CONFIDENTIAL TREATMENT REQUESTED
be entitled to, as set forth in more detail in Section 9.6.5(b)), but shall not prevent or require Vitae to reduce its reimbursement percentage.
5.4.3 Responsibility for Development. BI shall remain solely responsible for Development and continue to have sole responsibility for all Development activities even if Vitae exercises its Co-Development Option.
6.1 General. BI shall use Diligent Efforts to Commercialize Products in the Major Markets. No later than six (6) months before the First Commercial Sale of a Product, BI shall prepare and oversee the implementation of an overall commercialization plan (Commercialization Plan). BI will present a summary of said Commercialization Plan to the Joint Steering Committee (or the appropriate subcommittee created by the Joint Steering Committee) for such Product.
6.2 BI Responsibilities. BI shall have the sole right and responsibility for Commercialization of Products for distribution and sale. BI shall bear all costs and expenses associated with the Commercialization of Products. Without limiting the foregoing, BI shall have the sole right and responsibility to perform the following responsibilities:
(a) Receive, accept and fill orders for Products;
(b) Distribute, sell, record sales and collect payments for Products;
(c) Establish and modify the terms and conditions with respect to the sale of Products, including, but not limited to, the price or prices at which Products will be sold, any discount, rebates or other deductions applicable to payments or receivables, and similar matters; and
(d) Record Product sales in its books of account.
6.3 Promotional Materials, Samples and Labeling.
6.3.1 Markings. To the extent permitted or required by applicable Law, the package insert for all Products will indicate that the Product has been jointly discovered and developed by BI together with Vitae. Labeling of Products shall include all required notices needed to comply with all statutory patent marking requirements and other legal notice requirements or best practices.
6.3.2 Statements Consistent with Labeling. BI shall ensure that sales representatives detail Products in a fair and balanced manner and consistent with the requirements of all applicable Laws.
6.3.3 Samples. BI shall ensure that all samples are labeled and distributed in accordance with applicable Law.