Pipeline Products. The Seller or one of its Affiliates is the registered holder of each of the Pipeline Product Approvals, and the benefit of each Pipeline Product Approval can be transferred to the Purchaser (or another member of the Purchaser’s Group) regardless as to whether such transfer occurs directly (whether by way of transfer, reissuance or any other equivalent mechanism under Applicable Law of the relevant jurisdiction) or indirectly (through the transfer of the Target Group Companies).
Pipeline Products. 23.1 The Seller or one of its Affiliates is the registered holder of each of the Pipeline Product Approvals, and the benefit of each Pipeline Product Approval can be transferred to the Purchaser (or another member of the Purchaser’s Group) regardless as to whether such transfer occurs directly (whether by way of transfer, reissuance or any other equivalent mechanism under Applicable Law of the relevant jurisdiction) or indirectly (through the transfer of the Vaccines Group Companies).
23.2 All development activities in relation to the Pipeline Products have been conducted in the ordinary course and in accordance with all Applicable Law and standards and to the Seller’s Knowledge there are no circumstances relating to the development of the Pipeline Products that could involve or lead to a material violation of any material Applicable Law or standards.
23.3 No material regulatory, clinical or safety event has occurred in relation to the Pipeline Products and no member of the Seller’s Group has received any notification or claim from any person of any such event (or the possibility of any such event).
Pipeline Products. 20.1 The information set out in Schedule 1 with respect to the Product Expansions is true and accurate.
20.2 The Seller or one of its Affiliates is the registered holder of each of the Product Expansion Applications, and each Product Expansion Application can be transferred to the Purchaser (or another member of the Purchaser’s Group) regardless as to whether such transfer occurs directly (whether by way of transfer, reissuance or any other equivalent mechanism under Applicable Law of the relevant jurisdiction) or indirectly (through the transfer to a member of the Purchaser Group).
20.3 All development activities in relation to the Product Expansions have been conducted in the ordinary course and in accordance with Applicable Law and standards and to the Seller’s Knowledge there are no circumstances relating to the development of the Product Expansions that could involve or lead to a material violation of any material Applicable Law or standards.
20.4 No material regulatory, clinical or safety event has occurred in relation to the Products and no member of the Seller’s Group has received any notification or claim from any person of any such event (or the possibility of any such event).
Pipeline Products. (a) BeiGene shall be solely responsible for, and shall use Commercially Reasonable Efforts for, the promotion and sale of the Pipeline Products in accordance with the Global Brand Plan, Commercialization Plan, Commercialization Budget and Access and Pricing Plan for seven (7) years following Regulatory Approval for promotion and sale of each such Product in the Collaboration Territory (the “Pipeline Product Commercialization Period”); provided, however, that, the Pipeline Product Commercialization Period for each Retained Pipeline Product selected according to the selection methodology set forth in Section 5.1.5 shall be extended for so long as such Pipeline Product is sold in the Collaboration Territory. On a Product-by-Product basis, following the Pipeline Product Commercialization Period for each Product, all rights to Exploit any and all Pipeline Products (other than the Retained Pipeline Product(s)) shall revert to Amgen and shall be subject to Section 14.9 (Transition Obligations).
(b) BeiGene acknowledges and agrees that, without the prior written consent of Amgen, BeiGene shall not Commercialize a Pipeline Product with [*] until after the First Commercial Sale of such Pipeline Product in (i) any one of [*] and (ii) [*]. If the Applicable Retail Baseline Price for a Pipeline Product in the Collaboration Territory will likely be higher than [*] for such Product then BeiGene shall promptly report to the JSC (including by providing supporting documentation) its business case that [*]. Thereafter, Amgen shall have the right, at its sole discretion, to: (i) [*] or (ii) [*]. If Amgen elects to exercise its option described in the foregoing clause (ii), then the Parties shall discuss and agree in good faith upon [*] and upon such agreement [*] provided that [*]. Notwithstanding the foregoing, if the Parties cannot reach agreement with respect to the foregoing [*], either Party may request such Dispute be arbitrated in accordance with Section 15.4.4. [*].
Pipeline Products. (a) Identity. Forte Line products under development prior to the Effective Date that are being transferred to Buyer are listed on Exhibit A attached hereto (the “Transferred Forte Pipeline Products”). Forte Line products under development prior to the Effective Date that are being retained by Allergan are listed on Exhibit B attached hereto (the “Retained Forte Pipeline Products”). Formulations Line products under development prior to the Effective Date that are being transferred to Buyer are listed on Exhibit C attached hereto (the “Transferred Formulations Pipeline Products”). Products or technologies under development prior to the Effective Date that will relate to both the Forte Line and the Formulations Line are listed on Exhibit D attached hereto (the “Crossover Pipeline Products”) (the Transferred Forte Pipeline Products, the Retained Forte Pipeline Products, the Transferred Formulations Pipeline Products and the Crossover Pipeline Products are hereinafter referred to collectively as the “Pipeline Product”). The applicable design specifications of the Pipeline Products are listed on Exhibits A, B, C and D (the “Pipeline Specifications”).
