Common use of Product Development Clause in Contracts

Product Development. 4.1 Novo Nordisk shall, at its own cost and discretion, develop and obtain Regulatory Approval for the Licensed Product(s). (a) Subject to the limitations provided in the definition of Program Carriers and Section 2.2(g) above, the Parties shall jointly select the Program Carriers for use in Licensed Products which are to be provided to, and screened by, Novo Nordisk. Emisphere shall use Commercially Reasonable Efforts to provide documentation specified by Novo Nordisk concerning the Program Carriers. The Parties agree that the Know-How related to the Program Carriers provided to Novo Nordisk, including structures of such Program Carriers and their availability as Exclusive Program Carriers at the time, must be disclosed by Emisphere to Novo Nordisk. Any Know-How related to Program Carriers provided to Novo Nordisk prior to the Effective Date shall be provided to Novo Nordisk promptly following execution of the Agreement, if any such Know-How has not already been provided. For the avoidance of doubt, once a specific Carrier has been jointly selected as a Program Carrier, Emisphere may not enter such Carrier on the Excluded Carrier List. (b) Upon selection of a Carrier to be a Program Carrier in accordance with Section 4.2 (a), Know-How related to such Program Carrier shall become Licensed Know-How as of the Selection Date. Emisphere shall continue to provide Licensed Know-How to Program Carriers to Novo Nordisk throughout the Term. (c) If requested by Novo Nordisk, representatives of Emisphere shall participate, at Novo Nordisk’s cost, in a technology transfer session(s) of commercially reasonable scope and length to be held in Denmark or in the US as decided by Novo Nordisk at its sole discretion. 4.3 Novo Nordisk shall be solely responsible for the development, development plan(s), and commercialization for the Licensed Product(s) and for all of the costs of the development and commercialization of the Licensed Product(s). Novo Nordisk shall own all clinical data and other results, without limitation, arising out of the work under this Agreement and shall continue to own all data and results which were generated under the Option Agreement from the carrying out of the Work Plan (as defined in the Option Agreement) and reports describing such data and results. Novo Nordisk shall not, directly or indirectly, attempt to chemically modify, or create derivative materials from any Program Carriers. 4.4 Emisphere shall use Commercially Reasonable Efforts to perform any development or commercialization activity undertaken by Emisphere as part of the development plan(s). Novo Nordisk shall compensate Emisphere for its out of pocket costs, including costs for personnel at an hourly rate of $[*****] USD for any development or commercialization activities including technical support, manufacturing support, regulatory support, and support of scale-up/supply activities undertaken by Emisphere at Novo Nordisk’s written request, subject to annual revision to reflect inflation. Novo Nordisk shall be notified in writing in advance of such revision of the hourly rate. 4.5 Novo Nordisk shall use Commercially Reasonable Efforts to develop Licensed Product(s) for one Indication in the Territory as decided by Novo Nordisk at its sole discretion and shall comply with all governmental laws and regulations applicable in any such jurisdiction in the development of and obtaining Regulatory Approval for Licensed Products in the jurisdiction. 4.6 Novo Nordisk may, at its sole discretion, decide on development of any additional Licensed Product(s) and/or Indications for any Licensed Product(s) at its own expense. 4.7 Novo Nordisk shall provide Emisphere with (a) Starting with the Calendar Year 2012, a written annual report within one month after Novo Nordisk’s annual project review, such report to be limited to the Novo Nordisk [*****] for all Licensed Product(s), including significant progress toward achievement of each of the D&C Events and future projected time lines for each of the D&C Events; (b) A written notice 30 days prior to any upcoming D&C Events; and (c) A written notice 30 days after the first occurrence of any D&C Events as specified in Section 3.2. In addition, (d) Novo Nordisk shall inform Emisphere with no undue delay in the event a D&C Event is postponed by at least one quarter as compared to the most recent annual report; and (e) Novo Nordisk shall provide to Emisphere within (10) days any information reasonably requested by Emisphere on an ad hoc basis on the progress of the development of all Licensed Product(s). 4.8 Novo Nordisk shall be solely responsible for all regulatory and filing activities and shall solely own all regulatory documents and registrations including all clinical trial applications and marketing applications filed with any regulatory agency in any jurisdiction. Novo Nordisk shall inform Emisphere of scheduled meetings, teleconferences and other interactions with regulators to the extent regulators allow them but Emisphere shall not be allowed to participate in any of the aforementioned except to the extent that they pertain to Non-Exclusive Program Carriers. Novo Nordisk shall also provide copies of any subsection of any regulatory submission which is related to Program Carriers to Emisphere in a timely fashion. Emisphere may disclose such information as it pertains to any Non-Exclusive Carrier to its Third Party licensees provided (1) such Third Party is not developing or commercializing any formulation of an [*****] and (2) Emisphere and such Third Party licensees enter into a written agreement (A) under terms and conditions regarding use, handling and non-disclosure of such information that are at least as restrictive as under this Agreement and (B) specifying that if such Third Party later initiates development or commercialization of any formulation of an [*****], then at the time of such initiation the Third Party must return to Emisphere any information provided under this section. Upon the reasonable request of Novo Nordisk, Emisphere shall promptly, at Novo Nordisk’s costs, provide Novo Nordisk with information and reasonable assistance for any Novo Nordisk submission to a Regulatory Authority including but not limited to activities to support timely fulfillment of postapproval and/or postmarketing requirements. Upon the reasonable request of Emisphere, Novo Nordisk shall promptly, at Emisphere’s costs, provide Emisphere with information and reasonable assistance for any submission to a Regulatory Authority regarding or relating to a Non-Exclusive Program Carrier. Each Party shall promptly inform the other Party of any material change in information provided under this Section 4.8.

Product Development. 4.1 Novo Nordisk shall, at its own cost and discretion, develop and obtain Regulatory Approval regulatory approval for the Licensed Product(s). (a) Subject to the limitations provided in the definition of Program Carriers and Section 2.2(g) above, the The Parties shall jointly select the Program Carriers for use in Licensed Products which are to be provided to, and screened by, Novo Nordisk. Emisphere shall use Commercially Reasonable Efforts to provide documentation specified by Novo Nordisk concerning the Program Carriers. The Parties agree that the Know-How related to the Program Carriers provided to Novo Nordisk, including structures of such Program Carriers and their availability as Exclusive Program Carriers at the time, must be disclosed by Emisphere to Novo NordiskNordisk at the time of transfer of the Carriers. Any Know-How related to Program Carriers provided to Novo Nordisk prior to the Effective Date shall be provided transferred to Novo Nordisk promptly following execution of the Agreement, if any such Know-How has not already been provided. For the avoidance of doubt, once a specific Carrier has been jointly selected as a Program Carrier, Emisphere may not enter such Carrier on the Excluded Carrier List. (b) Upon selection by Novo Nordisk of a Carrier to be a Program Carrier in accordance with Section 4.2 (a)Carrier, Know-How related to such Program Carrier provided under Section 4.2(a) shall become Licensed Know-How as of the Selection Date. Emisphere shall continue to provide Licensed Know-How to Program Carriers to Novo Nordisk throughout through out the Term. (c) If requested by Novo Nordisk, representatives of Emisphere shall participate, at Novo Nordisk’s cost, in a technology transfer session(s) of commercially reasonable scope and length to be held in Denmark or in the US as decided by Novo Nordisk at its sole discretion. 4.3 Novo Nordisk shall be solely responsible for the development, development plan(s), and commercialization for the Licensed Product(s) and for all of the costs of the development and commercialization of the Licensed Product(s). Novo Nordisk shall own all clinical data and other results, without limitation, arising out of the work under this Agreement and shall continue to own all data and results which were generated under the Option Agreement from the carrying out of the Work Plan (as defined in the Option Agreement) and reports describing such data and results. Novo Nordisk shall not, directly or indirectly, attempt to chemically modify, or create derivative materials from any Program Carriers. 4.4 Emisphere shall use Commercially Reasonable Efforts to perform any development or commercialization activity undertaken by Emisphere as part of the development plan(s). Novo Nordisk shall compensate Emisphere for its out of pocket costs, including costs for personnel at an hourly rate of $[*****] USD for any development or commercialization activities including technical support, manufacturing support, regulatory support, and support of scale-up/supply activities undertaken by Emisphere at Novo Nordisk’s written request, subject to annual revision to reflect inflation. Novo Nordisk shall be notified in writing in advance of such revision of the hourly rate. Activities requested by Novo Nordisk. Emisphere shall use Commercially Reasonable Efforts to perform any development or commercialization activity undertaken by Emisphere. 4.5 Novo Nordisk shall use Commercially Reasonable Efforts to develop Licensed Product(s) for one Indication indication in the Territory as decided by Novo Nordisk at its sole discretion and shall comply with all governmental laws and regulations applicable in any such jurisdiction in the development of and obtaining Regulatory Approval regulatory approval for Licensed Products in the jurisdiction. 4.6 Novo Nordisk may, at its sole discretion, decide on development of any additional Licensed Product(s) and/or Indications indications for any Licensed Product(s) at its own expense. 4.7 Novo Nordisk shall provide Emisphere with (a) Starting with the Calendar Year 2012, a A written annual report within one month after Novo Nordisk’s 's annual project review, such report to be limited to the Novo Nordisk [*****] for all Licensed Product(s), including significant progress toward achievement of each of the D&C Events and future projected time lines for each of the D&C Events; (b) A written notice 30 days prior to any upcoming D&C Events; and (c) A written notice 30 days after the first occurrence of any D&C Events as specified in Section 3.2. In addition, (d) Novo Nordisk shall inform Emisphere with no undue delay in the event a D&C Event is postponed by at least one quarter as compared to the most recent annual report; and (e) Novo Nordisk Emisphere shall provide to Emisphere within (10) days any information reasonably requested by Emisphere have the right on an ad hoc basis to reasonably contact relevant members of upper R&D management of Novo Nordisk to reasonably get further information on the progress of the development of all Licensed Product(s)) as compared to the most recent written annual report. 4.8 Novo Nordisk shall be solely responsible for all regulatory and filing activities and shall solely own all regulatory documents and registrations including all clinical trial applications and marketing applications filed with any regulatory agency in any jurisdiction. Novo Nordisk shall inform Emisphere of scheduled meetings, teleconferences and other interactions with regulators to the extent regulators allow them but Emisphere shall not be allowed to participate in any of the aforementioned except to the extent those that they pertain to Non-Exclusive Program Carriers. Novo Nordisk shall also provide copies of any subsection of any regulatory submission which is related to Program Carriers to Emisphere in a timely fashion. Emisphere may disclose such information as it pertains to any Non-Exclusive Carrier to its Third Party licensees provided (1) such Third Party is not developing or commercializing any formulation of an [*****] a GLP-1 Receptor Agonist and (2) Emisphere and such Third Party licensees enter into a written agreement (A) under terms and conditions regarding use, handling and non-disclosure of such information that are at least as restrictive as under this Agreement and (B) specifying that if such Third Party later initiates development or commercialization of any formulation of an [*****]a GLP-1 Receptor Agonist, then at the time of such initiation the Third Party must return to Emisphere any information provided under this section. Upon the reasonable request of Novo Nordisk, Emisphere shall promptly, at Novo Nordisk’s costs, provide Novo Nordisk with information and reasonable assistance for any Novo Nordisk submission to a Regulatory Authority including but not limited to activities to support timely fulfillment of postapproval and/or postmarketing requirementsAuthority. Upon the reasonable request of Emisphere, Novo Nordisk shall promptly, at Emisphere’s costs, provide Emisphere with information and reasonable assistance for any submission to a Regulatory Authority Agency regarding or relating to a Non-Exclusive Program Carrier. Each Party shall promptly inform the other Party of any material change in information provided under this Section 4.8.

Product Development. 4.1 Novo Nordisk shall, at its own cost and discretion, develop and obtain Regulatory Approval for the Exclusive Licensed Product(s)) or Non-Exclusive Licensed Product. (a) Subject to the limitations provided in the definition of Program Carriers and Section 2.2(g) above, the The Parties shall jointly select the Program Carriers for use in Exclusive Licensed Products Product or Non-Exclusive Licensed Product which are to be provided to, and screened by, Novo Nordisk. Emisphere shall use Commercially Reasonable Efforts to provide documentation specified by Novo Nordisk concerning the Program Carriers. The Parties agree that the Know-How related to the Program Carriers provided to Novo Nordisk, including structures of such Program Carriers and their availability as Exclusive Program Carriers at the time, must be disclosed by Emisphere to Novo NordiskNordisk at the time of transfer of the Carriers. Any Know-How related to Program Carriers provided to Novo Nordisk prior to the Effective Date shall be provided transferred to Novo Nordisk promptly following execution of the Agreement, if any such Know-How has not already been provided. For the avoidance of doubt, once a specific Carrier has been jointly selected as a Program Carrier, Emisphere may not enter such Carrier on the Excluded Carrier List. (b) Upon selection by Novo Nordisk of a Carrier to be a Program Carrier in accordance with Section 4.2 (a)Carrier, Know-How related to such Program Carrier provided under Section 4.2(a) shall become Licensed Know-How as of the Selection Date. Emisphere shall continue to provide Licensed Know-How to Program Carriers to Novo Nordisk throughout the Term. (c) If requested by Novo Nordisk, representatives of Emisphere shall participate, at Novo Nordisk’s cost, in a technology transfer session(s) of commercially reasonable scope and length to be held in Denmark or in the US as decided by Novo Nordisk at its sole discretion. 4.3 Novo Nordisk shall be solely responsible for the development, development plan(s), and commercialization for the Exclusive Licensed Product(s) or Non-Exclusive Licensed Product and for all of the costs of the development and commercialization of the Exclusive Licensed Product(s)) or Non-Exclusive Licensed Product. Novo Nordisk shall own all clinical data and other results, without limitation, arising out of the work under this Agreement and shall continue to own all data and results which were generated under the Option Agreement from the carrying out of the Work Plan (as defined in the Option Agreement) and reports describing such data and results. Novo Nordisk shall not, directly or indirectly, attempt to chemically modify, or create derivative materials from any Program Carriers. 4.4 Emisphere shall use Commercially Reasonable Efforts to perform any development or commercialization activity undertaken by Emisphere as part of the development plan(s). Novo Nordisk shall compensate Emisphere for its out of pocket costs, including costs for personnel at an hourly rate of $[*****] USD for any development or commercialization activities including technical support, manufacturing support, regulatory support, and support of scale-up/supply activities undertaken by Emisphere at Novo Nordisk’s written request, subject to annual revision to reflect inflation. Novo Nordisk shall be notified in writing in advance of such revision of the hourly rate. Emisphere shall use Commercially Reasonable Efforts to perform any development or commercialization activity undertaken by Emisphere. 4.5 Novo Nordisk shall use Commercially Reasonable Efforts to develop Exclusive Licensed Product(s) , and Active Efforts to develop Non-Exclusive Licensed Product(s) in each Molecule Class, for one Indication in the Territory as decided by Novo Nordisk at its sole discretion and shall comply with all governmental laws and regulations applicable in any such jurisdiction in the development of and obtaining Regulatory Approval for Licensed Products Product(s) in the jurisdiction. 4.6 Novo Nordisk may, at its sole discretion, decide on development of any additional develop more than one Exclusive Licensed Product(s) or Non-Exclusive Licensed Product per Molecule Class and/or Indications for any Exclusive Licensed Product(s) at its own expenseor Non-Exclusive Licensed Product. 4.7 Novo Nordisk shall provide Emisphere with (a) Starting with the Calendar Year 2012, a A written annual report within one month after Novo Nordisk’s annual project review, such report to be limited to the Novo Nordisk [*****] management approved development plans for all Exclusive Licensed Product(s)) and Non-Exclusive Licensed Products, including significant progress toward achievement of each of the D&C Events and future projected time lines for each of the D&C Events; (b) A written notice 30 days prior to any upcoming D&C Events; and (c) A written notice 30 days after the first occurrence of any D&C Events as specified in Section 3.2. In addition, (d) Novo Nordisk shall inform Emisphere with no undue delay in the event a D&C Event for an Exclusive Licensed Product or Non-Exclusive Licensed Products is postponed by at least one quarter as compared to the most recent annual report; and (e) Novo Nordisk shall provide to Emisphere within thirty (1030) days any information reasonably requested by Emisphere on an ad hoc basis on the progress of the development of all Exclusive Licensed Product(s)) and Non-Exclusive Licensed Products. 4.8 Novo Nordisk shall be solely responsible for all regulatory and filing activities and shall solely own all regulatory documents and registrations including all clinical trial applications and marketing applications filed with any regulatory agency in any jurisdiction. Novo Nordisk shall inform Emisphere of scheduled meetings, teleconferences and other interactions with regulators to the extent regulators allow them but Emisphere shall not be allowed to participate in any of the aforementioned except to the extent that they pertain to Non-Exclusive Program Carriersaforementioned. Novo Nordisk shall also provide copies of any subsection of any regulatory submission which is related to Program Carriers to Emisphere in a timely fashion. Comments furnished by Emisphere may disclose such information as it pertains to any Non-Exclusive Carrier Novo Nordisk in respect of the foregoing shall be considered in good faith to its Third Party licensees provided (1) such Third Party is not developing or commercializing any formulation of an [*****] and (2) Emisphere and such Third Party licensees enter into a written agreement (A) under terms and conditions regarding use, handling and non-disclosure of such information that are at least as restrictive as under this Agreement and (B) specifying that if such Third Party later initiates development or commercialization of any formulation of an [*****], then at the time of such initiation extent the Third Party must return comments relate to Emisphere any information provided under this sectionProgram Carriers. Upon the reasonable request of Novo Nordisk, Emisphere shall promptly, at Novo Nordisk’s costs, provide Novo Nordisk with information and reasonable assistance for any Novo Nordisk submission to a Regulatory Authority including but not limited to activities to support timely fulfillment of postapproval post-approval and/or postmarketing post-marketing requirements. Upon the reasonable request of Emisphere, Novo Nordisk shall promptly, at Emisphere’s costs, provide Emisphere with information and reasonable assistance for any submission to a Regulatory Authority regarding or relating to a Non-Exclusive Program Carrier. Each Party shall promptly inform the other Party of any material change in information provided under this Section 4.8.