Common use of Additional Milestones Clause in Contracts

Additional Milestones. (i) In addition to the foregoing, Biogen Idec and PTI will each use Commercially Reasonable Efforts to achieve each applicable Harvard Development Milestone within the applicable time periods; provided that, neither Party will be in default of its obligations under this Section 3.2(b)(i) if the reason that such Party or its Sublicensee failed to achieve such a milestone was due to factors beyond its control, including, without limitation, (1) any force majeure, (2) any delay (not attributable to such Party, any Sublicensee, or any of their Affiliates) or change in the regulatory requirements or the regulatory process, including, without limitation, any such delays or changes associated with obtaining approvals for development or commercialization from Regulatory Authorities, (3) unavailability of supply of raw materials or products, (4) adverse pre-clinical or clinical results with respect to Licensed Product in terms of safety or efficacy, (5) change in laws or legal requirements, (6) inability to identify or develop suitable formulation for Licensed Product and (7) unanticipated problems with manufacturing process and scale-up of Licensed Product. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. Execution Version (ii) If the Parties, by themselves or through Sublicensees, fail to meet any of the Harvard Development Milestones within such specified time periods, then the Parties will cooperate with each other in complying with the procedures in Sections 3.4 of the Harvard License, including by working together to present to Harvard an Explanation and a Plan (as such terms are defined in the Harvard License) that are acceptable to Harvard. If such failure to meet a Harvard Milestone is due solely to Biogen Idec’s actions or omissions, Biogen Idec agrees to reimburse PTI for any and all payments that PTI makes to Harvard under Section 3.5 of the Harvard License that are necessary thereunder to avoid or delay the termination of the Harvard License to the maximum extent permitted, which reimbursement payments will be non-refundable by PTI, but will be treated as Biogen Idec Development costs with respect to the affected Co-Developed Licensed Products. If such failure to meet a Harvard Milestone is due solely to PTI’s actions or omissions, PTI will bear all such costs, but such costs will be treated as PTI Development costs with respect to the affected Co-Developed Licensed Products. If such failure to meet a Harvard Milestone is due to actions or omissions by both Parties, the Parties will split such costs and such costs will be treated as Development costs by each Party.

Additional Milestones. (i) In addition to the foregoing, Biogen Idec and PTI will each use Commercially Reasonable Efforts to achieve each applicable of the Development Milestones from the Harvard License that are listed on Exhibit G (the “Harvard Development Milestone within the applicable time periodsMilestones”) with regard to each Sole Licensed Product; provided that, neither Party Biogen Idec will not be in default of its obligations under this Section 3.2(b)(i3.1(d)(i) if the reason that such Party Biogen Idec or its Sublicensee failed to achieve such a milestone was due to factors beyond its control, including, without limitation, (1) any force majeure, (2) any delay (not attributable to such PartyBiogen Idec, any Sublicensee, or any of their Affiliates) or change in the regulatory requirements or the regulatory process, including, without limitation, any such delays or changes associated with obtaining approvals for development or commercialization from Regulatory Authorities, (3) unavailability of supply of raw materials or products, (4) adverse pre-clinical or clinical results with respect to Licensed Product in terms of safety or efficacy, (5) change in laws or legal requirements, (6) inability to identify or develop suitable formulation for Licensed Product and (7) unanticipated problems with manufacturing process and scale-up of Licensed Product. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. Execution VersionVersion suitable formulation for Licensed Product and (7) unanticipated problems with manufacturing process and scale-up of Licensed Product; and provided further that, in the event that Biogen Idec has materially breached its diligence obligations under this Section 3.1(d)(i) with respect to a Licensed Product, PTI shall only have the right to terminate this Agreement with respect to such Licensed Product and not with respect to any other Licensed Product as to which Biogen Idec is not in breach of its diligence obligations under this Section 3.1(d). (ii) If the PartiesIf, subject to Section 3.1(d)(i), Biogen Idec, by themselves itself or through its Sublicensees, fail fails to meet any of the Harvard Development Milestones within such specified the applicable time periodsperiod, then the Parties Biogen Idec will cooperate with each other PTI in complying with the procedures in Sections 3.4 of the Harvard License, including by working together to present assisting PTI in presenting to Harvard an Explanation and a Plan (as such terms are defined in the Harvard License) that are acceptable to Harvard. If such failure to meet a Harvard Milestone is due solely to Biogen Idec’s actions or omissions, Biogen Idec agrees to reimburse PTI for any and all payments that PTI makes to Harvard under Section 3.5 of the Harvard License that are necessary thereunder to avoid or delay the termination of the Harvard License to the maximum extent permitted, which reimbursement payments will be non-refundable by PTI, but will be treated as creditable by Biogen Idec Development costs against the next milestone payment(s) that become payable by Biogen Idec under this Agreement with respect to the affected Co-Developed Sole Licensed Products. If such failure to meet a Harvard Milestone is due solely to PTI’s actions or omissions, PTI will bear all such costs, but such costs will be treated as PTI Development costs with respect to the affected Co-Developed Licensed Products. If such failure to meet a Harvard Milestone is due to actions or omissions by both Parties, the Parties will split such costs and such costs will be treated as Development costs by each Party.

Additional Milestones. (i) In addition to the foregoing, Biogen Idec and PTI will each use Commercially Reasonable Efforts to achieve each applicable of the Development Milestones from the Harvard License that are listed on Exhibit G (the “Harvard Development Milestone within the applicable time periodsMilestones”) with regard to each Sole Licensed Product; provided that, neither Party Biogen Idec will not be in default of its obligations under this Section 3.2(b)(i3.1(d)(i) if the reason that such Party Biogen Idec or its Sublicensee failed to achieve such a milestone was due to factors beyond its control, including, without limitation, (1) any force majeure, (2) any delay (not attributable to such PartyBiogen Idec, any Sublicensee, or any of their Affiliates) or change in the regulatory requirements or the regulatory process, including, without limitation, any such delays or changes associated with obtaining approvals for development or commercialization from Regulatory Authorities, (3) unavailability of supply of raw materials or products, (4) adverse pre-clinical or clinical results with respect to Licensed Product in terms of safety or efficacy, (5) change in laws or legal requirements, (6) inability to identify or develop suitable formulation for Licensed Product and (7) unanticipated problems with manufacturing process and scale-up of Licensed Product. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. Execution Versionsuitable formulation for Licensed Product and (7) unanticipated problems with manufacturing process and scale-up of Licensed Product; and provided further that, in the event that Biogen Idec has materially breached its diligence obligations under this Section 3.1(d)(i) with respect to a Licensed Product, PTI shall only have the right to terminate this Agreement with respect to such Licensed Product and not with respect to any other Licensed Product as to which Biogen Idec is not in breach of its diligence obligations under this Section 3.1(d). (ii) If the PartiesIf, subject to Section 3.1(d)(i), Biogen Idec, by themselves itself or through its Sublicensees, fail fails to meet any of the Harvard Development Milestones within such specified the applicable time periodsperiod, then the Parties Biogen Idec will cooperate with each other PTI in complying with the procedures in Sections 3.4 of the Harvard License, including by working together to present assisting PTI in presenting to Harvard an Explanation and a Plan (as such terms are defined in the Harvard License) that are acceptable to Harvard. If such failure to meet a Harvard Milestone is due solely to Biogen Idec’s actions or omissions, Biogen Idec agrees to reimburse PTI for any and all payments that PTI makes to Harvard under Section 3.5 of the Harvard License that are necessary thereunder to avoid or delay the termination of the Harvard License to the maximum extent permitted, which reimbursement payments will be non-refundable by PTI, but will be treated as creditable by Biogen Idec Development costs against the next milestone payment(s) that become payable by Biogen Idec under this Agreement with respect to the affected Co-Developed Sole Licensed Products. If such failure to meet a Harvard Milestone is due solely to PTI’s actions or omissions, PTI will bear all such costs, but such costs will be treated as PTI Development costs with respect to the affected Co-Developed Licensed Products. If such failure to meet a Harvard Milestone is due to actions or omissions by both Parties, the Parties will split such costs and such costs will be treated as Development costs by each Party.

Additional Milestones. (i) In addition to the foregoing, Biogen Idec and PTI will each use Commercially Reasonable Efforts to achieve each applicable Harvard Development Milestone within the applicable time periods; provided that, neither Party will be in default of its obligations under this Section 3.2(b)(i) if the reason that such Party or its Sublicensee failed to achieve such a milestone was due to factors beyond its control, including, without limitation, (1) any force majeure, (2) any delay (not attributable to such Party, any Sublicensee, or any of their Affiliates) or change in the regulatory requirements or the regulatory process, including, without limitation, any such delays or changes associated with obtaining approvals for development or commercialization from Regulatory Authorities, (3) unavailability of supply of raw materials or products, (4) adverse pre-clinical or clinical results with respect to Licensed Product in terms of safety or efficacy, (5) change in laws or legal requirements, (6) inability to identify or develop suitable formulation for Licensed Product and (7) unanticipated problems with manufacturing process and scale-up of Licensed Product. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. Execution Version. (ii) If the Parties, by themselves or through Sublicensees, fail to meet any of the Harvard Development Milestones within such specified time periods, then the Parties will cooperate with each other in complying with the procedures in Sections 3.4 of the Harvard License, including by working together to present to Harvard an Explanation and a Plan (as such terms are defined in the Harvard License) that are acceptable to Harvard. If such failure to meet a Harvard Milestone is due solely to Biogen Idec’s actions or omissions, Biogen Idec agrees to reimburse PTI for any and all payments that PTI makes to Harvard under Section 3.5 of the Harvard License that are necessary thereunder to avoid or delay the termination of the Harvard License to the maximum extent permitted, which reimbursement payments will be non-refundable by PTI, but will be treated as Biogen Idec Development costs with respect to the affected Co-Developed Licensed Products. If such failure to meet a Harvard Milestone is due solely to PTI’s actions or omissions, PTI will bear all such costs, but such costs will be treated as PTI Development costs with respect to the affected Co-Developed Licensed Products. If such failure to meet a Harvard Milestone is due to actions or omissions by both Parties, the Parties will split such costs and such costs will be treated as Development costs by each Party.