Commencement; Roles. 8 3.2 Clinical Development Plan . . . . . . . . . . . . . . . . . . . . . . . . . . 9 3.3
Commencement; Roles. 9 4.2 Process Development Plan . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 4.3 Bulk Process Development Program . . . . . . . . . . . . . . . . . . . . . . . 10 4.4 Product Process Development Program . . . . . . . . . . . . . . . . . . . . . 10 4.5
Commencement; Roles. 10 5.2 Manufacturing Plan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 5.3 Manufacturing Bulk Drug Substance . . . . . . . . . . . . . . . . . . . . . . 11 5.4 Processing Bulk Drug Substance into Drug Product . . . . . . . . . . . . . . . 12 5.5 Costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Commencement; Roles. The Clinical Development Program shall commence as soon as practicable after the Effective Date. Lilly shall have principal responsibility for the conduct of the Clinical Development Program, and Ophidian shall provide consultation and advice. The Project Team shall coordinate the efforts of the parties with respect to the Clinical Development Program.
Commencement; Roles. The Bulk Process Development Program and the Product Process Development Program shall commence as soon as practicable after the Effective Date. Ophidian shall have principal responsibility for the conduct of the Bulk Process Development Program, and Lilly shall have principal responsibility for the conduct of the Product Process Development Program. Each party shall provide advice and consultation with respect to the area of principal responsibility of the other party. The Project Team shall coordinate the
Commencement; Roles. The Manufacturing Program shall commence as soon as practicable after the Effective Date. Ophidian shall have principal responsibility for the Bulk Manufacturing Program, and Lilly shall have principal responsibility for the Product Manufacturing Program. The Project Team shall coordinate the efforts of the parties with respect to the Manufacturing Program.
Commencement; Roles. 26 6.2 Process Development Plan............................................... 26 6.3 Bulk Process Development Program....................................... 26 6.4
Commencement; Roles. 27 7.2 Manufacturing Plan..................................................... 28 7.3 Manufacturing Bulk Drug Substance...................................... 28 7.4 Processing Bulk Drug Substance into Drug Product....................... 29 7.5 Audit; Contract Manufacturers.......................................... 29 7.6 Costs.................................................................. 30 Article 8-- Mutual Exclusivity............................................... 30
Commencement; Roles. The joint Research Program between Lilly and Vertex shall commence as soon as practicable after the Effective Date. Except as otherwise provided in this Agreement, Vertex shall have principal responsibility for the conduct of the Research Program, and Lilly shall provide consultation, advice, and research efforts as deemed appropriate by the Research Team. Such activities may include [*]. The Research Team shall coordinate the efforts of the parties with respect to the Research Program.
Commencement; Roles. The Clinical Development Program shall commence as soon as practicable after Lilly exercises its Development Option with respect to a particular Drug Product Candidate. Lilly shall have principal responsibility for the conduct of the Clinical Development Program, and Vertex shall provide consultation and advice. The Project Team shall coordinate the efforts of the parties with respect to the Clinical Development Program.
