Collaboration Programs. Prior to the Effective Date, each of Voyager and Genzyme have engaged in certain development programs of Gene Therapy Products in the CNS field. Under this Agreement, Voyager and Genzyme shall collaborate in the further Development of products under such programs, and Genzyme shall have the exclusive option to develop and commercialize such programs (and the products generated by or that are the subjects of such programs) as set forth in Section 3.1 (Option Grants). As of the Effective Date, the four Collaboration Programs shall be (a) the PD Collaboration Program, (b) the HD Collaboration Program, (c) the FA Collaboration Program, and (d) the SMA Collaboration Program. In addition, Genzyme shall have the right, exercisable in accordance with Section 2.2.4 (Designation of Future Collaboration Program), to designate any one Voyager CNS Orphan Disease Program as a Collaboration Program under this Agreement (the Future Collaboration Program). In accordance with Section 3.1.1 (Split Territory Program Option Grants), the Split Territory Program Option applies to the HD Collaboration Program, the PD Collaboration Program, the FA Collaboration Program and the Future Collaboration Program, which collectively comprise the Split Territory Collaboration Programs. The Co-Co Option applies to the HD Collaboration Program, in accordance with Section 3.1.2 (HD Licensed Product Co-Co Option Grant). The SMA Program Option applies to the SMA Collaboration Program, in accordance with Section 3.1.3 (SMA Program Option Grant).
Collaboration Programs. During the Option Period, on a Collaboration Program-by-Collaboration Program basis, Biogen will be responsible for any Biogen Activities under the ASO Development Candidate Identification Plan and the Initial Development Plan and all costs and expenses associated therewith. In addition, Biogen will be responsible for paying any Biogen-Approved Costs resulting from Biogen-Approved Changes using the payment mechanisms set forth in Section 1.14.
Collaboration Programs. The objective of each Collaboration Program is to (i) discover and Develop a Lead Vector for each Program for further Development under the terms of this Agreement and (ii) progress each Lead Vector to the completion of the POC Study. The JSC will commence a review at the point at which the first Lead Vector(s) is within [***] of achieving the Clinical Candidate Selection Criteria (or as otherwise may be earlier agreed by the JSC) in the relevant Collaboration Program to determine the liabilities associated with such Lead Vector(s). During the Research Term, TELETHON-HSR shall use Commercially Reasonable Efforts to conduct each Collaboration Program and related Research and Development activities for such Collaboration Program in accordance with the applicable Development Plan once such plan has been approved by the JSC in accordance with Section 2.2. If in relation to any Collaboration Program, TELETHON-HSR is unable to identify a Lead Vector which meets the Clinical Candidate Selection Criteria within the Research Term, TELETHON-HSR’s obligations under this Section 2 shall cease in relation to that Collaboration Program, unless otherwise agreed by the JSC.
Collaboration Programs. The specific Indications to be pursued in the Collaboration will be chosen by Generex in its sole discretion, but with consultation with Amarantus. Non-clinical, clinical, quality, and regulatory Collaboration programs for Indications, including, without limitation, non-clinical and clinical trial protocols, will be designed jointly by Generex and Amarantus.
Collaboration Programs. During the Option Period, on a Collaboration Program-by-Collaboration Program basis, Ionis will be responsible for all Ionis Activities under the ASO Development Candidate Identification Plan and the Initial Development Plan and, except as otherwise provided under Section 1.13.1, all costs and expenses associated therewith.
Collaboration Programs. Right to Opt-Out
Collaboration Programs. (a) [***] Program Before Opt-In and MGNX Program Within the Territory. With respect to (1) the [***] Program before the Opt-In and (2) the MGNX Program, as between the Parties, subject to this Section 7.1, Zai shall be solely responsible for the Commercialization of Collaboration Products in the applicable Collaboration Territory, at [***], including developing and executing a plan for commercial launch, obtaining all required approvals from Regulatory Authorities for Commercialization (including reimbursement activities), marketing and promotion, booking sales and distribution and performance of related services, providing customer support, including handling medical queries, and performing other related functions. Following Regulatory Approval of a Collaboration Product in the Field in any country or Region in the applicable Collaboration Territory, (i) Zai shall use Commercially Reasonable Efforts to Commercialize such Collaboration Product in the Field in such country or Region, and (ii) at each JCC meeting, Zai shall provide the JCC with an update with respect to its Commercialization activities for such Collaboration Product in the Field in such country or Region, and consider in good faith any comments thereto provided by the JCC. As between the Parties, Zai shall book all sales of Collaboration Products in any country or Region in the applicable Collaboration Territory, and shall have the sole right to determine all pricing of Collaboration Products in such country or Region.
(b) [***] Program Before Opt-In and MGNX Program Outside the Territory. With respect to (1) the [***] Program before the Opt-In and (2) the MGNX Program, as between the Parties, subject to this Section 7.1, MacroGenics shall be solely responsible for the Commercialization of Collaboration Products in the Field outside the applicable Collaboration Territory.
Collaboration Programs. On a Collaboration Program-by-Collaboration Program basis, if, at any time during the Option Period, a Change of Control occurs involving Isis and a Person that, at the time of the close of such Change of Control, is developing in human clinical trials or commercializing a Directly Competitive Collaboration Product within the Field or is engaged in a Directly Competitive Collaboration Program or, at any time during the Term after the closing of such Change of Control, develops or acquires a Directly Competitive Collaboration Product or begins a Directly Competitive Collaboration Program (such Person being hereinafter referred to as a “Competing Collaboration Acquirer”) and such Competing Collaboration Acquirer has not, within [***] of either (i) the closing of the Change of Control in the event the Directly Competitive Collaboration Product is being developed in human clinical trials or commercialized, or the Directly Competitive Collaboration Program exists, as of such closing date or (ii) the date of first development or acquisition of such Directly Competitive Collaboration Product or the date on which such Competing Collaboration Acquirer begins such Directly Competitive Collaboration Program (the “Collaboration Divestiture Period”) divested itself of the Directly Competitive Collaboration Product or Directly Competitive Collaboration Program, or terminated development and commercialization of such Directly Competitive Collaboration Product or such Directly Competitive Collaboration Program, then (A) Isis will provide written notice to Biogen Idec of the closing of such Change of Control or Collaboration Divestiture Period, as applicable, (B) [***], (C) solely with respect to any Collaboration Program that relates to such Directly Competitive Collaboration Product or Directly Competitive Collaboration Program for which Initiation of IND-Enabling Toxicology Studies have not occurred, subject to Section 12.5.3, elect to have Isis complete Isis Activities under this Agreement for such Collaboration Program until such time as the applicable Collaboration Program is ready to begin IND-Enabling Toxicology Studies, after which Biogen Idec may elect to exercise its rights under clause (D) of this Section 12.5.2 with respect to such Collaboration Program (in which case the applicable deadline for Biogen Idec’s Notice under such clause will be extended until [***] after designation of a Development Candidate for such Collaboration Program), and (D) solely with r...
Collaboration Programs. Subject to and in accordance with the terms of this Agreement, Isis and Biogen Idec will be responsible for conducting three programs to Discover, Develop, Manufacture and Commercialize Products (each, a “Collaboration Program”), each to be focused on a different Collaboration Target, pursuant to which:
1.2.1. Isis will use its Commercially Reasonable Efforts to (i) conduct drug discovery activities including drug screening, identification, characterization, optimization and other necessary activities according to the applicable Collaboration Program Research Plans to achieve Target Sanction status, (ii) identify a Development Candidate for the applicable Collaboration Program, and (iii) conduct drug development activities for each Development Candidate through completion of the first PoC Trial under a Collaboration Program in accordance with the applicable Development Plan; provided that Isis will not be required to commence work on more than [***] Collaboration Programs in any rolling [***] month period; and
1.2.2. following each Option exercise, Biogen Idec will use its Commercially Reasonable Efforts to Develop, Manufacture and Commercialize at least one Product from each Collaboration Program for which Biogen Idec has exercised an Option in accordance with this Agreement.
Collaboration Programs. On a Collaboration Program-by-Collaboration Program basis, Ionis will be responsible for all Ionis Activities under the Neurology Plans for such Collaboration Program and, except as otherwise provided under Section 1.8.4, Section 1.8.6, Section 1.13.1, Section 1.13.3, and Section 5.2.2, all costs and expenses associated with its performance of such activities. For clarity, Ionis shall not have the right to use, in any such activities, any resources or funding provided to Ionis by Biogen under the Ionis/Biogen Additional Agreements.
