Fully Burdened Development Costs

Fully Burdened Development Costs. Shall mean [CONFIDENTIAL TREATMENT REQUESTED] costs for development of the Compound in the Field from the Effective Date through (A) cessation of such activities as described in Section 4.2 of this Agreement; or (B) Registration of the Product (as defined using Inspire's generally accepted accounting policies consistently applied) [CONFIDENTIAL TREATMENT REQUESTED], and shall include, without limitation, all direct expenses of research or development including costs of studies on the... toxicological, pharmacokinetical, metabolical or clinical aspects of the Compound conducted internally or by individual investigators, consultants or other external services providers considered necessary in Inspire's efforts to further development, and obtain Registration, of the Product in the Territory, process development, process improvement and scale-up and recovery costs, qualification lots, costs for preparing, submitting, reviewing or developing data or information for the purpose of submission to a governmental authority to obtain, maintain and/or expand the Registration of the Product. View More