“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.

Licensed Product. Zolgensma is a Licensed Product.

means any pharmaceutical product for injection or infiltration or similar manner of administration # comprising the Active Ingredient as the sole active pharmaceutical ingredient and # comprising ​, including the product described on [Exhibit 1.24] (the “Initial Product”) and any Reformulations thereof. For clarity, Licensed Product shall exclude any product Controlled by INNOCOLL as of the Effective Date and any modification, revision, reformulation or improvement to any such product made after the Effective Date, so long as such modification, revision, reformulation or improvement does not use or incorporate ​.

“Licensee Collaboration IP” means any # Know-How first created, conceived or generated by or on behalf of Licensee or its Affiliates (whether solely or jointly with any Third Party(ies)), in the course of activities performed under this Agreement, as determined pursuant to Section 12.7.1, and # Patents that claim such Know-How, but excluding, in each case of (a) and (b), Joint Collaboration IP.

Licensed Product. The Parties agree that the licenses under Section 2.1 are granted for the purpose of carrying out the development objectives as mentioned in the original Joint Development Agreement executed between the Parties on November 6, 2015 and the restated Joint Development Agreement effective April 1, 2018, and the Licensee shall not be selling the Licensed Product. In no event shall Licensee sell, transfer or otherwise utilize the Licensed Product.

Licensed Product Manufacturing. In connection with any audit by a Regulatory Authority relating to the Clinical Trial or the Licensed Product, [[Organization A:Organization]] (or its Third Party manufacturer) will reasonably accommodate requests to allow representatives of any Regulatory Authority to inspect the relevant parts of facilities where the Manufacture of the Licensed Product is carried out and to inspect batch records and related documentation to verify compliance with cGMP and Applicable Law, and will promptly notify [[Agenus:Organization]] of any deficiencies identified and remediation plans with respect thereto. To the extent allowable under Applicable Law, Persons inspecting or auditing such facilities, books or records shall be required to enter into separate confidentiality agreements and to abide by the safety protocols and 36165924.6

As between the Parties, Acorda is and shall remain the owner of the Licensed Product Trademarks, and all goodwill associated therewith, in all countries of the world, and all uses of the Licensed Product Trademarks by Licensee, its Affiliates and Third Party Distributors shall inure to the benefit of Acorda. Licensee shall have the right to review and comment on any documentation related to the filing, prosecution, defense or maintenance of the Licensed Product Trademarks in the Territory and Acorda shall consider in good faith any comments made by Licensee. If and to the extent that Licensee or its Affiliates or Third Party Distributors obtain any rights (other than the licenses granted herein) to the Licensed Product Trademarks in any country in the world, Licensee shall immediately and automatically assign, and ensure that its Affiliates and Third Party Distributors immediately and automatically assign, to Acorda all right, title and interest in and to the Licensed Product Trademarks, and all goodwill with respect thereto, subject to the licenses granted to Licensee hereunder. Acorda shall deliver copies of all filings related to the Licensed Product Trademarks in the Territory, including responses and other correspondence with the relevant registrar promptly to Licensee upon the distribution or receipt of such materials.

Manufacture of Licensed Product. Subject to Section 3.2.2, Licensee shall have the sole responsibility for, at its expense, Manufacturing (or having Manufactured) and supplying the Licensed Compound and the Licensed Product for their Development and Commercialization activities in accordance with Applicable Law in the Territory, either by itself or through its Affiliates, its and their Sublicensees or Third-Party contract manufacturers. Notwithstanding the foregoing, [[AstraZeneca:Organization]] agrees to, at Licensee’s cost, supply to Licensee with inventory of the Licensed Product (whether in the form of drug tablets or drug substance) in accordance with the Transition Plan at [[AstraZeneca:Organization]]’s ​. Such supply shall include all appropriate documentation including accurate certificates of analysis and any release documentation. The Parties shall execute a quality agreement to set forth the Parties’ respective responsibilities with respect to quality matters relating to supply and compliance with cGMP (the “Quality Agreement”) ​ of the Effective Date. In the event of any conflict between the Quality Agreement and this Agreement, the terms of the Quality Agreement shall control all quality matters. Further terms applicable to such supply are set forth in [Schedule 3.2.1] (Transition Plan).

Licensed Product Royalty Rate. Subject to [Section 8.5.3] and subject to any adjustments expressly permitted under [Section 8.5.5] below, Janssen shall pay to Arrowhead royalties at the following incremental royalty rates on the incremental tiers of aggregate reported Net Sales of Licensed Products in the Territory, excluding aggregate reported Net Sales of Licensed Products in the Access Territory if any reductions for the Access Territory have then been agreed to, during a particular Janssen Calendar Year during the Royalty Term as set forth in the table below.

Licensed Product Royalty from EyePoint. Subject to the remainder of Section 4.3, EyePoint shall pay to Equinox the following tiered royalties on Annual Net Sales of Licensed Products in the Territory: