Provision Language
Definitions
“Field of Use” consists of all fields of use including all therapeutic applications and uses (the “Therapeutics Field”), and all diagnostic and imaging applications and uses (the “Imaging Field”).
“Licensed Product” means any product that comprises an antibody conjugated to a radioisotope (or any service provided using such product)to the extent that the manufacture, use, sale, offer for sale, importation, lease, disposition or provision of such product or service would, absent the license granted hereunder, constitute infringement (including direct, contributory or inducement) of any Valid Claims of the Patent Rights.
“Licensed Territory” means all territories where Patent Rights exist or may come to exist.
“Major Territory” means any and all of the United States of America, any member state of the European Patent Convention, Canada, Australia and Japan.
2. GRANT
2.1 License. Subject to the limitations and other terms and conditions set forth in this Agreement, including the limitations outlined in Section 2.2 below, The Regents grants to Licensee an exclusive license under the Valid Claims of the Patent Rights to make, use, sell, offer for sale and import Licensed Products in the Licensed Territory and Field of Use, provided that in addition to the right that The Regents has to grant licenses under the Patent Rights to other companies to make, use, sell, offer for sale and import products and services that are not Licensed Products (as such term is defined herein), The Regents shall have the right to grant licenses to other companies under the Patent Rights to make and use (but not to market or sell) Licensed Products (as such term is defined herein) in the Imaging Research Field.
2.2 License Conditions. The license granted in Section 2.1 is subject to the following: The Regents expressly reserves the right (i) for itself and other nonprofit and academic research institutions to use Patent Rights and associated technology for educational and research purposes (including clinical research and research sponsored by commercial entities) and to publish their respective results, and (ii) for the University of California (“UC”) to offer and perform clinical diagnostic and prognostic services for patients in the UC healthcare system.
3. SUBLICENSES
3.1 Permitted Sublicensing. The Regents also grants to Licensee the right to sublicense to third parties (up to a maximum of three tiers) the rights licensed to Licensee hereunder so long as Licensee’s rights remain exclusive (each, a “Sublicense” and each such third party that receives a Sublicense “Sublicensee”). All Sublicenses must be in writing and will be subject to, and contain terms consistent with, the terms in this Agreement, including, without limitation, the provisions contained in Articles 2.3 (License Conditions), 3 (Sublicenses), 4.4 (Validity Challenge),7 (Books and Records), 9 (Use of Names and Trademarks), 10 (Limited Warranty and Liability), 11 (Patent Marking), 12 (Patent Infringement),14 (Indemnification), 18 (Compliance with Laws), etc. For clarity, Licensee will be obligated to pay Earned Royalties on its Sublicensees’ Net Sales irrespective of whether its Sublicensees pay royalties to Licensee. For the purposes of this Agreement, the operations of all Sublicensees will be deemed to be the operations of Licensee, for which Licensee will be responsible and liable. Licensee must provide The Regents with a copy of each Sublicense issued, including any agreements and amendments executed in relation thereto, within thirty (30) days of its execution. Upon termination of this Agreement, all Sublicenses will likewise terminate. Sublicensees will not be deemed to constitute third party beneficiaries under this Agreement.
5. COMMERCIAL DILIGENCE
5.1 Development of Licensed Products. Licensee, upon execution of this Agreement, will diligently proceed with the development, manufacture and sale of Licensed Products in quantities sufficient to meet the market demands therefore and will diligently market the same after execution of this Agreement. Licensee or a Sublicensee will obtain all necessary governmental approvals in each country where Licensed Products are manufactured, used, sold, offered for sale or imported.
5.2 Development Milestones. On or before the dates indicated below (which unless indicated below are relative to the Effective Date), Licensee will achieve each of the following development milestones with respect to a Licensed Product (“Development Milestones”). If Licensee fails to achieve a Development Milestone by the deadline set forth below, then The Regents has the right and option, at its sole discretion, to either terminate this Agreement or reduce Licensee’s exclusive license to a nonexclusive license, under the terms set forth in Section 8 (LIFE OF THIS AGREEMENT). This right, if exercised by The Regents, supersedes the rights granted in Section 2 (GRANT):
A. General Diligence: Licensee will meet the following Development Milestones with respect to a Licensed Product. All dates below are relative to the license Effective Date.
(i) Complete in vivo pre-clinical toxicity, in vivo PK, and in vivo biodistribution studies within two (2) years.
Licensee may extend the deadline to meet the General Diligence Development Milestone in six (6) month increments, but not more than twice, by making a Ten Thousand Dollar ($10,000) payment to The Regents for each such milestone extension (each such milestone extension a “Paid Milestone Extension”).
B. Imaging Field Diligence: Licensee will meet the following Development Milestones with respect to a Licensed Product in the Imaging Field. All dates below are relative to the license Effective Date.
(i) File an IND with FDA within three (3) years.
(ii) Enrol the first patient in a clinical trial within four (4) years.
(iii) Achieve a First Commercial Sale within ten (10) years.
Licensee may extend the deadline to meet any of these Development Milestones in the Imaging Field by six (6) month increments, but not more than twice for each Development Milestone and not more than three (3) years in total across all Development Milestones in the Imaging Field, by making a Ten Thousand Dollar ($10,000) payment to The Regents for each such milestone extension (each such milestone extension a “Paid Milestone Extension”). In the event of any extension, the deadlines to meet any later occurring Development Milestones in the Imaging Field will be similarly extended.
C. Therapeutics Field Diligence: Licensee will meet the following Development Milestones with respect to a Licensed Product in the Therapeutics Field. All dates below are relative to the license Effective Date.
(i) File an IND with the FDA within four (4) years.
(ii) Enrol the first patient in a phase I clinical trial within five (5) years.
(iii) Enrol the first patient in a phase II clinical trial within seven (7) years.
(iv) Enrol the first patient in a phase III clinical trial within nine (9) years.
(v) Obtain an approved NDA or BLA from the FDA within ten (10) years.
(vi) Achieve a First Commercial Sale within eleven (11) years.
Licensee may extend the deadline to meet any of these Development Milestones in the Therapeutics Field in six (6) month increments, but not more than twice for each Development Milestone and not more than three (3) years in total across all Development Milestones in the Therapeutics Field, by making a Ten Thousand Dollar ($10,000) payment to The Regents for each such milestone extension (each such milestone extension a “Paid Milestone Extension”). In the event of any extension, the deadlines to meet any later occurring Development Milestones in the Therapeutics Field will be similarly extended.
If after obtaining the maximum number of Paid Milestone Extensions the completion of any of the Development Milestones is delayed beyond the corresponding deadline set forth in this Agreement (taking into account the Paid Milestone Extensions set forth above) on account of either a (a) Regulatory Delay or (b) Clinical Trial Failure Delay (collectively, “Excused Delays”), upon a written request by Licensee to The Regents setting forth the basis for the Excused Delay and providing copies to The Regents of documents and correspondence from the FDA or EMA that set forth the basis for Licensee’s assertion that an Excused Delay exists, The Regents shall execute an amendment to this Agreement to extend such Development Milestone and all subsequent Development Milestones (such amendment the “Clinical/Regulatory Delay Amendment”). Any documents and correspondence provided in support of a reason for an Excused Delay shall be treated as Licensee’s Confidential Information.
The duration of the Development Milestone extension(s) set forth in the Clinical/Regulatory Delay Amendment shall be reasonably related to the cause and effect of the Excused Delay as determined by good faith negotiation between The Regents and Licensee after The Regents has had an opportunity to review all such relevant documentation. In no event shall The Regents have any obligation to allow Licensee to extend the deadline for meeting such Development Milestone by more than two (2) years (in addition to the extensions taken under the Paid Milestone Extensions).
5.3 Affordable Access Plan. Within three (3) months of receiving FDA or EMA approval of a Licensed Product, Licensee will provide The Regents with either (a) an Affordable Access Plan (defined below), or (b) a written explanation as to why such an Affordable Access Plan is not needed or infeasible. In the case of (b), Licensee agrees to discuss such reasoning with The Regents in good faith within one (1) month thereafter (“Initial Discussion”) and, if following such Initial Discussion The Regents concludes an Affordable Access Plan is reasonable and desired, to provide an Affordable Access Plan to The Regents within three (3) months of such Initial Discussion. The “Affordable Access Plan” will include the following –to the extent such Plan includes confidential information, Licensee will also provide a non-confidential version or statement of such Plan that The Regents can make available to third parties:
A. A specified set of low-and middle-income countries (as defined by the World Bank, and collectively referred to as “LMICs”) in which the Licensee does not intend to commercialize the Licensed Products (the “Non-Commercialized Territory”); and
B. Licensee’s and/or its Sublicensees’ plans (including strategies and timelines) reasonably intended to support affordable access in LMICs and Non-Commercialized Territories, such as through licensing or partnerships including with non-profit organizations.
Within thirty (30) days of The Regents’ request (but no more often than once annually), Licensee agrees to confer with The Regents to review Licensee’s progress, and to consider in good faith any reasonable modifications suggested by The Regents, with respect to its Affordable Access Plan (“Progress Discussions”). For clarity, while The Regents may invite a designated entity to join either the Initial and/or Progress Discussions under this Section 5.3, such discussions will at all times be made subject to the confidentiality obligations set forth in Section 19 (Confidentiality).
10. DISCLAIMER OF WARRANTIES AND LIMITATION OF LIABILITIES
10.1 Except as expressly set forth in this Agreement, this license and the associated Patent Rights and Licensed Products are provided by The Regents WITHOUT WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR ANY OTHER WARRANTY OF ANY KIND, EXPRESS OR IMPLIED. THE REGENTS MAKES NO EXPRESS OR IMPLIED REPRESENTATION OR WARRANTY THAT USE OR COMMERCIALIZATION OF THE PATENT RIGHTS OR LICENSED PRODUCTS WILL NOT INFRINGE ANY PATENT, COPYRIGHT, TRADEMARK OR OTHER RIGHTS.
This Agreement does not express or imply (a) a warranty or representation as to the validity, enforceability, or scope of any Patent Rights; (b) a warranty or representation that anything made, used, sold, offered for sale, imported or otherwise exploited under any license granted in this Agreement is or will be free from infringement of patents, copyrights, or other rights of third parties; (c) an obligation on behalf of The Regents to bring or prosecute actions or suits against third parties for patent infringement; (d) by implication, estoppel or otherwise, any grant of any license or other rights under any patents or other rights of The Regents other than Patent Rights, regardless of whether such patents or other rights are dominant or subordinate to Patent Rights; or (e) any obligation for The Regents to furnish (i) any advancements, developments, or other improvements to the Patent Rights which are not entitled to the priority dates of Patent Rights, or (ii) any know-how, technology or information not provided in the Patent Rights.