Sales and Distribution; Recalls. Each Party shall have the sole right and responsibility, and shall bear all costs related thereto, to take such actions with respect to its Product Line in its sole discretion in accordance with legal requirements to maintain the authorization and/or ability to market its Product in the Territory and to establish the terms and conditions for sale of its Product Line, including, without limitation, the following: manufacturing and distributing, sales, providing customer support in a timely, comprehensive manner, including handling medical queries, all interactions that are technical or clinical in nature and which require more than a basic knowledge of its Product Line and its characteristics and performing other functions consistent with consumer practice and the Marketing Plan with respect to its Product Line, responding to product and medical complaints relating to its Product Line, quality assurance, technical support, returns, voluntary and regulatory recalls of product, Regulatory Approvals and compliance, and communications with regulatory agencies. Notwithstanding the foregoing, each Party may communicate directly with regulatory agencies regarding its own marketing activities. Each Party shall use its commercially reasonable efforts to assist and cooperate with the other Party as may be necessary or required in any recall or market withdrawal of the other Party’s Product Line and any and all reasonable and documented costs and expenses incurred by the assisting Party shall be reimbursed by the other Party, except to the extent such recall or market withdrawal was the result of the failure of assisting Party to comply with its obligations under this Agreement.
Sales and Distribution; Recalls. Each Party shall have the sole right and responsibility, and shall bear all costs related thereto, to take such actions with respect to its Products as it would normally take in accordance with accepted business practices and legal requirements to maintain the authorization and/or ability to market such Products in the Territory, including, without limitation, the following:
Sales and Distribution; Recalls. Oculus shall have the sole right and responsibility for: (a) Manufacturing, labeling and distributing the Products; (b) Booking sales of the Products hereunder and performance of related services (if Oculus receives any orders for the Products during the Term of this Agreement, it shall promptly refer such orders to Oculus; (c) Handling all aspects of order processing, invoicing and collection, inventory and receivables; (d) Providing customer support, including handling medical queries, and performing other functions consistent with consumer practice for prescription pharmaceuticals; (e) Responding to product and medical complaints relating to the Products (Quinnova shall instruct the Quinnova Sales Forces to direct all medical questions or inquiries relating to the Products to Oculus); (f) Handling all returns of the Products; (g) Handling all recalls and market withdrawals of the Products. Quinnova will make available to Oculus, upon request, all of Quinnova’s pertinent records only on the Products, which Oculus may reasonably request, to assist it in effecting any recall or market withdrawals with respect to the Products. Any and all reasonable and documented costs and expenses incurred by Quinnova in the conduct of any such recall or market withdrawal of the Products shall be reimbursed by Oculus, except to the extent such recall or market withdrawal was the exclusive result of the failure of Quinnova to comply with its obligations under this Agreement; (h) Communicating with any governmental agencies and satisfying their requirements regarding Regulatory Approvals of the Products; provided Quinnova may, but is not obligated to, communicate directly with a governmental agency, after notification and consultation with Oculus, which has contacted Quinnova in connection with is Detailing Activities hereunder; 6 (i) Reporting adverse reaction reports to U.S. regulatory authorities as required by applicable U.S. law or regulation; and (j) Negotiating any and all agreements with managed care organizations, payers, wholesalers, group purchasing organizations, and the like, regarding the Products. 3.
Sales and Distribution; Recalls. During the term of this Agreement, AHPC shall be responsible for:
Sales and Distribution; Recalls. AcelRx shall have the sole right and responsibility, and shall bear all costs related thereto, to take such actions with respect to the Products as it would normally take in accordance with accepted business practices and legal requirements to maintain the authorization and/or ability to market such Products in the Territory, including, without limitation, the following:
Sales and Distribution; Recalls. During the Co-Promotion Term, Wyeth-Ayerst shall be responsible for:
Sales and Distribution; Recalls. During the term of the Agreement, Wyeth-Ayerst shall be responsible for all sales, distribution and customer support and for conducting all recalls of the Product in the Territory.
Sales and Distribution; Recalls. Oculus shall have the sole right and responsibility for:
Sales and Distribution; Recalls. During the term of this Agreement, Wyeth shall be responsible for:
