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, GKI shall have full responsibility for (i) monitoring such adverse reactions; and (ii) data collection activities that occur between GKI and the patient or medical professional, as appropriate, including any follow-up inquiries which 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 GKI's standard operating procedure for reporting and identifying adverse drug reactions (the "SOP") in effect from time to time, a copy of which GKI will provide to ABI. In the event the SOP is modified or amended during the Term, 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. 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 GKI. GKI shall have the authority to make the final decision with regard to any labeling revisions provided that 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. 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, GKI shall comply with such requirements and provide all such information in writing to ABI and the Governmental Authorities in accordance with Applicable Laws. 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 Term, GKI BME shall have full responsibility for (i) monitoring such adverse reactions; and (ii) data collection activities that occur between GKI BME and the patient or medical professional, as appropriate, including any follow-up inquiries which GKI deems BME or 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. Confidential ------------ **** Indicates that a portion of the text has been omitted and filed separately with the Commission. 26 The Parties agree to follow GKIBME's standard operating procedure for reporting and identifying adverse drug reactions (the "SOP") in effect from time to time, a copy of which GKI BME will provide to ABI. In the event the SOP is modified or amended during the Term, GKI 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. GKI 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 GKIBME. GKI BME shall have the authority to make the final decision with regard to any labeling revisions provided that GKI 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. GKI 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, GKI BME shall comply with such requirements and provide all such information in writing to ABI and the Governmental Authorities in accordance with Applicable Laws. GKI 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. (a) 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, GKI Atrix shall have full responsibility for (i) monitoring such adverse reactions; and (ii) data collection activities that occur between GKI Atrix and the patient or medical professional, as appropriate, including any follow-up inquiries which GKI Atrix deems necessary or appropriate. . (b) In the event either Party requires information, 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 . (c) The Parties agree to follow GKIAtrix's standard operating procedure for reporting and identifying adverse drug reactions (the "SOP") in effect from time to time, a copy of which GKI Atrix will provide to ABI. In the event the SOP is modified or amended during the Term, GKI Atrix 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. GKI Atrix shall designate a qualified person under Applicable Laws to be responsible for ADE reporting in each country in the Territory. . (d) 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 GKIAtrix. GKI Atrix shall have the authority to make the final decision with regard to any labeling revisions provided that GKI Atrix 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. GKI Atrix agrees that should Applicable Laws require that any such interim data and results from such Phase IV surveillance programs be prepared in written form, GKI Atrix shall comply with such requirements and provide all such information in writing to ABI and the Governmental Authorities in accordance with Applicable Laws. GKI further agrees **** Indicates that ABI shall have a portion of 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.text has been omitted Confidential

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, GKI IPL shall have full responsibility for (i) monitoring such adverse reactions; and (ii) data collection activities that occur between GKI IPL and the patient or medical professional, as appropriate, including any follow-up inquiries which GKI deems 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. Confidential ------------ **** Indicates that a portion of the text has been omitted and filed separately with the Commission. 26 The Parties agree to follow GKI's IPL’s standard operating procedure for reporting and identifying adverse drug reactions (the "“SOP"”) in effect from time to time, a copy of which GKI IPL will provide to ABI. In the event the SOP is modified or amended during the TermTERM, GKI 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. GKI 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 GKIIPL. GKI IPL shall have the authority to make the final decision with regard to any labeling revisions provided that GKI 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. GKI 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, GKI IPL shall comply with such requirements and provide all such information in writing to ABI and the Governmental Authorities in accordance with Applicable Laws. GKI 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 TermTERM, GKI CYTO shall have full responsibility for (i) monitoring such adverse reactions; and (ii) data collection activities that occur between GKI CYTO and the patient or medical professional, as appropriate, including any follow-up inquiries which GKI deems 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. Confidential ------------ **** Indicates that a portion of the text has been omitted and filed separately with the Commission. 26 The Parties agree to follow GKI's CYTO’s standard operating procedure for reporting and identifying adverse drug reactions (the "“SOP"”) in effect from time to time, a copy of which GKI CYTO will provide to ABI. In the event the SOP is modified or amended during the TermTERM, GKI 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. GKI 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 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 GKICYTO. GKI CYTO shall have the authority to make the final decision with regard to any labeling revisions provided that GKI 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. GKI 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, GKI CYTO shall comply with such requirements and provide all such information in writing to ABI and the Governmental Authorities in accordance with Applicable Laws. GKI 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.

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, GKI CYTOB shall have full responsibility for (i) monitoring such adverse reactions; and (ii) data collection activities that occur between GKI CYTOB and the patient or medical professional, as appropriate, including any follow-up inquiries which GKI deems CYTOB or 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. Confidential ------------ **** Indicates that a portion of the text has been omitted and filed separately with the Commission. 26 The Parties agree to follow GKI's CYTOB’s standard operating procedure for reporting and identifying adverse drug reactions (the "“SOP"”) in effect from time to time, a copy of which GKI CYTOB will provide to ABIAMAR. In the event the SOP is modified or amended during the TermTERM, GKI 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. GKI 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 GKICYTOB. GKI CYTOB shall have the authority to make the final decision with regard to any labeling revisions provided that GKI 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. GKI 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, GKI 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. GKI 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. (a) Each Party, including its permitted sublicensees, shall advise the other Party, by telephone or facsimile, immediately but in no event later than 24 72 hours after a Party, its Affiliates or its sublicensees, becomes aware of any potentially serious or unexpected adverse event (including adverse drug experiencesexperiences or events, as defined in Applicable Laws) involving the Product (each, an "ADE")) involving the Product or the Professional Samples. Such advising Party shall provide the other Party with a written report delivered by confirmed facsimile of any adverse reactionADE, 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 For so long as Fujisawa has an exclusive license to market, promote and sell the TermProduct in any country in the Territory for use in the Field, GKI Fujisawa shall have full responsibility for (i) monitoring such adverse reactionsADEs; and (ii) data collection activities that occur between GKI Fujisawa and the patient or medical professional, as appropriate, including any follow-up inquiries which GKI Fujisawa deems necessary or appropriate. Atrix will be responsible for meeting the requirements of the Competent Authorities including the submission of ADE individual reports and periodic reports. If Atrix exercises its right to co-market the Product as set forth in Section 12.01 then upon the occurrence of an ADE the Parties shall promptly meet, in person or by telephone, as appropriate, to discuss and determine how to mutually handle and resolve any issues relating to or arising from any such ADE. (b) In the event either Party requires information, information regarding adverse drug events ADEs 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 Competent Authorities, each Party agrees to provide such information to the other on a timely basisother, []** in sufficient time to enable each Party to report such ADEs to the Competent Authorities in accordance with Applicable Laws. Confidential ------------ []** agrees to provide []** with []**** Indicates that a portion (c) Subject to the last paragraph of Section 9.02(a), the text has been omitted and filed separately with the Commission. 26 The Parties agree to follow GKIFujisawa's standard operating procedure for reporting and identifying adverse drug reactions ADEs (the "SOP") in effect from time to time), a copy of which GKI will provide be provided by Fujisawa to ABIAtrix 12 months prior to the date of submission of an NDA. In the event the SOP is modified or amended during the Term, GKI -------- ** Confidential Treatment Requested 33 Fujisawa shall provide ABI Atrix 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 effectamending or modifying the same. GKI Atrix shall also timely provide Fujisawa with copies of any and all ADE reports for any Atrix New Indication in accordance with the terms and conditions of this Agreement. Fujisawa shall designate a qualified person under Applicable Laws to be responsible for ADE reporting in each country in the Territory. . (d) If the report of an ADE causes a Governmental Competent Authority to request a labeling Labeling revision and/or any other corrective action, or if either Party believes it is necessary to conduct a Phase IV surveillance program as a result of an ADE or that a Phase IV surveillance program be conductedADE, then the Parties shall promptly enter into discussions and shall mutually agree on determine all of the material terms and conditions of such labeling revision Labeling revision, corrective action or Phase IV surveillance program; provided, however program in consultation with the applicable Competent Authority. The Parties will cooperate with one another with respect to any of the foregoing. The costs of such labeling revision Labeling revision, corrective action or Phase IV surveillance program shall be paid by GKI. GKI shall have borne []** In the authority to make event the final decision with regard to any labeling revisions provided that GKI will consider, in making its decision, the effect Parties do not mutually agree on any such labeling revisions will have on Labeling revision, corrective action or surveillance program, such disagreement shall be resolved in the marketing and sale of the Product outside the Territorymanner set forth in Section 7.03(a). GKI Fujisawa agrees that should Applicable Laws require that any such interim data and results from such Phase IV surveillance programs be prepared in written form, GKI Fujisawa shall comply with such requirements and provide all such information in writing to ABI Atrix and the Governmental Competent Authorities in accordance with Applicable Laws. GKI Fujisawa further agrees that ABI Atrix shall have the right to incorporate, refer to and cross-reference such the results and underlying data from any such Phase IV surveillance program in any regulatory filing or any other filing or requirement ABI Atrix is required to undertake with respect to such ADE. Atrix, in consultation with Fujisawa, shall submit or file any necessary documentation, reports or forms to the Product, if anyCompetent Authority.

ADVERSE DRUG EVENT REPORTING AND PHASE IV SURVEILLANCE. (a) Each Party, including its permitted sublicensees, Party shall advise the other Party, by telephone or facsimile, immediately but in no event later than 24 hours within such time as is required to comply with Applicable Laws after a Party, or its sublicensees, it becomes aware of any potentially serious or unexpected adverse event (including adverse drug experiences, as defined in Applicable Laws21 C.F.R. Section 314.80 or other applicable regulations) involving the Product (each, an "ADE")) involving a Product. 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 but not limited to customer name, address, telephone number, batch, lot and serial numbers, and other information as required by Applicable Laws. During To the Termextent permitted by Applicable Laws, GKI Geneva shall have full responsibility for (i) monitoring such adverse reactions; and (ii) data collection activities that occur between GKI Geneva and the patient or medical professional, as appropriate, including any follow-up inquiries which GKI deems necessary Genexx xxxxx xxxessary or appropriate; and Atrix shall have full responsibility for making any reports to the Competent Authorities, with a complete copy provided to Geneva at the same time the report is made to the Competent Authorities. (b) Within thirty (30) days of receipt of all Governmental Approvals for a Product in a given country in the Territory, the Parties shall jointly develop a standard operating procedure for reporting and identifying adverse drug reactions (the "SOP") that conforms to Applicable Laws, and which, at the option of Atrix, may be Geneva's current SOP. In the event the SOP is modified or amended during the Term of this Agreement, Geneva shall provide Atrix with copies of any such modification or amendment to the SOP for approval at least five (5) days prior to such amendment taking effect. The Parties agree to follow the SOP. Geneva shall designate a qualified person under Applicable Laws to be responsible for ADE reporting in each country in the Territory. In the event either Party requires information, 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 Competent 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 GKI's standard operating procedure for reporting and identifying adverse drug reactions . (the "SOP"c) in effect from time to time, a copy of which GKI will provide to ABI. In the event the SOP is modified or amended during the Term, 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. 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 Competent Authority to request a labeling revision as a result of an ADE or that a Phase phase IV surveillance program be conducted, then the Parties PMC shall promptly enter into discussions and shall mutually agree on all of determine the material terms and conditions of such labeling revision or Phase phase IV surveillance program; provided, however the costs of such labeling revision or Phase phase IV surveillance program shall be paid borne [**] by GKIGeneva and [**] by Atrix. GKI shall have the authority to make the final decision with regard to any labeling revisions provided that 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. GKI Geneva agrees that should Applicable Laws require that any such interim data and results from such Phase IV surveillance programs be prepared in written form, GKI Geneva shall comply with such requirements and provide all such information in writing to ABI Atrix and Atrix shall then submit such information to the Governmental Competent Authorities in accordance with Applicable Laws. GKI Geneva further agrees that ABI Atrix 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 anyProducts.