Intellectual Property Strategy. (a) Hospira shall, at Hospira’s sole cost and expense, have sole control over the creation and implementation of any strategy related to any Actions (including inter partes reviews and declaratory judgments) with respect to Patents of Third Parties, in each case with respect to the development, manufacture, launch (including obtaining Regulatory Approval), marketing, commercialization and sale of Product in all markets, including the sole right to determine (i) when and if to initiate any such Action with respect to any Third Party’s Patent (other than as covered by the terms of Section 6.6), including by way of example any nullity or invalidity case brought against any Third Party’s Patents specific to the development, manufacture, launch, marketing, commercialization and sale of Product; (ii) the earliest date on which Product will be manufactured, imported, used, offered for sale and/or sold in any given country; (iii) when and how to change the development or manufacture of Product (provided that any modification to the Manufacturing Strain shall be subject to Section 3.1(e)) in order to minimize the effect of any Third Party’s Intellectual Property from the development, manufacture, launch, marketing, commercialization and sale of Product, such as the institution of circumvention strategies or the proactive seeking of a license from a Third Party; (iv) the appropriate course of action in the event any Third Party commences an Action alleging that Product or the development, manufacture, launch, marketing, commercialization or sale of Product infringes any Intellectual Property of such Third Party (other than as covered by the terms of Section 6.5), including assuming and controlling the defense of any such Action; and (v) when and if to settle, compromise or consent to any judgment with respect to any Action with respect to any Third Party’s Intellectual Property; provided, that Hospira shall be required to obtain Pfenex’s prior written consent (such consent not to be unreasonably withheld, conditioned or delayed) to the extent the same would likely have a material adverse effect on Pfenex, its Affiliate or their rights (the “IP Strategy”). For clarity, nothing in this Section 6.4 shall limit Pfenex’s right with respect to Actions related to Patents or other Intellectual Property of Third Parties in connection with the development, manufacture, launch (including obtaining Regulatory Approval), marketing, commercialization and sale of products other than Product hereunder. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. (b) Pfenex shall provide all cooperation and assistance reasonably requested by Hospira in connection with Hospira’s implementation of the IP Strategy, including (i) providing Hospira prompt written notice of any Action commenced by any Third Party against Pfenex alleging that Product or the Business infringes any Intellectual Property of such Third Party, (ii) providing Hospira with documents (whether in written, electronic or other form) related to Product and/or the Business, including documents related to the development of Product or the processes used to manufacture Product, (iii) identifying and describing any Intellectual Property that has been incorporated into Product by Pfenex, (iv) allowing inspection, whether court-ordered or otherwise, of any facility owned, operated or controlled by Pfenex or its Affiliates and (v) identifying and providing witnesses who will assist in the preparation of evidence, provide written evidence, appear as witnesses in court and assist in other ways that Hospira reasonably requests. To the extent that the cooperation or assistance requested results in external costs being incurred by Pfenex, then Hospira shall be responsible for the payment of all reasonably incurred external expenses in accordance with a budget to be mutually agreed upon by the Parties. (c) Pfenex shall not commence any Action with respect to any Patents of a Third Party in connection with the development, manufacture, launch (including obtaining Regulatory Approval), marketing, commercialization and sale of Product or take any other action that violates or conflicts with Hospira’s rights under Section 6.4(a) without Hospira’s prior written consent. Notwithstanding anything to the contrary in this Agreement, if Pfenex commences any such Action in contravention of the proceeding sentence (an “Off-Strategy Action”), such commencement shall constitute a material breach by Pfenex of this Agreement, and, without limiting Hospira’s rights with respect to such material breach and notwithstanding anything contained herein to the contrary, Pfenex shall act in accordance with any instructions from Hospira with respect to such Off-Strategy Action, including instructions to (i) terminate such Off-Strategy Action or (ii) relinquish control of such Off-Strategy Action to Hospira, whereupon Pfenex will be responsible for all IP Costs incurred by either Party in connection with such Off-Strategy Action.
Appears in 3 contracts
Sources: Development and License Agreement, Development and License Agreement (Pfenex Inc.), Development and License Agreement (Pfenex Inc.)