and all charges, complaints safety or claims reportable to any Regulatory Authority relating to the Goods that may come to the attention efficacy of a Party or its Sublicensees or Licensees (as applicable)Product. 9.2 Details regarding the adverse event reporting and recall procedures shall be set out in a pharmacovigilance agreement or a separate agreement which shall be negotiated and entered into by and between Onconova and SymBio separately within ** after the Effective Date. 9.3 In the event that: (ib) SymBio determines that an event, incident, or circumstance has occurred which may result in the need for a recall, market withdrawal or other removal of the Licensed Product or any lot or lots thereof from the market in the Licensed Territory, or Onconova determines that an event, incident, or circumstance that could reasonably adversely affect the Licensed Product in the Licensed Territory has occurred which is reasonably likely to result in the need for a recall, market withdrawal or other removal of the Licensed Product, or any lot or lots thereof from the market; (ii) either Party becomes aware that a Regulatory Authority is threatening or has initiated an action to remove the Licensed Product from the market in the Licensed Territory or, if such event could reasonably adversely affect the Licensed Product in the Licensed Territory, any Regulatory Authority is threatening or has initiated an action to remove the Licensed Product from the market; or (iii) either Party is required by any Regulatory Authority to distribute a “Dear Doctor” letter or its equivalent regarding use of the Licensed Product in the Licensed Territory or, if such event could reasonably adversely affect Licensed Product in the Licensed Territory, any Regulatory Authority has required distribution of a “Dear Doctor” letter or its equivalent regarding use of the Licensed Product, it shall promptly advise the other Party in writing with respect thereto, and shall provide to the other Party copies of all relevant correspondence, notices, and the like in the possession or Control of such Party. In such event, SymBio shall have the sole authority to determine if a recall or other removal of the Licensed Product is required in the Licensed Territory, and Endo shall be responsible for conducting any establishing and maintaining a global safety database with respect to Product, including in accordance with applicable laws and Regulatory Requirements. (c) If during Product’s development or commercialization, such recall Product becomes subject to adverse effects or other removal information of the Licensed type referred to in the last sentence of Section 4.3(a) is received, in each case which Endo, in good faith, reasonably believes would seriously impact the long-term viability of Product in the Licensed Territory, Endo shall determine whether voluntary or involuntarynot there exists such serious impact on the long-term viability of such Product and, what if anything, the Parties should do to address the matter. If Endo, upon consideration of the relevant facts and in its sole discretion acting in good faith, determines that the Parties are unable to successfully address and resolve the safety issue, Endo shall provide written notice to BDSI of such determination, which notice shall set forth the reasons therefor, and Endo may terminate its rights and obligations under this Agreement upon written notice as provided in Section 14.2(f). (d) Promptly following the Effective Date, but in no event later than *** thereafter, Endo and BDSI will develop and agree upon safety data exchange procedures in a separate and detailed safety agreement (the “Safety Agreement”). Such agreement will describe the coordination of collection, investigation, reporting, and exchange of information concerning adverse events or taking such any other remedial action safety problem of any significance, and product quality and product complaints involving adverse events, sufficient to permit each Party, its Affiliates, licensees or sublicensees to comply with its legal obligations. The safety data exchange procedures will be promptly updated if required by applicable Laws changes in the Licensed Territory. At SymBio’s request, Onconova shall assist SymBio, at SymBio’s expense, with respect to any such recall or remedial action, and shall provide SymBio with all information that SymBio may request in connection with its dealings with a Regulatory Authority in connection with such recall or remedial action. For avoidance of doubt, Onconova shall have the sole authority to determine if a recall or other removal of the Licensed Product is required outside of the Licensed Territorylegal requirements. 9.4 The Joint Committee will coordinate the maintenance of safety databases and the preparation of global safety reports.

Adverse Event Reporting. 9.1 a) NNBL shall be responsible for complying with all Legal Requirements governing adverse events inside the Territory and AZ shall be responsible for complying with Legal Requirements governing adverse events outside the Territory. NNBL shall submit copies of adverse events to AZ simultaneously with submission to the applicable Regulatory Authorities in the Territory. NNBL shall be responsible for complying with all Legal Requirements governing adverse events in the Territory. Each Party shall provide notify the other in a timely manner and in any event within forty eight (48) hours of receiving any notice from a Regulatory Authority, independent review committee, data safety monitoring board or another similar Clinical Trial or post-marketing monitoring body alleging concern regarding a patient safety issue or other material information relevant to the other Party all safety or efficacy of Product b) If during the Product’s Development or Commercialization, the Product becomes subject to adverse effects or information of the type referred to in the last sentence of Section 6.12(a) is received, in each case which it becomes aware (including without limitationNNBL, as in good faith, reasonably believes would seriously impact the long-term viability of Product in the Territory, NNBL shall determine whether or not there exists such serious impact on the long- term viability of such Product and, what if anything, the Parties should do to SymBioaddress the matter. If NNBL, information provided by upon consideration of the relevant facts and in its Sublicenseessole discretion, determines that the Parties are unable to successfully address and resolve the safety issue, NNBL shall provide written notice to AZ of such determination, which notice shall set forth the reasons therefor, and in NNBL may terminate its rights and obligations under this Agreement upon written notice. c) On April 1st, 2019, NNBL and AZ have entered into a separate and detailed safety data exchange agreement (the case “Safety Agreement”). Such agreement describes the coordination of Onconovacollection, investigation, reporting, and exchange of information provided by its Licensees) relating to the occurrence concerning adverse events or any other safety problem of any serious adverse event or any adverse event in connection with the Goodssignificance, and shall forward product quality and product complaints involving adverse events, sufficient to the other Party information concerning any and all chargespermit each Party, complaints its Affiliates, licensees or claims reportable sublicensees to any Regulatory Authority relating to the Goods that may come to the attention of a Party or comply with its Sublicensees or Licensees (as applicable). 9.2 Details regarding the adverse event reporting and recall legal obligations. The safety data exchange procedures shall will be set out promptly updated if required by changes in a pharmacovigilance agreement or a separate agreement which shall be negotiated and entered into by and between Onconova and SymBio separately within ** after the Effective Date. 9.3 Legal Requirements. In the event thatof any conflict or inconsistency between this Agreement and the Safety Agreement with respect to: (i) SymBio determines that an eventsafety-related matters, incident, or circumstance has occurred which may result in the need for a recall, market withdrawal or other removal of the Licensed Product or any lot or lots thereof from the market in the Licensed Territory, or Onconova determines that an event, incident, or circumstance that could reasonably adversely affect the Licensed Product in the Licensed Territory has occurred which is reasonably likely to result in the need for a recall, market withdrawal or other removal of the Licensed Product, or any lot or lots thereof from the marketSafety Agreement shall prevail; and (ii) either Party becomes aware that a Regulatory Authority is threatening or has initiated an action to remove the Licensed Product from the market in the Licensed Territory orany other matter, if such event could reasonably adversely affect the Licensed Product in the Licensed Territory, any Regulatory Authority is threatening or has initiated an action to remove the Licensed Product from the market; or (iii) either Party is required by any Regulatory Authority to distribute a “Dear Doctor” letter or its equivalent regarding use of the Licensed Product in the Licensed Territory or, if such event could reasonably adversely affect Licensed Product in the Licensed Territory, any Regulatory Authority has required distribution of a “Dear Doctor” letter or its equivalent regarding use of the Licensed Product, it this Agreement shall promptly advise the other Party in writing with respect thereto, and shall provide to the other Party copies of all relevant correspondence, notices, and the like in the possession or Control of such Party. In such event, SymBio shall have the sole authority to determine if a recall or other removal of the Licensed Product is required in the Licensed Territory, and shall be responsible for conducting any such recall or other removal of the Licensed Product in the Licensed Territory, whether voluntary or involuntary, or taking such other remedial action required by applicable Laws in the Licensed Territory. At SymBio’s request, Onconova shall assist SymBio, at SymBio’s expense, with respect to any such recall or remedial action, and shall provide SymBio with all information that SymBio may request in connection with its dealings with a Regulatory Authority in connection with such recall or remedial action. For avoidance of doubt, Onconova shall have the sole authority to determine if a recall or other removal of the Licensed Product is required outside of the Licensed Territoryprevail. 9.4 The Joint Committee will coordinate the maintenance of safety databases and the preparation of global safety reports.

Adverse Event Reporting. 9.1 Each Party of Purchaser and Xxxxxxxx shall provide promptly notify the other of any significant adverse events that relate to the Product or are required in accordance with any Requirements of Law, including adverse drug experiences and governmental inquiries, and each of Purchaser and Xxxxxxxx shall cooperate with the other in connection therewith as reasonably requested by the other party and as follows: (a) Serious Adverse Events related to the Product of which Xxxxxxxx becomes aware shall be submitted to Purchaser within three (3) business days but no more than four (4) calendar days from the date Xxxxxxxx first becomes aware of such Serious Adverse Event. Non-Serious Adverse Events for the Product that are reported to Xxxxxxxx shall be submitted to Purchaser no more than one (1) month from the date received by Xxxxxxxx; provided, however, that medical and scientific judgment should be exercised in deciding whether expedited reporting is appropriate in other situations, such as important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent a Serious Adverse Event outcome. In no event, shall Xxxxxxxx submit to Purchaser any adverse event report or similar information that does not relate to the Product. (b) Serious Adverse Events related to the Product of which Purchaser becomes aware shall be submitted to Xxxxxxxx within three (3) business days but no more than four (4) calendar days from the date Purchaser first became aware of such Serious Adverse Event. Upon the request of Xxxxxxxx, Purchaser shall submit to Xxxxxxxx any Non-Serious Adverse Events for the Product. (c) Until the reporting procedures referenced in Section 7.09 (e) herein have been instituted by Purchaser and Xxxxxxxx, a "Serious Adverse Event" for the Product shall have the meaning set forth in 21 C.F.R. (S) 314.80(a), as amended from time to time, and a "Non-Serious Adverse Event" for the Product is defined as an untoward medical occurrence at any dose of the Product that is not a Serious Adverse Event. (d) As provided in Section 7.01(b) above, Purchaser shall be solely responsible for reporting adverse events to Governmental Entities to the extent required by applicable Requirements of Law. Xxxxxxxx shall report all Serious Adverse Events and all Non-Serious Adverse Events involving the Product learned by it to: Women First HealthCare, Inc. 00000 Xx Xxxxxx Xxxx, Xxxxx 000 Xxx Xxxxx, XX 00000 Facsimile: (000) 000-0000 Telephone: (000) 000-0000 Attention: Xxxxxxx Xxxxx A CIOMS-I form or a form that contains the data elements of a CIOMS-I form is recommended. (e) As soon as reasonably practicable after the Closing Date, Purchaser and Xxxxxxxx shall discuss and develop mutually acceptable guidelines and procedures for the receipt, recordation, reporting, communication (as between the parties) and exchange of Serious Adverse Event and Non-Serious Adverse Event information, as applicable, to the other Party all information of which it becomes aware (including without limitation, as to SymBio, information party; provided by its Sublicensees, that Purchaser shall have exclusive responsibility for communications with Governmental Entities concerning the Product and in the case of Onconova, information provided by its Licensees) relating to the occurrence of any serious adverse event or any adverse event related Serious Adverse Event and Non-Serious Adverse Event information. The parties shall bear their respective costs incurred in connection with the Goodsreceiving, recording, reviewing, reporting, communicating and shall forward to the exchanging with each other Party information concerning any and all chargesregarding and, complaints or claims reportable to any Regulatory Authority relating to the Goods that may come to the attention of a Party or its Sublicensees or Licensees (as applicable), reporting and responding to Adverse Events. 9.2 Details regarding (f) At the adverse event request of Xxxxxxxx, Purchaser shall cease reporting all Serious Adverse Events involving the Product to Xxxxxxxx. Xxxxxxxx shall continue to make reports of Serious Adverse Events and recall procedures shall be set out Non-Serious Adverse Events to Purchaser in a pharmacovigilance agreement or a separate agreement which shall be negotiated and entered into by and between Onconova and SymBio separately within ** after the Effective Dateaccordance with this Section 7.09. 9.3 In the event that: (i) SymBio determines that an event, incident, or circumstance has occurred which may result in the need for a recall, market withdrawal or other removal of the Licensed Product or any lot or lots thereof from the market in the Licensed Territory, or Onconova determines that an event, incident, or circumstance that could reasonably adversely affect the Licensed Product in the Licensed Territory has occurred which is reasonably likely to result in the need for a recall, market withdrawal or other removal of the Licensed Product, or any lot or lots thereof from the market; (ii) either Party becomes aware that a Regulatory Authority is threatening or has initiated an action to remove the Licensed Product from the market in the Licensed Territory or, if such event could reasonably adversely affect the Licensed Product in the Licensed Territory, any Regulatory Authority is threatening or has initiated an action to remove the Licensed Product from the market; or (iii) either Party is required by any Regulatory Authority to distribute a “Dear Doctor” letter or its equivalent regarding use of the Licensed Product in the Licensed Territory or, if such event could reasonably adversely affect Licensed Product in the Licensed Territory, any Regulatory Authority has required distribution of a “Dear Doctor” letter or its equivalent regarding use of the Licensed Product, it shall promptly advise the other Party in writing with respect thereto, and shall provide to the other Party copies of all relevant correspondence, notices, and the like in the possession or Control of such Party. In such event, SymBio shall have the sole authority to determine if a recall or other removal of the Licensed Product is required in the Licensed Territory, and shall be responsible for conducting any such recall or other removal of the Licensed Product in the Licensed Territory, whether voluntary or involuntary, or taking such other remedial action required by applicable Laws in the Licensed Territory. At SymBio’s request, Onconova shall assist SymBio, at SymBio’s expense, with respect to any such recall or remedial action, and shall provide SymBio with all information that SymBio may request in connection with its dealings with a Regulatory Authority in connection with such recall or remedial action. For avoidance of doubt, Onconova shall have the sole authority to determine if a recall or other removal of the Licensed Product is required outside of the Licensed Territory. 9.4 The Joint Committee will coordinate the maintenance of safety databases and the preparation of global safety reports.

Adverse Event Reporting. 9.1 Each Party (a) The Parties agree, within *** after the Development Transfer Date, to commence negotiations of a detailed pharmacovigilance agreement. Such pharmacovigilance agreement shall provide to for the other Party all exchange by the Parties of any information of which it a Party becomes aware (including without limitationin the Territory concerning any side effect, as to SymBioinjury, information provided by its Sublicenseestoxicity or sensitivity reaction, and or any unexpected incident, in or involving a research patient or subject or, in the case of Onconovanon-clinical studies, an animal in a toxicology study, and the seriousness thereof, whether or not determined to be attributable to any Licensed Product or Compound (hereinafter “Adverse Experience”), including information provided regarding Adverse Experiences received by either Party from Third Parties. It is understood that each Party and its LicenseesAffiliates or licensees/sublicensees shall have the right to disclose such information as reasonably necessary to comply with Regulatory Authorities within the Territory with respect to their filings and activities related to Compounds, Licensed Products or Ocular Products, as applicable. (b) relating With respect to Adverse Experiences that are serious and associated with the occurrence use of any serious adverse event Licensed Product, whether or any adverse event in connection with the Goods, and shall forward not determined to the other Party information concerning any and all charges, complaints or claims reportable be attributable to any Regulatory Authority relating to the Goods that may come to the attention of a Party or its Sublicensees or Licensees such Licensed Product (as applicablehereinafter “Serious Adverse Experience”). 9.2 Details regarding the adverse event reporting and recall procedures shall be set out in a pharmacovigilance agreement or a separate agreement which shall be negotiated and entered into by and between Onconova and SymBio separately within ** after the Effective Date. 9.3 In the event that: , (i) SymBio determines that an event, incident, or circumstance has occurred which may result in the need for a recall, market withdrawal or other removal of the Licensed Product or any lot or lots thereof from the market in the Licensed Territory, or Onconova determines that an event, incident, or circumstance that could reasonably adversely affect the Licensed Product in the Licensed Territory has occurred which is reasonably likely to result in the need for a recall, market withdrawal or other removal of the Licensed Product, or any lot or lots thereof from the market; (ii) event either Party becomes aware that receives a Regulatory Authority is threatening or has initiated an action to remove Serious Adverse Experience report from any Third Party, the Licensed Product from the market in the Licensed Territory or, if Party receiving such event could reasonably adversely affect the Licensed Product in the Licensed Territory, any Regulatory Authority is threatening or has initiated an action to remove the Licensed Product from the market; or (iii) either Party is required by any Regulatory Authority to distribute a “Dear Doctor” letter or its equivalent regarding use of the Licensed Product in the Licensed Territory or, if such event could reasonably adversely affect Licensed Product in the Licensed Territory, any Regulatory Authority has required distribution of a “Dear Doctor” letter or its equivalent regarding use of the Licensed Product, it report shall promptly advise notify the other Party in writing with respect thereto***CONFIDENTIAL PORTIONS OF THIS AGREEMENT HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT. within two (2) calendar days of receipt of such report, and (ii) in the event a Serious Adverse Experience report is to be generated by either Party, such Party shall provide its report to the other Party copies of all relevant correspondence, noticeswithin four (4) calendar days for death and life threatening, and the like in the possession or Control of such Party. In such eventseven (7) calendar days for all other Serious Adverse Experience reports. (c) With respect to INDs filed by Merck, SymBio shall have the sole authority to determine if a recall or other removal of the Licensed Product is required in the Licensed Territory, and Merck shall be responsible for conducting reporting to Regulatory Authorities any such recall Adverse Events, whether in non-clinical or other removal clinical studies for or during Commercialization of the any Licensed Product in the Licensed TerritoryField in compliance with the requirements of the United States Federal Food, whether voluntary Drug, and Cosmetic Act, 21 U.S.C. § 321 et seq., the regulations promulgated thereunder, and equivalent foreign Laws. It is understood that these Adverse Experience reporting requirement provisions are based on the policies and procedures of Merck and regulatory requirements. (d) The relevant information can be transmitted by e-mail, facsimile, overnight courier or involuntary, or taking such any other remedial action required by applicable Laws means the Parties agree in the Licensed Territoryseparate pharmacovigilance agreement. At SymBio’s requestTransmission to Lpath: Drug Safety Vice President of Drug Development Lpath, Onconova shall assist SymBioInc. 0000 Xxxxxx Xxxxxx, at SymBio’s expenseSuite A San Diego, with respect California 92121 United States of America *** Facsimile: 0-000-000-0000 Transmission to any such recall or remedial actionMerck: Global Drug Safety Xxxxxxxxxxx Xxxxxx 000 00000 Xxxxxxxxx, and shall provide SymBio with all information that SymBio may request in connection with its dealings with a Regulatory Authority in connection with such recall or remedial action. For avoidance of doubt, Onconova shall have the sole authority to determine if a recall or other removal of the Licensed Product is required outside of the Licensed Territory. 9.4 The Joint Committee will coordinate the maintenance of safety databases and the preparation of global safety reports.Xxxxxxx Drug Safety Mailbox: Xxxx.xxxxxx@xxxxx.xx Facsimile: ***