Establishment and Responsibilities. The Borrower/Recipient shall establish an entity responsible for the administration, operation and maintenance of the bulk infrastructure for Outgrower Companies for the life of the Sugar Investment with structure, functions and responsibilities acceptable to the Fund, including a full recovery cost mechanism where the Outgrower Companies will finance the entity at full development. The entity will be mandated to manage funds received from Outgrower Companies and will open the necessary accounts.
Establishment and Responsibilities. 1.1Establishment of the Program.
Establishment and Responsibilities. The LDS Functions will be governed and overseen by a governing board established through this Agreement as a joint administrative entity pursuant to the Illinois Constitution and Intergovernmental Cooperation Act (the “Governing Board”). The Governing Board’s responsibilities include, without limitation:
Establishment and Responsibilities. In the event that Development Activities are required to obtain Regulatory Approval for the Product in the Territory [***], the Parties shall establish the JDC within a reasonable period following the Effective Date that is mutually acceptable to the Parties (and in any event, within [***] of a request by a Party to establish the JDC). The JDC shall perform the following functions:
Establishment and Responsibilities. Promptly following the Effective Date, but in no event later than [***] after the Effective Date, the Parties will form a joint steering committee (the “JSC”) to provide oversight and to facilitate information sharing between the Parties with respect to the activities of the Parties under this Agreement. In addition to its overall responsibility to provide oversight and to facilitate information sharing between the Parties with respect to the activities of the Parties under this Agreement, the JSC will:
Establishment and Responsibilities. The Parties shall establish the JDC within [***] after the Effective Date. The JDC shall perform the following functions:
Establishment and Responsibilities. At an appropriate and agreed time following the Effective Date, (but no later than [***]prior to anticipated filing for Regulatory Approval in the Territory), the Parties shall establish a joint commercial committee (the “Joint Commercialization Committee” or “JCC”) to oversee Commercialization of the Product in the Territory, including reviewing and approving the Commercialization Plan (and the Commercialization Budget contained therein) and overseeing the implementation of such plan. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
Establishment and Responsibilities. At an appropriate time (but at least [***] prior to [***]), the Parties shall establish a joint Product Materials review committee to review, discuss, and determine whether to approve all initial versions of all Product Materials (other than Approved Labeling) and any amendments thereto to be used by each Party in connection with its Medical Affairs activities, Commercialization activities, and Non-Promotional Activities related to the Licensed Products in the Territory under this Agreement (the “PMRC”), as described in Section 6.4 (Medical Education Materials), Section 7.10.1 (Approval and Branding of Training Materials), and Section 7.11 (CAN Product Materials). Each Party shall designate members of the PMRC, such that approval of the PMRC will constitute the approval of its own internal review committee. Each Party may replace its PMRC representatives at any time upon written notice to the other Party. At an appropriate time prior to the First Commercial Sale of the first Licensed Product in the Territory, the Parties will separate the PMRC into two separate committees, one to review and approve Medical Education [***] Portions of this exhibit have been redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. Materials and the other to review and approve all other Product Materials (other than the Approved Labeling, which will remain subject to the JDC’s [***] pursuant to Section 3.3.3(l) (Specific Responsibilities of the JDC)), and will have members from each Party such that approval of each such committee will constitute the approval of each Party’s own internal review committee. In addition, concurrently with the establishment of the PMRC, the Parties shall establish a committee to resolve disagreements arising at the PMRC (the “Super-PMRC”).
