Provision Language
2. CONDUCT OF THE RESEARCH
[…]
2.3 Principal Scientist. The Principal Scientist is considered essential to the Research being performed, and no substitution may be made without the prior written agreement of the Foundation. If for any reason the Principal Scientist ceases to be employed by Company or otherwise becomes unavailable, or cannot continue to oversee the conduct or completion of the Research, Company will propose a successor whose appointment as Principal Scientist shall be subject to the approval of the Foundation, such approval not to be unreasonably withheld. If the parties are unable to agree upon a successor within 90 days after the Principal Scientist ceases his involvement in the Research, this Agreement may be terminated by the Foundation pursuant to Section 7.3.
[…]
2.7 Communication; Research Reports. On a regular basis during the Research Term (but no less frequently than [**]), the parties shall conduct meetings, either in person or by telephone or video conference, to discuss the progress of the Research and strategies for achieving the objectives of the Research in an expeditious manner. Company shall keep the Foundation fully informed as to all results and discoveries (including, without limitation, assay development and all Hits and potential Lead Candidates and Drug Candidates) made in the course of performing activities under the Research Program at these meetings . In furtherance of the foregoing, on a [**] basis, Company shall prepare, and deliver to the Foundation no later than [**] days after the conclusion of [**] during the Research Term, a reasonably detailed written summary report of the results and progress of the Research during [**] (each, a “Research Report” ) . In addition, the Foundation may, at its option, during the Research Term, schedule up to [**] formal program review meetings with Company personnel and those of Foundation’s Third Party advisors who (i) have agreed to confidentiality restrictions substantially similar to those contained in this Agreement, and (ii) are reasonably acceptable to Company. Such meetings will be held at the times and locations mutually agreed upon by the parties. The purpose of such meetings will be to review the progress of the Research relative to the Research Plan.
AMENDMENT No. 1 TO SPONSORED RESEARCH AGREEMENT
3. Research Reports. In lieu of the Research Reports that would otherwise be due from PTC under Section 2.7 of the Agreement during the Research Term, PTC shall make the following reports: (a) [**] months following the Amendment Effective Date, a summary report showing progress with respect to the Additional Research and identifying any limiting factors or other considerations that may affect completion of the Additional Research (the “Mid-Stage Report”), and (b) within [**] days of completion of the Additional Research, a final report containing the recommendations by PTC for selection of compounds for further research and potential Lead Optimization (the “Final Report”). In addition, PTC will make itself available for Research Team conference calls following its internal research update meetings, which are expected to occur every [**] weeks, for informal discussion of the program.
[…]
6. Coordination of Funding. During the Research Term and any subsequent extension of the collaboration and for the [**] month period thereafter, should PTC require additional funds for the conduct of any Research Project, the Foundation will be consulted prior to any fundraising efforts for such Research Project. Should PTC identify an opportunity for agreement with any third party or parties with respect to additional or continued funding specifically directed to Research Projects, it will provide reasonable advance notice to Foundation, and the parties will negotiate in good faith (involving such third party or parties as appropriate) to develop a structure that supports such additional funding, based on the following principles: (a) entities co-funding a Research Project should share information on the Research with each other, subject to appropriate confidentiality provisions, (b) governance with respect to co-funded Research Projects should be via a joint steering committee including representatives of Foundation, PTC, and any third parties, (c) within the steering committee for a particular co-funded Research Project, role in decision-making with respect to matters within the sole purview of funding entities (including but not limited to strategic discussions as outlined in section 2.4 of the Agreement) should be [**], and (d) entities that have provided funding to a co-funded Research Project should have an opportunity (subject to compliance with the terms of their respective funding agreements) to continue their support of such Research Project. For clarity, PTC’s obligations under this First Amendment Section shall in no way limit PTC’s ability to engage in general fund-raising activities and to enter into agreements relating thereto.
AMENDMENT No. 2 TO SPONSORED RESEARCH AGREEMENT
2. Continuing Research
(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 terminate the Research Term pursuant to Second Amendment Section 3. If the affected party does not approve the Corrective Plan within [**] days after it is first formally proposed, then either party shall have the right to terminate the Research Term pursuant to Second Amendment Section 3.
4. Research Reports and Access to Information
(c) Availability for Communications. In addition to the foregoing and to Company’s obligations under Section 2.5 of the Agreement, Company will make appropriate representatives of the scientific team conducting the DC Research available for conference calls and meetings with appropriate representatives of Foundation at reasonable times and places for informal discussion of the progress of the DC Research. In further addition, the Foundation may, at its option, during the Term, schedule up to [**] formal program review meetings with Company personnel and those of Foundation’s Third Party advisors who (i) have been designated by Foundation in compliance with Second Amendment Section 18(f), and (ii) are reasonably acceptable to Company. Such meetings will be held at the times and locations mutually agreed upon by the parties. The purpose of such meetings will be to review the progress of the Research relative to the Research Plan.
5. Governance
The parties agree to the following provisions with respect to governance of their collaboration:
(a) Joint Steering Committee. The parties will establish a joint steering committee (“JSC”) consisting of equal representation from Foundation and Company within [**] days after the Second Amendment Effective Date. The parties acknowledge and agree that the individuals listed on Exhibit SA-8 have been approved, as of the Second Amendment Effective Date, to serve as the Foundation’s representatives to the JSC and there is no need for the parties to perform the procedures set forth in Second Amendment Section 18(f) with respect to their appointment to the JSC. The JSC shall be comprised of at least [**] representatives of each party, each with appropriate decision-making authority to enable the JSC to fulfill its obligations under this Agreement, and which in the case of Foundation may be Third Party advisors of Foundation, provided they are appointed pursuant to the conditions specified in Second Amendment Section 18(f). Changes in the designation of JSC members by each party may occur at any time during the Term upon written notification by a party to the other party. The JSC, as its first order of business, shall select a chairperson from one party and a secretary from the other party, to alternate on an annual basis. Subject to the confidentiality provisions of the Agreement and any appropriate agreements with respect to intellectual property or conflicts of interest, the JSC may invite other representatives of the parties with special skills or knowledge (and who, in the case of Foundation, may be Third Party advisors of Foundation) to attend JSC meetings where appropriate. Each party shall disclose to the other its proposed agenda items in advance of each JSC meeting, and the chairperson shall distribute a draft agenda reflecting such proposed agenda items reasonably in advance of each meeting. The JSC shall adopt such other procedural rules as are necessary or convenient for its work. Each party shall be responsible for all travel and other costs for its representatives to attend meetings of, and otherwise participate on, the JSC. The JSC shall continue to function until the earliest of: (i) the effective date of a Special Termination, (ii) the Company’s receipt of a Reversion Notice or a Buy-Out Notice or (iii) the end of the Term. If the JSC stopped functioning on account of a Special Termination and the Company subsequently provides a Development Election Notice pursuant to Second Amendment Section 3(d), then the JSC shall resume functioning promptly upon the Foundation’s receipt of such Development Election Notice. Such reconvened JSC shall have the duties specified in Second Amendment Section 2(c) and, regardless of whether Proof-of-Concept has been achieved as of the date of the Development Election Notice, it shall meet and make decisions in accordance with the provisions of Second Amendment Section 5(e) (and not Second Amendment Section 5(d)).
(b) Duties of the JSC during the Research Term. During the Research Term, the JSC shall be responsible for:
(i) monitoring the parties’ activities under the Research Plan and the Agreement;
(ii) reviewing and approving amendments to the Research Plan (and related budget), and at least once each calendar year formally reviewing and updating the Research Plan (and related budget) on a comprehensive basis;
(iii) in connection with the review and approval of the Research Plan (and related budget) and any amendments thereto, identifying appropriate resources necessary to conduct the DC Research and adjusting, as necessary to further the purpose of the DC Research, the budget for the Research Plan;
(iv) establishing timelines and criteria for continuation/discontinuation decision points under the DC Research;
(v) establishing and revising minimum activity and safety criteria for Lead Candidates from each Research Project within the DC Research (which criteria may be different for the [**] Research Projects within the DC Research);
(vi) maintaining and updating at each JSC meeting during the Research Term, one list for each of the [**] Research Projects within the DC Research that identifies and rank orders all potential and actual Lead Candidates and Development Candidates from such Research Project and denotes all Development Candidates and between [**] and [**] potential or actual Lead Candidates from such Research Project as “Reversion Candidates”;
(vii) deciding whether to pursue (1), (2) or (3) of Section 2(g) of this Second Amendment in the event of a Cost/Timeline Issue;
(viii) establishing criteria for, and designating, Development Candidate(s);
(ix) providing a forum for discussion/presentation regarding, and serving as the sole governance body for decision-making regarding, research, Development, commercialization, and Collaboration Activities with respect to Drug Candidates, Reversion Candidates, Development Candidate(s) and Product(s); for clarity the JSC’s role as such sole governance body shall not prevent the Company or its Licensee from making decisions necessary or useful to implement decisions made by the JSC regarding research, Development, commercialization, and Collaboration Activities with respect to Drug Candidates, Reversion Candidates, Development Candidate(s) and Product(s), so long as such implementation decisions are consistent with and faithful to the intent of the JSC’s decision;
(x) prior to the designation of a Development Candidate, preparing the Development Plan for such Development Candidate and reviewing and updating the Development Deadline Document as it may deem advisable, in each case as further provided in Article 3 of the Agreement;
(xi) serving in the role specified in Second Amendment Section 10 with respect to transactions arising in connection with Collaboration Activities;
(xii) establishing policies and procedures governing scientific publications and presentations, and if the JSC deems it advisable, establishing a publication committee to administer such policies and procedures, as further provided in Section 5.4(a) of the Agreement;
(xiii) except for those rights and obligations specified in Section 4 of this Second Amendment, serving in lieu of the parties with respect any rights or obligations to review, communicate, inform, meet or discuss otherwise provided for in Sections 2.2, 2.4, and 2.7 of the Agreement;
(xiv) developing the criteria specified in Second Amendment Sections 3(a) and 18(f) within [**] months of the Second Amendment Effective Date;
(xv) reviewing scientific and medical literature to identify diseases, indications or medical conditions that, [**] or [**], are [**] for [**] and [**] diseases, indications or medical conditions [**];
(xvi) performing those other tasks specifically allocated to it in this Agreement that are applicable during the Research Term; and
(xvii) otherwise serving as a forum for exchanging information and discussing the progress of the collaboration between Company and Foundation pursuant to the Agreement.
(c) Duties of the JSC Following the Research Term. Following the Research Term, the JSC shall be responsible for:
(i) at the first JSC meeting after the end of the Research Term, (1) reviewing each potential or actual Lead Candidate that was not designated as a Development Candidate during the Research Term and either designating it as a Development Candidate or determining that it does not meet the criteria for designation as a Development Candidate and (2) preparing a final list (which can only be subsequently changed by the written agreement of the parties) for each of the [**] Research Projects within the DC Research that identifies and rank orders all potential and actual Lead Candidates and Development Candidates from such Research Project and denotes all Development Candidates and between [**] and [**] potential or actual Lead Candidates from such Research Project as “Reversion Candidates”;
(ii) following the designation of a Development Candidate, and at least [**] thereafter, conducting a formal review and comprehensive update of the Development Plan and Development Deadline Document for such Development Candidate, in each case as further provided in Article 3 of the Agreement;
(iii) monitoring Company’s and its Affiliates and Licensees activities with respect to the Development Plan and Development Deadline Document;
(iv) providing a forum for discussion/presentation regarding, and serving as the sole governance body for decision-making regarding, Development, commercialization, and Collaboration Activities with respect to Reversion Candidates, Development Candidate(s) and Product(s); for clarity the JSC’s role as such sole governance body shall not prevent the Company or its Licensee from making decisions necessary or useful to implement decisions made by the JSC regarding Development, commercialization, and Collaboration Activities with respect to Reversion Candidates, Development Candidate(s) and Product(s), so long as such implementation decisions are consistent with and faithful to the intent of the JSC’s decision;
(v) serving in the role specified in Second Amendment Section 10 with respect to transactions arising in connection with Collaboration Activities;
(vi) establishing policies and procedures governing scientific publications and presentations, and if the JSC deems it advisable, establishing a publication committee to administer such policies and procedures, as further provided in Section 5.4(a) of the Agreement;
(vii) except for those rights and obligations specified in Section 4 of this Second Amendment, serving in lieu
of the parties with respect any rights or obligations to review, communicate, inform, meet or discuss otherwise provided for in Sections 2.2, 2.4, and 2.7 of the Agreement;
(viii) reviewing scientific and medical literature to identify diseases, indications or medical conditions that, [**] or [**], are [**] for [**] and [**] diseases, indications or medical conditions [**];
(ix) performing those other tasks specifically allocated to it in this Agreement that are applicable after the Research Term; and
(x) otherwise serving as a forum for exchanging information and discussing the progress of the collaboration between Company and Foundation pursuant to the Agreement.
(d) Meetings and Decision-Making by the JSC — Before Proof-of-Concept. During the Research Term and through achievement of Proof-of-Concept, the JSC shall meet periodically as needed, but in no event less than [**], in person (with locations to alternate between the parties) or by teleconference or other electronic means as mutually agreed, to discuss matters within its jurisdiction. In addition, the JSC may agree to hold special meetings at any time on reasonable notice given by the chairperson or the secretary to the other members of the JSC. Unless waived by a party in writing, at least [**] JSC representatives of each party must participate in a meeting of the JSC in order for there to be a quorum at such meeting. The members of the JSC shall seek to make all determinations to be made by them unanimously following full discussion thereof (with each party’s representatives having, collectively, one (1) vote). If the JSC is unable to reach a unanimous decision on any matter within its jurisdiction, the parties’ respective Chief Executive Officers shall meet in person to attempt to resolve the matter in good faith. If the parties’ respective Chief Executive Officers are unable to reach agreement on a matter referred to them pursuant to the foregoing sentence within [**] days after the matter referral, then either party may by written notice to the other submit the matter to Baseball Arbitration as provided in Section 17 of this Second Amendment; provided, however, that the following matters shall not be subject to such referral to Baseball Arbitration, and any disputes arising in the JSC with respect to them may only be resolved by mutual agreement of the parties: (i) [**]; (ii) any [**] described in Second Amendment Section [**]; (iii) any changes to the [**] that would require [**] than contemplated in the [**]; and (iv) deciding whether to pursue ([**] of this Second Amendment in the event of a [**].
(e) Meetings and Decision-Making by the JSC — Following Proof-of-Concept. Following achievement of Proof-of- Concept, the JSC shall meet periodically as needed, but in no event less than [**] during each calendar year, in person (with locations to alternate between the parties) or by teleconference or other electronic means as mutually agreed, to discuss matters within its jurisdiction. In addition, the JSC may agree to hold special meetings at any time on reasonable notice given by the chairperson or secretary to the other members of the JSC. Unless waived by a party in writing, at least [**] JSC representatives of each party must participate in a meeting of the JSC in order for there to be a quorum at such meeting. The members of the JSC shall seek to make all determinations to be made by them unanimously following full discussion thereof (with each party’s representatives having, collectively, one (1) vote). If the JSC is unable to reach a unanimous decision on any matter within its jurisdiction, the parties’ respective Chief Executive Officers shall attempt to resolve the matter in good faith. If the parties’ respective Chief Executive Officers are unable to reach agreement on a matter referred to them pursuant to the foregoing sentence within [**] days after the matter referral, then [**] shall have the deciding vote on the matter; provided, however, that the following matters shall not be subject to such [**] final determination, and any disputes arising in the JSC with respect to them may only be resolved as set forth below: (i) any [**], and (ii) the [**] with respect to [**] in connection with [**] set forth in, and subject to, Second Amendment Section [**].
(f) Meeting Minutes. The secretary (or if absent, such acting secretary as the chairperson shall designate) shall be responsible for preparing the minutes of the JSC meeting. Such JSC meeting minutes shall provide a description in reasonable detail of the discussions held at the meeting, and a list of any actions, decisions or determinations made by the JSC. Unless otherwise agreed by the JSC, the secretary shall distribute draft minutes of each meeting within [**] days after the meeting for review and comment, and final minutes shall be approved by both parties within [**] days after the meeting.
(g) Joint Teams. Within [**] days after the Second Amendment Effective Date, the JSC shall establish a Joint Team with appropriate representation from the parties, which in the case of the Foundation may be Third Party advisors of Foundation appointed pursuant to the conditions specified in Second Amendment Section 18(f), to assist the JSC in the execution of the Research Plan. The parties acknowledge and agree that the individuals listed on Exhibit SA-8 have been approved, as of the Second Amendment Effective Date, to serve as the Foundation’s representative to the Joint Team and there is no need for the parties to perform the procedures set forth in Second Amendment Section 18(f) with respect to their appointment to the Joint Team. The JSC shall have the authority to establish one or more additional Joint Teams with appropriate representation from the parties to assist the JSC in the performance of its duties. The JSC may establish such procedural rules and meeting schedules for such Joint Teams as it deems appropriate; provided, that unless otherwise agreed by the JSC each Joint Team shall meet at least [**], and shall report on its activities to the JSC at regularly-scheduled JSC [**] meetings. The JSC may change the composition of any Joint Team at any time upon notice to the parties.
(h) Appointment of JSC Members and Joint Team Members. The appointment of members of the JSC and any Joint Team is a right of each party and not an obligation and shall not be a “deliverable” as defined in EITF Issue No. 00-21. Each party shall be free to determine not to appoint members to the JSC and any Joint Team, and at any time during the Term and for any reason, either party shall have the right to withdraw from participation in the JSC and any Joint Team upon written notice to the other party, which notice shall be effective immediately upon receipt. If a party (“Appointing Party”) does not appoint members of the JSC or any Joint Team, or withdraws from the JSC or any Joint Team, 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, without regard to the provisions of this Second Amendment Section 5 with respect to voting, quorum or dispute resolution, may discharge the roles of the JSC and any Joint Team for which appointments were not made or with respect to which a withdrawal or removal has occurred by the Appointing Party (including designating a chairperson and secretary of the JSC and making all decisions within the decision- making authority of the JSC, which decisions shall be binding thereafter on both parties) 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 following the Second Amendment Effective Date, a party has not appointed or has pursuant to this Second Amendment Section 5(h) withdrawn from the JSC or any Joint Team, and such party wishes to resume participating in the JSC or any Joint Team, such party shall notify the other party in writing and, thereafter, such notifying party’s designees shall be entitled to attend any subsequent meeting of the JSC or any Joint Team and to participate in the activities of, and decision-making by, the JSC or any Joint Team, in each case as provided in this Second Amendment Section 5 as if a failure to appoint or submitting the withdrawal notice had not occurred.
7. Foundation Access to Company Meetings Following Declaration of a Development Candidate. Following the JSC’s determination that a particular compound is a Development Candidate and through the earlier of Regulatory Approval, abandonment of Development of such Development Candidate, or the granting of a Reversionary License to Foundation, Company shall invite a representative of Foundation (to be designated by Foundation) to observe regularly scheduled monthly meetings of the Company team charged with Development of such Development Candidate, subject to the terms of Second Amendment Section 18(f); provided, however, that failure of Foundation to designate such representative or failure of such representative to attend such meetings shall not constitute a breach of this Agreement. Company may request that Foundation representative recuse themselves from such meetings (or portions of such meetings) (a) that do not relate specifically to a Development Candidate, (b) to prevent the breach of an applicable legal or regulatory obligation of confidentiality or privacy or avoid a conflict of interest, (c) to protect the attorney-client privilege, and/or (d) to preserve intellectual property rights.
10. Partnering
(a) Company shall have the primary responsibility to evaluate the need for and timing of Collaboration Activities.
(b) During any period in which Company is not actively pursuing Collaboration Activities, Company shall report to the JSC on [**] basis Company’s views of the partnering/collaboration marketplace for drug discovery and lead optimization efforts at a similar stage to efforts under the DC Research or, if a Development Candidate has been declared, the partnering/collaboration marketplace for development candidates at a similar stage of development to such Development Candidate.
(c) If Company determines to actively pursue Collaboration Activities, whether at its own initiative or in response to inquiries from Third Parties, Company will first seek input from the JSC on the nature, scope, and potential terms of a transaction arising in connection with such Collaboration Activities, as well as a rank-ordered summary list of preferred potential counterparties to such transaction. To the extent prepared by Company rather than received by Company from a potential counterparty, Company shall also provide the JSC with an opportunity to review a draft term sheet and related materials in support of its proposed Collaboration Activities. The JSC shall promptly provide input on Company’s overall approach to Collaboration Activities, as well as specific input on any term sheet or related materials provided to the JSC.
(d) Prior to Company commencing formal term sheet negotiations or contractual negotiations with any Third Party in connection with Collaboration Activities, Company shall first notify Foundation in writing concerning such negotiations (a “Partnering Notice”). Such Partnering Notice shall be accompanied by any available drafts of term sheets or contracts, or if not available, a summary of the proposed transaction to the extent available, in either case subject to redactions of financial terms to the extent required to comply with any confidentiality agreements with the potential counterparty. Following receipt of a Partnering Notice, Foundation and Company shall have the following rights and obligations in connection with the proposed transaction described in the Partnering Notice (regardless of whether, in the course of negotiations, the terms change from those described the original Partnering Notice):
(i) Foundation shall designate a representative to serve in an advisory capacity with respect such transaction and, if requested by Company, to participate in negotiations subject to appropriate confidentiality protections; provided, however, that such representative shall not have the power to commit Foundation to enter into any amendments to the Agreement absent formal written approval by an appropriately authorized officer of Foundation.
(ii) Foundation may designate legal counsel and [**] of Foundation, each subject to appropriate confidentiality protections, to review and provide comments upon proposed term sheets and contracts for such transaction subject to reasonable time frames consistent with overall progress and status of negotiations and not less than [**]percent ([**]%) of the timeframe specified by Company for the receipt of comments from its senior management. For clarity, such reasonable time frames may be as short as [**] if, in Company’s reasonable judgment, such time frames are required to support a successful negotiation process and such time frames are not less than [**] percent ([**]%) of the timeframe specified by Company for the receipt of comments from its senior management. If requested by the potential counterparty, Company shall have the right to redact financial terms from such term sheets and contracts. In reviewing and commenting on such proposed term sheet and contracts, Foundation counsel and designated representative shall indicate the relative importance of their comments, and if practicable a range of potential responses for negotiation purposes. Company shall use Commercially Reasonable Efforts to implement comments and negotiating positions suggested by Foundation’s counsel and/or representative, with due consideration given to the relative importance assigned to the comments and reflecting the outcome of any discussions between Company and Foundation’s counsel and/or representative with respect to modification of such comments. In addition, Company shall, as non-negotiable contractual terms, require (1) that the counterparty commit, in response to the JSC’s invitation, to sending a representative of such counterparty to such JSC meetings or portions of meetings as the JSC shall request for the purposes of informing, discussing and serving in an advisory role with respect to decisions regarding the progress of and all future plans for the DC Research and the Development and commercialization of the Reversion Candidates, Development Candidate(s) and Product(s) that are the subject of the agreement between Company and such counterparty, (2) an acknowledgement that the JSC shall remain the sole governance body for all research, Development and commercialization decisions regarding the DC Research and the Development and commercialization of Reversion Candidates, Development Candidates and Products that are the subject of the agreement between Company and such counterparty (which acknowledgement may include a clarification that the JSC’s role as such sole governance body shall not prevent the Company or its Licensee from making decisions necessary or useful to implement decisions made by the JSC regarding research, Development, commercialization, and Collaboration Activities with respect to Drug Candidates, Reversion Candidates, Development Candidate(s) and Product(s), so long as such implementation decisions are consistent with and faithful to the intent of the JSC’s decision), (3) that to the extent the counterparty will assume responsibility for Development of a Development Candidate or Product in any country, that such counterparty assume the obligations and rights of Company pursuant to Second Amendment Section 13 in that country, (4) an acknowledgement that the counterparty’s rights and licenses from Company with respect to Reversion Candidates, Development Candidates and Products will terminate upon a Special Termination or Company’s receipt of a Reversion Notice or Buy-Out Notice and an obligation in such circumstance for the counterparty to grant the licenses and rights specified in Section 3 of this Second Amendment and Section 6.1(c)(2) of this Agreement (including licenses and rights to (A) all intellectual property that, if developed, acquired or otherwise Controlled by Company, rather than such counterparty, would be Company Technology or Data (“Licensee Technology” and “Licensee Data”, respectively) and (B) all INDs, NDAs or similar regulatory filings made or obtained by such counterparty with respect to the relevant Reversion Candidates, Development Candidates and Products) and perform the activities specified therein in each case as if such counterparty were Company, and (5) third party beneficiary rights for Foundation in the event that such counterparty fails to fulfill any of the foregoing obligations.
(iii) Prior to the conclusion of contractual negotiations pursuant to such Partnering Notice, Company shall schedule at least [**] with representatives of the negotiating team of potential counterparties to the transaction and the representatives designated by Foundation pursuant to the foregoing subsections (i) and (ii) to discuss Foundation’s goals and interests with respect to such proposed transaction. Unless otherwise agreed by Foundation, Company shall use Commercially Reasonable Efforts to cause [**] to take place in person at a location convenient to the New York metropolitan area.
(e) Prior to Company entering into a definitive written agreement with any Third Party in connection with Collaboration Activities, Company shall seek the review and approval of the JSC by providing the members of the JSC a proposed final draft of the definitive written agreement and a summary [**] of the proposed transaction, including an overview of any items or terms subject to finalization in the draft provided. If required by the Company’s confidentiality agreement with the potential counterparty, Company shall have the right to redact financial terms from such proposed final draft of the definitive written agreement. As promptly as reasonably possible, but in no event later then [**] business days following receipt by the JSC members of such proposed final draft of the definitive written agreement and summary, the JSC shall convene a meeting to either approve or deny for such proposed transaction; provided, however , that if Company has otherwise complied with requirements of this Second Amendment Section 10, Foundation shall only be entitled to cast its JSC vote against such proposed transaction if it agrees either (i) to fund [**] percent ([**]%) of ongoing Development and commercialization costs for the applicable Development Candidate(s) or Product(s), or (ii) [**] and any related rights pursuant to Section [**]; and provided further , that failure of either party to make itself available within the time frames specified in this Second Amendment Section 10(e) shall entitle the other party to either approve or deny the proposed transaction in the name of the JSC without the requirement of holding an actual JSC meeting. If the JSC denies approval in accordance with this Second Amendment Section 10(e), Company shall not enter into such proposed definitive written agreement, but shall have the right to continue the applicable negotiations consistent with this Second Amendment Section 10 for the purposes of achieving a form of such definitive written agreement acceptable to the JSC.
(f) Following the entry into a transaction pursuant to this Second Amendment Section 10, the following additional terms and conditions will apply:
(i) The JSC shall continue as the sole governance body for the conduct of the DC Research and the Development and commercialization of Reversion Candidates, Development Candidates and Products and shall continue to have all the rights and responsibilities specified in Second Amendment Section 5.
(ii) The JSC shall invite the representative of the counterparty designated pursuant to Second Amendment Section 10(d)(ii)(1) to such JSC meetings, or portions of meetings, as the JSC shall deem advisable for the purposes of informing, discussing and serving in an advisory role with respect to decisions regarding the progress of and all future plans for the DC Research and the Development and commercialization of the Reversion Candidates, Development Candidate(s) and Product(s) that are the subject of the agreement between Company and such counterparty.
13. Clinical Trials and Access to Materials. The terms and conditions of this Second Amendment Section 13 shall apply equally to each Licensee as if such Licensee were Company, shall be included in the agreement pursuant to which Company grants rights to such Licensee with respect to any Drug Candidate or Product, and Foundation shall be a third party beneficiary with respect to such terms and conditions and shall have the right to take action directly against such Licensee if such Licensee fails to comply with such terms and conditions.
(a) SMAF Clinical Trials Advisory Committee. Foundation shall have the right, but not the obligation, to create a committee of experts to advise Foundation and Company on clinical trials and expanded access with respect to Development Candidates and 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 at least one clinical investigator with experience in the Field, [**]. The SMAF Clinical Trials Advisory Committee shall have, as one of its principal mandates, the responsibility of balancing (i) the rapid and efficient Development and commercialization of Development Candidates and Products for the benefit of all potential patients in the Field and (ii) the appropriateness, based on available safety and efficacy information with respect to such Development Candidates and Products, of providing access to such Development Candidates or Products to individual patients via the extension protocols to Company Clinical Trials or expanded access programs further described in Second Amendment Sections 13(b) and 13(c). Such SMAF Clinical Trials Advisory Committee may establish its own procedures for meetings and decision-making.
17. Baseball Arbitration
(a) An arbitration under this Second Amendment Section 17 (a “Baseball Arbitration”) shall be initiated by written notice of one party to the other and may only be initiated with respect to disputes which meet both the following criteria: (i) the dispute arises from matters within the jurisdiction of the JSC following escalation to the respective Chief Executive Officers of the parties as provided elsewhere in the Agreement, and (ii) Baseball Arbitration is explicitly specified as the method for resolving such dispute pursuant to the Agreement.
(b) The Baseball Arbitration shall be held in a location mutually agreeable to the parties, or if no such location can be agreed, in New York City, according to the then-current commercial arbitration rules of the American Arbitration Association (“AAA”), except to the extent such rules are inconsistent with this Second Amendment Section 17.
(c) The Baseball Arbitration will be conducted by one (1) arbitrator who shall be reasonably acceptable to the parties and who shall be appointed in accordance with AAA rules. If the parties are unable to select an arbitrator within [**] days of the notice that initiated the Baseball Arbitration, then the arbitrator shall be appointed in accordance with AAA rules. Any arbitrator chosen hereunder shall have educational training and industry experience sufficient to demonstrate a reasonable level of scientific, financial, medical and industry knowledge relevant to the particular dispute.
(d) Within [**] days after the selection of the arbitrator, each party shall submit to the arbitrator and the other party a proposed resolution of the dispute that is the subject of the arbitration, together with any relevant evidence in support thereof (the “Proposals”). Within [**] business days after the delivery of the last Proposal to the arbitrator, each party may submit a written rebuttal of the other party’s Proposal and may also amend and re-submit its original Proposal. The parties and the arbitrator shall meet within [**] business days after the parties have submitted their final Proposals (and rebuttals, if any), at which time each party shall have [**] to argue in support of its Proposal. The parties shall [**]. Within [**] days after such meeting, the arbitrator shall select one of the final Proposals so submitted by one of the parties as the resolution of the dispute, but may not alter the terms of either final Proposal and may not resolve the dispute in a manner other than by selection of one of the submitted final Proposals. If a party fails to submit a Proposal within the initial [**] day time frame set forth in the first sentence of this Second Amendment Section 17, the arbitrator shall select the Proposal of the other party as the resolution of the dispute. Any time period set forth in this Second Amendment Section 17 may be extended by mutual agreement of the parties.
(e) No arbitrator shall have the power to award punitive damages under this Agreement regardless of whether any such damages are contained in a Proposal, and such award is expressly prohibited. The proceedings and decisions of the arbitrator shall be confidential, final and binding on the parties. Judgment on the award so rendered may be entered in a court having jurisdiction thereof.
(f) [**] the costs of such Baseball Arbitration.
18. Miscellaneous
(a) Compounds not Selected. During the Second Amendment Term and for the [**] period thereafter, should Company require additional funds for the conduct of research or Development in the Field of any Lead Candidate that was tested in the course of the DC Research but was not selected as a Reversion Candidate (such research and Development, “Non-DC Research”), Foundation will be consulted and provided the opportunity to fund such Non-DC Research in whole or in part prior to any fundraising efforts for such Non-DC Research. Should Company identify an opportunity for agreement with any Third Party or Third Parties with respect to such Non-DC Research during such [**] period, it will provide reasonable advance notice to Foundation, and the parties will negotiate in good faith (involving such Third Party or Third Parties as appropriate) to develop a structure that supports such additional funding, based on the following principles: (a) entities co-funding such Non-DC Research should share information on the Non-DC Research with each other, subject to appropriate confidentiality provisions, (b) governance with respect to co-funded Non-DC Research should be via a joint steering committee including representatives of Foundation, Company, and any Third Parties, and (c) entities that have provided funding to such co-funded Non-DC Research should have an opportunity (subject to compliance with the terms of their respective funding agreements) to continue their support of such Non-DC Research. For clarity, Company’s obligations under this Second Amendment Section 18(a) shall in no way limit Company’s ability to engage in general fund-raising activities and to enter into agreements relating thereto.
AMENDMENT No. 3 TO SPONSORED RESEARCH AGREEMENT
2. Governance. Second Amendment Section 5(d) is amended and restated in its entirety as follows:
“(d) Meetings and Decision-Making by the JSC — Before Proof-of-Concept. During the Research Term and through achievement of Proof-of-Concept, the JSC shall meet periodically as needed, but in no event less than [**], in person (with the location to be at Foundation’s offices in New York City unless otherwise agreed by the Parties) or by teleconference or other electronic means as mutually agreed, to discuss matters within its jurisdiction. In addition, the JSC may agree to hold special meetings at any time on reasonable notice given by the chairperson or the secretary to the other members of the JSC. Unless waived by a party in writing, at least [**] JSC representatives of each party must participate in a meeting of the JSC in order for there to be a quorum at such meeting. The members of the JSC shall seek to make all determinations to be made by them unanimously following full discussion thereof (with each party’s representatives having, collectively, one (1) vote). If the JSC is unable to reach a unanimous decision on any matter within its jurisdiction, the parties’ respective Chief Executive Officers shall meet in person to attempt to resolve the matter in good faith. If the parties’ respective Chief Executive Officers are unable to reach agreement on a matter referred to them pursuant to the foregoing sentence within [**] days after the matter referral, then either party may by written notice to the other submit the matter to Baseball Arbitration as provided in Section 17 of this Second Amendment; provided, however, that the following matters shall not be subject to such referral to Baseball Arbitration, : (i) [**]; (ii) any [**] described in Second Amendment Section [**] as [**] to or [**]; (iii) any changes to [**] for the [**] that would require [**] than contemplated in [**]; (iv) deciding whether to pursue [**] of this Second Amendment in the event of a [**]; and (v) any disputes referred to the CEOs pursuant to Second Amendment Section [**]. Disputes not subject to referral to Baseball Arbitration pursuant clauses (i) through (v) of the preceding sentence shall be resolved as follows: any dispute arising in the JSC with respect to clause (v) shall be decided by [**], and any disputes arising in the JSC with respect to clauses(i) through (iv) may only be resolved by mutual agreement of the parties.”
3. Partnering Activities. Second Amendment Section 10(c) is amended and restated in its entirety as follows:
“(c) If Company determines to actively pursue Collaboration Activities, whether at its own initiative or in response to inquiries from Third Parties, Company will first seek input from Foundation through a mutually-agreed team of Foundation representatives (the “Foundation Partnering Team”) on the nature, scope, and potential terms of a transaction arising in connection with such Collaboration Activities, as well as a rank-ordered summary list of preferred potential counterparties to such transaction. To the extent prepared by Company rather than received by Company from a potential counterparty, Company shall also provide the Foundation Partnering Team with an opportunity to review a draft term sheet and related materials in support of its proposed Collaboration Activities. The Foundation shall collect input from the Foundation Partnering Team on Company’s overall approach to Collaboration Activities, as well as specific input on any term sheet or related materials provided to the Foundation Partnering Team, and shall promptly provide such input to Company. The initial mutually-agreed members of the Foundation Partnering Team are set forth on Exhibit TA-4. The Foundation may replace the outside counsel member of the Foundation Partnering Team with an alternative outside counsel chosen by the Foundation; such replacement will be effective upon notice to Company. The Foundation may replace any other member of the Foundation Partnering Team with an alternative individual chosen by the Foundation; such replacement will be effective upon PTC’s written consent, which will not be unreasonably withheld or delayed.”
Second Amendment Section 10(e) is amended and restated in its entirety as follows:
“(e) Prior to Company entering into a definitive written agreement with any Third Party in connection with Collaboration Activities, Company shall seek the review and approval of the Foundation by providing the members of the Foundation Partnering Team with a proposed final draft of the definitive written agreement, a summary (which may be oral or written) of the proposed transaction, including an overview of any items or terms subject to finalization in the draft provided, and the timely opportunity (which may include one or more in-person meetings) to discuss such draft and summary and answer the Foundation’s questions with respect thereto. If required by the Company’s confidentiality agreement with the potential counterparty, Company shall have the right to redact financial terms from such proposed final draft of the definitive written agreement. As promptly as reasonably possible, but in no event later then [**] business days following receipt by the Foundation Partnering Team members of such proposed final draft of the definitive written agreement and summary, Foundation shall either approve or deny such proposed transaction; provided, however , that if Company has otherwise complied with requirements of this Second Amendment Section 10, Foundation shall only be entitled to deny such proposed transaction if it agrees either (i) to fund [**] percent ([**]%) of ongoing Development and commercialization costs for the applicable Development Candidate(s) or Product(s), or (ii) [**] or [**] and any related rights pursuant to [**]; and provided further , that failure of Foundation to communicate its approval or denial of a transaction pursuant to Second Amendment Section 10(e) shall entitle PTC to treat the proposed transaction as approved by Foundation. If the Foundation denies approval in accordance with this Second Amendment Section 10(e), Company shall not enter into such proposed definitive written agreement, but shall have the right to continue the applicable negotiations consistent with this Second Amendment Section 10 for the purposes of achieving a form of such definitive written agreement acceptable to Foundation.”