Provision Language
2. CONDUCT OF THE RESEARCH
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2.4 The Research
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(c) Company shall disclose the results of all Research activities regarding Hits and Lead Candidates to the Foundation in accordance with Section 2.7, and the parties shall consult with each other with the objective of identifying at least one Drug Candidate suitable for progression to the preparation and filing of an IND in the Field and, contingent on the effectiveness of such IND, progressing such Drug Candidate into human clinical trials in the most expeditious manner.
3. DEVELOPMENT OF PRODUCTS
3.1 Clinical Development Strategy. As soon as Company reasonably believes that it has identified a Drug Candidate for which it proposes to file an IND in the Field, Company will notify the Foundation in writing, and the parties will promptly discuss in good faith how to proceed with the clinical development of such Drug Candidate, taking into consideration the interests of SMA patients, the intellectual property and regulatory landscape and the commercial potential of the Drug Candidate. The parties agree to consider in good faith collaborating with the NIH in preclinical or clinical development activities regarding such Drug Candidate. Should Company elect to proceed with clinical development of the Drug Candidate, it may do so directly. In the alternative, at its discretion, the Company may decide to enter into a collaboration with one or more Third Parties for clinical development and/or commercialization of the Drug Candidate through licensing or other arrangement; provided, however, that if the Foundation has funded (or caused to be funded) [**], then until [**], any such collaborations shall be subject to the Foundation’s approval (which shall not be unreasonably withheld). If Company wishes to pursue clinical development of a Drug Candidate, the Company will consult with the SMA Foundation on the clinical trial network that will be used. Although the parties currently expect to use the clinical trial network established by the Foundation, the clinical trial network to be used shall be determined in good faith by Company in its reasonable judgment. For any Drug Candidate for which it files an IND, Company agrees to consider in good faith whether to obtain, (a) “Orphan Product” designation from the FDA, and (b) research funding from the FDA’s Office of Rare Diseases to support human clinical trials conducted for such Drug Candidate. The parties acknowledge that if the Drug Candidate is [**], or [**] due to [**] and [**], investment by Company in further development of such Drug Candidate may not be in the best interests of Company’s stockholders, and therefore shall not be required under this Agreement, and the failure to engage in such further development shall not be the basis of a Reversionary License under Section 6.1(c). In such case, the parties may elect to enter into an additional sponsored research agreement under which the Foundation would provide funding for further development efforts by Company, but neither party shall have any obligation to enter into such additional agreement.
3.2 Conduct of Clinical Development. Except as set forth in Section 3.1 above or as otherwise agreed by the parties in writing, Company shall be responsible for clinical development of any Drug Candidate for which Company files an IND. Company shall use commercially reasonable efforts to develop and commercialize (whether directly, through an Affiliate, or in collaboration with one or more Third Parties, through licensing or some combination of the foregoing) at least one Product. The parties anticipate that an IND will be submitted within [**] years of commencement of IND-enabling toxicology studies for a Lead Candidate, but the parties acknowledge that [**], and therefore [**], to be a [**]. Notwithstanding the preceding provisions of this Section 3.2, in no event shall Company have any obligation (i) to pursue clinical development or commercialization of any Drug Candidate which is [**], or which [**] the [**] due to its [**] and [**], or (ii) in the absence of complete funding by (or arranged by) the Foundation, to pursue clinical development or commercialization of any Drug Candidate which is not, [**]. In addition, Company shall not be obligated to pursue clinical development or commercialization of a Drug Candidate if the pharmaceutical preparation, composition of matter, method of manufacture and/or method of use of such Drug Candidate is covered by Patents of a Third Party, unless a license under such Third Party Patents is available to Company (or its Affiliate or Licensee, as applicable) on commercially reasonable terms (a “Third Party Patent License”).
AMENDMENT No. 2 TO SPONSORED RESEARCH AGREEMENT
8. Development of Products
(a) Article 3 of the Agreement (captioned “Development of Products”) shall, as of the Second Amendment Effective Date, be amended and restated as follows:
“3. DEVELOPMENT OF PRODUCTS.
“3.1 Development Plan and Development Deadline Document. Upon selection of a Development Candidate, the JSC will meet to prepare a plan for the Development of such Development Candidate (such plan, the “Development Plan” for such Development Candidate”) and to conduct a formal review of and prepare a comprehensive update to Exhibit SA-4A to the Second Amendment (the “Development Deadline Document”) that reflects anticipated activities directed towards Development and commercialization of such Development Candidate through Regulatory Approval in the United States, in each case taking into consideration available information concerning such Development Candidate, the interests of SMA patients, the intellectual property and regulatory landscape and the commercial potential of the Development Candidate. The parties acknowledge and agree that Exhibit SA-4A takes into account many delays in Development and receipt of Regulatory Approval that, while possible, are not anticipated as of the Second Amendment Effective Date to be likely; Company’s expectations, as of the Second Amendment Effective Date, of the activities required to obtain Regulatory Approval and its goal timelines for completing such activities are set forth in Exhibit SA-4B. When preparing the Development Plan and updating the Development Deadline Document for each Development Candidate, the JSC shall consider whether to obtain, (a) “Orphan Product” designation from the FDA, and (b) research funding from the FDA’s Office of Rare Diseases or other government agencies to support human clinical trials conducted for such Development Candidate, in each case taking into consideration the protection of intellectual property rights and confidential information. The Development Plan shall set forth, in at least the level of detail included in the Company’s or its Licensee’s plans for developing other preclinical or clinical (whichever reflects the status of the Development Candidate at such time) pharmaceutical products, both major and minor Development activities planned to be conducted with respect to such Development Candidate by or on behalf of Company or its Affiliates or Licensees, the anticipated timeline for performing such activities, the goals of such activities and the anticipated timeline for achieving such goals. The Development Deadlines Document shall set forth the deadline by which each major Development activity must be performed by on behalf of Company or its Affiliates or Licensees if the Company wishes to avoid granting the Foundation the right to obtain a Reversionary License pursuant to Section 3.3 of the Agreement. No change can be made to any Development Plan or Development Deadline Document without the approval of the JSC unless such change is approved by the parties’ respective Chief Executive Officers pursuant to Second Amendment Section 5(d) or 5(e), is implemented by Baseball Arbitration in accordance with Second Amendment Sections 5(d) and 17, or is approved by the Foundation in accordance with Second Amendment Section 9(b)(1).
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.
(b) Company Clinical Trials
(1) Foundation shall have the right, but not the obligation, to assist with patient recruitment for any Company Clinical Trial involving SMA patients by (i) referring to Company (or, at Company’s request, referring directly to any clinical investigator at a clinical trial site for the applicable Company Clinical Trial) up to [**] SMA patients meeting the enrollment criteria for the applicable Company Clinical Trial and identified by Foundation or its designee, and/or (ii) proposing up to [**] clinical trial sites with access to appropriate patient populations for such Company Clinical Trial. Company shall use Commercially Reasonable Efforts to enable such patients to be enrolled in such Company Clinical Trial consistent with the applicable enrollment criteria, protocol, and target patient number for such Company Clinical Trial (it being understood that such patients should be given priority over other patients who are equally qualified to participate in such Company Clinical Trial, provided that the final decision regarding such enrollment is made by the clinical investigator and/or clinical trial site personnel of the investigating institution), and to contract with such clinical trial sites for such Company Clinical Trial. If Foundation, in its sole discretion, determines not to assist in patient recruitment for any Company Clinical Trial, then it shall so inform Company and Company shall assume all responsibility for patient recruitment and selection of clinical trial sites.
(2) Each time that Company commences the drafting of a clinical trial protocol for a Development Candidate or Product and at reasonable times thereafter, Company will discuss with Foundation Company’s plans for making such Development Candidate or Product available to participants in such clinical trial after the completion of such trial. If mutually agreed by the parties based on such discussions, or if recommended by the SMAF Clinical Trials Advisory Committee in its sole discretion, Company will submit to the appropriate Regulatory Agency a suitable extension protocol and corresponding informed consent form providing for administration of such Drug Candidate or Product for at least [**] beyond the term provided for in a particular Company Clinical Trial. Company shall use Commercially Reasonable Efforts to obtain the applicable Regulatory Agency’s approval of such extension protocol and informed consent and subsequent approval from the Institutional Review Boards at the locations where such Company Clinical Trial is being conducted; provided, however , that the proposed [**] period for such extension protocol may be shortened based on the request or advice of the applicable Regulatory Agency. Upon receipt of such approvals, Company shall provide, in accordance with the approved extension protocol, such Development Candidate or Product to those SMA patients who enrolled in such Company Clinical Trial pursuant to this Second Amendment Section 13(b) and wish to continue to receive such Development Candidate or Product after the completion of such Company Clinical Trial (such patients, the “Enrollees”). For so long as Company is continuing to develop or seek approval from a Regulatory Agency for such Development Candidate or Product, and subject either to mutual agreement of Company and Foundation or to the recommendation of the SMAF Clinical Trials Advisory Committee in its sole discretion, Company shall use commercially reasonably efforts to obtain approval for an amended or new extension protocol providing for continued administration of such Development Candidate or Product to the Enrollees, and Company shall provide such Development Candidate or Product to the Enrollees in accordance with any such approved protocol. In any case in which Company, [**], does not concur in the decision to commence or continue any extension protocols pursuant to this Second Amendment Section 13(b)(2), then Company’s obligations to assist with such extension protocols and continue to supply such Development Candidate or Product to Enrollees shall [**], directly or indirectly, [**], and [**] of Development Candidate or Product to Enrollees.
(3) If Company stops Developing or seeking approval from a Regulatory Agency of a Development Candidate or Product for which it filed an extension protocol pursuant to Second Amendment Section 13(b)(2), and either the parties mutually agree or the SMAF Clinical Trials Advisory Committee in its sole discretion (but having considered any safety issues) recommends that the Enrollees continue to have access to such Development Candidate or Product for a longer period than provided for in any existing extension protocol submitted by Company with respect to such Development Candidate or Product, then upon Foundation’s request, Company shall facilitate Foundation’s efforts to arrange for prolonged continued access to such Development Candidate or Product for some or all of the Enrollees by taking all reasonable actions requested by Foundation (consistent with the SMAF Clinical Trials Advisory Committee’s recommendations, if applicable), including without limitation: (i) either (1) transferring Company’s IND for such Development Candidate or Product to Foundation or its designee or (2) providing Foundation or its designee with a right of reference to the manufacturing-related information and safety and efficacy data in Company’s IND or Drug Master File or equivalent regulatory filing (as applicable) so that Foundation or its designee can submit its own IND with respect to such continued access; (ii) providing (for the shorter of [**] months or the amount of time necessary for Foundation or its designee to establish an alternative supply of equivalent clinical grade product) such Development Candidate or Product to Foundation or its designee for administration to such Enrollees in accordance with any extension protocol for which Foundation or its designee has obtained approval from the FDA or the applicable Agency; (iii) assisting Foundation or its designee with obtaining an alternative, equivalent clinical grade supply of such Development Candidate or Product by (1) facilitating Foundation’s or its designee’s negotiation of a supply agreement with Company’s manufacturer of such Development Candidate or Product or (2) providing technology transfer and other technical assistance reasonably requested by Foundation to enable Foundation or its designee to manufacture such Development Candidate or Product; and (iv) providing Foundation with a non- exclusive, fully paid, sublicensable license under Company Technology and Data, and solely to the extent reasonably necessary for Foundation to exercise its rights under the foregoing license, to Company Base IP ( provided , that the license granted hereunder to Foundation [**] or [**] or [**] to perform or have performed on its behalf any and all activities necessary or reasonably useful to provide continued access to such Development Candidate or Product in accordance with this Second Amendment Section 13(b)(3). In any case in which Company, [**], does not concur in the decision to commence or continue any extension protocols pursuant to this Second Amendment Section 13(b)(3), then Company’s obligations to assist with such extension protocols and continue to supply such Development Candidate or Product to Enrollees shall [**], directly or indirectly, [**], and [**] of Development Candidate or Product to Enrollees. In connection with the foregoing, Foundation, [**], shall maintain clinical trial and/or product liability insurance, as applicable, in an amount consistent with industry standards and only if available on commercially reasonable terms, and shall [**] with respect to such insurance, with respect to losses arising out of or related to the activities contemplated under this Second Amendment Section 13(b)(3). Foundation shall provide a certificate of insurance evidencing such coverage to Company upon request.
(c) Expanded Access Program
(1) At such a time as the parties mutually agree, or the SMAF Clinical Trials Advisory Committee in its sole discretion determines, that results from Company Clinical Trials and other Development activities with respect to the applicable Development Candidate or Product support expanded access to such Development Candidate or Product for patients with SMA, then Company and Foundation shall cooperate to establish such an expanded access program in which at least [**] SMA patients identified by Foundation who do not meet the enrollment criteria for a particular Company Clinical Trial (whether or not such Company Clinical Trial is directed to SMA patients) for such Development Candidate or Product (such patients, the “Patients”) may gain access to such Development Candidate or Product. Company agrees that at its earliest reasonable opportunity following the commencement of such cooperation (e.g., at a meeting with FDA), Company will inquire about the feasibility of an expanded access protocol for such Drug Candidate or Product for SMA purposes and will invite a designee of Foundation with appropriate medical or regulatory experience to participate in discussions with the FDA regarding the establishment and maintenance of such expanded access program. In connection with such expanded access program, at Foundation’s request and consistent with any recommendation made by the SMAF Clinical Trials Advisory Committee, Company will either (i) submit to the FDA a protocol that is reasonably acceptable to Foundation and calls for administering such Development Candidate or Product to the Patients or (ii) notify Foundation that it will not be making such a submission and facilitate the submission and approval of such a protocol by the Foundation or its designee.
(2) If Company chooses option (i) above, then it shall use Commercially Reasonable Efforts to obtain approval of such protocol and upon receipt of such approval, it shall provide such Development Candidate or Product to the Patients in accordance with the approved protocol; provided , that the parties shall engage in good faith negotiations with respect to [**].
(3) If Company chooses option (ii) above, then Company shall facilitate Foundation’s efforts to arrange for such expanded access program for such Development Candidate or Product for the Patients by taking all reasonable actions requested by Foundation, in each case [**], including without limitation: (1) either (1) allowing the expanded access program to be performed pursuant to Company’s IND (in which case Foundation or its designee shall provide Company with all data arising from and other information with respect to such expanded access program that is necessary or reasonably useful for Company to fulfill its obligations as the IND holder) or (2) providing Foundation or its designee with a right of reference to the manufacturing-related information and safety and efficacy data in Company’s IND or Drug Master File or similar regulatory filing (as applicable) so that Foundation or its designee can file its own IND with respect to such expanded access program; (ii) providing such Development Candidate or Product to an appropriate designee of Foundation for administration to the Patients in accordance with any expanded access protocol for which Foundation or its designee has obtained approval from the FDA [**]); and (iii) providing Foundation with a non-exclusive, fully paid, sublicensable license under Company Technology and Data, and solely to the extent reasonably necessary for Foundation to exercise its rights under the foregoing license, to Company Base IP ( provided , that the license granted to Foundation hereunder [**] or [**] or [**] to perform or have performed on its behalf any and all activities necessary or reasonably useful to provide such expanded access to such Drug Candidate or Product in accordance with this Second Amendment Section 13(c)(3). In connection with the foregoing, Foundation, [**], shall maintain clinical trial and/or product liability insurance, as applicable, in an amount consistent with industry standards and only if available on commercially reasonable terms, and shall [**] with respect to such insurance, with respect to losses arising out of or related to the activities contemplated under this Second Amendment Section 13(c)(3). Foundation shall provide a certificate of insurance evidencing such coverage to Company upon request.