Global PDGF Development Plan means the three (3)-year rolling plan approved by the JSC for Developing Licensed Products in the Field as part of an integrated worldwide Development program, including the related Global PDGF Development Budget, as the same may be amended from time-to-time in accordance with the terms of this Agreement. Global PDGF Development Plan activities may be undertaken entirely or partially in the Excluded Territory if approved by the JSC. For clarity, the Global PDGF Development Plan will not include (a) any Development activities that are conducted or sponsored by a Party that are only required for an Approval specific to the Territory (including activities under the Territory PDGF Development Plan) or the Excluded Territory, (b) Non-Approval Trials or (c) any studies conducted for Pricing Approval or formulary approval.
Examples of Global PDGF Development Plan in a sentence
The Territory PDGF Development Plan shall include the Territory PDGF Development Budget, and the Global PDGF Development Plan shall include the Global PDGF Development Budget (each individually, a "Development Budget" and both collectively, the "Development Budgets"), and the Development Budgets shall be prepared, updated, reviewed and approved as part of the preparation, update and approval of the Development Plans in accordance with this Agreement.
To the extent any of the foregoing matters or activities in the Excluded Territory are undertaken pursuant to the Global PDGF Development Plan, each Party shall comply with the Global PDGF Development Plan; otherwise, Regeneron shall consider in good faith all comments of the JDC and the JCC (or Company's representatives on the JDC or JCC) with respect to its Licensed Product(s) in the Excluded Territory.
Notwithstanding the foregoing or any other provision in this Agreement, neither Company nor any Committee shall have the right or authority to manage or control the internal operations of Regeneron or to approve, modify, impede or delay any of Regeneron's commercialization or Development plans or activities for its PDGF Products in the Excluded Territory (other than as contemplated under or in connection with the Global PDGF Development Plan).
Company shall also provide Development Cost reporting under the Global PDGF Development Plan in United States Dollars and, if applicable and to the extent available and generated by Company's and its Affiliates' internal reporting systems, local currency.