Common use of License and Authorization Clause in Contracts

License and Authorization. 2.1. Subject to the terms, conditions and limitations hereof, including the conditions set forth in Section 3, MDCO hereby grants to Teva a non-exclusive license, under MDCO’s Patents to: (i) Manufacture, have Manufactured, import and Market the Teva Product in or for the Territory, on and after the applicable Teva Launch Date; and (ii) Manufacture, and have Manufactured, import and conduct regulatory activities regarding Teva Product prior to the Teva Launch Date (but not to Market (except as provided in Section 3.1) or Ship the Teva Product prior to the Teva Launch Date) in sufficient quantities for the Launch of Teva Product and to permit Teva to Market and Ship the Teva Product beginning on and after the Teva Launch Date. To the extent MDCO owns or controls any regulatory exclusivities granted by the FDA that may prevent Regulatory Approval of the Teva Product or Teva’s Manufacture, importing or Marketing of Teva Product in the Territory as permitted hereunder, MDCO hereby waives, effective as of the date that Teva is licensed to conduct the applicable activity hereunder, such exclusivities and shall, if requested by Teva and if applicable, send the FDA, a written confirmation of MDCO’s agreement to waive, effective as of the date that Teva is licensed to conduct the applicable activity hereunder, such regulatory exclusivities with respect to the Teva Product and/or the Teva ANDA; provided, however, that the foregoing waiver shall not apply with respect to any pediatric exclusivity attached to the ‘404 Patent. 2.2. The license, waiver and authorization granted in Sections 2.1 and 3.1 of this Agreement are referred to herein as the “License and Authorization.” Except to the extent permitted pursuant to Section 13.3, and without derogating from Teva’s “have Manufactured” rights set forth in Section 2.1, Teva shall not have the right to sublicense, assign or transfer any of its rights under the License and Authorization. 2.3. [**]. 2.4. Except as set forth in the License and Authorization or expressly set forth in this Agreement, there are no authorizations, licenses or rights granted by either Party under this Agreement, by implication, estoppel or otherwise, including any right granted to Teva to Market or Manufacture any Generic Equivalent Product except under the Teva ANDA. Nothing herein shall be construed as the granting or any license or right to or under the ‘404 Patent. All rights not expressly granted by MDCO herein are hereby retained by MDCO. In addition, MDCO explicitly retains the right itself or through an Affiliate to Market an generically Labeled version of Angiomax, and MDCO is free to grant a license under MDCO’s Patents and/or supply AG Product to any Third Party. 2.5. In the event MDCO authorizes, whether pursuant to a license, supply arrangement, covenant not to ▇▇▇, release, waiver or the like (other than the granting of a retroactive license, covenant not to ▇▇▇, release, waiver or the like, to a Third Party with respect to past Marketing or Manufacturing of a Generic Equivalent Product (including the future Marketing of Generic Equivalent Product already Manufactured or in the processes of being Manufactured)), a Third Party [**] to sell a Generic Equivalent Product or an Authorized AG Product [**], MDCO shall inform Teva [**].

License and Authorization. 2.1. Subject to the terms, conditions and limitations hereof, including the conditions set forth in Section 3, MDCO Supernus hereby grants to Teva Par a non-exclusive license, under MDCO’s the Licensed Patents to: (i) Manufacture, have Manufactured, import import, use and Market the Teva Par Product in or for the Territory, on and after the applicable Teva Launch Par License Date; and (ii) Manufacture, and have Manufactured, import and conduct regulatory activities regarding Teva the Par Product in or for the Territory prior to the Teva Launch Par License Date (but not to Market (except as provided in Section 3.1) or Ship the Teva Par Product prior to the Teva Launch Par License Date) in sufficient quantities for the Launch of Teva Product and to permit Teva Par to Market and Ship the Teva Par Product in or for the Territory beginning on and after the Teva Launch Par License Date. To the extent MDCO Supernus owns or controls any regulatory exclusivities granted by the FDA that may prevent Regulatory Approval of the Teva Par Product or Teva’s Manufacture, importing or Marketing of Teva Product in the Territory as permitted hereunder, MDCO Supernus hereby waives, effective as of the date that Teva Par is licensed to conduct the applicable activity hereunder, such exclusivities and shall, if requested by Teva Par and if applicable, send the FDA, FDA a written confirmation of MDCO’s Supernus’ agreement to waive, effective as of the date that Teva Par is licensed to conduct the applicable activity hereunder, such regulatory exclusivities with respect to the Teva Par Product and/or or the Teva Par ANDA; provided, however, that the foregoing waiver shall not apply with respect to any pediatric exclusivity attached to the ‘404 Patent. 2.2. The license, waiver license and authorization granted in Sections Section 2.1 and 3.1 of this License Agreement are referred to herein as the “License and Authorization.” Except to the extent permitted pursuant to Section 13.311.3, and without derogating from TevaPar’s “have Manufactured” rights set forth in Section 2.1, Teva Par and its Affiliates shall not have the right to sublicense, assign or transfer any of its rights under the License and Authorization. 2.3. [In the event the ** becomes effective due to an *]* and there are thereafter no longer any ** the ** in the ** (other than ** or ** subject to substantially the same provisions as set forth in this Section), ** from ** to ** under the ** shall immediately terminate, and ** and ** shall ** the ** of ** until such subsequent ** as another event constituting a ** shall have occurred. 2.4. Except as set forth in the License and Authorization or expressly set forth in this AgreementLicense Agreement or other Settlement Documents, there are no authorizations, licenses or rights granted by either Party under this Agreement, by implication, estoppel or otherwise, including any right granted to Teva Par or its Affiliates to Market or Manufacture any Generic Equivalent Product except under the Teva Par ANDA. Nothing herein shall be construed as the granting or any license or right to or under the ‘404 Patent. All rights not expressly granted by MDCO Supernus herein are hereby retained by MDCOSupernus. In addition, MDCO except as expressly set forth in this License Agreement or other Settlement Documents, Supernus explicitly retains the right itself or through an Affiliate to Market an generically Labeled version of AngiomaxAG Product, and MDCO Supernus is free to grant a license under MDCO’s the Licensed Patents and/or or supply AG Product to any Third Party. 2.5. In the event MDCO authorizes, whether pursuant to a license, supply arrangement, covenant not to ▇▇▇, release, waiver or the like (other than the granting of a retroactive license, covenant not to ▇▇▇, release, waiver or the like, to a Third Party with respect to past Marketing or Manufacturing of a Generic Equivalent Product (including the future Marketing of Generic Equivalent Product already Manufactured or in the processes of being Manufactured)), a Third Party [**] to sell a Generic Equivalent Product or an Authorized AG Product [**], MDCO shall inform Teva [**].

License and Authorization. 2.1. i. Subject to the terms, conditions conditions, and limitations hereof, including the conditions set forth in Section 3, MDCO Supernus hereby grants to Teva Apotex a nonroyalty-exclusive license, free license under MDCO’s the Licensed Patents to: (i) Manufacture, have Manufactured, import and Market the Teva Apotex Product in in, into, or for the Territory, on and after the applicable Teva Launch Apotex License Date; and (ii) Manufacture, Manufacture and have Manufactured, import import, and conduct regulatory activities regarding Teva the Apotex Product in, into, or for the Territory prior to the Teva Launch Apotex License Date (but not to Market (except as provided in Section 3.1) or Ship the Teva Apotex Product prior to the Teva Launch Apotex License Date) in sufficient quantities for the Launch of Teva Product and to permit Teva Apotex to Market and Ship the Teva Apotex Product in, into, or for the Territory beginning on and after [**]; provided that all [**] remain at [**] until an [**]. With the Teva Launch Date. To exception of the termination of the stay of approval under 21 U.S.C. § 3 5 5(j )(5)(B)(iii) as provided herein, including in Exhibit B, to the extent MDCO Supernus owns or controls any regulatory exclusivities granted by the FDA that may prevent or hinder Regulatory Approval of the Teva Product or Teva’s Manufacture, importing or Marketing of Teva Product in the Territory as permitted hereunderApotex Product, MDCO Supernus hereby waives, effective as of the date that Teva is licensed to conduct the applicable activity hereunderApotex License Date, such exclusivities and exclusivities. Supernus shall, if requested by Teva and if applicableApotex, send the FDA, FDA a written confirmation of MDCOSupernus’s grant of the foregoing license under the Licensed Patents and Supernus’s agreement to waive, effective as of the date that Teva Apotex is licensed to conduct the applicable activity hereunder, such regulatory exclusivities with respect to the Teva Apotex Product and/or or Apotex ANDA, as necessary to effectuate the Teva ANDA; provided, however, that the foregoing waiver shall not apply with respect licenses granted by this Agreement (in a form substantially identical to Exhibit C). The license granted to Apotex in this Section 2.1 and Section 3.1 will be exclusive as to any pediatric exclusivity attached Third Party Generic Equivalent Product during the Exclusive License Period and non-exclusive thereafter. For the avoidance of doubt, and notwithstanding the foregoing, the Parties agree that Supernus retains the right itself or through an Affiliate or through any Third Party to Market an AG Product, and Supernus is free to grant a license under the ‘404 PatentLicensed Patents or supply AG Product to any Third Party for purposes of Marketing an AG Product at any time and under any circumstances, including before, during, or after the Exclusive License Period. Supernus shall provide notice to Apotex pursuant to Section 11.2 not less than ninety (90) days before the First Commercial Sale of AG Product by Supernus or its Affiliates or a Third Party. 2.2ii. The license, waiver license and authorization granted in Sections Section 2.1 and Section 3.1 of this License Agreement are referred to herein as the “License and Authorization.” Except to the extent permitted pursuant to Section 13.311.3, and without derogating from TevaApotex’s “have Manufactured” rights set forth in Section 2.1, Teva Apotex and its Affiliates shall not have the right to sublicense, assign assign, or transfer any of its rights under the License and Authorization. 2.3▇▇▇. ▇▇ the event [**]] becomes effective due to an [**] and there are thereafter no longer any [**] the [**] in the [**] (other than [**] ), upon notice from [**] to [**] under [**] shall immediately terminate, and [**] and its [**] shall [**] (no [**] than the [**] of the [**] following Apotex’s receipt of such notice) the [**] and [**] of [**] until such subsequent [**] as another event constituting an [**] shall have occurred. 2.4iv. Except as set forth in the License and Authorization or expressly set forth in this AgreementLicense Agreement or other Settlement Documents, there are no authorizations, licenses licenses, or rights granted by either Party under this License Agreement, by implication, estoppel estoppel, or otherwise, including any right granted to Teva Apotex or its Affiliates to Market or Manufacture any Generic Equivalent Product except under the Teva Apotex ANDA. Nothing herein shall be construed as the granting or any license or right to or under the ‘404 Patent. All rights not expressly granted by MDCO Supernus herein are hereby retained by MDCO▇▇▇▇▇▇▇▇. In addition, MDCO Supernus explicitly retains the right itself or through an Affiliate or through any Third Party to Market an generically Labeled version of AngiomaxAG Product, and MDCO Supernus is free to grant a license under MDCO’s the Licensed Patents and/or or supply AG Product to any Third PartyParty for purposes of Marketing an AG Product, both at any time. 2.5. In the event MDCO authorizes, whether pursuant to a license, supply arrangement, covenant not to ▇▇▇, release, waiver or the like (other than the granting of a retroactive license, covenant not to ▇▇▇, release, waiver or the like, to a Third Party with respect to past Marketing or Manufacturing of a Generic Equivalent Product (including the future Marketing of Generic Equivalent Product already Manufactured or in the processes of being Manufactured)), a Third Party [**] to sell a Generic Equivalent Product or an Authorized AG Product [**], MDCO shall inform Teva [**].