Representations and Warranties by Licensor. Licensor hereby represents and warrants to ProPhase as follows: 12.01 Licensor is a corporation duly organized, validly existing and in good standing under the laws of Nevada. Licensor has been granted all requisite power and authority to carry on its business and to own and operate its properties and assets. The execution, delivery and performance of this Agreement have been duly authorized by Licensor. 12.02 There is no pending or, to Licensor’s knowledge, threatened litigation involving Licensor which would have any effect on this Agreement or on Licensor’s ability to perform its obligations hereunder. 12.03 To Licensor’s knowledge, there is no indenture, contract, or agreement to which Licensor is a party or by which Licensor is bound which prohibits or would prohibit the execution and delivery by Licensor of this Agreement or the performance or observance by Licensor of any term or condition of this Agreement. 12.04 All Licensed IP existing as of the Effective Date is solely and exclusively owned by Licensor. 12.05 To Licensor’s Knowledge, all Licensed Patents existing as of the Effective Date are subsisting and are not invalid or unenforceable, in whole or in part. 12.06 To Licensor’s Knowledge, the Licensed Patents existing as of the Effective Date (a) are being diligently prosecuted in the respective patent offices in the Territory in accordance with applicable laws, rules and regulations, (b) have been filed and maintained properly and correctly and all applicable fees have been paid on or before the due date for payment, and (c) identifies each and every inventor of the claims thereof as determined in accordance with the laws of the jurisdiction in which such Patent is issued or such application is pending. 12.07 To Licensor’s Knowledge, there are no claims, judgments, or settlements against, or amounts with respect thereto, owed by Licensor or any of its Affiliates relating to the Licensed IP. 12.08 No claim or litigation has been brought or, to Licensor’s Knowledge, threatened by any person or entity alleging, that (a) the Licensed Patents existing as of the Effective Date are invalid or unenforceable, or (b) the Licensed IP, or the disclosing, copying, making, assigning, or licensing of the Licensed IP, or the Exploitation of the Licensed Compounds or Licensed Products as contemplated herein, does or will violate, infringe, misappropriate or otherwise conflict or interfere with, any Patent or other intellectual property or proprietary right of any person or entity. 12.09 To Licensor’s Knowledge, the Exploitation of the Licensed Compound or Licensed IP does not violate, infringe, misappropriate, or otherwise conflict or interfere with any Patent or other intellectual property or proprietary right of any person or entity. 12.10 To Licensor’s Knowledge, no person or entity is infringing or threatening to infringe or misappropriating or threatening to misappropriate the Licensed IP. 12.11 To Licensor’s Knowledge, with respect to the pending patent applications included in the Licensed Patents existing as of the Effective Date, Licensor and its Affiliates have presented all relevant references, documents, or information of which it and the inventors are aware to the relevant patent examiner at the relevant patent office. 12.12 To Licensor’s Knowledge, no funding from any governmental entity of any kind was used in connection with development of any of the intellectual property rights included in the scope of the License. 12.13 To Licensor’s Knowledge the Licensed Compound has not been used in humans in any form on behalf of Licensor or its Affiliates prior to the Effective Date.
Appears in 4 contracts
Samples: License Agreement, License Agreement (Impact Biomedical Inc.), License Agreement (Impact Biomedical Inc.)
Representations and Warranties by Licensor. Licensor hereby represents and warrants to ProPhase as follows:
12.01 Licensor is a corporation duly organized, validly existing and in good standing under the laws of Nevada. Licensor has been granted all requisite power and authority to carry on its business and to own and operate its properties and assets. The execution, delivery and performance of this Agreement have been duly authorized by Licensor.
12.02 There is no pending or, to Licensor’s knowledge, threatened litigation involving Licensor which would have any effect on this Agreement or on Licensor’s ability to perform its obligations hereunder.
12.03 To Licensor’s knowledge, there There is no indenture, contract, or agreement to which Licensor is a party or by which Licensor is bound which prohibits or would prohibit the execution and delivery by Licensor of this Agreement or the performance or observance by Licensor of any term or condition of this Agreement.
12.04 Licensor has, and covenants that it will maintain during the Term, the lawful right to grant the License to ProPhase hereunder.
12.05 All Licensed IP existing as of the Effective Date is solely and exclusively owned by Licensor.
12.05 To Licensor’s Knowledge, all 12.06 All Licensed Patents existing as of the Effective Date are subsisting and are not invalid or or, to Licensor’s knowledge, unenforceable, in whole or in part.
12.06 To Licensor’s Knowledge, the 12.07 The Licensed Patents existing as of the Effective Date (a) are being diligently prosecuted in the respective patent offices in the Territory in accordance with applicable laws, rules and regulations, (b) have been filed and maintained properly and correctly and all applicable fees have been paid on or before the due date for payment, and (c) identifies each and every inventor of the claims thereof as determined in accordance with the laws of the jurisdiction in which such Patent is issued or such application is pending.
12.07 To Licensor’s Knowledge, there 12.08 There are no claims, judgments, or settlements against, or amounts with respect thereto, owed by Licensor or any of its Affiliates relating to the Licensed IP.
12.08 12.09 No claim or litigation has been brought or, to Licensor’s Knowledgeknowledge, threatened by any person or entity alleging, that (a) the Licensed Patents existing as of the Effective Date are invalid or unenforceable, or (b) the Licensed IP, or the disclosing, copying, making, assigning, or licensing of the Licensed IP, or the Exploitation of the Licensed Compounds or Licensed Products as contemplated herein, does or will violate, infringe, misappropriate or otherwise conflict or interfere with, any Patent or other intellectual property or proprietary right of any person or entity.
12.09 12.10 To Licensor’s Knowledgeknowledge, the Exploitation of the Licensed Compound or Licensed IP does not violate, infringe, misappropriate, or otherwise conflict or interfere with any Patent or other intellectual property or proprietary right of any person or entity.
12.10 12.11 To Licensor’s Knowledgeknowledge, no person or entity is infringing or threatening to infringe or misappropriating or threatening to misappropriate the Licensed IP.
12.11 To 12.12 The information provided to ProPhase in respect of the Licensed Patents existing as of the Effective Date is true, complete and correct.
12.13 The Patents set forth on Appendix I represent all Patents within Licensor’s Knowledgeor its Affiliates’ Control relating to the Licensed Compounds, with or the Exploitation thereof.
12.14 In respect to of the pending patent applications included in the Licensed Patents existing as of the Effective Date, Licensor and its Affiliates have presented all relevant references, documents, or information of which it and the inventors are aware to the relevant patent examiner at the relevant patent office.
12.12 To Licensor’s Knowledge, no 12.15 No funding from any governmental entity of any kind was used in connection with development of any of the intellectual property rights included in the scope of the License.
12.13 To 12.16 Neither Licensor’s Knowledge , nor its Affiliates, are (a) debarred under subsections 306(a) or (b) of the U.S. Federal Food Drug and Cosmetic Act (US Generic Drug Enforcement Act of 1992; 21 USC 335a (a) or (b)), or (b) excluded from any federal health care program, including but not limited to Medicare and Medicaid.
12.17 The Licensed Compound has not been used in humans in any form on behalf of Licensor or its Affiliates prior to the Effective Date.
12.18 Dxxxx Xxxxxxxx is, and to the extent Dxxxx Xxxxxxxx is made available by Licensor to Prophase under this Agreement, will remain during the Term, obligated to assign any and all intellectual property rights to any inventions (a) for which Dxxxx Xxxxxxxx is an inventor to Licensor, and (b) which relate to this Agreement, the Licensed Compound or a Licensed Product.
12.19 The representations and warranties of Licensor in this Agreement, and the Information, documents and materials furnished to ProPhase prior to the Effective Date, do not, taken as a whole, (a) contain any untrue statement of a material fact, or (b) omit to state any material fact necessary to make the statements or facts contained therein, in light of the circumstances under which they were made, not misleading.
Appears in 2 contracts
Samples: License Agreement (Impact Biomedical Inc.), License Agreement (Impact Biomedical Inc.)
Representations and Warranties by Licensor. Licensor hereby represents and warrants to ProPhase Licensee as followsof the Effective Date:
12.01 Licensor is a corporation duly organized, validly existing and in good standing under the laws of Nevada. 8.1.1 Licensor has been granted all requisite power the right, power, and authority to carry on its business enter into this Agreement and to own grant to Licensee the rights specified in this Agreement;
8.1.2 This Agreement when executed shall become the legal, valid, and operate binding obligation of it, enforceable against it, in accordance with its properties and assets. The executionterms;
8.1.3 There are no actions, delivery and performance of this Agreement have been duly authorized by Licensor.
12.02 There is no suits, proceedings, or arbitrations pending or, to Licensor’s knowledge, threatened litigation involving against Licensor which relating to the Licensed Patents that would have any effect on be inconsistent with the rights granted to Licensee under this Agreement or on Licensor’s ability to perform its obligations hereunder.Agreement;
12.03 8.1.4 To Licensor’s knowledge, there is no indenture, contract, or agreement to which Licensor is a party or by which Licensor is bound which prohibits or would prohibit the execution and delivery by Licensor of this Agreement or the performance or observance by Licensor of any term or condition of this Agreement.
12.04 All Licensed IP existing as of the Effective Date is solely and exclusively owned by Licensor.
12.05 To Licensor’s Knowledge, all Licensed Patents existing as of the Effective Date are subsisting and are not invalid or unenforceable, in whole or in part.
12.06 To Licensor’s Knowledge, the Licensed Patents existing as of the Effective Date (a) are being diligently prosecuted in the respective patent offices in the Territory in accordance with applicable laws, rules and regulations, (b) have been filed and maintained properly and correctly and all applicable fees have been paid on or before the due date for payment, and (c) identifies each and every inventor of the claims thereof as determined in accordance with the laws of the jurisdiction in which such Patent is issued or such application is pending.
12.07 To Licensor’s Knowledge, there are no claims, judgments, or settlements against, or amounts with respect thereto, owed by Licensor or any of its Affiliates relating to the Licensed IP.
12.08 No claim or litigation has been brought or, to Licensor’s Knowledge, threatened by any person or entity alleging, that (a) the Licensed Patents existing are solely owned by The Trustees of the University of Pennsylvania, and (b) no Third Party (other than the REGENXBIO Licensors) has any right, interest, or claim in or to such Licensed Patents in the Commercial Field that are inconsistent with those granted to Licensee in the Commercial Field under this Agreement;
8.1.5 To Licensor’s knowledge, Licensor does not Control as of the Effective Date are invalid any patent or unenforceable, or patent application (b) the Licensed IP, or the disclosing, copying, making, assigning, or licensing of the Licensed IP, or the Exploitation of the Licensed Compounds or Licensed Products as contemplated herein, does or will violate, infringe, misappropriate or otherwise conflict or interfere with, any Patent or other intellectual property or proprietary right of any person or entity.
12.09 To Licensor’s Knowledge, the Exploitation of the Licensed Compound or Licensed IP does not violate, infringe, misappropriate, or otherwise conflict or interfere with any Patent or other intellectual property or proprietary right of any person or entity.
12.10 To Licensor’s Knowledge, no person or entity is infringing or threatening to infringe or misappropriating or threatening to misappropriate the Licensed IP.
12.11 To Licensor’s Knowledge, with respect to the pending patent applications included in than the Licensed Patents existing (as defined in Section 1.17) that would necessarily be infringed by the use or sale of AAV9 in the CPVT Field. If it is determined, in accordance with the procedure of this Section 8.1.5, that Licensor Controls as of the Effective DateDate a patent or patent application (other than the Licensed Patents) that would necessarily be infringed by the use or sale of AAV9 in the CPVT Field, Licensor and its Affiliates have presented all relevant references, documents, then Licensee’s sole remedy shall be the inclusion of the applicable patent or information of which it and the inventors are aware patent application as a “Licensed Patent” hereunder but solely to the relevant patent examiner at extent of the relevant patent office.
12.12 To Licensor’s Knowledgeclaim(s) that would necessarily be infringed by the use or sale of AAV9. At any time during the term of this Agreement, no funding from any governmental entity Licensee may notify Licensor in writing of any kind was used in connection with development of any of the intellectual property rights such patent or patent application that Licensee believes should be included in the scope of the Licenseas a “Licensed Patent” pursuant to this Section 8.
12.13 To Licensor’s Knowledge the Licensed Compound has not been used in humans in any form on behalf of Licensor or its Affiliates prior to the Effective Date.
Appears in 2 contracts
Samples: License Agreement (Audentes Therapeutics, Inc.), License Agreement (Audentes Therapeutics, Inc.)
Representations and Warranties by Licensor. Licensor hereby represents and warrants to ProPhase Licensee as followsof the Effective Date:
12.01 Licensor is a corporation duly organized, validly existing and in good standing under the laws of Nevada. 8.1.1 Licensor has been granted all requisite power the right, power, and authority to carry on its business enter into this Agreement and to own grant to Licensee the rights specified in this Agreement;
8.1.2 This Agreement when executed shall become the legal, valid, and operate binding obligation of it, enforceable against it, in accordance with its properties and assets. The executionterms;
8.1.3 There are no actions, delivery and performance of this Agreement have been duly authorized by Licensor.
12.02 There is no suits, proceedings, or arbitrations pending or, to Licensor’s knowledge, threatened litigation involving against Licensor which relating to the Licensed Patents that would have any effect on be inconsistent with the rights granted to Licensee under this Agreement or on Licensor’s ability to perform its obligations hereunder.Agreement;
12.03 8.1.4 To Licensor’s knowledge, there is no indenture, contract, or agreement to which Licensor is a party or by which Licensor is bound which prohibits or would prohibit the execution and delivery by Licensor of this Agreement or the performance or observance by Licensor of any term or condition of this Agreement.
12.04 All Licensed IP existing as of the Effective Date is solely and exclusively owned by Licensor.
12.05 To Licensor’s Knowledge, all Licensed Patents existing as of the Effective Date are subsisting and are not invalid or unenforceable, in whole or in part.
12.06 To Licensor’s Knowledge, the Licensed Patents existing as of the Effective Date (a) are being diligently prosecuted in the respective patent offices in the Territory in accordance with applicable laws, rules and regulations, (b) have been filed and maintained properly and correctly and all applicable fees have been paid on or before the due date for payment, and (c) identifies each and every inventor of the claims thereof as determined in accordance with the laws of the jurisdiction in which such Patent is issued or such application is pending.
12.07 To Licensor’s Knowledge, there are no claims, judgments, or settlements against, or amounts with respect thereto, owed by Licensor or any of its Affiliates relating to the Licensed IP.
12.08 No claim or litigation has been brought or, to Licensor’s Knowledge, threatened by any person or entity alleging, that (a) the Licensed Patents existing are solely owned by The Trustees of the University of Pennsylvania, and (b) no Third Party (other than the REGENXBIO Licensors) has any right, interest, or claim in or to such Licensed Patents in the Field that are inconsistent with those granted to Licensee in the Field under this Agreement;
8.1.5 To Licensor’s knowledge, Licensor does not Control as of the Effective Date are invalid any patent or unenforceable, or patent application (b) the Licensed IP, or the disclosing, copying, making, assigning, or licensing of the Licensed IP, or the Exploitation of the Licensed Compounds or Licensed Products as contemplated herein, does or will violate, infringe, misappropriate or otherwise conflict or interfere with, any Patent or other intellectual property or proprietary right of any person or entity.
12.09 To Licensor’s Knowledge, the Exploitation of the Licensed Compound or Licensed IP does not violate, infringe, misappropriate, or otherwise conflict or interfere with any Patent or other intellectual property or proprietary right of any person or entity.
12.10 To Licensor’s Knowledge, no person or entity is infringing or threatening to infringe or misappropriating or threatening to misappropriate the Licensed IP.
12.11 To Licensor’s Knowledge, with respect to the pending patent applications included in than the Licensed Patents existing (as defined in Section 1.11) that would necessarily be infringed by the use or sale of AAV8 in the Field. If it is determined, in accordance with the procedure of this Section 8.1.5, that Licensor Controls as of the Effective DateDate a patent or patent application (other than the Licensed Patents) that would necessarily be infringed by the use or sale of AAV8 in the Field, Licensor and its Affiliates have presented all relevant references, documents, then Licensee’s sole remedy shall be the inclusion of the applicable patent or information of which it and the inventors are aware patent application as a “Licensed Patent” hereunder but solely to the relevant patent examiner at extent of the relevant patent office.
12.12 To Licensor’s Knowledgeclaim(s) that would necessarily be infringed by the use or sale of AAV8. At any time during the term of this Agreement, no funding from any governmental entity Licensee may notify Licensor in writing of any kind was used in connection with development of any of the intellectual property rights such patent or patent application that Licensee believes should be included in the scope of the Licenseas a “Licensed Patent” pursuant to this Section 8.
12.13 To Licensor’s Knowledge the Licensed Compound has not been used in humans in any form on behalf of Licensor or its Affiliates prior to the Effective Date.
Appears in 2 contracts
Samples: License Agreement, License Agreement (Audentes Therapeutics, Inc.)
Representations and Warranties by Licensor. Licensor hereby represents warrants, represents, and warrants to ProPhase as followsagrees that:
12.01 9.1 Licensor is a corporation duly organized, limited liability company validly existing and in good standing under the laws of NevadaTexas. Licensor has been granted all requisite power the full right, power, legal capacity and authority to enter into this Agreement, to carry on its business out the terms here and to own grant to Licensee the rights, licenses and operate its properties and assets. The executionprivileges granted to it.
9.2 With respect to the Rights, delivery and performance Licensor has no distribution contract or other agreement with any other person or entity with respect to Video Devices of the Program which might conflict or interfere with any of the provisions of this Agreement have been duly authorized or the enjoyment by LicensorLicensee of any rights granted to it under this agreement.
12.02 9.3 Licensor has secured and will maintain all rights throughout the Territory and during the Term to enable Licensee to exercise and enjoy its rights under this Agreement without Licensee incurring obligations or liability to anyone, and Licensor has (or third parties have) paid all the production costs of the Program.
9.4 There is are no claims, actions, suits, proceedings or investigations pending or, to Licensor’s 's knowledge, threatened litigation involving Licensor which would have against or affecting the Program, at law or in equity, or before any effect on this Agreement federal, state, county, municipal or on other governmental instrumentality or authority, domestic or foreign, and no arbitration proceedings are pending or to Licensor’s ability to perform its obligations hereunder.
12.03 To Licensor’s knowledge, 's knowledge threatened against or affecting the Program and there is no indenture, contract, legal or agreement to equitable basis on which Licensor is a party or the exercise by which Licensor is bound which prohibits or would prohibit Licensee of the execution and delivery by Licensor of rights granted under this Agreement or the performance or observance by Licensor exercise of any term or condition of this Agreement.
12.04 All Licensed IP existing as of the Effective Date is solely and exclusively owned by Licensor.
12.05 To Licensor’s Knowledge, all Licensed Patents existing as of the Effective Date are subsisting and are not invalid or unenforceable, in whole or in part.
12.06 To Licensor’s Knowledge, the Licensed Patents existing as of the Effective Date (a) are being diligently prosecuted in the respective patent offices in the Territory in accordance with applicable laws, rules and regulations, (b) have been filed and maintained properly and correctly and all applicable fees have been paid on or before the due date for payment, and (c) identifies each and every inventor of the claims thereof as determined in accordance with the laws of the jurisdiction in which such Patent is issued or such application is pending.
12.07 To Licensor’s Knowledge, there are no claims, judgments, or settlements against, or amounts with respect thereto, owed similar rights by Licensor or any of its Affiliates relating others with respect to the Licensed IPProgram may be enjoined or otherwise impeded.
12.08 No claim 9.5 Neither the Program, nor the titles thereof as submitted by Licensor, nor anything contained in the Program, including, but not limited to, any sound or litigation has been brought or, to Licensor’s Knowledge, threatened by any person or entity alleging, that (a) the Licensed Patents existing as of the Effective Date are invalid or unenforceable, or (b) the Licensed IPmusic synchronized therewith, or the disclosingdistribution and exploitation thereof of Video Devices in the Territory, copying, making, assigning, or licensing nor the exercise by Licensee of any of the Licensed IP, or the Exploitation of the Licensed Compounds or Licensed Products as contemplated hereinrights granted it under this Agreement, does or will violateviolate or infringe upon the trademark, infringetrade name, misappropriate copyright, literary, dramatic, musical, artistic, personal, private, civil or otherwise conflict property right or interfere with, rights of privacy or any Patent or other intellectual property or proprietary right of any person or entity.
12.09 To Licensor’s Knowledge, 9.6 The lists and other materials delivered to Licensee under this Agreement will be complete and accurate and Licensee will incur no liabilities to any third parties arising out of its compliance under this Agreement with such lists and the Exploitation use of the Licensed Compound or Licensed IP does not violate, infringe, misappropriate, or otherwise conflict or interfere with any Patent or other intellectual property or proprietary right of any person or entitysuch materials as authorized under this Agreement.
12.10 To 9.7 Licensor’s Knowledge's warranties, no person or entity is infringing or threatening to infringe or misappropriating or threatening to misappropriate the Licensed IP.
12.11 To Licensor’s Knowledgerepresentations, with respect to the pending patent applications included in the Licensed Patents existing and agreements here are true and complete as of the Effective Datedate of this Agreement, Licensor shall remain so throughout the Term of this Agreement and its Affiliates have presented all relevant references, documents, or information of which it and shall survive the inventors are aware to the relevant patent examiner at the relevant patent office.
12.12 To Licensor’s Knowledge, no funding from any governmental entity of any kind was used in connection with development of any expiration of the intellectual property rights included in the scope Term of the Licensethis Agreement.
12.13 To Licensor’s Knowledge the Licensed Compound has not been used in humans in any form on behalf of Licensor or its Affiliates prior to the Effective Date.
Appears in 1 contract
Samples: Distribution Agreement
Representations and Warranties by Licensor. Licensor hereby LICENSOR represents and warrants to ProPhase as follows:
12.01 Licensor is a corporation duly organized, validly existing and in good standing under the laws of Nevada. Licensor has been granted all requisite power and authority to carry on its business and to own and operate its properties and assets. The execution, delivery and performance of this Agreement have been duly authorized by Licensor.
12.02 There is no pending or, to Licensor’s knowledge, threatened litigation involving Licensor which would have any effect on this Agreement or on Licensor’s ability to perform its obligations hereunder.
12.03 To Licensor’s knowledge, there is no indenture, contract, or agreement to which Licensor is a party or by which Licensor is bound which prohibits or would prohibit the execution and delivery by Licensor of this Agreement or the performance or observance by Licensor of any term or condition of this Agreement.
12.04 All Licensed IP existing IMMEDICA as of the Effective Date that:
12.2.1. there is solely and exclusively owned by Licensor.
12.05 To Licensor’s no actual alleged or threatened claim that has been notified in writing to the Licensor or its Affiliates or, to its Knowledge, any pending or possible claim that the Development, Manufacture or Commercialization of the Product within the Territory infringes, misappropriates or otherwise violates the Intellectual Property Rights of a Third Party. As used in this Section 12.2, “Knowledge” means knowledge of the officers of LICENSOR, and is not meant to require or imply that any particular inquiry or investigation has been undertaken including, without limitation, obtaining any type of search (independent of that performed by the actual governmental authority during the normal course of patent prosecution, as applicable, in a jurisdiction) or opinion of counsel, provided that it shall include the knowledge that would be obtained from reasonable inquiries that a person in that position would normally be expected to have made;
12.2.2. there is no actual, pending, alleged or threatened claim by LICENSOR or its Affiliate alleging that a Third Party is or was infringing, misappropriating or otherwise violating the Licensed Technology within the Territory;
12.2.3. to its Knowledge, the practice of the Licensed Patents or the Licensed Know-How and the Development, Manufacture and/or Commercialization of any Product does not infringe, violate or misappropriate the Intellectual Property Rights of any Third Party;
12.2.4. Schedule A sets forth a true and complete list of all Licensed Patents existing Controlled by the LICENSOR or its Affiliates as of the Effective Date that Cover the Product, and the LICENSOR has the full right and authority to grant to IMMEDICA the right to use, sell, offer to sell, import and sublicense the Patent Rights in the Territory described in Schedule A, and to enforce such Patent Rights in accordance with Section 10 above;
12.2.5. the LICENSOR has not previously granted and will not grant any right, license or interest in or to a Product, Licensed Know-How and/or Licensed Patents, or any portion thereof, that is in conflict with, limits or derogates from the rights or licenses granted to IMMEDICA under this Agreement;
12.2.6. the Licensed Patents and the Licensed Know-How are subsisting free and clear of all liens, claims, security interests or other encumbrances of any kind and during the term of this Agreement, the LICENSOR shall not permit the Licensed Patents or the Licensed Know-How to become encumbered by any liens, claims, security interests or other encumbrances, in each case of the foregoing that could diminish IMMEDICA’s rights or licenses with respect to Licensed Patent Rights;
12.2.7. the LICENSOR has not knowingly withheld any Licensed Know-How that is reasonably relevant for IMMEDICA’s conduct of activities under this Agreement and, to the LICENSOR’S Knowledge, all Licensed Know-How provided to IMMEDICA is free from any material inaccuracies;
12.2.8. the LICENSOR has disclosed to IMMEDICA all material information relating to the safety and efficacy of the Product known to it or its Affiliates;
12.2.9. the LICENSOR has complied with all Applicable Laws, including any disclosure requirements, in connection with the filing, prosecution and maintenance of the Licensed Patents and, to the LICENSOR’s Knowledge, none of the issued Licensed Patents are not invalid or unenforceable;
12.2.10. the LICENSOR has conducted, in whole or in part.
12.06 To Licensor’s Knowledgeand its contractors and consultants have conducted, all its Development activities relating to the Licensed Patents existing as of Product, including the Effective Date (a) are being diligently prosecuted in the respective patent offices in the Territory Phase III Clinical Trial, in accordance with applicable lawsApplicable Laws including, rules as applicable, GLP and regulationsGCP;
12.2.11. neither the LICENSOR nor any of its Affiliates are, (b) or have been filed been, debarred or disqualified by any Regulatory Authority; and maintained properly and correctly and all applicable fees have been paid on or before the due date for payment, and (c) identifies each and every inventor none of the claims thereof as determined in accordance with the laws of the jurisdiction in which such Patent is issued or such application is pending.
12.07 To Licensor’s Knowledge, there are no claims, judgments, or settlements against, or amounts with respect thereto, owed by Licensor LICENSOR or any of its Affiliates Affiliates’ employees or contractors who were involved in the Development, Manufacture or Commercialization of the Product are, or have been, debarred or disqualified by any Regulatory Authority;
12.2.12. the materials and documents provided to IMMEDICA in the course of IMMEDICA’s due diligence preceding execution of this Agreement were free from any material inaccuracies;
12.2.13. the LICENSOR has made available to IMMEDICA all material information in the LICENSOR’s or its Affiliate’s control relating to the Licensed IP.
12.08 No claim or litigation has been brought or, to Licensor’s Knowledge, threatened by any person or entity alleging, that (a) the Licensed Patents existing as Development and Manufacture of the Effective Date are invalid or unenforceable, or (b) the Licensed IP, or the disclosing, copying, making, assigning, or licensing of the Licensed IP, or the Exploitation of the Licensed Compounds or Licensed Products as contemplated herein, does conducted by or will violate, infringe, misappropriate or otherwise conflict or interfere with, any Patent or other intellectual property or proprietary right of any person or entity.
12.09 To Licensor’s Knowledge, the Exploitation of the Licensed Compound or Licensed IP does not violate, infringe, misappropriate, or otherwise conflict or interfere with any Patent or other intellectual property or proprietary right of any person or entity.
12.10 To Licensor’s Knowledge, no person or entity is infringing or threatening to infringe or misappropriating or threatening to misappropriate the Licensed IP.
12.11 To Licensor’s Knowledge, with respect to the pending patent applications included in the Licensed Patents existing as of the Effective Date, Licensor and its Affiliates have presented all relevant references, documents, or information of which it and the inventors are aware to the relevant patent examiner at the relevant patent office.
12.12 To Licensor’s Knowledge, no funding from any governmental entity of any kind was used in connection with development of any of the intellectual property rights included in the scope of the License.
12.13 To Licensor’s Knowledge the Licensed Compound has not been used in humans in any form on behalf of Licensor or the LICENSOR and its Affiliates prior to the Effective Date, including complete and correct copies of the following: adverse event reports; clinical study reports and material study data; and Regulatory Authority inspection reports, notices of adverse findings, warning letters, Regulatory Filings and other material correspondence with Regulatory Authorities;
12.2.14. neither the LICENSOR nor any of its employees have been “debarred” by the FDA or the EMA, or subject to a similar sanction from another Regulatory Authority, nor have debarment proceedings against the LICENSOR or any of its employees been commenced. The LICENSOR will promptly notify IMMEDICA in writing if any such proceedings have commenced or if the LICENSOR or any of its employees are debarred by the FDA or the EMA or any other Regulatory Agency;
12.2.15. it shall not hire or retain as an officer or employee any person who has been convicted of a felony under the laws of the United States for conduct relating to the regulation of any drug product under the FDCA. If at any time this representation and warranty is no longer accurate, the LICENSOR shall immediately notify IMMEDICA of such fact;
12.2.16. all personal data and biological specimens collected from or disclosed by human subjects in Clinical Studies of the Products have been collected, used, processed and disclosed in compliance with Applicable Laws;
12.2.17. to the Knowledge of the LICENSOR, the Phase III Clinical Trial will, if it meets its primary endpoints, produce sufficient clinical data to support an application for Regulatory Approval of the Product in AML with the EMA without the need for additional Clinical Studies, provided that this representation and warranty shall not be taken as a representation and or warranty that the Phase III Clinical Trial will meet its primary endpoints or that any application for Regulatory Approval for the Product will be successful;
12.2.18. the Existing Agreements are in full force and effect and the Licensor has complied in all material respects with each of its obligations the Existing Agreements in a timely manner, and has paid all payments owed by the LICENSOR under the Existing Agreements in full and on time;
12.2.19. the LICENSOR is not in breach of any material term of the Manufacturing Agreements and, to its Knowledge, no counterparty to the Manufacturing Agreements is in breach of any material term of the Manufacturing Agreements; and
12.2.20. to its Knowledge, the Facility meets all requirements under Applicable Law, including under GMP, for the Manufacture of the Product for Commercialization in the European Union.
Appears in 1 contract
Samples: Exclusive License and Supply Agreement (Actinium Pharmaceuticals, Inc.)
Representations and Warranties by Licensor. Licensor hereby represents and warrants to ProPhase as followsLicensee that each of the following is true and correct on the Effective Date for the purpose of supporting Licensee’s representations and warranties to PM in clause 28.1 of the PM License:
12.01 (i) Licensor is a corporation duly organized, validly existing the legal and in good standing under beneficial owner of the laws of Nevada. Licensed IP and KBI Branding.
(ii) Licensor has been granted all requisite power the unconditional and irrevocable right, power, and authority to carry on its business grant the License set forth in this Agreement, subject to the terms and to own and operate its properties and assets. The executionconditions of the Side Letter.
(iii) Neither the grant of the License by Licensor, delivery and nor Licensor’s performance of any of its obligations set forth in this Agreement have been duly authorized by Licensor.
12.02 There is no pending does, or, to Licensor’s knowledgeits knowledge will: (A) violate any applicable law; (B) require the consent, threatened litigation involving Licensor which would have approval, or authorization of any effect on this Agreement governmental or on Licensor’s ability regulatory authority or other third party; or (C) require the payment of any consideration to perform its obligations hereunderany third party.
12.03 (iv) Other than the Third A/R Distribution Agreement and the Side Letter, Licensor has not granted any licenses or any other right, waiver, covenant not to assert or sxx, option or other beneficial right under or in connection with the Licensed IP or the KBI Branding in relation to any Market.
(v) To Licensor’s knowledge, there is no indentureinformation, contractfact, condition, circumstance, or agreement to which Licensor is a party or by which Licensor is bound which prohibits or prior art exists that would prohibit negatively affect the execution and delivery by Licensor of this Agreement or the performance or observance by Licensor of any term or condition of this Agreement.
12.04 All Licensed IP existing as of the Effective Date is solely and exclusively owned by Licensor.
12.05 To Licensor’s Knowledgevalidity, all Licensed Patents existing as of the Effective Date are subsisting and are not invalid or unenforceableenforceability, in whole or in part.
12.06 To Licensor’s Knowledge, the Licensed Patents existing as of the Effective Date (a) are being diligently prosecuted in the respective patent offices in the Territory in accordance with applicable laws, rules and regulations, (b) have been filed and maintained properly and correctly and all applicable fees have been paid on or before the due date for payment, and (c) identifies each and every inventor of the claims thereof as determined in accordance with the laws of the jurisdiction in which such Patent is issued or such application is pending.
12.07 To Licensor’s Knowledge, there are no claims, judgmentsterm, or settlements against, or amounts with respect thereto, owed by Licensor or any of its Affiliates relating to the Licensed IP.
12.08 No claim or litigation has been brought or, to Licensor’s Knowledge, threatened by any person or entity alleging, that (a) the Licensed Patents existing as of the Effective Date are invalid or unenforceable, or (b) the Licensed IP, or the disclosing, copying, making, assigning, or licensing Scope of the Licensed IPIP or the KBI Branding.
(vi) There is no pending, or to its knowledge threatened litigation or reissue application, re-examination, post-grant, inter partes or covered business method patent review, interference, derivation, opposition, claim of invalidity or other claim or proceeding: (i) alleging the Exploitation of unpatentability, invalidity, misuse, unregisterability, unenforceability, or non-infringement or, or error in any Licensed IP or KBI Branding; (ii) challenging Licensor’ ownership of, or right to practice, or license the Licensed Compounds IP or Licensed Products as contemplated herein, does KBI Branding; or will violate, infringe, misappropriate or otherwise conflict or interfere with, any Patent or other intellectual property or proprietary right (iii) alleging that the sale of any person product that uses or entity.
12.09 To Licensor’s Knowledge, embodies the Exploitation of the Licensed Compound or Licensed IP does not violate, or would infringe, misappropriate, or otherwise conflict or interfere with violate any Patent patent, trade secret, or other intellectual property or proprietary right of any person or entitythird party.
12.10 To Licensor’s Knowledge, no person or entity is infringing or threatening to infringe or misappropriating or threatening to misappropriate the Licensed IP.
12.11 To Licensor’s Knowledge, with respect to the pending patent applications included in the Licensed Patents existing as of the Effective Date, Licensor and its Affiliates have presented all relevant references, documents, or information of which it and the inventors are aware to the relevant patent examiner at the relevant patent office.
12.12 To Licensor’s Knowledge, no funding from any governmental entity of any kind was used in connection with development of any of the intellectual property rights included in the scope of the License.
12.13 To Licensor’s Knowledge the Licensed Compound has not been used in humans in any form on behalf of Licensor or its Affiliates prior to the Effective Date.
Appears in 1 contract
Samples: License Agreement (Kaival Brands Innovations Group, Inc.)
Representations and Warranties by Licensor. Licensor hereby represents and warrants to ProPhase as follows:
12.01 Licensor is a corporation duly organized, validly existing and in good standing under the laws of Nevada. Licensor has been granted all requisite power and authority to carry on its business and to own and operate its properties and assets. The execution, delivery and performance of this Agreement have been duly authorized by Licensor.
12.02 There is no pending or, to Licensor’s knowledge, threatened litigation involving Licensor which would have any effect on this Agreement or on Licensor’s ability to perform its obligations hereunder.
12.03 To Licensor’s knowledge, there There is no indenture, contract, or agreement to which Licensor is a party or by which Licensor is bound which prohibits or would prohibit the execution and delivery by Licensor of this Agreement or the performance or observance by Licensor of any term or condition of this Agreement.
12.04 Licensor has, and covenants that it will maintain during the Term, the lawful right to grant the License to ProPhase hereunder.
12.05 All Licensed IP existing as of the Effective Date is solely and exclusively owned by Licensor.
12.05 To Licensor’s Knowledge, all 12.06 All Licensed Patents existing as of the Effective Date are subsisting and are not invalid or or, to Licensor’s knowledge, unenforceable, in whole or in part.
12.06 To Licensor’s Knowledge, the 12.07 The Licensed Patents existing as of the Effective Date (a) are being diligently prosecuted in the respective patent offices in the Territory in accordance with applicable laws, rules and regulations, (b) have been filed and maintained properly and correctly and all applicable fees have been paid on or before the due date for payment, and (c) identifies each and every inventor of the claims thereof as determined in accordance with the laws of the jurisdiction in which such Patent is issued or such application is pending.
12.07 To Licensor’s Knowledge, there 12.08 There are no claims, judgments, or settlements against, or amounts with respect thereto, owed by Licensor or any of its Affiliates relating to the Licensed IP.
12.08 12.09 No claim or litigation has been brought or, to Licensor’s Knowledgeknowledge, threatened by any person or entity alleging, that (a) the Licensed Patents existing as of the Effective Date are invalid or unenforceable, or (b) the Licensed IP, or the disclosing, copying, making, assigning, or licensing of the Licensed IP, or the Exploitation of the Licensed Compounds or Licensed Products as contemplated herein, does or will violate, infringe, misappropriate or otherwise conflict or interfere with, any Patent or other intellectual property or proprietary right of any person or entity.
12.09 12.10 To Licensor’s Knowledgeknowledge, the Exploitation of the Licensed Compound or Licensed IP does not violate, infringe, misappropriate, or otherwise conflict or interfere with any Patent or other intellectual property or proprietary right of any person or entity.
12.10 12.11 To Licensor’s Knowledgeknowledge, no person or entity is infringing or threatening to infringe or misappropriating or threatening to misappropriate the Licensed IP.
12.11 To 12.12 The information provided to ProPhase in respect of the Licensed Patents existing as of the Effective Date is true, complete and correct.
12.13 The Patents set forth on Appendix I represent all Patents within Licensor’s Knowledgeor its Affiliates’ Control relating to the Licensed Compounds, with or the Exploitation thereof.
12.14 In respect to of the pending patent applications included in the Licensed Patents existing as of the Effective Date, Licensor and its Affiliates have presented all relevant references, documents, or information of which it and the inventors are aware to the relevant patent examiner at the relevant patent office.
12.12 To Licensor’s Knowledge, no 12.15 No funding from any governmental entity of any kind was used in connection with development of any of the intellectual property rights included in the scope of the License.
12.13 To 12.16 Neither Licensor’s Knowledge , nor its Affiliates, are (a) debarred under subsections 306(a) or (b) of the U.S. Federal Food Drug and Cosmetic Act (US Generic Drug Enforcement Act of 1992; 21 USC 335a (a) or (b)), or (b) excluded from any federal health care program, including but not limited to Medicare and Medicaid.
12.17 The Licensed Compound has not been used in humans in any form on behalf of Licensor or its Affiliates prior to the Effective Date.
12.18 Xxxxx Xxxxxxxx is, and to the extent Xxxxx Xxxxxxxx is made available by Licensor to Prophase under this Agreement, will remain during the Term, obligated to assign any and all intellectual property rights to any inventions (a) for which Xxxxx Xxxxxxxx is an inventor to Licensor, and (b) which relate to this Agreement, the Licensed Compound or a Licensed Product.
12.19 The representations and warranties of Licensor in this Agreement, and the Information, documents and materials furnished to ProPhase prior to the Effective Date, do not, taken as a whole, (a) contain any untrue statement of a material fact, or (b) omit to state any material fact necessary to make the statements or facts contained therein, in light of the circumstances under which they were made, not misleading.
Appears in 1 contract
Samples: License Agreement
Representations and Warranties by Licensor. Licensor hereby represents and warrants to ProPhase Novartis as followsof the Execution Date that:
12.01 (a) Schedule B sets forth a complete and accurate list of all Licensor Patent Rights in existence as of the Execution Date;
(b) Licensor is a corporation duly organizedthe sole and exclusive owner or exclusive licensee of all of the Licensor Patent Rights and Licensor Trademarks free from Encumbrances and is listed in the records of the appropriate United States and/or foreign governmental agencies as the sole and exclusive owner of record or exclusive licensee for each registration, validly existing grant and application included in the Licensor Patent Rights or Licensor Trademarks, as the case may be;
(c) Licensor has the right to grant to Novartis the licenses under the Licensor Technology that it purports to grant hereunder and to assign the Licensor Trademarks and Regulatory Filings to Novartis hereunder;
(d) Licensor has the right to use and disclose and to enable Novartis to use and disclose (in each case under appropriate conditions of confidentiality) the Licensor Know-How free from Encumbrances (other than Encumbrances imposed by this Agreement);
(e) to the knowledge of Licensor, the issued patents in the Licensor Patent Rights are valid and enforceable without any claims, challenges, oppositions, interference or other proceedings pending or threatened and Licensor has filed and prosecuted patent applications within the Licensor Patent Rights in good standing under the laws faith and complied with all duties of Nevadadisclosure with respect thereto. Licensor has been granted all requisite power and authority to carry on its business and to own and operate its properties and assets. The execution, delivery and performance of this Agreement have been duly authorized by Licensor.
12.02 There is no pending orIn addition, to Licensor’s knowledge, threatened litigation involving Licensor which would has not committed any act, or omitted to commit any act, that may cause the Licensor Patent Rights to expire prematurely or be declared invalid or unenforceable;
(f) except to the extent not yet due, all necessary and material application, registration, maintenance and renewal fees in respect of the Licensor Patent Rights and Licensor Trademarks in existence as of the Execution Date have been paid and, except to the extent not yet due, all necessary documents and certificates have been filed with the relevant agencies for the purpose of maintaining such Licensor Patent Rights and Licensor Trademarks;
(g) except for the agreements listed on Schedule J, Licensor has not granted to any effect on this Agreement Third Party or on Licensor’s ability other Person, including any academic organization or agency, any rights to perform its obligations hereunder.the Compound or Product;
12.03 To (h) to the best of Licensor’s knowledge, there the Development, registration, manufacture, use or Commercialization of the Compound and/or Product do not infringe the Patent Rights or misappropriate the Know-How of any Third Party, nor has Licensor received any written notice alleging such infringement;
(i) Licensor has not initiated or been a party to any proceedings or claims in which it alleges that any Third Party is or was infringing or misappropriating any Licensor Technology, nor have any such proceedings been threatened by Licensor in writing, nor does Licensor know of any valid basis for any such proceedings;
(j) Licensor has exercised commercially reasonable efforts to obtain from all individuals who participated in any respect in the invention or authorship of any Licensor Technology or Licensor Trademarks effective assignments of all ownership rights of such individuals in such Licensor Technology, either pursuant to written agreement or by operation of law;
(k) no indentureofficer or employee of Licensor is subject to any agreement with any other Third Party which requires such officer or employee to assign any interest in any Licensor Technology relating to the Compound and/or Product to any Third Party;
(l) Licensor has taken all reasonable precautions to preserve the confidentiality of the Licensor Know-How;
(m) Licensor has not entered into a government funding relationship that would result in rights to any Compound or Product residing in the US Government, contractNational Institutes of Health or other agency, and the licenses granted hereunder are not subject to overriding obligations to the US Government as set forth in Public Law 96-517 (35 U.S.C. 200-204), as amended, or agreement to which Licensor is a party or by which Licensor is bound which prohibits or would prohibit the execution and delivery by Licensor of this Agreement or the performance or observance by Licensor of any term or condition of this Agreement.
12.04 All Licensed IP existing as of the Effective Date is solely and exclusively owned by Licensor.
12.05 To Licensor’s Knowledge, all Licensed Patents existing as of the Effective Date are subsisting and are not invalid or unenforceable, in whole or in part.
12.06 To Licensor’s Knowledge, the Licensed Patents existing as of the Effective Date (a) are being diligently prosecuted in the respective patent offices in the Territory in accordance with applicable laws, rules and regulations, (b) have been filed and maintained properly and correctly and all applicable fees have been paid on or before the due date for payment, and (c) identifies each and every inventor of the claims thereof as determined in accordance with similar obligations under the laws of any other country;
(n) other than the jurisdiction in which such Patent is issued or such application is pending.
12.07 To Licensor’s KnowledgeExisting Third Party License Agreements, there are no claims, judgments, agreements or settlements against, or amounts with respect thereto, owed by arrangements to which Licensor or any of its Affiliates is a party relating to the Licensed IP.
12.08 No claim or litigation has been brought orProduct, Compound, Licensor Patent Rights, Licensor Know-How and/or Licensor Trademarks that would limit the rights granted to Licensor’s Knowledge, threatened by any person or entity alleging, that (a) the Licensed Patents existing as of the Effective Date are invalid or unenforceable, or (b) the Licensed IP, or the disclosing, copying, making, assigning, or licensing of the Licensed IP, or the Exploitation of the Licensed Compounds or Licensed Products as contemplated herein, does or will violate, infringe, misappropriate or otherwise conflict or interfere with, any Patent or other intellectual property or proprietary right of any person or entity.
12.09 To Licensor’s Knowledge, the Exploitation of the Licensed Compound or Licensed IP does not violate, infringe, misappropriate, or otherwise conflict or interfere with any Patent or other intellectual property or proprietary right of any person or entity.
12.10 To Licensor’s Knowledge, no person or entity is infringing or threatening to infringe or misappropriating or threatening to misappropriate the Licensed IP.
12.11 To Licensor’s Knowledge, Novartis under this Agreement with respect to the pending patent applications included Products, Compound, Licensor Patent Rights, Licensor Know-How and/or Licensor Trademarks or that restrict or will result in a restriction on Novartis’ or its Affiliates’ ability to Develop, manufacture, register, use or Commercialize the Compound and/or the Product in the Licensed Patents existing Territory;
(o) (i) the License Agreement dated as of the Effective DateOctober 3, 2001 between CTI and CTI Technologies, Inc. has been terminated and is no longer in force or effect and (ii) Licensor and its Affiliates have presented all relevant references, documents, or information of which it and the inventors are aware has delivered to the relevant patent examiner at the relevant patent office.
12.12 To Licensor’s Knowledge, no funding from any governmental entity of any kind was used in connection with development of any Novartis a copy of the intellectual property rights included in the scope executed written termination;
(p) CTI owns one hundred percent (100%) of the License.capital stock of CTI Europe, free of all Encumbrances; and
12.13 To Licensor’s Knowledge the Licensed Compound has not been used (q) no representation or warranty by Licensor in humans in any form this Agreement, and no information contained herein or otherwise delivered by or on behalf of Licensor or its Affiliates prior to Novartis in connection with the Effective Datetransactions contemplated in this Agreement contains any untrue statement of a material fact or omits to state any material fact necessary in order to make the statements contained herein or therein not misleading in light of the circumstances under which such statements were made.
Appears in 1 contract
Samples: License and Co Development Agreement (Cell Therapeutics Inc)
