Initial Plan. Subject to Section 2.2 and Section 2.3, Development of Shared Products shall be governed by the Development Plan for each of the US Territory and the ROW Territory that, collectively, describe the Development activities to be undertaken with respect to the Shared Products in the Territory, which shall include an annual budget of Development Costs and related Manufacturing Costs and other Allowable Expenses pursuant to Section 3.1(b) (“Development Budget”) and anticipated timelines for performance. Promptly after the Effective Date, but in any event within [***] days thereafter, the Lead US Party (with respect to Development of the Shared Products in the US Territory) and Celgene (with respect to Development of the Shared Product in the ROW Territory) shall each prepare and submit to the JDC for review the applicable portions of a Development Plan for inclusion in an initial global Development Plan for Shared Products, including any activities to be performed by Vividion for U.S. Administration, and such initial global Development Plan for Shared Products shall be subject to review and approval by the JSC. The JDC will review the required form and contents of the Development Plan (which shall be subject to review and approval by the JSC), and will review each Development Plan in accordance with Section 3.1(c). The Development Plan may be amended from time to time by the JDC. The Direct Costs of conducting Development activities in both the ROW Territory and the US Territory in relation to a Shared Product shall be reflected in the Development Budget and allocated and paid as set forth in Section 3.2.
Initial Plan. Subject to Section 2.1 and Section 2.2, Development of the Product for the US shall be governed by the development plan attached hereto as Schedule 3.2(a) (as amended from time to time in accordance with this Agreement, the “Development Plan”), which includes (a) Lannett’s annual budget of Development Costs attached as Appendix 1, which shall be paid pursuant to Section 3.2(b), and (b) anticipated timelines for performance. The Direct Costs of conducting Development activities in relation to a Product for the US shall be reflected in the Development Budget and allocated and paid as set forth in HEC’s Financial Responsibility and Lannett’s Financial Responsibility (as defined below). Pursuant to the Development Plan, (a) Lannett shall (i) be the sponsor for and design all Clinical Trials for the Product for the US commenced prior to the submission of the BLA Filing and (ii) be responsible for preparing the BLA Filing and (b) HEC shall be responsible for submitting the BLA Filing to the FDA.
Initial Plan. On or before the Effective Date of the Agreement, Licensee agrees to submit, in the form of a written proposal to Licensor, Licensee's plans and specifications (the "Initial Plan") regarding the development, design, building, construction and operation of the Entertainment Stores (the "Business"). Such Initial Plan shall be prepared by Licensee at its own expense and shall include, without limitation, detailed and specific plans regarding the management, marketing, advertising, design, attractions, building, construction, proposed locations of the Entertainment Stores, Site Trade Dress, and systems development for the Business as well as future plans for expansion of the Business. Licensor agrees to approve or disapprove the Initial Plan within thirty (30) days after the delivery of the Initial Plan to Licensor from License, such approval shall not be unreasonably withheld.
Initial Plan. 13.4.1 As soon as practicable and in any event within twenty (20) Business Days after service of a Defect Notice, the Company shall deliver to the Scottish Ministers a plan prepared by the Company (the Initial Plan) setting out:
Initial Plan. The Counties, acting in their capacity as County Approval Agencies, may approve or deny the MMP. If approved, each county will submit its written approval or minutes of the meeting where a motion was passed to the MMPC, the DPA, and the other counties. If rejected, a county will communicate in writing its objection and any suggestions for changes to the MMPC, the DPA, and the other counties.
Initial Plan. Guarantee: Preferred Provider guarantees that 100% of Medicare Plan services will take effect and be fully operational on the go live date as specified in the Contract. Measurement and Penalty: Preferred Provider shall pay Group $ for failure to meet the standard outlined in the chart in Exhibit I-C
Initial Plan. The Development of the Product for use in the Field in the Territory shall be governed by a comprehensive, multi-year plan detailing (i) the Development program (including pharmacokinetics studies) to be conducted by Sucampo on an activity-by-activity basis, and (ii) the regulatory strategy for obtaining Regulatory Approval for the Product in the Field in the Territory, which Development program is designed to generate all the Clinical Data and regulatory information required to obtain the Regulatory Approval required for Xxxxxx to be able to Commercialize the Product in the Field in the Territory (the “Development Plan”). Within thirty (30) days following the Effective Date, Sucampo shall prepare and provide to the JDC a proposed Development Plan for its review in accordance with the provisions of ARTICLE 3.
Initial Plan. Following the Target Selection Date for an Initial Target or the Target Substitution Date for a Substitute Target, the Research Plan for the Research Program for such Initial Target (or Substitute Target) will be developed by the Parties and approved by the JRC. Each Research Plan shall be consistent with and substantially similar in scope (including any timelines, as adjusted to reflect the actual commencement date of the applicable Research Program) to the high-level template attached as Schedule 2.2.2 (the “Research Plan Template”). The Parties shall develop, and the JRC shall approve, the Research Plan for the Research Program for each Initial Target (or Substitute Target) within [**] following the applicable Target Selection Date (or Target Substitution Date, as applicable), or as soon as reasonably practicable thereafter.
Initial Plan. An initial plan (the first “Global Development Plan”) regarding the global development of the Product and containing all of the On-going Clinical Trials shall be attached to this Agreement as Schedule 3.0.
Initial Plan. GSK has, as confirmed in a letter from Gilead to GSK dated as of the Effective Date, provided to Gilead a written plan describing GSK's plans for any clinical trials GSK plans to conduct to support Regulatory Approval of the Current Product for the HBV Indication in the GSK Territory, including the [ * ] (such plan, the "GSK Development Plan").
