Common use of ADVERSE DRUG EVENT REPORTING AND PHASE IV SURVEILLANCE Clause in Contracts

ADVERSE DRUG EVENT REPORTING AND PHASE IV SURVEILLANCE. Each Party, including its permitted sublicensees, shall advise the other Party, by telephone or facsimile, immediately but in no event later than 24 hours after a Party, or its sublicensees, becomes aware of any potentially serious or unexpected adverse event (including adverse drug experiences, as defined in Applicable Laws) involving the Product (each, an “ADE”). Such advising Party shall provide the other Party with a written report delivered by confirmed facsimile of any adverse reaction, 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. During the TERM, IPL shall have full responsibility for (i) monitoring such adverse reactions; and (ii) data collection activities that occur between IPL and the patient or medical professional, as appropriate, including any follow-up inquiries which IPL or AXX xxxx necessary or appropriate. In the event either Party requires information, regarding adverse drug events with respect to reports required to be filed by it in order to comply with Applicable Laws, including obligations to report ADEs to the Governmental Authorities, each Party agrees to provide such information to the other on a timely basis. The Parties agree to follow IPL’s standard operating procedure for reporting and identifying adverse drug reactions (the “SOP”) in effect from time to time, a copy of which IPL will provide to ABI. In the event the SOP is modified or amended during the TERM, IPL shall provide ABI with copies of any such modification or amendment to the SOP for ABI's prior approval, which will not be unreasonably withheld, conditioned or delayed, at least five business days prior to such amendment taking effect. IPL shall designate a qualified person under Applicable Laws to be responsible for ADE reporting in each country in the Territory. If the report of an ADE causes a Governmental Authority to request a labeling revision as a result of an ADE or that a Phase IV surveillance program be conducted, then the Parties shall promptly enter into discussions and shall mutually agree on all of the material terms and conditions of such labeling revision or Phase IV surveillance program; provided, however the costs of such labeling revision or Phase IV surveillance program shall be paid by IPL. IPL shall have the authority to make the final decision with regard to any labeling revisions provided that IPL will consider, in making its decision, the effect any such labeling revisions will have on the marketing and sale of the Product outside the Territory. IPL agrees that should Applicable Laws require that any such interim data and results from such Phase IV surveillance programs be prepared in written form, IPL shall comply with such requirements and provide all such information in writing to ABI and the Governmental Authorities in accordance with Applicable Laws. IPL further agrees that ABI shall have the right to incorporate, refer to and cross-reference such results and underlying data in any regulatory filing or any other filing or requirement ABI is required to undertake with respect to the Product, if any.

ADVERSE DRUG EVENT REPORTING AND PHASE IV SURVEILLANCE. Each Party, including its permitted sublicensees, shall advise the other Party, by telephone or facsimile, immediately but in no event later than 24 hours after a Party, or its sublicensees, becomes aware of any potentially serious or unexpected adverse event (including adverse drug experiences, as defined in Applicable Laws) involving the Product (each, an “ADE”). Such advising Party shall provide the other Party with a written report delivered by confirmed facsimile of any adverse reaction, 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. During the TERM, IPL CYTOB shall have full responsibility for (i) monitoring such adverse reactions; and (ii) data collection activities that occur between IPL CYTOB and the patient or medical professional, as appropriate, including any follow-up inquiries which IPL CYTOB or AXX AXXX xxxx necessary or appropriate. In the event either Party requires information, regarding adverse drug events with respect to reports required to be filed by it in order to comply with Applicable Laws, including obligations to report ADEs to the Governmental Authorities, each Party agrees to provide such information to the other on a timely basis. The Parties agree to follow IPLCYTOB’s standard operating procedure for reporting and identifying adverse drug reactions (the “SOP”) in effect from time to time, a copy of which IPL CYTOB will provide to ABIAMAR. In the event the SOP is modified or amended during the TERM, IPL CYTOB shall provide ABI AMAR with copies of any such modification or amendment to the SOP for ABIAMAR's prior approval, which will not be unreasonably withheld, conditioned or delayed, at least five business days prior to such amendment taking effect. IPL CYTOB shall designate a qualified person under Applicable Laws to be responsible for ADE reporting in each country in the Territory. If the report of an ADE causes a Governmental Authority to request a labeling revision as a result of an ADE or that a Phase IV surveillance program be conducted, then the Parties shall promptly enter into discussions and shall mutually agree on all of the material terms and conditions of such labeling revision or Phase IV surveillance program; provided, however the costs of such labeling revision or Phase IV surveillance program shall be paid by IPLCYTOB. IPL CYTOB shall have the authority to make the final decision with regard to any labeling revisions provided that IPL CYTOB will consider, in making its decision, the effect any such labeling revisions will have on the marketing and sale of the Product outside the Territory. IPL CYTOB agrees that should Applicable Laws require that any such interim data and results from such Phase IV surveillance programs be prepared in written form, IPL CYTOB shall comply with such requirements and provide all such information in writing to ABI AMAR and the Governmental Authorities in accordance with Applicable Laws. IPL CYTOB further agrees that ABI AMAR shall have the right to incorporate, refer to and cross-reference such results and underlying data in any regulatory filing or any other filing or requirement ABI AMAR is required to undertake with respect to the Product, if any.

ADVERSE DRUG EVENT REPORTING AND PHASE IV SURVEILLANCE. Each Party, including its permitted sublicensees, shall advise the other Party, by telephone or facsimile, immediately but in no event later than 24 hours after a Party, or its sublicensees, becomes aware of any potentially serious or unexpected adverse event (including adverse drug experiences, as defined in Applicable Laws) involving the Product (each, an “"ADE”"). Such advising Party shall provide the other Party with a written report delivered by confirmed facsimile of any adverse reaction, 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. During the TERMTerm, IPL GKI shall have full responsibility for (i) monitoring such adverse reactions; and (ii) data collection activities that occur between IPL GKI and the patient or medical professional, as appropriate, including any follow-up inquiries which IPL or AXX xxxx GKI deems necessary or appropriate. In the event either Party requires information, regarding adverse drug events with respect to reports required to be filed by it in order to comply with Applicable Laws, including obligations to report ADEs to the Governmental Authorities, each Party agrees to provide such information to the other on a timely basis. Confidential ------------ **** Indicates that a portion of the text has been omitted and filed separately with the Commission. 26 The Parties agree to follow IPL’s GKI's standard operating procedure for reporting and identifying adverse drug reactions (the “"SOP”") in effect from time to time, a copy of which IPL GKI will provide to ABI. In the event the SOP is modified or amended during the TERMTerm, IPL GKI shall provide ABI with copies of any such modification or amendment to the SOP for ABI's prior approval, which will not be unreasonably withheld, conditioned or delayed, at least five business days prior to such amendment taking effect. IPL GKI shall designate a qualified person under Applicable Laws to be responsible for ADE reporting in each country in the Territory. If the report of an ADE causes a Governmental Authority to request a labeling revision as a result of an ADE or that a Phase IV surveillance program be conducted, then the Parties shall promptly enter into discussions and shall mutually agree on all of the material terms and conditions of such labeling revision or Phase IV surveillance program; provided, however the costs of such labeling revision or Phase IV surveillance program shall be paid by IPLGKI. IPL GKI shall have the authority to make the final decision with regard to any labeling revisions provided that IPL GKI will consider, in making its decision, the effect any such labeling revisions will have on the marketing and sale of the Product outside the Territory. IPL GKI agrees that should Applicable Laws require that any such interim data and results from such Phase IV surveillance programs be prepared in written form, IPL GKI shall comply with such requirements and provide all such information in writing to ABI and the Governmental Authorities in accordance with Applicable Laws. IPL GKI further agrees that ABI shall have the right to incorporate, refer to and cross-reference such results and underlying data in any regulatory filing or any other filing or requirement ABI is required to undertake with respect to the Product, if any.

ADVERSE DRUG EVENT REPORTING AND PHASE IV SURVEILLANCE. Each Party, including its permitted sublicensees, shall advise the other Party, by telephone or facsimile, immediately but in no event later than 24 hours after a Party, or its sublicensees, becomes aware of any potentially serious or unexpected adverse event (including adverse drug experiences, as defined in Applicable Laws) involving the Product (each, an “"ADE”"). Such advising Party shall provide the other Party with a written report delivered by confirmed facsimile of any adverse reaction, 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. During the TERMTerm, IPL BME shall have full responsibility for (i) monitoring such adverse reactions; and (ii) data collection activities that occur between IPL BME and the patient or medical professional, as appropriate, including any follow-up inquiries which IPL BME or AXX xxxx ABI deem necessary or appropriate. **** Indicates that a portion of the text has been omitted and filed separately with the Commission. In the event either Party requires information, regarding adverse drug events with respect to reports required to be filed by it in order to comply with Applicable Laws, including obligations to report ADEs to the Governmental Authorities, each Party agrees to provide such information to the other on a timely basis. The Parties agree to follow IPL’s BME's standard operating procedure for reporting and identifying adverse drug reactions (the “"SOP”") in effect from time to time, a copy of which IPL BME will provide to ABI. In the event the SOP is modified or amended during the TERMTerm, IPL BME shall provide ABI with copies of any such modification or amendment to the SOP for ABI's prior approval, which will not be unreasonably withheld, conditioned or delayed, at least five business days prior to such amendment taking effect. IPL BME shall designate a qualified person under Applicable Laws to be responsible for ADE reporting in each country in the Territory. If the report of an ADE causes a Governmental Authority to request a labeling revision as a result of an ADE or that a Phase IV surveillance program be conducted, then the Parties shall promptly enter into discussions and shall mutually agree on all of the material terms and conditions of such labeling revision or Phase IV surveillance program; provided, however the costs of such labeling revision or Phase IV surveillance program shall be paid by IPLBME. IPL BME shall have the authority to make the final decision with regard to any labeling revisions provided that IPL BME will consider, in making its decision, the effect any such labeling revisions will have on the marketing and sale of the Product outside the Territory. IPL BME agrees that should Applicable Laws require that any such interim data and results from such Phase IV surveillance programs be prepared in written form, IPL BME shall comply with such requirements and provide all such information in writing to ABI and the Governmental Authorities in accordance with Applicable Laws. IPL BME further agrees that ABI shall have the right to incorporate, refer to and cross-reference such results and underlying data in any regulatory filing or any other filing or requirement ABI is required to undertake with respect to the Product, if any.

ADVERSE DRUG EVENT REPORTING AND PHASE IV SURVEILLANCE. Each Party, including its permitted sublicensees, shall advise the other Party, by telephone or facsimile, immediately but in no event later than 24 hours after a Party, or its sublicensees, becomes aware of any potentially serious or unexpected adverse event (including adverse drug experiences, as defined in Applicable Laws) involving the Product (each, an “ADE”). Such advising Party shall provide the other Party with a written report delivered by confirmed facsimile of any adverse reaction, 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. During the TERM, IPL CYTO shall have full responsibility for (i) monitoring such adverse reactions; and (ii) data collection activities that occur between IPL CYTO and the patient or medical professional, as appropriate, including any follow-up inquiries which IPL CYTO or AXX xxxx necessary or appropriate. In the event either Party requires information, regarding adverse drug events with respect to reports required to be filed by it in order to comply with Applicable Laws, including obligations to report ADEs to the Governmental Authorities, each Party agrees to provide such information to the other on a timely basis. The Parties agree to follow IPLCYTO’s standard operating procedure for reporting and identifying adverse drug reactions (the “SOP”) in effect from time to time, a copy of which IPL CYTO will provide to ABI. In the event the SOP is modified or amended during the TERM, IPL CYTO shall provide ABI with copies of any such modification or amendment to the SOP for ABI's prior approval, which will not be unreasonably withheld, conditioned or delayed, at least five business days prior to such amendment taking effect. IPL CYTO shall designate a qualified person under Applicable Laws to be responsible for ADE reporting in each country in the Territory. If the report of an ADE causes a Governmental Authority to request a labeling revision as a result of an ADE or that a Phase IV surveillance program be conducted, then the Parties shall promptly enter into discussions and shall mutually agree on all of the material terms and ****Indicates that a portion of the text has been omitted and filed separately with the Commission CONFIDENTIAL conditions of such labeling revision or Phase IV surveillance program; provided, however the costs of such labeling revision or Phase IV surveillance program shall be paid by IPLCYTO. IPL CYTO shall have the authority to make the final decision with regard to any labeling revisions provided that IPL CYTO will consider, in making its decision, the effect any such labeling revisions will have on the marketing and sale of the Product outside the Territory. IPL CYTO agrees that should Applicable Laws require that any such interim data and results from such Phase IV surveillance programs be prepared in written form, IPL CYTO shall comply with such requirements and provide all such information in writing to ABI and the Governmental Authorities in accordance with Applicable Laws. IPL CYTO further agrees that ABI shall have the right to incorporate, refer to and cross-reference such results and underlying data in any regulatory filing or any other filing or requirement ABI is required to undertake with respect to the Product, if any.