Common use of Continuing Research Clause in Contracts

Continuing Research. ​ (a) By letter dated [**], Foundation called a special meeting of the JSC pursuant to Second Amendment Section 2(g) to address the Cost/Timeline Issue that a [**] by the [**] of [**] and that the [**] of $[**] before a [**] would be [**]. As contemplated by Second Amendment Section 2(g)(1) the JSC has agreed upon the Corrective Plan and related budget that are attached as Exhibits TA-1 and TA-2, respectively. Such Corrective Plan and related budget constitutes an amendment of the Research Plan and related budget. Company shall conduct the DC Research in accordance with the Agreement, as amended. (b) In connection with adoption of the Corrective Plan, the JSC has also agreed upon the DC Criteria attached as Exhibit TA-3 and the parties have agreed to extend the DC Timeline Goal to [**] and the Research Term until the earliest of (i) the date upon which the JSC first designates a Development Candidate, (ii) [**] or (iii) the effective date of any termination of the Research Term pursuant to Second Amendment Section 3. If a Development Candidate is not selected by the extended DC Timeline Goal, the parties shall have the right to call a special meeting of the JSC to address [**] in accordance with Second Amendment Section [**], including by agreeing upon [**], and if applicable thereafter, the rights specified in Section Amendment Section 2(h) and/or Second Amendment Section [**]. (c) Notwithstanding Second Amendment Section 2(d), Company shall be responsible for funding one hundred percent (100%) of the total overall cost of all DC Research performed on or after the Third Amendment Effective Date; provided, however, that Company shall have the ability to set its own budgets with respect to the conduct of the research after [**] so long as the Company’s obligations under Section 2.5 of the Agreement (captioned “Performance Standards”) are met. Company acknowledges and agrees that Foundation has paid all amounts due to Company pursuant to Second Amendment Section 2(d) and does not have any further ​ obligation to reimburse Company for any amounts incurred by Company, whether before or after the Third Amendment Effective Date, with respect to the DC Research. If Foundation decides in its discretion to engage [**] or other external contract research organizations (“CROs”) or academic collaborators [**] to test, after the Third Amendment Effective Date, any compounds arising from the DC Research, Foundation shall be solely responsible for paying any amounts owed to [**] or such other CROs or academic collaborators in connection with such testing. ​

Continuing Research. ​ (a) By letter dated [**], Foundation called a special meeting of The parties agree to the JSC pursuant to Second Amendment Section 2(g) to address the Cost/Timeline Issue that a [**] by the [**] of [**] and that the [**] of $[**] before a [**] would be [**]. As contemplated by Second Amendment Section 2(g)(1) the JSC has agreed upon the Corrective Plan and related budget that are attached as Exhibits TA-1 and TA-2, respectively. Such Corrective Plan and related budget constitutes an amendment modification of the Research Plan and related budget. Company shall conduct the DC Research in accordance with the Agreement, as amended. (b) In connection with adoption of the Corrective Plan, the JSC has also agreed upon the DC Criteria budget attached as Exhibit TA-3 and SA-1 to allow for Company to perform continued research activities (the parties have agreed to extend the “DC Timeline Goal Research”) with respect to [**] Research Projects previously funded under the Agreement and the First Amendment. The goal of such research will be the presentation by Company of one (1) Development Candidate from one (1) Research Project for further discussion with Foundation with respect to potential funding of development of such Development Candidate by Foundation, and continuation of one (1) backup program with respect to the other Research Project (the “Secondary Research Project”). The expected duration of the DC Research is [**] months from the Second Amendment Effective Date (the “DC Timeline Goal”). ​ (b) Company shall conduct such DC Research (i) in accordance with Exhibit SA-1, subject to amendment by the JSC as provided in this Second Amendment, and (ii) in accordance with the terms of the Agreement as amended herein, including but not limited to Company’s obligations under Section 2.5 of the Agreement (captioned “Performance Standards”). (c) In connection with such DC Research, the Research Term shall be extended, without interruption, until the earliest of (i) the date upon which the JSC first designates a Development Candidate, (ii) the date which is [**] years following the Second Amendment Effective Date or (iii) the effective date of any termination of the Research Term pursuant to Second Amendment Section 3. (d) The parties will fund the overall total cost of the DC Research based on the Research Plan and related budget attached as Exhibit SA-1, with Foundation contributing approximately [**]% and Company contributing approximately [**]% of such overall total cost of the DC Research as more explicitly specified in such budget, such overall total cost not to exceed $[**] (the “Research Cap”) and the Foundation’s share of such total cost not to exceed $[**]. During the Research Term, Company will invoice Foundation on a quarterly basis for Foundation’s share of the costs incurred in connection with the Research Plan for the preceding calendar quarter, payable within [**] days of receipt by Foundation, subject to Second Amendment Sections 2(d)(i) and 2(d)(ii). Such invoices shall include: (A) an accounting, in reasonable detail sufficient to evaluate performance of the Research Plan by Company, of Company’s activities over the applicable period, (B) a breakout of FTEs and other resources allocated to each Research Project and (C) an itemization in reasonable detail of the categories of out-of-pocket costs incurred by Company that are included in such invoice. When invoicing Foundation or developing or presenting any budget related to the Research Plan, Company will in all cases apply the FTE rates specified in Exhibit SA-1 to the applicable category of FTE, and no additions or changes to the FTE categories or rates specified in Exhibit SA-1 shall be made by Company absent prior written consent of Foundation. Company will promptly respond to all requests by Foundation for additional information regarding such out-of-pocket costs. Company’s commitment, between [**] and [**], of [**] dollars ($[**]) in funding towards the DC Research shall be available to Company in the form of an invoice credit against Company’s share of the cost of the DC Research until expended and shall count towards the Research Cap. ​ Promptly after the Second Amendment Effective Date, Company will provide Foundation with an invoice for [**] percent ([**]%) of the amount that Company spent between [**] and the Second Amendment Effective Date to perform the DC Research. Such invoice shall include the information specified in (A), (B) and (C) within this Second Amendment Section 2(d) and shall be payable within [**] days of receipt by Foundation. The entire amount paid by Foundation pursuant to such invoice shall count towards the Research Cap and towards Foundation’s share of the Research Cap. ​ (i) Subject to Second Amendment Section 2(d)(ii), Foundation shall not be responsible for its share of any DC Research costs that exceed the budget for any calendar quarter unless: ​ (1) such costs exceed the budget for such calendar quarter by less than [**] dollars ($[**]) or [**] percent ([**]%) (whichever is less); ​ (2) such costs exceed the budget for such calendar quarter by more than [**] dollars ($[**]) or [**] percent ([**]%) (whichever is less) but less than [**] percent ([**]%) and Company provided written notice to Foundation prior to incurring such budget overrun; or ​ (3) such costs exceed the budget for such calendar quarter by more than [**] percent ([**]%) and Foundation approved such budget overrun in writing before it was incurred. ​ (ii) If at any time during the Second Amendment Term, the total cost incurred in the performance of the DC Research during the period from the Second Amendment Effective Date until the end of the most recent calendar quarter exceeds the cumulative budget for such period by [**] dollars ($[**]) or more, then Second Amendment Section 2(d)(i) shall not apply to any subsequent cost overruns and Foundation shall not be responsible for its share of any additional costs that exceed the applicable budget for any subsequent quarter unless Foundation approved such budget overrun in writing before it was incurred. ​ (e) Foundation may provide its share of the budget under the Research Plan via other sources of funding, subject to prior agreement of the parties and the existing terms of the Agreement. One hundred percent (100%) of all funds, if any, received by Company during the Second Amendment Term from the Department of Defense directed to the DC Research or the Development of a Development Candidate is as a result of the advocacy of the Foundation will count toward the Foundation’s share of the costs incurred in connection with the Research Plan; provided, however, that [**] in the [**] pursuant to [**] of the Agreement. At Foundation’s request, Company shall promptly complete all paperwork required or reasonably useful to secure receipt by Company of such funds from the Department of Defense. ​ (f) Company may provide its share of the budget via government grants or grants from nonprofit organizations; provided however, that, except for mandatory licenses and similar or related rights granted to government entities, Company’s acceptance of such grants shall not selected by have any effect on Foundation’s rights pursuant to this Agreement; further provided, however, that with respect to any nonprofit organizations that have as a specific aspect of their general ​ mission the extended DC Timeline Goalfunding of research on SMA, Company shall first seek Foundation’s written consent and the parties shall negotiate in good faith any required amendments to this Agreement or separate agreements to accommodate grants from such organizations, with the guiding principle that this Agreement remain the primary document governing the conduct of the DC Research by the parties. Company shall use Commercially Reasonable Efforts to obtain additional funding for the Secondary Research Project from government grants or grants from nonprofit organizations (subject to the provisions set forth in the preceding sentence with respect to funding from any nonprofit organizations that have as a specific aspect of their general mission the right funding of research on SMA); provided however, that, except for mandatory licenses and similar or related rights granted to government entities, Company’s acceptance of such grants shall not have any effect on Foundation’s rights pursuant to this Agreement. If Company obtains such funding in an amount that exceeds Company’s share of the budget for the Secondary Research Project, Company shall notify Foundation in writing and the JSC shall revise the Research Plan and related budget to reflect the additional work to be performed on the Secondary Research Project with such funds, (i) which additional work shall be under the purview of the JSC and the compounds resulting from such work shall remain Drug Candidates, Reversion Candidates, or Development Candidates, as the case may be, and (ii) which revised budget shall not require the Foundation to contribute any money to pay for or reimburse Company for research performed with respect to any aspect of the revised Research Plan for which Company has received such grant funds. (g) If (i) it becomes evident to either party at any time, based on budget forecasts or progress in the Research Plan, that a [**] may [**] for [**], or that the [**], or (ii) the [**] is [**] (each of the foregoing, a “Cost/Timeline Issue”), then either party may, on written notice to the other, call a special meeting of the JSC to address such Cost/Timeline Issue. At such meeting, representatives of each party shall present information in their control with respect to the reasons for such Cost/Timeline Issue, and (if applicable) each party’s plan or recommendation for addressing such Cost/Timeline Issue. The JSC shall review and address such Cost/Timeline Issue, and shall determine which of the following actions the parties shall pursue: ​ (1) develop, approve, and follow an amendment to the Research Plan (such amendment, the “Corrective Plan”) to address the Cost/Timeline Issue, which may (subject to the written consent of the affected party in such party’s sole discretion) require either party to [**] the DC Research, or provide that the [**] in accordance with which case (x) the [**] shall be [**] and/or, if the [**] is more than [**] years after the Second Amendment Section Effective Date, then the Research Term shall be deemed amended to extend until the earliest of (i) the date upon which the JSC first designates a Development Candidate, (ii) the [**], including by agreeing upon [**], and if applicable thereafter, or (iii) the rights specified in Section Amendment Section 2(h) and/or effective date of any termination of the Research Term pursuant to Second Amendment Section [**]. 3, and (cy) Notwithstanding Second Amendment Section 2(d)in addition to their other obligations under the Agreement, Company the parties shall be responsible for funding one hundred percent (100%) of the total overall cost of all DC Research performed on or after the Third Amendment Effective Dateduly perform their respective obligations pursuant to such Corrective Plan; provided, however, that Company shall have after the ability adoption of a Corrective Plan, failure to set its own budgets with respect to achieve the conduct of the research after [**] so long as or [**] shall not be deemed, by itself, to be a breach of this Agreement, but shall entitle either party to terminate the Company’s obligations under Section 2.5 of the Agreement (captioned “Performance Standards”) are met. Company acknowledges and agrees that Foundation has paid all amounts due to Company Research Term pursuant to Second Amendment Section 2(d3; (2) restructure the Research Plan and does related budget in a manner that resolves the Cost/Timeline Issue; provided, however, that such restructuring shall not have any further ​ obligation obligate either party to reimburse Company for any amounts incurred by Company, whether before or after [**] of the Third Amendment Effective Date, with respect to the DC Research. If Foundation decides in its discretion to engage [**] or other external contract research organizations be deemed to [**]; or ​ (“CROs”3) or academic collaborators determine that continuation of the DC Research would be futile, in which case the JSC shall recommend to the parties that they terminate the DC Research; provided further, that following such recommendation either party shall have the right to terminate the Research Term pursuant to Second Amendment Section 3. ​ (h) If the members of the JSC fail to unanimously agree upon one of the three actions described in Second Amendment Section 2(g) (1), (2) and (3), then the matter shall be referred to the parties’ Chief Executive Officers, and if the parties’ Chief Executive Officers do not agree upon one of such three actions within [**] days after matter referral, then either party shall have the right to test, after terminate the Third Research Term pursuant to Second Amendment Effective Date, any compounds arising from Section 3. If the DC Research, Foundation shall be solely responsible for paying any amounts owed to affected party does not approve the Corrective Plan within [**] or such other CROs or academic collaborators in connection with such testingdays after it is first formally proposed, then either party shall have the right to terminate the Research Term pursuant to Second Amendment Section 3. ​