Target List. (a) Subject to the other terms of this Section 2.4, (i) the Rolling Target List will include up to ************ designated for Immunization in each two-consecutive Contract Year period, and ******************************** (all such Targets selected by Sanofi for the Rolling Target List pursuant to this Section 2.4 being referred to as “Sanofi Targets”). The Parties shall conduct a meeting of the JRC within ten (10) Business Days of the Effective Date (the “Special JRC Meeting”) to ******************************. The Rolling Target List will be updated on an annual basis at a meeting of the JRC to be held in January of each Contract Year, commencing in 2010 and ending in 2017 (the “Annual Draft Meeting”). At least thirty (30) days prior to the Annual Draft Meeting to be held in 2017, Regeneron shall provide to Sanofi information on the identity and status of Targets validated by Regeneron under the Discovery Program that were not previously selected as Targets on to the Rolling Target List. Targets on the Rolling Target List are progressed from the Rolling Target List to the Immunized Target List at commencement of Immunization. Any Targets on the Rolling Target List which have not progressed to the Immunized Target List during a Contract Year shall remain on the Rolling Target List, subject to Sections 2.4(b), 2.4(c), and 2.8 below. At each Annual Draft Meeting, the Parties shall select Targets for the Available Slots to bring the total number of Targets on the Rolling Target List back to *******. At the Special JRC Meeting and each Annual Draft Meeting, the Parties shall alternate selecting Targets for the Available Slots on the Rolling Target List, with Sanofi designating first, Regeneron second and the process repeating until Sanofi has selected as many Targets as it desires up to ****************. Regeneron shall designate all Targets for the Available Slots remaining after Sanofi’s selections pursuant to this Section 2.4(a). For clarity, an Excluded Target cannot be selected onto the Rolling Target List without the mutual consent of the Parties. All Targets selected by the Parties for the Rolling Target List pursuant to this Section 2.4 shall be identified by their HUGO name, if applicable. (b) Targets may be removed from the Rolling Target List or replaced by new Targets at any time prior to Immunization by the mutual written consent of the Parties. Targets removed (either by removal or replacement) from the Rolling Target List pursuant to this Section 2.4(b) shall become Excluded Targets. Each Party shall have the right to select up to ******************************* to be added to the Rolling Target List outside the applicable Annual Draft Meeting at any time during each Contract Year (such Party being a “Pre-Selecting Party”). The applicable Pre-Selecting Party shall be considered to have included the applicable Target(s) onto the Rolling Target List upon its written notice to the other Party. Unless the Target selected by the Pre-Selecting Party is excluded or removed from the Rolling Target List pursuant to Section 2.4(c) or Section 2.8, it shall be considered one of the Targets selected by the Pre-Selecting Party for the Rolling Target List at the next scheduled Annual Draft Meeting and the number of Targets the Pre-Selecting Party may select for the Available Slots at such Annual Draft Meeting shall be reduced accordingly. In addition, Regeneron shall have the right to replace a Target removed from the Rolling Target List by Sanofi pursuant to Section 2.8 at any time during each Contract Year upon written notice to Sanofi. (c) Sanofi shall have the right to exclude from the Rolling Target List a Target selected by Regeneron for the Rolling Target List as provided in Section 2.4(c)(i), and shall have the right to remove a Program Target from the Target List, as provided in Sections 2.4(c)(ii) and (iii). (i) Sanofi shall have the right to exclude from the Rolling Target List a Target selected by Regeneron for the Rolling Target List (a “Regeneron Selected Target”) if *************. (d) Within sixty (60) days after the end of Contract Year 5 (ending December 31, 2012), the Executive Officers of both Parties may agree that the maximum percentage of Targets that Sanofi may select for the Rolling Target List should change *************************. In deciding whether to make such a change, the Executive Officers shall take into consideration, among other criteria agreed to by the Executive Officers, ******************************************. If the Executive Officers both agree to change the maximum percentage of Targets Sanofi may select for the Rolling Target List, then the Parties will promptly enter into an amendment to this Agreement solely for the purpose of amending the terms of Section 2.4(a) to reflect the new agreed upon percentage for each of the remaining Contract Years for which the Rolling Target List has not been designated.
Appears in 1 contract
Sources: Discovery and Preclinical Development Agreement (Regeneron Pharmaceuticals Inc)
Target List. (a) Subject to the other terms of this Section 2.4, (i) the Rolling Target List will include up to ************* designated for Immunization in each two-consecutive Contract Year period, and ********************************* (all such Targets selected by Sanofi for the Rolling Target List pursuant to this Section 2.4 being referred to as “Sanofi Targets”). The Parties shall conduct a meeting of the JRC within ten (10) Business Days of the Effective Date (the “Special JRC Meeting”) to ***********************************. The Rolling Target List will be updated on an annual basis at a meeting of the JRC to be held in January of each Contract Year, commencing in 2010 and ending in 2017 (the “Annual Draft Meeting”). At least thirty (30) days prior to the Annual Draft Meeting to be held in 2017, Regeneron shall provide to Sanofi information on the identity and status of Targets validated by Regeneron under the Discovery Program that were not previously selected as Targets on to the Rolling Target List. Targets on the Rolling Target List are progressed from the Rolling Target List to the Immunized Target List at commencement of Immunization. Any Targets on the Rolling Target List which have not progressed to the Immunized Target List during a Contract Year shall remain on the Rolling Target List, subject to Sections 2.4(b), 2.4(c), and 2.8 below. At each Annual Draft Meeting, the Parties shall select Targets for the Available Slots to bring the total number of Targets on the Rolling Target List back to ********. At the Special JRC Meeting and each Annual Draft Meeting, the Parties shall alternate selecting Targets for the Available Slots on the Rolling Target List, with Sanofi designating first, Regeneron second and the process repeating until Sanofi has selected as many Targets as it desires up to *************************************. Regeneron shall designate all Targets for the Available Slots remaining after Sanofi’s selections pursuant to this Section 2.4(a). For clarity, an Excluded Target cannot be selected onto the Rolling Target List without the mutual consent of the Parties. All Targets selected by the Parties for the Rolling Target List pursuant to this Section 2.4 shall be identified by their HUGO name, if applicable.
(b) Targets may be removed from the Rolling Target List or replaced by new Targets at any time prior to Immunization by the mutual written consent of the Parties. Targets removed (either by removal or replacement) from the Rolling Target List pursuant to this Section 2.4(b) shall become Excluded Targets. Each Party shall have the right to select up to ******************************* to be added to the Rolling Target List outside the applicable Annual Draft Meeting at any time during each Contract Year (such Party being a “Pre-Selecting Party”). The applicable Pre-Selecting Party shall be considered to have included the applicable Target(s) onto the Rolling Target List upon its written notice to the other Party. Unless the Target selected by the Pre-Selecting Party is excluded or removed from the Rolling Target List pursuant to Section 2.4(c) or Section 2.8, it shall be considered one of the Targets selected by the Pre-Selecting Party for the Rolling Target List at the next scheduled Annual Draft Meeting and the number of Targets the Pre-Selecting Party may select for the Available Slots at such Annual Draft Meeting shall be reduced accordingly. In addition, Regeneron shall have the right to replace a Target removed from the Rolling Target List by Sanofi pursuant to Section 2.8 at any time during each Contract Year upon written notice to Sanofi.
(c) Sanofi shall have the right to exclude from the Rolling Target List a Target selected by Regeneron for the Rolling Target List as provided in Section 2.4(c)(i), and shall have the right to remove a Program Target from the Target List, as provided in Sections 2.4(c)(ii) and (iii).
(i) Sanofi shall have the right to exclude from the Rolling Target List a Target selected by Regeneron for the Rolling Target List (a “Regeneron Selected Target”) if at the time of selection by Regeneron of such Regeneron Selected Target either (A) Sanofi or its Affiliate has an existing Antibody against the Regeneron Selected Target that is ****************, (B) Sanofi or its Affiliate has *****************************, or (C) Sanofi or its Affiliate has **************** or has ********************. With respect to its exclusion rights under Section 2.4(c)(i)(C), Sanofi may neither ************ for the Rolling Target List in any Contract Year, nor ******************* over any rolling three (3) Contract Year period. Sanofi must notify Regeneron of its exclusion pursuant to this Section 2.4(c)(i) within ten (10) Business Days of the Annual Draft Meeting or Special JRC Meeting at which Regeneron selects the applicable Regeneron Selected Target or Sanofi’s receipt of written notice from Regeneron regarding Regeneron’s selection of a Regeneron Selected Target pursuant to Section 2.4(b) above or this Section 2.4(c)(i). Sanofi’s exclusion of a Regeneron Selected Target pursuant to this Section 2.4(c)(i) must be followed promptly by written notice to Regeneron that describes the condition in either (A), (B), or (C) above that has been met supporting the Target exclusion. Regeneron shall have ten (10) Business Days from the exclusion of a Target under this Section 2.4(c) to select replacement Regeneron Selected Target(s) for the Rolling Target List under Section 2.4(a) or Section 2.4(b), as the case may be, in which case the terms of this Section 2.4(c) shall remain in effect.
(ii) Sanofi shall have the right to remove a Target from the Rolling Target List upon written notice to Regeneron if, ******************************** Regeneron has failed to progress a Target to the Immunized Target List. Sanofi shall have thirty (30) days from the Third Anniversary Date to exercise its right to remove the applicable Target from the Rolling Target List under this Section 2.4(c)(ii).
(iii) Sanofi shall have the right to remove a Program Target from the Immunized Target List upon written notice to Regeneron if, **************************************** Regeneron is no longer actively working on Antibodies against the applicable Target under the Discovery Program, or (B) *************************************, Regeneron has failed to submit an Opt-In Report for a Product Candidate against such Program Target. Sanofi shall have thirty (30) days from the applicable ********************** to exercise its right to remove the applicable Program Target from the Immunized Target List under this Section 2.4(c)(iii).
(d) Within sixty (60) days after the end of Contract Year 5 (ending December 31, 2012), the Executive Officers of both Parties may agree that the maximum percentage of Targets that Sanofi may select for the Rolling Target List should change **********************************. In deciding whether to make such a change, the Executive Officers shall take into consideration, among other criteria agreed to by the Executive Officers, ******************************************. If the Executive Officers both agree to change the maximum percentage of Targets Sanofi may select for the Rolling Target List, then the Parties will promptly enter into an amendment to this Agreement solely for the purpose of amending the terms of Section 2.4(a) to reflect the new agreed upon percentage for each of the remaining Contract Years for which the Rolling Target List has not been designated.
Appears in 1 contract
Sources: Discovery and Preclinical Development Agreement (Regeneron Pharmaceuticals Inc)