“Licensed Product”. Licensed Product means any pharmaceutical preparation or product comprising a Compound that is Covered by Novo Patent Rights or uses or embodies Novo Know-How and is # for sale by prescription, over-the-counter or any other method, or # for administration to patients in a clinical trial, and shall include any Licensed Product that is part of a Combination Product.

This Agreement is structured so that Product Agreements may be entered into by the parties (or their Affiliates) for the manufacture of Product at any [[Organization A:Organization]] site agreed to by the parties. Each Product Agreement will be governed by and will incorporate the terms and conditions of this Agreement. Unless otherwise agreed by the parties, each Product Agreement will be substantially in the general form, and contain the information referred to, in Appendix 1. Client must provide Patheon (or the applicable Affiliate) with a Purchase Order before any services are provided under the Product Agreement. Neither Client nor Patheon is obligated to execute any Product Agreement. A Product Agreement may not change any term or condition contained in this Agreement and if there is any irreconcilable inconsistency between any of the terms or conditions of this Agreement and those of a Product Agreement, the terms and conditions of this Agreement will control unless and only to the extent the Product Agreement states otherwise referencing the specific section or terms or conditions of this Agreement that are superseded by the Product Agreement.

Recalled Product. To the extent that a Recall results from, or arises from Deficient Product, Patheon will be responsible for the reasonable documented costs and expenses of the Recall including, without limitation, reasonable attorney’s fees, and will, at Client’s sole option, either # use commercially reasonable efforts to replace the Deficient Product with replacement Products as per Section 10, or # refund all amounts paid by Client in respect of the Deficient Product. In all other circumstances, Recalls, returns, or other corrective actions will be made at Client's cost and expense. Patheon’s only liability for DS loss is set out in Appendix 3.

The term “Combination Product” shall mean

The term “Generic Product” shall mean a product that is not produced, licensed or owned by the Roche Group that # contains a pharmaceutically active ingredient that is the same as the Compound in the Product which is approved through in reliance, in whole or in part, on the prior Regulatory Approval (or on safety or efficacy data submitted in support of the prior Regulatory Approval) of such Product, pursuant to Section 505(j) of the Act (21 U.S.C. 355(j)), or for countries outside the US, any international equivalent laws, and # has the same or substantially the same labelling as the applicable Product for at least one indication of such Product.

The term “Patent Product” shall mean any Product containing a Compound that is Covered by a Composition of Matter Claim.

If Roche or its Affiliates intend to sell a Combination Product, then the Parties shall meet approximately ​ prior to the anticipated First Commercial Sale of such Combination Product in the Territory to negotiate in good faith and agree to an appropriate adjustment to Net Sales to reflect the relative commercial value contributed by the components of the Combination Product (the “Relative Commercial Value”). If, after such good faith negotiations not to exceed ​ days, the Parties cannot agree to an appropriate adjustment, the dispute shall be initially referred to the executive officers of the Parties in accordance with Section 21.2.

Product Price. As further described in the Supply and Quality Agreement, prior to establishment of a Product price as approved by the applicable Regulatory Authority, the Parties will determine in good faith an estimated price per unit of Product for the supply of Product to AstraZeneca based on the then-current Commercialization Plan. Once such price is established, the price approved by the applicable Regulatory Authority will be used for such supply, and the Parties shall reconcile the estimated price with the actual price by means of a credit or additional payment, as applicable. Thereafter, COGS will be calculated based on ​ as set forth in the Supply and Quality Agreement.

Product Recalls. The rules on recalls of Finished Products are set out in the Quality Agreement.

Company shall have the right to discontinue the sale of Products or to modify the design, specifications and components of Products at any time in its sole discretion; provided, however, that Company shall notify Dealer, prior to shipment, of any major changes with respect to Products previously ordered by Dealer but not yet delivered, in which event Dealer shall have the right to terminate such order within five (5) days after such notification by providing written notice to Company. The failure by Dealer to provide such timely written notification shall be deemed acceptance by Dealer of such changes.