Common use of Failure to Meet Development Milestone; Opportunity to Cure Clause in Contracts

Failure to Meet Development Milestone; Opportunity to Cure. If Licensee believes that it will not meet its obligations pursuant to Section 3.1, it may notify Harvard in writing. Licensee shall include with such notice (a) a reasonable explanation of the reasons for such failure (“Explanation”) and (b) a reasonable, detailed, written plan for promptly achieving a reasonable extended and/or amended milestone or plan (“Plan”). If Licensee so notifies Harvard, but fails to provide Harvard with both an Explanation and Plan, then Licensee will have an additional seventy-five (75) days to meet such milestone or plan. Licensee’s failure to do so shall constitute a material breach of this Agreement and Harvard shall have the right to terminate this Agreement forthwith. If Licensee so notifies Harvard and provides Harvard with an Explanation and Plan, both of which are acceptable to Harvard in its reasonable discretion, then Exhibit 1.6 will be amended automatically to incorporate the Plan. If Licensee so notifies Harvard and provides Harvard with an Explanation and Plan, but the Explanation is not acceptable to Harvard in its reasonable discretion (e.g., Licensee asserts development preference for a non-Licensed Product or non-Licensed Service), then Licensee will have an additional seventy-five (75) days or until the original deadline of the relevant Development Milestone, whichever is later, to meet such milestone. Licensee’s failure to do so shall constitute a material breach of this Agreement and Harvard shall have the right to terminate this Agreement forthwith. If Licensee so notifies Harvard and provides Harvard with an Explanation and Plan, but the Plan is not acceptable to Harvard in its reasonable discretion, then Harvard will explain to Licensee why the Plan is not acceptable and provide Licensee with suggestions for an acceptable Plan. Licensee will have one opportunity to provide Harvard with an acceptable Plan within ninety (90) days, during which time Harvard agrees to work with Licensee in its effort to develop an acceptable Plan. If, within such ninety (90) days, Licensee provides Harvard with an acceptable Plan, then Exhibit 1.6 will be amended automatically to incorporate the extended and/or amended Plan. If, within such ninety (90) days, Licensee fails to provide an acceptable Plan, then Licensee will have an additional thirty (30) days or until the original deadline of the relevant Development Milestone, whichever is later, to meet such milestone. Licensee’s failure to do so shall constitute a material breach of this Agreement and Harvard shall have the right to terminate this Agreement forthwith. For clarity, if Licensee fails to achieve a Development Milestone and does not avail itself of the procedure set forth in this Section 3.4, such failure shall be a material breach that entitles Harvard to proceed under Section 10.2.2.1.

Failure to Meet Development Milestone; Opportunity to Cure. If Licensee believes that it will not meet its obligations pursuant to Section 3.1achieve a Development Milestone, it may notify Harvard BIRAD in writingwriting in advance of the relevant deadline. Licensee shall include with such notice (a) a reasonable explanation of the reasons for such failure (and lack of finances shall not constitute reasonable basis for such failure) (“Explanation”) and (b) a reasonable, detailed, written plan for promptly achieving a reasonable extended and/or amended milestone or plan (“Plan”). If Licensee so notifies HarvardBIRAD, but fails to provide Harvard BIRAD with both an Explanation and Plan, then the provisions of Section 10.2.3.1 shall apply if Licensee will have an additional seventy-five (75) days in fact fails to meet such milestone or plan. Licensee’s failure to do so shall constitute a material breach of this Agreement and Harvard shall have the right to terminate this Agreement forthwithDevelopment Milestone. If Licensee so notifies Harvard BIRAD and provides Harvard BIRAD with an Explanation and Plan, both of which are acceptable to Harvard BIRAD in its reasonable discretion, then Exhibit 1.6 will A shall be amended automatically to incorporate the extended and/or amended milestone set forth in the Plan. If Licensee so notifies Harvard BIRAD and provides Harvard BIRAD with an Explanation and Plan, but the Explanation is not acceptable reasonable to Harvard BIRAD in its reasonable discretion (e.g., e. g. Licensee asserts lack of finances or development preference for a non-Licensed Product or non-Licensed ServiceProduct), then Licensee will have an additional seventy-five (75) days or until the original deadline of for the relevant Development Milestone, whichever is later, milestone shall remain unchanged and the provisions of Section 10.2. 3.1 shall apply if Licensee in fact fails to meet such milestone. Licensee’s failure to do so shall constitute a material breach of this Agreement and Harvard shall have the right to terminate this Agreement forthwith. If Licensee so notifies Harvard BIRAD and provides Harvard BIRAD with an Explanation and Plan, but the Plan is not acceptable to Harvard BIRAD in its reasonable discretion, then Harvard will BIRAD shall explain to Licensee why the Plan is not acceptable and provide Licensee with suggestions for an acceptable Plan. Licensee will shall have one opportunity to provide Harvard BIRAD with an acceptable a reasonable Plan within ninety (90) days, during which time Harvard BIRAD agrees to work with Licensee in its effort to develop an acceptable a reasonable Plan. If, within such ninety (90) days, Licensee provides Harvard BIRAD with an acceptable a reasonable Plan, then Exhibit 1.6 will A shall be amended automatically to incorporate the extended and/or amended milestone set forth in the Plan. If, within such ninety (90) days, Licensee fails to provide an acceptable a reasonable Plan, then Licensee will shall have an additional thirty (30) days or until the original deadline of the relevant Development Milestone, whichever is later, to meet such milestone. Licensee’s failure to do so shall constitute a material breach of this Agreement and Harvard BIRAD shall have the right to terminate this Agreement forthwith. For clarity, if Licensee fails to achieve a Development Milestone and does not avail itself of the procedure set forth in this Section 3.4, such failure shall be a material breach that entitles Harvard to proceed under Section 10.2.2.1.

Failure to Meet Development Milestone; Opportunity to Cure. If Licensee believes that it will not meet its obligations pursuant to Section 3.1achieve a Development Milestone, it may notify Harvard in writingwriting in advance of the relevant deadline. Licensee shall include with such notice (a) a reasonable explanation of the reasons for such failure (and lack of finances will not constitute reasonable basis for such failure) (“Explanation”) and (b) a reasonable, detailed, written plan for promptly achieving a reasonable extended and/or amended milestone or plan (“Plan”). If Licensee so notifies Harvard, but fails to provide Harvard with both an Explanation and Plan, then Licensee will have an additional seventy-five thirty (7530) days or until the original deadline of the relevant Development Milestone, whichever is later, to meet such milestone or planmilestone. Licensee’s failure to do so shall constitute a material breach of this Agreement and Harvard shall have the right to terminate this Agreement forthwith. If Licensee so notifies Harvard and provides Harvard with an Explanation and Plan, both of which are acceptable to Harvard in its reasonable discretion, then Exhibit 1.6 1.4 will be amended automatically to incorporate the extended and/or amended milestone set forth in the Plan. If Licensee so notifies Harvard and provides Harvard with an Explanation and Plan, but the Explanation is not acceptable to Harvard in its reasonable discretion (e.g., Licensee asserts lack of finances or development preference for a non-Licensed Product or non-Licensed ServiceProduct), then Licensee will have an additional seventy-five thirty (7530) days or until the original deadline of the relevant Development Milestone, whichever is later, to meet such milestone. Licensee’s failure to do so shall constitute a material breach of this Agreement and Harvard shall have the right to terminate this Agreement forthwith. If Licensee so notifies Harvard and provides Harvard with an Explanation and Plan, but the Plan is not acceptable to Harvard in its reasonable discretion, then Harvard will explain to Licensee why the Plan is not acceptable and provide Licensee with suggestions for an acceptable Plan. Licensee will have one opportunity to provide Harvard with an acceptable Plan within ninety (90) days, during which time Harvard agrees to work with Licensee in its effort to develop an acceptable Plan. If, within such ninety (90) days, Licensee provides Harvard with an acceptable Plan, then Exhibit 1.6 1.4 will be amended automatically to incorporate the extended and/or amended milestone set forth in the Plan. If, within such ninety (90) days, Licensee fails to provide an acceptable Plan, then Licensee will have an additional thirty (30) days or until the original deadline of the relevant Development Milestone, whichever is later, to meet such milestone. Licensee’s failure to do so shall constitute a material breach of this Agreement and Harvard shall have the right to terminate this Agreement forthwith. For clarity, if Licensee fails to achieve a Development Milestone and does not avail itself of the procedure set forth in this Section 3.4, such failure shall be a material breach that entitles Harvard to proceed under Section 10.2.2.1.

Failure to Meet Development Milestone; Opportunity to Cure. 3.4.1 If Licensee believes that it will not meet its obligations pursuant to Section 3.1achieve a Development Milestone, it may notify Harvard in writingwriting in advance of the relevant deadline. Licensee shall include with such notice (a) a reasonable explanation of the reasons for such failure (“Explanation”) and (b) a reasonable, detailed, written plan for promptly achieving a reasonable extended deadline and/or amended milestone or plan (“Plan”). . 3.4.2 If Licensee so notifies Harvard, but fails to provide Harvard with both an Explanation and Plan, then Licensee will have an additional seventy-five [**] from such notice or until the original deadline of the relevant Development Milestone, whichever is later (75) days the “Initial Deadline”), to meet such milestone or planmilestone. Licensee’s failure to do so provide Harvard with both an Explanation and Plan by the Initial Deadline shall constitute a material breach of this Agreement and Harvard shall have the right to terminate this Agreement forthwith. . 3.4.3 If Licensee so notifies Harvard and provides Harvard with an Explanation and PlanPlan by the Initial Deadline, both of which are acceptable to Harvard in its reasonable discretion, then if Harvard agrees in writing or fails to provide written notice of its objection Licensee within [**] of the Initial Deadline, then Exhibit 1.6 1.11 will be amended automatically to incorporate the extended deadline and/or amended milestone set forth in the Plan. . 3.4.4 If Licensee so notifies Harvard and provides Harvard with an Explanation and Plan, but the Explanation is not acceptable to Harvard in its reasonable discretion (e.g., Licensee asserts development preference for a non-Licensed Product or non-Licensed Service)Product) then Harvard will provide written notice of its objection to Licensee explaining why the Explanation is not acceptable within [**] of the Initial Deadline, then and Licensee will have an additional seventy-five (75) days [**] from receipt of Harvard’s written notice or until the original deadline of the relevant Development Milestone, whichever is laterlater (the “Second Deadline”), to meet such milestonemilestone or to persuade Harvard that the Explanation is reasonable. Licensee’s failure to do so meet such milestone or to persuade Harvard that the Explanation is reasonable by the Second Deadline shall constitute a material breach of this Agreement and Harvard shall have the right to terminate this Agreement forthwith. * Confidential treatment has been requested for redacted portions of this exhibit. This copy omits the information subject to the confidentiality request. Omissions are designated as [**]. A complete version of this exhibit has been provided separately to the Securities and Exchange Commission. 3.4.5 If Licensee so notifies Harvard and provides Harvard with an Explanation and Plan, but the Plan is not acceptable to Harvard in its reasonable discretion, then Harvard will explain provide written notice of its objection to Licensee explaining why the Plan is not acceptable and provide providing Licensee with suggestions for an acceptable PlanPlan within [**] of the Initial Deadline. Licensee will then have one opportunity to provide Harvard with an a reasonably acceptable Plan (or to persuade Harvard that its Plan is reasonable) within ninety (90) days[**] after receipt of Harvard’s written notice and suggestions, during which time Harvard agrees to work in good faith with Licensee in its effort to develop an a reasonably acceptable Plan. If, within such ninety (90) days[**], Licensee provides Harvard with an a reasonably acceptable Plan, then Exhibit 1.6 1.11 will be amended automatically to incorporate the extended deadline and/or amended milestone set forth in the Plan. If, within such ninety (90) days[**], Licensee fails to provide an a reasonably acceptable Plan, then Licensee will have an additional thirty (30) days [**] or until the original deadline of the relevant Development Milestone, whichever is laterlater (the “Third Deadline”), to meet such milestone. Licensee’s failure to do so provide such acceptable Plan or meet such milestone by the Third Deadline shall constitute a material breach of this Agreement and Harvard shall have the right to terminate this Agreement forthwith. . 3.4.6 For clarity, if Licensee fails to achieve a Development Milestone and does did not avail itself of the procedure set forth in this Section 3.4, such failure shall be constitute a material breach that entitles of this Agreement and Harvard shall have the right to proceed under Section 10.2.2.1terminate this Agreement forthwith.

Failure to Meet Development Milestone; Opportunity to Cure. If Licensee believes that it will not meet its obligations pursuant to Section 3.1achieve a Development Milestone, it may notify Harvard in writingwriting in advance of the relevant deadline (a “Delayed Milestone Notice”). Licensee shall include with such notice Delayed Milestone Notice (a) a reasonable explanation of the reasons for such failure (and lack of finances will not constitute reasonable basis for such failure) (an “Explanation”) and (b) a reasonable, detailed, written plan for promptly achieving a reasonable extended and/or amended milestone or plan (a “Plan”). If Licensee so notifies Harvardprovides Harvard with a Delayed Milestone Notice, but fails to provide Harvard with both an Explanation and a Plan, then Harvard will notify Licensee in writing that it has not received such Explanation and such Plan. Licensee will have an additional seventy-five (75) days [***] after receipt of such notice to meet such milestone or planmilestone. Subject to Section 3.5, Licensee’s failure to do so meet the deadline set forth in the preceding sentence shall constitute a material breach of this Agreement and Harvard shall have the right to terminate this Agreement forthwithimmediately. If Licensee so notifies Harvard and provides Harvard with an Explanation and Plana Plan in or with its Delayed Milestone Notice, both of which are acceptable to Harvard in its reasonable discretion, then Exhibit 1.6 Harvard will so inform Licensee in writing and the Development Plan will be amended automatically to incorporate the extended and/or amended milestone set forth in the Plan. If Licensee so notifies provides Harvard with a Delayed Milestone Notice and provides Harvard with an Explanation and a Plan, but the Explanation is not acceptable to Harvard in its reasonable discretion (e.g., Licensee asserts lack of finances or development preference for a non-Licensed Product or non-Licensed ServiceProduct), then Harvard will provide Licensee a written notice explaining why the Explanation was not acceptable. Licensee will then have an additional seventy-five (75) days or until the original deadline [***] after receipt of the relevant Development Milestone, whichever is later, such notice to meet such milestone. Subject to Section 3.5, Licensee’s failure to do so meet the deadline set forth in the preceding sentence shall constitute a material breach of this Agreement and Harvard shall have the right to terminate this Agreement forthwithimmediately. If Licensee so notifies provides a Delayed Milestone Notice to Harvard and provides Harvard with an Explanation and a Plan, but the Plan is not acceptable to Harvard in its reasonable discretion, then Harvard will explain to Licensee why the Plan is not acceptable and provide Licensee with suggestions for an acceptable Plan. Licensee will have one opportunity to provide Harvard with an acceptable Plan within ninety (90) days[***], during which time Harvard agrees to work with Licensee in its effort to develop an acceptable Plan. If, within such ninety (90) days[***], Licensee provides Harvard with an acceptable Plan, then Exhibit 1.6 the Development Plan will be amended automatically to incorporate the extended and/or amended milestone set forth in the Plan. If, within such ninety (90) days[***], Licensee fails to provide an acceptable Plan, then Licensee will have an additional thirty (30) days or until [***] after the original deadline date of Harvard’s final rejection of the relevant Development Milestone, whichever is later, last Plan submitted by Licensee to meet such milestone. Subject to Section 3.5, Licensee’s failure to do so meet the deadline set forth in the preceding sentence shall constitute a material breach of this Agreement and Harvard shall have the right to terminate this Agreement forthwithimmediately. For clarity, if Licensee fails 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. to achieve a Development Milestone and does not avail itself of the procedure procedures set forth in this Section 3.4, such failure shall be a material breach that entitles Harvard to proceed under Section 10.2.2.1. The sole remedy of Harvard for any breach of Section 3.1 or this Section 3.4 shall be to terminate this Agreement in accordance with this Section 10.2.2.1 hereof. Notwithstanding anything in this Section 3.4 or elsewhere in this Agreement expressed or implied to the contrary, (i) Harvard shall not have the right to terminate this Agreement for failure to achieve a Development Milestone or for failure to comply with the provisions of this Section 3.4 if the reason that Licensee failed to achieve a Development Milestone was due to factors beyond its control, including, without limitation, (1) any force majeure, (2) any delay (not attributable to Licensee, any Sublicensee, any Third Party Licensee 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, and (ii) in the event that Licensee has materially breached its diligence obligations in Section 3.1 with respect to a Licensed Product, Harvard 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 Licensee is not in breach of its diligence obligations under Section 3.1 hereof.

Failure to Meet Development Milestone; Opportunity to Cure. If Licensee believes that it will not meet its obligations pursuant to Section 3.1achieve a Development Milestone, it may notify Harvard in writingwriting in advance of the relevant deadline. Licensee shall include with such notice (a) a reasonable explanation of the reasons for such failure [***] (“Explanation”) and (b) a reasonable, detailed, written plan for promptly achieving a reasonable extended and/or amended milestone or plan (“Plan”). If Licensee so notifies Harvard, but fails to provide Harvard with both an Explanation and Plan, then Licensee will have an additional seventy-five (75) days [***] or until the original deadline of the relevant Development Milestone, whichever is later, to meet such milestone or planDevelopment Milestone. Licensee’s failure to do so shall constitute a material breach of this Agreement and Harvard shall have the right to terminate this Agreement forthwithimmediately upon written notice to Licensee. If Licensee so notifies Harvard and provides Harvard with an Explanation and Plan, both of which are acceptable to Harvard in its reasonable discretion, then Exhibit 1.6 A will be amended automatically to incorporate the extended and/or amended milestone set forth in the Plan. If Licensee so notifies Harvard and provides Harvard with an Explanation and Plan, but the Explanation is not acceptable to Harvard in its reasonable discretion (e.g., Licensee asserts lack of finances or development preference for a non-Licensed Product or nonRoyalty-Licensed ServiceBearing Product), then Licensee will have an additional seventy-five (75) days [***] or until the original deadline of the relevant Development Milestone, whichever is later, to meet such milestoneDevelopment Milestone. Licensee’s failure to do so shall constitute a material breach of this Agreement and Harvard shall have the right to terminate this Agreement forthwithimmediately upon written notice to Licensee. If Licensee so notifies Harvard and provides Harvard with an Explanation and Plan, but the Plan is not acceptable to Harvard in its reasonable discretion, then Harvard will explain to Licensee why the Plan is not acceptable and provide Licensee with suggestions for an acceptable Plan. Licensee will have one opportunity to provide Harvard with an acceptable Plan within ninety (90) days[***], during which time Harvard agrees to work with Licensee in its effort to develop an acceptable Plan. If, within such ninety (90) days[***], Licensee provides Harvard with an acceptable Plan, then Exhibit 1.6 A will be amended automatically to incorporate the extended and/or amended milestone set forth in the Plan. If, within such ninety (90) days[***], Licensee fails to provide an acceptable Plan, then Licensee will have an additional thirty (30) days [***] or until the original deadline of the relevant Development Milestone, whichever is later, to meet such milestoneDevelopment Milestone. Licensee’s failure to do so shall constitute a material breach of this Agreement and Harvard shall have the right to terminate this Agreement forthwiththis 2.2.1. For clarityNotwithstanding the foregoing, if Licensee fails may make a first one-time only extension payment of [***] to achieve extend all Development Milestones for an additional [***] period and a second one-time only extension payment of [***] to extend all Development Milestone and does not avail itself of the procedure set forth in this Section 3.4, such failure shall be a material breach that entitles Harvard to proceed under Section 10.2.2.1Milestones for an additional [***] period.

Failure to Meet Development Milestone; Opportunity to Cure. 3.4.1 If Licensee believes that it will not meet its obligations pursuant to Section 3.1achieve a Development Milestone, it may notify Harvard in writingwriting in advance of the relevant deadline. Licensee shall include with such notice (a) a reasonable explanation of the reasons for such failure (“Explanation”) and (b) a reasonable, detailed, written plan for promptly achieving a reasonable extended deadline and/or amended milestone or plan (“Plan”). . 3.4.2 If Licensee so notifies Harvard, but fails to provide Harvard with both an Explanation and Plan, then Licensee will have an additional seventy-five [**] from such notice or until the original deadline of the relevant Development Milestone, whichever is later (75) days the “Initial Deadline”), to meet such milestone or planmilestone. Licensee’s failure to do so provide Harvard with both an Explanation and Plan by the Initial Deadline shall constitute a material breach of this Agreement and Harvard shall have the right to terminate this Agreement forthwith. . 3.4.3 If Licensee so notifies Harvard and provides Harvard with an Explanation and PlanPlan by the Initial Deadline, both of which are acceptable to Harvard in its reasonable discretion, then if Harvard agrees in writing or fails to provide written notice of its objection Licensee within [**] of the Initial Deadline, then Exhibit 1.6 1.11 will be amended automatically to incorporate the extended deadline and/or amended milestone set forth in the Plan. . 3.4.4 If Licensee so notifies Harvard and provides Harvard with an Explanation and Plan, but the Explanation is not acceptable to Harvard in its reasonable discretion (e.g., Licensee asserts development preference for a non-Licensed Product or non-Licensed Service)Product) then Harvard will provide written notice of its objection to Licensee explaining why the Explanation is not acceptable within [**] of the Initial Deadline, then and Licensee will have an additional seventy-five (75) days [**] from receipt of Harvard’s written notice or until the original deadline of the relevant Development Milestone, whichever is laterlater (the “Second Deadline”), to meet such milestonemilestone or to persuade Harvard that the Explanation is reasonable. Licensee’s failure to do so meet such milestone or to persuade Harvard that the Explanation is reasonable by the Second Deadline shall constitute a material breach of this Agreement and Harvard shall have the right to terminate this Agreement forthwith. . 3.4.5 If Licensee so notifies Harvard and provides Harvard with an Explanation and Plan, but the Plan is not acceptable to Harvard in its reasonable discretion, then Harvard will explain provide written notice of its objection to Licensee explaining why the Plan is not acceptable and provide providing Licensee with suggestions for an acceptable PlanPlan within [**] of the Initial Deadline. Licensee will then have one opportunity to provide Harvard with an a reasonably acceptable Plan (or to persuade Harvard that its Plan is reasonable) within ninety (90) days[**] after receipt of Harvard’s written notice and suggestions, during which time Harvard agrees to work in good faith with Licensee in its effort to develop an a reasonably acceptable Plan. If, within such ninety (90) days[**], Licensee provides Harvard with an a reasonably acceptable Plan, then Exhibit 1.6 1.11 will be amended automatically to incorporate the extended deadline and/or amended milestone set forth in the Plan. If, within such ninety (90) days[**], Licensee fails to provide an a reasonably acceptable Plan, then Licensee will have an additional thirty (30) days [**] or until the original deadline of the relevant Development Milestone, whichever is laterlater (the “Third Deadline”), to meet such milestone. Licensee’s failure to do so provide such acceptable Plan or meet such milestone by the Third Deadline shall constitute a material breach of this Agreement and Harvard shall have the right to terminate this Agreement forthwith. . 3.4.6 For clarity, if Licensee fails to achieve a Development Milestone and does did not avail itself of the procedure set forth in this Section 3.4, such failure shall be constitute a material breach that entitles of this Agreement and Harvard shall have the right to proceed under Section 10.2.2.1terminate this Agreement forthwith.