Joint Steering Committee Promptly after the Effective Date, the Parties will form a Joint Steering Committee (the “JSC”) composed of an equal number of employees of each of Curis and Genentech, but in no event to exceed four (4) members from each Party. The JSC shall determine the specific goals for the Collaboration, shall manage the ongoing research conducted under the Collaboration in accordance with the Research Plan, shall monitor the progress and results of such work, and shall oversee and coordinate the development and commercialization of Compounds (other than Collaboration Products); provided, however, that the JSC shall not have decision-making authority with respect to the development and commercialization of Collaboration Products, which shall be governed by the CSC. The presence of at least one (1) representative of each Party shall constitute a quorum for the conduct of any JSC meeting. All decisions of the JSC shall require unanimous approval, with the representatives of each Party collectively having one (1) vote, provided in the event of a deadlock, the issue shall be referred to the Chief Executive Officer of Curis and the Senior Vice President of Research of Genentech, or their respective designees, who shall promptly meet and attempt in good faith to resolve such issue within thirty (30) days. If such executives cannot resolve such matter, then Genentech shall have final decision-making authority with regard to decisions regarding the Collaboration (including, without limitation, the JSC’s designation of a Compound as either a Lead Product or Excluded Product); provided, however, that in no event shall Genentech have the right or power to take any of the following actions without the approval of Curis’ representatives on the JSC: (a) approve the initial Research Plan (an outline of which has been agreed upon by the Parties as of the Effective Date); (b) amend or modify this Agreement or the Research Plan; (c) resolve any such matter in a manner that conflicts with the provisions of this Agreement (including, without limitation, the Research Plan); (d) make any decision with respect to the development or commercialization of Curis Products; or (e) make any decision with respect to the prosecution, maintenance, defense or enforcement of any Curis Patents. The JSC shall meet at such frequency as the JSC agrees, except that, until the filing of the first IND for a Lead Product utilizing Systemic Delivery in a Major Market, the JSC shall meet on at least a quarterly basis. Meetings of the JSC, and JSC dispute resolution meetings between Curis’ Chief Executive Officer and Genentech’s Senior Vice President of Research (or their designees), may be conducted by videoconference, teleconference or in person, as agreed by the Parties, and the Parties shall agree upon the time and place of meetings. A reasonable number of additional representatives of a Party may attend meetings of the JSC in a non-voting capacity. The JSC shall exist for so long as either any work is being conducted under the Research Plan or any Compound is being developed or commercialized by Genentech, Curis, or any of their respective Affiliate(s) or sublicensee(s) in any Major Market. The JSC shall also be responsible for designating one or more representatives of each Party with expertise in patent law (which individuals need not be members of the JSC) to oversee intellectual property matters relating to the Collaboration, subject to the provisions of Article 10, and such patent committee shall coordinate with and report to the JSC.
Manufacturing Technology Transfer Except as provided in Section 4.3(f)(iii)(1) and Section 6.10, with respect to any Collaboration Product (or LGC Reserved Product, if applicable) for which LGC (or its Affiliate) performed CMC Development or CMC Manufacturing, if (a) Cue does not elect for LGC to perform CMC Step 2, CMC Step 3, or CMC Step 4 (or with respect to LGC Reserved Products, upon completion of CMC Step 1), or (b) upon failure of the Parties to reach agreement with respect to a Clinical Supply Agreement or a Commercial Supply Agreement or (c) [***] under this Agreement and does not cure such breach within [***] days (provided, that if such breach is not reasonably capable of cure within such [***] day period, then such cure period shall be automatically extended for an additional [***] day period as long as LGC continues to use diligent efforts to cure such breach in accordance with a reasonable cure plan and if such breach is not reasonably capable of cure within such combined [***] day period, then Cue shall reasonably consider consenting to any extension of such cure period as long as LGC continues to use diligent efforts to cure such breach in accordance with a reasonable cure plan), as applicable, then, in each case upon the written request of Cue, LGC shall use Commercially Reasonable Efforts to make a technology transfer to an Approved CMO the Manufacturing processes (including materials and such other information) but solely as is necessary to enable the Manufacture of such Collaboration Product (including the Collaboration Compound therein) (or LGC Reserved Product, including the LGC Reserved Compound therein, if applicable) by such Approved CMO to comparable biochemical structure, quality and purity as that Manufactured by LGC or its Affiliate or CMO, provided that neither Cue, LGC or any Third Party shall perform such a technology transfer to any CMO [***] without LGC’s consent, not to be unreasonably withheld, conditioned or delayed if LGC has approved the CMO to manufacture Collaboration Products (or LGC Reserved Products, if applicable). LGC shall conduct such technology transfer as soon as reasonably practicable after receiving such written notice, using good faith efforts to support supply needed to achieve timelines in the Cue Territory Development Plan (or Cue’s development plan for LGC Reserved Products, if applicable) or Cue Territory Commercialization Plan, as applicable. LGC shall conduct the first technology transfer for each Collaboration Product (or LGC Reserved Products, if applicable) [***] (provided that [***]) for a period of up to [***] months from the date Cue or its designee has provided notice it is ready to receive the technology transfer, provided, that such [***] month period [***]. After the expiration of the initial such [***] month period for a Collaboration Product (or LGC Reserved Products, if applicable), if required to complete the technology transfer to enable the Manufacture of such Collaboration Product (including the Collaboration Compound therein) (or LGC Reserved Product, including the LGC Reserved Compound therein, if applicable) by such Approved CMO to comparable biochemical structure, quality and purity as that Manufactured by LGC, LGC shall continue to provide support to Cue for up to an additional [***] period for up to [***] hours at the FTE Rate and thereafter at [***]. Thereafter, LGC will also provide [***] for such Collaboration Product (or LGC Reserved Products, if applicable). Neither Cue nor its Affiliates or Cue Collaborators shall reverse engineer any materials provided hereunder by LGC. Notwithstanding anything in this Agreement to the contrary, LGC’s CMC information may only be shared with an Approved CMO.
Project Steering Committee 1. For a sound implementation and management of the project, a steering committee shall be set up in line with provisions of the programme manual. 2. The steering committee is the decision-making body of the project and it shall be composed by representatives of the LP and all PPs duly authorised to represent the respective LP and PP institutions. It shall be chaired by the LP and it shall meet on a regular basis. Associated partners shall be invited to take part in the steering committee in an advisory capacity. External key stakeholders may also be invited to take part to one or more meetings in an observer/advisory capacity. 3. The steering committee shall at least: a. be responsible for monitoring and validating the implementation of the project and the achievement of the planned results as in the approved application form; b. perform the financial monitoring of the project implementation and to decide on any budget modifications as in § 11 of this agreement; c. monitor and manage deviations of the project implementation; d. decide on project modifications (e.g. partnership, budget, activities, and duration) if needed; e. be responsible for the settlement of any disputes within the partnership (as stipulated in § 22 of this agreement). 4. Further aspects, including the creation of sub-groups or task forces, may be set out in the rules of procedure of the steering committee.
Manufacturing and Marketing Rights The Company has not granted rights to manufacture, produce, assemble, license, market, or sell its products to any other person and is not bound by any agreement that affects the Company's exclusive right to develop, manufacture, assemble, distribute, market, or sell its products.
Joint Research Committee The Parties hereby establish a committee to facilitate the Research Program as follows:
