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.
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.
License and Authorization. (1) Subject to the terms and conditions set forth in this Agreement, PARI hereby grants to Serendex and its designees, a non-exclusive, nontransferable [***] Indicates that information has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. EXECUTION COPY right and license to use PARI’s trademark(s) set forth on Exhibit B attached hereto, in the Territory in connection with (w) the PARI Products, (x) the Serendex Products offered by Serendex 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 of PARI Products and Serendex Products. The license set forth herein shall immediately terminate upon expiration or sooner termination of this Agreement.
License and Authorization. (i) Subject to the terms and conditions set forth in this Agreement, PARI hereby grants to RAPTOR and its designees, a non-exclusive, non-transferable right and license to use PARI’s trademark(s) set forth on Exhibit D attached hereto, in the Territory in connection with (w) the PARI Products, (x) the RAPTOR Products offered [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission Confidential treatment has been requested with respect to portions of this agreement. by RAPTOR 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 Development Agreement.
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 EXECUTION COPY 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 Design...
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, Supernus hereby grants to Zydus a non-exclusive license, under the Licensed Patents to: (i) Manufacture, have Manufactured, import, use and Market the Zydus Product in, into or for the Territory, on and after the applicable Zydus License Date; and (ii) Manufacture, and have Manufactured, import and conduct regulatory activities regarding the Zydus Product in, into or for the Territory prior to the Zydus License Date (but not to Market or Ship the Zydus Product prior to the Zydus License Date) in sufficient quantities to permit Zydus to Market and Ship the Zydus Product in, into or for the Territory beginning ** prior to the Zydus License Date, (iii) beginning ** prior to a date in good faith anticipated by Zydus to be the date ** This portion has been redacted pursuant to a confidential treatment request.
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.
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 Par a non-exclusive license, under the Licensed Patents to: (i) Manufacture, have Manufactured, import, use and Market the Par Product in or for the Territory, on and after the applicable Par License Date; and (ii) Manufacture, and have Manufactured, import and conduct regulatory activities regarding the Par Product in or for the Territory prior to the Par License Date (but not to Market (except as provided in Section 3.1) or Ship the Par Product prior to the Par License Date) in sufficient quantities to permit Par to Market and Ship the Par Product in or for the Territory beginning on and after the Par License Date. To the extent Supernus owns or controls any regulatory exclusivities granted by the FDA that may prevent Regulatory Approval of the Par Product Supernus hereby waives, effective as of the date that Par is licensed to conduct the applicable activity hereunder, such exclusivities and shall, if requested by Par and if applicable, send the FDA a written confirmation of Supernus’ agreement to waive, effective as of the date that Par is licensed to conduct the applicable activity hereunder, such regulatory exclusivities with respect to the Par Product or the Par ANDA.
