Common use of Data Transfer and Cooperation Clause in Contracts

Data Transfer and Cooperation. (a) Genentech shall provide Connetics with reasonable access to all such relevant information and materials in its possession (subject to Genentech's own internal reasonable needs for the information and materials) that Connetics reasonably needs to develop and commercialize Licensed Products in the Field of Use under the license granted to Connetics under Section 2.1 above. Connetics shall submit requests for such information to Genentech's Clinical Collaborations Operations Department - Medical Affairs at the address set forth at the beginning of this Agreement. Access to such information and materials shall be made in a timely and orderly fashion and in a manner such that the value of the accessed information is preserved in all material respects. (b) Connetics shall provide Genentech with reasonable access to such relevant information and materials in its possession as is reasonably necessary for Genentech to exercise [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. the license rights granted by Connetics under Section 2.4 and Genentech shall submit requests for such information to Connetics' Vice President - Intellectual Property at the address set forth at the beginning of this Agreement. Access to such information and materials shall be made in a timely and orderly fashion and in a manner such that the value of the accessed information is preserved in all material respects. (c) Commencing on May 1, 1998 Connetics or its sublicensees shall be responsible for any costs associated with maintaining the Genentech breeding colony of interferon gamma gene knock-out mice at ▇▇▇▇▇▇▇ River Labs (the "Knock-Out Mice"). In consideration for Connetics paying these costs, Genentech hereby transfers all ownership of such particular Knock-Out Mice to Connetics, subject to Genentech's right to use such Knock-Out Mice and the progeny thereof for Genentech's own research purposes to the extent such Knock-Out Mice are not being used (or planned to be used) by Connetics or its sublicensees. If Connetics and its sublicensees wish to discontinue the maintenance of such Knock-Out Mice colony, Connetics shall give Genentech sixty (60) days prior notice and the right to take over such maintenance, at Genentech's sole discretion, before Connetics discontinues such maintenance. Connetics acknowledges that Genentech has, prior to the Effective Date hereof, transferred interferon gamma gene knock-out mice to other third parties. (d) Connetics shall use its Best Efforts to obtain a license from the FDA, which shall include obtaining a U.S. license number and an NDC number, to enable the effective transfer from Genentech to Connetics of the PLA for CGD on file with the FDA (the "CGD [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. PLA"). Genentech shall use its Best Efforts to assist such transfer, to the extent reasonably requested by Connetics. Genentech also shall, before the Transfer Date, reasonably assist Connetics in initiating Connetics' sales of Licensed Product in the Area of the Field of Use of CGD by transferring to Connetics information reasonably requested by Connetics that relates to such sales efforts for CGD. Connetics shall reimburse Genentech for all reasonable costs associated with Genentech's providing of such information within ninety (90) days of Connetics' receipt of an invoice of such cost from Genentech. (e) Genentech shall transfer the CGD PLA, IND and copies of all material correspondence with the FDA regarding such PLA and IND to Connetics as soon as reasonably possible after the Effective Date of this Agreement and Connetics shall be responsible for all activities, at its own cost, necessary to maintain the CGD PLA and IND and keep them active with the FDA after such date. Connetics shall reimburse Genentech for 50% of all reasonable costs associated with Genentech's transfer of the CGD PLA, IND and such FDA correspondence within ninety (90) days of Connetics' receipt of an invoice of such cost from Genentech. (f) Connetics shall not commence marketing and sales of Finished Product prior to the Transfer Date. On the Transfer Date, Genentech shall transfer to Connetics the responsibility for all marketing and sales of Finished Product in the Field of Use in the Territory, provided that all the activities listed on Exhibit H attached hereto are completed. The Parties shall use Best Efforts to complete the tasks set forth on Exhibit H as expeditiously as possible. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. (g) Genentech shall provide Connetics with reasonable access to relevant data and regulatory information in its possession in the form existing as of the Effective Date, whether written or electronic, including all clinical safety data and clinical efficacy data that are related to the manufacture, use and sale of Interferon Gamma within the Field of Use and the right to cross-reference Genentech's IND, ELA, and PLA information for Interferon Gamma in any Genentech regulatory filings related to Interferon Gamma within the Field of Use. Other than as expressly set forth herein, Genentech shall have no further obligation with respect to Connetics' efforts to obtain the FDA license referred to in Section 2.5(d) above. At Genentech's sole discretion, Genentech may participate in regulatory filings in the Field of Use in the Territory if the Parties agree that Genentech's participation in such regulatory filings would expedite the approval and commercialization of a Licensed Product. Connetics shall reimburse Genentech for all reasonable costs associated with Genentech's providing of data and regulatory information and referencing within ninety (90) days of Connetics' receipt of an invoice of such cost from Genentech. Connetics shall submit requests for such information to Genentech's Clinical Collaborations Operations Dept. - Medical Affairs at the address set forth in the beginning of this Agreement. Such requests shall not be submitted more than two (2) times in any twelve (12) month period, unless such requests concern information that is critical to product registration activities. Access to such information shall be made in a timely and orderly fashion and in a manner such that the value of the accessed information is preserved in all material respects. (h) To the extent reasonably requested by Genentech, Connetics shall provide [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. Genentech with access to all data and regulatory information in its possession, whether written or electronic, in the form existing as of the date of Genentech's request, including all clinical safety data and clinical efficacy data, that directly relates to the use of Interferon Gamma outside the Field of Use and shall give Genentech the right to cross-reference Connetics' IND, ELA, BLA and PLA information, if applicable, in any Genentech regulatory filings that are related to the use or sale of Interferon Gamma outside the Field of Use. Genentech shall reimburse Connetics for all reasonable actual costs associated with Connetics' providing of data and regulatory information and referencing within ninety (90) days of the receipt of an invoice of such cost by Genentech from Connetics. Such requests shall not be submitted more than two (2) times in any twelve (12) month period, unless such requests concern information that is critical to product registration activities. Access to such information shall be made in a timely and orderly fashion and in a manner such that the value of the accessed information is preserved in all material respects. (i) Commencing from Genentech's first delivery to Connetics or Intermune of Finished Product for clinical studies in accordance with the Supply Agreement, Connetics shall thereafter be responsible for supplying ACTIMUNE free of charge to, and funding (if any) of, the third party sponsors of the clinical studies listed in Exhibit D attached hereto and incorporated herein. Connetics shall enter into clinical research agreements with such third party sponsors governing such studies that commence after the Effective Date hereof. With respect to clinical research agreements between Genentech and such sponsors in effect prior to the Effective Date, [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. Connetics shall replace Genentech, pursuant to an assignment, as a party. ACTIMMUNE (and funding, if any) for all such studies shall be supplied by Connetics to such sponsors as described in such clinical research agreements. (j) As of the Transfer Date, Connetics shall conduct an indigent patient program for Licensed Products sold for use in the field of CGD. As soon as reasonably possible after Genentech transfers information regarding patients who have participated in Genentech's indigent patient program, Connetics will inform Genentech whether or not such patients will be eligible and participating in Connetics' indigent patient program.