License and Authorization. The agreements and obligations expressed herein are subject to such initial and continuing governmental permission and authorization as may be required. Each Party shall be responsible for securing and paying for any approvals required by it from any regulatory agency of competent jurisdiction relating to its participation in this Agreement and will reasonably cooperate with the other Party in seeking such approvals.
License and Authorization. (i) Subject to the terms and conditions set forth in this Agreement, PARI hereby grants to INSMED and its designees, a non-exclusive, non-transferable right and license to use PARI’s trademark(s) set forth on Exhibit H attached hereto, in the INSMED Territory in connection with (w) the PARI Products, (x) the INSMED Products offered by INSMED and its designees, and (y) any advertising or promotional materials associated therewith, in the manner mutually agreed to by the Parties pursuant to Section 3.4 of this Agreement, and (z) packaging and prescribing information. The license set forth herein shall immediately terminate with respect to (w), (x), and (y), upon expiration or sooner termination of this Agreement and with respect to (z), upon expiration or sooner termination of the License Agreement.
(ii) Subject to the terms and conditions set forth in this Agreement, INSMED hereby grants to PARI a non-exclusive, non-transferable right and license to use INSMED’s trademark(s) set forth on Exhibit H attached hereto, in the INSMED Territory in connection with (x) the PARI Products and (y) any advertising or promotional materials associated therewith, in the manner mutually agreed to by the Parties pursuant to Section 3.4 of this Agreement, and (z) packaging and prescribing information. The license set forth herein shall immediately terminate with respect to (x), and (y), upon expiration or sooner termination of this Agreement and with respect to (z), upon expiration or sooner termination of the License Agreement.
License and Authorization. 2.1 Supernus hereby grants to Actavis and its Affiliates a non-exclusive, non-transferable (except as set forth in Section 10.3) license, without the right to sublicense, under the Licensed Patents to: (i) on and after the applicable **, to **, **, **, ** for **, ** and ** the ** in or for the **; (ii) starting ** to a reasonably anticipated **, to **, **, and/or ** the ** solely for the purpose of ** for a ** of such Actavis Product in or for the ** on the **; and (iii) starting ** to a reasonably anticipated **, to engage in ** including ** and ** in **, and enter into ** beginning ** to a reasonably anticipated **. To the extent Supernus owns or controls any regulatory exclusivities granted by the FDA that may prevent Regulatory Approval or Marketing of the Actavis Product Supernus hereby unconditionally and irrevocably waives, effective as of the date that Actavis is licensed to conduct the applicable activity hereunder, such regulatory exclusivities and shall, if requested by Actavis and if applicable, send the FDA a written confirmation of Supernus’ agreement to waive, effective as of the date that Actavis is licensed to conduct the applicable activity hereunder, such regulatory exclusivities with respect to the Actavis Product or the Actavis ANDA. Supernus will also cooperate with Actavis to submit a letter pursuant to 21 C.F.R. §314.94(a)(12)(v), attached hereto as Attachment A.
2.2 Except as set forth in Section 2.1 or expressly set forth in this License Agreement or other Settlement Documents, there are no authorizations, licenses or rights granted by either Party under this License Agreement, by implication, estoppel or otherwise, including any right granted to Actavis or its Affiliates to Market or Manufacture any Generic Equivalent Product except under the Actavis ANDA. All rights not expressly granted by Supernus herein are hereby retained by Supernus. In addition, except as expressly set forth in this License Agreement or other Settlement Documents, ** explicitly ** the ** itself or through an Affiliate to ** an **, and ** is ** to ** a ** the ** or, subject to the requirements of **, ** to any **. ** This portion has been redacted pursuant to a confidential treatment request.
License and Authorization i. Subject to the terms, conditions, and limitations hereof, including the conditions set forth in Section 3, Supernus hereby grants to Apotex a royalty-free license under the Licensed Patents to: (i) Market the Apotex Product in, into, or for the Territory, on and after the applicable Apotex License Date; (ii) Manufacture and have Manufactured, import, and conduct regulatory activities regarding the Apotex Product in, into, or for the Territory prior to the Apotex License Date (but not to Market or Ship the Apotex Product prior to the Apotex License Date) in sufficient quantities to permit Apotex to Market and Ship the Apotex Product in, into, or for the Territory beginning [**]; provided that all [**] remain at [**] until an [**]. With the 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 Supernus owns or controls any regulatory exclusivities granted by the FDA that may prevent or hinder Regulatory Approval or Marketing of the Apotex Product, Supernus hereby waives, effective as of the Apotex License Date, such exclusivities. Supernus shall, if requested by Apotex, send the FDA a written confirmation of Supernus’s grant of the foregoing license under the Licensed Patents and Supernus’s agreement to waive, effective as of the date that Apotex is licensed to conduct the applicable activity hereunder, such regulatory exclusivities with respect to the Apotex Product or Apotex ANDA, as necessary to effectuate the 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 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 Licensed 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.
ii. The license and authorization granted ...
License and Authorization. 2.1. Subject to the terms, conditions, and limitations hereof, including the conditions set forth in Section 3, Supernus hereby grants to Zydus a non-exclusive license, under the Licensed Patents to: (i) Manufacture, have Manufactured, import, use, and Market the Zydus 200 mg Product in, into, or for the Territory, on and after the applicable Zydus 200 mg Product License Date; and (ii) Manufacture, and have Manufactured, import, and conduct regulatory activities regarding the Zydus 200 mg Product in, into, or for the Territory prior to the Zydus 200 mg Product License Date (but not to Market or Ship the Zydus 200 mg Product prior to the Zydus 200 mg Product License Date) in sufficient quantities to permit Zydus to Market and Ship the Zydus 200 mg Product in, into, or for the Territory beginning [**] prior to the Zydus 200 mg Product License Date, (iii) beginning [**] to a date in good faith anticipated by Zydus to be the date that a Final Court Decision will be entered finding all the claims of the Litigated Patents asserted and finally adjudicated against a Third Party [**] with respect to a Generic Equivalent 200 mg Product to be invalid, unenforceable, or not infringed by such Generic Equivalent 200 mg Product (a “Potential Final Court Decision”), Manufacture, and have Manufactured, import, and conduct regulatory activities regarding the Zydus 200 mg Product in, into, or for the Territory prior to the Zydus 200 mg Product License Date (but not to Market or Ship the Zydus 200 mg Product prior to the Zydus 200 mg Product License Date) in sufficient quantities to permit Zydus to Market and Ship the Zydus 200 mg Product in, into, or for the Territory on and after the Zydus 200 mg Product License Date; provided that all Zydus 200 mg Product remain at Zydus’ or its distributor’s warehouse until a Zydus 200 mg Product License Date; and further provided, that Zydus shall re-export (or, at Zydus’ option, destroy) any Zydus 200 mg Product which remains in the Territory at such time that Zydus in good faith determines that no such Final Court Decision will be issued with respect to a Third Party’s Generic Equivalent 200 mg Product and no Accelerated Zydus 200 mg Product License Date will result from such Potential Final Court Decision. To the extent Supernus owns or controls any regulatory exclusivities granted by the FDA that may prevent or hinder Regulatory Approval or Marketing of the Zydus 200 mg Product, Supernus hereby waives, effective as of the date that Z...
License and Authorization. 17.1 Subject to the terms, conditions, and limitations hereof, including the conditions set forth in Section 3, Supernus hereby grants to Ascent a non-exclusive license, under the Licensed Patents to: (i) Manufacture, have Manufactured, import, use, and Market the Ascent Product in, into, or for the Territory, on and after the applicable Ascent License Date; and (ii) Manufacture, and have Manufactured, import, and conduct regulatory activities regarding the Ascent Product in, into, or for the Territory prior to the Ascent License Date (but not to Market or Ship the Ascent Product prior to the Ascent License Date) in sufficient quantities to permit Ascent to Market and Ship the Ascent Product in, into, or for the Territory beginning [**] prior to the Ascent License Date, and (iii) beginning [**] prior to a date in good faith anticipated by Ascent to be the date that one or more Final PTO Decisions and/or Final Court Decisions will be entered finding all the claims of the Litigated Patents asserted and finally adjudicated against a Third Party which had originally filed an ANDA or 505(b)(2) application with respect to a Generic Equivalent Product or product subject to a Section 505(b)(2) application referencing the Trokendi XR Product as the reference listed drug after January 1, 2015, with a “Paragraph IV Certification” under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (as amended or replaced) or 21 U.S.C. § 355(b)(2)(A)(iv) (as amended or replaced) with respect to a Generic Equivalent Product or product subject to a Section 505(b)(2) application referencing the Trokendi XR Product as the reference listed drug to be invalid, unenforceable, or not infringed by such Generic Equivalent 52483680.4 08/01/2024 Product or product subject to a Section 505(b)(2) application referencing the Trokendi XR Product as the reference listed drug (a “Potential Final Court Decision”), Manufacture, and have Manufactured, import, and conduct regulatory activities regarding the Ascent Product in, into, or for the Territory prior to the Ascent License Date (but not to Market or Ship the Ascent Product prior to the Ascent License Date) in sufficient quantities to permit Ascent to Market and Ship the Ascent Product in, into, or for the Territory on and after the Ascent License Date; provided that all Ascent Product in the Territory shall be remain at Ascent’s or its Designated Distributor’s warehouse until an Ascent License Date; and further provided, that Ascent or its Designated Distributo...
License and Authorization. Subject to and conditioned on the Customer’s compliance with the Customer Agreement (including Customer’s timely payment of the fees specified under the Customer Agreement) and Screening Agency’s compliance with this Agreement, HealthIM grants Screening Agency a limited, non-exclusive, revocable and non-transferable license to:
a. download, install and use the Client Software on one or more devices or computers owned or otherwise controlled by Screening Agency, solely for the purpose of accessing and using the Services;
b. permit Receiving Agencies to download, install and use the Client Software on one or more devices or computers owned or otherwise controlled by the Receiving Agency, solely for the purpose of accessing and using the Services on a restricted basis as described above; and
c. access and use the Services, in the form provided to Screening Agency by HealthIM by and through the Client Software and Server Software, in each case strictly in accordance with this Agreement. Any Client Software or Server Software upgrades, updates or versions shall be provided in HealthIM’s sole discretion, and are subject to the terms and conditions of this Agreement. Screening Agency and Receiving Agencies do not have the right to obtain or use any source code for the Server Software or Client Software. Screening Agency shall be responsible for such Receiving Agencies’ and its and each such Receiving Agency’s Authorized Users’ access to and use of the Client Software and Services and for compliance with this Agreement by such persons and organizations, and a breach of this Agreement by such Receiving Agency or Authorized User will be deemed to be a breach of this Agreement by Screening Agency (and Screening Agency will be liable for such breach).
License and Authorization. As between HealthIM and Screening Agency, Screening Agency will be and remain the owner of all Data. Screening Agency grants HealthIM a license to use and transmit such Data for the purposes described in Sections 4.2, 4.3 and 4.4 below and otherwise solely to provide Screening Agency and the Receiving Agencies with the Services in accordance with this Agreement and to comply with any mandatory legal requirements.
License and Authorization. 2.1 Subject to the terms, conditions and limitations hereof, including the conditions set forth in
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. ...
