“HUMANITARIAN PURPOSES” means:
(a) the use of LICENSED PRODUCTS and LICENSED SERVICES for research and development purposes by any nonprofit organization or other third party, anywhere in the world that has the express purpose of developing the LICENSED PRODUCTS or LICENSED SERVICES for use solely for protection from, treatment of, or diagnosis of Neglected Diseases in a Low- or Middle-income country as that term is defined by the World Bank (hereinafter “LMI COUNTRY(IES)”);
(b) SALE of LICENSED PRODUCTS and LICENSED SERVICES in LMI COUNTRIES at or below the cost of manufacture and distribution.
“LICENSED METHOD” means any process or method the use or practice of which, but for the license pursuant to this AGREEMENT, would infringe, or contribute to or induce the infringement of, any VALID CLAIM under REGENTS’ Patent Rights in that country in which the LICENSED METHOD is used or practiced.
“LICENSED PRODUCTS” means all kits, compositions of matter, articles of manufacture, materials, and products, the manufacture, use, SALE, offer for SALE, or import of which: a) would require the performance of the LICENSED METHOD; or b) but for the license granted pursuant to this AGREEMENT, would infringe, or contribute to or induce the infringement of, a VALID CLAIM.
“LICENSED SERVICE” means a service provided using a LICENSED PRODUCT or LICENSED METHOD.
“LICENSED TERRITORY” means the United States of America, its territories and possessions, and any foreign countries where REGENTS’ PATENT RIGHTS are licensed to LICENSEE under this AGREEMENT.
3.1 License Grant. Subject to the limitations set forth in this AGREEMENT, including the license granted to the U.S. Government and the rights reserved in Paragraph 3.2 (Reservation of Rights), REGENTS hereby grants and LICENSEE hereby accepts an exclusive license under REGENTS’ PATENT RIGHTS to make, use, offer for SALE, import, and SELL LICENSED PRODUCTS and LICENSED SERVICES, and to practice LICENSED METHOD, in the LICENSED FIELD OF USE in the LICENSED TERRITORY.
3.2 Reservation of Rights. The REGENTS reserves on behalf of itself and any other educational or nonprofit institutions the right to make, use, and practice the INVENTION, the REGENTS’ PATENT RIGHTS, and any technology created by the REGENTS relating to any of the foregoing for educational and research purposes, including publication and other communication of any research results.
3.3 Humanitarian Purposes.
(a) REGENTS further reserves the right to license REGENTS’ PATENT RIGHTS to any third parties solely for HUMANITARIAN PURPOSES. Such licenses for HUMANITARIAN PURPOSES will (i) expressly exclude the right of the third party licensee to export or SELL the LICENSED PRODUCTS from a LMI COUNTRY into a market outside of the LMI COUNTRY where LICENSEE has introduced or will introduce a LICENSED PRODUCT and where REGENTS’ PATENT RIGHTS exist (such markets hereinafter the ”LICENSEE MARKETS“) and (ii) require the third party licensee to create and maintain distinctive trade dress and trademarks that clearly distinguish third party LICENSED PRODUCTS and LICENSED SERVICES from LICENSEE’S LICENSED PRODUCTS and LICENSED SERVICES, (iii) require such third party LICENSEE’s sale of LICENSED PRODUCTS and LICENSED SERVICES in such LMI COUNTRIES be at or below cost. For avoidance of doubt, such third party licensee may be permitted to export LICENSED PRODUCTS from the LMI COUNTRY of origin to other LMI COUNTRIES and all other countries that are mutually agreed to by REGENTS and LICENSEE; and
(b) Notwithstanding the foregoing, prior to issuance of any such license to REGENTS’ PATENT RIGHTS to a third party, REGENTS will notify LICENSEE of its intention to grant such license so that LICENSEE may have the opportunity to fill the anticipated market need itself and/or to engage in discussions for a sublicense with such third party in accordance with the procedures set forth in Paragraph 4.8. In the event any LICENSED PRODUCT SOLD in any LMI COUNTRY by any such third party according to the provisions of Paragraph 3.3(a) is exported, re-SOLD or otherwise introduced in any LICENSEE MARKETS, LICENSEE will provide REGENTS with written notification thereof, and if such exportation, re-sale or introduction does not cease within ninety (90) days after the date of such notice, then an amount equal to the retail price of LICENSED PRODUCT so exported, re-SOLD or introduced to such LICENSEE Market will be credited to royalties due to REGENTS hereunder.
4.1 REGENTS also grants to LICENSEE the right to SUBLICENSE to AFFILIATES and third parties the right to make, use, offer for SALE, import, and SELL LICENSED PRODUCTS and LICENSED SERVICES, and to practice LICENSED METHOD, provided that LICENSEE has exclusive rights under this AGREEMENT at the time of sublicensing. Every such SUBLICENSE will include:
(a) a statement setting forth the date upon which LICENSEE’s exclusive rights, privileges, and license hereunder will expire;
(b) terms consistent with and be subject to, the terms in this AGREEMENT, including without limitation, all applicable obligations due to REGENTS and the provisions contained in: (i) Paragraph 3.2 (Reservation of Rights); (ii) (if applicable) Paragraph 3.5 (U.S. Government Rights); (iii) Article 4 (Sublicenses); (iv) Paragraph 6.5 (Validity Challenge); (v) Article 9 (Books and Records); (vi) Article 15 (Marking); (vii) Article 16 (Use of Names and Trademarks); (viii) Article 17 (Limited Warranties); (ix) Article 18 (Patent Infringement); (x) Article 19 (Indemnification); (xi) Article 20 (Compliance with Laws), (xii) Article 31 (Bankruptcy) etc., other than those rights and obligations specified in Paragraph
5.1 (License Issue Fee), Paragraph 6.2 (License Maintenance Fee) and Paragraph 6.3 (Minimum Annual Royalty) and, it being understood that, except as otherwise set forth in the AGREEMENT, LICENSEE is responsible to pay REGENTS a royalty as described in this AGREEMENT on SUBLICENSEE’S SALES of LICENSED PRODUCT or LICENSED SERVICE;
(c) a provision requiring payment of royalties to LICENSEE in an amount sufficient to permit LICENSEE to meet its royalty obligations to REGENTS at the rates and bases set forth in this AGREEMENT; and
(d) a prohibition on the grant of further SUBLICENSES.
4.3 LICENSEE will notify REGENTS of each SUBLICENSE granted hereunder and furnish to REGENTS a copy of each such SUBLICENSE.
4.4 AFFILIATES will have no licenses under REGENTS’ PATENT RIGHTS except as granted by SUBLICENSE pursuant to this AGREEMENT.
4.5 For the purposes of this AGREEMENT, the operations of all SUBLICENSEES are deemed to be the operations of LICENSEE, for which LICENSEE is responsible.
(a) If REGENTS (to the extent of the actual knowledge of the licensing professional responsible for administration of this case) or a third party discovers and notifies that licensing professional that the INVENTION is useful for an application covered by the LICENSED FIELD OF USE, but for which LICENSED PRODUCTS have not been developed or are not currently under development by LICENSEE, then REGENTS, as represented by the Office of Technology Licensing, will give written notice to LICENSEE, except for: 1) information that is subject to restrictions of confidentiality with third parties, and 2) information which originates with REGENTS’ personnel who do not assent to its disclosure to LICENSEE. LICENSEE will have ninety (90) days to give REGENTS written notice stating whether LICENSEE elects to develop LICENSED PRODUCTS for the application.
(b) If LICENSEE elects to develop and commercialize the proposed LICENSED PRODUCTS for the new application, LICENSEE will submit progress reports or royalty reports to REGENTS pursuant to Article 8 (Progress and Royalty Reports). If LICENSEE elects not to develop and commercialize the proposed LICENSED PRODUCTS for use in the new application, REGENTS may seek (a) third party(ies) to develop and commercialize the proposed LICENSED PRODUCTS for the new application. If REGENTS is successful in finding a third party, it will refer such third party to LICENSEE. If the third party requests a SUBLICENSE under this AGREEMENT, then LICENSEE will report the request to REGENTS within thirty (30) days from the date of such written request. If the request results in a SUBLICENSE, then LICENSEE will report it to REGENTS pursuant to Paragraph 4.3
(c) If LICENSEE refuses to grant a SUBLICENSE to the third party, then within thirty (30) days after such refusal LICENSEE will submit to REGENTS a report specifying the license terms proposed by the third party and a written justification for LICENSEE’s refusal to grant the proposed SUBLICENSE. If REGENTS, at its sole discretion, determines that the terms of the SUBLICENSE proposed by the third party are reasonable under the totality of the circumstances, taking into account
LICENSEE’s LICENSED PRODUCTS in development, then REGENTS will have the right to grant to the third party a license to make, have made, use, SELL, offer for sale and import products for use in the LICENSED FIELD OF USE at substantially the same terms last proposed to LICENSEE by the third party providing royalty rates are at least equal to those paid by LICENSEE.
7.1 Development of Licensed Products and/or Licensed Services. LICENSEE, upon execution of this AGREEMENT, will diligently proceed with the development, manufacture, and SALE of LICENSED PRODUCTS and/or LICENSED SERVICES, and will diligently market them in quantities sufficient to meet the market demand.
7.2 Development Milestones. In addition to its obligations under Paragraph 7.1, LICENSEE specifically commits to achieving the following development milestones in its diligence activities under this AGREEMENT: (a) (b).
7.3 Failure to Meet Development Milestones.
(a) If LICENSEE is unable to meet any of its diligence obligations set forth in Paragraphs 7.1 and 7.2, then REGENTS will so notify LICENSEE of failure to perform. LICENSEE will have the right and option to extend the target date of any such due diligence obligation for a period of six (6) months upon the payment of [Written amount]_thousand dollars ($ Number) within thirty (30) days of the date to be extended for each such extension option exercised by LICENSEE. LICENSEE may further extend the target date of any diligence obligation for an additional six (6) months upon payment of an additional [Written amount] thousand dollars ($ Number). Additional extensions may be granted only by mutual written AGREEMENT of the parties to this AGREEMENT. These payments are in addition to the minimum royalty payments specified in Paragraph 6.5. Should LICENSEE opt not to extend the obligation or fail to meet it by the extended target date, then REGENTS will have the right and option either to terminate this AGREEMENT or to reduce LICENSEE’s exclusive license to a non-exclusive royalty-bearing license. This right, if exercised by REGENTS, supersedes the rights granted in Article 3 (Grant). The right to terminate this AGREEMENT or reduce LICENSEE’s exclusive license granted hereunder to a non-exclusive license will be REGENTS’ sole remedy for breach of Paragraph 7.1 or 7.2.
(b) To exercise either the right to terminate this AGREEMENT or to reduce the license to a non-exclusive license for lack of diligence under Paragraph 7.1 or 7.2, REGENTS will give LICENSEE written notice of the deficiency. LICENSEE thereafter has sixty (60) days to cure the deficiency. If REGENTS has not received satisfactory tangible evidence that the deficiency has been cured by the end of the sixty (60) – day period, then REGENTS may, at its option, either terminate the AGREEMENT or reduce LICENSEE’s exclusive license to a non-exclusive license by giving written notice to LICENSEE. These notices will be subject to Article 23 (Notices).