Responsibilities of Genzyme. Genzyme shall be solely responsible for all aspects of the marketing of the Collaboration Products in accordance with the strategy, policies and procedures established in the Commercialization Plan, including without limitation the responsibilities described in this Section 6.5. (a) Genzyme shall be primarily responsible for the implementation of each Commercialization Plan, including without limitation setting all terms of sale, including establishing pricing policies, credit terms and cash discounts and allowances, formulating marketing plans, negotiating agreements with Third Party distributors (if any), providing patient information, providing customer support services, providing reimbursement counseling services and sales force training. (b) Genzyme shall employ sufficiently trained and experienced individuals in numbers adequate to carry out its responsibilities under this Article 6. Sales and support personnel shall be familiar with the Collaboration Products and with competitive products and shall respond promptly to customer requests for support. (c) Genzyme shall provide instructions and appropriate training to customers in the proper use and handling of the Collaboration Products and shall monitor performance of the Collaboration Products. (d) Genzyme shall have sole responsibility for responding to all requests for medical information regarding Collaboration Products. (e) Genzyme shall comply with all laws and government regulations applicable to the sale of Collaboration Products within the Territory. (f) The Collaboration Products shall be sold under trademarks selected by the Steering Committee and owned by or licensed to Kallikrein LLC in accordance with Section 9.1.2 hereof. (g) Genzyme shall maintain complete and accurate records of all movements and transactions involving Collaboration Products by an appropriate identifier and by customer so that all such movements and transactions can be traced quickly and effectively. Upon written request, Genzyme will provide copies of such records to the other Parties, with access to facilities used by Genzyme in performing its duties under this Article 6 during normal business hours and upon reasonable advance notice for the purpose of inspecting such facilities for compliance with the terms of this Agreement. The records maintained by Genzyme pursuant to this clause (g) shall be subject to the other Parties' audit rights under Section 4.6 hereof. (h) Genzyme shall report to the Steering Committee in writing the occurrence of each material incident of Collaboration Product performance required to be reported to regulatory authorities, including without limitation adverse reaction information in accordance with Section 5.2.3 hereof, within three (3) business days of the happening of such occurrence.
Appears in 2 contracts
Samples: Collaboration Agreement (Genzyme Corp), Collaboration Agreement (Dyax Corp)
Responsibilities of Genzyme. Genzyme shall be solely responsible for all aspects of the marketing of the Collaboration Products in accordance with the strategy, policies and procedures established in the Commercialization Plan, including without limitation the responsibilities described in this Section 6.5.
(a) Genzyme shall be primarily responsible for the implementation of each Commercialization Plan, including without limitation setting all terms of sale, including establishing pricing policies, credit terms and cash discounts and allowances, formulating marketing plans, negotiating agreements with Third Party distributors (if any), providing patient information, providing customer support services, providing reimbursement counseling services and sales force training.
(b) Genzyme shall employ sufficiently trained and experienced individuals in numbers adequate to carry out its responsibilities under this Article 6. Sales and support personnel shall be familiar with the Collaboration Products and with competitive products and shall respond promptly to customer requests for support.
(c) Genzyme shall provide instructions and appropriate training to customers in the proper use and handling of the Collaboration Products and shall monitor performance of the Collaboration Products.
(d) Genzyme shall have sole responsibility for responding to all requests for medical information regarding Collaboration Products.
(e) Genzyme shall comply with all laws and government regulations applicable to the sale of Collaboration Products within the Territory.
(f) The Collaboration Products shall be sold under trademarks selected by the Steering Committee and owned by or licensed to Kallikrein LLC in accordance with Section 9.1.2 hereof.
(g) Genzyme shall maintain complete and accurate records of all movements and transactions involving Collaboration Products by an appropriate identifier and by customer so that all such movements and transactions can be traced quickly and effectively. Upon written request, Genzyme will provide copies of such records to the other Parties, with access to facilities used by Genzyme in performing its duties under this Article 6 during normal business hours and upon reasonable advance notice for the purpose of inspecting such facilities for compliance with the terms of this Agreement. The records maintained by Genzyme pursuant to this clause (g) shall be subject to the other Parties' audit rights under Section 4.6 4.5 hereof.
(h) Genzyme shall report to the Steering Committee in writing the occurrence of each material incident of Collaboration Product performance required to be reported to regulatory authorities, including without limitation adverse reaction information in accordance with Section 5.2.3 hereof, within three (3) business days of the happening of such occurrence.
Appears in 2 contracts
Samples: Collaboration Agreement (Dyax Corp), Collaboration Agreement (Dyax Corp)
Responsibilities of Genzyme. Genzyme shall be solely responsible for --------------------------- all aspects of the marketing and sale of the Collaboration Products in accordance with the strategy, policies and procedures established in the Commercialization Plan, including without limitation the responsibilities described in this Section 6.5.
(a) Genzyme shall be primarily responsible for the implementation of each Commercialization Plan, including without limitation setting all terms of sale, including establishing pricing policies, credit terms and cash discounts and allowances, formulating marketing plans, negotiating agreements with Third Party distributors (if any), providing patient information, providing customer support services, providing reimbursement counseling services and conducting sales force training, all in accordance with good business practices and industry standards.
(b) Genzyme shall employ sufficiently trained and experienced individuals in numbers adequate to carry out its responsibilities under this Article 6. Sales and support personnel shall be familiar with the Collaboration Products and with competitive products and shall respond promptly to customer requests for support.
(c) Genzyme shall provide instructions and appropriate training to customers in the proper use and handling of the Collaboration Products and shall monitor performance of the Collaboration Products.
(d) Genzyme shall have sole responsibility for responding to all requests for medical information regarding Collaboration Products. Notwithstanding the foregoing, BioMarin may maintain a website or other informational resources where it may publish general medical information relating to MPS I, so long as such website complies in all respects with applicable laws and regulations, including without limitation regulations of the FDA regarding "off-label" promotion of Collaboration Products.
(e) Genzyme shall comply with all laws and government regulations applicable to the marketing and sale of Collaboration Products within the Territory.
(f) The Collaboration Products shall be sold under trademarks selected by the Steering Committee and owned by or licensed to Kallikrein BioMarin/Genzyme LLC in accordance with Section 9.1.2 hereof.
(g) Genzyme shall maintain complete and accurate records of all movements and transactions involving Collaboration Products by an appropriate identifier and by customer so that all such movements and transactions can be traced quickly and effectively. Upon written request, Genzyme will provide copies of such records to the other Parties, with access to facilities used by Genzyme in performing its duties under this Article 6 during normal business hours and upon reasonable advance notice for the purpose of inspecting such facilities for compliance with the terms of this Agreement. The records maintained by Genzyme pursuant to this clause (g) shall be subject to the other Parties' audit rights under Section 4.6 4.5 hereof.
(h) Genzyme shall report promptly to the Steering Committee in writing the occurrence of each material incident of Collaboration Product performance required to be reported to regulatory authorities, including without limitation adverse reaction information Adverse Reaction Information in accordance with Section 5.2.3 5.2.2 hereof, within three (3) business days of the happening of such occurrence.
Appears in 1 contract
Samples: Collaboration Agreement (Biomarin Pharmaceutical Inc)
Responsibilities of Genzyme. Genzyme shall be solely responsible for all aspects of the marketing of the Collaboration Products in accordance with the strategy, policies and procedures established in the Commercialization Plan, including without limitation the responsibilities described in this Section 6.5.
(a) Genzyme shall be primarily responsible for the implementation of each Commercialization Plan, including without limitation setting all terms of sale, including establishing pricing policies, credit terms and cash discounts and allowances, formulating marketing plans, negotiating agreements with Third Party distributors (if any), providing patient information, providing customer support services, providing reimbursement counseling services and sales force training.
(b) Genzyme shall employ sufficiently trained and experienced individuals in numbers adequate to carry out its responsibilities under this Article 6. Sales and support personnel shall be familiar with the Collaboration Products and with competitive products and shall respond promptly to customer requests for support.
(c) Genzyme shall provide instructions and appropriate training to customers in the proper use and handling of the Collaboration Products and shall monitor performance of the Collaboration Products.
(d) Prior to sale, Genzyme shall have sole responsibility for responding store, maintain and handle Collaboration Products in accordance with the requirements of the Regulatory Scheme and the normal and customary commercial practice with respect to all requests for regulated medical information regarding Collaboration Productsproducts.
(e) Genzyme shall comply with all laws and government regulations applicable to the sale of Collaboration Products within the Territory.
(f) The Collaboration Products shall be sold under trademarks selected by the Steering Committee and owned by or licensed to Kallikrein ATIII LLC in accordance with Section 9.1.2 hereof.
(g) Genzyme shall not (i) establish any branch, sales offices, warehouses or other facilities outside the Territory with respect to the Collaboration Products, (ii) adopt a policy of actively selling Collaboration Products outside the Territory nor undertake the active sale or promotion of sales of Collaboration Products outside the Territory or (iii) seek customers or solicit orders from a prospective customer with its principal address or place of business located outside the Territory. Without ATIII LLC's prior consent, Genzyme may not deliver or tender, or cause to be delivered or tendered, Collaboration Products outside of the Territory. Genzyme shall not sell Collaboration Products to a customer if Genzyme knows that such customer intends to remove those Collaboration Products from the Territory. If Genzyme receives an order from a prospective customer located outside of the Territory or who Genzyme knows intends to remove the Collaboration Products from the Territory, Genzyme shall immediately refer that customer to GTC.
(h) Genzyme shall maintain complete and accurate records of all movements and transactions involving Collaboration Products by an appropriate identifier unit, by batch number and by customer so that all such movements and transactions can be traced quickly and effectively. Upon written request, Genzyme will provide copies of such records to the other Parties, with access to facilities used by Genzyme in performing its duties under this Article 6 during normal business hours and upon reasonable advance notice for the purpose of inspecting such facilities for compliance with the terms of this Agreement. The records maintained by Genzyme pursuant to this clause (gh) shall be subject to the other Parties' audit rights under Section 4.6 4.5 hereof.
(hi) Within forty-five (45) days after the end of each calendar quarter, Genzyme will report to ATIII LLC the actual prices at which all sales of Collaboration Products were made to its customers during the preceding calendar quarter, future prospects for the Collaboration Products and related issues. Genzyme shall report promptly to the Steering Committee in writing the occurrence of each material incident of Collaboration Product performance required to be reported to regulatory authorities, including without limitation adverse reaction information in accordance with Section 5.2.3 5.2.2 hereof, within three (3) business days of the happening of such occurrence.
Appears in 1 contract
Responsibilities of Genzyme. Genzyme shall be solely responsible for * Confidential Treatment requested for information omitted and filed separately with the SEC. all aspects of the marketing of the Collaboration Products in accordance with the strategy, policies and procedures established in the Commercialization Plan, including without limitation the responsibilities described in this Section 6.5listed below.
(a) Genzyme shall be primarily responsible for the implementation of each Commercialization Plan, including without limitation setting all terms of sale, including establishing pricing policies, credit terms and cash discounts and allowances, formulating marketing plans, negotiating agreements with Third Party distributors (if any), providing patient information, providing customer support services, providing reimbursement counseling counselling services and sales force training.
(b) Genzyme shall employ sufficiently trained and experienced individuals in numbers adequate to carry out its responsibilities under this Article 6. Sales and support personnel shall be familiar with the Collaboration Products and with competitive products and shall respond promptly to customer requests for support.
(c) Genzyme shall provide instructions and appropriate training to customers in the proper use and handling of the Collaboration Products and shall monitor performance of the Collaboration Products.
(d) Prior to sale, Genzyme shall have sole responsibility for responding store, maintain and handle Collaboration Products in accordance with the requirements of the Regulatory Schemes and the normal and customary commercial practice with respect to all requests for regulated medical information regarding Collaboration Productsproducts.
(e) Genzyme shall comply with all laws and government regulations applicable to the sale of Collaboration Products within the Territory.
(f) The Collaboration Products shall be sold under trademarks selected by the Steering Committee and owned by or licensed to Kallikrein RenaGel LLC in accordance with Section Sections 3.1.1 and 9.1.2 hereof.
(g) Genzyme shall not (i) establish any branch, sales offices, warehouses or other facilities outside the Territory with respect to the Collaboration Products, (ii) adopt a policy of actively selling Collaboration Products outside the Territory nor undertake the active sale or promotion of sales of Collaboration Products outside the Territory or (iii) seek customers or solicit orders from a prospective customer with its principal address or place of business located outside the Territory. Without RenaGel LLC's prior consent, Genzyme may not deliver or tender, or cause to be delivered or tendered, Collaboration Products outside of the Territory. Genzyme shall not sell Collaboration Products to a customer if Genzyme knows that such customer intends to remove those Collaboration Products from the Territory. If Genzyme receives an order from a prospective customer located outside of the Territory or who Genzyme knows intends to remove the Collaboration Products from the Territory, Genzyme shall immediately refer that customer to GelTex.
(h) Genzyme shall maintain complete and accurate records of all movements and transactions involving Collaboration Products by an appropriate identifier unit, by batch number and by customer so that all such movements and transactions can be traced quickly and effectively. Upon written request, Genzyme will provide copies of such records to the other Parties, with access to facilities used by Genzyme in performing its duties under this Article 6 during normal business hours and upon reasonable advance notice for the purpose of inspecting such facilities for compliance with the terms of this Agreement. The records maintained by Genzyme pursuant to this clause (gh) shall be subject to the other Parties' audit rights under Section 4.6 4.5 hereof.
(hi) Within forty-five (45) days after the end of each calendar quarter, Genzyme will report to RenaGel LLC the actual prices at which all sales of Collaboration Products were made to its customers during the preceding calendar quarter, future prospects for the Collaboration Products and related issues. Genzyme shall report promptly to the Steering Committee in writing the occurrence of each material incident of Collaboration Product performance required to be reported to regulatory authorities, including without limitation adverse reaction information in accordance with Section 5.2.3 5.2.2 hereof, within three (3) business days of the happening of such occurrence.
Appears in 1 contract
Samples: Collaboration Agreement (Geltex Pharmaceuticals Inc)
Responsibilities of Genzyme. Genzyme shall be solely responsible for all aspects of the marketing of the Collaboration Products in accordance with the strategy, policies and procedures established in the Commercialization Plan, including without limitation the responsibilities described in this Section 6.5listed below.
(a) Genzyme shall be primarily responsible for the implementation of each Commercialization Plan, including without limitation setting all terms of sale, including establishing pricing policies, credit terms and cash discounts and allowances, formulating marketing plans, negotiating agreements with Third Party distributors (if any), providing patient information, providing customer support services, providing reimbursement counseling counselling services and sales force training.
(b) Genzyme shall employ sufficiently trained and experienced individuals in numbers adequate to carry out its responsibilities under this Article 6. Sales and support personnel shall be familiar with the Collaboration Products and with competitive products and * Confidential Information omitted and filed separately. shall respond promptly to customer requests for support.
(c) Genzyme shall provide instructions and appropriate training to customers in the proper use and handling of the Collaboration Products and shall monitor performance of the Collaboration Products.
(d) Prior to sale, Genzyme shall have sole responsibility for responding store, maintain and handle Collaboration Products in accordance with the requirements of the Regulatory Schemes and the normal and customary commercial practice with respect to all requests for regulated medical information regarding Collaboration Productsproducts.
(e) Genzyme shall comply with all laws and government regulations applicable to the sale of Collaboration Products within the Territory.
(f) The Collaboration Products shall be sold under trademarks selected by the Steering Committee and owned by or licensed to Kallikrein RenaGel LLC in accordance with Section Sections 3.1.1 and 9.1.2 hereof.
(g) Genzyme shall not (i) establish any branch, sales offices, warehouses or other facilities outside the Territory with respect to the Collaboration Products, (ii) adopt a policy of actively selling Collaboration Products outside the Territory nor undertake the active sale or promotion of sales of Collaboration Products outside the Territory or (iii) seek customers or solicit orders from a prospective customer with its principal address or place of business located outside the Territory. Without RenaGel LLC's prior consent, Genzyme may not deliver or tender, or cause to be delivered or tendered, Collaboration Products outside of the Territory. Genzyme shall not sell Collaboration Products to a customer if Genzyme knows that such customer intends to remove those Collaboration Products from the Territory. If Genzyme receives an order from a prospective customer located outside of the Territory or who Genzyme knows intends to remove the Collaboration Products from the Territory, Genzyme shall immediately refer that customer to GelTex.
(h) Genzyme shall maintain complete and accurate records of all movements and transactions involving Collaboration Products by an appropriate identifier unit, by batch number and by customer so that all such movements and transactions can be traced quickly and effectively. Upon written request, Genzyme will provide copies of such records to the other Parties, with access to facilities used by Genzyme in performing its duties under this Article 6 during normal business hours and upon reasonable advance notice for the purpose of inspecting such facilities for compliance with the terms of this Agreement. The records maintained by Genzyme pursuant to this clause (gh) shall be subject to the other Parties' audit rights under Section 4.6 4.5 hereof.
(hi) Within forty-five (45) days after the end of each calendar quarter, Genzyme will report to RenaGel LLC the actual prices at which all sales of Collaboration Products were made to its customers during the preceding calendar quarter, future prospects for the Collaboration Products and related issues. Genzyme shall report promptly to the Steering Committee in writing the occurrence of each material incident of Collaboration Product performance required to be reported to regulatory authorities, including without limitation adverse reaction information in accordance with Section 5.2.3 5.2.2 hereof, within three (3) business days of the happening of such occurrence.
Appears in 1 contract
Samples: Collaboration Agreement (Geltex Pharmaceuticals Inc)
Responsibilities of Genzyme. Genzyme shall be solely responsible for --------------------------- all aspects of the marketing and sale of the Collaboration Products in accordance with the strategy, policies and procedures established in the Commercialization Plan, including without limitation the responsibilities described in this Section 6.5.
(a) Genzyme shall be primarily responsible for the implementation of each Commercialization Plan, including without limitation setting all terms of sale, including establishing pricing policies, credit terms and cash discounts and allowances, formulating marketing plans, negotiating agreements with Third Party distributors (if any), providing patient information, providing customer support services, providing reimbursement counseling services and conducting sales force training, all in accordance with good business practices and industry standards.
(b) Genzyme shall employ sufficiently trained and experienced individuals in numbers adequate to carry out its responsibilities under this Article 6. Sales and support personnel shall be familiar with the Collaboration Products and with competitive products and shall respond promptly to customer requests for support.
(c) Genzyme shall provide instructions and appropriate training to customers in the proper use and handling of the Collaboration Products and shall monitor performance of the Collaboration Products.
(d) Genzyme shall have sole responsibility for responding to all requests for medical information regarding Collaboration Products.. Notwithstanding the foregoing, BioMarin may maintain a website or other informational resources where it may publish general medical information relating to MPS I, so long as such website complies in all respects with applicable laws and regulations, including without limitation regulations of the FDA regarding "off-label" promotion of Collaboration Products. [* CONFIDENTIAL TREATMENT REQUESTED]
(e) Genzyme shall comply with all laws and government regulations applicable to the marketing and sale of Collaboration Products within the Territory.
(f) The Collaboration Products shall be sold under trademarks selected by the Steering Committee and owned by or licensed to Kallikrein BioMarin/Genzyme LLC in accordance with Section 9.1.2 hereof.
(g) Genzyme shall maintain complete and accurate records of all movements and transactions involving Collaboration Products by an appropriate identifier and by customer so that all such movements and transactions can be traced quickly and effectively. Upon written request, Genzyme will provide copies of such records to the other Parties, with access to facilities used by Genzyme in performing its duties under this Article 6 during normal business hours and upon reasonable advance notice for the purpose of inspecting such facilities for compliance with the terms of this Agreement. The records maintained by Genzyme pursuant to this clause (g) shall be subject to the other Parties' audit rights under Section 4.6 4.5 hereof.
(h) Genzyme shall report promptly to the Steering Committee in writing the occurrence of each material incident of Collaboration Product performance required to be reported to regulatory authorities, including without limitation adverse reaction information Adverse Reaction Information in accordance with Section 5.2.3 5.2.2 hereof, within three (3) business days of the happening of such occurrence.
Appears in 1 contract
Samples: Collaboration Agreement (Biomarin Pharmaceutical Inc)
