Specific Commercialization Obligations. Without limiting the generality of the provisions of Section 6.1, in connection with the Commercialization of the Product in the Territory for use in the Field by Pfizer hereunder: (a) Pfizer shall be solely responsible for (i) receiving, accepting and filling orders for the Product in the Field in the Territory, (ii) handling all returns of the Product in the Field in the Territory, (iii) controlling invoicing, order processing and collection of accounts receivable for the sales of the Product in the Field in the Territory, and (iv) distributing and managing inventory of the Product in the Field in the Territory. (b) Pfizer shall use Commercially Reasonable Efforts to launch the Product in each country (or other regulatory jurisdiction) in the Territory after all applicable Regulatory Approvals for the Product in such country (or other regulatory jurisdiction) have been obtained. Pfizer shall commercially launch the Product in each country in the Territory within sixty (60) days after the receipt of Pricing Approval and final label agreement of the Product in such country (to the extent Pricing Approval and final label agreement are required in such country, and otherwise within sixty (60) days after receipt of Product Approval in, or otherwise covering, such country); provided that Auxilium complies with its obligations to supply Product in accordance with Article 7 of this Agreement. (c) Pfizer [***] of [***] from the Effective Date through [***]. (d) On an [***]: (i) with respect [***] such Product [***]: (1) [***] ** CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST. (2) [***] (1) [***] (2) [***]
Appears in 2 contracts
Samples: Development, Commercialization and Supply Agreement (Auxilium Pharmaceuticals Inc), Development, Commercialization and Supply Agreement (Auxilium Pharmaceuticals Inc)
Specific Commercialization Obligations. Without limiting the generality of the provisions of Section 6.15.1, in connection with the Commercialization of the Product in the Territory for use in the Field by Pfizer Licensee hereunder:
(a) Pfizer Licensee shall [***] (i) Commercialize the Product for use in the Field in the Territory, (ii) maximize the commercial potential for the Product in the Field in the Territory, (iii) represent the Product accurately and fairly, and (iv) not sell Product as part of a bundle in any manner that would disadvantage the Product relative to any other product(s) in such bundle including, without limitation, the discount or rebate for any Product is greater than the discount or rebate for any other product(s) included in such bundle.
(b) Licensee shall not (i) utilize deceptive, misleading or unethical business practices, or (ii) take any action or inaction that is incompatible with using [***] to Commercialize the Product, or which the Licensee should reasonably know is likely to prejudice the value of the Product.
(c) Licensee shall be solely responsible for (i) receiving, accepting and filling orders for the Product in the Field in the Territory, (ii) handling all returns of the Product in the Field in the Territory, (iii) controlling invoicing, order processing and collection of accounts receivable for the sales of the Product in the Field in the Territory, and (iv) distributing and managing inventory of the Product in the Field in the Territory.
(bd) Pfizer Licensee shall use Commercially Reasonable Efforts to [***] (i) launch the Product in each country (or other regulatory jurisdiction) as Licensee deems commercially appropriate to do so in the Territory after all applicable Regulatory Approvals for the Product in such country (or other regulatory jurisdiction) have been obtained. Pfizer shall commercially launch ; and, (ii) ensure that once launched, the Product remains commercially available in each country in which it has been launched for the Territory within sixty (60) days after the receipt of Pricing Approval and final label agreement duration of the Product in such country (to the extent Pricing Approval and final label agreement are required Royalty Term in such country, and otherwise within sixty (60) days after receipt of Product Approval in, or otherwise covering, such country); provided that Auxilium complies with its obligations to supply Product in accordance with Article 7 of this Agreement.
(c) Pfizer [***] of [***] from the Effective Date through [***].
(d) On an [***]:
(i) with respect [***] such Product [***]:
(1) [***] ** CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.
(2) [***]
(1) [***]
(2) [***]
Appears in 2 contracts
Samples: License, Development and Commercialization Agreement (JATT Acquisition Corp), License, Development and Commercialization Agreement (JATT Acquisition Corp)
Specific Commercialization Obligations. Without limiting the generality of the provisions of Section 6.1, in connection with the Commercialization of the Finished Product in the Territory for use in the Field by Pfizer Actelion hereunder:
(a) Pfizer Actelion shall be solely responsible for (i) receiving, accepting and filling orders for the Finished Product in the Field in the Territory, (ii) handling all returns of the Finished Product in the Field in the Territory, (iii) controlling invoicing, order processing and collection of accounts receivable for the sales of the Finished Product in the Field in the Territory, and (iv) distributing and managing inventory of the Finished Product in the Field in the Territory.
(b) Pfizer Actelion shall use Commercially Reasonable Efforts to launch the Finished Product in each country (or other regulatory jurisdiction) in the Territory after all applicable Regulatory Approvals for the Finished Product in such country (or other regulatory jurisdiction) have been obtained. Pfizer Actelion shall (i) commercially launch the Finished Product in each country in the Territory within sixty (60) days after the receipt of Pricing Approval and final label agreement of the Finished Product in such country (to the extent Pricing Approval and final label agreement are required in such country, and otherwise within sixty (60) days after receipt of Product Approval in, or otherwise covering, such country)) and (ii) ensure that once launched the Finished Product remains commercially available in each country in which it has been launched for the duration of the Royalty Term in such country; provided that Auxilium complies with its obligations to supply Bulk Product in accordance with Article ARTICLE 7 of this Agreement.
(c) Pfizer [***] Schedule 6.3.1 sets forth the annual minimum Finished Product sales commitments of [***] from Actelion in the Effective Date through [***]Field in the Territory, it being understood that such minimums are based on assumptions regarding the date of obtaining Regulatory Approval in a given country in the Territory (including Pricing Approval for Canada and Australia).
(d) On an [***]:
(i) with respect [***] such Product [***]:
(1) [***] ** CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.
(2) [***]
(1) [***]
(2) [***]
Appears in 1 contract
Samples: Collaboration Agreement (Auxilium Pharmaceuticals Inc)
Specific Commercialization Obligations. Without limiting the generality of the provisions of Section 6.1, in connection with the Commercialization by Licensee of the Product in the Territory for use in the Field by Pfizer hereunder, during the Term, Licensee shall be responsible for, and each Commercialization Plan shall reflect that:
(a) Pfizer Licensee shall be solely responsible for (ia) receiving, accepting and filling orders for the Product in the Field in the Territory, (iib) handling all returns of the Product in the Field in the Territory, (iiic) controlling invoicing, order processing and collection of accounts receivable for the sales of the Product in the Field in the Territory, (d) booking and (iv) distributing and managing inventory recording sales of the Product in the Field in the Territory in its books of account and (e) distributing and managing inventory of Product in the Field in the Territory, in each case in accordance with GAAP to the extent applicable.
(b) Pfizer Licensee shall use Commercially Reasonable Efforts to launch the Product for use in the Field (i) in each country Major Market Country (or other regulatory jurisdiction) except that such efforts in *** are subject to the Territory provisions of Section 6.2 no later than *** after all applicable the receipt of Regulatory Approvals for Approval of the Product in such country Major Market Country and (or other regulatory jurisdictionii) have been obtained. Pfizer shall commercially launch subject to a good faith evaluation of the Product market potential in each country in the Territory other than the Major Market Countries, within sixty (60) days *** after the receipt of Pricing Regulatory Approval and final label agreement of the Product in such country country. Notwithstanding the foregoing clause (i), Licensee shall have no obligation to launch the extent Pricing Approval and final label agreement are required in such country, and otherwise within sixty (60) days after receipt of Product Approval in, or otherwise covering, such country); provided that Auxilium complies with its obligations to supply Product in accordance with Article 7 of this Agreementany Major EU Country ***Major EU Country. *** Portion for which confidential treatment requested.
(c) Pfizer [Licensee shall Detail the Product in the Territory for use in the Field to those categories of physicians (“Specialists”) as set forth in the Commercialization Plan, and in connection therewith, Licensee shall assign a reasonable number of Sales and Educational Representatives for each country in the Territory to perform the Details set forth in the Commercialization Plan. Licensee shall also ensure that it assigns a reasonable number of qualified supervisors to oversee the conduct of the Sales and Educational Representatives. Licensee shall provide to Immunomedics within ***] * of [the conclusion of each ***] from * a detailed report setting forth the Effective Date through [***]types, number and targets of Details actually performed by Licensee in each of the Major Market Countries, as well as report of the type, number and targets of Details actually performed by Licensee in each other country in the Territory, and such report shall be subject to the audit requirements set forth in Section 9.11.
(d) On an [***]:
(i) with respect [***] such Product [***]:
(1) [***] ** CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.
(2) [***]
(1) [***]
(2) [***]
Appears in 1 contract
Samples: License and Collaboration Agreement (Immunomedics Inc)
Specific Commercialization Obligations. Without limiting the generality of the provisions of Section 6.1, in connection with the Commercialization of the Product in the Territory for use in the Field by Pfizer Asahi hereunder:
(a) Pfizer Asahi shall be solely responsible for (i) receiving, accepting and filling orders for the Product in the Field in the Territory, (ii) handling all returns of the Product in the Field in the Territory, (iii) controlling invoicing, order processing and collection of accounts receivable for the sales of the Product in the Field in the Territory, and (iv) distributing and managing inventory of the Product in the Field in the Territory.
(b) Pfizer Asahi shall use Commercially Reasonable Efforts to launch the Product in each country (or other regulatory jurisdiction) in the Territory after all applicable Regulatory Approvals for the Product in such country (or other regulatory jurisdiction) have been obtained. Pfizer Asahi shall commercially (i) launch the Product in each country in the Territory within sixty (60) days after the receipt of Pricing Product Approval and final label agreement of the Product in such country (or, to the extent Pricing Approval and final label agreement are required in such countryis required, and otherwise then within sixty (60) days after receipt of Pricing Approval) and (ii) ensure that once launched the Product Approval in, or otherwise covering, such country)remains commercially available throughout the Territory for the duration of the Royalty Term; provided that Auxilium complies with its obligations to supply Product in accordance with Article ARTICLE 7 of this Agreement.
(c) Pfizer Asahi shall [***] of [***] from the Effective Date through [***].
(d) On an [**], Asahi shall [**]:
(i) with respect to [***] of such Product [***]:
(1) [**] during [*] ** CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.]; and
(2) [**] during [**]; and
(ii) with respect to [**] of such Product [**]:
(1) [**] during [**]; and
(2) [**] during [**].
(e) Notwithstanding the foregoing [**] expenditure requirements, such requirements are subject to the following: (i) such expenditures may be subject to limitations, restrictions or regulations by a Governmental Authority, in which case Asahi’s obligations under Sections 6.3.1(c) and (d) shall be tolled for so long as such limitations, restrictions or regulations prohibit the expenditure of such Advertising and Promoting Costs, and (ii) Asahi shall be obligated to incur at least one-third (1/3) of the amounts indicated in Sections 6.3.1(c) and (d) through Out-of-Pocket Costs.
Appears in 1 contract
Samples: Development, Commercialization and Supply Agreement (Auxilium Pharmaceuticals Inc)