Provision Language
5. Product Development
5.1 SRA Product Development. Roche, at its sole cost, shall be responsible for pursuing clinical development of SRA Products, including any non-clinical studies required to support such clinical development, subject to the terms of the SRA (with Roche having responsibility for fulfilling all of PTC’s obligations thereunder with respect to clinical development of SRA Products).
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5.1.2 Roche Clinical Trials. Foundation has the right, but not the obligation, to assist with patient recruitment for any SRA Company Clinical Trial involving SMA patients by (i) referring to Roche (or, at Roche’s request, referring directly to any clinical investigator at a clinical trial site for the applicable clinical trial) up to [**] SMA patients meeting the enrollment criteria for the applicable 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 clinical trial. With regard to clinical trials involving any Compound or Product, Roche shall use Commercially Reasonable Efforts to enable such patients to be enrolled in such clinical trial consistent with the applicable enrollment criteria, protocol, and target patient number for such clinical trial (it being understood that such patients should be given priority over other patients who are equally qualified to participate in such 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 clinical trial. If Foundation, in its sole discretion, determines not to assist in patient recruitment for any such clinical trial, then it shall so inform Roche and Roche shall assume all responsibility for patient recruitment and selection of clinical trial sites.
Each time that Roche commences the drafting of a clinical trial protocol for a SRA Development Candidate or SRA Product, and at reasonable times thereafter, Roche will discuss with Foundation Roche’s plans for making such SRA Development Candidate or SRA Product available to participants in such clinical trial after the completion of such trial. If mutually agreed by Roche and Foundation based on such discussions, or if recommended by the SMAF Clinical Trials Advisory Committee in its sole discretion, Roche will submit to the appropriate Regulatory Authority a suitable extension protocol and corresponding informed consent form providing for administration of such SRA Drug Candidate or SRA Product for at least [**] beyond the term provided for in a particular clinical trial. Roche shall use Commercially Reasonable Efforts to obtain the applicable Regulatory Authority’s approval of such extension protocol and informed consent and subsequent approval from the institutional review boards at the locations where such 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 Authority. Upon receipt of such approvals, Roche shall provide, in accordance with the approved extension protocol, such SRA Development Candidate or SRA Product to those patients who enrolled in such clinical trial (such patients, the “Enrollees”). For so long as Roche is continuing to develop or seek approval from a Regulatory Authority for such SRA Development Candidate or SRA Product, and subject either to mutual agreement of Roche and Foundation or to the recommendation of the SMAF Clinical Trials Advisory Committee in its sole discretion, Roche shall use Commercially Reasonably Efforts to obtain approval for an amended or new extension protocol providing for continued administration of such SRA Development Candidate or SRA Product to the Enrollees, and Roche shall provide such SRA Development Candidate or SRA Product to the Enrollees in accordance with any such approved protocol. If Roche [**] does not concur in the decision to commence or continue any extension protocol pursuant to this Section 5.1.2, then Roche’s obligations to assist with such extension protocol and continue to supply such SRA Development Candidate or SRA Product to Enrollees shall [**] directly or indirectly, [**], and [**] of SRA Development Candidate or SRA Product to Enrollees.
If Roche stops developing or seeking approval from a Regulatory Authority of a SRA Development Candidate or SRA Product pursuant to the above paragraph, and either Roche and Foundation 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 SRA Development Candidate or SRA Product for a longer period than provided for in any existing extension protocol submitted by Roche with respect to such SRA Development Candidate or SRA Product, then upon the Foundation’s request, Roche shall facilitate Foundation’s efforts to arrange for prolonged continued access to such SRA Development Candidate or SRA 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 Roche’s SRA IND for such SRA Development Candidate or SRA 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 Roche’s SRA IND or Drug Master File or equivalent regulatory filing (as applicable) so that Foundation or its designee can submit its own SRA 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 SRA Development Candidate or SRA 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 Regulatory Authority; (iii) assisting Foundation or its designee with obtaining an alternative, equivalent clinical grade supply of such SRA Development Candidate or SRA Product by (1) facilitating Foundation’s or its designee’s negotiation of a supply agreement with Roche or Roche’s manufacturer of such SRA Development Candidate or SRA Product or (2) providing technology transfer and other technical assistance reasonably requested by Foundation to enable Foundation or its designee to manufacture such SRA Development Candidate or SRA Product; and (iv) providing Foundation with a non-exclusive, fully paid-up, sublicensable license under SRA Licensee Technology and SRA Licensee Data (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 SRA Development Candidate or SRA Product in accordance with this Section 5.1.2. In any case in which Roche [**], does not concur in the decision to commence or continue any extension protocol pursuant to this Section 5.1.2, then Roche’s obligations to assist with such extension protocol and continue to supply such SRA Development Candidate or SRA Product to Enrollees shall [**], directly or indirectly, [**], and [**] of SRA Development Candidate or SRA 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 losses arising out of or related to the activities contemplated under this Section 5.1.2. Foundation shall provide a certificate of insurance evidencing such coverage to Roche upon request.
For clarity, nothing in this Section 5.1.2 shall be interpreted as limiting PTC’s obligations pursuant to the SRA, including to provide licenses to SRA Company Technology, SRA Data and SRA Company Base IP to facilitate Foundation’s efforts to arrange for prolonged continued access to such SRA Development Candidate or SRA Product for some or all of the Enrollees.
5.1.3 Expanded Access Program. At such time as Foundation and Roche mutually agree, or the SMAF Clinical Trials Advisory Committee in its sole discretion determines, that results from clinical trials and other development activities with respect to the applicable SRA Development Candidate or SRA Product support expanded access to such SRA Development Candidate or SRA Product for patients with SMA, then Roche 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 clinical trial (whether or not such clinical trial is directed to SMA patients) for such SRA DevelopmentCandidate or SRA Product (such patients, the “Patients”) may gain access to such SRA Development Candidate or SRA Product. Roche agrees that at its earliest reasonable opportunity following the commencement of such cooperation (e.g., at a meeting with the FDA), Roche will inquire about the feasibility of an expanded access protocol for such SRA Development Candidate or SRA 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 recommendations made by the SMAF Clinical Trials Advisory Committee, Roche will either(i) submit to the FDA a protocol that is reasonably acceptable to Foundation and calls for administering such SRA Development Candidate or SRA 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.
If Roche 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 SRA Development Candidate or SRA Product to the Patients in accordance with the approved protocol; provided, that Roche and Foundation shall engage in good faith negotiations with respect to [**].
If Roche chooses option (ii) above, then Roche shall facilitate Foundation’s efforts to arrange for such expanded access program for such SRA Development Candidate or SRA Product for the Patients by taking all reasonable actions requested by Foundation, in each case [**], including without limitation: either (1) allowing the expanded access program to be performed pursuant to Roche’s SRA IND (in which case Foundation or its designee shall provide Roche with all data arising from and other information with respect to such expanded access program that is necessary or reasonably useful for Roche to fulfill its obligations as the SRA 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 Roche’s SRA IND or Drug Master File or similar regulatory filing (as applicable) so that Foundation or its designee can file its own SRA IND with respect to such expanded access program; (ii) providing such SRA Development Candidate or SRA 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-up, sublicensable license under SRA Licensee Technology and SRA Licensee Data (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 such expanded access to such SRA Development Candidate or SRA Product in accordance with this Section 5.1.3. 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 Section 5.1.3. Foundation shall provide a certificate of insurance evidencing such coverage to Roche upon request.
For clarity, nothing in this Section 5.1.3 shall be interpreted as limiting PTC’s obligations pursuant to the SRA, including to provide licenses to SRA Company Technology, SRA Data and SRA Company Base IP to facilitate Foundation’s efforts to arrange for such expanded access program for such SRA Development Candidate or SRA Product for the Patients.