Common use of Representations, Warranties and Indemnities Clause in Contracts

Representations, Warranties and Indemnities. 9.1 Each party represents and warrants to the other that, to the best of its current knowledge, it has the full right and authority to enter into this Agreement and to grant the licenses granted herein. Each party believes, to the best of its current knowledge, that any existing patents licensed by it to the other party under this Agreement are valid. 9.2 Penwest represents and warrants that any Formulated TIMERx supplied by it to Mylan hereunder for use in the Designated Product, at the point of delivery: 9.2.1 will conform to the product Specifications that Penwest and Mylan have agreed in writing are to apply to such delivery of TIMERx; and 9.2.2 to the best of Penwest's current knowledge, will not infringe upon an article patent of any third party. CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS. PENWEST MAKES NO REPRESENTATIONS OR WARRANTIES AS TO ANY TIMERx OR FORMULATED TIMERx SUPPLIED BY IT TO MYLAN EXCEPT AS ARE EXPLICITLY STATED HEREIN. 9.3 Each party represents and warrants to the other party that it has obtained and will at all times during the term of this Agreement, hold and comply with all licenses, permits and authorizations necessary to perform this Agreement and to test, manufacture, market, export, and import the products and assistance to be provided by it hereunder, as now or hereafter required under any applicable statutes, laws, ordinances, rules and regulations of the United States and any applicable foreign, state, and local governments and governmental entities. 9.4 Mylan warrants that any Designated Product manufactured, marketed or distributed by Mylan or its Affiliates or sublicensees shall meet and be manufactured, packaged, labeled, sold, and promoted in accordance with all applicable regulatory requirements within the Territory. 9.5 Penwest shall indemnify, defend and hold harmless Mylan and its Affiliates and sublicensees from any claim, action or damages arising out of any alleged infringement by reason of the manufacture, use or sale by Mylan of the Designated Product to the extent such infringement would apply as well to the manufacture, sale or distribution of TIMERx alone. If Mylan or its Affiliate or sublicensee, by reason of its manufacture, sale or distribution of Designated Product, is accused of infringing the patent of a third party, and such claim of infringement, as framed by the claimant, would apply as well to the manufacture, sale or distribution of TIMERx alone, Mylan shall immediately so notify Penwest and provide Penwest all available information, and the parties shall consult reasonably as to the proper course of action. If Penwest and Mylan jointly determine that such claim is likely to prevail, or if an arbitrator hereunder or a court of competent jurisdiction so determines, Mylan shall be entitled to offset against any Royalties payable to Penwest hereunder any third party royalties for which Mylan or its Affiliate or sublicensee becomes liable. 9.6 Penwest shall indemnify, defend and hold Mylan and its Affiliates and sublicensees harmless from any and all third-party claims to the extent arising from, in connection with, based upon, by reason of, or relating in any way to: 9.6.1 the ************************************************ TIMERx in the Designated Product; CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS 9.6.2 Penwest's *********************************************** and the Specifications therefor hereunder; 9.6.3 any failure of the Formulated TIMERx manufactured by Penwest or its alternate supplier (but not by Mylan under Section ), as delivered to Mylan hereunder for use in the Designated Product, to conform to the Specifications; or 9.6.4 any failure of Penwest to comply with its obligation under Section 5.13 to notify Mylan of any information coming into Penwest's possession and *************************** the Designated Product and not arising from any other aspect of the Designated Product or its formulation, development, supply, production, manufacture, sale, delivery, distribution or use, nor from any act or omission of Mylan with respect to the Formulated TIMERx following its delivery to Mylan hereunder. 9.7 Mylan shall indemnify, defend and hold Penwest harmless from any and all third-party claims to the extent arising from, in connection with, based upon, by reason of, or relating in any way to, the formulation, development, supply, production, manufacture, sale, delivery, distribution or use of the Designated Product, ************************************************. 9.8 Notwithstanding anything to the contrary set forth elsewhere herein, neither Mylan nor Penwest shall be obligated to indemnify the other party for claims or liabilities to the extent arising from such other party's, or its Affiliates', sublicensees' or assigns', negligence, intentional misconduct, or breach of its duties, obligations, warranties or representations set forth herein. 9.9 Whenever indemnification is provided for a party under this Agreement, such right of indemnification shall extend also to the indemnified party's Affiliates, officers, directors, shareholders, successors, assigns, agents, employees, and insurers to the extent the same become subject to such claim in such capacity. The party seeking indemnification shall provide the indemnifying party with written notice of any claim or action within ten (10) days of its receipt thereof, and shall afford the indemnifying party the right to control the defense and settlement of such claim or action. The party seeking indemnification shall provide reasonable assistance to the indemnifying party in the defense of such claim or action. If the defendants in any such action include both Mylan and Penwest and either party concludes that there may be legal defenses available to it which are different from, additional to, or inconsistent with, those available to the other, that party shall have the right to select separate counsel to participate in the defense of such action on its behalf, and such party shall thereafter bear the cost and expense of such separate defense. Should the indemnifying party determine not to defend such claim or action, the other party shall have the right to maintain the defense of such claim or action and the indemnifying party agrees to provide reasonable assistance to it in the defense of such claim or action. Neither party shall settle any such claim or action in a way that prejudices or adversely impacts the other party to this Agreement without the prior approval of such other party (which approval shall not be unreasonably withheld). 9.10 Any dispute concerning indemnification will be determined by arbitration in accordance with Section of this Agreement. 9.11 THE FOREGOING WARRANTIES ARE IN LIEU OF ALL OTHER WARRANTIES, EXPRESS, IMPLIED OR ARISING BY LAW, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. NOTHING IN THIS AGREEMENT SHALL BE CONSTRUED AS A REPRESENTATION OR WARRANTY (i) BY PENWEST AS TO THE PATENTABILITY, VALIDITY (EXCEPT AS STATED IN SECTION ), OR SCOPE OF ANY PENWEST PATENTS, PENWEST'S CONFIDENTIAL TECHNOLOGY, TIMERx PRODUCTION TECHNOLOGY, JOINT DEVELOPMENTS, OR PENWEST TEST AND REGULATORY DATA; OR (ii) BY MYLAN AS TO THE PATENTABILITY, VALIDITY (EXCEPT AS STATED IN SECTION ), OR SCOPE OF ANY MYLAN IMPROVEMENTS, JOINT DEVELOPMENTS, OR MYLAN TEST AND REGULATORY DATA. 9.12 NOTWITHSTANDING ANYTHING TO THE CONTRARY CONTAINED HEREIN (OTHER THAN THE INDEMNITIES STATED IN THIS SECTION ), NEITHER PARTY SHALL UNDER ANY CIRCUMSTANCES BE LIABLE FOR ANY THIRD PARTY CLAIMS OR FOR ANY INCIDENTAL, CONSEQUENTIAL, INDIRECT OR SPECIAL DAMAGES, INCLUDING ANY LOST PROFITS OR SAVINGS, ARISING FROM ANY BREACH OF WARRANTY OR THE PERFORMANCE OR BREACH OF ANY OTHER PROVISION OF THIS AGREEMENT OR THE USE OR INABILITY TO USE TIMERx, THE DESIGNATED PRODUCT, PENWEST PATENTS, PENWEST'S CONFIDENTIAL TECHNOLOGY, TIMERx PRODUCTION TECHNOLOGY, PENWEST TEST AND REGULATORY DATA, MYLAN IMPROVEMENTS, OR MYLAN TEST AND REGULATORY DATA, EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. 9.13 Each party shall, at its own cost and expense, obtain and maintain from a qualified insurance company comprehensive general liability and products liability insurance coverage during the term of this Agreement (and any subsequent period of sale or distribution pursuant to Section ). Such insurance shall be in an amount no CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS less than ************************* combined single limit for each occurrence for bodily injury and/or property damage. Each party agrees to provide the other party with a certificate of insurance evidencing such insurance within thirty (30) days after the execution of this Agreement and again thereafter from time to time as reasonably requested by such other party.

Appears in 2 contracts

Samples: Product Development and Supply Agreement (Penwest Pharmaceuticals Co), Product Development and Supply Agreement (Penwest Pharmaceuticals Co)

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Representations, Warranties and Indemnities. 9.1 Each party represents and warrants to the other that, to the best of its current knowledge, without undertaking any special investigation, it has the full right and authority to enter into this Agreement and to grant the licenses granted herein. Each party believes, to the best of its current knowledge, that any existing patents licensed by it to the other party under this Agreement are valid. 9.2 Penwest TIMERx Technologies represents and warrants that any Formulated TIMERx supplied by it to Mylan Schwxxx Xxxrma hereunder for use in the Designated Product, at the point of delivery: 9.2.1 will conform to the product Specifications that Penwest and Mylan have agreed in writing are to apply to such delivery effect as of TIMERxthe order date therefor; and 9.2.2 to the best of Penwest's TIMERx Technologies' current knowledge, without undertaking any special investigation, will not infringe upon an article patent of any third party. CONFIDENTIAL MATERIAL OMITTED OTHERWISE, TIMERx TECHNOLOGIES PROVIDES "AS-IS," AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS. PENWEST MAKES NO REPRESENTATIONS OR WARRANTIES AS TO TO, ANY TIMERx OR FORMULATED TIMERx SUPPLIED BY IT TO MYLAN SCHWXXX XXXRMA FOR TESTING, DEVELOPMENT, OR ANY OTHER PURPOSES EXCEPT AS ARE EXPLICITLY STATED HEREINFOR USE IN THE DESIGNATED PRODUCT FOR COMMERCIAL USE OR SALE. 9.3 Each party represents and warrants to the other party that it has obtained obtained, and will at all times during the term of this Agreement, Agreement hold and comply with with, all licenses, permits and authorizations necessary to perform this Agreement and to test, manufacture, market, export, and import the products and assistance to be provided by it hereunderDesignated Product or Formulated TIMERx, as now or hereafter required under any applicable statutes, laws, ordinances, rules and regulations of the United States and any applicable foreign, state, and local governments and governmental entities. 9.4 Mylan warrants that any Designated Product manufacturedTHE FOREGOING WARRANTIES ARE IN LIEU OF, marketed or distributed by Mylan or its Affiliates or sublicensees shall meet and be manufacturedAND THE PARTIES EACH DISCLAIM, packagedALL OTHER WARRANTIES, labeledEXPRESS, soldIMPLIED OR ARISING BY LAW, and promoted in accordance with all applicable regulatory requirements within the TerritoryINCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND NON-INFRINGEMENT. NOTHING IN THIS AGREEMENT SHALL BE CONSTRUED AS A REPRESENTATION OR WARRANTY (I) BY TIMERx TECHNOLOGIES AS TO THE PATENTABILITY, VALIDITY, OR SCOPE OF ANY TIMERx TECHNOLOGIES PATENTS, TIMERX TECHNOLOGIES' CONFIDENTIAL TECHNOLOGY, TIMERx PRODUCTION TECHNOLOGY, OR TIMERX TECHNOLOGIES TEST AND REGULATORY DATA, NOR AS TO THE UTILITY, EFFICACY, NONTOXICITY, SAFETY OR APPROPRIATENESS OF TIMERx OR THE DESIGNATED PRODUCT; OR (II) BY SCHWXXX XXXRMA AS TO THE PATENTABILITY, VALIDITY, OR SCOPE OF ANY SCHWXXX XXXRMA IMPROVEMENTS OR SCHWXXX XXXRMA TEST AND CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS. REGULATORY DATA, NOR AS TO THE UTILITY, EFFICACY, NONTOXICITY, SAFETY OR APPROPRIATENESS OF ANY PRODUCTS MADE THEREFROM. 9.5 Penwest TIMERx Technologies shall indemnify, defend and hold harmless Mylan Schwxxx Xxxrma and its Affiliates and sublicensees from any claim, action or damages arising out of any alleged infringement by reason of the manufacture, use or sale by Mylan Schwxxx Xxxrma of the Designated Product to the extent such infringement would apply as well to the manufacture, sale or distribution of TIMERx alone. If Mylan alone or its Affiliate or sublicensee, by reason of its manufacture, sale or distribution of Designated Product, is accused of infringing the patent of a third party, and such claim of infringement, as framed by the claimant, would apply as well to the manufacture, sale or distribution of TIMERx alone, Mylan shall immediately so notify Penwest and provide Penwest all available information, and the parties shall consult reasonably as to the proper course of action. If Penwest and Mylan jointly determine that such claim is likely to prevail, or if an arbitrator hereunder or a court of competent jurisdiction so determines, Mylan shall be entitled to offset against any Royalties payable to Penwest hereunder any third party royalties for which Mylan or its Affiliate or sublicensee becomes liable. 9.6 Penwest shall indemnify, defend and hold Mylan and its Affiliates and sublicensees harmless from any and all third-party claims to the extent arising from, in connection with, based upon, by reason of, or relating in any way to: 9.6.1 the ************************************************ TIMERx in the Designated Product; CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS 9.6.2 Penwest's *********************************************** and the Specifications therefor hereunder; 9.6.3 any failure of the Formulated TIMERx manufactured by Penwest or its alternate supplier (but not by Mylan under Section ), as delivered to Mylan hereunder for use in the Designated Product, to conform to the Specifications; or 9.6.4 any failure of Penwest to comply with its obligation under Section 5.13 to notify Mylan of any information coming into Penwest's possession and *************************** the Designated Product and not arising from any other aspect of the Designated Product or its formulation, development, supply, production, manufacture, sale, delivery, distribution or use, nor from any act or omission of Mylan with respect to the Formulated TIMERx following its delivery to Mylan hereunder. 9.7 Mylan shall indemnify, defend and hold Penwest harmless from any and all third-party claims to the extent arising from, in connection with, based upon, by reason of, or relating in any way to, the formulation, development, supply, production, manufacture, sale, delivery, distribution or use of the Designated Product, ************************************************. 9.8 Notwithstanding anything to the contrary set forth elsewhere herein, neither Mylan nor Penwest shall be obligated to indemnify the other party for claims or liabilities to the extent arising from such other party's, or its Affiliates', sublicensees' or assigns', negligence, intentional misconduct, or breach of its duties, obligations, warranties or representations set forth herein. 9.9 Whenever indemnification is provided for a party under this Agreement, such right of indemnification shall extend also to the indemnified party's Affiliates, officers, directors, shareholders, successors, assigns, agents, employees, and insurers otherwise to the extent the same become subject to such claim in such capacity. The party seeking indemnification shall provide the indemnifying party with written notice of any claim or action within ten (10) days of its receipt thereof, and shall afford the indemnifying party the right to control the defense and settlement of such claim or action. The party seeking indemnification shall provide reasonable assistance to the indemnifying party in the defense of such claim or action. If the defendants in any such action include both Mylan and Penwest and either party concludes that there may be legal defenses available to it which are different from, additional to, or inconsistent with, those available to the other, that party shall have the right to select separate counsel to participate in the defense of such action on its behalf, and such party shall thereafter bear the cost and expense of such separate defense. Should the indemnifying party determine not to defend such claim or action, the other party shall have the right to maintain the defense of such claim or action and the indemnifying party agrees to provide reasonable assistance to it in the defense of such claim or action. Neither party shall settle any such claim or action in a way that prejudices or adversely impacts the other party to this Agreement without the prior approval of such other party (which approval shall not be unreasonably withheld). 9.10 Any dispute concerning indemnification will be determined is covered by arbitration in accordance with Section of this Agreement. 9.11 THE FOREGOING WARRANTIES ARE IN LIEU OF ALL OTHER WARRANTIES, EXPRESS, IMPLIED OR ARISING BY LAW, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. NOTHING IN THIS AGREEMENT SHALL BE CONSTRUED AS A REPRESENTATION OR WARRANTY (i) BY PENWEST AS TO THE PATENTABILITY, VALIDITY (EXCEPT AS STATED IN SECTION ), OR SCOPE OF ANY PENWEST PATENTS, PENWEST'S CONFIDENTIAL TECHNOLOGY, TIMERx PRODUCTION TECHNOLOGY, JOINT DEVELOPMENTS, OR PENWEST TEST AND REGULATORY DATA; OR (ii) BY MYLAN AS TO THE PATENTABILITY, VALIDITY (EXCEPT AS STATED IN SECTION ), OR SCOPE OF ANY MYLAN IMPROVEMENTS, JOINT DEVELOPMENTS, OR MYLAN TEST AND REGULATORY DATA. 9.12 NOTWITHSTANDING ANYTHING TO THE CONTRARY CONTAINED HEREIN (OTHER THAN THE INDEMNITIES STATED IN THIS SECTION ), NEITHER PARTY SHALL UNDER ANY CIRCUMSTANCES BE LIABLE FOR ANY THIRD PARTY CLAIMS OR FOR ANY INCIDENTAL, CONSEQUENTIAL, INDIRECT OR SPECIAL DAMAGES, INCLUDING ANY LOST PROFITS OR SAVINGS, ARISING FROM ANY BREACH OF WARRANTY OR THE PERFORMANCE OR BREACH OF ANY OTHER PROVISION OF THIS AGREEMENT OR THE USE OR INABILITY TO USE TIMERx, THE DESIGNATED PRODUCT, PENWEST PATENTS, PENWEST'S CONFIDENTIAL TECHNOLOGY, TIMERx PRODUCTION TECHNOLOGY, PENWEST TEST AND REGULATORY DATA, MYLAN IMPROVEMENTS, OR MYLAN TEST AND REGULATORY DATA, EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. 9.13 Each party shall, at its own cost and expense, obtain and maintain from a qualified insurance company comprehensive general liability and products liability insurance coverage during the term of this Agreement (and any subsequent period of sale or distribution pursuant to Section ). Such insurance shall be in an amount no CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS less than ************************* combined single limit for each occurrence for bodily injury and/or property damage. Each party agrees to provide the other party with a certificate of insurance evidencing such insurance within thirty (30) days after the execution of this Agreement and again thereafter from time to time as reasonably requested by such other party.Section

Appears in 2 contracts

Samples: Product Development and Supply Agreement (Penwest Pharmaceuticals Co), Product Development and Supply Agreement (Penwest Pharmaceuticals Co)

Representations, Warranties and Indemnities. 9.1 A. Each party represents and warrants to the other that, to that it is duly organized and validly existing under the best laws of the state of its current knowledgeorganization, that it has the full right and requisite corporate or limited liability company authority to enter into execute and deliver this Agreement and to grant perform its obligations hereunder, and that the licenses granted herein. Each party believes, to the best execution and performance of its current knowledge, that obligations hereunder are not and will not be in violation of or in conflict with any existing patents licensed by material obligation it may have to the other party under this Agreement are validany third party. 9.2 Penwest B. PPG represents and warrants that any Formulated TIMERx supplied by it to Mylan Endo hereunder for use in the Designated Product, at the point of delivery: 9.2.1 1. will conform to the product Specifications that Penwest and Mylan have agreed in writing are to apply to such delivery effect as of TIMERxthe order date therefor; and 9.2.2 2. to the best of PenwestPPG's current knowledge, without undertaking any special investigation, will not infringe upon an article patent the intellectual property rights of any third party. CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS. PENWEST MAKES NO REPRESENTATIONS OR WARRANTIES AS TO ANY TIMERx OR FORMULATED TIMERx SUPPLIED BY IT TO MYLAN EXCEPT AS ARE EXPLICITLY STATED HEREIN. 9.3 C. Each party represents and warrants to the other party that it has obtained obtained, and will at all times during the term of this Agreement, Agreement hold and comply with with, all licenses, permits and authorizations necessary to perform this Agreement and to test, manufacture, market, export, and import the products and assistance Designated Product(s), Oxymorphone, or Formulated TIMERx to be provided so tested, manufactured, marketed, exported or imported by it hereunderas provided herein, as now or hereafter required under any applicable 27 CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS. statutes, laws, ordinances, rules and regulations of the United States and any applicable foreign, state, and local governments and governmental entities, including without limitation all Facilities Certifications (as to Endo). 9.4 Mylan warrants that any Designated Product manufacturedD. THE FOREGOING WARRANTIES ARE IN LIEU OF, marketed or distributed by Mylan or its Affiliates or sublicensees shall meet and be manufacturedAND THE PARTIES EACH DISCLAIM, packagedALL OTHER WARRANTIES, labeledEXPRESS, soldIMPLIED OR ARISING BY LAW, and promoted in accordance with all applicable regulatory requirements within the TerritoryINCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND NON-INFRINGEMENT. NOTHING IN THIS AGREEMENT SHALL BE CONSTRUED AS A REPRESENTATION OR WARRANTY (i) BY PPG AS TO THE PATENTABILITY, VALIDITY, OR SCOPE OF ANY PPG PATENTS, PPG'S CONFIDENTIAL TECHNOLOGY, TIMERx PRODUCTION TECHNOLOGY, PPG TEST AND REGULATORY DATA, OR JOINT TECHNOLOGY, NOR AS TO THE UTILITY, EFFICACY, NONTOXICITY, SAFETY OR APPROPRIATENESS OF TIMERx OR THE DESIGNATED PRODUCT; OR (ii) BY ENDO AS TO THE PATENTABILITY, VALIDITY, OR SCOPE OF ANY ENDO TECHNOLOGY, ENDO TEST AND REGULATORY DATA, OR JOINT TECHNOLOGY, NOR AS TO THE UTILITY, EFFICACY, NONTOXICITY, SAFETY OR APPROPRIATENESS OF ANY PRODUCTS MADE THEREFROM. 9.5 Penwest E. PPG shall indemnify, defend and hold harmless Mylan and its Affiliates and sublicensees from any claim, action or damages arising out of any alleged infringement by reason of the manufacture, use or sale by Mylan of the Designated Product to the extent such infringement would apply as well to the manufacture, sale or distribution of TIMERx alone. If Mylan or its Affiliate or sublicensee, by reason of its manufacture, sale or distribution of Designated Product, is accused of infringing the patent of a third party, and such claim of infringement, as framed by the claimant, would apply as well to the manufacture, sale or distribution of TIMERx alone, Mylan shall immediately so notify Penwest and provide Penwest all available information, and the parties shall consult reasonably as to the proper course of action. If Penwest and Mylan jointly determine that such claim is likely to prevail, or if an arbitrator hereunder or a court of competent jurisdiction so determines, Mylan shall be entitled to offset against any Royalties payable to Penwest hereunder any third party royalties for which Mylan or its Affiliate or sublicensee becomes liable. 9.6 Penwest shall indemnify, defend and hold Mylan Endo and its Affiliates and sublicensees harmless from any and all third-party claims to the extent arising from, in connection with, based upon, by reason of, or relating in any way to: 9.6.1 1. any claim, action or damages arising out of any alleged infringement by reason of the manufacture, use or sale by Endo of the Designated Product(s) to the extent such infringement would apply as well to the manufacture, sale or distribution of TIMERx alone; 2. PPG's *************************************************************** ************* and the Specifications therefor hereunder; provided, however, that matters of infringement of third party rights or intellectual properties shall be included under this clause only to the extent the same are covered by Section 9.5.1 or are within PPG's knowledge, without undertaking any special investigation, and of which PPG failed to inform Endo within 30 days following the later of the Effective Date or PPG's first obtaining such knowledge; 3. any failure of the Formulated TIMERx manufactured by PPG or its alternate supplier (but not by Endo under Section 7.4), as delivered to Endo hereunder for use in the Designated ProductProduct(s), to conform to the Specifications; CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSIONor 4. ASTERISKS DENOTE SUCH OMISSIONS 9.6.2 Penwest's any failure of PPG to comply with its obligation under Section 7.9 to notify Endo of any information coming into PPG possession and *********************************************************************** ***, and the Specifications therefor hereunder; 9.6.3 not arising from any failure other aspect of the Formulated TIMERx manufactured by Penwest or its alternate supplier (but not by Mylan under Section )Designated Product(s) ************, as delivered to Mylan hereunder for use in the Designated Product, to conform to the Specifications; or 9.6.4 any failure of Penwest to comply with its obligation under Section 5.13 to notify Mylan of any information coming into Penwest's possession and ******************************************************************************* the Designated Product and not arising from any other aspect of the Designated Product or its formulation, development, supply, production, manufacture, sale, delivery, distribution or use, nor from any act or omission of Mylan with respect to the Formulated TIMERx ****************************************************************************** ************************************** following its delivery to Mylan Endo hereunder. 9.7 Mylan F. Endo shall indemnify, defend and hold Penwest PPG harmless from any and all third-party claims to the extent arising from, in connection with, based upon, by reason of, or relating in any way to, the formulation, development, supply, production, manufacture, sale, delivery, distribution or use of the Designated ProductProduct(s) by Endo, its Affiliates or sublicensees, *************************** *****************************. 9.8 G. Notwithstanding anything to the contrary set forth elsewhere herein, neither Mylan Endo nor Penwest PPG shall be obligated to indemnify the other party for claims or liabilities to the extent arising from such other party's, or its Affiliates', sublicensees' or assigns', negligence, intentional misconduct, or breach of its duties, obligations, warranties or representations set forth herein. 9.9 H. Whenever indemnification is provided for a party under this Agreement, such right of indemnification shall extend also to the indemnified party's Affiliates, officers, directors, shareholders, successors, assigns, agents, employees, and insurers to the extent the same become subject to such claim in such capacity. The party seeking indemnification shall provide the indemnifying party with written notice of any claim or action within ten (10) days of its receipt thereof, and shall afford the indemnifying party the right to control the defense and settlement of such claim or action. The party seeking indemnification shall provide reasonable assistance to the indemnifying party in the defense of such claim or action. If the defendants in any such action include both Mylan Endo and Penwest PPG, and either party concludes that there may be legal defenses available to it which are different from, additional to, or inconsistent with, those available to the other, that party shall have the right to select separate counsel to participate in the defense of such action on its behalf, and such party shall thereafter bear the cost and expense of such separate defense, unless and to the extent the parties otherwise agree, or it is determined through arbitration hereunder that such costs and expense are or were required to be indemnified by the other party hereunder and are or were required to be incurred separately due to such different, additional, or inconsistent defenses. Should the indemnifying party determine not to defend such claim or action, the other party shall have the right to maintain the defense of such claim or action and the indemnifying party agrees to provide reasonable assistance to it in the defense of such claim or actionaction and to bear the reasonable cost and expense of such defense (including attorneys' and experts' fees and expenses). Neither party shall settle any such claim or action in a way that prejudices or adversely impacts the other party to this Agreement without the prior approval of such other party (which approval shall not be unreasonably withheld). 9.10 Any dispute concerning indemnification will be determined by arbitration in accordance with Section of this Agreement. 9.11 THE FOREGOING WARRANTIES ARE IN LIEU OF ALL OTHER WARRANTIES, EXPRESS, IMPLIED OR ARISING BY LAW, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. NOTHING IN THIS AGREEMENT SHALL BE CONSTRUED AS A REPRESENTATION OR WARRANTY (i) BY PENWEST AS TO THE PATENTABILITY, VALIDITY (EXCEPT AS STATED IN SECTION ), OR SCOPE OF ANY PENWEST PATENTS, PENWEST'S CONFIDENTIAL TECHNOLOGY, TIMERx PRODUCTION TECHNOLOGY, JOINT DEVELOPMENTS, OR PENWEST TEST AND REGULATORY DATA; OR (ii) BY MYLAN AS TO THE PATENTABILITY, VALIDITY (EXCEPT AS STATED IN SECTION ), OR SCOPE OF ANY MYLAN IMPROVEMENTS, JOINT DEVELOPMENTS, OR MYLAN TEST AND REGULATORY DATA. 9.12 I. NOTWITHSTANDING ANYTHING TO THE CONTRARY CONTAINED HEREIN IN THIS AGREEMENT (OTHER THAN THE FOR: BREACHES OF SECTION 9.3; INDEMNITIES STATED IN THIS UNDER SECTIONS 9.5 AND 9.6 FOR PATENT INFRINGEMENT OR FOR HARM TO PERSONS OR TANGIBLE PROPERTY; AND BREACHES OF SECTION 10), NEITHER PARTY SHALL UNDER ANY CIRCUMSTANCES BE LIABLE FOR ANY THIRD PARTY CLAIMS OR FOR ANY INCIDENTAL, CONSEQUENTIAL, INDIRECT OR SPECIAL DAMAGES, INCLUDING ANY LOST PROFITS OR SAVINGS, ARISING FROM ANY BREACH OF WARRANTY OR THE PERFORMANCE OR BREACH OF ANY OTHER PROVISION OF THIS AGREEMENT OR THE USE OR INABILITY TO USE TIMERx, THE DESIGNATED PRODUCT, PENWEST PPG PATENTS, PENWESTPPG'S CONFIDENTIAL TECHNOLOGY, TIMERx PRODUCTION TECHNOLOGY, PENWEST PPG TEST AND REGULATORY DATA, MYLAN IMPROVEMENTSENDO TECHNOLOGY, OR MYLAN ENDO TEST AND REGULATORY DATA, OR JOINT TECHNOLOGY, OR ANY CLAIMS ARISING IN TORT, PERSONAL INJURY, OR PRODUCT LIABILITY, EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. 9.13 Each party shall, at its own cost and expense, obtain and maintain from a qualified insurance company comprehensive general liability and products liability insurance coverage during the term of this Agreement (and any subsequent period of sale or distribution pursuant to Section ). Such insurance shall be in an amount no CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS less than ************************* combined single limit for each occurrence for bodily injury and/or property damage. Each party agrees to provide the other party with a certificate of insurance evidencing such insurance within thirty (30) days after the execution of this Agreement and again thereafter from time to time as reasonably requested by such other party.

Appears in 2 contracts

Samples: Strategic Alliance Agreement (Penwest Pharmaceuticals Co), Strategic Alliance Agreement (Penwest Pharmaceuticals Co)

Representations, Warranties and Indemnities. 9.1 Each party represents and warrants to the other that, to the best of its current knowledge, without undertaking any special investigation, it has the full right and authority to enter into this Agreement and to grant the licenses granted herein. Each party believes, to the best of its current knowledge, that any existing patents licensed by it to the other party under this Agreement are valid. 9.2 Penwest TIMERx Technologies represents and warrants that any Formulated TIMERx supplied by it to Mylan Schwxxx Xxxrma hereunder for use in the Designated Product, at the point of delivery: 9.2.1 will conform to the product Specifications that Penwest and Mylan have agreed in writing are to apply to such delivery effect as of TIMERxthe order date therefor; and 9.2.2 to the best of Penwest's TIMERx Technologies' current knowledge, without undertaking any special investigation, will not infringe upon an article patent of any third party. CONFIDENTIAL MATERIAL OMITTED Without limiting the generality of this clause, TIMERx specifically warrants that it will be able to formulate the Designated Product such that it will not be infringing of that certain United States Patent No. 5,419,917, issued May 30, 1995 and assigned to Andrx Pharmaceuticals, Inc. (the "Andrx Patent"). OTHERWISE, TIMERx TECHNOLOGIES PROVIDES "AS-IS," AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS. PENWEST MAKES NO REPRESENTATIONS OR WARRANTIES AS TO TO, ANY TIMERx OR FORMULATED TIMERx SUPPLIED BY IT TO MYLAN SCHWXXX XXXRMA FOR TESTING, DEVELOPMENT, OR ANY OTHER PURPOSES EXCEPT AS ARE EXPLICITLY STATED HEREINFOR USE IN THE DESIGNATED PRODUCT FOR COMMERCIAL USE OR SALE. 9.3 Each party represents and warrants to the other party that it has obtained obtained, and will at all times during the term of this Agreement, Agreement hold and comply with with, all licenses, permits and authorizations necessary to perform this Agreement and to test, manufacture, market, export, and import the products and assistance to be provided by it hereunderDesignated Product or Formulated TIMERx, as now or hereafter required under any applicable statutes, laws, ordinances, rules and regulations of the United States and any applicable foreign, state, and local governments and governmental entities. 9.4 Mylan warrants that any Designated Product manufacturedTHE FOREGOING WARRANTIES ARE IN LIEU OF, marketed or distributed by Mylan or its Affiliates or sublicensees shall meet and be manufacturedAND THE PARTIES EACH DISCLAIM, packagedALL OTHER WARRANTIES, labeledEXPRESS, soldIMPLIED OR ARISING BY LAW, and promoted in accordance with all applicable regulatory requirements within the TerritoryINCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND NON-INFRINGEMENT. NOTHING IN THIS AGREEMENT SHALL BE CONSTRUED AS A REPRESENTATION OR WARRANTY (i) BY TIMERx TECHNOLOGIES AS TO THE PATENTABILITY, VALIDITY, OR SCOPE OF ANY TIMERX TECHNOLOGIES PATENTS, TIMERx TECHNOLOGIES' CONFIDENTIAL TECHNOLOGY, TIMERx PRODUCTION TECHNOLOGY, OR TIMERx TECHNOLOGIES TEST AND REGULATORY DATA, NOR AS TO THE UTILITY, EFFICACY, NONTOXICITY, SAFETY OR APPROPRIATENESS OF TIMERx OR THE DESIGNATED PRODUCT; OR (ii) BY SCHWXXX XXXRMA AS TO THE PATENTABILITY, VALIDITY, OR SCOPE OF ANY SCHWXXX XXXRMA IMPROVEMENTS OR SCHWXXX XXXRMA TEST AND REGULATORY DATA, NOR AS TO THE UTILITY, EFFICACY, NONTOXICITY, SAFETY OR APPROPRIATENESS OF ANY PRODUCTS MADE THEREFROM. 9.5 Penwest TIMERx Technologies shall indemnify, defend and hold harmless Mylan Schwxxx Xxxrma and its Affiliates and sublicensees from any claim, action or damages arising out of any alleged infringement by reason of the manufacture, use or sale by Mylan Schwxxx Xxxrma of the Designated Product to the extent such infringement would apply as well to the manufacture, sale or distribution of TIMERx alonealone or otherwise to the extent the same is covered by Section . If Mylan Schwxxx Xxxrma or its Affiliate or sublicensee, by reason of its manufacture, sale or distribution of Designated Product, is accused of infringing the patent of a third party, and such claim of infringement, as framed by the claimant, would apply as well to the manufacture, sale or distribution of TIMERx alonealone or otherwise to the extent the same is covered by Section , Mylan Schwxxx Xxxrma shall immediately so notify Penwest TIMERx Technologies and provide Penwest TIMERx Technologies all available information, and the parties shall consult reasonably as to the proper course of action. If Penwest TIMERx Technologies and Mylan Schwxxx Xxxrma jointly determine that such claim is likely to prevail, or if an arbitrator hereunder or a court of competent jurisdiction so determines, Mylan Schwxxx Xxxrma shall be entitled to offset against any Royalties payable to Penwest TIMERx Technologies hereunder any third party royalties for which Mylan Schwxxx Xxxrma or its Affiliate or sublicensee becomes liable. 9.6 Penwest TIMERx Technologies shall indemnify, defend and hold Mylan Schwxxx Xxxrma and its Affiliates and sublicensees harmless from any and all third-party claims to the extent arising from, in connection with, based upon, by reason of, or relating in any way to: 9.6.1 the formulation, development, supply, production, manufacture, sale, delivery, distribution or use of TIMERx in the Designated Product; 9.6.2 TIMERx Technologies' ***************************************** ************************ and the Specifications therefor hereunder, including without limitation any infringement claims based on the Andrx Patent; 9.6.3 any failure of the Formulated TIMERx manufactured by TIMERx Technologies or its alternate supplier (but not by Schwxxx Xxxrma under Section ), as delivered to Schwxxx Xxxrma hereunder for use in the Designated Product, to conform to the Specifications; or 9.6.4 any failure of TIMERx Technologies to comply with its obligation under Section to notify Schwxxx Xxxrma of any information coming into TIMERx Technologies' possession and ************************************************ TIMERx in the Designated Product; CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS 9.6.2 Penwest's *********************************************** and the Specifications therefor hereunder; 9.6.3 any failure of the Formulated TIMERx manufactured by Penwest or its alternate supplier (but not by Mylan under Section ), as delivered to Mylan hereunder for use in the Designated Product, to conform to the Specifications; or 9.6.4 any failure of Penwest to comply with its obligation under Section 5.13 to notify Mylan of any information coming into Penwest's possession and *************************** the Designated Product and not arising from any other aspect of the Designated Product or its formulation, development, supply, production, manufacture, sale, delivery, distribution or use, nor from any act or omission of Mylan Schwxxx Xxxrma with respect to the Formulated TIMERx following its delivery to Mylan Schwxxx Xxxrma hereunder. 9.7 Mylan Schwxxx Xxxrma shall indemnify, defend and hold Penwest TIMERx Technologies harmless from any and all third-party claims to the extent arising from, in connection with, based upon, by reason of, or relating in any way to, the formulation, development, supply, production, manufacture, sale, delivery, distribution or use of the Designated ProductProduct by Schwxxx Xxxrma, ************************************************its Affiliates or sublicensees, except for any matters which are covered by TIMERx Technologies' indemnities under Sections and . 9.8 Notwithstanding anything to the contrary set forth elsewhere herein, neither Mylan Schwxxx Xxxrma nor Penwest TIMERx Technologies shall be obligated to indemnify the other party for claims or liabilities to the extent arising from such other party's, or its Affiliates', sublicensees' or assigns', negligence, intentional misconduct, or breach of its duties, obligations, warranties or representations set forth herein. 9.9 Whenever indemnification is provided for a party under this Agreement, such right of indemnification shall extend also to the indemnified party's Affiliates, officers, directors, shareholders, successors, assigns, agents, employees, and insurers to the extent the same become subject to such claim in such capacity. The party seeking indemnification shall provide the indemnifying party with written notice of any claim or action within ten (10) days of its receipt thereof, and shall afford the indemnifying party the right to control the defense and settlement of such claim or action. The party seeking indemnification shall provide reasonable assistance to the indemnifying party in the defense of such claim or action. If the defendants in any such action include both Mylan Schwxxx Xxxrma and Penwest TIMERx Technologies and either party concludes that there may be legal defenses available to it which are different from, additional to, or inconsistent with, those available to the other, that party shall have the right to select separate counsel to participate in the defense of such action on its behalf, and such party shall thereafter bear the cost and expense of such separate defense. Should the indemnifying party determine not to defend such claim or action, the other party shall have the right to maintain the defense of such claim or action and the indemnifying party agrees to provide reasonable assistance to it in the defense of such claim or action. Neither party shall settle any such claim or action in a way that prejudices or adversely impacts the other party to this Agreement without the prior approval of such other party (which approval shall not be unreasonably withheld). 9.10 Any dispute concerning indemnification will be determined by arbitration in accordance with Section of this Agreement. 9.11 THE FOREGOING WARRANTIES ARE IN LIEU OF ALL OTHER WARRANTIES, EXPRESS, IMPLIED OR ARISING BY LAW, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. NOTHING IN THIS AGREEMENT SHALL BE CONSTRUED AS A REPRESENTATION OR WARRANTY (i) BY PENWEST AS TO THE PATENTABILITY, VALIDITY (EXCEPT AS STATED IN SECTION ), OR SCOPE OF ANY PENWEST PATENTS, PENWEST'S CONFIDENTIAL TECHNOLOGY, TIMERx PRODUCTION TECHNOLOGY, JOINT DEVELOPMENTS, OR PENWEST TEST AND REGULATORY DATA; OR (ii) BY MYLAN AS TO THE PATENTABILITY, VALIDITY (EXCEPT AS STATED IN SECTION ), OR SCOPE OF ANY MYLAN IMPROVEMENTS, JOINT DEVELOPMENTS, OR MYLAN TEST AND REGULATORY DATA. 9.12 NOTWITHSTANDING ANYTHING TO THE CONTRARY CONTAINED HEREIN IN THIS AGREEMENT (OTHER THAN THE SECTION WITH RESPECT TO BREACHES OF CONFIDENTIALITY AND NONSOLICITATION AND SECTION WITH RESPECT TO INDEMNITIES STATED IN THIS SECTION FOR PATENT INFRINGEMENT AND SECTIONS AND WITH RESPECT TO INDEMNITIES FOR HARM TO PERSONS OR TANGIBLE PROPERTY), NEITHER PARTY SHALL UNDER ANY CIRCUMSTANCES BE LIABLE FOR ANY THIRD PARTY CLAIMS OR FOR ANY INCIDENTAL, CONSEQUENTIAL, INDIRECT OR SPECIAL DAMAGES, INCLUDING ANY LOST PROFITS OR SAVINGS, ARISING FROM ANY BREACH OF WARRANTY OR THE PERFORMANCE OR BREACH OF ANY OTHER PROVISION OF THIS AGREEMENT OR THE USE OR INABILITY TO USE TIMERx, THE DESIGNATED PRODUCT, PENWEST TIMERx TECHNOLOGIES PATENTS, PENWEST'S TIMERx TECHNOLOGIES' CONFIDENTIAL TECHNOLOGY, TIMERx PRODUCTION TECHNOLOGY, PENWEST TIMERx TECHNOLOGIES TEST AND REGULATORY DATA, MYLAN SCHWXXX XXXRMA IMPROVEMENTS, OR MYLAN SCHWXXX XXXRMA TEST AND REGULATORY DATA, OR ANY CLAIMS ARISING IN TORT, PERSONAL INJURY, OR PRODUCT LIABILITY, EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. 9.13 Each party shall, at its own cost and expense, obtain and maintain from a qualified insurance company comprehensive general liability and products liability insurance coverage during the term of this Agreement (and any subsequent period of sale or distribution pursuant to Section ). Such insurance shall be in an amount no CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS less than ************************* combined single limit for each occurrence for bodily injury and/or property damage. Each party agrees to provide the other party with a certificate of insurance evidencing such insurance within thirty (30) days after the execution of this Agreement and again thereafter from time to time as reasonably requested by such other party.

Appears in 2 contracts

Samples: Product Development and Supply Agreement (Penwest Pharmaceuticals Co), Product Development and Supply Agreement (Penwest Pharmaceuticals Co)

Representations, Warranties and Indemnities. 9.1 Each 3.1 As at the date of this Agreement, Hogg xxxresents and warrants to WTT that: 3.1.1 Hogg xx the sole beneficial owner of all the issued and allotted Shares free of all liens, charges, encumbrances or other third party rights; 3.1.2 the Company has not traded nor has it received any income or made any gains since its date of incorporation; 3.1.3 the Company has no assets (other than cash with accrued interest in respect of its one fully paid up Ordinary Share) or liabilities (whether actual, contingent or otherwise); and 3.1.4 the Ordinary Share referred to in Clause 3.1.3 constitutes the whole of the issued and allotted share capital of the Company. 3.2 As at the date of this Agreement, each of HRPLC and Hogg xxxresents and warrants to WTT and WT Technologies that it has the right, power and authority, and has taken all action and sought all approvals and consents necessary to execute, deliver and exercise its rights, and perform its obligations under this Agreement and the Completion Agreements to which it is a party. 3.3 As at the date of this Agreement, each of WTT and WT Technologies represents and warrants to Hogg xxx HRPLC that it has the other thatright, power and authority, and has taken all action and sought all approvals and consents necessary to execute, deliver and exercise its rights, and perform its obligations under this Agreement and the Completion Agreements to which it is a party. 3.4 WT Technologies represents and warrants to Hogg xxx the Company that WorldTravel Technologies LLC has adequate title to the Software for the purposes of granting the software licence to TLC and that to the best of its current knowledge, it has knowledge there are no third party rights or claims in respect of the full right and authority to enter into this Agreement and to grant the licenses granted herein. Each party believes, to the best of its current knowledge, that any existing patents licensed by it to the other party under this Agreement are validSoftware. 9.2 Penwest represents 3.5 Hogg xxx HRPLC agree with WT Technologies and warrants that any Formulated TIMERx supplied by it WTT (contracting for itself and as trustee for the Company) to Mylan hereunder for use in indemnify WT Technologies, WTT and the Designated ProductCompany against all losses (excluding indirect or consequential loss), at liabilities and costs which WT Technologies, WTT or the point of delivery: 9.2.1 will conform to the product Specifications that Penwest and Mylan have agreed in writing are to apply to such delivery of TIMERx; and 9.2.2 to the best of Penwest's current knowledge, will not infringe upon an article patent of any third party. CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS. PENWEST MAKES NO REPRESENTATIONS OR WARRANTIES AS TO ANY TIMERx OR FORMULATED TIMERx SUPPLIED BY IT TO MYLAN EXCEPT AS ARE EXPLICITLY STATED HEREIN. 9.3 Each party represents and warrants to the other party that it has obtained and will at all times during the term of this Agreement, hold and comply with all licenses, permits and authorizations necessary to perform this Agreement and to test, manufacture, market, export, and import the products and assistance to be provided by it hereunder, as now or hereafter required under any applicable statutes, laws, ordinances, rules and regulations of the United States and any applicable foreign, state, and local governments and governmental entities. 9.4 Mylan warrants that any Designated Product manufactured, marketed or distributed by Mylan or its Affiliates or sublicensees shall meet and be manufactured, packaged, labeled, sold, and promoted in accordance with all applicable regulatory requirements within the Territory. 9.5 Penwest shall indemnify, defend and hold harmless Mylan and its Affiliates and sublicensees from any claim, action or damages Company may incur arising out of any alleged infringement by reason of the manufacture, use or sale by Mylan of the Designated Product to the extent such infringement would apply as well to the manufacture, sale or distribution of TIMERx alone. If Mylan or its Affiliate or sublicensee, by reason of its manufacture, sale or distribution of Designated Product, is accused of infringing the patent of a third party, and such claim of infringement, as framed by the claimant, would apply as well to the manufacture, sale or distribution of TIMERx alone, Mylan shall immediately so notify Penwest and provide Penwest all available information, and the parties shall consult reasonably as to the proper course of action. If Penwest and Mylan jointly determine that such claim is likely to prevailof, or if an arbitrator hereunder or a court of competent jurisdiction so determines, Mylan shall be entitled to offset against any Royalties payable to Penwest hereunder any third party royalties for which Mylan or its Affiliate or sublicensee becomes liable. 9.6 Penwest shall indemnify, defend and hold Mylan and its Affiliates and sublicensees harmless from any and all third-party claims to the extent arising from, in connection with, based uponany breach of the representations or warranties set out in Clauses 3.1 and/or 3.2. 3.6 WTT and WT Technologies agree with HRPLC and Hogg (xxntracting for itself and as trustee for the Company) to indemnify HRPLC, by reason Hogg xxx the Company against all losses (excluding indirect or consequential loss), liabilities and costs which HRPLC, Hogg xx the Company may incur arising out of, or relating in any way to: 9.6.1 the ************************************************ TIMERx in the Designated Product; CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS 9.6.2 Penwest's *********************************************** and the Specifications therefor hereunder; 9.6.3 any failure of the Formulated TIMERx manufactured by Penwest or its alternate supplier (but not by Mylan under Section ), as delivered to Mylan hereunder for use in the Designated Product, to conform to the Specifications; or 9.6.4 any failure of Penwest to comply with its obligation under Section 5.13 to notify Mylan of any information coming into Penwest's possession and *************************** the Designated Product and not arising from any other aspect of the Designated Product or its formulation, development, supply, production, manufacture, sale, delivery, distribution or use, nor from any act or omission of Mylan with respect to the Formulated TIMERx following its delivery to Mylan hereunder. 9.7 Mylan shall indemnify, defend and hold Penwest harmless from any and all third-party claims to the extent arising from, in connection with, based upon, by reason of, or relating in any way to, the formulation, development, supply, production, manufacture, sale, delivery, distribution or use breach of the Designated Product, ************************************************representations or warranties set out in Clause 3.3. 9.8 Notwithstanding anything 3.7 Without prejudice to the contrary set forth elsewhere hereinindemnity given in Clause 6 of the WTT Licence, neither Mylan nor Penwest shall be obligated WT Technologies agrees to indemnify the other party for claims or liabilities to the extent Company in respect of any loss arising from such other party's, or its Affiliates', sublicensees' or assigns', negligence, intentional misconduct, or breach any claim made by ICC in respect of its duties, obligations, warranties or representations set forth herein. 9.9 Whenever indemnification is provided for a party under this Agreement, such right of indemnification shall extend also to the indemnified party's Affiliates, officers, directors, shareholders, successors, assigns, agents, employees, and insurers to the extent the same become subject to such claim in such capacity. The party seeking indemnification shall provide the indemnifying party with written notice use of any claim or action within ten (10) days intellectual property rights granted under the WTT Licence following the termination of its receipt thereof, and shall afford the indemnifying party the right to control the defense and settlement of such claim or action. The party seeking indemnification shall provide reasonable assistance to the indemnifying party in the defense of such claim or action. If the defendants in any such action include both Mylan and Penwest and either party concludes that there may be legal defenses available to it which are different from, additional to, or inconsistent with, those available to the other, that party shall have the right to select separate counsel to participate in the defense of such action on its behalf, and such party shall thereafter bear the cost and expense of such separate defense. Should the indemnifying party determine not to defend such claim or action, the other party shall have the right to maintain the defense of such claim or action and the indemnifying party agrees to provide reasonable assistance to it in the defense of such claim or action. Neither party shall settle any such claim or action in a way that prejudices or adversely impacts the other party to this Agreement without the prior approval of such other party (which approval shall not be unreasonably withheld). 9.10 Any dispute concerning indemnification will be determined by arbitration in accordance with Section of this ICC Distribution Agreement. 9.11 THE FOREGOING WARRANTIES ARE IN LIEU OF ALL OTHER WARRANTIES, EXPRESS, IMPLIED OR ARISING BY LAW, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. NOTHING IN THIS AGREEMENT SHALL BE CONSTRUED AS A REPRESENTATION OR WARRANTY (i) BY PENWEST AS TO THE PATENTABILITY, VALIDITY (EXCEPT AS STATED IN SECTION ), OR SCOPE OF ANY PENWEST PATENTS, PENWEST'S CONFIDENTIAL TECHNOLOGY, TIMERx PRODUCTION TECHNOLOGY, JOINT DEVELOPMENTS, OR PENWEST TEST AND REGULATORY DATA; OR (ii) BY MYLAN AS TO THE PATENTABILITY, VALIDITY (EXCEPT AS STATED IN SECTION ), OR SCOPE OF ANY MYLAN IMPROVEMENTS, JOINT DEVELOPMENTS, OR MYLAN TEST AND REGULATORY DATA. 9.12 NOTWITHSTANDING ANYTHING TO THE CONTRARY CONTAINED HEREIN (OTHER THAN THE INDEMNITIES STATED IN THIS SECTION ), NEITHER PARTY SHALL UNDER ANY CIRCUMSTANCES BE LIABLE FOR ANY THIRD PARTY CLAIMS OR FOR ANY INCIDENTAL, CONSEQUENTIAL, INDIRECT OR SPECIAL DAMAGES, INCLUDING ANY LOST PROFITS OR SAVINGS, ARISING FROM ANY BREACH OF WARRANTY OR THE PERFORMANCE OR BREACH OF ANY OTHER PROVISION OF THIS AGREEMENT OR THE USE OR INABILITY TO USE TIMERx, THE DESIGNATED PRODUCT, PENWEST PATENTS, PENWEST'S CONFIDENTIAL TECHNOLOGY, TIMERx PRODUCTION TECHNOLOGY, PENWEST TEST AND REGULATORY DATA, MYLAN IMPROVEMENTS, OR MYLAN TEST AND REGULATORY DATA, EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. 9.13 Each party shall, at its own cost and expense, obtain and maintain from a qualified insurance company comprehensive general liability and products liability insurance coverage during the term of this Agreement (and any subsequent period of sale or distribution pursuant to Section ). Such insurance shall be in an amount no CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS less than ************************* combined single limit for each occurrence for bodily injury and/or property damage. Each party agrees to provide the other party with a certificate of insurance evidencing such insurance within thirty (30) days after the execution of this Agreement and again thereafter from time to time as reasonably requested by such other party.

Appears in 1 contract

Samples: Shareholders Agreement (TRX Inc/Ga)

Representations, Warranties and Indemnities. 9.1 Each party represents and warrants to the other that, to the best of its current knowledge, it has the full right and authority to enter into this Agreement and to grant the licenses granted herein. Each party believes, to the best of its current knowledge, that any existing patents licensed by it to the other party under this Agreement are valid. 9.2 Penwest represents and warrants that any Formulated TIMERx supplied by it to Mylan hereunder for use in the Designated Product, at the point of delivery: 9.2.1 will conform to the product Specifications that Penwest and Mylan have agreed in writing are to apply to such delivery of TIMERx; and 9.2.2 to the best of Penwest's current knowledge, will not infringe upon an article patent of any third party. CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS. PENWEST MAKES NO REPRESENTATIONS OR WARRANTIES AS TO ANY TIMERx OR FORMULATED TIMERx SUPPLIED BY IT TO MYLAN EXCEPT AS ARE EXPLICITLY STATED HEREIN. 9.3 Each party represents and warrants to the other party that it has obtained and will at all times during the term of this Agreement, hold and comply with all licenses, permits and authorizations necessary to perform this Agreement and to test, manufacture, market, export, and import the products and assistance to be provided by it hereunder, as now or hereafter required under any applicable statutes, laws, ordinances, rules and regulations of the United States and any applicable foreign, state, and local governments and governmental entities. 9.4 Mylan warrants that any Designated Product manufactured, marketed or distributed by Mylan or its Affiliates or sublicensees shall meet and be manufactured, packaged, labeled, sold, and promoted in accordance with all applicable regulatory requirements within the Territory. 9.5 Penwest shall indemnify, defend and hold harmless Mylan and its Affiliates and sublicensees from any claim, action or damages arising out of any alleged infringement by reason of the manufacture, use or sale by Mylan of the Designated Product to the extent such infringement would apply as well to the manufacture, sale or distribution of TIMERx alone. If Mylan or its Affiliate or sublicensee, by reason of its manufacture, sale or distribution of Designated Product, is accused of infringing the patent of a third party, and such claim of infringement, as framed by the claimant, would apply as well to the manufacture, sale or distribution of TIMERx alone, Mylan shall immediately so notify Penwest and provide Penwest all available information, and the parties shall consult reasonably as to the proper course of action. If Penwest and Mylan jointly determine that such claim is likely to prevail, or if an arbitrator hereunder or a court of competent jurisdiction so determines, Mylan shall be entitled to offset against any Royalties payable to Penwest hereunder any third party royalties for which Mylan or its Affiliate or sublicensee becomes liable. 9.6 Penwest shall indemnify, defend and hold Mylan and its Affiliates and sublicensees harmless from any and all third-party claims to the extent arising from, in connection with, based upon, by reason of, or relating in any way to: 9.6.1 the ************************************************ TIMERx in the Designated Product; CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS 9.6.2 Penwest's *********************************************** and the Specifications therefor hereunder; 9.6.3 any failure of the Formulated TIMERx manufactured by Penwest or its alternate supplier (but not by Mylan under Section ), as delivered to Mylan hereunder for use in the Designated Product, to conform to the Specifications; or 9.6.4 any failure of Penwest to comply with its obligation under Section 5.13 to notify Mylan of any information coming into Penwest's possession and *************************** the Designated Product and not arising from any other aspect of the Designated Product or its formulation, development, supply, production, manufacture, sale, delivery, distribution or use, nor from any act or omission of Mylan with respect to the Formulated TIMERx following its delivery to Mylan hereunder. 9.7 Mylan shall indemnify, defend and hold Penwest harmless from any and all third-party claims to the extent arising from, in connection with, based upon, by reason of, or relating in any way to, the formulation, development, supply, production, manufacture, sale, delivery, distribution or use of the Designated Product, ************************************************except for any matters which are covered by Penwest's indemnities under Sections 9.5 and 9. 9.8 Notwithstanding anything to the contrary set forth elsewhere herein, neither Mylan nor Penwest shall be obligated to indemnify the other party for claims or liabilities to the extent arising from such other party's, or its Affiliates', sublicensees' or assigns', negligence, intentional misconduct, or breach of its duties, obligations, warranties or representations set forth herein. 9.9 Whenever indemnification is provided for a party under this Agreement, such right of indemnification shall extend also to the indemnified party's Affiliates, officers, directors, shareholders, successors, assigns, agents, employees, and insurers to the extent the same become subject to such claim in such capacity. The party seeking indemnification shall provide the indemnifying party with written notice of any claim or action within ten (10) days of its receipt thereof, and shall afford the indemnifying party the right to control the defense and settlement of such claim or action. The party seeking indemnification shall provide reasonable assistance to the indemnifying party in the defense of such claim or action. If the defendants in any such action include both Mylan and Penwest and either party concludes that there may be legal defenses available to it which are different from, additional to, or inconsistent with, those available to the other, that party shall have the right to select separate counsel to participate in the defense of such action on its behalf, and such party shall thereafter bear the cost and expense of such separate defense. Should the indemnifying party determine not to defend such claim or action, the other party shall have the right to maintain the defense of such claim or action and the indemnifying party agrees to provide reasonable assistance to it in the defense of such claim or action. Neither party shall settle any such claim or action in a way that prejudices or adversely impacts the other party to this Agreement without the prior approval of such other party (which approval shall not be unreasonably withheld). 9.10 Any dispute concerning indemnification will be determined by arbitration in accordance with Section of this Agreement. 9.11 THE FOREGOING WARRANTIES ARE IN LIEU OF ALL OTHER WARRANTIES, EXPRESS, IMPLIED OR ARISING BY LAW, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. NOTHING IN THIS AGREEMENT SHALL BE CONSTRUED AS A REPRESENTATION OR WARRANTY (i) BY PENWEST AS TO THE PATENTABILITY, VALIDITY (EXCEPT AS STATED IN SECTION ), OR SCOPE OF ANY PENWEST PATENTS, PENWEST'S CONFIDENTIAL TECHNOLOGY, TIMERx PRODUCTION TECHNOLOGY, JOINT DEVELOPMENTS, OR PENWEST TEST AND REGULATORY DATA; OR (ii) BY MYLAN AS TO THE PATENTABILITY, VALIDITY (EXCEPT AS STATED IN SECTION ), OR SCOPE OF ANY MYLAN IMPROVEMENTS, JOINT DEVELOPMENTS, OR MYLAN TEST AND REGULATORY DATA. 9.12 NOTWITHSTANDING ANYTHING TO THE CONTRARY CONTAINED HEREIN (OTHER THAN THE INDEMNITIES STATED IN THIS SECTION ), NEITHER PARTY SHALL UNDER ANY CIRCUMSTANCES BE LIABLE FOR ANY THIRD PARTY CLAIMS OR FOR ANY INCIDENTAL, CONSEQUENTIAL, INDIRECT OR SPECIAL DAMAGES, INCLUDING ANY LOST PROFITS OR SAVINGS, ARISING FROM ANY BREACH OF WARRANTY OR THE PERFORMANCE OR BREACH OF ANY OTHER PROVISION OF THIS AGREEMENT OR THE USE OR INABILITY TO USE TIMERx, THE DESIGNATED PRODUCT, PENWEST PATENTS, PENWEST'S CONFIDENTIAL TECHNOLOGY, TIMERx PRODUCTION TECHNOLOGY, PENWEST TEST AND REGULATORY DATA, MYLAN IMPROVEMENTS, OR MYLAN TEST AND REGULATORY DATA, EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. 9.13 Each party shall, at its own cost and expense, obtain and maintain from a qualified insurance company comprehensive general liability and products liability insurance coverage during the term of this Agreement (and any subsequent period of sale or distribution pursuant to Section ). Such insurance shall be in an amount no CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS less than ************************* combined single limit for each occurrence for bodily injury and/or property damage. Each party agrees to provide the other party with a certificate of insurance evidencing such insurance within thirty (30) days after the execution of this Agreement and again thereafter from time to time as reasonably requested by such other party.

Appears in 1 contract

Samples: Product Development and Supply Agreement (Penwest Pharmaceuticals Co)

Representations, Warranties and Indemnities. 9.1 Each party (1) Sandoz represents and warrants to Alder that (a) it will comply with all applicable Legal Requirements relevant for the other Manufacture, (b) it has and shall maintain all necessary and applicable licenses and permits for the Manufacture of the BDS, (c) it shall deliver with the BDS the Certificates, and (d) it is not debarred and has not and will not use in any capacity the services of any person debarred under Section 306(a) or (b) of the U.S. Generic Drug Enforcement Act of 1992 or any comparable EU law, as each may be amended from time to time. (2) Sandoz further represents and warrants to Alder that it performs cGMP audits of its facilities, vendors and suppliers no less than [***] in order to ensure compliance with the requirements of the BDS Specifications and agrees to give a written certification of compliance with cGMP to (a) Alder upon Alder’s request, (b) an independent Third Party appointed by Alder upon Alder’s request, and/or (c) Regulatory Authorities upon such Regulatory Authorities’ request. (3) Alder represents and warrants to Sandoz that it has the right, title and interest in any intellectual property in the Product covered by this Agreement (whether such right, title and interest is held solely by Alder or jointly with others) and that it has the legal right, authority and power to enter into this Agreement, and to authorize Sandoz to Manufacture the BDS under and in accordance with this Agreement. Alder represents and warrants that, to the best actual knowledge of its current knowledge[***], as of the Effective Date it has is not aware of any other Third Party patent rights, under which Alder is not already licensed with the full right to sub-license, that may be asserted to be valid and authority infringed by the Manufacture of the BDS by Sandoz under and in accordance with the terms of this Agreement. Alder shall promptly inform Sandoz in the event that after the Effective Date Alder becomes aware of any other Third Party patent rights, under which Alder is not already licensed with the right to enter into sub-license, that may be asserted to be valid and infringed by the Manufacture of the BDS by Sandoz under and in accordance with the terms of this Agreement Agreement. (4) EXCEPT FOR THE EXPRESS WARRANTIES CONTAINED IN THIS AGREEMENT, THE PARTIES PROVIDE NO OTHER WARRANTIES, EXPRESS OR IMPLIED, REGARDING THE BDS, THE PRODUCT, THE PROCESS, OR OTHERWISE, AND DISCLAIM ALL OTHER EXPRESS AND IMPLIED WARRANTIES, INCLUDING (A) THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND NONINFRINGEMENT, AND (B) ANY IMPLIED WARRANTIES ARISING FROM ANY COURSE OF DEALING, USAGE OR TRADE PRACTICE. (5) Subject to and to grant the licenses granted herein. Each party believes, except to the best extent of any indemnification from Alder pursuant to Clause 27(6), Sandoz shall indemnify and hold Alder, its current knowledgeAffiliates and their respective directors, that officers, employees and agents harmless from and against all losses, liabilities, damages and expenses (including reasonable [***] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. (a) breach of any existing patents licensed by it to the other party representation or warranty of Sandoz under this Agreement or the Quality Agreement; (b) breach of this Agreement or the Quality Agreement attributable to Sandoz; (c) claims by any Third Party or Sandoz Affiliate which are valid.parties to agreements and equipment leases with Sandoz concerning the equipment used by Sandoz to Manufacture the BDS; 9.2 Penwest represents (d) negligence, fraud, gross negligence, willful misconduct or wrongful intentional acts or omissions by Sandoz or its Affiliates, and warrants that their respective directors, officers, employees and agents under the Agreement or the Quality Agreement; and/or (e) any Formulated TIMERx supplied infringement by it to Mylan hereunder for use in the Designated Product, at the point of delivery: 9.2.1 will conform to the product Specifications that Penwest and Mylan have agreed in writing are to apply to such delivery of TIMERx; and 9.2.2 to the best of Penwest's current knowledge, will not infringe upon an article patent Sandoz of any third party. CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS. PENWEST MAKES NO REPRESENTATIONS OR WARRANTIES AS TO ANY TIMERx OR FORMULATED TIMERx SUPPLIED BY IT TO MYLAN EXCEPT AS ARE EXPLICITLY STATED HEREIN. 9.3 Each party represents and warrants to the other party that it has obtained and will at all times during the term Third Party Intellectual Property or of this Agreement, hold and comply with all licenses, permits and authorizations necessary to perform this Agreement and to test, manufacture, market, export, and import the products and assistance to be provided by it hereunder, as now or hereafter required under any applicable statutes, laws, ordinances, rules and regulations Sandoz’s Affiliate’s Intellectual Property arising from its use of the United States Process and any applicable foreign, state, and local governments and governmental entities. 9.4 Mylan warrants that any Designated Product manufactured, marketed or distributed by Mylan or its Affiliates or sublicensees shall meet and be manufactured, packaged, labeled, sold, and promoted the Process Transfer Information for Manufacture of the BDS in accordance with all applicable regulatory requirements within this Agreement; provided that such infringement is resulting from any deviation from or modification of the TerritoryProcess which were not requested or approved by Alder. 9.5 Penwest (6) Subject to and except to the extent of any indemnification from Sandoz pursuant to Clause 27(5), Alder shall indemnify, defend indemnify and hold harmless Mylan and Sandoz, its Affiliates and sublicensees from any claimtheir respective officers, action or damages arising out of any alleged infringement by reason of the manufacture, use or sale by Mylan of the Designated Product to the extent such infringement would apply as well to the manufacture, sale or distribution of TIMERx alone. If Mylan or its Affiliate or sublicensee, by reason of its manufacture, sale or distribution of Designated Product, is accused of infringing the patent of a third party, employees and such claim of infringement, as framed by the claimant, would apply as well to the manufacture, sale or distribution of TIMERx alone, Mylan shall immediately so notify Penwest and provide Penwest all available information, and the parties shall consult reasonably as to the proper course of action. If Penwest and Mylan jointly determine that such claim is likely to prevail, or if an arbitrator hereunder or a court of competent jurisdiction so determines, Mylan shall be entitled to offset against any Royalties payable to Penwest hereunder any third party royalties for which Mylan or its Affiliate or sublicensee becomes liable. 9.6 Penwest shall indemnify, defend and hold Mylan and its Affiliates and sublicensees agents harmless from and against all losses, liabilities, damages and expenses (including reasonable attorneys’ fees and costs) resulting from all claims, demands, actions and other proceedings by any and all third-party claims Third Party or Alder Affiliate to the extent arising from, in connection with, based upon, by reason of, (a) the breach of any representation or relating in any way to: 9.6.1 warranty of Alder under this Agreement or the ************************************************ TIMERx in the Designated Product; CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS 9.6.2 Penwest's *********************************************** and the Specifications therefor hereunderQuality Agreement; 9.6.3 any failure (b) the negligence, gross negligence or willful misconduct of Alder under the Agreement or the Quality Agreement; (c) personal injury (including death) or property damage relating to or arising out of the Formulated TIMERx manufactured research, development, commercialization, use, marketing or sale of the Product (or drugs containing the BDS) by Penwest Alder or its alternate supplier (but not by Mylan under Section ), as delivered to Mylan hereunder for use in the Designated Product, to conform to the SpecificationsAffiliates; or 9.6.4 (d) any failure of Penwest to comply with its obligation under Section 5.13 to notify Mylan infringement by Sandoz of any information coming into Penwest's possession and *************************** the Designated Product and not Third Party Intellectual Property or any Alder Affiliate’s Intellectual Property arising from any other aspect of the Designated Product or its formulation, development, supply, production, manufacture, sale, delivery, distribution or use, nor from any act or omission of Mylan with respect to the Formulated TIMERx following its delivery to Mylan hereunder. 9.7 Mylan shall indemnify, defend and hold Penwest harmless from any and all third-party claims to the extent arising from, in connection with, based upon, by reason of, or relating in any way to, the formulation, development, supply, production, manufacture, sale, delivery, distribution or use of the Designated ProductProcess and the Process Transfer Information for Manufacture of the BDS under and in accordance with this Agreement; provided that such infringement is not resulting from any deviation from or modification of the Process, ************************************************except for deviations or modification which were requested or approved by Alder. 9.8 Notwithstanding anything to (7) The Party claiming the contrary set forth elsewhere herein, neither Mylan nor Penwest shall be obligated to indemnify benefit of any indemnity hereunder must promptly notify the other party for claims or liabilities to the extent arising from such other party's, or its Affiliates', sublicensees' or assigns', negligence, intentional misconduct, or breach of its duties, obligations, warranties or representations set forth herein. 9.9 Whenever indemnification is provided for a party under this Agreement, such right of indemnification shall extend also to the indemnified party's Affiliates, officers, directors, shareholders, successors, assigns, agents, employees, and insurers to the extent the same become subject to such claim in such capacity. The party seeking indemnification shall provide the indemnifying party with written notice of any claim or action within ten (10) days as soon as it becomes aware of its receipt thereofany claim, and shall afford permit the indemnifying party the right other Party to control the defense and of the action, not accept any compromise or settlement of such claim or actiontake any material steps in relation to such claim without the prior consent of the other Party (not to be unreasonably withheld or delayed) and shall fully cooperate with the other Party in the handling of any such claim, provided however that the failure to give such notice of such claim shall not relieve the indemnifying Party of its obligations under this Clause 27 except to the extent the defense, resolution or outcome of such claim is thereby compromised. The party seeking indemnification indemnifying Party shall provide reasonable assistance to the indemnifying party in control the defense of such claim or action. If the defendants in any such action include both Mylan and Penwest and either party concludes that there may be legal defenses available to it which are different from, additional to, or inconsistent with, those available to the other, that party shall have the right to select separate counsel to participate in bear the defense of such action on its behalf, and such party shall thereafter bear the cost and expense of such separate defense. Should the indemnifying party determine not to defend such claim or action, the other party shall have the right to maintain the defense of such claim or action and the indemnifying party agrees to provide reasonable assistance to it in the defense of such claim or action. Neither party shall settle any such claim or action in a way that prejudices or adversely impacts the other party to this Agreement without the prior approval of such other party (which approval shall not be unreasonably withheld)costs. 9.10 Any dispute concerning indemnification will be determined by arbitration in accordance with Section of this Agreement. 9.11 THE FOREGOING WARRANTIES ARE IN LIEU OF ALL OTHER WARRANTIES, EXPRESS, IMPLIED OR ARISING BY LAW, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. NOTHING IN THIS AGREEMENT SHALL BE CONSTRUED AS A REPRESENTATION OR WARRANTY (i) BY PENWEST AS TO THE PATENTABILITY, VALIDITY (EXCEPT AS STATED IN SECTION ), OR SCOPE OF ANY PENWEST PATENTS, PENWEST'S CONFIDENTIAL TECHNOLOGY, TIMERx PRODUCTION TECHNOLOGY, JOINT DEVELOPMENTS, OR PENWEST TEST AND REGULATORY DATA; OR (ii) BY MYLAN AS TO THE PATENTABILITY, VALIDITY (EXCEPT AS STATED IN SECTION ), OR SCOPE OF ANY MYLAN IMPROVEMENTS, JOINT DEVELOPMENTS, OR MYLAN TEST AND REGULATORY DATA. 9.12 NOTWITHSTANDING ANYTHING TO THE CONTRARY CONTAINED HEREIN (OTHER THAN THE INDEMNITIES STATED IN THIS SECTION ), NEITHER PARTY SHALL UNDER ANY CIRCUMSTANCES BE LIABLE FOR ANY THIRD PARTY CLAIMS OR FOR ANY INCIDENTAL, CONSEQUENTIAL, INDIRECT OR SPECIAL DAMAGES, INCLUDING ANY LOST PROFITS OR SAVINGS, ARISING FROM ANY BREACH OF WARRANTY OR THE PERFORMANCE OR BREACH OF ANY OTHER PROVISION OF THIS AGREEMENT OR THE USE OR INABILITY TO USE TIMERx, THE DESIGNATED PRODUCT, PENWEST PATENTS, PENWEST'S CONFIDENTIAL TECHNOLOGY, TIMERx PRODUCTION TECHNOLOGY, PENWEST TEST AND REGULATORY DATA, MYLAN IMPROVEMENTS, OR MYLAN TEST AND REGULATORY DATA, EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. 9.13 Each party shall, at its own cost and expense, obtain and maintain from a qualified insurance company comprehensive general liability and products liability insurance coverage during the term of this Agreement (and any subsequent period of sale or distribution pursuant to Section ). Such insurance shall be in an amount no CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS less than ************************* combined single limit for each occurrence for bodily injury and/or property damage. Each party agrees to provide the other party with a certificate of insurance evidencing such insurance within thirty (30) days after the execution of this Agreement and again thereafter from time to time as reasonably requested by such other party.

Appears in 1 contract

Samples: Contract Manufacturing Agreement (Alder Biopharmaceuticals Inc)

Representations, Warranties and Indemnities. 9.1 Each party represents and warrants to the other that, to the best of its current knowledge, it has the full right and authority to enter into this Agreement and to grant the licenses granted herein. Each party believes, to the best of its current knowledge, that any existing patents licensed by it to the other party under this Agreement are ate valid. 9.2 Penwest represents and warrants that any Formulated TIMERx supplied by it to Mylan hereunder for use in the Designated Product, at the point of delivery: 9.2.1 will conform to the product Specifications that Penwest and Mylan have agreed in writing are to apply to such delivery of TIMERx; and 9.2.2 to the best of Penwest's current knowledge, will not infringe upon an article patent of any third party. CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS. PENWEST MAKES NO REPRESENTATIONS OR WARRANTIES AS TO ANY TIMERx OR FORMULATED TIMERx SUPPLIED BY IT TO MYLAN EXCEPT AS ARE EXPLICITLY STATED HEREIN. 9.3 Each party represents and warrants to the other party that it has obtained and will at all times during the term of this Agreement, hold and comply with all licenses, permits and authorizations necessary to perform this Agreement and to test, manufacture, market, export, and import the products and assistance to be provided by it hereunder, as now or hereafter required under any applicable statutes, laws, ordinances, rules and regulations of the United States and any applicable foreign, state, and local governments and governmental entities. 9.4 Mylan warrants that any Designated Product manufactured, marketed or distributed by Mylan or its Affiliates or sublicensees shall meet and be manufactured, packaged, labeled, sold, and promoted in accordance with all applicable regulatory requirements within the Territory. 9.5 Penwest shall indemnify, defend and hold harmless Mylan and its Affiliates and sublicensees from any claim, action or damages arising out of any alleged infringement by reason of the manufacture, use or sale by Mylan of the Designated Product to the extent such infringement would apply as well to the manufacture, sale or distribution of TIMERx alone. If Mylan or its Affiliate or sublicensee, by reason of its manufacture, sale or distribution of Designated Product, is accused of infringing the patent of a third party, and such claim of infringement, as framed by the claimant, would apply as well to the manufacture, sale or distribution of TIMERx alone, Mylan shall immediately so notify Penwest and provide Penwest all available information, and the parties shall consult reasonably as to the proper course of action. If Penwest and Mylan jointly determine that such claim is likely to prevail, or if an arbitrator hereunder or a court of competent jurisdiction so determines, Mylan shall be entitled to offset against any Royalties payable to Penwest hereunder any third party royalties for which Mylan or its Affiliate or sublicensee becomes liable. 9.6 Penwest shall indemnify, defend and hold Mylan and its Affiliates and sublicensees harmless from any and all third-party claims to the extent arising from, in connection with, based upon, by reason of, or relating in any way to:: CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS. 9.6.1 the ************************************************************* TIMERx in the Designated Product; CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS; 9.6.2 Penwest's ******************************************************* and the Specifications therefor hereunder; 9.6.3 any failure of the Formulated TIMERx manufactured by Penwest or its alternate supplier (but not by Mylan under Section 5.8), as delivered to Mylan hereunder for use in the Designated Product, to conform to the Specifications; or 9.6.4 any failure of Penwest to comply with its obligation under Section 5.13 to notify Mylan of any information coming into Penwest's possession and ************************************************* the Designated Product Product,and not arising from any other aspect of the Designated Product or its formulation, development, supply, production, manufacture, sale, delivery, distribution or use, nor from any act or omission of Mylan with respect to the Formulated TIMERx following its delivery to Mylan hereunder. 9.7 Mylan shall indemnify, defend and hold Penwest harmless from any and all third-party claims to the extent arising from, in connection with, based upon, by reason of, or relating in any way to, the formulation, development, supply, production, manufacture, sale, delivery, distribution or use of the Designated Product, ************************************************.*********** 9.8 Notwithstanding anything to the contrary set forth elsewhere herein, neither Mylan nor Penwest shall be obligated to indemnify the other party for claims or liabilities to the extent arising from such other party's, or its Affiliates', sublicensees' or assigns', negligence, intentional misconduct, or breach of its duties, obligations, warranties or representations set forth herein. 9.9 Whenever indemnification is provided for a party under this Agreement, such right of indemnification shall extend also to the indemnified party's Affiliates, officers, directors, shareholders, successors, assigns, agents, employees, and insurers to the extent the same become subject to such claim in such capacity. The party seeking indemnification shall provide the indemnifying party with written notice of any claim or action within ten (10) days of its receipt thereof, and shall afford the indemnifying party the right to control the defense and settlement of such claim or action. The party seeking indemnification shall provide reasonable assistance to the indemnifying party in the defense of such claim or action. If the defendants in any such action include both Mylan and Penwest and either party concludes that there may be legal defenses available to it which are different from, additional to, or inconsistent with, those available to the other, that party shall have the right to select separate counsel to participate in the defense of such action on its behalf, and such party shall thereafter bear the cost and expense of such separate defense. Should the indemnifying party determine not to defend such claim or action, the other party shall have the right to maintain the defense of such claim or action and the indemnifying party agrees to provide reasonable assistance to it in the defense of such claim or action. Neither party shall settle any such claim or action in a way that prejudices or adversely impacts the other party to this Agreement without the prior approval of such other party (which approval shall not be unreasonably withheld)) . 9.10 Any dispute concerning indemnification will be determined by arbitration in accordance with Section 11.10 of this Agreement. 9.11 THE FOREGOING WARRANTIES ARE IN LIEU OF ALL OTHER WARRANTIES, EXPRESS, IMPLIED OR ARISING BY LAW, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. NOTHING IN THIS AGREEMENT SHALL BE CONSTRUED AS A REPRESENTATION OR WARRANTY (i) BY PENWEST AS TO THE PATENTABILITY, VALIDITY (EXCEPT AS STATED IN SECTION 9.1), OR SCOPE OF ANY PENWEST PATENTS, PENWEST'S CONFIDENTIAL TECHNOLOGY, TIMERx PRODUCTION TECHNOLOGY, JOINT DEVELOPMENTS, OR PENWEST TEST AND REGULATORY DATA; OR (ii) BY MYLAN AS TO THE PATENTABILITY, VALIDITY (EXCEPT AS STATED IN SECTION 9.1), OR SCOPE OF ANY MYLAN IMPROVEMENTS, JOINT DEVELOPMENTS, OR MYLAN TEST AND REGULATORY DATA. 9.12 NOTWITHSTANDING ANYTHING TO THE CONTRARY CONTAINED HEREIN (OTHER THAN THE INDEMNITIES STATED IN THIS SECTION 9), NEITHER PARTY SHALL UNDER ANY CIRCUMSTANCES BE LIABLE FOR ANY THIRD PARTY CLAIMS OR FOR ANY INCIDENTAL, CONSEQUENTIAL, INDIRECT OR SPECIAL DAMAGES, INCLUDING ANY LOST PROFITS OR SAVINGS, ARISING FROM ANY BREACH OF WARRANTY OR THE PERFORMANCE OR BREACH OF ANY OTHER PROVISION OF THIS AGREEMENT OR THE USE OR INABILITY TO USE TIMERx, THE DESIGNATED PRODUCT, PENWEST PATENTS, PENWEST'S CONFIDENTIAL TECHNOLOGY, TIMERx PRODUCTION TECHNOLOGY, PENWEST TEST AND REGULATORY DATA, MYLAN IMPROVEMENTS, OR MYLAN TEST AND REGULATORY DATA, EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS. 9.13 Each party shall, at its own cost and expense, obtain and maintain from a qualified insurance company comprehensive general liability and products liability insurance coverage during the term of this Agreement (and any subsequent period of sale or distribution pursuant to Section 10.8). Such insurance shall be in an amount no CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS less than ********************************** combined single limit for each occurrence for bodily injury and/or property damage. Each party agrees to provide the other party with a certificate of insurance evidencing such insurance within thirty (30) days after the execution of this Agreement and again thereafter from time to time as reasonably requested by such other party.

Appears in 1 contract

Samples: Product Development and Supply Agreement (Penwest Pharmaceuticals Co)

Representations, Warranties and Indemnities. 9.1 Each party represents 23. Warranty and warrants to the other thatIndemnity re: Authority, to the best of its current knowledge, it has the full right Title and authority to enter into this Agreement and to grant the licenses granted herein. Each party believes, to the best of its current knowledge, that any existing patents licensed by it to the other party under this Agreement are validProprietary Rights. 9.2 Penwest (1) XXX.XXX represents and warrants that any Formulated TIMERx supplied by it has the right to Mylan hereunder for use in grant the Designated Product, at licence hereby granted and that XXX.XXX has the point of delivery: 9.2.1 will conform right to provide the product Specifications that Penwest and Mylan have agreed in writing are to apply to such delivery of TIMERx; and 9.2.2 to the best of Penwest's current knowledge, will not infringe upon an article patent of any third party. CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS. PENWEST MAKES NO REPRESENTATIONS OR WARRANTIES AS TO ANY TIMERx OR FORMULATED TIMERx SUPPLIED BY IT TO MYLAN EXCEPT AS ARE EXPLICITLY STATED HEREINAIM E-Commerce Service. 9.3 Each party represents and warrants (2) XXX.XXX agrees to the other party that it has obtained and will at all times during the term of this Agreement, hold and comply with all licenses, permits and authorizations necessary to perform this Agreement and to test, manufacture, market, export, and import the products and assistance to be provided by it hereunder, as now or hereafter required under any applicable statutes, laws, ordinances, rules and regulations of the United States and any applicable foreign, state, and local governments and governmental entities. 9.4 Mylan warrants that any Designated Product manufactured, marketed or distributed by Mylan or its Affiliates or sublicensees shall meet and be manufactured, packaged, labeled, sold, and promoted in accordance with all applicable regulatory requirements within the Territory. 9.5 Penwest shall indemnify, defend and indemnify AIM and hold it harmless Mylan from all losses, claims, damages or liabilities, including court costs and its Affiliates and sublicensees from any claimlegal fees, action in connection with or damages arising out of any alleged infringement by reason claim asserted against AIM based upon a contention that the AIM E-Commerce Service, the XXX.XXX Technology or the Software or any of the manufactureDeliverables, use or sale any portion thereof used by Mylan AIM or the Joint Venture within the scope of this Agreement infringe the Intellectual Property Rights of any third Party provided that: (1) AIM or the Joint Venture promptly notify XXX.XXX in writing of the Designated Product to the extent such infringement would apply as well to the manufacture, sale or distribution claim and of TIMERx alone. If Mylan or its Affiliate or sublicensee, by reason of its manufacture, sale or distribution of Designated Product, is accused of infringing the patent of a third party, and all material developments in connection with such claim of infringement, as framed and provides all assistance otherwise reasonably requested by the claimant, would apply as well to the manufacture, sale or distribution of TIMERx alone, Mylan shall immediately so notify Penwest and provide Penwest all available information, and the parties shall consult reasonably as to the proper course of action. If Penwest and Mylan jointly determine that such claim is likely to prevail, or if an arbitrator hereunder or a court of competent jurisdiction so determines, Mylan shall be entitled to offset against any Royalties payable to Penwest hereunder any third party royalties for which Mylan or its Affiliate or sublicensee becomes liable. 9.6 Penwest shall indemnify, defend and hold Mylan and its Affiliates and sublicensees harmless from any and all third-party claims to the extent arising from, in connection with, based upon, by reason of, or relating in any way to: 9.6.1 the ************************************************ TIMERx in the Designated Product; CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS 9.6.2 Penwest's *********************************************** and the Specifications therefor hereunderXXX.XXX; 9.6.3 any failure of the Formulated TIMERx manufactured by Penwest or its alternate supplier (but not by Mylan under Section ), as delivered to Mylan hereunder for use in the Designated Product, to conform to the Specifications; or 9.6.4 any failure of Penwest to comply with its obligation under Section 5.13 to notify Mylan of any information coming into Penwest's possession and *************************** the Designated Product and not arising from any other aspect of the Designated Product or its formulation, development, supply, production, manufacture, sale, delivery, distribution or use, nor from any act or omission of Mylan with respect to the Formulated TIMERx following its delivery to Mylan hereunder. 9.7 Mylan shall indemnify, defend and hold Penwest harmless from any and all third-party claims to the extent arising from, in connection with, based upon, by reason of, or relating in any way to, the formulation, development, supply, production, manufacture, sale, delivery, distribution or use of the Designated Product, ************************************************. 9.8 Notwithstanding anything to the contrary set forth elsewhere herein, neither Mylan nor Penwest shall be obligated to indemnify the other party for claims or liabilities to the extent arising from such other party's, or its Affiliates', sublicensees' or assigns', negligence, intentional misconduct, or breach of its duties, obligations, warranties or representations set forth herein. 9.9 Whenever indemnification is provided for a party under this Agreement, such right of indemnification shall extend also to the indemnified party's Affiliates, officers, directors, shareholders, successors, assigns, agents, employees, and insurers to the extent the same become subject to such claim in such capacity. The party seeking indemnification shall provide the indemnifying party with written notice of any claim or action within ten (102) days of its receipt thereof, and shall afford the indemnifying party XXX.XXX has the right to control control, at its own expense, the defense defence and all related settlement of such claim or action. The party seeking indemnification shall provide reasonable assistance to the indemnifying party in the defense of such claim or action. If the defendants in any such action include both Mylan and Penwest and either party concludes that there may be legal defenses available to it which are different from, additional to, or inconsistent with, those available to the other, that party shall have negotiations (AIM has the right to select separate counsel to participate in at its own expense); (3) AIM or the defense of such action on its behalf, and such party shall thereafter bear the cost and expense of such separate defense. Should the indemnifying party determine Joint Venture does not to defend such claim pay or action, the other party shall have the right to maintain the defense of such claim or action and the indemnifying party agrees to provide reasonable assistance to it in the defense of such claim or action. Neither party shall settle any such claim or action in a way that prejudices or adversely impacts the other party to this Agreement without the prior approval express written consent of such other party XXX.XXX; and (4) the claim in respect of which approval shall indemnity is sought does not be unreasonably withheld). 9.10 Any dispute concerning indemnification will be determined arise out of or in connection with any unauthorized use of the XXX.XXX Technology by arbitration in accordance with Section AIM. In addition, if the XXX.XXX Technology, any of this Agreement. 9.11 THE FOREGOING WARRANTIES ARE IN LIEU OF ALL OTHER WARRANTIESthe Deliverables, EXPRESSor any portion thereof is held to constitute an infringement of another Person's rights, IMPLIED OR ARISING BY LAWand use thereof is enjoined, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. NOTHING IN THIS AGREEMENT SHALL BE CONSTRUED AS A REPRESENTATION OR WARRANTY (i) BY PENWEST AS TO THE PATENTABILITYor XXX.XXX enters into a settlement of the claim which includes an agreement to refrain from the use thereof, VALIDITY (EXCEPT AS STATED IN SECTION ), OR SCOPE OF ANY PENWEST PATENTS, PENWEST'S CONFIDENTIAL TECHNOLOGY, TIMERx PRODUCTION TECHNOLOGY, JOINT DEVELOPMENTS, OR PENWEST TEST AND REGULATORY DATA; OR (ii) BY MYLAN AS TO THE PATENTABILITY, VALIDITY (EXCEPT AS STATED IN SECTION ), OR SCOPE OF ANY MYLAN IMPROVEMENTS, JOINT DEVELOPMENTS, OR MYLAN TEST AND REGULATORY DATA. 9.12 NOTWITHSTANDING ANYTHING TO THE CONTRARY CONTAINED HEREIN (OTHER THAN THE INDEMNITIES STATED IN THIS SECTION ), NEITHER PARTY SHALL UNDER ANY CIRCUMSTANCES BE LIABLE FOR ANY THIRD PARTY CLAIMS OR FOR ANY INCIDENTAL, CONSEQUENTIAL, INDIRECT OR SPECIAL DAMAGES, INCLUDING ANY LOST PROFITS OR SAVINGS, ARISING FROM ANY BREACH OF WARRANTY OR THE PERFORMANCE OR BREACH OF ANY OTHER PROVISION OF THIS AGREEMENT OR THE USE OR INABILITY TO USE TIMERx, THE DESIGNATED PRODUCT, PENWEST PATENTS, PENWEST'S CONFIDENTIAL TECHNOLOGY, TIMERx PRODUCTION TECHNOLOGY, PENWEST TEST AND REGULATORY DATA, MYLAN IMPROVEMENTS, OR MYLAN TEST AND REGULATORY DATA, EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. 9.13 Each party XXX.XXX shall, at its own cost election and expense, obtain either: 1) procure the right to use the infringing element thereof; 2) procure the right to an element which performs the same function without any material loss of functionality; or 3) replace or modify the element thereof so that the infringing portion is no longer infringing and maintain from a qualified insurance company comprehensive general liability still performs the same function without any material loss of functionality; and products liability insurance coverage during shall make every reasonable effort to correct the term situation with minimal effect upon the operations of this Agreement (and any subsequent period of sale AIM or distribution pursuant to Section )AIM affiliates. 24. Such insurance shall be in an amount no CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS less than ************************* combined single limit for each occurrence for bodily injury and/or property damage. Each party agrees to provide the other party with a certificate of insurance evidencing such insurance within thirty (30) days after the execution of this Agreement and again thereafter from time to time as reasonably requested by such other partyGeneral Limitation on Liability.

Appears in 1 contract

Samples: License Agreement (Bid Com International Inc)

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Representations, Warranties and Indemnities. 9.1 10.1 Salk warrants that it has not received written notice of any pending or threatened claim of infringement relating to the Collection, the Licensed Patents, the Salk Program Technology, or the Salk Background Technology, and that it shall immediately inform Agritope should any such notice be received at any time by Salk. Nothing in this Agreement is or shall be construed as a warranty or representation by Salk as to the validity or scope of any Licensed Patent, or that anything made, used, sold or otherwise disposed of under any license granted in this Agreement is or will be free from infringement of patents, copyrights and other rights of third parties, or as an obligation to bring or prosecute actions or suits against third parties for infringement, except to the extent and in the circumstances described in Section 9. 10.2 Salk has informed Agritope, and Agritope acknowledges, that the laboratories of Salk's Program Coordinator have received, and expect to continue to receive, certain supports and grants from one or more U.S. federal governmental agencies. To the extent any of the Salk Background Technology, Salk Program Technology, or Salk Program Patents has been, or later is, conceived or first reduced to practice in the performance of work under any such governmental funding, the U.S. Government may have certain rights with respect thereto. This Agreement and the grants hereunder are explicitly made subject to the U.S. Government's rights under any agreement whereby such governmental funding was provided to Salk, and any applicable law or regulation, including P.L. 96-517, as amended by P.L. 98-620. To the extent permitted by such governmental funding agreements, laws and regulations, Salk shall promptly elect to retain title to any subject inventions that may be applicable to this Agreement. 10.3 Each party represents and warrants to the other that, to the best of its current knowledge, it has the full right and authority to enter into this Agreement and to grant the licenses granted herein. Each party believes, to the best of its current knowledge, that any existing patents licensed by it to the other party under this Agreement are valid. 9.2 Penwest represents and warrants that any Formulated TIMERx supplied by it to Mylan hereunder for use in the Designated Product, at the point of delivery: 9.2.1 will conform to the product Specifications that Penwest and Mylan have agreed in writing are to apply to such delivery of TIMERx; and 9.2.2 to the best of Penwest's current knowledge, will not infringe upon an article patent of any third party. CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS. PENWEST MAKES NO REPRESENTATIONS OR WARRANTIES AS TO ANY TIMERx OR FORMULATED TIMERx SUPPLIED BY IT TO MYLAN EXCEPT AS ARE EXPLICITLY STATED HEREIN. 9.3 Each party represents and warrants to the other party that it has obtained obtained, and will at all times during the term of this Agreement, Agreement hold and comply with with, all licenses, permits and authorizations necessary to perform this Agreement and to test, manufacture, market, export, and import the products and assistance to be provided by it hereunderAgreement, as now or hereafter required under any applicable statutes, laws, ordinances, rules and regulations of the United States and any applicable foreign, state, and local governments and governmental entities. 9.4 Mylan warrants that any Designated Product manufactured, marketed or distributed by Mylan or its Affiliates or sublicensees shall meet and be manufactured, packaged, labeled, sold10.4 Salk hereby waives all claims against, and promoted in accordance with all applicable regulatory requirements within the Territory. 9.5 Penwest shall indemnify, defend and hold harmless Mylan indemnify Agritope and its Affiliates Affiliates, personnel, and sublicensees from any claim, action or damages arising out of any alleged infringement by reason of the manufacture, use or sale by Mylan of the Designated Product to the extent such infringement would apply as well to the manufacture, sale or distribution of TIMERx alone. If Mylan or its Affiliate or sublicensee, by reason of its manufacture, sale or distribution of Designated Product, is accused of infringing the patent of a third party, and such claim of infringement, as framed by the claimant, would apply as well to the manufacture, sale or distribution of TIMERx alone, Mylan shall immediately so notify Penwest and provide Penwest all available information, and the parties shall consult reasonably as to the proper course of action. If Penwest and Mylan jointly determine that such claim is likely to prevail, or if an arbitrator hereunder or a court of competent jurisdiction so determines, Mylan shall be entitled to offset against any Royalties payable to Penwest hereunder any third party royalties for which Mylan or its Affiliate or sublicensee becomes liable. 9.6 Penwest shall indemnify, defend and hold Mylan and its Affiliates and sublicensees harmless from any and all third-party claims to liability, loss, damage, costs, legal costs (including without limitation reasonable attorneys' fees) which may arise from the extent arising from, injury or death of an employee or agent of Salk engaged in connection with, based upon, conducting the research contemplated by reason of, or relating in any way to: 9.6.1 the ************************************************ TIMERx in the Designated Product; CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS 9.6.2 Penwest's *********************************************** and the Specifications therefor hereunder; 9.6.3 any failure of the Formulated TIMERx manufactured by Penwest or its alternate supplier (but not by Mylan under Section ), as delivered to Mylan hereunder for use in the Designated Product, to conform to the Specifications; or 9.6.4 any failure of Penwest to comply with its obligation under Section 5.13 to notify Mylan of any information coming into Penwest's possession and *************************** the Designated Product and not arising from any other aspect of the Designated Product or its formulation, development, supply, production, manufacture, sale, delivery, distribution or use, nor from any act or omission of Mylan with respect to the Formulated TIMERx following its delivery to Mylan hereunder. 9.7 Mylan shall indemnify, defend and hold Penwest harmless from any and all third-party claims to the extent arising from, in connection with, based upon, by reason of, or relating in any way to, the formulation, development, supply, production, manufacture, sale, delivery, distribution or use of the Designated Product, ************************************************. 9.8 Notwithstanding anything to the contrary set forth elsewhere herein, neither Mylan nor Penwest shall be obligated to indemnify the other party for claims or liabilities to the extent arising from such other party's, or its Affiliates', sublicensees' or assigns', negligence, intentional misconduct, or breach of its duties, obligations, warranties or representations set forth herein. 9.9 Whenever indemnification is provided for a party performed under this Agreement, working in the facility in which such right research is conducted, or damage to or loss of indemnification the property of Salk, caused by the negligence or willful misconduct of Salk in conducting such research. With respect to any matter for which Salk has indemnified Agritope hereunder, Salk shall extend also to the indemnified party's Affiliates, officers, directors, shareholders, successors, assigns, agents, employees, and insurers to the extent the same become subject to such claim in such capacity. The party seeking indemnification shall provide the indemnifying party with written notice of any claim or action within ten (10) days of its receipt thereof, and shall afford the indemnifying party be afforded the right to control the defense of all actions, to enter into all settlements, judgments or other arrangements in respect thereof. Agritope agrees to notify Salk promptly after it becomes aware of any claim, action or proceeding by a third party and settlement of such claim to co-operate with Salk, at Salk's expense, in any defense or action. The party seeking indemnification shall provide reasonable assistance prosecution thereof. 10.5 Except to the indemnifying party extent of the limited waiver and indemnity by Salk set forth in Section 10.4: (i) Salk shall not be liable for any direct, consequential, or other damages suffered by Agritope, any licensee, or otherwise resulting from the use of the research or any invention or product under this Agreement; and (ii) Agritope shall be liable for and shall defend and indemnify Salk against any and all liability, loss, claim, damage, costs, legal costs (including without limitation reasonable attorneys' fees) in respect of any injury or damage caused by Agritope's or its Affiliates', or sublicensees' use or exploitation of the Collection, the Licensed Patents, the Salk Program Technology, the Salk Background Technology, or any Licensed Products. With respect to any matter for which Agritope has indemnified Salk hereunder, Agritope shall be afforded the right to control the defense of such claim all actions, to enter into all settlements, judgments or actionother arrangements in respect thereof. If the defendants Salk agrees to notify Agritope promptly after it becomes aware of any claim, action or proceeding by a third party and to co-operate with Agritope, at Agritope's expense, in any such action include both Mylan and Penwest and either party concludes that there may be legal defenses available to it which are different fromdefense or prosecution thereof. 10.6 Before the first commercial sale of a Licensed Product, additional to, or inconsistent with, those available to the other, that party shall have the right to select separate counsel to participate in the defense of such action on its behalf, and such party shall thereafter bear the cost and expense of such separate defense. Should the indemnifying party determine not to defend such claim or action, the other party shall have the right to maintain the defense of such claim or action and the indemnifying party Agritope agrees to provide reasonable assistance to it in the defense of such claim or action. Neither party shall settle any such claim or action in a way that prejudices or adversely impacts the other party to this Agreement without the prior approval of such other party (which approval shall not be unreasonably withheld). 9.10 Any dispute concerning indemnification will be determined by arbitration in accordance with Section of this Agreement. 9.11 THE FOREGOING WARRANTIES ARE IN LIEU OF ALL OTHER WARRANTIES, EXPRESS, IMPLIED OR ARISING BY LAW, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. NOTHING IN THIS AGREEMENT SHALL BE CONSTRUED AS A REPRESENTATION OR WARRANTY (i) BY PENWEST AS TO THE PATENTABILITY, VALIDITY (EXCEPT AS STATED IN SECTION ), OR SCOPE OF ANY PENWEST PATENTS, PENWEST'S CONFIDENTIAL TECHNOLOGY, TIMERx PRODUCTION TECHNOLOGY, JOINT DEVELOPMENTS, OR PENWEST TEST AND REGULATORY DATA; OR (ii) BY MYLAN AS TO THE PATENTABILITY, VALIDITY (EXCEPT AS STATED IN SECTION ), OR SCOPE OF ANY MYLAN IMPROVEMENTS, JOINT DEVELOPMENTS, OR MYLAN TEST AND REGULATORY DATA. 9.12 NOTWITHSTANDING ANYTHING TO THE CONTRARY CONTAINED HEREIN (OTHER THAN THE INDEMNITIES STATED IN THIS SECTION ), NEITHER PARTY SHALL UNDER ANY CIRCUMSTANCES BE LIABLE FOR ANY THIRD PARTY CLAIMS OR FOR ANY INCIDENTAL, CONSEQUENTIAL, INDIRECT OR SPECIAL DAMAGES, INCLUDING ANY LOST PROFITS OR SAVINGS, ARISING FROM ANY BREACH OF WARRANTY OR THE PERFORMANCE OR BREACH OF ANY OTHER PROVISION OF THIS AGREEMENT OR THE USE OR INABILITY TO USE TIMERx, THE DESIGNATED PRODUCT, PENWEST PATENTS, PENWEST'S CONFIDENTIAL TECHNOLOGY, TIMERx PRODUCTION TECHNOLOGY, PENWEST TEST AND REGULATORY DATA, MYLAN IMPROVEMENTS, OR MYLAN TEST AND REGULATORY DATA, EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. 9.13 Each party shall, at its own cost and expense, obtain procure and maintain from a qualified insurance company comprehensive general liability and products product liability insurance coverage during the term of this Agreement (and against any subsequent period of sale claims or distribution pursuant expenses for which it is obligated to Section )indemnify Salk as provided above. Such insurance shall be in an amount no CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS not less than ************************[ * combined single limit for each occurrence for bodily injury and/or property damage. Each party agrees to provide the other party with a certificate of insurance evidencing such insurance within thirty (30) days after the execution of this Agreement ] per incident and again thereafter from time to time as reasonably requested by such other party[ * ] annual aggregate.

Appears in 1 contract

Samples: Research, License and Option Agreement (Agritope Inc)

Representations, Warranties and Indemnities. 9.1 Each party represents and warrants to the other that, to the best of its current knowledge, it has the full right and authority to enter into this Agreement and to grant the licenses granted herein. Each party believes, to the best of its current knowledge, that any existing patents licensed by it to the other party under this Agreement are ate valid. 9.2 Penwest represents and warrants that any Formulated TIMERx supplied by it to Mylan hereunder for use in the Designated Product, at the point of delivery: 9.2.1 will conform to the product Specifications that Penwest and Mylan have agreed in writing are to apply to such delivery of TIMERx; and 9.2.2 to the best of Penwest's current knowledge, will not infringe upon an article patent of any third party. CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS. PENWEST MAKES NO REPRESENTATIONS OR WARRANTIES AS TO ANY TIMERx OR FORMULATED TIMERx SUPPLIED BY IT TO MYLAN EXCEPT AS ARE EXPLICITLY STATED HEREIN. 9.3 Each party represents and warrants to the other party that it has obtained and will at all times during the term of this Agreement, hold and comply with all licenses, permits and authorizations necessary to perform this Agreement and to test, manufacture, market, export, and import the products and assistance to be provided by it hereunder, as now or hereafter required under any applicable statutes, laws, ordinances, rules and regulations of the United States and any applicable foreign, state, and local governments and governmental entities. 9.4 Mylan warrants that any Designated Product manufactured, marketed or distributed by Mylan or its Affiliates or sublicensees shall meet and be manufactured, packaged, labeled, sold, and promoted in accordance with all applicable regulatory requirements within the Territory. 9.5 Penwest shall indemnify, defend and hold harmless Mylan and its Affiliates and sublicensees from any claim, action or damages arising out of any alleged infringement by reason of the manufacture, use or sale by Mylan of the Designated Product to the extent such infringement would apply as well to the manufacture, sale or distribution of TIMERx alone. If Mylan or its Affiliate or sublicensee, by reason of its manufacture, sale or distribution of Designated Product, is accused of infringing the patent of a third party, and such claim of infringement, as framed by the claimant, would apply as well to the manufacture, sale or distribution of TIMERx alone, Mylan shall immediately so notify Penwest and provide Penwest all available information, and the parties shall consult reasonably as to the proper course of action. If Penwest and Mylan jointly determine that such claim is likely to prevail, or if an arbitrator hereunder or a court of competent jurisdiction so determines, Mylan shall be entitled to offset against any Royalties payable to Penwest hereunder any third party royalties for which Mylan or its Affiliate or sublicensee becomes liable. 9.6 Penwest shall indemnify, defend and hold Mylan and its Affiliates and sublicensees harmless from any and all third-party claims to the extent arising from, in connection with, based upon, by reason of, or relating in any way to:: CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS. 9.6.1 the ************************************************************* TIMERx in the Designated Product; CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS; 9.6.2 Penwest's ******************************************************* and the Specifications therefor hereunder; 9.6.3 any failure of the Formulated TIMERx manufactured by Penwest or its alternate supplier (but not by Mylan under Section 5.8), as delivered to Mylan hereunder for use in the Designated Product, to conform to the Specifications; or 9.6.4 any failure of Penwest to comply with its obligation under Section 5.13 to notify Mylan of any information coming into Penwest's possession and ************************************************* the Designated Product Product,and not arising from any other aspect of the Designated Product or its formulation, development, supply, production, manufacture, sale, delivery, distribution or use, nor from any act or omission of Mylan with respect to the Formulated TIMERx following its delivery to Mylan hereunder. 9.7 Mylan shall indemnify, defend and hold Penwest harmless from any and all third-party claims to the extent arising from, in connection with, based upon, by reason of, or relating in any way to, the formulation, development, supply, production, manufacture, sale, delivery, distribution or use of the Designated Product, ************************************************except for any matters which are covered by Penwest's indemnities under Sections 9.5 and 9. 9.8 Notwithstanding anything to the contrary set forth elsewhere herein, neither Mylan nor Penwest shall be obligated to indemnify the other party for claims or liabilities to the extent arising from such other party's, or its Affiliates', sublicensees' or assigns', negligence, intentional misconduct, or breach of its duties, obligations, warranties or representations set forth herein. 9.9 Whenever indemnification is provided for a party under this Agreement, such right of indemnification shall extend also to the indemnified party's Affiliates, officers, directors, shareholders, successors, assigns, agents, employees, and insurers to the extent the same become subject to such claim in such capacity. The party seeking indemnification shall provide the indemnifying party with written notice of any claim or action within ten (10) days of its receipt thereof, and shall afford the indemnifying party the right to control the defense and settlement of such claim or action. The party seeking indemnification shall provide reasonable assistance to the indemnifying party in the defense of such claim or action. If the defendants in any such action include both Mylan and Penwest and either party concludes that there may be legal defenses available to it which are different from, additional to, or inconsistent with, those available to the other, that party shall have the right to select separate counsel to participate in the defense of such action on its behalf, and such party shall thereafter bear the cost and expense of such separate defense. Should the indemnifying party determine not to defend such claim or action, the other party shall have the right to maintain the defense of such claim or action and the indemnifying party agrees to provide reasonable assistance to it in the defense of such claim or action. Neither party shall settle any such claim or action in a way that prejudices or adversely impacts the other party to this Agreement without the prior approval of such other party (which approval shall not be unreasonably withheld)) . 9.10 Any dispute concerning indemnification will be determined by arbitration in accordance with Section 11.10 of this Agreement. 9.11 THE FOREGOING WARRANTIES ARE IN LIEU OF ALL OTHER WARRANTIES, EXPRESS, IMPLIED OR ARISING BY LAW, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. NOTHING IN THIS AGREEMENT SHALL BE CONSTRUED AS A REPRESENTATION OR WARRANTY (i) BY PENWEST AS TO THE PATENTABILITY, VALIDITY (EXCEPT AS STATED IN SECTION 9.1), OR SCOPE OF ANY PENWEST PATENTS, PENWEST'S CONFIDENTIAL TECHNOLOGY, TIMERx PRODUCTION TECHNOLOGY, JOINT DEVELOPMENTS, OR PENWEST TEST AND REGULATORY DATA; OR (ii) BY MYLAN AS TO THE PATENTABILITY, VALIDITY (EXCEPT AS STATED IN SECTION 9.1), OR SCOPE OF ANY MYLAN IMPROVEMENTS, JOINT DEVELOPMENTS, OR MYLAN TEST AND REGULATORY DATA. 9.12 NOTWITHSTANDING ANYTHING TO THE CONTRARY CONTAINED HEREIN (OTHER THAN THE INDEMNITIES STATED IN THIS SECTION 9), NEITHER PARTY SHALL UNDER ANY CIRCUMSTANCES BE LIABLE FOR ANY THIRD PARTY CLAIMS OR FOR ANY INCIDENTAL, CONSEQUENTIAL, INDIRECT OR SPECIAL DAMAGES, INCLUDING ANY LOST PROFITS OR SAVINGS, ARISING FROM ANY BREACH OF WARRANTY OR THE PERFORMANCE OR BREACH OF ANY OTHER PROVISION OF THIS AGREEMENT OR THE USE OR INABILITY TO USE TIMERx, THE DESIGNATED PRODUCT, PENWEST PATENTS, PENWEST'S CONFIDENTIAL TECHNOLOGY, TIMERx PRODUCTION TECHNOLOGY, PENWEST TEST AND REGULATORY DATA, MYLAN IMPROVEMENTS, OR MYLAN TEST AND REGULATORY DATA, EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS. 9.13 Each party shall, at its own cost and expense, obtain and maintain from a qualified insurance company comprehensive general liability and products liability insurance coverage during the term of this Agreement (and any subsequent period of sale or distribution pursuant to Section 10.8). Such insurance shall be in an amount no CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS less than ********************************** combined single limit for each occurrence for bodily injury and/or property damage. Each party agrees to provide the other party with a certificate of insurance evidencing such insurance within thirty (30) days after the execution of this Agreement and again thereafter from time to time as reasonably requested by such other party.

Appears in 1 contract

Samples: Product Development and Supply Agreement (Penwest Pharmaceuticals Co)

Representations, Warranties and Indemnities. 9.1 Each party represents and warrants to the other that, to that it is duly organized and validly existing under the best laws of the state of its current knowledgeorganization, that it has the full right and requisite corporate or limited liability company authority to enter into execute and deliver this Agreement and to grant perform its obligations hereunder, and that the licenses granted herein. Each party believes, to the best execution and performance of its current knowledge, that obligations hereunder are not and will not be in violation of or in conflict with any existing patents licensed by material obligation it may have to the other party under this Agreement are validany third party. 9.2 Penwest PPG represents and warrants that any Formulated TIMERx supplied by it to Mylan Endo hereunder for use in the Designated Product, at the point of delivery: 9.2.1 will conform to the product Specifications that Penwest and Mylan have agreed in writing are to apply to such delivery effect as of TIMERxthe order date therefor; and 9.2.2 to the best of PenwestPPG's current knowledge, without undertaking any special investigation, will not infringe upon an article patent the intellectual property rights of any third party. CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS. PENWEST MAKES NO REPRESENTATIONS OR WARRANTIES AS TO ANY TIMERx OR FORMULATED TIMERx SUPPLIED BY IT TO MYLAN EXCEPT AS ARE EXPLICITLY STATED HEREIN. 9.3 Each party represents and warrants to the other party that it has obtained obtained, and will at all times during the term of this Agreement, Agreement hold and comply with with, all licenses, permits and authorizations necessary to perform this Agreement and to test, manufacture, market, export, and import the products and assistance Designated Product(s), ***, or Formulated TIMERx to be provided so tested, manufactured, marketed, exported or imported by it hereunderas provided herein, as now or hereafter required under any applicable statutes, laws, ordinances, rules and regulations of the United States and any applicable foreign, state, and local governments and governmental entities, including without limitation all Facilities Certifications (as to Endo). 9.4 Mylan warrants that any Designated Product manufacturedTHE FOREGOING WARRANTIES ARE IN LIEU OF, marketed or distributed by Mylan or its Affiliates or sublicensees shall meet and be manufacturedAND THE PARTIES EACH DISCLAIM, packagedALL OTHER WARRANTIES, labeledEXPRESS, soldIMPLIED OR ARISING BY LAW, and promoted in accordance with all applicable regulatory requirements within the TerritoryINCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND NON- INFRINGEMENT. NOTHING IN THIS AGREEMENT SHALL BE CONSTRUED AS A REPRESENTATION OR WARRANTY (i) BY PPG AS TO THE PATENTABILITY, VALIDITY, OR SCOPE OF ANY PPG PATENTS, PPG'S CONFIDENTIAL TECHNOLOGY, TIMERx PRODUCTION TECHNOLOGY, PPG TEST AND REGULATORY DATA, OR JOINT TECHNOLOGY, NOR AS TO THE UTILITY, EFFICACY, NONTOXICITY, SAFETY OR *** OR THE DESIGNATED PRODUCT; OR (ii) BY ENDO AS TO THE PATENTABILITY, VALIDITY, OR SCOPE OF ANY ENDO TECHNOLOGY, ENDO TEST AND REGULATORY DATA, OR JOINT TECHNOLOGY, NOR AS TO THE UTILITY, EFFICACY, NONTOXICITY, SAFETY OR APPROPRIATENESS OF ANY PRODUCTS MADE THEREFROM. 9.5 Penwest PPG shall indemnify, defend and hold harmless Mylan and its Affiliates and sublicensees from any claim, action or damages arising out of any alleged infringement by reason of the manufacture, use or sale by Mylan of the Designated Product to the extent such infringement would apply as well to the manufacture, sale or distribution of TIMERx alone. If Mylan or its Affiliate or sublicensee, by reason of its manufacture, sale or distribution of Designated Product, is accused of infringing the patent of a third party, and such claim of infringement, as framed by the claimant, would apply as well to the manufacture, sale or distribution of TIMERx alone, Mylan shall immediately so notify Penwest and provide Penwest all available information, and the parties shall consult reasonably as to the proper course of action. If Penwest and Mylan jointly determine that such claim is likely to prevail, or if an arbitrator hereunder or a court of competent jurisdiction so determines, Mylan shall be entitled to offset against any Royalties payable to Penwest hereunder any third party royalties for which Mylan or its Affiliate or sublicensee becomes liable. 9.6 Penwest shall indemnify, defend and hold Mylan Endo and its Affiliates and sublicensees harmless from any and all third-party claims to the extent arising from, in connection with, based upon, by reason of, or relating in any way to: 9.6.1 9.5.1 any claim, action or damages arising out of any alleged infringement by reason of the ************************************************ TIMERx in manufacture, use or sale by Endo of the Designated Product; CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONSProduct(s) to the extent such infringement would apply as well to the manufacture, sale or distribution of TIMERx alone; 9.6.2 Penwest9.5.2 PPG's *********************************************** contributions to the formulation or development of the Designated Product(s) and the Specifications therefor hereunder; provided, however, that matters of infringement of third party rights or intellectual properties shall be included under this clause only to the extent the same are covered by Section 9.5.1 or are within PPG's knowledge, without undertaking any special investigation, and of which PPG failed to inform Endo within 30 days following the later of the Effective Date or PPG's first obtaining such knowledge; 9.6.3 9.5.3 any failure of the Formulated TIMERx manufactured by Penwest PPG or its alternate supplier (but not by Mylan Endo under Section 7.4), as delivered to Mylan Endo hereunder for use in the Designated ProductProduct(s), to conform to the Specifications; or 9.6.4 9.5.4 any failure of Penwest PPG to comply with its obligation under Section 5.13 7.9 to notify Mylan Endo of any information coming into Penwest's PPG possession and *************************** bearing on the safety of TIMERx or the Designated Product Product(s), and not arising from any other aspect of the Designated Product Product(s) or its formulation, development, supply, production, manufacture, sale, delivery, distribution or use, nor from any act act, omission or omission contribution of Mylan Endo with respect to the Designated Product, or with respect to the Formulated TIMERx following its delivery to Mylan Endo hereunder. 9.7 Mylan 9.6 Endo shall indemnify, defend and hold Penwest PPG harmless from any and all third-party claims to the extent arising from, in connection with, based upon, by reason of, or relating in any way to, the formulation, development, supply, production, manufacture, sale, delivery, distribution or use of the Designated ProductProduct(s) by Endo, ************************************************its Affiliates or sublicensees, except for any matters which are covered by PPG's indemnities under Section 9.5. 9.8 9.7 Notwithstanding anything to the contrary set forth elsewhere herein, neither Mylan Endo nor Penwest PPG shall be obligated to indemnify the other party for claims or liabilities to the extent arising from such other party's, or its Affiliates', sublicensees' sublicensees or assigns', negligence, intentional misconduct, or breach of its duties, obligations, warranties or representations set forth herein. 9.9 9.8 Whenever indemnification is provided for a party under this Agreement, such right of indemnification shall extend also to the indemnified party's Affiliates, officers, directors, shareholders, successors, assigns, agents, employees, and insurers to the extent the same become subject to such claim in such capacity. The party seeking indemnification shall provide the indemnifying party with written notice of any claim or action within ten (10) days of its receipt thereof, and shall afford the indemnifying party the right to control the defense and settlement of such claim or action. The party seeking indemnification shall provide reasonable assistance to the indemnifying party in the defense of such claim or action. If the defendants in any such action include both Mylan Endo and Penwest PPG, and either party concludes that there may be legal defenses available to it which are different from, additional to, or inconsistent with, those available to the other, that party shall have the right to select separate counsel to participate in the defense of such action on its behalf, and such party shall thereafter bear the cost and expense of such separate defense, unless and to the extent the parties otherwise agree, or it is determined through arbitration hereunder that such costs and expense are or were required to be indemnified by the other party hereunder and are or were required to be incurred separately due to such different, additional, or inconsistent defenses. Should the indemnifying party determine not to defend such claim or action, the other party shall have the right to maintain the defense of such claim or action and the indemnifying party agrees to provide reasonable assistance to it in the defense of such claim or actionaction and to bear the reasonable cost and expense of such defense (including attorneys' and experts' fees and expenses). Neither party shall settle any such claim or action in a way that prejudices or adversely impacts the other party to this Agreement without the prior approval of such other party (which approval shall not be unreasonably withheld). 9.10 Any dispute concerning indemnification will be determined by arbitration in accordance with Section of this Agreement. 9.11 THE FOREGOING WARRANTIES ARE IN LIEU OF ALL OTHER WARRANTIES, EXPRESS, IMPLIED OR ARISING BY LAW, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. NOTHING IN THIS AGREEMENT SHALL BE CONSTRUED AS A REPRESENTATION OR WARRANTY (i) BY PENWEST AS TO THE PATENTABILITY, VALIDITY (EXCEPT AS STATED IN SECTION ), OR SCOPE OF ANY PENWEST PATENTS, PENWEST'S CONFIDENTIAL TECHNOLOGY, TIMERx PRODUCTION TECHNOLOGY, JOINT DEVELOPMENTS, OR PENWEST TEST AND REGULATORY DATA; OR (ii) BY MYLAN AS TO THE PATENTABILITY, VALIDITY (EXCEPT AS STATED IN SECTION ), OR SCOPE OF ANY MYLAN IMPROVEMENTS, JOINT DEVELOPMENTS, OR MYLAN TEST AND REGULATORY DATA. 9.12 9.9 NOTWITHSTANDING ANYTHING TO THE CONTRARY CONTAINED HEREIN IN THIS AGREEMENT (OTHER THAN THE FOR: 38 BREACHES OF SECTION 9.3; INDEMNITIES STATED IN THIS UNDER SECTIONS 9.5 AND 9.6 FOR PATENT INFRINGEMENT OR FOR HARM TO PERSONS OR TANGIBLE PROPERTY; AND BREACHES OF SECTION 10), NEITHER PARTY SHALL UNDER ANY CIRCUMSTANCES BE LIABLE FOR ANY THIRD PARTY CLAIMS OR FOR ANY INCIDENTAL, CONSEQUENTIAL, INDIRECT OR SPECIAL DAMAGES, INCLUDING ANY LOST PROFITS OR SAVINGS, ARISING FROM ANY BREACH OF WARRANTY OR THE PERFORMANCE OR BREACH OF ANY OTHER PROVISION OF THIS AGREEMENT OR THE USE OR INABILITY TO USE TIMERx, THE DESIGNATED PRODUCT, PENWEST PPG PATENTS, PENWEST'S PPG's CONFIDENTIAL TECHNOLOGY, TIMERx PRODUCTION TECHNOLOGY, PENWEST PPG TEST AND REGULATORY DATA, MYLAN IMPROVEMENTSCONFIDENTIAL ENDO TECHNOLOGY, OR MYLAN ENDO TEST AND REGULATORY DATA, OR JOINT TECHNOLOGY, OR ANY CLAIMS ARISING IN TORT, PERSONAL INJURY, OR PRODUCT LIABILITY, EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. 9.13 Each party shall, at its own cost and expense, obtain and maintain from a qualified insurance company comprehensive general liability and products liability insurance coverage during the term of this Agreement (and any subsequent period of sale or distribution pursuant to Section ). Such insurance shall be in an amount no CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS less than ************************* combined single limit for each occurrence for bodily injury and/or property damage. Each party agrees to provide the other party with a certificate of insurance evidencing such insurance within thirty (30) days after the execution of this Agreement and again thereafter from time to time as reasonably requested by such other party.

Appears in 1 contract

Samples: Strategic Alliance Agreement (Endo Pharmaceuticals Holdings Inc)

Representations, Warranties and Indemnities. 9.1 Each party represents (a) the ELA 1857 Claims have been validly issued and warrants are in good standing, and all Government Payments required on or before the Effective Date to keep the ELA 1857 Claims in full force and effect have been timely and properly made; (b) the Seller is the legal and beneficial owner of a 100% interest in the mineral rights to the ELA 1857 Claims free and clear of all liens, charges, encumbrances, royalties, agreements, underlying interests and conflicting rights or claims of whatsoever nature, other thatthan taxes or royalties that may become payable to a governmental authority in the Province of British Columbia if the ELA 1857 Claims are put into production; (c) the ELA 1857 Claims have been validly staked, located, recorded and properly acquired by the Seller in accordance with all applicable laws and regulations of Papua New Guinea and any other regulatory authority having jurisdiction over the ELA 1857 Claims; (d) except as provided for by operation of this Agreement, no person, firm, corporation or other entity of any kind whatsoever has any form of right to explore, develop, mine or otherwise exploit minerals from the ELA 1857 Claims or the Property; (e) except as provided for by this Agreement, there are no outstanding agreements or options of any kind whatsoever to acquire or purchase the ELA 1857 Claims or any interest of any kind whatsoever in the ELA 1857 Claims, and no person has any royalty or other interest of any kind whatsoever in the ELA 1857 Claims, other than taxes or royalties that may become payable to a governmental authority in the Papua New Guinea if the ELA 1857 Claims are put into production; (f) no third party consent or approval is required to be obtained by the Seller to allow it to enter into and perform obligations under this Agreement; (g) the Seller has delivered or made available to XXXXXXX CAPITAL CORP. copies of all material reports, data, and information within the Seller’s possession which concern the ELA 1857 Claims or the Property, provided, however, the Seller shall be deemed not to warrant the completeness or accuracy of any such data or interpretations; (h) the Seller has exclusive possession of the ELA 1857 Claims; (i) the Seller is unaware of any material facts or circumstances which have not been disclosed, which should be disclosed to XXXXXXX CAPITAL CORP. in order to prevent the representations in this Agreement from being materially misleading; (j) neither the Seller, nor, to the best of its current the Seller’s knowledge, it any of the Seller’s predecessors in title has done anything or omitted to do anything whereby the full right ELA 1857 Claims or the Property may become subject to any liens, charges, encumbrances, royalties, agreements, underlying interests and authority conflicting rights or claims; (k) there are no adverse claims or challenges of any kind whatsoever, including without limitation, claims or challenges by native or aboriginal peoples or other third parties, against or to enter into the ownership of, or title to, the ELA 1857 Claims nor is there any basis therefor; (l) the Seller has no knowledge of anything with respect to the current or former ownership or usage of the ELA 1857 Claims or the Property whereby any litigation affecting the Seller’s interest or use of the ELA 1857 Claims or the Property may be commenced; and (m) there are no material actions, claims, investigations or proceedings, judicial or otherwise, pending, or to the knowledge of the Seller threatened, against or relating to the Seller, the ELA 1857 Claims or the Property which relate to or could adversely affect the Seller’s interest in the ELA 1857 Claims. (n) the Seller has exclusive possession of the ELA 1857Claims; (o) the Seller is unaware of any material facts or circumstances which have not been disclosed, which should be disclosed to XXXXXXX CAPITAL CORP. in order to prevent the representations in this Agreement and to grant from being materially misleading; (p) neither the licenses granted herein. Each party believesSeller, nor, to the best of its current the Seller’s knowledge, that any existing patents licensed of the Seller’s predecessors in title has done anything or omitted to do anything whereby the ELA 1857Claims or the Property may become subject to any liens, charges, encumbrances, royalties, agreements, underlying interests and conflicting rights or claims; (q) there are no adverse claims or challenges of any kind whatsoever, including without limitation, claims or challenges by it native or aboriginal peoples or other third parties, against or to the other party under this Agreement are valid. 9.2 Penwest represents and warrants that any Formulated TIMERx supplied by it to Mylan hereunder for use in the Designated Product, at the point of delivery: 9.2.1 will conform to the product Specifications that Penwest and Mylan have agreed in writing are to apply to such delivery of TIMERx; and 9.2.2 to the best of Penwest's current knowledge, will not infringe upon an article patent of any third party. CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS. PENWEST MAKES NO REPRESENTATIONS OR WARRANTIES AS TO ANY TIMERx OR FORMULATED TIMERx SUPPLIED BY IT TO MYLAN EXCEPT AS ARE EXPLICITLY STATED HEREIN. 9.3 Each party represents and warrants to the other party that it has obtained and will at all times during the term of this Agreement, hold and comply with all licenses, permits and authorizations necessary to perform this Agreement and to test, manufacture, market, export, and import the products and assistance to be provided by it hereunder, as now or hereafter required under any applicable statutes, laws, ordinances, rules and regulations of the United States and any applicable foreign, state, and local governments and governmental entities. 9.4 Mylan warrants that any Designated Product manufactured, marketed or distributed by Mylan or its Affiliates or sublicensees shall meet and be manufactured, packaged, labeled, sold, and promoted in accordance with all applicable regulatory requirements within the Territory. 9.5 Penwest shall indemnify, defend and hold harmless Mylan and its Affiliates and sublicensees from any claim, action or damages arising out of any alleged infringement by reason of the manufacture, use or sale by Mylan of the Designated Product to the extent such infringement would apply as well to the manufacture, sale or distribution of TIMERx alone. If Mylan or its Affiliate or sublicensee, by reason of its manufacture, sale or distribution of Designated Product, is accused of infringing the patent of a third party, and such claim of infringement, as framed by the claimant, would apply as well to the manufacture, sale or distribution of TIMERx alone, Mylan shall immediately so notify Penwest and provide Penwest all available information, and the parties shall consult reasonably as to the proper course of action. If Penwest and Mylan jointly determine that such claim is likely to prevail, or if an arbitrator hereunder or a court of competent jurisdiction so determines, Mylan shall be entitled to offset against any Royalties payable to Penwest hereunder any third party royalties for which Mylan or its Affiliate or sublicensee becomes liable. 9.6 Penwest shall indemnify, defend and hold Mylan and its Affiliates and sublicensees harmless from any and all third-party claims to the extent arising from, in connection with, based upon, by reason ownership of, or relating in title to, the ELA 1857Claims nor is there any way to: 9.6.1 the ************************************************ TIMERx in the Designated Product; CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS 9.6.2 Penwest's *********************************************** and the Specifications therefor hereunderbasis therefor; 9.6.3 any failure (r) the Seller has no knowledge of the Formulated TIMERx manufactured by Penwest or its alternate supplier (but not by Mylan under Section ), as delivered to Mylan hereunder for use in the Designated Product, to conform to the Specifications; or 9.6.4 any failure of Penwest to comply with its obligation under Section 5.13 to notify Mylan of any information coming into Penwest's possession and *************************** the Designated Product and not arising from any other aspect of the Designated Product or its formulation, development, supply, production, manufacture, sale, delivery, distribution or use, nor from any act or omission of Mylan anything with respect to the Formulated TIMERx following its delivery to Mylan hereunder. 9.7 Mylan shall indemnify, defend and hold Penwest harmless from current or former ownership or usage of the ELA 1857Claims or the Property whereby any and all third-party claims to litigation affecting the extent arising from, in connection with, based upon, by reason of, or relating in any way to, the formulation, development, supply, production, manufacture, sale, delivery, distribution Seller’s interest or use of the Designated ProductELA 1857Claims or the Property may be commenced; and (s) there are no material actions, ************************************************. 9.8 Notwithstanding anything claims, investigations or proceedings, judicial or otherwise, pending, or to the contrary set forth elsewhere hereinknowledge of the Seller threatened, neither Mylan nor Penwest shall be obligated to indemnify the other party for claims against or liabilities relating to the extent arising from such other party'sSeller, the ELA 1857Claims or its Affiliates', sublicensees' the Property which relate to or assigns', negligence, intentional misconduct, or breach of its duties, obligations, warranties or representations set forth herein. 9.9 Whenever indemnification is provided for a party under this Agreement, such right of indemnification shall extend also to could adversely affect the indemnified party's Affiliates, officers, directors, shareholders, successors, assigns, agents, employees, and insurers to the extent the same become subject to such claim in such capacity. The party seeking indemnification shall provide the indemnifying party with written notice of any claim or action within ten (10) days of its receipt thereof, and shall afford the indemnifying party the right to control the defense and settlement of such claim or action. The party seeking indemnification shall provide reasonable assistance to the indemnifying party Seller’s interest in the defense of such claim or action. If the defendants in any such action include both Mylan and Penwest and either party concludes that there may be legal defenses available to it which are different from, additional to, or inconsistent with, those available to the other, that party shall have the right to select separate counsel to participate in the defense of such action on its behalf, and such party shall thereafter bear the cost and expense of such separate defense. Should the indemnifying party determine not to defend such claim or action, the other party shall have the right to maintain the defense of such claim or action and the indemnifying party agrees to provide reasonable assistance to it in the defense of such claim or action. Neither party shall settle any such claim or action in a way that prejudices or adversely impacts the other party to this Agreement without the prior approval of such other party (which approval shall not be unreasonably withheld). 9.10 Any dispute concerning indemnification will be determined by arbitration in accordance with Section of this Agreement. 9.11 THE FOREGOING WARRANTIES ARE IN LIEU OF ALL OTHER WARRANTIES, EXPRESS, IMPLIED OR ARISING BY LAW, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. NOTHING IN THIS AGREEMENT SHALL BE CONSTRUED AS A REPRESENTATION OR WARRANTY (i) BY PENWEST AS TO THE PATENTABILITY, VALIDITY (EXCEPT AS STATED IN SECTION ), OR SCOPE OF ANY PENWEST PATENTS, PENWEST'S CONFIDENTIAL TECHNOLOGY, TIMERx PRODUCTION TECHNOLOGY, JOINT DEVELOPMENTS, OR PENWEST TEST AND REGULATORY DATA; OR (ii) BY MYLAN AS TO THE PATENTABILITY, VALIDITY (EXCEPT AS STATED IN SECTION ), OR SCOPE OF ANY MYLAN IMPROVEMENTS, JOINT DEVELOPMENTS, OR MYLAN TEST AND REGULATORY DATA. 9.12 NOTWITHSTANDING ANYTHING TO THE CONTRARY CONTAINED HEREIN (OTHER THAN THE INDEMNITIES STATED IN THIS SECTION ), NEITHER PARTY SHALL UNDER ANY CIRCUMSTANCES BE LIABLE FOR ANY THIRD PARTY CLAIMS OR FOR ANY INCIDENTAL, CONSEQUENTIAL, INDIRECT OR SPECIAL DAMAGES, INCLUDING ANY LOST PROFITS OR SAVINGS, ARISING FROM ANY BREACH OF WARRANTY OR THE PERFORMANCE OR BREACH OF ANY OTHER PROVISION OF THIS AGREEMENT OR THE USE OR INABILITY TO USE TIMERx, THE DESIGNATED PRODUCT, PENWEST PATENTS, PENWEST'S CONFIDENTIAL TECHNOLOGY, TIMERx PRODUCTION TECHNOLOGY, PENWEST TEST AND REGULATORY DATA, MYLAN IMPROVEMENTS, OR MYLAN TEST AND REGULATORY DATA, EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. 9.13 Each party shall, at its own cost and expense, obtain and maintain from a qualified insurance company comprehensive general liability and products liability insurance coverage during the term of this Agreement (and any subsequent period of sale or distribution pursuant to Section ). Such insurance shall be in an amount no CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS less than ************************* combined single limit for each occurrence for bodily injury and/or property damage. Each party agrees to provide the other party with a certificate of insurance evidencing such insurance within thirty (30) days after the execution of this Agreement and again thereafter from time to time as reasonably requested by such other party.ELA 1857Claims

Appears in 1 contract

Samples: Purchase Agreement (Daulton Capital Corp.)

Representations, Warranties and Indemnities. 9.1 Each party represents 5.1 Warranty and warrants to the other thatIndemnity re: Authority, to the best of its current knowledge, it has the full right Title and authority to enter into this Agreement and to grant the licenses granted herein. Each party believes, to the best of its current knowledge, that any existing patents licensed by it to the other party under this Agreement are validProprietary Rights. 9.2 Penwest (1) XXX.XXX represents and warrants that any Formulated TIMERx supplied by it has the right to Mylan hereunder for use in grant the Designated Product, at license hereby granted and that XXX.XXX has the point of delivery: 9.2.1 will conform right to provide the product Specifications that Penwest and Mylan have agreed in writing are to apply to such delivery of TIMERx; and 9.2.2 to the best of Penwest's current knowledge, will not infringe upon an article patent of any third party. CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS. PENWEST MAKES NO REPRESENTATIONS OR WARRANTIES AS TO ANY TIMERx OR FORMULATED TIMERx SUPPLIED BY IT TO MYLAN EXCEPT AS ARE EXPLICITLY STATED HEREINAIM E-Commerce Service. 9.3 Each party represents and warrants (2) XXX.XXX agrees to the other party that it has obtained and will at all times during the term of this Agreement, hold and comply with all licenses, permits and authorizations necessary to perform this Agreement and to test, manufacture, market, export, and import the products and assistance to be provided by it hereunder, as now or hereafter required under any applicable statutes, laws, ordinances, rules and regulations of the United States and any applicable foreign, state, and local governments and governmental entities. 9.4 Mylan warrants that any Designated Product manufactured, marketed or distributed by Mylan or its Affiliates or sublicensees shall meet and be manufactured, packaged, labeled, sold, and promoted in accordance with all applicable regulatory requirements within the Territory. 9.5 Penwest shall indemnify, defend and indemnify AIM and hold it harmless Mylan from all losses, claims, damages or liabilities, including court costs and its Affiliates and sublicensees from any claimlegal fees, action in connection with or damages arising out of any alleged infringement by reason claim asserted against AIM based upon a contention that the AIM E-Commerce Service, the XXX.XXX Technology or the Software or any of the manufactureDeliverables, use or sale any portion thereof used by Mylan AIM or the Joint Venture within the scope of this Agreement infringe the Intellectual Property Rights of any third Party provided that: (i) AIM or the Joint Venture promptly notify XXX.XXX in writing of the Designated Product to the extent such infringement would apply as well to the manufacture, sale or distribution claim and of TIMERx alone. If Mylan or its Affiliate or sublicensee, by reason of its manufacture, sale or distribution of Designated Product, is accused of infringing the patent of a third party, and all material developments in connection with such claim of infringement, as framed and provides all assistance otherwise reasonably requested by the claimant, would apply as well to the manufacture, sale or distribution of TIMERx alone, Mylan shall immediately so notify Penwest and provide Penwest all available information, and the parties shall consult reasonably as to the proper course of action. If Penwest and Mylan jointly determine that such claim is likely to prevail, or if an arbitrator hereunder or a court of competent jurisdiction so determines, Mylan shall be entitled to offset against any Royalties payable to Penwest hereunder any third party royalties for which Mylan or its Affiliate or sublicensee becomes liable. 9.6 Penwest shall indemnify, defend and hold Mylan and its Affiliates and sublicensees harmless from any and all third-party claims to the extent arising from, in connection with, based upon, by reason of, or relating in any way to: 9.6.1 the ************************************************ TIMERx in the Designated Product; CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS 9.6.2 Penwest's *********************************************** and the Specifications therefor hereunderXXX.XXX; 9.6.3 any failure of the Formulated TIMERx manufactured by Penwest or its alternate supplier (but not by Mylan under Section ), as delivered to Mylan hereunder for use in the Designated Product, to conform to the Specifications; or 9.6.4 any failure of Penwest to comply with its obligation under Section 5.13 to notify Mylan of any information coming into Penwest's possession and *************************** the Designated Product and not arising from any other aspect of the Designated Product or its formulation, development, supply, production, manufacture, sale, delivery, distribution or use, nor from any act or omission of Mylan with respect to the Formulated TIMERx following its delivery to Mylan hereunder. 9.7 Mylan shall indemnify, defend and hold Penwest harmless from any and all third-party claims to the extent arising from, in connection with, based upon, by reason of, or relating in any way to, the formulation, development, supply, production, manufacture, sale, delivery, distribution or use of the Designated Product, ************************************************. 9.8 Notwithstanding anything to the contrary set forth elsewhere herein, neither Mylan nor Penwest shall be obligated to indemnify the other party for claims or liabilities to the extent arising from such other party's, or its Affiliates', sublicensees' or assigns', negligence, intentional misconduct, or breach of its duties, obligations, warranties or representations set forth herein. 9.9 Whenever indemnification is provided for a party under this Agreement, such right of indemnification shall extend also to the indemnified party's Affiliates, officers, directors, shareholders, successors, assigns, agents, employees, and insurers to the extent the same become subject to such claim in such capacity. The party seeking indemnification shall provide the indemnifying party with written notice of any claim or action within ten (10ii) days of its receipt thereof, and shall afford the indemnifying party XXX.XXX has the right to control control, at its own expense, the defense defence and all related settlement of such claim or action. The party seeking indemnification shall provide reasonable assistance to the indemnifying party in the defense of such claim or action. If the defendants in any such action include both Mylan and Penwest and either party concludes that there may be legal defenses available to it which are different from, additional to, or inconsistent with, those available to the other, that party shall have negotiations (AIM has the right to select separate counsel to participate in at its own expense); (iii) AIM or the defense of such action on its behalf, and such party shall thereafter bear the cost and expense of such separate defense. Should the indemnifying party determine Joint Venture does not to defend such claim pay or action, the other party shall have the right to maintain the defense of such claim or action and the indemnifying party agrees to provide reasonable assistance to it in the defense of such claim or action. Neither party shall settle any such claim or action in a way that prejudices or adversely impacts the other party to this Agreement without the prior approval express written consent of such other party XXX.XXX; and (iv) the claim in respect of which approval shall indemnity is sought does not be unreasonably withheld). 9.10 Any dispute concerning indemnification will be determined arise out of or in connection with any unauthorized use of the XXX.XXX Technology by arbitration in accordance with Section AIM. In addition, if the XXX.XXX Technology, any of this Agreement. 9.11 THE FOREGOING WARRANTIES ARE IN LIEU OF ALL OTHER WARRANTIESthe Deliverables, EXPRESSor any portion thereof is held to constitute an infringement of another Person's rights, IMPLIED OR ARISING BY LAWand use thereof is enjoined, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. NOTHING IN THIS AGREEMENT SHALL BE CONSTRUED AS A REPRESENTATION OR WARRANTY (i) BY PENWEST AS TO THE PATENTABILITYor XXX.XXX enters into a settlement of the claim which includes an agreement to refrain from the use thereof, VALIDITY (EXCEPT AS STATED IN SECTION ), OR SCOPE OF ANY PENWEST PATENTS, PENWEST'S CONFIDENTIAL TECHNOLOGY, TIMERx PRODUCTION TECHNOLOGY, JOINT DEVELOPMENTS, OR PENWEST TEST AND REGULATORY DATA; OR (ii) BY MYLAN AS TO THE PATENTABILITY, VALIDITY (EXCEPT AS STATED IN SECTION ), OR SCOPE OF ANY MYLAN IMPROVEMENTS, JOINT DEVELOPMENTS, OR MYLAN TEST AND REGULATORY DATA. 9.12 NOTWITHSTANDING ANYTHING TO THE CONTRARY CONTAINED HEREIN (OTHER THAN THE INDEMNITIES STATED IN THIS SECTION ), NEITHER PARTY SHALL UNDER ANY CIRCUMSTANCES BE LIABLE FOR ANY THIRD PARTY CLAIMS OR FOR ANY INCIDENTAL, CONSEQUENTIAL, INDIRECT OR SPECIAL DAMAGES, INCLUDING ANY LOST PROFITS OR SAVINGS, ARISING FROM ANY BREACH OF WARRANTY OR THE PERFORMANCE OR BREACH OF ANY OTHER PROVISION OF THIS AGREEMENT OR THE USE OR INABILITY TO USE TIMERx, THE DESIGNATED PRODUCT, PENWEST PATENTS, PENWEST'S CONFIDENTIAL TECHNOLOGY, TIMERx PRODUCTION TECHNOLOGY, PENWEST TEST AND REGULATORY DATA, MYLAN IMPROVEMENTS, OR MYLAN TEST AND REGULATORY DATA, EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. 9.13 Each party XXX.XXX shall, at its own cost election and expense, obtain either: (A) procure the right to use the infringing element thereof; (B) procure the right to an element which performs the same function without any material loss of functionality; or (C) replace or modify the element thereof so that the infringing portion is no longer infringing and maintain from a qualified insurance company comprehensive general liability still performs the same function without any material loss of functionality; and products liability insurance coverage during shall make every reasonable effort to correct the term situation with minimal effect upon the operations of this Agreement (and any subsequent period of sale AIM or distribution pursuant to Section ). Such insurance shall be in an amount no CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS less than ************************* combined single limit for each occurrence for bodily injury and/or property damage. Each party agrees to provide the other party with a certificate of insurance evidencing such insurance within thirty (30) days after the execution of this Agreement and again thereafter from time to time as reasonably requested by such other partyAIM affiliates.

Appears in 1 contract

Samples: License Agreement (American Interactive Media Inc)

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