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

ADVERSE DRUG EVENT REPORTING AND PHASE IV SURVEILLANCE. (a) Each Party shall advise the other Party, by telephone or facsimile, within such time as is required to comply with Applicable Laws after it becomes aware of any potentially serious or unexpected adverse event (including adverse drug experiences, as defined in 21 C.F.R. Section 314.80 or other applicable regulations) (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. To the extent permitted by Applicable Laws, Geneva shall have full responsibility for (i) monitoring such adverse reactions; and (ii) data collection activities that occur between Geneva and the patient or medical professional, as appropriate, including any follow-up inquiries which 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 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 Competent Authorities, each Party agrees to provide such information to the other on a timely basis. (c) If the report of an ADE causes a Competent Authority to request that a phase IV surveillance program be conducted, then the PMC shall determine the material terms and conditions of such phase IV surveillance program; provided, however the costs of such phase IV surveillance program shall be borne [**] by Geneva and [**] by Atrix. Geneva agrees that should Applicable Laws require that any such interim data and results from such programs be prepared in written form, Geneva shall comply with such requirements and provide all such information in writing to Atrix and Atrix shall then submit such information to the Competent Authorities in accordance with Applicable Laws. Geneva further agrees that Atrix shall have the right to incorporate, refer to and cross-reference such results and underlying data in any regulatory filing with respect to the Products.

ADVERSE DRUG EVENT REPORTING AND PHASE IV SURVEILLANCE. (a) Each Party Party, including its permitted sublicensees, shall advise the other Party, by telephone or facsimile, within such time as is required to comply with Applicable Laws immediately but in no event later than 24 hours after it a Party, or its sublicensees, becomes aware of any potentially serious or unexpected adverse event (including adverse drug experiences, as defined in 21 C.F.R. Section 314.80 or other applicable regulationsApplicable Laws) 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. To During the extent permitted by Applicable LawsTerm, Geneva GKI shall have full responsibility for (i) monitoring such adverse reactions; and (ii) data collection activities that occur between Geneva GKI and the patient or medical professional, as appropriate, including any follow-up inquiries which Genexx xxxxx xxxessary GKI deems necessary 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 Competent 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 (cthe "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 Competent Governmental Authority to request a labeling revision as a result of an ADE or that a phase Phase IV surveillance program be conducted, then the PMC Parties shall determine promptly enter into discussions and shall mutually agree on all of the material terms and conditions of such phase labeling revision or Phase IV surveillance program; provided, however the costs of such phase labeling revision or Phase IV surveillance program shall be borne [**] paid by Geneva 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 [**] by Atrixsale of the Product outside the Territory. Geneva 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, Geneva GKI shall comply with such requirements and provide all such information in writing to Atrix ABI and Atrix shall then submit such information to the Competent Governmental Authorities in accordance with Applicable Laws. Geneva GKI further agrees that Atrix 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 ProductsProduct, if any.

ADVERSE DRUG EVENT REPORTING AND PHASE IV SURVEILLANCE. (a) Each Party shall advise the other Party, by telephone or facsimile, within such time as is required to comply with Applicable Laws twenty-four (24) hours after it a Party becomes aware of any potentially serious or unexpected adverse event (including adverse drug experiences, as defined in 21 C.F.R. Section 314.80 or other applicable regulationsRegulations) (an "ADE") involving a Productthe Product or the Demonstration Samples. 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. To For so long as Sanofi-Synthelabo has an exclusive license to market, promote and sell the extent permitted by Applicable LawsProduct in the Territory for use in the Field, Geneva Sanofi-Synthelabo shall have full responsibility for (i) monitoring such adverse reactions; and (ii) data collection activities that occur between Geneva Sanofi-Synthelabo and the patient or medical professional, as appropriate, including any follow-up inquiries which Genexx xxxxx xxxessary Sanofi-Synthelabo deems necessary or appropriate; and Atrix . Sanofi-Synthelabo shall have full responsibility for making make any necessary reports to the Competent Authorities, with a complete copy provided to Geneva Atrix at the same time the report is made by Sanofi-Synthelabo to the Competent Authorities. If Atrix exercises its right to co-market as set forth in Section 13.01 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) 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 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 Competent Authorities, each Party agrees to provide such information to the other on a timely basis. (c) The Parties agree to follow Sanofi-Synthelabo's standard operating procedure for reporting and identifying adverse drug reactions (the "SOP") a copy of which is attached hereto as Exhibit F. In the event the SOP is modified or amended during the term of this Agreement, Sanofi-Synthelabo shall provide Atrix with copies of any such modification or amendment to the SOP for Atrix's prior approval, which will not be unreasonably withheld, conditioned or delayed, at least five (5) business days prior to such amendment taking effect. Sanofi-Synthelabo shall designate a qualified person under Applicable Laws to be responsible for ADE reporting in each country in the Territory. In the event Atrix requires information regarding adverse drug events with respect to reports required to be filed by Atrix in order to comply with Applicable Laws, Sanofi-Synthelabo agrees to provide such information to Atrix on a basis sufficient to allow Atrix to timely comply with Applicable Laws. (d) If the report of an ADE causes a Competent Authority to request labeling revision as a result of an ADE or that a phase Phase IV surveillance program be conducted, then the PMC Parties shall determine promptly enter into discussions and shall mutually agree on all of the material terms and conditions of such phase labeling revision or Phase IV surveillance program; provided, however the costs of such phase labeling revision or Phase IV surveillance program shall be borne [**] by Geneva and [**] by Atrix]. Geneva Atrix shall have the authority to make the final decision with regard to any labeling revisions. 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, Geneva Atrix shall comply with such requirements and provide all such information in writing to Atrix Sanofi-Synthelabo and Atrix shall then submit such information to the Competent Authorities in accordance with Applicable Laws. Geneva Atrix further agrees that Atrix Sanofi-Synthelabo 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 Sanofi-Synthelabo is required to undertake with respect to the ProductsProduct.

ADVERSE DRUG EVENT REPORTING AND PHASE IV SURVEILLANCE. (a) Each Party Party, including its permitted sublicensees, shall advise the other Party, by telephone or facsimile, within such time as is required to comply with Applicable Laws immediately but in no event later than 24 hours after it a Party, or its sublicensees, becomes aware of any potentially serious or unexpected adverse event (including adverse drug experiences, as defined in 21 C.F.R. Section 314.80 or other applicable regulations) (an "ADE"Applicable Laws) involving a Productthe 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 but not limited to customer name, address, telephone number, batch, lot and serial numbers, and other information as required by Applicable Laws. To During the extent permitted by Applicable LawsTERM, Geneva CYTO shall have full responsibility for (i) monitoring such adverse reactions; and (ii) data collection activities that occur between Geneva CYTO and the patient or medical professional, as appropriate, including any follow-up inquiries which Genexx xxxxx xxxessary CYTO or AXX xxxx necessary 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 Competent Governmental Authorities, each Party agrees to provide such information to the other on a timely basis. . The Parties agree to follow CYTO’s standard operating procedure for reporting and identifying adverse drug reactions (cthe “SOP”) in effect from time to time, a copy of which CYTO will provide to ABI. In the event the SOP is modified or amended during the TERM, 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. 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 Competent Governmental Authority to request a labeling revision as a result of an ADE or that a phase Phase IV surveillance program be conducted, then the PMC Parties shall determine 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 phase labeling revision or Phase IV surveillance program; provided, however the costs of such phase labeling revision or Phase IV surveillance program shall be borne [**] paid by Geneva CYTO. CYTO shall have the authority to make the final decision with regard to any labeling revisions provided that CYTO will consider, in making its decision, the effect any such labeling revisions will have on the marketing and [**] by Atrixsale of the Product outside the Territory. Geneva 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, Geneva CYTO shall comply with such requirements and provide all such information in writing to Atrix ABI and Atrix shall then submit such information to the Competent Governmental Authorities in accordance with Applicable Laws. Geneva CYTO further agrees that Atrix 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 ProductsProduct, if any.

ADVERSE DRUG EVENT REPORTING AND PHASE IV SURVEILLANCE. (a) Each Party Party, including its permitted sublicensees, shall advise the other Party, by telephone or facsimile, within such time as is required to comply with Applicable Laws immediately but in no event later than 24 hours after it a Party, or its sublicensees, becomes aware of any potentially serious or unexpected adverse event (including adverse drug experiences, as defined in 21 C.F.R. Section 314.80 or other applicable regulations) (an "ADE"Applicable Laws) involving a Productthe 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 but not limited to customer name, address, telephone number, batch, lot and serial numbers, and other information as required by Applicable Laws. To During the extent permitted by Applicable LawsTERM, Geneva CYTOB shall have full responsibility for (i) monitoring such adverse reactions; and (ii) data collection activities that occur between Geneva CYTOB and the patient or medical professional, as appropriate, including any follow-up inquiries which Genexx xxxxx xxxessary CYTOB or AXXX xxxx necessary 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 Competent Governmental Authorities, each Party agrees to provide such information to the other on a timely basis. . The Parties agree to follow CYTOB’s standard operating procedure for reporting and identifying adverse drug reactions (cthe “SOP”) in effect from time to time, a copy of which CYTOB will provide to AMAR. In the event the SOP is modified or amended during the TERM, CYTOB shall provide AMAR with copies of any such modification or amendment to the SOP for AMAR's prior approval, which will not be unreasonably withheld, conditioned or delayed, at least five business days prior to such amendment taking effect. 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 Competent Governmental Authority to request a labeling revision as a result of an ADE or that a phase Phase IV surveillance program be conducted, then the PMC Parties shall determine promptly enter into discussions and shall mutually agree on all of the material terms and conditions of such phase labeling revision or Phase IV surveillance program; provided, however the costs of such phase labeling revision or Phase IV surveillance program shall be borne [**] paid by Geneva CYTOB. CYTOB shall have the authority to make the final decision with regard to any labeling revisions provided that CYTOB will consider, in making its decision, the effect any such labeling revisions will have on the marketing and [**] by Atrixsale of the Product outside the Territory. Geneva 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, Geneva CYTOB shall comply with such requirements and provide all such information in writing to Atrix AMAR and Atrix shall then submit such information to the Competent Governmental Authorities in accordance with Applicable Laws. Geneva CYTOB further agrees that Atrix 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 AMAR is required to undertake with respect to the ProductsProduct, if any.

ADVERSE DRUG EVENT REPORTING AND PHASE IV SURVEILLANCE. (a) Each Party Party, including its permitted sublicensees, shall advise the other Party, by telephone or facsimile, within such time as is required to comply with Applicable Laws immediately but in no event later than 72 hours after it a Party, its Affiliates or sublicensees, becomes aware of any potentially serious or unexpected adverse event (including adverse drug experiencesexperiences or events, as defined in 21 C.F.R. Section 314.80 or other applicable regulationsApplicable Laws) (an "ADE") involving a Productthe 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 but not limited to customer name, address, telephone number, batch, lot and serial numbers, and other information as required by Applicable Laws. To For so long as Fujisawa has an exclusive license to market, promote and sell the extent permitted by Applicable LawsProduct in any country in the Territory for use in the Field, Geneva Fujisawa shall have full responsibility for (i) monitoring such adverse reactionsADEs; and (ii) data collection activities that occur between Geneva Fujisawa and the patient or medical professional, as appropriate, including any follow-up inquiries which Genexx xxxxx xxxessary Fujisawa deems necessary or appropriate; and . Atrix shall have full responsibility will be responsible for making any reports to meeting the requirements of the Competent AuthoritiesAuthorities 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, with a complete copy provided in person or by telephone, as appropriate, to Geneva at the same time the report is made discuss and determine how to the Competent Authoritiesmutually handle and resolve any issues relating to or arising from any such ADE. (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 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 Competent Authorities, each Party agrees to provide such information to the other on other, []** in sufficient time to enable each Party to report such ADEs to the Competent Authorities in accordance with Applicable Laws. []** agrees to provide []** with []** (c) Subject to the last paragraph of Section 9.02(a), the Parties agree to follow Fujisawa's standard operating procedure for reporting and identifying ADEs (the "SOP"), a copy of which will be provided by Fujisawa to Atrix 12 months prior to the date of submission of an NDA. In the event the SOP is modified or amended during the Term, -------- ** Confidential Treatment Requested 33 Fujisawa shall provide Atrix with copies of any such modification or amendment to the SOP prior to amending or modifying the same. Atrix shall also timely basisprovide 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. (cd) If the report of an ADE causes a Competent Authority to request that a phase Labeling revision and/or any other corrective action, or if either Party believes it is necessary to conduct a Phase IV surveillance program be conductedas a result of an ADE, then the PMC Parties shall determine all of the material terms and conditions of such phase 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 phase Labeling revision, corrective action or Phase IV surveillance program shall be borne []**] by Geneva and [**] by Atrix* In the event the Parties do not mutually agree on any such Labeling revision, corrective action or surveillance program, such disagreement shall be resolved in the manner set forth in Section 7.03(a). Geneva 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, Geneva Fujisawa shall comply with such requirements and provide all such information in writing to Atrix and Atrix shall then submit such information to the Competent Authorities in accordance with Applicable Laws. Geneva Fujisawa further agrees that 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 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 ProductsCompetent Authority.

ADVERSE DRUG EVENT REPORTING AND PHASE IV SURVEILLANCE. (a) Each Party Party, including its permitted sublicensees, shall advise the other Party, by telephone or facsimile, within such time as is required to comply with Applicable Laws immediately but in no event later than 24 hours after it a Party, or its sublicensees, becomes aware of any potentially serious or unexpected adverse event (including adverse drug experiences, as defined in 21 C.F.R. Section 314.80 or other applicable regulations) (an "ADE"Applicable Laws) involving a Productthe 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 but not limited to customer name, address, telephone number, batch, lot and serial numbers, and other information as required by Applicable Laws. To During the extent permitted by Applicable LawsTERM, Geneva IPL shall have full responsibility for (i) monitoring such adverse reactions; and (ii) data collection activities that occur between Geneva IPL and the patient or medical professional, as appropriate, including any follow-up inquiries which Genexx xxxxx xxxessary IPL or AXX xxxx necessary 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 Competent 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 (cthe “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 Competent Governmental Authority to request a labeling revision as a result of an ADE or that a phase Phase IV surveillance program be conducted, then the PMC Parties shall determine promptly enter into discussions and shall mutually agree on all of the material terms and conditions of such phase labeling revision or Phase IV surveillance program; provided, however the costs of such phase labeling revision or Phase IV surveillance program shall be borne [**] paid by Geneva 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 [**] by Atrixsale of the Product outside the Territory. Geneva 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, Geneva IPL shall comply with such requirements and provide all such information in writing to Atrix ABI and Atrix shall then submit such information to the Competent Governmental Authorities in accordance with Applicable Laws. Geneva IPL further agrees that Atrix 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 ProductsProduct, if any.

ADVERSE DRUG EVENT REPORTING AND PHASE IV SURVEILLANCE. (a) Each Party Party, including its permitted sublicensees, shall advise the other Party, by telephone or facsimile, within such time as is required to comply with Applicable Laws immediately but in no event later than 24 hours after it a Party, or its sublicensees, becomes aware of any potentially serious or unexpected adverse event (including adverse drug experiences, as defined in 21 C.F.R. Section 314.80 or other applicable regulationsApplicable Laws) 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. To During the extent permitted by Applicable LawsTerm, Geneva Atrix shall have full responsibility for (i) monitoring such adverse reactions; and (ii) data collection activities that occur between Geneva Atrix and the patient or medical professional, as appropriate, including any follow-up inquiries which Genexx xxxxx xxxessary Atrix deems necessary 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 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 Competent Governmental Authorities, each Party agrees to provide such information to the other on a timely basis. (c) The Parties agree to follow Atrix's standard operating procedure for reporting and identifying adverse drug reactions (the "SOP") in effect from time to time, a copy of which Atrix will provide to ABI. In the event the SOP is modified or amended during the Term, 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. 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 Competent Governmental Authority to request a labeling revision as a result of an ADE or that a phase Phase IV surveillance program be conducted, then the PMC Parties shall determine promptly enter into discussions and shall mutually agree on all of the material terms and conditions of such phase labeling revision or Phase IV surveillance program; provided, however the costs of such phase labeling revision or Phase IV surveillance program shall be borne [**] by Geneva and [**] paid by Atrix. Geneva Atrix shall have the authority to make the final decision with regard to any labeling revisions provided that 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. 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, Geneva Atrix shall comply with such requirements and provide all such information in writing to Atrix ABI and Atrix shall then submit such information to the Competent Authorities in accordance with Applicable Laws. Geneva further agrees Governmental **** Indicates that Atrix shall have a portion of the right to incorporate, refer to and cross-reference such results and underlying data in any regulatory filing with respect to the Products.text has been omitted Confidential

ADVERSE DRUG EVENT REPORTING AND PHASE IV SURVEILLANCE. (a) Each Party shall advise the other Party, by telephone or facsimile, within such time as is required to comply with Applicable Laws twenty-four (24) hours after it a Party becomes aware of any potentially serious or unexpected adverse event (including adverse drug experiences, as defined in 21 C.F.R. Section 314.80 or other applicable regulationsRegulations) (an "ADE") involving a Productthe Product or the Demonstration Samples. 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. To For so long as Sanofi-Synthelabo has an exclusive license to market, promote and sell the extent permitted by Applicable LawsProduct in the Territory for use in the Field, Geneva Sanofi-Synthelabo shall have full responsibility for (i) monitoring such adverse reactions; and (ii) data collection activities that occur between Geneva Sanofi-Synthelabo and the patient or medical professional, as appropriate, including any follow-up inquiries which Genexx xxxxx xxxessary Sanofi-Synthelabo deems necessary or appropriate; and Atrix . Sanofi-Synthelabo shall have full responsibility for making make any necessary reports to the Competent Authorities, with a complete copy provided to Geneva Atrix at the same time the report is made by Sanofi-Synthelabo to the Competent Authorities. If Atrix exercises its right to co-market as set forth in Section 13.01 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) 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 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 Competent Authorities, each Party agrees to provide such information to the other on a timely basis. (c) The Parties agree to follow Sanofi-Synthelabo's standard operating procedure for reporting and identifying adverse drug reactions (the "SOP") a copy of which is attached hereto as Exhibit F. In the event the SOP is modified or amended during the term of this Agreement, Sanofi-Synthelabo shall provide Atrix with copies of any such modification or amendment to the SOP for Atrix's prior approval, which will 25 30 not be unreasonably withheld, conditioned or delayed, at least five (5) business days prior to such amendment taking effect. Sanofi-Synthelabo shall designate a qualified person under Applicable Laws to be responsible for ADE reporting in each country in the Territory. In the event Atrix requires information regarding adverse drug events with respect to reports required to be filed by Atrix in order to comply with Applicable Laws, Sanofi-Synthelabo agrees to provide such information to Atrix on a basis sufficient to allow Atrix to timely comply with Applicable Laws. (d) If the report of an ADE causes a Competent Authority to request labeling revision as a result of an ADE or that a phase Phase IV surveillance program be conducted, then the PMC Parties shall determine promptly enter into discussions and shall mutually agree on all of the material terms and conditions of such phase labeling revision or Phase IV surveillance program; provided, however the costs of such phase labeling revision or Phase IV surveillance program shall be borne [**] by Geneva and [**] by Atrix]. Geneva Atrix shall have the authority to make the final decision with regard to any labeling revisions. 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, Geneva Atrix shall comply with such requirements and provide all such information in writing to Atrix Sanofi-Synthelabo and Atrix shall then submit such information to the Competent Authorities in accordance with Applicable Laws. Geneva Atrix further agrees that Atrix Sanofi-Synthelabo 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 Sanofi-Synthelabo is required to undertake with respect to the ProductsProduct.

ADVERSE DRUG EVENT REPORTING AND PHASE IV SURVEILLANCE. (a) Each Party Party, including its permitted sublicensees, shall advise the other Party, by telephone or facsimile, within such time as is required to comply with Applicable Laws immediately but in no event later than 24 hours after it a Party, or its sublicensees, becomes aware of any potentially serious or unexpected adverse event (including adverse drug experiences, as defined in 21 C.F.R. Section 314.80 or other applicable regulationsApplicable Laws) 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. To During the extent permitted by Applicable LawsTerm, Geneva BME shall have full responsibility for (i) monitoring such adverse reactions; and (ii) data collection activities that occur between Geneva BME and the patient or medical professional, as appropriate, including any follow-up inquiries which Genexx xxxxx xxxessary BME or ABI deem necessary or appropriate; . **** Indicates that a portion of the text has been omitted and Atrix shall have full responsibility for making any reports to filed separately with 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 TerritoryCommission. 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 Competent Governmental Authorities, each Party agrees to provide such information to the other on a timely basis. . The Parties agree to follow BME's standard operating procedure for reporting and identifying adverse drug reactions (cthe "SOP") in effect from time to time, a copy of which BME will provide to ABI. In the event the SOP is modified or amended during the Term, 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. 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 Competent Governmental Authority to request a labeling revision as a result of an ADE or that a phase Phase IV surveillance program be conducted, then the PMC Parties shall determine promptly enter into discussions and shall mutually agree on all of the material terms and conditions of such phase labeling revision or Phase IV surveillance program; provided, however the costs of such phase labeling revision or Phase IV surveillance program shall be borne [**] paid by Geneva BME. BME shall have the authority to make the final decision with regard to any labeling revisions provided that BME will consider, in making its decision, the effect any such labeling revisions will have on the marketing and [**] by Atrixsale of the Product outside the Territory. Geneva 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, Geneva BME shall comply with such requirements and provide all such information in writing to Atrix ABI and Atrix shall then submit such information to the Competent Governmental Authorities in accordance with Applicable Laws. Geneva BME further agrees that Atrix 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 ProductsProduct, if any.