Common use of Adverse Drug Event Reporting and Post Marketing Surveillance Clause in Contracts

Adverse Drug Event Reporting and Post Marketing Surveillance. (a) Each Party, on behalf of itself, its Affiliates and any permitted sublicensees, shall advise the other Party, by telephone or facsimile, promptly but in no event later than seventy-two (72) hours or such shorter time period as may be required by a Competent Authority after a Party, its Affiliates and/or sublicensees becomes aware of any serious adverse drug event (as defined in 21 CFR Section 312.32(a) or its equivalent under Applicable Law(s) as the same may be amended, supplemented or replaced from time to time) (a “SADE”) involving the Product or the Compound. Such advising Party shall provide the other Party with a written report delivered by confirmed facsimile of any SADE, stating the full facts known to such Party, including customer name, address, telephone number, batch, lot and serial numbers, and other information as required by Applicable Laws. After receipt by the Parties of an Approval Letter in any country, Strata shall have full responsibility in such country for: (i) monitoring such SADEs; (ii) data collection activities that occur between Strata and the patient or medical professional, as appropriate, including any follow-up inquiries which Strata deems necessary or appropriate; and (iii) meeting the requirements of the Competent Authorities, including the submission of SADE individual reports and periodic reports as necessary. As the holder of the Marketing Authorizations, any reporting (and follow-up thereto) to the Competent Authorities relating to the Compound and the Product in the Field in the Territory shall remain the responsibility of Strata. (b) In the event either Party requires information regarding SADEs with respect to reports required to be filed by it in order to comply with Applicable Laws, including obligations to report SADEs to the Competent Authorities, each Party agrees to provide such information to the other in sufficient time to enable each Party to report such SADEs to the Competent Authorities in accordance with Applicable Laws. (c) If the report of an SADE causes a Competent Authority to request a Labelling revision and/or any other corrective action, or if Strata believes it is necessary to have a Labelling revision or conduct a post marketing surveillance program as a result of an SADE, then Strata shall determine all of the material terms and conditions of such Labelling revision, corrective action or post marketing surveillance program in consultation with the applicable Competent Authority. Upon Strata’s request, Micrologix will cooperate with Strata with respect to any of the foregoing. The costs of such Labelling revision, corrective action or post marketing surveillance program shall be borne one hundred percent (100%) by Strata. Notwithstanding the foregoing, however, the Parties agree that if any such Labelling revision or corrective action or post marketing surveillance program is due to the negligence or willful misconduct in the conduct by Micrologix and/or its Representatives of the pre-clinical and clinical research and development activities in connection with the Product prior to and after the Effective Date, then, in such event, the costs of any such Labelling revision, corrective action, or post marketing surveillance program, as the case may be, shall be borne one hundred percent (100%) by Micrologix. Subject to Section 5.3 and Section 6.2, the Parties agree that Strata shall own the results and underlying data from any Phase IV Study. (d) Within thirty (30) days of the filing of each report with the FDA on drug related adverse events associated with the Compound as may be required under Applicable Laws, each Party will provide to the other Party particulars of such adverse events.

Adverse Drug Event Reporting and Post Marketing Surveillance. (a) Each Party, on behalf of itself, its Affiliates and any permitted sublicensees, shall advise the other Party, by telephone or facsimile, promptly but in no event later than seventy-two five (725) hours or such shorter time period as may be required by a Competent Authority calendar days after a Party, its Affiliates and/or or sublicensees becomes aware of any serious adverse drug event experience (as defined in 21 CFR Section §312.32(a) or its equivalent under Applicable Law(s) as the same may be amended, supplemented or replaced from time to time) time (a “SADE”) involving the Product or the CompoundProduct. Such advising Party shall provide the other Party with a written report delivered by confirmed facsimile of any SADE, stating the full facts known to such Party, including investigator name, site details, if any, customer name, if any, address, telephone number, batch, lot and serial numbers, and other information as required by Applicable Laws. After receipt by the Parties of an Approval Letter in any country, Strata Fujisawa shall have full responsibility in such country (along with the assistance and cooperation of Cardiome) for: (i) monitoring such SADEsall adverse experiences, including SADEs (collectively, “AEs”); (ii) data collection activities that occur between Strata Fujisawa and the patient or medical professional, as appropriate, including any follow-up inquiries which Strata Fujisawa deems necessary or appropriate; and (iii) meeting the requirements of the Competent Authorities, including the submission of SADE AE individual reports and periodic reports as necessaryreports. As the holder of the Marketing Authorizations, any reporting (and follow-up thereto) to the Competent Authorities relating to the Compound and the Product in the Field in the Territory shall remain the responsibility of StrataFujisawa. (b) In the event either Party requires information regarding SADEs AEs with respect to reports required to be filed by it in order to comply with Applicable Laws, including obligations to report SADEs AEs to the Competent Authorities, each Party agrees to provide such information to the other in sufficient time to enable each Party to report such SADEs AEs to the Competent Authorities in accordance with Applicable Laws. (c) Each Party shall designate to the other Party a qualified person under Applicable Laws to be responsible for AE reporting in each country in the Territory. (d) If the report of an SADE AE causes a Competent Authority to request a Labelling Labeling revision and/or or any other corrective action, or if Strata Fujisawa believes it is necessary to have a Labelling Labeling revision or conduct a post marketing surveillance program as a result of an SADEAE, then Strata Fujisawa shall determine all of the material terms and conditions of such Labelling Labeling revision, corrective action or post marketing surveillance program in consultation with the applicable Competent Authority. Upon StrataFujisawa’s request, Micrologix Cardiome will cooperate with Strata Fujisawa with respect to any of the foregoing. The costs of such Labelling Labeling revision, corrective action or post marketing surveillance program shall be borne one hundred percent (100%) by StrataFujisawa. Notwithstanding the foregoing, however, the Parties agree that if any such Labelling Labeling revision or corrective action or post marketing surveillance program is due to the negligence or willful misconduct in the conduct of the Development by Micrologix and/or Cardiome or its Representatives or their conduct of the pre-clinical and clinical research and development activities in connection with the Product or RSD1235 prior to and or after the Effective Signing Date, then, in such event, the costs of any such Labelling Labeling revision, corrective action, or post marketing surveillance program, as the case may be, shall be borne one hundred percent (100%) by Micrologix. Subject to Section 5.3 and Section 6.2, the Parties agree that Strata shall own the results and underlying data from any Phase IV StudyCardiome. (d) Within thirty (30) days of the filing of each report with the FDA on drug related adverse events associated with the Compound as may be required under Applicable Laws, each Party will provide to the other Party particulars of such adverse events.

Adverse Drug Event Reporting and Post Marketing Surveillance. (a) 3.2.1 Each Party, on behalf of itself, its Affiliates and any permitted sublicenseesSublicensees, shall advise the other Party, by telephone or facsimile, promptly as soon as reasonably possible but in no event later than seventy-two (72) hours or such shorter [Redacted - time period as may be required by a Competent Authority period] after the first of a Party, its Affiliates and/or sublicensees Affiliate or a Sublicensee becomes aware (provided that the Party is aware) of any serious adverse drug event experience (as defined in 21 CFR Section §312.32(a) or its equivalent under Applicable Law(s) Laws, as the same may be amended, supplemented or replaced from time to time) (a “SADE”) involving the Product or the CompoundProduct. Such advising Party shall provide the other Party with a written report delivered by confirmed facsimile of any SADE, stating the full facts known to such Party, including investigator name, site details, if any, customer name, if any, address, telephone number, batch, lot and serial numbers, and other information as required by Applicable Laws. After receipt by the Parties of an Regulatory Approval Letter of a Product in any countrycountry in the Territory, Strata MERCK shall have full responsibility responsibility, as the holder of such Regulatory Approval, in such country (along with the assistance and cooperation of CARDIOME) for: (i) monitoring such SADEsall adverse experiences, including SADEs (collectively, “AEs”); (ii) data collection activities that occur between Strata MERCK and the patient or medical professional, as appropriate, including any follow-up inquiries which Strata MERCK deems necessary or appropriate; and (iii) meeting the requirements of the Competent Regulatory Authorities, including the submission of SADE AE individual reports and periodic reports as necessaryreports. As the holder of the Marketing AuthorizationsRegulatory Approvals, any reporting (and follow-up thereto) to the Competent Regulatory Authorities relating with respect to the Compound and the Product in the Field in the Territory shall remain the responsibility of StrataMERCK. (b) 3.2.2 In the event either Party requires information regarding SADEs AEs with respect to reports required to be filed by it in order to comply with Applicable Laws, including obligations to report SADEs AEs to the Competent Regulatory Authorities, each Party agrees to provide such information to the other in sufficient time to enable each Party to report such SADEs AEs to the Competent Regulatory Authorities in accordance with Applicable Laws. (c) 3.2.3 Each Party shall designate to the other Party a qualified person under Applicable Laws to be responsible for AE reporting in each country in the Territory. 3.2.4 If the report of an SADE AE causes a Competent Regulatory Authority to request a Labelling labeling revision and/or or any other corrective action, or if Strata MERCK believes it is necessary to have a Labelling labeling revision or conduct a post marketing surveillance program as a result of an SADEAE, then Strata MERCK shall determine determine, in its sole discretion, all of the material terms and conditions of such Labelling labeling revision, corrective action or post marketing surveillance program in consultation with the applicable Competent AuthorityRegulatory Authority and CARDIOME. Upon StrataMERCK’s request, Micrologix CARDIOME will cooperate with Strata MERCK with respect to any of the foregoing. The costs of such Labelling Labeling revision, corrective action or post marketing surveillance program shall be borne one hundred percent (100%) by Strata. Notwithstanding the foregoing, however, the Parties agree that if any such Labelling revision or corrective action or post marketing surveillance program is due to the negligence or willful misconduct in the conduct by Micrologix and/or its Representatives of the pre-clinical and clinical research and development activities in connection with the Product prior to and after the Effective Date, then, in such event, the costs of any such Labelling revision, corrective action, or post marketing surveillance program, as the case may be, shall be borne one hundred percent (100%) by Micrologix. Subject to Section 5.3 and Section 6.2, the Parties agree that Strata shall own the results and underlying data from any Phase IV StudyMERCK. (d) Within thirty (30) days of the filing of each report with the FDA on drug related adverse events associated with the Compound as may be required under Applicable Laws, each Party will provide to the other Party particulars of such adverse events.

Adverse Drug Event Reporting and Post Marketing Surveillance. (a) 4.4.1 Each Partyparty, on behalf of itself, its Affiliates and any permitted sublicenseesSublicensees, shall advise the other Partyparty, by telephone or facsimile, promptly but in no event later than seventy-two five (725) hours business days or such shorter time period as may be required by a Competent Authority after a Partyparty, its Affiliates and/or sublicensees Sublicensees becomes aware of any serious adverse drug event (as defined in 21 CFR Section 312.32(a) or its equivalent under Applicable Law(s) as the same may be amended, supplemented or replaced from time to time) (a “SADE”) involving the Product Licensed Products or the Compound. Such advising Party party shall provide the other Party party with a written report delivered by confirmed facsimile of any SADE, stating the full facts known to such Partyparty, including customer name, address, telephone number, batch, lot and serial numbers, and other information as required by Applicable Laws. After receipt by the Parties parties of an Approval Letter in any country, Strata the Company shall have full responsibility in such country for: (i) monitoring such SADEs; (ii) data collection activities that occur between Strata the Company and the patient or medical professional, as appropriate, including any follow-up inquiries which Strata the Company deems necessary or appropriate; and (iii) meeting the requirements of the Competent Authorities, including the submission of SADE individual reports and periodic reports as necessary. As the holder of the Marketing Authorizations, any reporting (and follow-up thereto) to the Competent Authorities relating to the Compound and the Product Licensed Products in the Field of Use in the Territory shall remain the responsibility of Stratathe Company. Subject to Section 6.5, the Company will bear all costs and expenses of compliance with this Section 4.4.1. Any information disclosed to Licensor pursuant to this Article 4 may be disclosed as required by Competent Authorities or Applicable Laws, and may be disclosed to other licensees of Licensor who are licensees of the same product. Subject to the foregoing, such information shall be treated as confidential pursuant to Article 16 of this Agreement. (b) 4.4.2 In the event either Party party requires information regarding SADEs with respect to reports required to be filed by it in order to comply with Applicable Laws, including obligations to report SADEs to the Competent Authorities, each Party party agrees to provide such information to the other in sufficient time to enable each Party party to report such SADEs to the Competent Authorities in accordance with Applicable Laws. (c) If the report of an SADE causes a Competent Authority to request a Labelling revision and/or any other corrective action, or if Strata believes it is necessary to have a Labelling revision or conduct a post marketing surveillance program as a result of an SADE, then Strata shall determine all of the material terms and conditions of such Labelling revision, corrective action or post marketing surveillance program in consultation with the applicable Competent Authority. Upon Strata’s request, Micrologix will cooperate with Strata with respect to any of the foregoing. The costs of such Labelling revision, corrective action or post marketing surveillance program shall be borne one hundred percent (100%) by Strata. Notwithstanding the foregoing, however, the Parties agree that if any such Labelling revision or corrective action or post marketing surveillance program is due to the negligence or willful misconduct in the conduct by Micrologix and/or its Representatives of the pre-clinical and clinical research and development activities in connection with the Product prior to and after the Effective Date, then, in such event, the costs of any such Labelling revision, corrective action, or post marketing surveillance program, as the case may be, shall be borne one hundred percent (100%) by Micrologix. Subject to Section 5.3 and Section 6.2, the Parties agree that Strata shall own the results and underlying data from any Phase IV Study. (d) 4.4.3 Within thirty (30) days of the filing of each report with the FDA on drug related adverse events associated with the Compound as may be required under Applicable Laws, each Party party will provide to the other Party party particulars of such adverse events.

Adverse Drug Event Reporting and Post Marketing Surveillance. (a) Each Party, on behalf of itself, its Affiliates and any permitted sublicensees, shall advise the other Party, by telephone or facsimile, promptly but in no event later than seventy-two (72) hours or such shorter time period as may be required by a Competent Authority after a Party, its Affiliates and/or sublicensees becomes aware of any serious adverse drug event (as defined in 21 CFR Section 312.32(a) or its equivalent under Applicable Law(s) as the same may be amended, supplemented or replaced from time to time) (a “"SADE”") involving the Product or the Compound. Such advising Party shall provide the other Party with a written report delivered by confirmed facsimile of any SADE, stating the full facts known to such Party, including customer name, address, telephone number, batch, lot and serial numbers, and other information as required by Applicable Laws. After receipt by the Parties of an Approval Letter in any country, Strata shall have full responsibility in such country for: (i) monitoring such SADEs; (ii) data collection activities that occur between Strata and the patient or medical professional, as appropriate, including any follow-up inquiries which Strata deems necessary or appropriate; and (iii) meeting the requirements of the Competent Authorities, including the submission of SADE individual reports and periodic reports as necessary. As the holder of the Marketing Authorizations, any reporting (and follow-up thereto) to the Competent Authorities relating to the Compound and the Product in the Field in the Territory shall remain the responsibility of Strata. (b) . In the event either Party requires information regarding SADEs with respect to reports required to be filed by it in order to comply with Applicable Laws, including obligations to report SADEs to the Competent Authorities, each Party agrees to provide such information to the other in sufficient time to enable each Party to report such SADEs to the Competent Authorities in accordance with Applicable Laws. (c) . If the report of an SADE causes a Competent Authority to request a Labelling revision and/or any other corrective action, or if Strata believes it is necessary to have a Labelling revision or conduct a post marketing surveillance program as a result of an SADE, then Strata shall determine all of the material terms and conditions of such Labelling revision, corrective action or post marketing surveillance program in consultation with the applicable Competent Authority. Upon Strata’s 's request, Micrologix will cooperate with Strata with respect to any of the foregoing. The costs of such Labelling revision, corrective action or post marketing surveillance program shall be borne one hundred percent (100%) by Strata. Notwithstanding the foregoing, however, the Parties agree that if any such Labelling revision or corrective action or post marketing surveillance program is due to the negligence or willful misconduct in the conduct by Micrologix and/or its Representatives of the pre-clinical and clinical research and development activities in connection with the Product prior to and after the Effective Date, then, in such event, the costs of any such Labelling revision, corrective action, or post marketing surveillance program, as the case may be, shall be borne one hundred percent (100%) by Micrologix. Subject to Section 5.3 and Section 6.2, the Parties agree that Strata shall own the results and underlying data from any Phase IV Study. (d) . Within thirty (30) days of the filing of each report with the FDA on drug related adverse events associated with the Compound as may be required under Applicable Laws, each Party will provide to the other Party particulars of such adverse events.

Adverse Drug Event Reporting and Post Marketing Surveillance. (a) Each Party, on behalf of itself, its Affiliates and any permitted sublicensees, shall advise the other Party, by telephone or facsimile, promptly but in no event later than seventy-two five (725) hours or such shorter time period as may be required by a Competent Authority calendar days after a Party, its Affiliates and/or or sublicensees becomes aware of any serious adverse drug event experience (as defined in 21 CFR Section §312.32(a) or its equivalent under Applicable Law(s) as the same may be amended, supplemented or replaced from time to time) time (a “"SADE”") involving the Product or the CompoundProduct. Such advising Party shall provide the other Party with a written report delivered by confirmed facsimile of any SADE, stating the full facts known to such Party, including investigator name, site details, if any, customer name, if any, address, telephone number, batch, lot and serial numbers, and other information as required by Applicable Laws. After receipt by the Parties of an Approval Letter in any country, Strata Fujisawa shall have full responsibility in such country (along with the assistance and cooperation of Cardiome) for: (i) monitoring such SADEsall adverse experiences, including SADEs (collectively, "AEs"); (ii) data collection activities that occur between Strata Fujisawa and the patient or medical professional, as appropriate, including any follow-up inquiries which Strata Fujisawa deems necessary or appropriate; and (iii) meeting the requirements of the Competent Authorities, including the submission of SADE AE individual reports and periodic reports as necessaryreports. As the holder of the Marketing Authorizations, any reporting (and follow-up thereto) to the Competent Authorities relating to the Compound and the Product in the Field in the Territory shall remain the responsibility of StrataFujisawa. (b) In the event either Party requires information regarding SADEs AEs with respect to reports required to be filed by it in order to comply with Applicable Laws, including obligations to report SADEs AEs to the Competent Authorities, each Party agrees to provide such information to the other in sufficient time to enable each Party to report such SADEs AEs to the Competent Authorities in accordance with Applicable Laws. (c) Each Party shall designate to the other Party a qualified person under Applicable Laws to be responsible for AE reporting in each country in the Territory. (d) If the report of an SADE AE causes a Competent Authority to request a Labelling Labeling revision and/or or any other corrective action, or if Strata Fujisawa believes it is necessary to have a Labelling Labeling revision or conduct a post marketing surveillance program as a result of an SADEAE, then Strata Fujisawa shall determine all of the material terms and conditions of such Labelling Labeling revision, corrective action or post marketing surveillance program in consultation with the applicable Competent Authority. Upon Strata’s Fujisawa's request, Micrologix Cardiome will cooperate with Strata Fujisawa with respect to any of the foregoing. The costs of such Labelling Labeling revision, corrective action or post marketing surveillance program shall be borne one hundred percent (100%) by StrataFujisawa. Notwithstanding the foregoing, however, the Parties agree that if any such Labelling Labeling revision or corrective action or post marketing surveillance program is due to the negligence or willful misconduct in the conduct of the Development by Micrologix and/or Cardiome or its Representatives or their conduct of the pre-clinical and clinical research and development activities in connection with the Product or RSD1235 prior to and or after the Effective Signing Date, then, in such event, the costs of any such Labelling Labeling revision, corrective action, or post marketing surveillance program, as the case may be, shall be borne one hundred percent (100%) by Micrologix. Subject to Section 5.3 and Section 6.2, the Parties agree that Strata shall own the results and underlying data from any Phase IV StudyCardiome. (d) Within thirty (30) days of the filing of each report with the FDA on drug related adverse events associated with the Compound as may be required under Applicable Laws, each Party will provide to the other Party particulars of such adverse events.