Common use of Certain Additional Covenants Clause in Contracts

Certain Additional Covenants. (a) Each Party shall comply in all material respects with all laws, rules and regulations applicable to its performance under this Agreement. Without limiting the foregoing, Licensee shall conduct its marketing and sales activities under this Agreement in compliance with applicable laws, rules and regulations and prevailing pharmaceutical industry standards. (b) Teikoku shall not grant to any Third Party any rights inconsistent with the rights and licenses granted to Licensee under this Agreement and Teikoku will (i) use Commercially Reasonable Efforts to maintain the Teikoku Patent Rights during the Term and (ii) give prompt written notice to Licensee a reasonable time in advance of any action by Teikoku to abandon, or that may adversely affect the prosecution and/or maintenance of, the Teikoku Patent Rights and provide Licensee with a reasonable opportunity to prosecute and/or maintain the affected Teikoku Patent Rights at Licensee’s sole cost and expense. If Licensee assumes the prosecution and/or maintenance thereof, such Teikoku Patent Rights shall cease to be included in the definition of Teikoku Patent Rights as set forth in Section 1.64. (c) Teikoku shall promptly notify Licensee in writing upon becoming aware: (i) of any actual or threatened claim, judgment or settlement against or owed by Teikoku with respect to any of the Teikoku Intellectual Property, or of any threatened claims or litigation seeking to invalidate the Teikoku Patent Rights; (ii) of any actual or threatened investigation, inquiry, action or proceeding by any Regulatory Authority or other government agency with respect to the Current Product; (iii) of any actual or threatened action, suit or proceeding by any Third Party which, if adversely determined, would have a material adverse effect upon the ability of Licensee to use the Teikoku Intellectual Property as licensed hereunder; or (iv) that the manufacture, use or sale of the Current Product or the use of the Teikoku Know-How may infringe any Patent Rights or other intellectual property rights of a Third Party. (d) Teikoku will promptly disclose to Licensee all Teikoku Developments that arise, if any. Information provided by Teikoku to Licensee with respect to such Teikoku Developments will be in reasonable detail but in no circumstance less than would be sufficient to permit an understanding of the nature of the Teikoku Developments by a practitioner reasonably skilled in the relevant technical or scientific area.

Appears in 2 contracts

Samples: License Agreement (Eagle Pharmaceuticals, Inc.), License Agreement (Eagle Pharmaceuticals, Inc.)

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Certain Additional Covenants. (a) Each Party shall comply in all material respects with all laws, rules and regulations applicable to its performance under this Agreement and the Trademark License Agreement. Without limiting the foregoing, Licensee Inspire shall conduct its marketing and sales activities under this Agreement in compliance with applicable laws, rules and regulations and prevailing pharmaceutical industry standards. Inspire shall use Commercially Reasonable Efforts to maintain an adequate sales force to market and sell the Inspired Licensed Products as contemplated by this Agreement. (b) Teikoku InSite shall not grant to any Third Party any rights inconsistent with the rights and licenses granted to Licensee Inspire under this Agreement and Teikoku will (i) use Commercially Reasonable Efforts to maintain the Teikoku Patent Rights during the Term and (ii) give prompt written notice to Licensee a reasonable time in advance of any action by Teikoku to abandon, or that may adversely affect the prosecution and/or maintenance of, the Teikoku Patent Rights and provide Licensee with a reasonable opportunity to prosecute and/or maintain the affected Teikoku Patent Rights at Licensee’s sole cost and expense. If Licensee assumes the prosecution and/or maintenance thereof, such Teikoku Patent Rights shall cease to be included in the definition of Teikoku Patent Rights as set forth in Section 1.64Trademark License Agreement. (c) Teikoku InSite shall promptly notify Licensee Inspire in writing upon becoming aware: (i) of any actual or threatened claim, judgment or settlement against or owed by Teikoku InSite with respect to any of the Teikoku InSite Intellectual Property, or of any threatened claims or litigation seeking to invalidate the Teikoku Patent RightsInSite Licensed Patents; (ii) of any actual or threatened investigation, inquiry, action or proceeding by any Regulatory Authority or other government agency with respect to the Current any Subject Product; (iii) of any actual or threatened action, suit or proceeding by any Third Party which, if adversely determined, would have a material adverse effect upon the ability of Licensee Inspire to use the Teikoku InSite Intellectual Property as licensed hereunderhereunder or under the Trademark License Agreement in connection with the Subject Products in the Field in the Territory; or (iv) that the manufacture, use or sale of the Current any Subject Product or the use of the Teikoku InSite Know-How, the InSite Formulation Know-How or InSite Trademarks may infringe any Patent Rights or other intellectual property rights of a Third Party. (d) Teikoku InSite will promptly disclose to Licensee Inspire all Teikoku InSite Developments that arise, if any. Information provided by Teikoku InSite to Licensee Inspire with respect to such Teikoku InSite Developments will be in reasonable detail but in no circumstance less than would be sufficient to permit an understanding of the nature of the Teikoku InSite Developments by a practitioner reasonably skilled in the relevant technical or scientific area. (e) Except in connection with an assignment or transfer of this Agreement as permitted under Section 12.2, InSite shall not sell, assign or transfer any of the Material Agreements without Inspire’s prior written consent (such consent not to be unreasonably withheld). InSite shall deploy and conduct itself under each of the Material Agreements in a manner that will enable Inspire to perform its obligations and exercise its rights with regard to Subject Products and Inspire Licensed Products under this Agreement. In this regard, and without limiting the foregoing, InSite shall: (i) comply in all material respects with and perform all of its duties and obligations under each of the Material Agreements; (ii) not intentionally take or fail to take any action within InSite’s reasonable control under any of the Material Agreements that could have a materially adverse effect on Inspire’s rights under this Agreement, including but not limited to any action or inaction that would empower Pfizer, Columbia, Cardinal or [***] to terminate any of the Material Agreements or otherwise limit or reduce InSite’s rights thereunder in any material respect; (iii) enforce the material provisions of each of the Material Agreements against Pfizer, Columbia, Cardinal, or [***], as applicable, if failure to do so could have a materially adverse effect on Inspire’s rights with respect to Subject Products or Inspire Licensed Products under this Agreement; and (iv) not modify, amend or terminate any of the Material Agreements without the prior written consent of Inspire. (f) InSite shall promptly (but no later than within five (5) Business Days) notify Inspire in writing of any actual or threatened (or InSite’s receipt of notice of any actual or threatened) default (including failure to pay royalties when due, if applicable), breach, suspension of compliance or performance, or termination (in whole or in part) under or of any of the Material Agreements. InSite shall promptly (but no later than within five (5) Business Days) notify Inspire in writing of the actual or threatened commencement of (or receipt of notice of the actual or threatened commencement of) any dispute, claim, suit, litigation or arbitration proceeding related to any of the Material Agreements, including without limitation those disputes, claims, suits, litigations or arbitration proceedings alleging a Third Party’s infringement or misappropriation of any of the Patent Rights licensed or sublicensed under the Pfizer Agreement or the Columbia Agreement. Each such notification shall contain a summary of the event described therein. At the request of Inspire, InSite shall promptly provide to Inspire full particulars, of which it is aware, in writing of the applicable matter. InSite shall keep Inspire reasonably informed as to the status and proposed resolution of each such matter. *Indicates that certain information contained herein has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. (g) In the event that InSite receives notice of any default (including failure to pay royalties when due) or breach under any of the Material Agreements and has not cured such breach or default within ten (10) days of receiving such notice, Inspire shall be entitled, but not obligated, to undertake payment or performance of the applicable underlying obligation on behalf of InSite as necessary to cure such default or breach and to offset, against amounts payable to InSite under this Agreement, any reasonable costs and expenses incurred by Inspire in the course thereof. (h) InSite shall notify Inspire in writing promptly after receipt by InSite of any notice from Pfizer or Columbia relating to the status, validity, or change thereto, of any of the Patent Rights licensed or sublicensed under the Pfizer Agreement or the Columbia Agreement (including maintenance, filings, extensions, abandonments, surrenders, patent office proceedings, Third Party interference or other challenges to, or Third Party potential infringement or misappropriation of such Patent Rights) (each, an “IP Communication”). InSite shall inform Inspire of the receipt and substance of each IP Communication and if in writing shall furnish Inspire with a copy of such IP Communication. InSite shall promptly inform Inspire in writing if InSite receives, or becomes aware of, any certification filed under the U.S. “Drug Price Competition and Patent Term Restoration Act of 1984” claiming that any patent licensed or sublicensed under the Pfizer Agreement or the Columbia Agreement is invalid or that infringement thereof will not arise from the manufacture, use, import, offer for sale or sale of any product by a Third Party. (i) InSite shall be responsible for and comply in all material respects with and materially perform all of its duties and obligations under the [***] Agreement and under any other agreement by or through which any Third Party has any right, title or interest in or to any of the InSite Intellectual Property. (j) InSite shall not create, incur, or allow any Lien on any of the InSite Intellectual Property, unless the Person that is to hold such Lien shall have first entered into a mutually acceptable non-disturbance agreement with Inspire providing to the effect that, in the event such Person exercises its rights with respect to the InSite Intellectual Property under such Lien, such Person agrees to recognize the existence and validity of, and Inspire’s rights with respect to the InSite Intellectual Property under, this Agreement or any agreement supplementary hereto. (k) Inspire and its Affiliates shall not directly or indirectly challenge or induce any Third Party to challenge the validity or enforceability of the Pfizer Patent Rights, or any patent claim(s) therein, or initiate or participate in any re-examination or other proceeding related to the validity, enforceability or patentability of any claim of the Pfizer Patent Rights before any tribunal or patent office. This section shall not prohibit Inspire and its Affiliates from responding to a subpoena, process, or discovery requests in any litigation or administrative proceeding provided that Inspire gives prompt notice to Pfizer of the receipt of said subpoena, process or discovery requests. (l) The Parties acknowledge the provisions of Section 4(b) of the Pfizer Agreement regarding estimated monthly net sales and the Parties agree to cooperate reasonably to facilitate compliance with such provisions. The Parties further acknowledge that to the extent Inspire delivers information regarding such estimated monthly net sales to InSite for further delivery by InSite to Pfizer then such further delivery shall not constitute a breach of Section 8.1 of this Agreement, provided that InSite shall advise Pfizer that such disclosure is Confidential Information under the Pfizer Agreement and subject to the obligations of non-disclosure and non-use in Section 11(a) of the Pfizer Agreement.

Appears in 1 contract

Samples: License Agreement (Inspire Pharmaceuticals Inc)

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Certain Additional Covenants. (a) Each Party shall comply in all material respects with all laws, rules and regulations applicable to its performance under this Agreement and the Trademark License Agreement. Without limiting the foregoing, Licensee Inspire shall conduct its marketing and sales activities under this Agreement in compliance with applicable laws, rules and regulations and prevailing pharmaceutical industry standards. Inspire shall use Commercially Reasonable Efforts to maintain an adequate sales force to market and sell the Inspired Licensed Products as contemplated by this Agreement. (b) Teikoku InSite shall not grant to any Third Party any rights inconsistent with the rights and licenses granted to Licensee Inspire under this Agreement and Teikoku will (i) use Commercially Reasonable Efforts to maintain the Teikoku Patent Rights during the Term and (ii) give prompt written notice to Licensee a reasonable time in advance of any action by Teikoku to abandon, or that may adversely affect the prosecution and/or maintenance of, the Teikoku Patent Rights and provide Licensee with a reasonable opportunity to prosecute and/or maintain the affected Teikoku Patent Rights at Licensee’s sole cost and expense. If Licensee assumes the prosecution and/or maintenance thereof, such Teikoku Patent Rights shall cease to be included in the definition of Teikoku Patent Rights as set forth in Section 1.64Trademark License Agreement. (c) Teikoku InSite shall promptly notify Licensee Inspire in writing upon becoming aware: (i) of any actual or threatened claim, judgment or settlement against or owed by Teikoku InSite with respect to any of the Teikoku InSite Intellectual Property, or of any threatened claims or litigation seeking to invalidate the Teikoku Patent RightsInSite Licensed Patents; (ii) of any actual or threatened investigation, inquiry, action or proceeding by any Regulatory Authority or other government agency with respect to the Current any Subject Product; (iii) of any actual or threatened action, suit or proceeding by any Third Party which, if adversely determined, would have a material adverse effect upon the ability of Licensee Inspire to use the Teikoku InSite Intellectual Property as licensed hereunderhereunder or under the Trademark License Agreement in connection with the Subject Products in the Field in the Territory; or (iv) that the manufacture, use or sale of the Current any Subject Product or the use of the Teikoku InSite Know-How, the InSite Formulation Know-How or InSite Trademarks may infringe any Patent Rights or other intellectual property rights of a Third Party. (d) Teikoku InSite will promptly disclose to Licensee Inspire all Teikoku InSite Developments that arise, if any. Information provided by Teikoku InSite to Licensee Inspire with respect to such Teikoku InSite Developments will be in reasonable detail but in no circumstance less than would be sufficient to permit an understanding of the nature of the Teikoku InSite Developments by a practitioner reasonably skilled in the relevant technical or scientific area. (e) Except in connection with an assignment or transfer of this Agreement as permitted under Section 12.2, InSite shall not sell, assign or transfer any of the Material Agreements without Inspire’s prior written consent (such consent not to be unreasonably withheld). InSite shall deploy and conduct itself under each of the Material Agreements in a manner that will enable Inspire to perform its obligations and exercise its rights with regard to Subject Products and Inspire Licensed Products under this Agreement. In this regard, and without limiting the foregoing, InSite shall: (i) comply in all material respects with and perform all of its duties and obligations under each of the Material Agreements; (ii) not intentionally take or fail to take any action within InSite’s reasonable control under any of the Material Agreements that could have a materially adverse effect on Inspire’s rights under this Agreement, including but not limited to any action or inaction that would empower Pfizer, Columbia, Cardinal or [***] to terminate any of the Material Agreements or otherwise limit or reduce InSite’s rights thereunder in any material respect; (iii) enforce the material provisions of each of the Material Agreements against Pfizer, Columbia, Cardinal, or [***], as applicable, if failure to do so could have a materially adverse effect on Inspire’s rights with respect to Subject Products or Inspire Licensed Products under this Agreement; and (iv) not modify, amend or terminate any of the Material Agreements without the prior written consent of Inspire. (f) InSite shall promptly (but no later than within five (5) Business Days) notify Inspire in writing of any actual or threatened (or InSite’s receipt of notice of any actual or threatened) default (including failure to pay royalties when due, if applicable), breach, suspension of compliance or performance, or termination (in whole or in part) under or of any of the Material Agreements. InSite shall promptly (but no later than within five (5) Business Days) notify Inspire in writing of the actual or threatened commencement of (or receipt of notice of the actual or threatened commencement of) any dispute, claim, suit, litigation or arbitration proceeding related to any of the Material Agreements, including without limitation those disputes, claims, suits, litigations or arbitration proceedings alleging a Third Party’s infringement or misappropriation of any of the Patent Rights licensed or sublicensed under the Pfizer Agreement or the Columbia Agreement. Each such notification shall contain a summary of the event described therein. At the request of Inspire, InSite shall promptly provide to Inspire full particulars, of which it is aware, in writing of the applicable matter. InSite shall keep Inspire reasonably informed as to the status and proposed resolution of each such matter. (g) In the event that InSite receives notice of any default (including failure to pay royalties when due) or breach under any of the Material Agreements and has not cured such breach or default within ten (10) days of receiving such notice, Inspire shall be entitled, but not obligated, to undertake payment or performance of the applicable underlying obligation on behalf of InSite as necessary to cure such default or breach and to offset, against amounts payable to InSite under this Agreement, any reasonable costs and expenses incurred by Inspire in the course thereof. (h) InSite shall notify Inspire in writing promptly after receipt by InSite of any notice from Pfizer or Columbia relating to the status, validity, or change thereto, of any of the Patent Rights licensed or sublicensed under the Pfizer Agreement or the Columbia Agreement (including maintenance, filings, extensions, abandonments, surrenders, patent office proceedings, Third Party interference or other challenges to, or Third Party potential infringement or misappropriation of such Patent Rights) (each, an “IP Communication”). InSite shall inform Inspire of the receipt and substance of each IP Communication and if in writing shall furnish Inspire with a copy of such IP Communication. InSite shall promptly inform Inspire in writing if InSite receives, or becomes aware of, any certification filed under the U.S. “Drug Price Competition and Patent Term Restoration Act of 1984” claiming that any patent licensed or sublicensed under the Pfizer Agreement or the Columbia Agreement is invalid or that infringement thereof will not arise from the manufacture, use, import, offer for sale or sale of any product by a Third Party. (i) InSite shall be responsible for and comply in all material respects with and materially perform all of its duties and obligations under the [***] Agreement and under any other agreement by or through which any Third Party has any right, title or interest in or to any of the InSite Intellectual Property. (j) InSite shall not create, incur, or allow any Lien on any of the InSite Intellectual Property, unless the Person that is to hold such Lien shall have first entered into a mutually acceptable non-disturbance agreement with Inspire providing to the effect that, in the event such Person exercises its rights with respect to the InSite Intellectual Property under such Lien, such Person agrees to recognize the existence and validity of, and Inspire’s rights with respect to the InSite Intellectual Property under, this Agreement or any agreement supplementary hereto. (k) Inspire and its Affiliates shall not directly or indirectly challenge or induce any Third Party to challenge the validity or enforceability of the Pfizer Patent Rights, or any patent claim(s) therein, or initiate or participate in any re-examination or other proceeding related to the validity, enforceability or patentability of any claim of the Pfizer Patent Rights before any tribunal or patent office. This section shall not prohibit Inspire and its Affiliates from responding to a subpoena, process, or discovery requests in any litigation or administrative proceeding provided that Inspire gives prompt notice to Pfizer of the receipt of said subpoena, process or discovery requests. (l) The Parties acknowledge the provisions of Section 4(b) of the Pfizer Agreement regarding estimated monthly net sales and the Parties agree to cooperate reasonably to facilitate compliance with such provisions. The Parties further acknowledge that to the extent Inspire delivers information regarding such estimated monthly net sales to InSite for further delivery by InSite to Pfizer then such further delivery shall not constitute a breach of Section 8.1 of this Agreement, provided that InSite shall advise Pfizer that such disclosure is Confidential Information under the Pfizer Agreement and subject to the obligations of non-disclosure and non-use in Section 11(a) of the Pfizer Agreement.

Appears in 1 contract

Samples: License Agreement (Insite Vision Inc)

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