Provision Language
5. Product Development
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5.1.1. SMAF Clinical Trials Advisory Committee. Foundation has the right, but not the obligation, to create a committee of experts to advise Foundation/Roche/PTC, as applicable, on clinical trials and expanded access with respect to SRA Development Candidates and SRA Products (the “SMAF Clinical Trials Advisory Committee”). Such SMAF Clinical Trials Advisory Committee shall consist of such individuals as Foundation may designate, but shall include [**]. The SMAF Clinical Trials Advisory Committee shall have, as one (1) of its principal mandates, the responsibility of balancing (i) the rapid and efficient development and commercialization of SRA Development Candidates and SRA Products for the benefit of all potential patients in the SRA Field and (ii) the appropriateness, based on available safety and efficacy information with respect to such SRA DevelopmentCandidates and SRA Products, of providing access to such SRA Development Candidates and SRA Products to individual patients via the extension protocols or expanded access programs further described in Sections 5.1.2 and 5.1.3. Such SMAF Clinical Trials Advisory Committee may establish its own procedures for meetings and decision-making.
7. Governance
7.1 Joint Steering Committee. Within [**] days after the Effective Date of this Agreement, the Parties and the Foundation shall establish a joint steering committee (“JSC”) to oversee the Research Program and the Product Development Program activities under this Agreement.
7.2 Acknowledgement Concerning the JSC
7.2.1 Sole Governance Body for Certain Decisions.
Each Party and the Foundation acknowledges that the JSC, in addition to its other functions as described herein, shall be the sole governance body for all research and SRA Development decisions regarding the SRA DC Research and the SRA Development of SRA Reversion Candidates, SRA Development Candidates and SRA Products that are the subject of this Agreement.
7.2.2 Excepted Decisions. The JSC’s role as such sole governance body under Section 7.2.1 shall not prevent PTC or Roche from making decisions necessary or useful to implement decisions made by the JSC regarding research, SRA Development and SRA Collaboration Activities with respect to SRA Compounds, so long as such implementation decisions are consistent with and faithful to the intent of the JSC’s decision.
7.3 Members. The JSC shall be composed of [**] persons (“Members”). Roche, PTC and the Foundation each shall be entitled to appoint [**] Members with appropriate seniority and functional expertise. Each Member shall be an employee of the appointing Party or the Foundation, as applicable, unless otherwise agreed by the other Party and the Foundation, or the Parties, as applicable. Each Party and the Foundation may replace any of its Members and appoint a person to fill the vacancy arising from each such replacement. If PTC, Roche or the Foundation replaces a Member, it shall notify the other Party and the Foundation, or the Parties, as applicable, at least [**] days prior to the next scheduled meeting of the JSC. Both Parties and the Foundation shall use Commercially Reasonable Efforts to keep an appropriate level of continuity in representation. Members may be represented at any meeting by another person designated by the absent Member. The JSC shall be chaired by a Roche Member (the “Chairperson”). The Chairperson shall be responsible for calling meetings of the JSC and for leading the meetings.
7.4 Responsibilities of the JSC. The JSC shall have the responsibility and authority to:
a) monitor and implement the transfer of the SRA Product to Roche;
b) oversee, monitor and approve the Research Plan;
c) revise and approve any revisions to the Research Plan;
d) review and oversee the execution of the Research Plan;
e) establish timelines and criteria for decision points;
f) review the efforts of the Parties and allocate those resources for the Research Plan (including the budget);
g) identify appropriate resources necessary to conduct the Research Plan;
h) decide whether to pursue options (1), (2) or (3) of Section 2(g) of the Second SRA Amendment in the event of an SRA Cost/Timeline Issue;
i) maintain and update, at each JSC meeting prior to [**], a list that identifies and rank orders all potential and actual SRA Lead Candidates and SRA Development Candidates and denotes all SRA Development Candidates and between [**] potential or actual SRA Lead Candidates as SRA Reversion Candidates and as “Reversion Candidates” under the SRA;
j) prior to the designation of an SRA Development Candidate, prepare the SRA Development Plan and the “Development Plan” under the SRA for such SRA Development Candidate, and review and update the SRA Development Deadline Document and the “Development Deadline Document” under the SRA as it may deem advisable, in each case as further provided in Article 3 of the SRA;
k) establish and set expectations and mandates for each joint operational team (each, a “JOT”);
l) create or disband JOTs as deemed appropriate;
m) oversee the JOTs, including without limitation the joint intellectual property team (“Joint IP Team” or “JIPT”);
n) approve variations of Invention assignment agreements pursuant to Section 15.1;
o) revise and approve any revisions to the Development Candidate Criteria;
p) determine whether an SRA Drug Candidate has become an SRA Development Candidate or whether New Compound has become a New Compound Development Candidate;
q) following the designation of an SRA Development Candidate, and at least [**] thereafter, conduct a formal review and comprehensive update of the SRA Development Plan and SRA Development Deadline Document for such SRA Development Candidate, in each case as further provided in Article 3 of the SRA;
r) review scientific and medical literature to identify diseases, indications or medical conditions that, [**] are [**] for[**], and [**] and [**] diseases, indications or medical conditions [**];
s) at the first JSC meeting after [**], (i) review each potential or actual SRA Lead Candidate that was not designated as an SRA Development Candidate during the SRA Research Term and either designating it as an SRA Development Candidate or determining that it does not meet the Development Candidate Criteria, and (ii) prepare a final list (which can only be subsequently changed by the written agreement of Roche, PTC and Foundation) that identifies and rank orders all potential and actual SRA Lead Candidates and SRA Development Candidates and denotes all SRA Development Candidates and between [**] potential or actual SRA Lead Candidates as SRA Reversion Candidates and as “Reversion Candidates” under the SRA;
t) oversee the progress of the Product Development Program, including without limitation, with respect to SRA Development, pursuant to Article 3 of the SRA;
u) monitor the development of the New Compounds and the New Products in the Field;
v) recommend action items to each Party’s or the Foundation’s respective decision-making bodies for approval or rejection by such decision-making bodies;
w) attempt to resolve any disputes on an informal basis; and
x) otherwise serve as a forum for exchanging information and discussing the progress of the collaboration between PTC, Roche and the Foundation under this Agreement, including, without limitation, Product commercialization activities.
The JSC shall have no responsibility and authority other than that expressly set forth in this Section.
7.5 Meetings. The Chairperson or his/her delegate is responsible for sending invitations and agendas for all JSC meetings to all Members at least [**] days before the next scheduled meeting of the JSC, and shall include any agenda item reasonably requested by PTC or the Foundation. The venue for the meetings shall be agreed by the JSC. During the Research Term, the JSC shall meet at least [**]; thereafter, the JSC shall meet at least [**] per Calendar Year. JSC meetings may be held in person or by videoconference; provided that no more than [**] such meetings in any Calendar Year may be by videoconference. The Alliance Directors may attend the JSC meetings as permanent participants.
At least [**] representatives from each Party and from the Foundation must be present at each JSC meeting to achieve a quorum. In addition, each Party and the Foundation may, at its discretion, invite a reasonable number of non-voting employees, and, with the consent of the other Party and the Foundation, or the Parties, as applicable, consultants or scientific advisors, to attend JSC meetings or the relevant portion thereof; provided that any such consultants or scientific advisors are bound by written obligations of confidentiality that are at least as stringent as those set forth in this Agreement.
Either Party or the Foundation may also request that a special JSC meeting be convened for the purpose of resolving a dispute(s) in connection with, or for the purpose of reviewing or making a decision pertaining to, any matter within the purview of the JSC by providing written notice to the other Party. Such meeting shall be convened at such time as may be mutually agreed upon by the Parties, but in any event shall be held within [**] days after the date of such notice.
At its initial meeting, the JSC shall, among other things, review the Research Plan, including the associated budgets.
7.6 Minutes. The Chairperson is responsible for designating a Member to record in reasonable detail and circulate draft minutes of JSC meetings to all members of the JSC for comment and review within [**] days after the relevant meeting. The Members of the JSC shall have [**] days to provide comments. The Member preparing the minutes shall incorporate timely received comments and distribute finalized minutes to all Members of the JSC within [**] days after the relevant meeting, for final approval at the next JSC meeting.
7.7 Decisions
7.7.1 Decision Making Authority. The JSC shall decide matters within its responsibilities as set forth in Section 7.4.
7.7.2 Consensus; Good Faith. The Members of the JSC shall act in good faith to cooperate with one another and seek agreement with respect to issues to be decided by the JSC. The Parties and the Foundation shall endeavor to make decisions by consensus. Each Party and the Foundation shall have one (1) vote on the JSC; provided, however that the Foundation [**] except to the extent the Foundation [**] under the [**] (and, for clarity,Foundation shall not be obligated to [**] without Foundation’s prior approval). Both Parties, and, as applicable, the Foundation, must vote in the affirmative to allow the JSC to take any action that requires the vote of the JSC. Action on any matter may be taken at a meeting by teleconference, videoconference or by written agreement.
7.7.3 Escalation. If the JSC is unable to decide a matter, then such matter shall be referred to the Chief Executive Officer of PTC or equivalent position or his/her nominee, the Head of Roche Partnering or equivalent position or his/her nominee, and, for matters on which the Foundation is entitled to vote, the President of the Foundation or equivalent position or his/her nominee, for resolution, who together shall use reasonable and good faith efforts to reach a decision by consensus within [**] days after the date such matter is referred to them. If PTC, Roche and the Foundation still fail to reach a decision within such [**] days, then the final decision shall be Roche’s, which shall be exercised in good faith. Any such decision shall constitute a decision of the JSC.
Notwithstanding the foregoing, Roche shall not have the right to exercise its final decision-making authority unilaterally with respect to the following (each, a “Consensus Matter”):
a) increasing PTC’s or the Foundation’s obligations or reduce PTC’s or the Foundation’s rights under this Agreement, including without limitation, amending the Research Plan and/or imposing any obligation on PTC and/or the Foundation to devote additional personnel or financial resources to a specific activity or project;
b) determining that the R&D Events set forth in Section 11.3 have not occurred;
c) determining that it has fulfilled any obligation under this Agreement or that PTC or the Foundation has breached any obligation under this Agreement;
d) making a decision that is expressly stated in this Section 7.7.2 or elsewhere in this Agreement to require the mutual agreement of the Parties or the Foundation;
e) otherwise expanding Roche’s rights or reducing Roche’s obligations under this Agreement;
f) designating, or determining not to designate, an SRA Development Candidate;
g) updating or amending any SRA Development Plan or SRA Development Deadline Document; or
h) deciding whether to pursue option (1), (2) or (3) of Section 2(g) of the Second SRA Amendment.
7.8 Information Exchange. Roche shall disclose to PTC and the Foundation all material information in relation to Roche’s activities under this Agreement through the JSC and, where applicable, the JSC, the Foundation and PTC may ask reasonable questions in relation to such matters and offer advice in relation thereto, and Roche shall give due consideration to PTC’s and the Foundation’s input.
7.9 Joint Operational Teams
7.9.1 Establishment. The JSC shall have the right to establish JOTs, which may include, but will not be limited to the following: a Research JOT, a New Product Development JOT, an SRA Development JOT, and a Joint IP Team. Each Party and the Foundation shall be free to change its members of each JOT, on prior written notice to the other Party and the Foundation. Each JOT shall determine the frequency and form of its interactions, subject to the requirements set forth in this Section 7.9.
7.9.2 Role of JOTs. The JSC shall determine the objectives and areas of responsibility for each JOT, potentially including clinical, research or development matters. Each JOT will develop and present to the JSC for approval specific plans for achieving its respective objectives and will be responsible for performing any duties assigned to such JOT by the JSC. Each JOT may form additional sub-groups as such JOT deems appropriate.
7.9.3 Votes; Disputes. Each JOT shall decide by vote on any subject matter within the decision-making authority of such JOT by a reasonable process to be established by the JOT. If a JOT is unable to reach a unanimous decision on any matter that is subject to the JOT’s decision-making authority within [**] days after the JOT first fails to reach consensus regarding such matter (or such later date as may be mutually acceptable to the Parties and the Foundation), then such matter shall be resolved by the JSC.
7.9.4 Joint IP Team. The JSC shall form a JIPT consisting of at least [**] from each Party’s patent or legal department. It shall be the responsibility of the JIPT to (i) determine the need to license Third Party Patent Rights that are required or useful for the development and commercialization of Products and, subject to Section 11.5.4, the allocation of costs between the Parties in connection therewith, (ii) serve as a forum for the communication between the Parties regarding the Handling of Patent Rights, including but not limited to, with respect to any Joint Patent Right, determining which Party shall have the first right to Handle such Joint Patent Right, (iii) determine strategy for Handling Patent Rights,(iv) discuss the actual or suspected infringement that is the subject of an Infringement Notice, (v) determine the geographic scope of patent filings, including foreign filing decisions at the end of the priority year, PCT national/regional phase and European validations, and(vi) determine any matter regarding the enforcement or defense of the PTC Patent Rights, Roche Patent Rights or Joint Patent Rights. The JIPT shall meet as required to fulfill its duties as set forth in Sections 11.5.4, 15.5 and 15.8, or as otherwise mutually agreed by the Parties, and shall participate in and report to regular meetings of the JSC as requested by the JSC. The JIPT shall coordinate with Foundation to satisfy Foundation’s right, pursuant to Section 6.2(a) of the SRA to comment and consultation on all filing, prosecution and maintenance activities with respect to any Patent Right that claims or covers any SRA Compound, and shall promptly provide Foundation with copies of all summaries of JIPT meetings that are prepared. If the JIPT is unable to resolve any dispute, or unanimously agree on any other matter before it, then, notwithstanding anything to the contrary in Section 7.9.3, such dispute or other matter shall be referred to the chief patent counsels of each Party or their designees to be resolved by negotiation in good faith as soon as practicable but in no event later than [**] days (or sooner if necessity so dictates) after referral. If the chief patent counsels or their designees are unable to resolve such matter, then Roche shall have final decision-making authority except as to (a) the allocation of costs under clause (i) of this Section 7.9.4, and (b) any Consensus Matter as set forth in Section 7.7.3. For clarity, the authority of the JIPT shall be subject to the rights of Foundation pursuant to Section 6.2(c) of the SRA.
7.10 Alliance Director. PTC, Roche and the Foundation shall each appoint an Alliance Director. The Alliance Directors shall be the point of contact within each Party and the Foundation with responsibility for facilitating communication and collaboration between PTC, Roche and the Foundation. They are permanent participants of the JSC meetings and may attend JOT meetings as appropriate. The Alliance Directors shall facilitate resolution of potential and pending issues and potential disputes to enable the JSC to reach consensus and avert escalation of such issues or potential disputes.
7.11 Limitations of Authority. The JSC shall have no authority to amend or waive any terms of this Agreement or the SRA.
7.12 Expenses. Each Party and the Foundation shall be responsible for its own expenses including travel and accommodation costs incurred in connection with the JSC and any JOT.
7.13 Lifetime. The JSC shall end upon the later to occur of (i) the conclusion of all research and development activities to be performed hereunder or (ii) the First Commercial Sale of the first Product in the second Major Country.
7.14 Appointment of JSC Members, JOT Members and Alliance Directors. The appointment of members of the JSC, any JOT and the Alliance Directors is a right of each Party and the Foundation and not an obligation and shall not be a “deliverable” as defined in EITF Issue No. 00-21. Each Party and the Foundation shall be free to determine not to appoint members to the JSC and any JOT and not to appoint an Alliance Director, and at any time during the Agreement Term and for any reason, either Party shall have the right to withdraw from participation in the JSC and any JOT and to remove its Alliance Director upon written notice to the other Party and the Foundation, or the Parties, as applicable, which notice shall be effective immediately upon receipt. If a Party or the Foundation (“Appointing Party”) does not appoint members of the JSC or any JOT or an Alliance Director, or withdraws from the JSC or any JOT or removes its Alliance Director, it shall not be a breach of this Agreement, nor shall there be any associated penalty due nor shall there be any impact on the consideration otherwise provided for or due to the Appointing Party under this Agreement, and unless and until such persons are again appointed: (i) the other Party and the Foundation, or the Parties, as applicable, without regard to the provisions of this Article 7 with respect to voting, quorum or dispute resolution, may discharge the roles of the JSC, any JOT and the Alliance Director for which appointments were not made or with respect to which a withdrawal or removal has occurred by the Appointing Party (including without limitation, where the Appointing Party has not made appointments to the JSC or has withdrawn from the JSC, making all decisions within the decision-making authority of the JSC, which decisions shall be binding thereafter) and (ii) where the Appointing Party has not made appointments to the JSC or has withdrawn from the JSC, the Appointing Party shall not participate in any meetings of the JSC and shall not have the right to approve the minutes of any JSC meeting. If, at any time after the Effective Date, a Party or the Foundation has not appointed or has pursuant to this Section 7.14 withdrawn from the JSC or any JOT or removed its Alliance Director, and such Party or the Foundation wishes to resume participating in the JSC or any JOT or re-appoint its Alliance Director, such Party or the Foundation shall notify the other Party and the Foundation, or the Parties, as applicable, in writing and, thereafter, such Party’s or the Foundation’s designees shall be entitled to attend any subsequent meeting of the JSC or any JOT and to participate in the activities of, and decision-making by, the JSC or any JOT, and such Party’s or Foundation’s Alliance Director shall resume his or her duties, in each case as provided in this Article 7 as if a failure to appoint or submitting the withdrawal notice has not occurred.
7.15 Change of Control. If there is a Change of Control of PTC, PTC shall provide prompt written notice thereof to Roche; provided that PTC may (but shall not be obligated to) notify Roche on a confidential basis of a contemplated Change of Control prior to the effective date of such Change of Control (the “Change of Control Notice”). Within [**] days after receipt of a Change of Control Notice (the “Election Period”), Roche shall provide PTC with written notice of its election to proceed with one of the following mutually exclusive options: (i) to continue the Research Program pursuant to this Agreement and the Research Plan, (ii) to exclude PTC from participation in the JSC and any JOT and thereafter internalize at Roche all activities allocated to PTC under the Research Plan, or (iii) to terminate this Agreement in accordance with Section 20.3.2; provided that regardless of the option elected, such election shall become effective only upon or after the effective date of such Change of Control of PTC. If Roche fails to provide a written election under the preceding sentence within the Election Period, then Roche shall be deemed to have elected to proceed under Section 7.15(i). If Roche makes a written election pursuant to Section 7.15(ii) within the Election Period, then the Quarterly R&D Fees with respect to Research Program activities conducted by PTC after the effective date of the Change of Control shall be adjusted accordingly to reflect the change in activities. The Parties acknowledge and agree that if Roche makes a written election within the Election Period pursuant to Section 7.15(ii) or Section 7.15(iii), PTC shall have no obligation to transfer the AS Assay to Roche, and Roche will not obtain any right or license with respect to the AS Assay or any intellectual property right therein.
22. Miscellaneous
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22.6. Disputes. Unless otherwise set forth in this Agreement, any dispute in connection with this Agreement shall be referred to the respective executive officers of the Parties and the Foundation designated below or their designees, for good faith negotiations attempting to resolve the dispute. The Designated executive officers are as follows:
For PTC: Chief Executive Officer
For Roche: Head of Partnering
For Foundation: President
Should the good faith negotiations fail to agree within [**] days after a dispute has first arisen, either Party or the Foundation, as applicable, may seek to resolve such dispute in any court having jurisdiction over whichever of PTC, Roche or the Foundation are in dispute.