“Government Rights” means the rights of the United States of America or other government entity in subject matter licensed under this Agreement, including without limitation those set forth in 35 U.S.C. §200 et seq. or any successor thereto, as well as federal regulations promulgated thereunder, all as modified and in effect from time to time.
2.01 Grant. Subject to all of the terms, conditions set forth in this Agreement, the University hereby grants to Licensee, and Licensee hereby accepts, a right and license: (a) under the Patent Rights, to make, have made, use, lease, offer to sell, sell and import Licensed Products; and/or to practice Licensed Processes; and/or (b) under the Copyright, to use, reproduce, prepare derivative works, perform, display, and distribute all or any part of the Software [Remove all references to Software and/or Copyright if not part of license], separately or with or as part of any product or service; in each case: (i) directly or by sublicense (subject to Section 2.03 hereof); and (ii) only in the Field of Use within the Territory during the Term.
2.02 Exclusivity. Subject to the Reserved Rights and the Government Rights (if any), which are expressly reserved in this Agreement, the license granted under Section 2.01(a) hereof is exclusive during the Exclusive Period, and thereafter is non–exclusive. All other aspects of the license granted in Section 2.01 are non–exclusive to Licensee.
2.03 Sublicenses. Subject to sections 2.03 (A)-(K), below, the grant under Section 2.01, above, includes a right for Licensee to enter into Sublicenses provided that Licensee shall not grant any Sublicenses (other than a Label License) after the expiration or termination of the Exclusive Period.
(A) Obligations To University. Any Sublicense (excluding Label Licenses which are separately addressed in Section 2.03(J), below) will specify that it is subject to – 6 – this Agreement and that any Permitted Sublicensee agrees to be bound directly to the University in respect of all obligations to the University set forth in ARTICLE II, Sections 2.03, 2.04, 2.05, 2.06, 2.07 [Remove 2.07 if no healthcare technology] and 2.08 [DELETE IF NO COPYRIGHT], ARTICLE III, Section 3.01(E), ARTICLE IV, Sections 4.01(D) and (E) as applicable, ARTICLE V (all), ARTICLE VI, Sections 6.01, 6.02 and 6.03, ARTICLE VII (all), ARTICLE IX (all), ARTICLE X (all) and ARTICLE XI, Section 11.01.
(B) Copy To University. A copy of each Sublicense and each amendment thereto or waiver issued in connection therewith will be sent to the University within thirty (30) days of execution by the parties thereto and Licensee will send a comtemporanous copy to University of any termination notice sent to a Permitted Sublicensee.
(C) Consideration. Subject to Section 2.03(K), Licensee is not permitted to grant sublicenses to the Patent Rights and/or Copyright [DELETE IF NO COPYRIGHT] for no consideration without prior written consent of University. Moreover, without the prior written consent of the University, consideration for any Sublicense will not include anything of value in lieu of cash payments. For the avoidance of any doubt, the requirements of this Section 2.03(C) forbid Licensee from sublicensing the Patent Rights and/or Copyright [DELETE IF NO COPYRIGHT] as part of a cross–license agreement or as part of a settlement agreement without the University’s prior written consent after full disclosure of the entire transaction contemplated by Licensee that in any way involves the Patent Rights and/or Copyright [DELETE IF NO COPYRIGHT].
(D) No Waivers. Without the prior written consent of the University, Licensee will not waive any material default or breach under any Sublicense and will not waive any breach or default of any of the requirements of Section 2.03(A).
(E) Termination. Any Sublicense may specify that in the event of termination of this Agreement, so long as Sublicense complies with this Agreement said Sublicense will continue in full force and effect and all rights and obligations of the – 7 – Sublicensee, including without limitation the payment of royalties specified in said Sublicense, will inure to the benefit of the University or its designee. Notwithstanding any other provision of this Agreement, University shall not assume any obligation under any Sublicense without its prior written consent.
(F) Further Sublicensing. Without the prior written consent of University, a Permitted Sublicensee shall not grant any sublicense except that a Permitted Sublicensee may: 1) grant a Label License so that any product it sells to an EndUser may be used for its intended purpose only with respect to amounts of product purchased; and/or 2) grant a royalty–free sublicense solely to conduct Clinical Trials as specified in Section 2.03(K). Any purported sublicense granted by a Permitted Sublicensee (other than as expressly permitted herein) that has not been authorized by written consent of the University will be null and void and constitute a material breach of this Agreement.
(G) No Enforcement of Patents. Without prior written consent of University, no Sublicense granted by Licensee may grant any Permitted Sublicensee a right to enforce the Patent Rights and/or rights in the Copyright [DELETE IF NO COPYRIGHT].
(H) Compulsory Licensing. Licensee or its Permitted Sublicensee(s) (as applicable) will promptly notify University should a compulsory license be granted, or be the subject of a possible grant, by Licensee or a Permitted Sublicensee to a third party under the applicable laws, rules, regulations, guidelines, or other directives of any governmental or supranational agency in the Territory under the Patent Rights and/or Copyright [DELETE IF NO COPYRIGHT]. Said notice will include any material information concerning such compulsory license, and the running royalty rates payable. To the extent that any terms and/or conditions of said compulsory license are: 1) inconsistent with Licensee’s obligations under this Agreement; and 2) dictated by said applicable laws, rules, regulations, guidelines, or other directives of any governmental or supranational agency, there is no breach of this Agreement. Notwithstanding the foregoing, to the extent permitted by law – 8 – Licensee must still pay to University all applicable royalties and fees due under Section 4.01 on amounts actually collected under said compulsory license(s).
(I) Sublicensing To A Large Entity. Licensee will notify University within ten (10) business days if it grants a Sublicense to any entity that is not a ‘small entity’ within the meaning set forth in 37 C.F.R.§1.27. Licensee will likewise require its Permitted Sublicensees to notify University within ten (10) business days in the event that said Permitted Sublicensee grants a sublicense to any entity that is not a ‘small entity’ within the meaning set forth in 37 C.F.R. §1.27. For the avoidance of any doubt, a Label License is not a Sublicense for purposes of this Section 2.03(I).
(J) Label Licenses. Any Label License (or the product associated therewith) is subject to this Agreement and, in particular, must comply, or be consistent, with Sections 2.03(G), 6.01 and 6.02. All Licensed Product sold under a Label License will be subject to all of ARTICLE VII provided that the Licensee or its Permitted Sublicensee, rather than the End User, will be the responsible/liable party. Any right or license under a Label License applies only to the amount of Licensed Product contained in the container or packaging bearing the Label License. Any dispute with University associated with any Label License or product under a Label License will be resolved in accordance with ARTICLE X.
(K) Clinical Trials. Licensee and its Permitted Sublicensees may grant to a third party a royalty–free sublicense solely for the purpose of conducting a clinical trial or other research and/or development activity associated with the use of Licensed Products and/or Licensed Processes as may be required by the Food and Drug Administration (FDA) or other governmental regulatory agency from time to time (collectively “Clinical Trials”). This grant is limited to the duration of and activities directly associated with any Clinical Trials.
2.04 Reserved Rights. University reserves the right to itself, Boston Medical Center Corporation and other non–profit academic research institutions (individually and – 9 – collectively the “Institutions”) to in any way practice and/or use the Patent Rights and/or Copyright [DELETE IF NO COPYRIGHT] for any non–profit purpose, including sponsored research and/or collaborations (collectively, the “Reserved Rights”). Licensee agrees that, notwithstanding any other provision of this Agreement, it has no right to enforce any of the Patent Rights and/or Copyright [DELETE IF NO COPYRIGHT] against the Institutions when used by them for a non–profit purpose. Licensee also agrees that the Institutions have the right to publish any information included in the Patent Rights and/or Copyright [DELETE IF NO COPYRIGHT].
2.05 Government Rights. This Agreement is subject to, and University hereby reserves, any applicable Government Rights.
2.06 Other Rights. The license granted in this Agreement shall not be construed to confer any rights upon Licensee by implication, estoppel or otherwise: (a) to any technology or other intellectual property right of University not specifically set forth in the Patent Rights and/or Copyright [DELETE IF NO COPYRIGHT] regardless of whether such technology or patent rights shall be dominate or subordinate to any Patent Rights; or (b) beyond such rights as are expressly set forth herein. Without limitation, Licensor further reserves the right to practice, license or otherwise commercialize or use (A) all intellectual property rights that are not Patent Rights and/or Copyright [DELETE IF NO COPYRIGHT] and/or (B) any of the Patent Rights and/or Copyright [DELETE IF NO COPYRIGHT] outside the Field of Use and/or the Territory.
3. Representations & Due Diligence
3.02 Commercially Reasonable Efforts. Licensee will use commercially reasonable efforts to bring the Licensed Products to market in the United States and throughout the remainder of the Territory through a diligent program for exploiting the Patent Rights and/or Copyright [DELETE IF NO COPYRIGHT] in the Field of Use and will, throughout the Term, use commercially reasonable efforts to continue development and marketing efforts with respect to the Licensed Products and/or Licensed Processes, in each case consistent with reasonable business practices and judgments.