Common use of Development Candidate Designation Clause in Contracts

Development Candidate Designation. (i) Within [***] days following Ionis’ delivery of a Development Candidate Data Package with respect to a Collaboration Program to Biogen pursuant to Section 1.8.3(a) (which period will begin upon resolution of any dispute regarding omissions or deficiencies with respect to such Development Candidate Data Package in accordance with Section 1.8.3(a), including the delivery of information to resolve such omissions or deficiencies, if applicable), the Neurology JDC will discuss whether to designate the Compound proposed by Ionis as the Development Candidate (or any Related Program Compounds) as the lead Development Candidate for such Collaboration Program, taking into account the input of the [***] with respect to its [***] assessment of such proposed Development Candidate and Related Program Compounds. Any designation of a Development Candidate for a Collaboration Program by the Neurology JDC will be documented in the written minutes of the Neurology JDC. If the Neurology JDC mutually agrees to designate the Compound recommended by Ionis as the lead Development Candidate or any Related Program Compound as a Development Candidate for a Collaboration Program, then the Parties will conduct the IND-Enabling Toxicology Studies for such selected Development Candidates under the applicable Toxicology Strategy that has been agreed to in accordance with Section 1.8.3(c). (ii) If the Neurology JDC cannot agree as to whether to designate any Compound proposed by Ionis as the lead Development Candidate or Related Program Compound as Development Candidates within [***] days after the Neurology JDC meets to discuss the applicable Development Candidate Data Package (such [***]-day period for a Collaboration Program, the “Development Candidate Decision Period”), then Biogen will have final decision-making authority as to whether to designate any such proposed Development Candidate or Related Program Compound as a Development Candidate for such Collaboration Program and Biogen will notify the Neurology JDC in writing of its determination. (iii) If the Neurology JDC (or Biogen through the exercise of its final decision-making authority) does not designate any of the Ionis-proposed lead Development Candidate or Related Program Compounds as Development Candidates for a given Collaboration Program within the Development Candidate Decision Period, and Biogen has not cured such failure to designate a Development Candidate within the earlier of [***] days following the missed deadline or [***] days following a written notice from Ionis of the missed deadline (the “Development Candidate Designation Deadline”), then, (A) Biogen’s Option with respect to such Collaboration Program will terminate; (B) neither Ionis nor Biogen will have an obligation to perform any further activities under this ARTICLE 1 with respect to such Collaboration Program; (C) such program will no longer be a Collaboration Program, (D) unless the applicable Collaboration Target that is the subject of such Collaboration Program is an Active Target, such target shall cease to be a Collaboration Target and shall no longer be a Neurology Target under this Agreement at such time; (E) upon Ionis’ request, Biogen will provide to Ionis any data generated under the Collaboration Program to the extent licensed to Ionis under Section 4.3.4; (F) upon Biogen’s request, Ionis will provide to Biogen any data generated under the Collaboration Program to the extent licensed to Biogen under Section 4.3.3; and (G) with respect to any Ionis-proposed lead Development Candidate and any Related Program Compounds included in the applicable Development Candidate Data Package, effective on the day that the applicable Collaboration Target that such proposed Development Candidates and Related Program Compounds target becomes a Terminated Target, Biogen will, and does hereby, grant to Ionis a sublicensable, worldwide, non-exclusive royalty-bearing (in accordance with Section 1.8.3(d)(iv)) license or sublicense, as the case may be, to Biogen Background Technology Controlled by Biogen as of such date solely as necessary to Develop, make, have made, use, sell, offer for sale, have sold, import and otherwise Commercialize such Ionis-proposed lead Development Candidate and such Related Program Compounds, in each case, targeting such Terminated Target, in the Field in the form such Compounds exist as of such date other than Permitted Changes in Form with respect to such lead Development Candidate or Related Program Compounds (such license will be sublicensable by Ionis in accordance with Section 4.1.2, mutatis mutandis). Ionis will reimburse Biogen for any amounts owed by Biogen to Third Parties as a result of the grant of any such license to Ionis under, or Ionis’ practice of, any Biogen Background Technology; provided that Ionis has been notified of the terms of such payment obligations to any such Third Party, and, if Ionis notifies Biogen that it does not wish to be granted a license under any Patent Rights or Know-How that are subject to such payment obligations included in the Biogen Background Technology, then such Patent Rights or Know-How (as applicable) will be excluded from the Biogen Background Technology licensed to Ionis hereunder, and Ionis will have no obligation to reimburse Biogen for any such payments. (iv) If Ionis or its Affiliates or Sublicensee sells any product that includes any such proposed Ionis-proposed lead Development Candidate or Related Program Compounds, in each case, that Biogen fails to designate as a Development Candidate by the applicable Development Candidate Designation Deadline that is Covered by any Patent Rights within the Biogen Background Technology, then on a country-by-country basis Ionis will pay to Biogen a royalty equal to [***]of net sales of any such product sold by Ionis, its Affiliates or Sublicensees, for so long as such product is Covered by such Patent Rights within the Biogen Background Technology in such country. For the purpose of the foregoing royalty calculation, “net sales” will be calculated in accordance with the definition of “Net Sales” as set forth in Appendix 1, applied mutatis mutandis to such calculation. The provisions of Sections 6.12, 6.13, 6.14 and 6.15 shall apply, mutatis mutandis, to any royalty payments by Ionis to Biogen under this Section 1.8.3(d)(iv). If the Parties are unable to agree as to the [***] under this Section 1.8.3(d)(iv) within a period of [***] days after the applicable Development Candidate Designation Deadline, then either Party may refer the matter to Expert Resolution under Section 12.1.4. (v) If at the time of the Development Candidate Designation Deadline, the applicable Collaboration Target is an Active Target, then Biogen’s rights in such Collaboration Target in connection with all other Strategies and Collaboration Programs for such Collaboration Target shall remain unaffected and each Party’s rights and obligations under Section 2.1 shall continue in full force and effect.

Development Candidate Designation. (i) Within [***] days following Ionis’ delivery of a Development Candidate Data Package with respect to a Collaboration Program to Biogen pursuant to Section 1.8.3(a1.4.2(a) (which period will begin upon and resolution of any dispute regarding omissions or deficiencies with respect to such Development Candidate Data Package in accordance with Section 1.8.3(a1.4.2(a), including the delivery of information to resolve such omissions or deficiencies, if applicable), the Neurology JDC JSC will discuss whether to designate the Compound proposed that is recommended by Ionis Ionis’ RMC as the lead compound under such Development Candidate Data Package (or any other Compound listed in the Development Candidate Data Package as a potential backup Compound (or any Related Program Compoundssuch Compound, a “Backup Compound”)) as the lead Development Candidate for such Collaboration Program, taking into account the input of the [***] JPC with respect to its [***] intellectual property assessment of such proposed Development Candidate and Related Program CompoundsCompound(s). Any designation of a Development Candidate for a Collaboration Program by the Neurology JDC JSC will be documented in the written minutes of the Neurology JDCJSC. If the Neurology JDC JSC mutually agrees to designate the Compound recommended by Ionis as the lead Development Candidate or any Related Program such a Compound as a Development Candidate then, following the JSC’s agreement to a high level preclinical toxicology strategy for a Collaboration Programsuch Development Candidate in accordance with Section 1.5 below, then the Parties Biogen will conduct the IND-Enabling Toxicology Studies for under such selected Development Candidates strategy under the applicable Toxicology Strategy that has been agreed to in accordance with Section 1.8.3(c). (ii) 1.5. If the Neurology JDC JSC cannot agree as to whether to designate any the Compound proposed that is recommended by Ionis Ionis’ RMC as the lead compound under such Development Candidate Data Package (or Related any Backup Compound) as a Development Candidate for a given Collaboration Program Compound as Development Candidates within [***] days after the Neurology JDC JSC meets to discuss the applicable Development Candidate Data Package (such [***]-day period for a Collaboration Programperiod, the “Development Candidate JSC Decision Period”), then Biogen [***] will have final decision-making authority as to determine whether or not to designate any the Compound that is recommended by Ionis’ RMC as the lead compound under such proposed Development Candidate Data Package (or Related Program Compound any Backup Compound) as a Development Candidate for such Collaboration Program and Biogen will notify the Neurology JDC JSC in writing of its determination. (iii) [***] determination within [***] days after the end of the JSC Decision Period. If the Neurology JDC JSC (or Biogen [***] through the exercise of its final decision-making authority) does not designate any of the Ionis-proposed lead such a Compound as a Development Candidate or Related Program Compounds as Development Candidates for a given Collaboration Program within the Development Candidate Decision Period, and Biogen has not cured such failure to designate a Development Candidate within the earlier of [***] days following after the missed deadline or [***] days following a written notice from Ionis of date Biogen receives the missed deadline (the “complete Development Candidate Designation Deadline”Data Package under Section 1.4.2(a), then, unless the Parties mutually agree to amend the applicable ASO Development Candidate Identification Plan to conduct additional Development activities (Ai) Biogen’s Option with respect to such Collaboration Program will terminate; , (Bii) neither Ionis nor Biogen will have an obligation to perform any further activities under this ARTICLE 1 with respect to such Collaboration Program; (Ciii) such program will no longer be a Collaboration Program, ; (Div) unless the applicable Collaboration Target that is the subject of Ionis’ obligations and Biogen’s rights under this Agreement with respect to any ASOs under such Collaboration Program is an Active Target, such target shall cease to be a Collaboration Target will then terminate except as expressly set forth in Section 1.10 and shall no longer be a Neurology Target under this Agreement at such timeARTICLE 2; (Eiv) upon Ionis’ request, Biogen will provide to Ionis any data generated under the Collaboration Program to the extent and licensed to Ionis under Section 4.3.44.3.2; and (Fv) upon Biogen’s request, Ionis will provide to Biogen any data generated under the Collaboration Program to the extent and licensed to Biogen under Section 4.3.3; and (G) with respect to any Ionis-proposed lead Development Candidate and any Related Program Compounds included in the applicable Development Candidate Data Package, effective on the day that the applicable Collaboration Target that such proposed Development Candidates and Related Program Compounds target becomes a Terminated Target, Biogen will, and does hereby, grant to Ionis a sublicensable, worldwide, non-exclusive royalty-bearing (in accordance with Section 1.8.3(d)(iv)) license or sublicense, as the case may be, to Biogen Background Technology Controlled by Biogen as of such date solely as necessary to Develop, make, have made, use, sell, offer for sale, have sold, import and otherwise Commercialize such Ionis-proposed lead Development Candidate and such Related Program Compounds, in each case, targeting such Terminated Target, in the Field in the form such Compounds exist as of such date other than Permitted Changes in Form with respect to such lead Development Candidate or Related Program Compounds (such license will be sublicensable by Ionis in accordance with Section 4.1.2, mutatis mutandis). Ionis will reimburse Biogen for any amounts owed by Biogen to Third Parties as a result of the grant of any such license to Ionis under, or Ionis’ practice of, any Biogen Background Technology; provided that Ionis has been notified of the terms of such payment obligations to any such Third Party, and, if Ionis notifies Biogen that it does not wish to be granted a license under any Patent Rights or Know-How that are subject to such payment obligations included in the Biogen Background Technology, then such Patent Rights or Know-How (as applicable) will be excluded from the Biogen Background Technology licensed to Ionis hereunder, and Ionis will have no obligation to reimburse Biogen for any such payments4.3.1. (iv) If Ionis or its Affiliates or Sublicensee sells any product that includes any such proposed Ionis-proposed lead Development Candidate or Related Program Compounds, in each case, that Biogen fails to designate as a Development Candidate by the applicable Development Candidate Designation Deadline that is Covered by any Patent Rights within the Biogen Background Technology, then on a country-by-country basis Ionis will pay to Biogen a royalty equal to [***]of net sales of any such product sold by Ionis, its Affiliates or Sublicensees, for so long as such product is Covered by such Patent Rights within the Biogen Background Technology in such country. For the purpose of the foregoing royalty calculation, “net sales” will be calculated in accordance with the definition of “Net Sales” as set forth in Appendix 1, applied mutatis mutandis to such calculation. The provisions of Sections 6.12, 6.13, 6.14 and 6.15 shall apply, mutatis mutandis, to any royalty payments by Ionis to Biogen under this Section 1.8.3(d)(iv). If the Parties are unable to agree as to the [***] under this Section 1.8.3(d)(iv) within a period of [***] days after the applicable Development Candidate Designation Deadline, then either Party may refer the matter to Expert Resolution under Section 12.1.4. (v) If at the time of the Development Candidate Designation Deadline, the applicable Collaboration Target is an Active Target, then Biogen’s rights in such Collaboration Target in connection with all other Strategies and Collaboration Programs for such Collaboration Target shall remain unaffected and each Party’s rights and obligations under Section 2.1 shall continue in full force and effect.