Except for the first Global PDGF Development Plan incorporating the Initial Development Plan, an updated Global PDGF Development Plan (and, if applicable, Territory PDGF Development Plan) will be presented by the JDC for approval by the JSC, and approved by the JSC, at least two (2) months prior to the end of each Contract Year.
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).
No later than sixty (60) days after the Opt-In Effective Date, the JDC will meet to finalize the first Global PDGF Development Plan (which, as provided above, shall incorporate, or be substantially consistent with, the Initial Global PDGF Development Plan) (and, if applicable, the first Territory PDGF Development Plan).
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.
For the avoidance of doubt, nothing in this Section 8.2 entitles Company to attend meetings with Regulatory Authorities in the Excluded Territory or review Registration Filings in connection with the Development of Licensed Products in the Excluded Territory, except as they relate to the performance of the Global PDGF Development Plan.