Development Subcommittee Clause Samples

Development Subcommittee. One such subcommittee the JSC may form may be the Development Subcommittee, which to the extent agreed by the JSC may have one or more of the following responsibilities: (i) discuss regular reports regarding the development of the Product, and discuss, prepare and consider for approval annual and interim amendments to the Development Plan (and the development budget) for the Licensed Product; (ii) discuss and manage the implementation of the Development Plan; (iii) oversee the conduct of development; (iv) create, implement and review the development strategy for development and Regulatory Approval in the Territory and the design of all clinical trials,; (v) oversee any CMC related development activities, e.g. stability studies or packaging development, as well as other activities to prepare for supply of drug substance and finished form of the Licensed Product; (vi) allocate budgeted resources and determine priorities for each clinical trial and under the Development Plan other than Territory Specific Trials; (vii) review Third Party contractors proposed to conduct clinical trials of the Licensed Product; (viii) facilitate the flow of information between the Parties with respect to the potential development of the Licensed Product outside of the Field and Territory; [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. (ix) discuss whether to develop the Licensed Product for other indications in the Field in the Territory; (x) allocate primary responsibility as between the Parties for tasks relating to development of the Licensed Product where not already specified in the Development Plan; (xi) discuss the requirements for Regulatory Approval in the Territory and oversee and coordinate regulatory matters with respect to the Licensed Product in the Territory, including to review material regulatory filings prior to submission thereof; (xii) establish a publication strategy for publications and presentations related to the Licensed Product in the Territory; (xiii) facilitate the flow of Information between the Parties with respect to obtaining Regulatory Approval for the Licensed Product; and (xiv) review global harmonization of the Product, including annual review of the Development Plan and the Commercialization Plan, identify opportunities for brand synergy, discuss,...

Development Subcommittee. 51 6.7 Cooperation...............................................51 6.8 Visitation................................................52 6.9

Development Subcommittee. Within [ ]* after the Effective Date, the Parties shall form a subcommittee of the Steering Committee to address development issues relating to Licensed Products as provided below in Article 3 (the "Development Subcommittee").

Development Subcommittee. Pursuant to Section 5.6(a) of the License Agreement, the Parties will form a joint development committee (the “JDC”) as soon as practicable, but no later than [***] after the nHCM Supplemental Agreement Effective Date. Notwithstanding anything to the contrary in the last sentence of Section 5.6(a) of the License Agreement, the JSC may delegate specifically-defined responsibilities of the JSC out of those set forth in Section 4.1 to the JDC, for which the JDC will be able to make decisions by unanimous vote by the Parties pursuant to the following sentence. Company’s representatives on the JDC will collectively have one vote, Licensee’s representatives on the JDC will collectively have one vote, and no decision will be made by the JDC without a unanimous vote by the Parties. Should the JDC not be able to reach agreement with respect to a matter at a duly called meeting of the JDC, at the written request of either Company or Licensee, such matter shall promptly, and in any event within [***] (or [***] in the event of an urgent matter) after such request, be referred to the JSC for resolution as set forth in Section 4.6.

Development Subcommittee. 2.3.1 Within [***] calendar days following the Effective Date, each Party shall appoint [***] representative as its chair-person for the development subcommittee and may appoint additional non-voting representatives (the “Development Subcommittee” or “DSC”) and give notice of the name and contact information of its respective subcommittee representative(s) to the other Party. 11 2.3.2 The DSC shall be responsible for (a) reviewing and evaluating the progress of the Parties under the Development Program; provided, that, the DSC shall not have authority to [***] is in [***]; (b) attempting to [***] regarding the [***] under this Agreement; (c) reviewing all relevant proposed scientific publications and presentations of any of the Parties or their respective Affiliates pursuant to Section 12.1; (d) reviewing and discussing the [***] and [***] of the Product, including any plans to [***] of the Products; and (e) performing such other responsibilities as may be assigned by the Executive Steering Committee from time to time. For the avoidance of doubt, [***] on the DSC has [***] decision rights in the Territory in relation to Product [***] and [***] strategy, provided that in no event may [***] exercise its [***] decision rights to require that [***] take any action that would (i) require [***] to incur expenses in excess of the [***], or (ii) be unethical or require [***] to violate any Applicable Law. 2.3.3 The DSC will terminate on [***], unless the Parties agree in writing to extend the duration of the DSC.

Development Subcommittee