Common use of Sales and Distribution; Recalls Clause in Contracts

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; (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.

Sales and Distribution; Recalls. Oculus AcelRx shall have the sole right and responsibility forresponsibility, 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: (a) Manufacturing, labeling Manufacturing (if applicable) and distributing the ProductsProducts in the Territory; (b) Booking booking sales and distribution of the such Products hereunder and performance of related services (if Oculus services. If La Jolla receives any orders for Products in the Products Territory during the Term of this AgreementPromotion Period, it shall promptly refer such orders to OculusAcelRx; (c) Handling handling all aspects of order processing, invoicing and collection, inventory and receivables; (d) Providing ensuring that sufficient stock of the Products will be available in its inventory to promptly fill orders to the Target Audience in the Field, subject to Section 12.8; (e) providing customer support, including handling medical queries, and performing other functions consistent with consumer practice for prescription pharmaceuticalspharmaceuticals and with the applicable Marketing Plan; (ef) Responding 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 handling all returns of the Products. If any Product is returned to La Jolla, it shall be shipped to AcelRx’s nearest facility, with any reasonable or authorized shipping or other documented direct cost to be paid by AcelRx. La Jolla, if requested by AcelRx, shall advise the customer who made the return that the Product has been returned to AcelRx; (h) handling all voluntary recalls and market withdrawals of the Products. Quinnova La Jolla will make available to OculusAcelRx, upon request, all of QuinnovaLa Jolla’s pertinent records only on the Products, which Oculus AcelRx may reasonably request, request to assist it in effecting any recall or market withdrawals with respect to the Productswithdrawals. Any and all reasonable and documented costs and expenses incurred by Quinnova La Jolla in the conduct of any such recall or market withdrawal of the Products a Product shall be reimbursed by OculusAcelRx, except to the extent such recall or market withdrawal was the exclusive result of the failure of Quinnova La Jolla to comply with its obligations under this Agreement; (hi) Communicating communicating with any governmental agencies and satisfying their requirements regarding Regulatory Approvals of the ProductsProducts in the Territory; provided Quinnova may, but is not obligated to, La Jolla may communicate directly with a governmental agency, after notification and consultation with Oculus, agency which has contacted Quinnova La Jolla in connection with its detailing activities hereunder (and if La Jolla is Detailing Activities so contacted with respect to its detailing activities regarding the Products hereunder;, La Jolla shall to the extent La Jolla is legally permitted to do so notify and consult with AcelRx regarding such communication with such governmental agency); and (ij) Reporting reporting adverse reaction reports for the Products to U.S. regulatory authorities as required by applicable U.S. law or regulation; and (j) Negotiating . Notwithstanding the applicable Marketing Plan or any other provision herein to the contrary, AcelRx shall have the sole right and all agreements responsibility for establishing and modifying the terms and conditions with managed care organizations, payers, wholesalers, group purchasing organizations, and respect to the like, regarding sale of the Products, including, without limitation, the price at which the Products will be sold, any discounts attributable to payments on receivables and distribution of the Products. In addition, notwithstanding any other provision herein to the contrary, AcelRx and its Affiliates shall at all times retain the right to promote and detail the Products in the Territory using its sales force in any manner.

Sales and Distribution; Recalls. Oculus Each Party shall have the sole right and responsibility forresponsibility, 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: (a) Manufacturing, labeling Manufacturing (if applicable) and distributing its Products in the ProductsTerritory; (b) Booking booking sales and distribution of the such Products hereunder and performance of related services (if Oculus services. If Tetraphase receives any orders for AcelRx Products in the Products Territory during the Term of this AgreementCo-Promotion Period, it shall promptly refer such orders to OculusAcelRx, and, if AcelRx receives any orders for Tetraphase Products in the Territory during the Co-Promotion Period, it shall promptly refer such orders to Tetraphase; (c) Handling handling all aspects of order processing, invoicing and collection, inventory and receivables; (d) Providing ensuring that sufficient stock of its Products will be available in its inventory to promptly fill orders to the Target Audience in the Field, subject to Section 11.8; (e) providing customer support, including handling medical queries, and performing other functions consistent with consumer practice for prescription pharmaceuticalspharmaceuticals and with the applicable Marketing Plan; (ef) Responding 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 its Products; (g) Handling handling all returns of its Products. If any AcelRx Product is returned to Tetraphase, it shall be shipped to AcelRx’s nearest facility, with any reasonable or authorized shipping or other documented direct cost to be paid by AcelRx. Tetraphase, if requested by AcelRx, shall advise the customer who made the return that the AcelRx Product has been returned to AcelRx. If any Tetraphase Product is returned to AcelRx, it shall be shipped to Tetraphase’s nearest facility, with any reasonable or authorized shipping or other documented direct cost to be paid by Tetraphase. AcelRx, if requested by Tetraphase, shall advise the customer who made the return that the Tetraphase Product has been returned to Tetraphase; (h) handling all voluntary recalls and market withdrawals of the its Products. Quinnova Each Party will make available to Oculusthe other Party, upon request, all of Quinnovasuch Party’s pertinent records only on which the Products, which Oculus other Party may reasonably request, request to assist it in effecting any recall or market withdrawals with respect to the Productswithdrawals. Any and all reasonable and documented costs and expenses incurred by Quinnova a Party in the conduct of any such recall or market withdrawal of the Products a Product shall be reimbursed by Oculusthe Product Party, except to the extent such recall or market withdrawal was the exclusive result of the failure of Quinnova the other Party to comply with its obligations under this Agreement; (hi) Communicating communicating with any governmental agencies and satisfying their requirements regarding Regulatory Approvals of its Products in the ProductsTerritory; provided Quinnova may, but is not obligated to, a Party may communicate directly with a governmental agency, after notification and consultation with Oculus, agency which has contacted Quinnova such Party in connection with its detailing activities hereunder (and if a Party is Detailing Activities so contacted with respect to its detailing activities regarding the other Party’s Product hereunder;, such Party shall to the extent such Party is legally permitted to do so notify and consult with such other Party regarding such communication with such governmental agency); and (ij) Reporting reporting adverse reaction reports for its Products to U.S. regulatory authorities as required by applicable U.S. law or regulation; and (j) Negotiating . Notwithstanding the applicable Marketing Plan or any other provision herein to the contrary, each Product Party shall have the sole right and responsibility for establishing and modifying the terms and conditions with respect to the sale of its Products, including, without limitation, the price at which its Products will be sold, any discounts attributable to payments on receivables and distribution of its Products. In addition, notwithstanding any other provision herein to the contrary, each Product Party and its Affiliates shall at all agreements times retain the right to promote and detail its Products in the Territory using their respective Sales Forces in any manner that is not inconsistent with managed care organizations, payers, wholesalers, group purchasing organizations, and the like, regarding the ProductsMarketing Plan therefor.

Sales and Distribution; Recalls. Oculus Each Party shall have the sole right and responsibility forresponsibility, 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: (a) Manufacturing, labeling Manufacturing (if applicable) and distributing its Products in the ProductsTerritory; (b) Booking booking sales and distribution of the such Products hereunder and performance of related services (if Oculus services. If Tetraphase receives any orders for AcelRx Products in the Products Territory during the Term of this AgreementCo-Promotion Period, it shall promptly refer such orders to OculusAcelRx, and, if AcelRx receives any orders for Tetraphase Products in the Territory during the Co-Promotion Period, it shall promptly refer such orders to Tetraphase; (c) Handling handling all aspects of order processing, invoicing and collection, inventory and receivables; (d) Providing ensuring that sufficient stock of its Products will be available in its inventory to promptly fill orders to the Target Audience in the Field, subject to Section 11.8; (e) providing customer support, including handling medical queries, and performing other functions consistent with consumer practice for prescription pharmaceuticalspharmaceuticals and with the applicable Marketing Plan; (ef) Responding 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 its Products; (g) Handling handling all returns of its Products. If any AcelRx Product is returned to Tetraphase, it shall be shipped to AcelRx’s nearest facility, with any reasonable or authorized shipping or other documented direct cost to be paid by AcelRx. Tetraphase, if requested by AcelRx, shall advise the customer who made the return that the AcelRx Product has been returned to AcelRx. If any Tetraphase Product is returned to AcelRx, it shall be shipped to Tetraphase’s nearest facility, with any reasonable or authorized shipping or other documented direct cost to be paid by Tetraphase. AcelRx, if requested by Tetraphase, shall advise the customer who made the return that the Tetraphase Product has been returned to Tetraphase; (h) handling all voluntary recalls and market withdrawals of the its Products. Quinnova Each Party will make available to Oculusthe other Party, upon request, all of Quinnovasuch Party’s pertinent records only on which the Products, which Oculus other Party may reasonably request, request to assist it in effecting any recall or market withdrawals with respect to the Productswithdrawals. Any and all reasonable and documented costs and expenses incurred by Quinnova a Party in the conduct of any such recall or market withdrawal of the Products a Product shall be reimbursed by Oculusthe Product Party, except to the extent such recall or market withdrawal was the exclusive result of the failure of Quinnova the other Party to comply with its obligations under this Agreement; (hi) Communicating communicating with any governmental agencies and satisfying their requirements regarding Regulatory Approvals of its Products in the ProductsTerritory; provided Quinnova may, but is not obligated to, a Party may communicate directly with a governmental agency, after notification and consultation with Oculus, agency which has contacted Quinnova such Party in connection with its detailing activities hereunder (and if a Party is Detailing Activities so contacted with respect to its detailing activities regarding the other Party’s Product hereunder;, such Party shall to the extent such Party is legally permitted to do so notify and consult with such other Party regarding such communication with such governmental agency); and (ij) Reporting reporting adverse reaction reports for its Products 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.