Additional Representations and Warranties of Licensor. Licensor represents and warrants to Coronado as of the Effective Date that: (a) No consent by any Third Party or Governmental Body is required with respect to the execution and delivery of this Agreement by Licensor or the consummation by Licensor of the transactions contemplated hereby; (b) The Licensor Technology is wholly-owned by Licensor, free and clear of all mortgages, pledges, charges, liens, equities, security interests, shop rights, or other encumbrances or similar agreements, or any other obligation; (c) To Licensor’s knowledge, no claims have been asserted or threatened by any Person (i) challenging the validity, effective status, or ownership of Licensor Technology, and/or (ii) to the effect that the use, reproduction, modification, manufacturing, distribution, licensing, sublicensing, sale or any other exercise of rights in any of Licensor Technology infringes or will infringe on any intellectual property right of any Person; and no such claims have been asserted or are threatened; (d) To Licensor’s knowledge, the Licensor Patents are subsisting and are not the subject of any litigation procedure, discovery process, interference, reissue, reexamination, opposition, appeal proceedings or any other legal dispute; (e) Licensor and its Affiliates have taken all reasonable actions necessary or appropriate to preserve the confidentiality of all trade secrets, proprietary and other confidential information material to Licensor Technology; (f) Neither Licensor nor any Affiliate thereof is aware of any Third Party activities which would constitute misappropriation or infringement of any Licensor Technology (g) The Licensor Patents constitute all Patent Rights owned or Controlled by Licensor that pertain directly and particularly to the research, Development, manufacture, use and Commercialization of the Licensed Products; and (h) To Licensor’s knowledge, no Third Party has filed, pursued or maintained or threatened in writing to file, pursue or maintain any claim, lawsuit, charge, complaint or other action alleging that any Licensor Technology is invalid or unenforceable.
Appears in 2 contracts
Samples: License Agreement (Checkpoint Therapeutics, Inc.), License Agreement (Checkpoint Therapeutics, Inc.)
Additional Representations and Warranties of Licensor. Licensor represents and warrants to Coronado Licensee that:
15.1 Except as set forth on Exhibit I, as of the Effective Date that:date hereof, Licensor exclusively owns all right, title and interest in and to the Trademarks in the Sales Territory. The Trademarks that are registered in the Sales Territory are valid and enforceable.
15.2 Except as set forth on Exhibit I, as of the date hereof, (a) No consent by any Third Party or Governmental Body is required with respect to the execution and delivery of this Agreement by Licensor or the consummation by Licensor of the transactions contemplated hereby;
(b) The Licensor Technology is wholly-owned by Licensor, free and clear of all mortgages, pledges, charges, liens, equities, security interests, shop rights, or other encumbrances or similar agreements, or any other obligation;
(c) To Licensor’s knowledge, no claims have been asserted person or threatened by entity is infringing, conflicting with, violating or diluting any Person of the Trademarks in the Sales Territory in any material respect, and (ib) challenging within the validity, effective status, or ownership of Licensor Technology, and/or three (ii3) year period prior to the effect that the usedate hereof, reproductionLicensor has not provided any written or, modification, manufacturing, distribution, licensing, sublicensing, sale or any other exercise of rights in any of Licensor Technology infringes or will infringe on any intellectual property right of any Person; and no such claims have been asserted or are threatened;
(d) To to Licensor’s knowledge, the Licensor Patents are subsisting unwritten notice or other communication to any person or entity, and are not the subject of no action or proceeding or claim has been asserted by Licensor, alleging that any litigation procedureperson or entity is infringing, discovery processconflicting with, interference, reissue, reexamination, opposition, appeal proceedings violating or diluting any other legal dispute;
(e) Licensor and its Affiliates have taken all reasonable actions necessary or appropriate to preserve the confidentiality of all trade secrets, proprietary and other confidential information material to Licensor Technology;
(f) Neither Licensor nor any Affiliate thereof is aware of any Third Party activities which would constitute misappropriation or infringement of any Licensor Technology
(g) The Licensor Patents constitute all Patent Rights owned or Controlled by Licensor that pertain directly and particularly to the research, Development, manufacture, use and Commercialization of the Licensed Products; andTrademarks in the Sales Territory.
15.3 Except as set forth on Exhibit I, as of the date hereof, (ha) To to Licensor’s knowledge, none of the Trademarks or the use, practice or exploitation of any of the Trademarks infringes, conflicts with, violates or dilutes any intellectual property rights owned by any person or entity; (b) within the three (3) year period prior to the date hereof, no Third Party has filed, pursued or maintained or threatened in writing to file, pursue or maintain any written claim, lawsuit, charge, complaint notice or other action communication alleging that any of the Trademarks infringes, conflicts with, violates or dilutes any intellectual property rights owned by any person or entity has been served on or otherwise received by Licensor Technology from any person or entity; and (c) there is invalid no claim or unenforceableaction or proceeding pending or threatened against Licensor with respect to any of the Trademarks or the ownership, use, validity or enforceability thereof, other than any non-final determinations of any governmental authority with respect to the Trademarks.
15.4 All necessary registration, maintenance, renewal and other relevant filing fees in connection with any registrations or pending applications for any of the Trademarks have been timely paid, and all necessary documents, certificates and other relevant filings in connection with any registrations or pending applications for any of the Trademarks have been timely filed, with the relevant governmental authorities for the purpose of maintaining the Trademarks and all registrations and applications therefor. No registration obtained by Licensor for any of the Trademarks in the Territory has been cancelled, abandoned or not renewed except where Licensor has, in its reasonable business judgment, decided to cancel, abandon or not renew such registration.
15.5 Licensor makes no representation that the use of the Marks or IP Rights in connection with the Manufacturing License does not or will not infringe or violate the rights of any third party.
Appears in 2 contracts
Samples: License Agreement (Claiborne Liz Inc), License Agreement (Claiborne Liz Inc)
Additional Representations and Warranties of Licensor. Licensor further represents and warrants to Coronado AbbVie, as of the Effective Date, and as applicable under Sections 9.2.4, 9.2.10, 9.2.12, 9.2.14 and 9.2.15, covenants, as follows:
9.2.1 All Licensor Patents existing as of the Effective Date that:that claim or cover any Licensed Compounds or Licensed Products or the Exploitation thereof are listed on Schedule 9.2.1 (the “Existing Patents”). All Existing Patents existing as of the Effective Date are subsisting and are to Licensor’s Knowledge not invalid or unenforceable, in whole or in part, are being diligently prosecuted in the respective patent offices in the Territory in accordance with Applicable Law, and have been filed and maintained properly and correctly and all applicable fees have been paid on or before the due date for payment.
(a) 9.2.2 There are no claims, judgments, or settlements against, or amounts with respect thereto, relating to the Existing Patents or the Licensor Know-How. No consent claim or litigation has been brought or threatened by any Person alleging, and Licensor has no knowledge of any claim, whether or not asserted, that the Existing Patents are invalid or unenforceable. To Licensor’s Knowledge, the Development and Commercialization of the Licensed Compound and Licensed Products as contemplated herein, does not violate, infringe, misappropriate or otherwise conflict or interfere with any intellectual property or proprietary right of any Person. To Licensor’s Knowledge, no Person is infringing or threatening to infringe or misappropriating or threatening to misappropriate the Existing Patents or the Licensor Know-How.
9.2.3 Licensor is the sole and exclusive owner of the entire right, title and interest in the Existing Patents and the Licensor Program Know-How free of any encumbrance, lien, or claim of ownership by any Third Party Party. Licensor is entitled to grant the licenses specified herein. To Licensor’s Knowledge, there is no Information Controlled by Licensor or Governmental Body its Affiliates as of the Effective Date that relates to the Licensed Compound that is required not within the Licensor Know-How. Licensor has the right to use all Information and Patents reasonably necessary for the Development and Manufacture of Licensed Compounds as contemplated herein for the conduct of its activities and such Patents are not subject to any license or agreement to which Licensor or any of its Affiliates is a party that would restrict AbbVie’s ability to Exploit a Licensed Compound or Licensed Product (other than with respect to the execution agreements listed on Schedule 1.5). [ ] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and delivery of this Agreement by Licensor or the consummation by Licensor Exchange Commission pursuant to Rule 406 of the transactions contemplated hereby;Securities Act of 1933, as amended.
9.2.4 During the Term, neither Licensor nor any of its Affiliates shall encumber or diminish the rights granted to AbbVie hereunder with respect to the Licensor Patents.
9.2.5 True, complete, and correct copies of: (a) the file wrapper and other documents and materials relating to the prosecution, defense, maintenance, validity, and enforceability of the Existing Patents; and (b) The Licensor Technology is wholly-owned by all material adverse information with respect to the safety and efficacy of the Licensed Compound known to Licensor, free in each case ((a) and clear of all mortgages, pledges, charges, liens, equities, security interests, shop rights, (b)) have been provided or other encumbrances made available to AbbVie prior to the Effective Date.
9.2.6 Licensor and its Affiliates have not generated any Regulatory Documentation.
9.2.7 Each Person who has or similar agreements, has had any rights in or to any Existing Patents or any other obligation;
(c) Licensor Program Know-How, has assigned and has executed an agreement assigning its entire right, title, and interest in and to such Existing Patents and Licensor Program Know-How to Licensor. To Licensor’s knowledge, no claims current officer, employee, agent, or consultant of Licensor or any of its Affiliates is in violation of any term of any assignment or other agreement regarding the protection of Patents or other intellectual property or proprietary information of Licensor related to the Existing Patents or Licensor Program Know-How.
9.2.8 All rights in all inventions and discoveries, made, developed, or conceived by any employee or independent contractor of Licensor or any of its Affiliates during the course of their employment (or other retention) by Licensor or such Affiliate, and relating to or included in Licensor Program Know-How or that are the subject of one (1) or more Existing Patents have been asserted assigned in writing to Licensor or threatened such Affiliate.
9.2.9 Licensor has obtained the right (including under any Patents and other intellectual property rights) to use all Information and all other materials (including any formulations and manufacturing processes and procedures) developed or delivered by any Person (i) challenging Third Party under any agreements between Licensor and any such Third Party with respect to the validityLicensed Compound, effective statusand Licensor has the rights under each such agreement to transfer such Information or other materials to AbbVie and its designees and to grant AbbVie the right to use such know-how or other materials in the Development or Commercialization of the Licensed Compound or the Licensed Products without restriction.
9.2.10 Neither Licensor nor any of its Affiliates has any knowledge of any scientific or technical facts or circumstances that would adversely affect the scientific, therapeutic, or ownership commercial potential of the Licensed Compound or Licensed Products.
9.2.11 Neither Licensor Technologynor any of its Affiliates, and/or (ii) nor any of its or their respective officers, employees, or agents has made an untrue statement of material fact or fraudulent statement to the effect that the use, reproduction, modification, manufacturing, distribution, licensing, sublicensing, sale FDA or any other exercise Regulatory Authority with respect to the Development of rights in any of Licensor Technology infringes the Licensed Compound or will infringe on any intellectual property right of any Person; and no such claims have been asserted or are threatened;
(d) To Licensor’s knowledgethe Licensed Products, failed to disclose a material fact required to be disclosed to the Licensor Patents are subsisting and are not the subject of any litigation procedure, discovery process, interference, reissue, reexamination, opposition, appeal proceedings FDA or any other legal dispute;Regulatory Authority with respect to the Development of the Licensed Compound or the Licensed Products, or committed an act, made a statement, or failed to [ ] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. make a statement with respect to the Development of the Licensed Compound or the Licensed Products that could reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto or any analogous laws or policies in the Territory.
(e) 9.2.12 Licensor and its Affiliates have taken conducted, and their respective contractors and consultants have conducted, all reasonable actions necessary or appropriate to preserve the confidentiality of all trade secrets, proprietary and other confidential information material to Licensor Technology;
(f) Neither Licensor nor any Affiliate thereof is aware of any Third Party activities which would constitute misappropriation or infringement of any Licensor Technology
(g) The Licensor Patents constitute all Patent Rights owned or Controlled by Licensor that pertain directly and particularly to the research, Development, manufacture, use and Commercialization Development of the Licensed Compound or the Licensed Products that they have conducted prior to the Effective Date in accordance with good laboratory and clinical practice and Applicable Law. Licensor has conducted, and has caused its contractors and consultants to conduct, any and all pre-clinical and clinical studies related to the Licensed Compound and Licensed Products in accordance with good laboratory and clinical practice and Applicable Law. Licensor and its Affiliates have employed (and, with respect to such tests and studies that Licensor will perform, will employ) Persons with appropriate education, knowledge and experience to conduct and to oversee the conduct of the pre-clinical and clinical studies with respect to the Licensed Compound and Licensed Products; and.
(h) To Licensor’s knowledge, 9.2.13 There are no amounts that will be required to be paid to a Third Party has filedas a result of the Development or Commercialization of Licensed Compound or the Licensed Products that arise out of any agreement to which Licensor or any of its Affiliates is a party.
9.2.14 Licensor and its Affiliates have not ever been, pursued are not currently, nor are they the subject of a proceeding that could lead to it or maintained its Affiliates becoming a Debarred Entity, Excluded Entity or threatened Convicted Entity and it and its Affiliates will not use in writing any capacity, in connection with the obligations to filebe performed under this Agreement, pursue any person who is a Debarred Individual, Excluded Individual or maintain a Convicted Individual. Licensor further covenants that if, during the Term, it or its Affiliates become a Debarred Entity, Excluded Entity or Convicted Entity, or listed on the FDA’s Disqualified/Restricted List or if any claimemployee or agent performing any of its obligations hereunder becomes a Debarred Individual, lawsuitExcluded Individual or a Convicted Individual, chargeor added to the FDA’s Disqualified/Restricted List, complaint Licensor shall immediately notify AbbVie and AbbVie shall have the option, at its sole discretion, to either: (a) prohibit such Person from performing work under this Agreement, (b) terminate all work being performed or other action alleging that any to be performed by Licensor Technology is invalid pursuant to this Agreement or unenforceable.(c) terminate this Agreement. This provision shall survive termination or expiration of this Agreement. For purposes of this provision, the following definitions shall apply:
Appears in 2 contracts
Samples: Development and License Agreement, Development and License Agreement (Principia Biopharma Inc.)
Additional Representations and Warranties of Licensor. Licensor represents and warrants to Coronado Company that, as of the Effective Date thatDate:
(a) No no consent by any Third Party or Governmental Body is required with respect to the execution and delivery of this Agreement by Licensor or the consummation by Licensor of the transactions contemplated hereby;
(b) The Licensor Technology is wholly-owned by Licensor, free and clear of all mortgages, pledges, charges, liens, equities, security interests, shop rights, or other encumbrances or similar agreements, or any other obligation;
(c) To Licensor’s knowledge, no claims have been asserted or threatened by any Person Person, nor to Licensor’s Knowledge, are there any valid grounds for any claim of any such kind, (i) challenging the validity, effective statuseffectiveness, or ownership of Licensor Technology, and/or (ii) to the effect that the use, reproduction, modification, manufacturing, distribution, licensing, sublicensing, sale or any other exercise of rights in any of Licensor Technology infringes or will infringe on any intellectual property right of any Person; and ;
(c) to Licensor’s Knowledge, there is no such claims have been asserted unauthorized use, infringement or are threatenedmisappropriation of any of Licensor Technology by any employee or former employee of Licensor, or any other Third Party in the Territory;
(d) To Licensor’s knowledge, the Licensor Patents are subsisting and all registration, renewal, maintenance and other official fees with respect to the Licensor Patents due on or before the date of this Agreement have been paid in full. Licensor is the sole assignee and owner of each item listed on Schedule 1.38. To Licensor’s Knowledge, the Licensor Patents are not the subject of any litigation procedure, discovery process, interference, reissue, reexamination, opposition, appeal proceedings or any other legal dispute;
(e) Licensor and its Affiliates have taken all reasonable actions necessary or appropriate to preserve the confidentiality of all trade secrets, proprietary and other confidential information material to Licensor Technology;
(f) Neither Licensor nor any Affiliate thereof is aware of any Third Party activities which would constitute misappropriation or infringement of any Licensor Technology
(g) The Licensor Patents (i) constitute all Patent Rights owned or Controlled by Licensor as of the Effective Date that pertain are directly related to, necessary or useful for, or used in, the Development, regulatory approval, manufacture, use, marketing, sale, offer for sale, import, export or Commercialization of the Existing Product in the Territory and particularly to (ii) listed on Schedule 1.38 hereto constitute all Patent Rights that are directly related to, necessary or useful for, or used in, the researchDevelopment, regulatory approval, manufacture, use, marketing sale, offer for sale, import, export or Commercialization of the Existing Product in the Territory;
(f) the Licensor Know-How (i) constitutes all Know-How owned or Controlled by Licensor as of the Effective Date that is directly related to, or are necessary or useful for, the Development, manufacture, use and or Commercialization of the Existing Product under the Licensed Products; andRights and (ii) to Licensor’s Knowledge, constitutes all Know-How that is directly related to, or are necessary or useful for, the Development, manufacture, use or Commercialization of the Existing Product under the Licensed Rights;
(g) all of the Licensor Technology is owned by Licensor or its Affiliates and Licensor has not in-licensed, or otherwise obtained any rights, from a Third Party with respect to the Existing Product or the Licensor Technology;
(h) To Licensor’s knowledge, Licensor has not licensed to a Third Party the right to develop a Product;
(i) no Third Party has filed, pursued or maintained or threatened in writing to file, pursue or maintain any claim, lawsuit, charge, complaint or other action alleging that any Licensor Technology Patent is invalid or unenforceable;
(j) to Licensor’s Knowledge, Company’s and its Affiliates’ and Sublicensees’ practice and use of the inventions claimed in the Licensor Patents under the Licensed Rights as permitted herein (including the sale, offer for sale, Commercialization or regulatory approval of Product) will not infringe any intellectual property rights of any Third Party;
(k) all Representatives of Licensor who have performed any activities on its behalf in connection with Development regarding Product have assigned to Licensor the whole of their rights in any intellectual property made, discovered or developed by them as a result of such Development, and no Third Party has any rights to any such intellectual property;
(l) Licensor has all right, title and interest in and to the Licensor Technology and Licensor Technology is free and clear of any liens, charges, encumbrances or rights of others to possession or use;
(m) Licensor has not previously licensed, assigned, transferred, or otherwise conveyed any right, title or interest in and to the Licensor Technology to any Third Party in the Territory, including any rights with respect to Product;
(n) to Licensor’s Knowledge, the Licensor Technology constitutes all of the intellectual property which could reasonably be expected to be necessary or useful for, or used in, the Development, manufacture, regulatory approval, import, export, use, marketing, sale, offer for sale or Commercialization of the Existing Product;
(o) the Existing Product falls within the scope of at least one valid claim of at least one of the Licensor Patents listed on Schedule 1.38;
(p) to Licensor’s Knowledge, there is no additional Third Party licenses that have to be taken now or in the future to guarantee freedom-to-operate to Develop, manufacture and Commercialize the Existing Product without any limitation;
(q) except as set forth in Schedule 9.2(q), Licensor has the right, power and authority to assign the Existing Third Party Agreements to Company. In particular, except as set forth in Schedule 9.2(q), no such assignment requires consent, waiver or other action by any party to the applicable Existing Third Party Agreement;
(r) the Existing Third Party Agreements constitute all agreements that were entered into by Licensor or its Affiliates with Third Parties for the conduct of Clinical Trials for the Existing Product. Licensor has provided to Company an accurate, true and complete copy of each of the Existing Third Party Agreements, as amended to date and each of the Existing Third Party Agreements is in full force and effect. Licensor is not, and to Licensor’s Knowledge no other party to any Existing Third Party Agreement is, in breach or default in the performance of its obligations under any of the Existing Third Party Agreements. Licensor has not received any notice from any Third Party of any breach, default or non-compliance of Licensor under the terms of any of the Existing Third Party Agreements. There have been no amendments or other modification to any Existing Third Party Agreements, except as have been disclosed to Company in writing;
(s) all tangible information and data provided by or on behalf of Licensor to Company on or before the Effective Date in contemplation of this Agreement was and is true, accurate and complete in all material respects, and Licensor has not failed to disclose, or cause to be disclosed, any information or data that would cause the information and data that has been disclosed to be misleading in any material respect;
(t) Licensor (and its Affiliates) has not employed or otherwise used in any capacity, and will not employ or otherwise use in any capacity, the services of any Person debarred under any Law, including under Section 21 USC 335a or any foreign equivalent thereof, with respect to the Licensor Technology or Product;
(u) all Development related to Existing Product prior to the Effective Date has been conducted in accordance with all Laws; and
(v) Licensor has on hand as of the Effective Date the inventory of materials set forth in Exhibit A to the Asset Transfer Agreement (including in the quantities set forth therein). Such materials to be provided to Company pursuant to the Asset Transfer Agreement were (and at all times up until delivery of such materials hereunder shall remain) manufactured, packaged, labeled, tested, stored and handled in accordance with all Laws and specifications (including, to the extent applicable, release specifications as provided by Licensor to Company in writing prior to the Effective Date). Such materials are not adulterated or misbranded within the meaning of any Law. All such materials are free and clear of all encumbrances (including through lien, charge, security interest, mortgage, encumbrance or otherwise) and are suitable for use in Clinical Trials.
Appears in 2 contracts
Samples: License Agreement (Liquidia Corp), License Agreement (Liquidia Corp)
Additional Representations and Warranties of Licensor. Except as otherwise disclosed on Schedule 10.2, Licensor further represents and warrants to Coronado AbbVie, as of the Effective Date thatExecution Date, and covenants, as follows:
10.2.1 All Licensor Background Patents existing as of the Execution Date are listed on Schedule 10.2.1 (the “Existing Patents”). All Existing Patents are subsisting and, to Licensor’s Knowledge, are not invalid or unenforceable, in whole or in part.
10.2.2 There are no claims, judgments, or settlements that have been brought or obtained against Licensor or any of its Affiliates relating to the Existing Regulatory Documentation, the Existing Patents, or the Licensor Background Know-How. No claim or litigation has been brought or to Licensor’s Knowledge threatened in writing by any Person alleging, and Licensor has no Knowledge of any claim, whether or not asserted, that (a) No consent by the Existing Patents are invalid or unenforceable, or (b) the Existing Regulatory Documentation, the Existing Patents, or the Licensor Background Know-How, or the disclosing, copying, making, assigning, or licensing of the Existing Regulatory Documentation, the Existing Patents, or the Licensor Background Know-How, or the Development or Commercialization of the Licensed Antibodies or Licensed Products as contemplated herein, does or will violate, infringe, misappropriate or otherwise conflict or interfere with, any Third Party Patent or Governmental Body other intellectual property or proprietary right of any Person.
10.2.3 Licensor is required either (a) the sole and exclusive owner of the entire right, title and interest in or (b) the sole and exclusive licensee, with respect to the execution and delivery of this Agreement by Licensor or the consummation by Licensor Licensed Antibodies, of the transactions contemplated hereby;
Existing Patents listed on Schedule 10.2.1, in each case ((a) and (b)) The Licensor Technology is whollyfree of any encumbrance (other than Non-owned by LicensorMaterial Licenses), free and clear of all mortgages, pledges, charges, liens, equities, security interests, shop rightslien, or other encumbrances claim of ownership by any Third Party. Licensor is entitled to grant the licenses specified herein. The Patents listed on Schedule 10.2.1 constitute all of the Existing Patents. Licensor has the right to use, and to include within the Background Know-How all Information that was used for the Development of AL002 or similar agreements, or any other obligation;AL003 and is reasonably necessary for the continued Development and Commercialization thereof.
(c) 10.2.4 To Licensor’s knowledgeKnowledge, no claims have been asserted Licensor has the right to use all Information, and Patents necessary to conduct the Pre Exercise Development Activities, and the Development or threatened by any Person (i) challenging the validity, effective status, or ownership of Licensor Technology, and/or (ii) to the effect that the use, reproduction, modification, manufacturing, distribution, licensing, sublicensing, sale or any other exercise of rights in any of Licensor Technology infringes or will infringe on any intellectual property right of any Person; and no such claims have been asserted or are threatened;
(d) To Licensor’s knowledge, the Licensor Patents are subsisting and are not the subject of any litigation procedure, discovery process, interference, reissue, reexamination, opposition, appeal proceedings or any other legal dispute;
(e) Licensor and its Affiliates have taken all reasonable actions necessary or appropriate to preserve the confidentiality of all trade secrets, proprietary and other confidential information material to Licensor Technology;
(f) Neither Licensor nor any Affiliate thereof is aware of any Third Party activities which would constitute misappropriation or infringement of any Licensor Technology
(g) The Licensor Patents constitute all Patent Rights owned or Controlled by Licensor that pertain directly and particularly to the research, Development, manufacture, use and Commercialization of the Licensed Products; andAntibody or the Licensed Products as contemplated herein will not be subject to any other license or agreement to which Licensor or any of its Affiliates is a party other than the Existing License Agreements.
(h) 10.2.5 To Licensor’s knowledgeKnowledge none of Licensor, no Third Party its Affiliates or any counter party is in breach of any In-License Agreement. Licensor has filednot threatened to terminate, pursued nor alleged any material breach under, any such In-License Agreement. Licensor has not received any written notice from any counter party to any In-License Agreement threatening to terminate an In License Agreement or maintained or threatened in writing to file, pursue or maintain any claim, lawsuit, charge, complaint or other action alleging that Licensor is in material breach of an In-License Agreement. To Licensor’s Knowledge, the letter dated September 19, 2017, executed by Licensor and Adimab, LLC, and the letter dated October 1, 2017, executed by Licensor and Adimab, LLC and each In-License Agreement are in full force and effect and have not been superseded by any other agreements or arrangements. Licensor has exercised its option pursuant to Section 3.2 of the Adimab Agreement with respect to all Licensed Antibodies on Schedule 1.127 and Schedule 1.129 of this Agreement generated under the Adimab Agreement and has obtained (a) the corresponding licenses under Section 3.3 of the Adimab Agreement and (b) assignment of Patent applications [***] (the “Adimab Applications”). Other than the Adimab Applications, to Licensor’s knowledge there are no Patents generated under the Adimab Agreement or owned by Adimab that claim or cover the Licensed Antibodies. The Adimab Applications fall under the definition of Antibody Sequence Coverage and Licensed Program Antibody Patents (as each is defined in the Adimab Agreement). To Licensor’s Knowledge, the Licensed Antibodies are not covered by any Adimab Platform/Core Technology is invalid Improvement, Broad Target/Non-CDR Antibody Patent, Adimab Program Inventions, Adimab Platform/Background Patents, or unenforceableEpitope Patent, (as such terms are defined in the Adimab Agreement).
10.2.6 The Existing Patents are being diligently prosecuted in the respective patent offices in the Territory in accordance with Applicable Law. To Licensor’s Knowledge, the Existing Patents have been filed and maintained properly and correctly. All applicable fees have been paid on or before the due date for payment for each Existing Patent.
Appears in 2 contracts
Samples: Co Development and Option Agreement (Alector, Inc.), Co Development and Option Agreement (Alector, Inc.)
Additional Representations and Warranties of Licensor. Licensor represents and warrants to Coronado Merck, as of the Effective Execution Date that:
(a) No consent by any Third Party or Governmental Body is required with respect to the execution and delivery of this Agreement by Licensor or the consummation by Licensor of the transactions contemplated hereby;
(b) The Licensor Technology is wholly-owned by Licensor, free and clear of all mortgages, pledges, charges, liens, equities, security interests, shop rights, or other encumbrances or similar agreements, or any other obligation;
(c) To Licensor’s knowledge, no claims have been asserted or asserted, or, to Licensor’s Knowledge, threatened in writing by any Person against Licensor, (i) challenging the validity, effective statuseffectiveness, or ownership of Licensor Technology, and/or (ii) to the effect alleging that the use, reproduction, modification, manufacturing, distribution, licensing, sublicensing, sale or any other exercise of rights in any of Licensor Technology infringes or will infringe on any intellectual property right of any Person; and .
(b) to the Knowledge of Licensor, there is no such claims have been asserted unauthorized use, infringement or are threatenedmisappropriation of any of Licensor Technology by any employee or former employee of Licensor, or any other Third Party;
(dc) To Licensor’s knowledge, the Licensor Patents are subsisting and are not the subject of any litigation procedure, discovery process, interference, reissue, reexamination, opposition, appeal proceedings or any other legal disputedispute (other than ongoing patent prosecution), and no claims have been asserted, or, to Licensor’s Knowledge, threatened in writing by any Person against Licensor, alleging that any Licensor Patent is invalid or unenforceable;
(d) Licensor has not licensed to a Third Party the right to develop the Compound or Licensed Product;
(e) it has the full right to provide to Merck the Licensor and its Affiliates have taken all reasonable actions necessary or appropriate Material to preserve the confidentiality of all trade secrets, proprietary and other confidential information material be provided to Licensor TechnologyMerck pursuant to this Agreement;
(f) Neither Licensor nor any Affiliate thereof is aware of any not party to an agreement with a Third Party activities which would constitute misappropriation or infringement licenses rights to Licensor that are necessary for the Development, manufacture and Commercialization of any Licensor Technologya Licensed Product.
(g) The all employees of Licensor Patents constitute all Patent Rights owned or Controlled by Licensor that pertain directly and particularly who have performed any activities on its behalf in connection with research regarding the Compound have entered into Licensor’s standard invention assignment agreements assigning to Licensor, to the extent permitted by Law, the whole of their rights in any intellectual property made, discovered or developed by them in the course of their employment as a result of such research, Development, manufacture, use and Commercialization of the Licensed Products; and;
(h) To Licensor’s knowledgeLicensor has all right, no title and interest in and to the Licensor Technology, Licensor has not previously licensed, assigned, transferred, or otherwise conveyed any right, title or interest in and to the Licensor Technology to any Third Party in a manner that would conflict with the rights and licenses granted under this Agreement;
(i) as of the Execution Date, Licensor has filed, pursued or maintained or threatened in writing to file, pursue or maintain any claim, lawsuit, charge, complaint or other action alleging that any Licensor Technology is invalid or unenforceableno Knowledge of the unblinded results of the Phase II Pancreatic Cancer Trial.
Appears in 2 contracts
Samples: License and Co Development Agreement (Threshold Pharmaceuticals Inc), License and Co Development Agreement (Threshold Pharmaceuticals Inc)
Additional Representations and Warranties of Licensor. Licensor Each of Ligand, Neurogen and CyDex (jointly and severally) represents and warrants to Coronado as of the Effective Date Seelos that:
(a) No consent by Licensor has the right to grant the rights granted to Seelos under this Agreement, and no rights granted to Seelos under this Agreement are in violation of any agreement between Licensor or any of its Affiliates and any Third Party or Governmental Body is required with respect to the execution and delivery of this Agreement by Licensor or the consummation by Licensor of the transactions contemplated herebyParty;
(b) The Licensor Technology is wholly-owned by Licensor, free and clear of all mortgages, pledges, charges, liens, equities, security interests, shop rights, or other encumbrances or similar agreements, or any other obligation;
(c) To Licensor’s knowledge, no No claims have been asserted or threatened by any Person Person, and Licensor does not believe that there is a valid basis for, (i) challenging the validity, effective status, status or ownership of Licensor IP or Licensor Technology, and/or or (ii) to the effect that the use, development, reproduction, modification, manufacturing, distribution, commercialization, licensing, sublicensing, sale or any other exercise of rights in or under any of Licensor IP or Licensor Technology infringes on or misappropriates or will infringe on or misappropriate any intellectual property right of any Person; and no such claims have been asserted or are threatened;
(dc) To Licensor’s knowledge, the The Licensor Patents are subsisting and, to the knowledge of Licensor, valid and are not the subject of any litigation procedurelitigation, discovery process, interference, reissue, reexamination, revocation, opposition, appeal proceedings or any other legal disputeor administrative dispute or action;
(d) Licensor does not Control Patent Rights that Cover any Compound, Licensor Know-How or Licensed Products other than Licensor Patents;
(e) Licensor and its Affiliates have taken all reasonable actions necessary or appropriate to preserve the confidentiality of all trade secrets, proprietary and other confidential information material to Licensor Technology;
(f) Neither Licensor nor any Affiliate thereof is aware of any Third Party activities which would constitute misappropriation or infringement of any Licensor Technology
(g) The Licensor Patents constitute all Patent Rights owned or Controlled licensed-in by Licensor that pertain directly and particularly primarily to or are necessary for or are or were actually used for the use, research, Development, manufacture, use Commercialization and Commercialization other exercise of rights with respect to the Compounds or Licensed Products as currently envisioned by Licensor or as envisioned by express provisions of this Agreement;
(f) All Licensor Patents are listed on Schedule 2;
(g) None of CyDex, its Affiliates, or any of their employees, consultants, contractors or subcontractors (i) is debarred under Section 335a of the Licensed ProductsFood, Drug and Cosmetic Act or by the analogous applicable laws of any regulatory agency or body, (ii) has been charged with, or convicted of, any felony or misdemeanor within the ambit of 42 U.S.C. §§ 1320a-7(a), 1320a-7(b)(l)-(3), or pursuant to the analogous applicable laws of any regulatory agency or body, or is proposed for exclusion, or the subject of exclusion or debarment proceedings by a regulatory agency or body, (iii) is or has been excluded, suspended or debarred from participation, or otherwise ineligible to participate, in any United States or non-United States health care programs (or has been convicted of a criminal offense that falls within the scope of 42 U.S.C. §1320a-7, but not yet excluded, debarred, suspended, or otherwise declared ineligible) or (iv) is or has been excluded, suspended or debarred by a regulatory agency or body from participation, or is otherwise ineligible to participate, in any procurement or non-procurement programs;
(h) Through the Effective Date CyDex has filed and maintained and during the Term will (subject to Section 6.1(b) of the Supply Agreement) file and maintain with the appropriate regulatory agencies or bodies in all Major Markets all permits, licenses, regulatory filings (including the DMF), registration and approvals related to Captisol and the manufacture and sale thereof, necessary for CyDex to carry out its obligations and for Seelos to exercise its rights under this Agreement and the Supply Agreement;
(i) Ligand is acquiring the Article VI Convertible Notes, any Seelos equity securities underlying the Article VI Convertible Notes, any Seelos common stock upon conversion of such Seelos equity securities, any Seelos common stock issued to Ligand pursuant to Section 5.1 and any Seelos common stock issued to Ligand pursuant to Section 5.2 (collectively, the “Securities”) for its own account for the purpose of investment and not with a view to distribution. Ligand does not have any contract, agreement or arrangement with any person to sell, transfer or grant participations, to such person or to any third person with respect to the Securities. Notwithstanding this subsection (i), Ligand can intend to transfer and can in fact transfer the Securities to any accredited investor who is an Affiliate of Ligand and who gives Seelos representations, warranties, acknowledgements and agreements similar to those which Ligand is giving in subsections (i)-(m) of this Section 9.2 and in Section 9.3;
(j) At no time was Ligand or any of its officers, employees or agents presented with or solicited by, directly or indirectly, any form of general solicitation or any general advertising as to the Securities, including, but not limited to, any advertisement, article, notice or other communication published in any newspaper, magazine, or similar media or broadcast over television or radio or presented at any seminar or meeting whose attendees have been invited by any general solicitation or general advertising;
(k) Ligand is able, without impairing Ligand’s financial condition, to hold the Securities for an indefinite period of time and suffer a complete loss of the investment;
(l) Ligand, by reason of Ligand’s business or financial experience or the business or financial experience of Ligand’s professional advisors who are unaffiliated with and who are not compensated by Seelos, directly or indirectly, has the capacity to protect Ligand’s interests in connection with the investment in the Securities, including without limitation to evaluate the merits and risks of an investment in the Securities and to make an informed investment decision with respect thereto. Ligand is able to bear the economic risk of this investment for an indefinite period of time; and
(hm) To Licensor’s knowledge, no Third Party has filed, pursued or maintained or threatened in writing Ligand is an “accredited investor” as defined by the rules and regulations of the Securities and Exchange Commission pursuant to file, pursue or maintain any claim, lawsuit, charge, complaint or other action alleging that any Licensor Technology is invalid or unenforceablethe Securities Act.
Appears in 2 contracts
Samples: License Agreement (Apricus Biosciences, Inc.), License Agreement (Apricus Biosciences, Inc.)
Additional Representations and Warranties of Licensor. Licensor represents and warrants to Coronado Company that, as of the Effective Date thatDate:
(ai) No consent by any Third Party or Governmental Body is required with respect no claims have been asserted, or, to the execution and delivery of this Agreement by Licensor or the consummation by Licensor of the transactions contemplated hereby;
(b) The Licensor Technology is wholly-owned by Licensor, free and clear of all mortgages, pledges, charges, liens, equities, security interests, shop rights, or other encumbrances or similar agreements, or any other obligation;
(c) To Licensor’s knowledge, no claims have been asserted or threatened by any Person Person, nor, to Licensor’s knowledge, are there any valid grounds for any claim of any such kind (ia) challenging the validity, effective statuseffectiveness, or ownership of Licensor TechnologyLicensed Technology (with the caveat that Company is aware of certain presentations (“Inventor Presentations”) given by the inventors of the Edinburgh Licensed Patents as shown in Schedule 8.2), and/or (iib) to the effect that the use, reproduction, modification, manufacturing, distribution, licensing, sublicensing, sale or any other exercise of rights in any of Licensor Licensed Technology infringes or will infringe on any intellectual property right of any Person; and no such claims have been asserted or are threatened;
(dii) To to the knowledge of Licensor’s knowledge, there is no unauthorized use, infringement or misappropriation of any of Licensed Technology by any employee or former employee of Licensor, or any other Third Party;
(iii) the Licensor Licensed Patents are subsisting and are not the subject of any litigation procedure, discovery process, interference, reissue, reexamination, opposition, appeal proceedings or any other legal dispute;
(eiv) Licensor and its Affiliates have taken all reasonable actions necessary or appropriate to preserve the confidentiality of all trade secrets, proprietary and other confidential information material to Licensor Technology;
(f) Neither Licensor nor any Affiliate thereof is aware of any Third Party activities which would constitute misappropriation or infringement of any Licensor Technology
(g) The Licensor Licensed Patents constitute all Patent Rights owned or Patents Controlled by Licensor as of the Effective Date that pertain are directly and particularly to related to, or are necessary or useful for, the research, Development, manufacture, use and or Commercialization of Licensed Product;
(v) the Licensed ProductsKnow-How (a) constitutes all Know-How Controlled by Licensor as of the Effective Date that is reasonably necessary for the research, Development, manufacture, use or Commercialization of Licensed Product and (b) constitutes all Know-How that is, to Licensor’s knowledge, reasonably necessary for the research, Development, manufacture, use or Commercialization of Licensed Product;
(vi) it has the full right to license and provide the Licensed Materials to Company;
(vii) all Representatives of Licensor who have performed any activities on its behalf in connection with research regarding Licensed Product have assigned to Licensor in all material respects their rights in any intellectual property made, discovered or developed by them as a result of such research, and no Third Party has any rights to any such intellectual property;
(viii) Licensor has the right, power and authority to grant to Company the rights granted to Company hereunder, including, but not limited to, with respect to the Existing Third-Party Agreements. In particular, the grant of such sublicense requires no consent, waiver or other action by any party to the Existing Third-Party Agreements and the rights and obligations of Company set forth in this Agreement do not contravene nor are they inconsistent with or in conflict with the terms of any Existing Third-Party Agreement;
(ix) The Existing Third-Party Agreements constitute all agreements with Third Parties pursuant to which Licensor has in-licensed, or otherwise obtained rights, with respect to Licensed Product. Licensor has provided to Company an accurate, true and complete copy of each of the Existing Third Party Agreements, as amended to-date and each of the Existing Third Party Agreements is in full force and effect and Licensor is not in breach or default in the performance of its obligations under any of the Existing Third Party Agreements. Licensor has not received any notice from any Third Party of any breach, default or non-compliance of Licensor under the terms of any of the Existing Third-Party Agreements. There have been no amendments or other modification to any Existing Third-Party Agreements, except as have been disclosed to Company in writing;
(x) Licensor has not received any communication from Edinburgh regarding any failure to achieve the Performance Criteria (as defined in the Edinburgh Agreement);
(xi) all tangible information and data provided by or on behalf of Licensor to Company on or before the Effective Date in contemplation of this Agreement was and is true, accurate and complete in all material respects, and Licensor has not failed to disclose, or cause to be disclosed, any information or data that would cause the information and data that has been disclosed to be misleading in any material respect;
(xii) Licensor (and its Affiliates) has not employed or otherwise used in any capacity the services of any Person debarred under United States law, including under 21 USC §335a or any foreign equivalent thereof, with respect to Licensed Product; and
(hxiii) To Licensor’s knowledge, no Third Party all research and development (including non-clinical studies and Clinical Trials) related to Licensed Product prior to the Effective Date has filed, pursued or maintained or threatened been conducted in writing to file, pursue or maintain any claim, lawsuit, charge, complaint or other action alleging that any Licensor Technology is invalid or unenforceableaccordance with all Laws.
Appears in 1 contract
Additional Representations and Warranties of Licensor. Licensor represents and warrants to Coronado Company that, as of the Effective Date thatDate:
(ai) No consent by any Third Party or Governmental Body is required with respect no claims have been asserted, or, to the execution and delivery of this Agreement by Licensor or the consummation by Licensor of the transactions contemplated hereby;
(b) The Licensor Technology is wholly-owned by Licensor, free and clear of all mortgages, pledges, charges, liens, equities, security interests, shop rights, or other encumbrances or similar agreements, or any other obligation;
(c) To Licensor’s knowledge, no claims have been asserted or threatened by any Person Person, nor, to Licensor’s knowledge, are there any valid grounds for any claim of any such kind (ia) challenging the validity, effective statuseffectiveness, or ownership of Licensor Licensed Technology, and/or (iib) to the effect that the use, reproduction, modification, manufacturing, distribution, licensing, sublicensing, sale or any other exercise of rights in any of Licensor Licensed Technology infringes or will infringe on any intellectual property right of any Person; and no such claims have been asserted or are threatened;
(dii) To to the knowledge of Licensor’s knowledge, there is no unauthorized use, infringement or misappropriation of any of Licensed Technology by any employee or former employee of Licensor, or any other Third Party;
(iii) the Licensor Licensed Patents are subsisting and are not the subject of any litigation procedure, discovery process, interference, reissue, reexamination, opposition, appeal proceedings or any other legal dispute;
(eiv) Licensor and its Affiliates have taken all reasonable actions necessary or appropriate to preserve the confidentiality of all trade secrets, proprietary and other confidential information material to Licensor Technology;
(f) Neither Licensor nor any Affiliate thereof is aware of any Third Party activities which would constitute misappropriation or infringement of any Licensor Technology
(g) The Licensor Licensed Patents constitute all Patent Rights owned or Patents Controlled by Licensor as of the Effective Date that pertain are directly and particularly to related to, or are necessary or useful for, the research, Development, manufacture, use and or Commercialization of Licensed Product;
(v) the Licensed ProductsKnow-How (a) constitutes all Know-How Controlled by Licensor as of the Effective Date that is reasonably necessary for the research, Development, manufacture, use or Commercialization of Licensed Product and (b) constitutes all Know-How that is, to Licensor’s knowledge, reasonably necessary for the research, Development, manufacture, use or Commercialization of Licensed Product;
(vi) it has the full right to provide the Licensed Materials to Company;
(vii) all Representatives of Licensor who have performed any activities on its behalf in connection with research regarding Licensed Product have assigned to Licensor in all material respects their rights in any intellectual property made, discovered or developed by them as a result of such research, and no Third Party has any rights to any such intellectual property;
(viii) Licensor has the right, power and authority to grant to Company the rights granted to Company hereunder, including, but not limited to, with respect to the Existing Third-Party Agreements. In particular, the grant of such sublicense requires no consent, waiver or other action by any party to the Existing Third-Party Agreements and the rights and obligations of Company set forth in this Agreement do not contravene nor are they inconsistent with or in conflict with the terms of any Existing Third-Party Agreement;
(ix) The Existing Third-Party Agreements constitute all agreements with Third Parties pursuant to which Licensor has in-licensed, or otherwise obtained rights, with respect to Licensed Product. Licensor has provided to Company an accurate, true and complete copy of each of the Existing Third Party Agreements, as amended to-date and each of the Existing Third Party Agreements is in full force and effect and Licensor is not in breach or default in the performance of its obligations under any of the Existing Third Party Agreements. Licensor has not received any notice from any Third Party of any breach, default or non-compliance of Licensor under the terms of any of the Existing Third-Party Agreements. There have been no amendments or other modification to any Existing Third-Party Agreements, except as have been disclosed to Company in writing;
(x) Licensor has not received any communication from University regarding any failure to achieve any milestone set forth on Appendix B of the UNC Agreement, including any failure to achieve any milestone within the time period set forth therein;
(xi) all tangible information and data provided by or on behalf of Licensor to Company on or before the Effective Date in contemplation of this Agreement was and is true, accurate and complete in all material respects, and Licensor has not failed to disclose, or cause to be disclosed, any information or data that would cause the information and data that has been disclosed to be misleading in any material respect;
(xii) Licensor (and its Affiliates) has not employed or otherwise used in any capacity the services of any Person debarred under United States law, including under 21 USC §335a or any foreign equivalent thereof, with respect to Licensed Product;
(xiii) all research and development (including non-clinical studies and Clinical Trials) related to Licensed Product prior to the Effective Date has been conducted in accordance with all Laws; and
(hxiv) To Licensor’s knowledgethe cGMP Inventory to be provided to Company in connection herewith was (and at all times up until delivery of such materials hereunder shall remain) stored and handled in accordance with cGMP and all Laws and specifications (including, no Third Party has filedto the extent applicable, pursued or maintained or threatened release specifications as provided by Licensor to Company in writing prior to filethe Effective Date) during the period in which such cGMP Inventory was in the possession or control of Licensor. Such cGMP Inventory is not adulterated or misbranded within the meaning of any Law and is not articles that could not, pursue or maintain any claimunder the provisions of Law, lawsuitbe introduced into interstate commerce. All such cGMP Inventory is free and clear of all encumbrances (including through lien, charge, complaint security interest, mortgage, encumbrance or other action alleging that any Licensor Technology is invalid or unenforceableotherwise).
Appears in 1 contract
Additional Representations and Warranties of Licensor. Licensor further represents and warrants to Coronado Licensee, as of the Effective Date thatas follows:
(a) No consent 11.2.1. Licensor or one of its Affiliates Controls the Licensed Patents listed in Schedule 1.69 and the Licensed Know-How described in Schedule 1.68. Other than Patents or Information in-licensed under the In-licensing Agreements, there exists no Patent or Information that is owned or in-licensed by Licensor or any of its Affiliates that is necessary or reasonably useful for the Development, Manufacture or Commercialization of the Licensed Compound or Licensed Product in the Field in the Territory that is not Controlled by Licensor or such Affiliate;
11.2.2. Schedule 1.69 sets forth a complete and accurate list of all Licensed Patents in the Territory;
11.2.3. Licensor has the right to grant to Licensee the licenses under the Licensed Technology in Section 7.1 and has not granted to any Third Party any license or Governmental Body is required other right with respect to Licensed Compounds, Licensed Products or Licensed Technology that conflicts with the execution and delivery of this Agreement by Licensor or the consummation by Licensor of the transactions contemplated herebylicenses granted to Licensee hereunder;
(b) The Licensor Technology is wholly-owned by Licensor, free and clear of all mortgages, pledges, charges, liens, equities, security interests, shop rights, or other encumbrances or similar agreements, or any other obligation;
(c) To Licensor’s knowledge, no claims have been asserted or threatened by any Person (i) challenging the validity, effective status, or ownership of Licensor Technology, and/or (ii) to the effect that the use, reproduction, modification, manufacturing, distribution, licensing, sublicensing, sale or any other exercise of rights in any of Licensor Technology infringes or will infringe on any intellectual property right of any Person; and no such claims have been asserted or are threatened;
(d) To 00.0.0. xx Licensor’s knowledge, the Licensor Development of the Licensed Products in the Territory prior to the Effective Date did not infringe any valid claims of Patents are subsisting and are not the subject of any litigation procedure, discovery process, interference, reissue, reexamination, opposition, appeal proceedings owned or any other legal dispute;
(e) Licensor and its Affiliates have taken all reasonable actions necessary or appropriate to preserve the confidentiality of all trade secrets, proprietary and other confidential information material to Licensor Technology;
(f) Neither Licensor nor any Affiliate thereof is aware of possessed by any Third Party activities which would constitute misappropriation and did not breach any obligation of confidentiality or infringement of any Licensor Technology
(g) The Licensor Patents constitute all Patent Rights owned or Controlled non-use owed by Licensor that pertain directly and particularly or its Affiliates to the research, Development, manufacture, use and Commercialization of a Third Party with respect to Information related to the Licensed Products; and;
(h) To 00.0.0. xx Licensor’s knowledge, Licensor has provided to Licensee all material pre-clinical data and clinical data relating to Licensed Products that has been requested by Licensee; and
11.2.6. Licensor has received no written notice that a claim or action has been brought against Licensor, and Licensor has not received any written claim or demand as of the Effective Date alleging (a) that the Licensed Patents are invalid or unenforceable or (b) that the use of the Licensed Patents by Licensor in the Territory infringes or misappropriates the intellectual property rights of any Third Party Party. Licensor has filedreceived no written notice that an interference, pursued or maintained or threatened in writing to fileopposition, pursue or maintain any claim, lawsuit, charge, complaint cancellation or other action alleging that any Licensor Technology is invalid or unenforceableprotest proceeding has been filed against a Licensed Patent owned by Licensor.
Appears in 1 contract
Additional Representations and Warranties of Licensor. Licensor represents and warrants to Coronado OnCore that, as of the Effective Execution Date thatand as of the Closing Date:
(a) No 10.2.1 no consent by any Third Party or Governmental Body governmental authority is required with respect to the execution and delivery of this Agreement by Licensor or the consummation by Licensor of the transactions contemplated hereby;
(b) The Licensor Technology is wholly-owned by Licensor, free and clear of all mortgages, pledges, charges, liens, equities, security interests, shop rights, or other encumbrances or similar agreements, or any other obligation;
(c) To Licensor’s knowledge10.2.2 except for the claims detailed on Schedule 10.2.2, no claims have been asserted or asserted, or, to Licensor’s Knowledge, threatened by any Person Person, (ia) challenging the validity, effective statuseffectiveness, or ownership of Licensor Technology, and/or (iib) to the effect that the use, reproduction, modification, manufacturing, distribution, licensing, sublicensing, sale or any other exercise of rights in any of Licensor Technology infringes or will shall infringe on any intellectual property Intellectual Property right of any Person; and no such claims have been asserted or are threatened;
(d) To 10.2.3 to the Knowledge of Licensor’s knowledge, there is no unauthorized use, infringement or misappropriation of any of Licensor Technology by any employee or former employee of Licensor, or any other Third Party;
10.2.4 to the Knowledge of Licensor, the Licensor Patents are subsisting and are not the subject of any litigation procedure, discovery process, interference, reissue, reexamination, opposition, appeal proceedings or any other legal dispute;
(e) Licensor and its Affiliates have taken all reasonable actions necessary or appropriate to preserve 10.2.5 except as disclosed in Schedule 10.2.5, the confidentiality of all trade secrets, proprietary and other confidential information material to Licensor Technology;
(f) Neither Licensor nor any Affiliate thereof is aware of any Third Party activities which would constitute misappropriation or infringement of any Licensor Technology
(g) The Licensor Patents listed on Schedule 1.44 constitute all Patent Rights owned or Controlled controlled by Licensor as of the Execution Date that pertain are directly and particularly to related to, or are necessary or useful for, the research, Development, manufacture, use and or Commercialization of Licensed Compounds and Licensed Products in the Field;
10.2.6 the Licensor Patents are not now and have not at any time in the past been pledged, hypothecated or in any way used to secure a loan or debt of any kind whatsoever;
10.2.7 the Licensor Know-How constitutes all Know-How owned or controlled by Licensor as of the Execution Date that is directly related to, or are necessary or useful for, the research, Development, manufacture, use or Commercialization of Licensed Products; andCompounds and Licensed Products in the Field;
(h) To 10.2.8 Licensor has not developed, subcontracted or licensed to a Third Party the right to develop or commercialize a Competing Product;
10.2.9 to the Knowledge of Licensor’s knowledge, no Third Party has filed, pursued or maintained or threatened in writing to file, pursue or maintain any claim, lawsuit, charge, complaint or other action alleging that any Licensor Technology Patent is invalid or unenforceable;
10.2.10 to Licensor’s Knowledge, without having made any inquiry with respect to the subject matter of this representation, OnCore’s and its Affiliates’ and Sublicensees’ practice and use of the inventions claimed in the Licensor Patents as permitted herein will not infringe any intellectual property rights of any Third Party to Develop and Commercialize Licensed Compound and Licensed Product in the Field. In addition, and without limiting the foregoing, Licensor represents and warrants to OnCore that, to Licensor’s Knowledge as of the Execution Date and as of the Closing Date, (a) OnCore’s and its Affiliates’ and Sublicensees’ practice and use of the inventions claimed in the Licensor Patents as permitted herein will not infringe any intellectual property rights of any Third Party specifically directed to unconjugated CYT003 and Qb VLPs encapsulating [***], and (b) the practice of the [***] described and enabled in [***] for the [***] and [***] will not infringe any intellectual property rights of any Third Party.
10.2.11 all issuance, renewal, maintenance and other material payments that are or have become finally due with respect to the Licensor Technology have been timely paid by or on behalf of Licensor;
10.2.12 all Licensor Patents have been properly filed, prosecuted and maintained;
10.2.13 it has the full right to provide the Licensor Materials to OnCore and to transfer to OnCore all right, title and interest in and to the Licensor Material to be provided to OnCore pursuant to this Agreement;
10.2.14 all Representatives of Licensor who have performed any activities on its behalf in connection with research regarding Licensed Compound or Licensed Product have assigned to Licensor the whole of their rights in any Intellectual Property made, discovered or developed by them as a result of such research, and no Third Party has any rights to any such Intellectual Property;
10.2.15 Licensor has all right, title and interest in and to the Licensor Technology and Licensor Technology is free and clear of any liens, charges, encumbrances or rights of others to possession or use that would preclude OnCore’s use of the Licensed Technology pursuant to the licenses granted in this Agreement;
10.2.16 Except as set forth in the Existing Licenses, Licensor has not previously licensed, assigned, transferred, or otherwise conveyed any right, title or interest in and to the Licensor Technology to any Third Party, including any rights with respect to Licensed Compound or Licensed Product, that would preclude OnCore’s use of the Licensed Technology pursuant to the licenses granted in this Agreement;
10.2.17 Except as disclosed in Schedule 10.2.5, the Licensor Copyrights, Licensor Patents and Licensor Know-How constitutes all of the Intellectual Property Controlled by Licensor, which, to the Knowledge of Licensor as of the Effective Date, could reasonably be expected to be necessary or useful in the research, Development, manufacture, import, export, use or Commercialization of Licensed Compound or Licensed Product;
10.2.18 all tangible information and data provided by or on behalf of Licensor to OnCore on or before the Closing Date in contemplation of this Agreement was and is true, accurate in all material respects, and Licensor has not failed to disclose, or cause to be disclosed, any information or data that would cause the information and data that has been disclosed to be misleading in any material respect;
10.2.19 Licensor (and its Affiliates) has not employed or otherwise used in any capacity, and shall not employ or otherwise use in any capacity, the services of any Person debarred under United States law, including under Section 21 USC 335a or any foreign equivalent thereof, with respect to a Licensed Compound or Licensed Product;
10.2.20 all research and development related to Licensed Compounds and Licensed Products prior to the Effective Date has been conducted in all material respects in accordance with all applicable Laws; and
10.2.21 the materials to be provided to OnCore hereunder were (and at all times up until delivery of such materials hereunder shall remain) manufactured, packaged, labeled, tested, stored and handled in accordance with all Laws and specifications (including, to the extent applicable, release specifications as provided by Licensor to OnCore in writing prior to the Effective Date);
10.2.22 there are no (a) Claims relating to the Licensor Technology, the Licensed Compound or the Licensed Products pending or, to the Knowledge of Licensor, threatened against Licensor or any of its Affiliates; and (b) there are no Claims pending or, to the Knowledge of Licensor, threatened, that question the legality or propriety of the transactions contemplated by this Agreement or the consummation of the transactions contemplated herein or therein or which would reasonably be expected to prevent, hinder or delay the consummation of any of the transactions contemplated by this Agreement.
Appears in 1 contract
Additional Representations and Warranties of Licensor. Licensor further represents and warrants to Coronado Licensee, as of the Effective Date thatas follows:
(a) No consent 11.2.1. Licensor or one of its Affiliates Controls the Licensed Patents listed in Schedule 1.69 and the Licensed Know-How described in Schedule 1.68. Other than Patents or Information in-licensed under the In-licensing Agreements, there exists no Patent or Information that is owned or in-licensed by Licensor or any of its Affiliates that is necessary or reasonably useful for the Development, Manufacture or Commercialization of the Licensed Compound or Licensed Product in the Field in the Territory that is not Controlled by Licensor or such Affiliate;
11.2.2. Schedule 1.69 sets forth a complete and accurate list of all Licensed Patents in the Territory;
11.2.3. Licensor has the right to grant to Licensee the licenses under the Licensed Technology in Section 7.1 and has not granted to any Third Party any license or Governmental Body is required other right with respect to Licensed Compounds, Licensed Products or Licensed Technology that conflicts with the execution and delivery of this Agreement by Licensor or the consummation by Licensor of the transactions contemplated herebylicenses granted to Licensee hereunder;
(b) The Licensor Technology is wholly-owned by Licensor, free and clear of all mortgages, pledges, charges, liens, equities, security interests, shop rights, or other encumbrances or similar agreements, or any other obligation;
(c) To Licensor’s knowledge, no claims have been asserted or threatened by any Person (i) challenging the validity, effective status, or ownership of Licensor Technology, and/or (ii) 11.2.4. to the effect that the use, reproduction, modification, manufacturing, distribution, licensing, sublicensing, sale or any other exercise of rights in any of Licensor Technology infringes or will infringe on any intellectual property right of any Person; and no such claims have been asserted or are threatened;
(d) To Licensor’s knowledge, the Licensor Development of the Licensed Products in the Territory prior to the Effective Date did not infringe any valid claims of Patents are subsisting and are not the subject of any litigation procedure, discovery process, interference, reissue, reexamination, opposition, appeal proceedings owned or any other legal dispute;
(e) Licensor and its Affiliates have taken all reasonable actions necessary or appropriate to preserve the confidentiality of all trade secrets, proprietary and other confidential information material to Licensor Technology;
(f) Neither Licensor nor any Affiliate thereof is aware of possessed by any Third Party activities which would constitute misappropriation and did not breach any obligation of confidentiality or infringement of any Licensor Technology
(g) The Licensor Patents constitute all Patent Rights owned or Controlled non-use owed by Licensor that pertain directly and particularly or its Affiliates to the research, Development, manufacture, use and Commercialization of a Third Party with respect to Information related to the Licensed Products; and;
(h) To 11.2.5. to Licensor’s knowledge, Licensor has provided to Licensee all material pre-clinical data and clinical data relating to Licensed Products that has been requested by Licensee; and
11.2.6. Licensor has received no written notice that a claim or action has been brought against Licensor, and Licensor has not received any written claim or demand as of the Effective Date alleging (a) that the Licensed Patents are invalid or unenforceable or (b) that the use of the Licensed Patents by Licensor in the Territory infringes or misappropriates the intellectual property rights of any Third Party Party. Licensor has filedreceived no written notice that an interference, pursued or maintained or threatened in writing to fileopposition, pursue or maintain any claim, lawsuit, charge, complaint cancellation or other action alleging that any Licensor Technology is invalid or unenforceableprotest proceeding has been filed against a Licensed Patent owned by Licensor.
Appears in 1 contract
Additional Representations and Warranties of Licensor. Licensor represents and warrants to Coronado Merck, as of the Effective Execution Date that:
(a) No consent by any Third Party or Governmental Body is required with respect to the execution and delivery of this Agreement by Licensor or the consummation by Licensor of the transactions contemplated hereby;
(b) The Licensor Technology is wholly-owned by Licensor, free and clear of all mortgages, pledges, charges, liens, equities, security interests, shop rights, or other encumbrances or similar agreements, or any other obligation;
(c) To Licensor’s knowledge, no claims have been asserted or asserted, or, to Licensor’s Knowledge, threatened in writing by any Person against Licensor, (i) challenging the validity, effective statuseffectiveness, or ownership of Licensor Technology, and/or (ii) to the effect alleging that the use, reproduction, modification, manufacturing, distribution, licensing, sublicensing, sale or any other exercise of rights in any of Licensor Technology infringes or will infringe on any intellectual property right of any Person; and .
(b) to the Knowledge of Licensor, there is no such claims have been asserted unauthorized use, infringement or are threatenedmisappropriation of any of Licensor Technology by any employee or former employee of Licensor, or any other Third Party;
(dc) To Licensor’s knowledge, the Licensor Patents are subsisting and are not the subject of any litigation procedure, discovery process, interference, reissue, reexamination, opposition, appeal proceedings or any other legal disputedispute (other than ongoing patent prosecution), and no claims have been asserted, or, to Licensor’s Knowledge, threatened in writing by any Person against Licensor, alleging that any Licensor Patent is invalid or unenforceable;
(d) Licensor has not licensed to a Third Party the right to develop the Compound or Licensed Product;
(e) it has the full right to provide to Merck the Licensor and its Affiliates have taken all reasonable actions necessary or appropriate Material to preserve the confidentiality of all trade secrets, proprietary and other confidential information material be provided to Licensor TechnologyMerck pursuant to this Agreement;
(f) Neither Licensor nor any Affiliate thereof is aware of any not party to an agreement with a Third Party activities which would constitute misappropriation or infringement licenses rights to Licensor that are necessary for the Development, manufacture and Commercialization of any Licensor Technologya Licensed Product. 50
(g) The all employees of Licensor Patents constitute all Patent Rights owned or Controlled by Licensor that pertain directly and particularly who have performed any activities on its behalf in connection with research regarding the Compound have entered into Licensor’s standard invention assignment agreements assigning to Licensor, to the extent permitted by Law, the whole of their rights in any intellectual property made, discovered or developed by them in the course of their employment as a result of such research, Development, manufacture, use and Commercialization of the Licensed Products; and;
(h) To Licensor’s knowledgeLicensor has all right, no title and interest in and to the Licensor Technology, Licensor has not previously licensed, assigned, transferred, or otherwise conveyed any right, title or interest in and to the Licensor Technology to any Third Party in a manner that would conflict with the rights and licenses granted under this Agreement;
(i) as of the Execution Date, Licensor has filed, pursued or maintained or threatened in writing to file, pursue or maintain any claim, lawsuit, charge, complaint or other action alleging that any Licensor Technology is invalid or unenforceableno Knowledge of the unblinded results of the Phase II Pancreatic Cancer Trial.
Appears in 1 contract
Samples: License and Co Development Agreement
Additional Representations and Warranties of Licensor. Licensor represents and warrants to Coronado as of the Effective Date Licensee that:
(a) No consent As of the Effective Date, to the knowledge of Licensor, (i) there is no Third Party infringing, misappropriating or violating of any of the Licensor Intellectual Property; and (ii) the Licensor Intellectual Property is valid and enforceable where filed; (iii) the Licensor Patent Rights where filed are not subject to any pending or threatened re-examination, re-issue, opposition, interference, challenge, litigation proceeding or other claim, (iv) Licensor has timely filed and prosecuted the patents and patent applications with respect to the Licensor Intellectual Property in the Territory and (v) the use of the Licensor Intellectual Property as authorized by this Agreement will not infringe, misappropriate or violate the Intellectual Property rights of any Third Party.
(b) Licensor has not committed any act, or omitted to commit any act, that may cause the Licensor Patent Rights where filed to expire prematurely or be declared invalid or unenforceable, or that would otherwise prohibit Licensor from enforcing the Licensor Patent Rights where filed against any Third Party.
(c) As of the Effective Date in the Territory, (i) Licensor has the right to use and disclose and to enable Licensee to use and disclose (in each case under appropriate conditions of confidentiality) the Licensor Intellectual Property; and (ii) the Licensor Intellectual Property is not subject to any encumbrance, lien, license or claim of ownership by any Third Party or Governmental Body is required that would conflict with respect to the execution and delivery terms of this Agreement by Licensor or the consummation by Licensor of the transactions contemplated hereby;
(b) The Licensor Technology is wholly-owned by Licensor, free and clear of all mortgages, pledges, charges, liens, equities, security interests, shop rights, or other encumbrances or similar agreements, or any other obligation;
(c) To Licensor’s knowledge, no claims have been asserted or threatened by any Person (i) challenging the validity, effective status, or ownership of Licensor Technology, and/or (ii) to the effect that the use, reproduction, modification, manufacturing, distribution, licensing, sublicensing, sale or any other exercise of rights in any of Licensor Technology infringes or will infringe on any intellectual property right of any Person; and no such claims have been asserted or are threatened;
(d) To Licensor’s knowledge, the Licensor Patents are subsisting and are not the subject of any litigation procedure, discovery process, interference, reissue, reexamination, opposition, appeal proceedings or any other legal dispute;
(e) Licensor and its Affiliates have taken all reasonable actions necessary or appropriate to preserve the confidentiality of all trade secrets, proprietary and other confidential information material to Licensor Technology;
(f) Neither Licensor nor any Affiliate thereof is aware of any Third Party activities which would constitute misappropriation or infringement of any Licensor Technology
(g) The Licensor Patents constitute all Patent Rights owned or Controlled by Licensor that pertain directly and particularly to the research, Development, manufacture, use and Commercialization of the Licensed Products; and
(h) To Licensor’s knowledge, no Third Party has filed, pursued or maintained or threatened in writing to file, pursue or maintain any claim, lawsuit, charge, complaint or other action alleging that any Licensor Technology is invalid or unenforceableAgreement.
Appears in 1 contract
Samples: License Agreement (Athenex, Inc.)
Additional Representations and Warranties of Licensor. Licensor represents and warrants to Coronado Checkmate that, as of the Effective Date thatDate:
(a) No 8.2.1 no consent by any Third Party or Governmental Body governmental authority is required with respect to the execution and delivery of this Agreement by Licensor or the consummation by Licensor of the transactions contemplated hereby;
(b) The 8.2.2 to Licensor’s actual knowledge, without having conducted any further inquiry or investigation, there are no limits or conditions in Licensor’s agreements for the Licensed Product or Licensor Technology is wholly-owned by Licensor, free with any Third Party which may have a material adverse effect on Checkmate’s use of Licensor Technology pursuant to the licenses granted in this Agreement or on Checkmate’s diligent and clear complete fulfillment of all mortgages, pledges, charges, liens, equities, security interests, shop rights, or other encumbrances or similar agreements, or any other obligation;its obligations under this Agreement:
(c) To Licensor’s knowledge, 8.2.3 no claims have been asserted or asserted, or, to Licensor’s Knowledge, threatened by any Person Person, (ia) challenging the validity, effective statuseffectiveness, or ownership of Licensor Technology, and/or (iib) to the effect that the use, reproduction, modification, manufacturing, distribution, licensing, sublicensing, sale or any other exercise of rights in any of Licensor Technology infringes or will shall infringe on any intellectual property Intellectual Property right of any Person; and no such claims have been asserted or are threatened;
(d) To 8.2.4 to the Knowledge of Licensor’s knowledge, the Licensor Patents are subsisting and are not the subject of any litigation procedure, discovery process, interference, reissue, reexamination, opposition, appeal proceedings or any other legal dispute;
(e) Licensor and its Affiliates have taken all reasonable actions necessary or appropriate to preserve the confidentiality of all trade secrets, proprietary and other confidential information material to Licensor Technology;
(f) Neither Licensor nor any Affiliate thereof is aware of any Third Party activities which would constitute misappropriation or infringement of any Licensor Technology
(g) The Licensor Patents constitute all Patent Rights owned or Controlled by Licensor that pertain directly and particularly 8.2.5 to the research, Development, manufacture, use and Commercialization Knowledge of the Licensed Products; and
(h) To Licensor’s knowledge, no Third Party has filed, pursued or maintained or threatened in writing to file, pursue or maintain any claim, lawsuit, charge, complaint or other action alleging that any Licensor Technology Patent is invalid or unenforceable;
8.2.6 all issuance, renewal, maintenance and other material payments that are or have become finally due with respect to the Licensor Technology have been timely paid by or on behalf of Licensor;
8.2.7 all Licensor Patents have been properly filed, prosecuted and maintained;
8.2.8 it has the fell right to provide the Licensor Materials to Checkmate and to transfer to Checkmate all right, title and interest in and to the Licensor Material to be provided to Checkmate pursuant to this Agreement;
8.2.9 To the Know ledge of Licensor, each of the patents and patent applications included among the Licensor Patents that is owned (in w hole nr in part) by the Licensor properly identifies each and every inventor of the inventions claimed therein and does not identify any person as an inventor who is not correctly identified as an inventor, as determined in accordance with applicable Laws. Each inventor named on the patents and patent applications included among the Licensor Patents that are owned (in whole’ or in part) by the Licensor has executed an assignment of his or her entire right, title, and interest in and to such patent or patent application, and in and to each and ever) invention described, embodied, or claimed therein, to the Licensor. To the Knowledge of Licensor, no such inventor has any contractual or other obligation that would preclude or otherwise interfere with any such assignment or otherwise conflict with the obligations of such inventor to the Licensor under such agreement with the Licensor.
8.2.10 subject to the terms of the Existing Licenses, Licensor has all right, title and interest in and to the Licensor Technology and Licensor Technology is free and clear of any liens, charges, security interests, mortgage, encumbrances or rights of others to possession or use that would preclude Checkmate’s use of the Licensor Technology pursuant to the licenses granted in this Agreement or which would impede of preclude the diligent and complete fulfillment of its obligations under this Agreement:
8.2.11 except as set forth in the Existing Licenses, Licensor has not previously licensed, assigned, transferred, or otherwise conveyed any right, title or interest in and to the Licensor Technology to any Third Party, including any rights with respect to Licensed Compound or Licensed Product, that would preclude Checkmate’s use of Licensor Technology pursuant to the licenses granted in this Agreement;
8.2.12 there are no (a) Actions relating to the Licensor Technology, the Licensed Compound or the Licensed Products pending or, to the Knowledge of Licensor, threatened against Licensor or any of its Affiliates; and (b) there are no Actions pending or, to the Knowledge of Licensor, threatened, that question the legality or propriety of the transactions contemplated by this Agreement or the consummation of the transactions contemplated herein or therein or which would reasonably be expected to prevent, hinder or delay the consummation of any of the transactions contemplated by this Agreement; and
8.2.13 to Licensor’s actual knowledge, without having conducted any further inquiry or investigation, and except as cited during prosecution of the Licensor Patents or as intended to be cited upon commencement of substantive prosecution, there are no patents, patent applications, patent publications, articles or other prior art references, public use or disclosure, sales or offers to sell, prior invention, other prior art, or any other material information, that could adversely affect the validity or enforceability of, or is otherwise pertinent to, any patent or patent application included among the Licensor Patents. The Licensor (to the extent the Licensor is or was an applicant in respect of any patent or patent application included within the Licensor Patents) and, to Licensor’s actual knowledge, without having conducted any further inquiry or investigation, each inventor of the inventions claimed in the patents and patent applications included in the Licensor Patents has complied in all material respects with all applicable duties of candor and good faith in dealing with the U.S. Patent and Trademark Office and any foreign patent offices, including, without limitation, the duty to disclose to any such patent office all information known to be material to the patentability of each such invention.
Appears in 1 contract
Samples: License Agreement (Checkmate Pharmaceuticals, Inc.)
Additional Representations and Warranties of Licensor. Licensor represents and warrants to Coronado Company that, as of the Effective Date thatDate:
(a) No 9.2.1 no consent by any Third Party or Governmental Body is required with respect to the execution and delivery of this Agreement by Licensor or the consummation by Licensor of the transactions contemplated hereby;.
(b) The Licensor Technology is wholly-owned by 9.2.2 to the knowledge of Licensor, free and clear of all mortgages, pledges, charges, liens, equities, security interests, shop rights, or other encumbrances or similar agreements, or any other obligation;
(c) To Licensor’s knowledge, no claims have been asserted or threatened by any Person (i) challenging the validityin writing, effective status, or ownership of Licensor Technology, and/or (ii) to the effect that the usemanufacture, reproduction, modification, manufacturing, distribution, licensing, sublicensing, use or sale or of AR-101 and AR-301 infringes any other exercise of rights in any of Licensor Technology infringes or will infringe on any intellectual property right issued Patent Right of any Person; and no such claims have been asserted or are threatenedThird Party;
(d) To Licensor’s knowledge, 9.2.3 the Licensor Patents are subsisting and to the knowledge of Licensor, are not the subject of any litigation procedure, discovery process, interference, reissue, reexamination, opposition, appeal proceedings or any other legal dispute;
(e) Licensor and its Affiliates have taken all reasonable actions necessary or appropriate to preserve 9.2.4 the confidentiality of all trade secrets, proprietary and other confidential information material to Licensor Technology;
(f) Neither Licensor nor any Affiliate thereof is aware of any Third Party activities which would constitute misappropriation or infringement of any Licensor Technology
(g) The Licensor Patents constitute all material Patent Rights owned or Controlled by Licensor as of the Effective Date that pertain directly and particularly to Cover the research, Development, manufactureManufacture, use and or Commercialization of the Licensed Products; andProduct, are necessary for, the research, Development, Manufacture, use or Commercialization of the Product;
(h) To 9.2.5 the Licensor Know-How constitutes all material Know-How owned or Controlled by Licensor as of the Effective Date that is directly related to, and are necessary for, the research, Development, Manufacture, use or Commercialization of the Product;
9.2.6 the Licensor Materials constitute all key materials owned or Controlled by Licensor as of the Effective Date that is directly related to, and are necessary for, the research, Development, Manufacture, use or Commercialization of the Product;
9.2.7 Licensor has not licensed to a Third Party the right to develop a Competing Product within the Territory;
9.2.8 to the knowledge of Licensor’s knowledge, no Third Party has filed, pursued or maintained filed or threatened in writing to file, pursue or maintain file any claim, lawsuit, charge, complaint lawsuit or other action alleging that any Licensor Technology Patent is invalid or unenforceable;
9.2.9 it has the full right to provide the Licensor Technology to Company pursuant to this Agreement, and to the knowledge of Licensor, neither Company’s use of the Licensor Material as contemplated by this Agreement, nor such transfer, will violate any agreement with any Third Party;
9.2.10 to the knowledge of Licensor, all Representatives of Licensor who have performed any activities on its behalf in connection with research regarding the Product have assigned to Licensor the whole of their rights in any intellectual property made, discovered or developed by them as a result of such research;
9.2.11 the Licensor Technology is free and clear of any liens, charges, encumbrances or rights of others to possession or use, in each case that were created by an action of Licensor, other than those liens, charges, encumbrances or rights of others to possession or use that do not individually or in the aggregate materially detract from the value or use of the Licensor Technology;
9.2.12 except with respect to rights granted to Company in the Territory, Licensor has not previously licensed, assigned, transferred, or otherwise conveyed any right, title or interest in and to the Licensor Technology to any Third Party in the Territory, including any rights with respect to any Product;
9.2.13 there are no Third Party Agreements related to AR-101 and AR-301 except those in Schedule 9.2.13;
9.2.14 Licensor (and its Affiliates) has not employed or otherwise used in any capacity, and will not employ or otherwise use in any capacity, the services of any Person debarred under United States law, including under Section 21 USC 335a or any foreign equivalent thereof, with respect to the Product; and
9.2.15 to the knowledge of Licensor, all research and development related to the Product prior to the Effective Date has been conducted in accordance with all Laws in all material aspects. Except as expressly set forth in this Section 9, Licensor does not make any representations, warranties or guarantee, whether expressed or implied, with respect to the Licensor Technology or other services provided by Licensor under this Agreement.
Appears in 1 contract
Samples: Technology License and Collaboration Agreement (Aridis Pharmaceuticals, Inc.)
Additional Representations and Warranties of Licensor. Licensor hereby represents and warrants to Coronado Licensee, as of the Effective Date, as set forth below:
12.3.1 Licensor is a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware, and has full power and authority and the legal right to own and operate its property and assets and to carry on its business as it is now being conducted and as is contemplated to be conducted by this Agreement.
12.3.2 To the knowledge of Licensor, the Licensor Patents existing as of the Effective Date that:
are [***]. To the knowledge of Licensor, the conception, development and reduction to practice of the subject matter claimed and/or disclosed in Licensor Patents and the information embodied in the Licensor Know-How existing as of the Effective Date have not [***] of any Third Party. There are no judgments or settlements against Licensor or amounts owed by Licensor (aother than amounts owed in the ordinary course of business and/or pursuant to the Licensor In-Licenses) with respect to the Licensor Patents or the Licensor Know-How. No consent litigation has been commenced or threatened, and Licensor is not aware of any claim, by any Third Party or Governmental Body is required with respect to the execution and delivery of this Agreement by Licensor or the consummation by Licensor of the transactions contemplated hereby;
(b) The Licensor Technology is wholly-owned by Licensor, free and clear of all mortgages, pledges, charges, liens, equities, security interests, shop rights, or other encumbrances or similar agreements, or any other obligation;
(c) To Licensor’s knowledge, no claims have been asserted or threatened by any Person (i) challenging the validity, effective status, or ownership of Licensor Technology, and/or (ii) to the effect Regulatory Authority alleging that the use, reproduction, modification, manufacturing, distribution, licensing, sublicensing, sale or any other exercise of rights in any of Licensor Technology infringes or will infringe on any intellectual property right of any Person; and no such claims have been asserted or are threatened;
(d) To Licensor’s knowledge, the Licensor Patents are subsisting and are not invalid or unenforceable.
12.3.3 Except for the subject of any litigation procedurelicense grants in Section 3.1, discovery process, interference, reissue, reexamination, opposition, appeal proceedings or any other legal dispute;
(e) Licensor and its Affiliates have taken all reasonable actions necessary or appropriate to preserve the confidentiality of all trade secrets, proprietary and other confidential information material to Licensor Technology;
(f) Neither neither Licensor nor any Affiliate thereof is aware of any Third Party activities which would constitute misappropriation its Affiliates has, directly or infringement indirectly, expressly or by implication, by action or omission or otherwise (i) [***]; (ii) [***], or (iii) [***].
12.3.4 To the knowledge of any Licensor Technology
(g) The Licensor Patents constitute all Patent Rights owned or Controlled by Licensor that pertain directly and particularly to the research, Development, manufacture, use and Commercialization of the Licensed Products; and
(h) To Licensor’s knowledge, no Third Party has filed, pursued or maintained infringed or threatened in writing to fileinfringe the Licensor Patents.
12.3.5 The Licensor In-Licenses are in full force and effect and, pursue to the knowledge of Licensor, there is no basis upon which termination could occur. Licensor has [***]. The copies of the Licensor In-Licenses provided to Licensee by Licensor are true, complete and correct. Licensor shall promptly provide Licensee with notice of any alleged, threatened, or maintain actual breach of any In-License Agreement. To the extent permitted by the In-License Agreements, Licensor agrees that Licensee [***] by Licensor under the [***]. [***] Confidential treatment has been requested with respect to the omitted portions.
12.3.6 Neither Licensor nor any of its Affiliates has been debarred or is subject to debarment and neither Licensor nor any of its Affiliates will knowingly use in any capacity, in connection with the services to be performed under this Agreement, any Third Party who has been debarred pursuant to Section 306 of the Federal Food, Drug, and Cosmetic Act, or who is the subject of a conviction described in such section. Licensor agrees to inform Licensee in writing immediately if it or any Third Party who is performing services hereunder is debarred or is the subject of a conviction described in Section 306, or if any action, suit, claim, lawsuitinvestigation or legal or administrative proceeding is pending or, chargeto the best of Licensor’ knowledge, complaint is threatened, relating to the debarment or other action alleging that conviction of Licensor or any Licensor Technology is invalid or unenforceableThird Party performing services hereunder.
Appears in 1 contract
Samples: Collaboration and License Agreement (Seattle Genetics Inc /Wa)
Additional Representations and Warranties of Licensor. Licensor represents and warrants to Coronado TGTX as of the Effective Date that:
(a) No consent by any Third Party or Governmental Body is required with respect to the execution and delivery of this Agreement by Licensor or the consummation by Licensor of the transactions contemplated hereby;
(b) The Licensor Technology is wholly-owned by Licensor, free and clear To the best of all mortgages, pledges, charges, liens, equities, security interests, shop rights, or other encumbrances or similar agreements, or any other obligation;
(c) To Licensor’s actual knowledge, no valid claims have been asserted or threatened by any Person (i) challenging the validity, effective status, or ownership of Licensor Technology, and/or (ii) to the effect that the use, reproduction, modification, manufacturing, distribution, licensing, sublicensing, sale or any other exercise of rights in any of Licensor Technology infringes or will infringe on any intellectual property right of any Person; and no such claims have been asserted or are threatened;
(dc) To Licensor’s knowledge, the The Licensor Patents are subsisting and are not the subject of any litigation procedure, discovery process, interference, reissue, reexamination, opposition, appeal proceedings or any other legal dispute;
(e) Licensor and its Affiliates have taken all reasonable actions necessary or appropriate to preserve the confidentiality of all trade secrets, proprietary and other confidential information material to Licensor Technology;
(f) Neither Licensor nor any Affiliate thereof is aware of any Third Party activities which would constitute misappropriation or infringement of any Licensor Technology
(gd) The Licensor Patents constitute all Patent Rights owned or Controlled by Licensor that pertain directly and particularly to the research, Development, manufacture, use and Commercialization of the Licensed Products; andProducts in the Field and in the Territory as currently envisioned;
(he) To the best of Licensor’s actual knowledge, no Third Party has filed, pursued or maintained or threatened in writing to file, pursue or maintain any claim, lawsuit, charge, complaint or other action alleging that any Licensor Technology is invalid or unenforceable; and
(f) Licensor has ceased its research and development activities to discover compounds under a BTK Inhibitor Program (as defined herein) and will not initiate research and development activities aimed at discovering compounds under a BTK Inhibitor Program prior to the * ( * ) anniversary of the Effective Date. For the purposes of this provision, a “BTK Inhibitor Program” is one that seeks to discover a selective compound that *, and which may be suitable for treating hematological malignancies and/or autoimmune indications.
Appears in 1 contract
Additional Representations and Warranties of Licensor. Licensor represents and warrants to Coronado Company that, as of the Effective Date thatDate:
(a) No no consent by any Third Party or Governmental Body is required with respect to the execution and delivery of this Agreement by Licensor or the consummation by Licensor of the transactions contemplated hereby;
(b) The Licensor Technology is wholly-owned by Licensor, free and clear of all mortgages, pledges, charges, liens, equities, security interests, shop rights, or other encumbrances or similar agreements, or any other obligation;
(c) To Licensor’s knowledge, no claims have been asserted or threatened by any Person Person, nor to Licensor’s Knowledge, are there any valid grounds for any claim of any such kind, (i) challenging the validity, effective statuseffectiveness, or ownership of Licensor Technology, and/or (ii) to the effect that the use, reproduction, modification, manufacturing, distribution, licensing, sublicensing, sale or any other exercise of rights in any of Licensor Technology infringes or will infringe on any intellectual property right of any Person; and ;
(c) to Licensor’s Knowledge, there is no such claims have been asserted unauthorized use, infringement or are threatenedmisappropriation of any of Licensor Technology by any employee or former employee of Licensor, or any other Third Party in the Territory;
(d) To Licensor’s knowledge, the Licensor Patents are subsisting and all registration, renewal, maintenance and other official fees with respect to the Licensor Patents due on or before the date of this Agreement have been paid in full. Licensor is the sole assignee and owner of each item listed on Schedule 1.30. To Licensor’s Knowledge, the Licensor Patents are not the subject of any litigation procedure, discovery process, interference, reissue, reexamination, opposition, appeal proceedings or any other legal dispute;
(e) Licensor and its Affiliates have taken all reasonable actions necessary or appropriate to preserve the confidentiality of all trade secrets, proprietary and other confidential information material to Licensor Technology;
(f) Neither Licensor nor any Affiliate thereof is aware of any Third Party activities which would constitute misappropriation or infringement of any Licensor Technology
(g) The Licensor Patents (i) constitute all Patent Rights owned or Controlled by Licensor as of the Effective Date that pertain are directly related to, necessary or useful for, or used in, the Development, Regulatory Approval, manufacture, use, marketing, sale, offer for sale, import, export or Commercialization of the PN2[***] Device or PN1[***] Device in the Territory and particularly to (ii) listed on Schedule 1.30 hereto constitute all Patent Rights that are directly related to, necessary or useful for, or used in, the researchDevelopment, Regulatory Approval, manufacture, use, marketing sale, offer for sale, import, export or Commercialization of the PN2[***] Device or the PN1[***] in the Territory;
(f) the Licensor Know-How (i) constitutes all Know-How owned or Controlled by Licensor as of the Effective Date that is directly related to, or are necessary or useful for, the Development, manufacture, use and or Commercialization of the PN2[***] Device or the PN1[***] Device under the Licensed Products; andRights and (ii) to Licensor’s Knowledge, constitutes all Know-How that is directly related to, or are necessary or useful for, the Development, manufacture, use or Commercialization of the PN2[***] Device or PN1[***] Device under the Licensed Rights;
(g) all of the Licensor Technology is owned by Licensor or its Affiliates and Licensor has not in-licensed, or otherwise obtained any rights, from a Third Party with respect to the PN2[***] Device or PN1[***] Device or the Licensor Technology;
(h) To Licensor’s knowledge, Licensor has not licensed to a Third Party the right to develop the PN2[***] Device or PN1[***] Device;
(i) no Third Party has filed, pursued or maintained or threatened in writing to file, pursue or maintain any claim, lawsuit, charge, complaint or other action alleging that any Licensor Technology Patent is invalid or unenforceable.;
(j) to Licensor’s Knowledge, Company’s and its Affiliates’ and Sublicensees’ practice and use of the inventions claimed in the Licensor Patents under the Licensed Rights as permitted herein (including the sale, offer for sale, Commercialization or Regulatory Approval of the PN2[***] Device or PN1[***] Device) will not infringe any intellectual property rights of any Third Party;
(k) all Representatives of Licensor who have performed any activities on its behalf in connection with Development regarding the PN2[***] Device or PN1[***] Device have assigned to Licensor the whole of their rights in any intellectual property made, discovered or developed by them as a result of such Development, and no Third Party has any rights to any such intellectual property;
(l) Licensor has all right, title and interest in and to the Licensor Technology and Licensor Technology is free and clear of any liens, charges, encumbrances or rights of others to possession or use;
(m) Licensor has not previously licensed, assigned, transferred, or otherwise conveyed any right, title or interest in and to the Licensor Technology to any Third Party in the Territory, including any rights with respect to the PN2[***] Device or the PN1[***] Device;
(n) to Licensor’s Knowledge, the Licensor Technology constitutes all of the intellectual property which could reasonably be expected to be necessary or useful for, or used in, the Development, manufacture, Regulatory Approval, import, export, use, marketing, sale, offer for sale or Commercialization of the PN2[***] Device or PN1[***] Device;
(o) the PN2[***] Device and PN1[***] Device each fall within the scope of at least one Valid Claim of at least one of the Licensor Patents listed on Schedule 1.30;
(p) to Licensor’s Knowledge, there is no additional Third Party licenses that have to be taken now or in the future to guarantee freedom-to-operate to Develop, manufacture and Commercialize the PN2[***] Device or PN1[***] Device without any limitation;
(q) the Existing Third Party Agreements constitute all agreements that were entered into by Licensor or its Affiliates with Third Parties for the development or manufacture or supply of the PN2[***] Device or the PN1[***] Device. Licensor has provided to Company an accurate, true and complete copy of each of the Existing Third Party Agreements, as amended to date, and each of the Existing Third Party Agreements is in full force and effect. Licensor is not, and to Licensor’s Knowledge no other party to any Existing Third Party Agreement is, in breach or default in the performance of its obligations under any of the Existing Third Party Agreements. Licensor has not received any notice from any Third Party of any breach, default or non-compliance of Licensor under the terms of any of the Existing Third Party Agreements. There have been no amendments or other modification to any Existing Third Party Agreements, except as have been disclosed to Company in writing;
(r) all tangible information and data provided by or on behalf of Licensor to Company on or before the Effective Date in contemplation of this Agreement was and is true, accurate and complete in all material respects, and Licensor has not failed to disclose, or cause to be disclosed, any information or data that would cause the information and data that has been disclosed to be misleading in any material respect;
(s) Licensor (and its Affiliates) has not employed or otherwise used in any capacity, and will not employ or otherwise use in any capacity, the services of any Person debarred under any Law, including under Section 21 USC 335a or any foreign equivalent thereof, with respect to the Licensor Technology or a Device;
(t) all Development related to the PN2[***] Device and PN1[***] Device prior to the Effective Date has been conducted in accordance with all Laws; and
Appears in 1 contract
Additional Representations and Warranties of Licensor. Licensor represents and warrants to Coronado Merck, as of the Effective Date Signing Date, that:
(a) No consent by any Third Party or Governmental Body is required with respect to the execution and delivery of this Agreement by Licensor or the consummation by Licensor of the transactions contemplated hereby[**];
(b) The to the Knowledge of Licensor, there is no unauthorized use, infringement or misappropriation of any of Licensor Technology is wholly-owned by any employee or former employee of Licensor, free and clear of all mortgages, pledges, charges, liens, equities, security interests, shop rights, or other encumbrances or similar agreements, or any other obligationThird Party;
(c) To Licensor’s knowledge, no claims have been asserted or threatened by any Person (i) challenging the validity, effective status, or ownership of Licensor Technology, and/or (ii) to the effect that the use, reproduction, modification, manufacturing, distribution, licensing, sublicensing, sale or any other exercise Knowledge of rights in any of Licensor Technology infringes or will infringe on any intellectual property right of any Person; and no such claims have been asserted or are threatened;
(d) To Licensor’s knowledge, the Licensor Patents are subsisting and are not the subject of any litigation procedure, discovery process, interference, reissue, reexamination, opposition, appeal proceedings or any other legal dispute;
(e) Licensor and its Affiliates have taken all reasonable actions necessary or appropriate to preserve the confidentiality of all trade secrets, proprietary and other confidential information material to Licensor Technology;
(f) Neither Licensor nor any Affiliate thereof is aware of any Third Party activities which would constitute misappropriation or infringement of any Licensor Technology
(gd) The Licensor Patents constitute all Patent Rights owned or Controlled by Licensor as of the Signing Date that pertain directly and particularly to are necessary or useful for the research, Development, manufacture, use or Commercialization of Compounds and Follow-On Compounds in the Field;
(e) The Compounds provided hereunder contain the molecular structures described in Section 1.11;
(f) Licensor has not licensed to a Third Party the right to perform research, Develop, manufacture, use or Commercialize (i) a Compound for use in the Field, or (ii) a Follow-On Compound for use in or outside the Field;
(g) Licensor has not granted rights to Compounds or Follow-On Compounds in or outside the Field to (i) [**], or (ii) [**];
(h) the Licensor Know-How constitutes all Know-How Controlled by Licensor as of the Signing Date that is necessary for the research, Development, manufacture, use or Commercialization of the Licensed ProductsCompounds and Follow-On Compounds in the Field;
(i) to Licensor’s Knowledge, the exercise of the licenses granted to Merck with respect to the Compounds and Follow-On Compounds in the Field will not infringe any intellectual property rights owned or possessed by any Third Party Covering the composition of matter or method of use in the Field of such Compound or Follow-On Compound;
(j) the Compounds and Follow-On Compounds can be manufactured without infringing any Third Party manufacturing process intellectual property rights;
(k) it has the full right to provide the Licensor Materials to Merck and to transfer to Merck all right, title and interest in and to the Licensor Material to be provided to Merck pursuant to this Agreement;
(l) all employees of Licensor who have performed any activities on its behalf in connection with research regarding the Compounds and the Follow-On Compounds, and all other inventors of Licensor Patents, have assigned to Licensor the whole of their rights in any intellectual property made, discovered or developed by them as a result of such research, and no Third Party has any rights to any such intellectual property in the Field; and
(hm) To Licensor’s knowledgeto its Knowledge, no Third Party all tangible information and data provided by or on behalf of Licensor to Merck on or before the Signing Date in contemplation of this Agreement was and is true, accurate and complete in all material respects, and to its Knowledge, Licensor has filednot failed to disclose, pursued or maintained or threatened in writing cause to filebe disclosed, pursue or maintain any claim, lawsuit, charge, complaint or other action alleging that any Licensor Technology is invalid or unenforceableKnow-How that would cause the information and data that has been disclosed to be misleading in any material respect.
Appears in 1 contract
Additional Representations and Warranties of Licensor. Licensor further represents and warrants to Coronado AGT, as of the Effective Date, as follows:
11.2.1 All Licensor Patents existing as of the Effective Date that:
are listed on Schedule 11.2.1 (the “Existing Licensor Patents”). All Existing Licensor Patents are (a) No consent by any Third Party subsisting and, to Licensor’s Knowledge, are not invalid or Governmental Body is required unenforceable, in whole or in part, (b) are being diligently prosecuted in the respective patent offices in the Territory in accordance with Applicable Law, and (c) have been filed and maintained properly and correctly and all applicable fees have been paid on or before the due date for payment.
11.2.2 There are no claims, judgments, or settlements against, or amounts with respect to the execution and delivery of this Agreement thereto, owed by Licensor or any of its Affiliates relating to the consummation by Existing Licensor of Regulatory Documentation, the transactions contemplated hereby;
(b) The Existing Licensor Technology is wholly-owned by Licensor, free and clear of all mortgages, pledges, charges, liens, equities, security interests, shop rightsPatents, or other encumbrances the Licensor Know-How. No claim or similar agreements, or any other obligation;
(c) To Licensor’s knowledge, no claims have litigation has been asserted brought or threatened by any Person (i) challenging alleging, and Licensor has no Knowledge of any claim, whether or not asserted, that the validityExisting Licensor Patents or the Licensor Know-How are invalid or unenforceable. To Licensor’s Knowledge, effective statusthe Exploitation of the 4D Vector as contemplated herein, does not and will not violate, infringe, misappropriate, or ownership of Licensor Technology, and/or (ii) to the effect that the use, reproduction, modification, manufacturing, distribution, licensing, sublicensing, sale otherwise conflict or any other exercise of rights in any of Licensor Technology infringes or will infringe on interfere with any intellectual property or proprietary right of any Person; and no such claims have been asserted or are threatened;
(d) . To Licensor’s knowledgeKnowledge, no Person is infringing or threatening to infringe or misappropriating or threatening to misappropriate the Existing Licensor Patents or the Licensor Know-How in connection with any Competing Product in the Field.
11.2.3 Licensor is the sole and exclusive owner of the entire right, title and interest in the Existing Licensor Patents are subsisting and are not the subject Licensor Know-How free of any litigation procedureencumbrance, discovery processlien, interferenceor claim of ownership by any Third Party.
11.2.4 Licensor is entitled to grant the licenses to AGT specified herein under the terms and conditions of this Agreement. The Existing Licensor Patents represent all Patents within Licensor’s or its Affiliates’ ownership or Control relating to the Exploitation of the 4D Vector in connection with a Licensed Compound or Licensed Product in the Field.
11.2.5 Except for [ * ], reissue, reexamination, opposition, appeal proceedings or any other legal dispute;
(e) neither Licensor and nor its Affiliates have taken all reasonable actions necessary licensed, authorized, appointed, or appropriate to preserve the confidentiality of all trade secrets, proprietary and other confidential information material to Licensor Technology;
(f) Neither Licensor nor any Affiliate thereof is aware of otherwise enabled any Third Party activities which would constitute misappropriation to directly or infringement indirectly, research, develop, commercialize, or otherwise exploit any AAV-based gene therapy product that is directed to the Initial Target, any of the Reserved Target Candidates as defined in subsections (a)-(c) of the definition thereof, or any Rare Ophthalmology Target in any country or other jurisdiction in the Territory.
11.2.6 Licensor Technology
(g) The has the right to use all Licensor Know-How and Existing Licensor Patents constitute all Patent Rights owned or Controlled by necessary for AGT to Manufacture and use the 4D Vector as contemplated herein. Licensor that pertain directly and particularly has the right to provide the research, Development, manufacture, Transferred Materials to AGT for use and Commercialization of the Licensed Products; and
(h) To Licensor’s knowledge, no Third Party has filed, pursued or maintained or threatened as contemplated in writing to file, pursue or maintain any claim, lawsuit, charge, complaint or other action alleging that any Licensor Technology is invalid or unenforceablethis Agreement.
Appears in 1 contract
Samples: License Agreement (4D Molecular Therapeutics, Inc.)
Additional Representations and Warranties of Licensor. Licensor represents and warrants to Coronado Company that, as of the Effective Date thatDate:
(a) No 9.2.1 no consent by any Third Party or Governmental Body is required with respect to the execution and delivery of this Agreement by Licensor or the consummation by Licensor of the transactions contemplated hereby;.
(b) The Licensor Technology is wholly-owned by 9.2.2 to the knowledge of Licensor, free and clear of all mortgages, pledges, charges, liens, equities, security interests, shop rights, or other encumbrances or similar agreements, or any other obligation;
(c) To Licensor’s knowledge, no claims have been asserted or threatened by any Person (i) challenging the validityin writing, effective status, or ownership of Licensor Technology, and/or (ii) to the effect that the usemanufacture, reproductionuse or sale of XX-000, modification, manufacturing, distribution, licensing, sublicensing, sale or XX-000 and AR-301 infringes any other exercise of rights in any of Licensor Technology infringes or will infringe on any intellectual property right issued Patent Right of any Person; and no such claims have been asserted or are threatenedThird Party;
(d) To Licensor’s knowledge, 9.2.3 the Licensor Patents are subsisting and to the knowledge of Licensor, are not the subject of any litigation procedure, discovery process, interference, reissue, reexamination, opposition, appeal proceedings or any other legal dispute;
(e) Licensor and its Affiliates have taken all reasonable actions necessary or appropriate to preserve 9.2.4 the confidentiality of all trade secrets, proprietary and other confidential information material to Licensor Technology;
(f) Neither Licensor nor any Affiliate thereof is aware of any Third Party activities which would constitute misappropriation or infringement of any Licensor Technology
(g) The Licensor Patents constitute all material Patent Rights owned or Controlled by Licensor as of the Effective Date that pertain directly and particularly to Cover the research, Development, manufactureManufacture, use and or Commercialization of the Licensed Products; andProduct, are necessary for, the research, Development, Manufacture, use or Commercialization of the Product;
(h) To 9.2.5 the Licensor Know-How constitutes all material Know-How owned or Controlled by Licensor as of the Effective Date that is directly related to, and are necessary for, the research, Development, Manufacture, use or Commercialization of the Product;
9.2.6 the Licensor Materials constitute all key materials owned or Controlled by Licensor as of the Effective Date that is directly related to, and are necessary for, the research, Development, Manufacture, use or Commercialization of the Product;
9.2.7 Licensor has not licensed to a Third Party the right to develop a Competing Product within the Territory;
9.2.8 to the knowledge of Licensor’s knowledge, no Third Party has filed, pursued or maintained filed or threatened in writing to file, pursue or maintain file any claim, lawsuit, charge, complaint lawsuit or other action alleging that any Licensor Technology Patent is invalid or unenforceable;
9.2.9 subject to the disclosure in Section 2.7.4, it has the full right to provide the Licensor Technology to Company pursuant to this Agreement, and to the knowledge of Licensor, neither Company’s use of the Licensor Material as contemplated by this Agreement, nor such transfer, will violate any agreement with any Third Party;
9.2.10 to the knowledge of Licensor, all Representatives of Licensor who have performed any activities on its behalf in connection with research regarding the Product have assigned to Licensor the whole of their rights in any intellectual property made, discovered or developed by them as a result of such research;
9.2.11 the Licensor Technology is free and clear of any liens, charges, encumbrances or rights of others to possession or use, in each case that were created by an action of Licensor, other than those liens, charges, encumbrances or rights of others to possession or use that do not individually or in the aggregate materially detract from the value or use of the Licensor Technology;
9.2.12 except with respect to rights granted to Company in the Territory, Licensor has not previously licensed, assigned, transferred, or otherwise conveyed any right, title or interest in and to the Licensor Technology to any Third Party in the Territory, including any rights with respect to any Product;
9.2.13 there are no Third Party Agreements related to XX-000, XX-000 xxx XX-000 except those in Schedule 9.2.13;
9.2.14 Licensor (and its Affiliates) has not employed or otherwise used in any capacity, and will not employ or otherwise use in any capacity, the services of any Person debarred under United States law, including under Section 21 USC 335a or any foreign equivalent thereof, with respect to the Product; and
9.2.15 to the knowledge of Licensor, all research and development related to the Product prior to the Effective Date has been conducted in accordance with all Laws in all material aspects. Except as expressly set forth in this Section 9, Licensor does not make any representations, warranties or guarantee, whether expressed or implied, with respect to the Licensor Technology or other services provided by Licensor under this Agreement.
Appears in 1 contract
Samples: Technology License and Collaboration Agreement (Aridis Pharmaceuticals, Inc.)
Additional Representations and Warranties of Licensor. Licensor hereby represents and warrants to Coronado Licensee, as of the Effective Date, as set forth below:
12.3.1 Licensor is a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware, and has full power and authority and the legal right to own and operate its property and assets and to carry on its business as it is now being conducted and as is contemplated to be conducted by this Agreement.
12.3.2 To the knowledge of Licensor, the Licensor Patents existing as of the Effective Date that:
are [***]. To the knowledge of Licensor, the conception, development and reduction to practice of the subject matter claimed and/or disclosed in Licensor Patents and the information embodied in the Licensor Know-How existing as of the Effective Date have not [***] of any Third Party. There are no judgments or settlements against Licensor or amounts owed by Licensor (aother than amounts owed in the ordinary course of business and/or pursuant to the Licensor In-Licenses) with respect to the Licensor Patents or the Licensor Know-How. No consent litigation has been commenced or threatened, and Licensor is not aware of any claim, by any Third Party or Governmental Body is required with respect to the execution and delivery of this Agreement by Licensor or the consummation by Licensor of the transactions contemplated hereby;
(b) The Licensor Technology is wholly-owned by Licensor, free and clear of all mortgages, pledges, charges, liens, equities, security interests, shop rights, or other encumbrances or similar agreements, or any other obligation;
(c) To Licensor’s knowledge, no claims have been asserted or threatened by any Person (i) challenging the validity, effective status, or ownership of Licensor Technology, and/or (ii) to the effect Regulatory Authority alleging that the use, reproduction, modification, manufacturing, distribution, licensing, sublicensing, sale or any other exercise of rights in any of Licensor Technology infringes or will infringe on any intellectual property right of any Person; and no such claims have been asserted or are threatened;
(d) To Licensor’s knowledge, the Licensor Patents are subsisting and are not invalid or unenforceable.
12.3.3 Except for the subject of any litigation procedurelicense grants in Section 3.1, discovery process, interference, reissue, reexamination, opposition, appeal proceedings or any other legal dispute;
(e) Licensor and its Affiliates have taken all reasonable actions necessary or appropriate to preserve the confidentiality of all trade secrets, proprietary and other confidential information material to Licensor Technology;
(f) Neither neither Licensor nor any Affiliate thereof is aware of any Third Party activities which would constitute misappropriation its Affiliates has, directly or infringement indirectly, expressly or by implication, by action or omission or otherwise (i) [***]; (ii) [***], or (iii) [***].
12.3.4 To the knowledge of any Licensor Technology
(g) The Licensor Patents constitute all Patent Rights owned or Controlled by Licensor that pertain directly and particularly to the research, Development, manufacture, use and Commercialization of the Licensed Products; and
(h) To Licensor’s knowledge, no Third Party has filed, pursued or maintained infringed or threatened in writing to fileinfringe the Licensor Patents.
12.3.5 The Licensor In-Licenses are in full force and effect and, pursue or maintain any claimto the knowledge of Licensor, lawsuitthere is no basis upon which termination could occur. Licensor has [***]. The copies of the Licensor In-Licenses provided to Licensee by Licensor are true, charge, complaint or other action alleging that any Licensor Technology is invalid or unenforceablecomplete and *** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Appears in 1 contract
Samples: Collaboration and License Agreement (Seattle Genetics Inc /Wa)
Additional Representations and Warranties of Licensor. Licensor represents represents, warrants, and warrants covenants (as applicable) to Coronado as of the Effective Date Licensee that:
(a) No consent by any Third Party or Governmental Body is required with respect to except for the execution and delivery of this Agreement Licensed Technology in-licensed by Licensor or under the consummation by [***], Licensor is the sole and exclusive owner of the transactions contemplated hereby;
(b) The Licensor Technology is wholly-owned by LicensorLicensed Technology, free and clear of all mortgagesliens that would prevent or limit Licensee’s exercise of its rights under the licenses granted to Licensee under Article 2, pledgesand Licensor has the right to grant to Licensee the rights and licenses as purported to be granted hereunder;
(b) except for the Upstream Agreements, charges, liens, equities, security interests, shop rightsthere are no agreements existing as of the Execution Date between Licensor (or its Affiliates) and any Third Party pursuant to which Licensor or its Affiliates are required, or other encumbrances would be required with the passage of time or similar agreementsupon satisfaction of a condition subsequent, to make any payment to such Third Party for the Exploitation of the Licensed Compound or any other obligationLicensed Product in the Field in the Territory;
(c) To the Knowledge of Licensor’s knowledge, no claims Licensor has obtained all necessary government approvals required for the grant of the license and the transfer of Licensed Know-How to Licensee, including such approvals required by applicable technology export control Laws, and Licensor will do and execute or procure to be done and have been asserted or threatened by any Person (i) challenging the validityexecuted all such further acts, effective statusthings, or ownership of Licensor Technology, and/or (ii) agreements and other documents as may be reasonably necessary to give effect to the effect that the use, reproduction, modification, manufacturing, distribution, licensing, sublicensing, sale or any other exercise terms of rights in any of Licensor Technology infringes or will infringe on any intellectual property right of any Person; and no such claims have been asserted or are threatenedthis Agreement;
(d) To Licensor’s knowledgeLicensor and its Affiliates have not granted , and will not grant during the Licensor Patents Term, any rights in the Licensed Technology that are subsisting and are not inconsistent with the subject of any litigation procedure, discovery process, interference, reissue, reexamination, opposition, appeal proceedings or any other legal disputerights granted to Licensee under this Agreement;
(e) Licensor and its Affiliates have taken all reasonable actions necessary not received any written notice (including any such notice styled as an offer to license) from any Third Party on or appropriate prior to preserve the confidentiality Execution Date asserting or alleging that the research or development of all trade secretsthe Licensed Compound or Licensed Product infringed, proprietary and other confidential information material to Licensor Technologymisappropriated or otherwise violated the IP rights of such Third Party;
(f) Neither Licensor nor any Affiliate thereof is aware of any Third Party activities which would constitute misappropriation or infringement of any Licensor Technology
(g) The Licensor Patents constitute all Patent Rights owned or Controlled by Licensor that pertain directly and particularly to the researchKnowledge of Licensor, the Development, manufacture, use Manufacture and Commercialization of the Licensed ProductsCompound and Licensed Product can be carried out as mutually contemplated by the Parties as of the Execution Date without infringing, misappropriating or otherwise violating any [***];
(g) there are no pending or, to the Knowledge of Licensor, alleged or threatened, adverse actions, suits, proceedings, or claims against Licensor or its Affiliates involving the Licensed Technology, Licensed Compound or Licensed Product;
(h) to the Knowledge of Licensor, no Third Party is infringing, misappropriating or otherwise violating any Licensed Technology;
(i) Schedule 1.48 (Licensed Patents) lists all Patent Rights Controlled by Licensor and its Affiliates as of the Execution Date that Cover the Licensed Compound or the Licensed Product (including composition of matter, methods of making and using) or are necessary or reasonably useful for the Exploitation of the Licensed Compound or Licensed Product in the Territory;
(j) there is no pending or, or to the Knowledge of Licensor and its Affiliates, alleged or threatened, re-examination, opposition, interference, claim or litigation, or any written communication alleging that any Licensed Patent is invalid or unenforceable anywhere in the world;
(k) Licensor (including its Affiliates) and, to its Knowledge, Licensor’s contractors, have complied with all applicable Laws in connection with Licensor’s development of the Licensed Compound and Licensed Product, and have not used any employee, or to the Knowledge of Licensor, consultant or contractor who has been debarred by any Regulatory Authority, or to Licensor’s Knowledge, is the subject of a debarment proceeding by any Regulatory Authority;
(l) to the knowledge of Licensor, all material information provided by Licensor to Licensee for due diligence purposes in relation to this Agreement is complete and accurate in all material respects. Without limiting the foregoing, to the Knowledge of Licensor, Licensor has disclosed to Licensee and made available to Licensee for review all material non-clinical and clinical data for the Licensed Compound and Licensed Product, and all other material information (including relevant correspondence with Regulatory Authorities) in its possession or Control relating to the Licensed Compound and Licensed Product, in each case that would be material for Licensee to assess the safety and efficacy of the Licensed Compound and Licensed Product as contemplated for the proposed indications in the Development Plan;
(m) Licensor has provided Licensee with a true and complete copy of the Upstream Agreements; the Upstream Agreements are in full force and effect; no written notice of default or termination has been received or given under the Upstream Agreements as of the Execution Date; and, to its Knowledge, there is no act or omission by Licensor or its Affiliates that would provide a right to terminate the Upstream Agreements; as of the Execution Date, Licensor has obtained all written consents and approvals that Licensor is required to obtain prior to entering into this Agreement under the terms of the Upstream Agreements; and
(hn) To Licensorduring the Term of this Agreement, Licensor shall maintain the Upstream Agreements in full force and effect and shall not terminate, amend, waive or otherwise modify (or consent to any of the foregoing) its rights under the Upstream Agreements in any manner that materially diminishes the rights or licenses granted to Licensee hereunder, without Licensee’s knowledge, no Third Party has filed, pursued or maintained or threatened in writing to file, pursue or maintain any claim, lawsuit, charge, complaint or other action alleging that any Licensor Technology is invalid or unenforceableexpress written consent.
Appears in 1 contract
Additional Representations and Warranties of Licensor. Licensor represents and warrants to Coronado Merck that, as of the Effective Date thatDate, subject to the disclosures on Schedule 11.2, and as of the Option Exercise Date, subject to an updated Schedule 11.2 provided in accordance with, and subject to, Section 2.1:
(ai) No no consent by any Third Party or Governmental Body is required with respect to the execution and delivery of this Agreement by Licensor or the consummation by Licensor of the transactions contemplated hereby;
(bii) The Licensor Technology is wholly-owned by Licensor, free and clear of all mortgages, pledges, charges, liens, equities, security interests, shop rights, or other encumbrances or similar agreements, or any other obligation;
(c) To Licensor’s knowledge, no claims have been asserted or asserted, or, to Licensor’s Knowledge, threatened by any Person Person, nor to Licensor’s Knowledge are there any valid grounds for any claim of any such kind (ia) challenging the validity, effective statuseffectiveness, or ownership of the Licensor Technology, and/or (iib) to the effect that the use, reproduction, modification, manufacturing, distribution, licensing, sublicensing, sale or any other exercise of rights in any of the Licensor Technology infringes infringes, will infringe, misappropriates or will infringe on misappropriate any intellectual property right of any Person; and no . No such claims have been asserted or or, to the Knowledge of Licensor, are threatened;
(diii) To to the Knowledge of Licensor’s knowledge, there is no unauthorized use, infringement or misappropriation of any of Licensor Technology by any employee or former employee of Licensor, or any other Third Party;
(iv) the Licensor Patents (a) owned by Licensor are subsisting and are not the subject of any litigation procedure, discovery process, interference, reissue, reexamination, opposition, appeal proceedings or any other legal dispute, and (b) in-licensed by Licensor are subsisting and are not to Licensor’s Knowledge the subject of any litigation procedure, discovery process, interference, reissue, reexamination, opposition, appeal proceedings or any other legal dispute;
(ev) Licensor and its Affiliates have taken all reasonable actions necessary or appropriate to preserve the confidentiality of all trade secrets, proprietary and other confidential information material to Licensor Technology;
(f) Neither Licensor nor any Affiliate thereof is aware of any Third Party activities which would constitute misappropriation or infringement of any Licensor Technology
(g) The Licensor Patents (a) constitute all Patent Rights owned or Controlled by Licensor as of the Effective Date (and, in conjunction with the exercise of the Option, the Option Exercise Date), that pertain are directly and particularly to related to, or necessary or useful for, the research, Development, manufacture, use or Commercialization of Product and (b) listed on Schedule 1.40 hereto constitute all Patent Rights that are, to Licensor’s Knowledge, necessary for, the research, Development, manufacture, use or Commercialization of Product as proposed or conducted by Licensor as of the Effective Date (and, in conjunction with the exercise of the Option, the Option Exercise Date);
(vi) the Licensor Know-How (a) constitutes all Know-How owned or Controlled by Licensor as of the Effective Date (and, in conjunction with the exercise of the Option, the Option Exercise Date) that is directly related to, or necessary or useful for, the research, Development, manufacture, use or Commercialization of the Licensed Products; Product and (b) constitutes all Know-How that is, to Licensor’s Knowledge, necessary for, the research, Development, manufacture, use or Commercialization of Product as proposed or conducted by Licensor as of the Effective Date (and, in conjunction with the exercise of the Option, the Option Exercise Date);
(hvii) To Licensor has not developed, subcontracted or licensed to a Third Party the right to develop a Competing Product;
(viii) to Licensor’s knowledgeKnowledge, no Third Party has filed, pursued or maintained or threatened in writing to file, pursue or maintain any claim, lawsuit, charge, complaint or other action alleging that any Licensor Technology Patent is invalid or unenforceable;
(ix) to Licensor’s Knowledge, Merck’s and its Affiliates’ and Sublicensees’ practice and use of the inventions claimed in, or covered by, the Licensor Patents as the Product has been Developed by Licensor prior to the Effective Date (and, in conjunction with the exercise of the Option, the Option Exercise Date), will not infringe any intellectual property rights of any Third Party;
(x) all Representatives of Licensor who have performed any activities on its behalf in connection with research regarding the Product have assigned to Licensor the whole of their rights in any intellectual property made, discovered or developed by them as a result of such research, and no Third Party has any rights to any such intellectual property except as provided in an Existing Third Party Agreement;
(xi) Licensor has all right, title and interest in and to the Licensor Technology and Licensor Technology is free and clear of any liens, charges, encumbrances or rights of others to possession or use, except for those existing liens for secured creditors that are identified on Schedule 11.2;
(xii) Licensor has not previously licensed, assigned, transferred, or otherwise conveyed any right, title or interest in and to the Licensor Technology to any Third Party, including any rights with respect to Product, in conflict with the option or license rights granted herein;
(xiii) the Licensor Technology constitutes all of the intellectual property of Licensor, which, to the Knowledge of Licensor as of the Effective Date (and, in conjunction with the exercise of the Option, the Option Exercise Date) could reasonably be expected to be necessary or useful in the research, Development, manufacture, import, export, use or Commercialization of Product in the Field;
(xiv) Licensor has the right, power and authority to grant to Merck the rights granted to Merck hereunder with respect to the Existing Third Party Agreements. In particular, the grant of such sublicense requires no consent, waiver or other action by any party to the Existing Third Party Agreements and the rights and obligations of Merck set forth in this Agreement do not contravene nor are they inconsistent with or in conflict with the terms of any Existing Third Party Agreement;
(xv) The Existing Third Party Agreements constitute all agreements with Third Parties pursuant to which Licensor has in-licensed, or otherwise obtained rights, with respect to the Product. Licensor has provided to Merck an accurate, true and complete copy of each of the Existing Third Party Agreements, as amended to date and each of the Existing Third Party Agreements is in full force and effect and Licensor is not in breach or default in the performance of its obligations under any of the Existing Third Party Agreements. Licensor has not received any notice from any Third Party of any breach, default or non-compliance of Licensor under the terms of any of the Existing Third Party Agreements. There have been no amendments or other modification to any Existing Third Party Agreements, except as have been disclosed to Merck in writing;
(xvi) except as set forth on Schedule 11.2(xvi), Licensor is not aware of any additional Third Party licenses that have to be taken now or in the future to guarantee freedom-to-operate to Develop, manufacture and Commercialize Products without any limitation;
(xvii) all tangible information and data provided by or on behalf of Licensor to Merck on or before, on the Effective Date, the Effective Date, and on the Option Exercise Date, the Option Exercise Date, in contemplation of entering into this Agreement as of the Effective Date (and, in conjunction with the exercise of the Option, the Option Exercise Date) was and is true, accurate and complete in all material respects, and Licensor has not failed to disclose, or cause to be disclosed, any information or data that would cause the information and data that has been disclosed to be misleading in any material respect;
(xviii) Licensor (and its Affiliates) has not employed or otherwise used in any capacity, and will not employ or otherwise use in any capacity, the services of any Person debarred under United States law, including under Section 21 USC 335a or any foreign equivalent thereof, with respect to the Product (including in the context of performing the Abili-T Trial);
(xix) all research and development (including non-clinical studies, Clinical Studies and the Abili-T Trial) related to the Product prior to the Effective Date (and, in conjunction with the exercise of the Option, the Option Exercise Date), has been conducted in accordance with all Laws;
(xx) no Governmental Authority has notified Licensor or its Affiliates, and Licensor is not otherwise aware, that the Development, manufacture, use or Commercialization of Product was or is in violation of any Law or the subject of any investigation;
(xxi) Licensor has not received notice from any Regulatory Authority and is not otherwise aware that there are any circumstances currently existing which would reasonably be expected to lead to: (1) any loss of or refusal to renew any Regulatory Approvals relating to Product; (2) renewal on terms less advantageous to Licensor or any of its Affiliates, if applicable, or any subsequent holder thereof, than the terms of those Regulatory Approvals currently in force; (iii) recall, withdrawal, suspensions or seizure of Product; or (iv) an action to enjoin production of Product;
(xxii) Licensor has delivered to Merck copies of all: (1) reports of FDA Form 483 inspection observations, or any equivalent report by inspectors or officials from any other Regulatory Authority of any situation requiring attention or correction or of conditions or circumstances that are objectionable or otherwise in contrary to Law; (2) FDA Notices of Adverse Findings or any equivalent correspondence, notice or communication from any other Regulatory Authority indicating a failure to comply with Law or other requirements; (3) establishment inspection reports; (4) warning letters or untitled letters; and (v) other documents that assert ongoing lack of compliance in any material respect with any Law or regulatory requirements (including those of the FDA), in each case received by Licensor from the FDA or any other Regulatory Authority relating to Product or arising out of the conduct of Licensor’s business relating to Product; and
(xxiii) Licensor and each of its Affiliates, as applicable, has made all necessary filings and received all necessary approvals and consents for the conduct of all Clinical Trials performed by it or them with respect to Product from the necessary Regulatory Authorities and: (1) Licensor is not aware of any proceedings or actions threatened or taken by any Regulatory Authorities to suspend or terminate any ongoing Clinical Trials for Product; (2) Licensor has not received any notice, charge, subpoena or other request for information, which has not been complied with or withdrawn, by a Regulatory Authority asserting any material breach of the conditions for approval of any ongoing Clinical Trials; and (3) Licensor and its Affiliates, as applicable, have conducted all Clinical Trials for Product pursuant to valid protocols, and have received no notice or indication, in writing or orally, from any Regulatory Authority to the effect that any such protocol is not sufficient to support approval of Product or any Indications for Product.
Appears in 1 contract
Samples: Option and License Agreement (Opexa Therapeutics, Inc.)
Additional Representations and Warranties of Licensor. Licensor represents hereby represents, warrants, and warrants covenants (as applicable) to Coronado Licensee that as of the Effective Date thatDate:
(a) No consent by any Third Party or Governmental Body is required with respect to the execution and delivery of this Agreement by Licensor or the consummation by Licensor of the transactions contemplated hereby[***];
(b) The Licensor has not granted, and will not grant during the Term, any license or right in the Licensed Technology is wholly-owned by Licensor, free that are inconsistent with the licenses and clear of all mortgages, pledges, charges, liens, equities, security interests, shop rights, or other encumbrances or similar agreements, or any other obligationrights granted to Licensee under this Agreement;
(c) To Licensor’s knowledge, no claims have been asserted or threatened by any Person (i) challenging the validity, effective status, or ownership of Licensor Technology, and/or (ii) to the effect that the use, reproduction, modification, manufacturing, distribution, licensing, sublicensing, sale or any other exercise of rights in any of Licensor Technology infringes or will infringe on any intellectual property right of any Person; and no such claims have been asserted or are threatened;
(d) To Licensor’s knowledge, the Licensor Patents are subsisting and are not the subject of any litigation procedure, discovery process, interference, reissue, reexamination, opposition, appeal proceedings or any other legal dispute;
(e) Licensor and its Affiliates have taken all reasonable actions necessary not received any written notice from any Third Party asserting or appropriate alleging that the research, Development, or manufacture of the Compound or Product infringed or misappropriated the intellectual property rights of such Third Party;
(d) [***];
(e) there are no pending or, to preserve the confidentiality knowledge of all trade secretsLicensor and its Affiliates, proprietary and other confidential information material to alleged or threatened, adverse actions, suits, proceedings, or claims against Licensor or its Affiliates involving the Licensed Technology, Compound, or Product;
(f) Neither Licensor nor any Affiliate thereof is and its Affiliates are not aware of any Third Party activities which would constitute infringement or misappropriation or infringement of any Licensor TechnologyLicensed Technology by any Third Party;
(g) The Licensor Patents constitute Exhibit B includes all Patent Rights owned or Controlled by Licensor and its Affiliates as of the Effective Date that pertain directly claim or cover the Compound or Product (including composition of matter and particularly methods of making and using the Compound and Product) as they exist as of the Effective Date;
(h) there is no pending or, or to the researchknowledge of Licensor and its Affiliates, Developmentalleged or threatened, manufacturere-examination, use opposition, interference, or litigation, or any written communication alleging that any Licensed Patent is invalid or unenforceable anywhere in the world;
(i) all application, registration, maintenance, and Commercialization renewal fees in respect of the Licensed ProductsPatents have been paid and all necessary documents and certificates for the purpose of maintaining the Licensed Patents have been filed with the applicable Government Authority, except as would not have an adverse effect;
(j) Licensor and its Affiliates (including their contractors) have complied with all applicable Laws in connection with the Development of the Compound and Product, except as would not have an adverse effect, and have not used any employee, consultant, or contractor who has been debarred by any Regulatory Authority, or to its knowledge, is the subject of a debarment proceeding by any Regulatory Authority; and
(hk) To Licensor’s knowledgeLicensor has provided Licensee with complete and accurate copies of all INDs held by Licensor for the Product;
(l) all Regulatory Materials filed by Licensor with respect to the Product were, no Third Party at the time of filing, true, complete and accurate, except as would not have an adverse effect;
(m) Licensor has fileddisclosed all material facts required to be disclosed with respect to the Product to each applicable Regulatory Authority, pursued or maintained or threatened in writing and Licensor has filed with the applicable Regulatory Authority all material and required notices, and all required reports and other Regulatory Materials with respect to file, pursue or maintain each IND held by Licensor for the Product;
(n) Licensor has not received any claim, lawsuit, charge, complaint written notice from any Regulatory Authority or other action alleging Governmental Authority commencing or threatening withdrawal of any active IND for the Product held by Licensor;
(o) all Product manufactured by Licensor for use in clinical trials of the Product has been manufactured in accordance with cGMPs; and
(p) all information provided by Licensor or its Affiliates to Licensee for due diligence purposes in relation to this Agreement is complete and accurate in all material respects. Without limiting the foregoing, Licensor and its Affiliates have disclosed to Licensee, and made available to Licensee for review, all material data for the Compound and Product and all other material information (including relevant correspondence with Regulatory Authorities) relating to the Compound and Product, in each case that any Licensor Technology is invalid or unenforceablewould be material for Licensee to assess the safety and efficacy of the Compound and Product.
Appears in 1 contract
Additional Representations and Warranties of Licensor. Licensor hereby represents and warrants to Coronado Xxxxxxx that, as of the Effective Date thatExecution Date:
(a) No consent by any Third Party or Governmental Body 8.2.1 Licensor is required with respect to the execution sole and delivery of this Agreement by Licensor or the consummation by Licensor exclusive owner of the transactions contemplated hereby;
(b) The Licensor Technology is wholly-owned by LicensorLicensed Technology, free and clear of all mortgages, pledges, charges, any liens, equities, security interests, shop rights, charges or other encumbrances or similar agreements, or any other obligationencumbrances;
(c) To Licensor’s knowledge, no claims have been asserted or threatened by any Person 8.2.2 Licensor has all rights necessary to grant the licenses under the Licensed Technology that it grants to Xxxxxxx under this Agreement;
8.2.3 Licensor has not previously (i) challenging the validitylicensed, effective statusassigned, transferred, or ownership of Licensor otherwise conveyed any right, title or interest in, to or under the Licensed Technology, and/or or (ii) otherwise granted any rights under the Licensed Technology, in each case ((i) and (ii)), to any Third Party, in any way that would conflict with or limit the effect scope of the licenses and rights granted to Xxxxxxx under this Agreement;
8.2.4 the Patents listed in Schedule 1.58 include all Patents that Licensor or any of its Affiliates owns or Controls as of the Execution Date that Cover, claim or disclose (a) any Licensed Compound or Licensed Product or (b) any method of use, reproduction, modification, manufacturing, distribution, licensing, sublicensing, sale method of treatment or any other exercise method of rights in any of Licensor Technology infringes or will infringe on any intellectual property right manufacture of any Person; and no such claims have been asserted Licensed Compound or are threatenedLicensed Product. Schedule 1.58 lists all Existing Licensed Patents;
(d) To 8.2.5 to Licensor’s knowledge, the Licensor Existing Licensed Patents are subsisting and are, or, upon issuance, will be, valid and enforceable patents; CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
8.2.6 Licensor has (i) complied in all material respects with all applicable Laws, including all disclosure requirements and requirements to properly identify inventors, with respect to the Prosecution of the Existing Licensed Patents and (ii) timely paid all maintenance and annuity fees with respect to the Existing Licensed Patents;
8.2.7 Licensor has obtained assignments from the inventors of all inventorship rights relating to the Existing Licensed Patents, and all such assignments of inventorship rights are not valid and enforceable;
8.2.8 to the subject knowledge of Licensor, there is no pending or threatened claim (i) asserting the invalidity, misuse, unregisterability, unenforceability or non-infringement of any litigation procedureof the Existing Licensed Patents, discovery process(ii) challenging Licensor’s Control of the Existing Licensed Patents or making any adverse claim of ownership of the Existing Licensed Patents, interference, reissue, reexamination, opposition, appeal proceedings (iii) disputing the inventorship of any of the Existing Licensed Patents or (iv) otherwise relating to any other legal disputeLicensed Technology;
8.2.9 neither Licensor nor any of its Affiliates or their respective current or former employees has misappropriated any (ei) Know-How that is necessary or useful for, or actually used by or on behalf of Licensor at any time prior to the Execution Date with respect to, the Exploitation of the Licensed Compounds or Licensed Products, or (ii) Licensed Know-How, in each case ((i) and (ii)), from any Third Party, and Licensor is not aware of any claim by a Third Party that any such misappropriation has occurred;
8.2.10 Licensor and its Affiliates have taken commercially reasonable measures consistent with industry practices to protect the secrecy, confidentiality and value of Licensed Know-How that constitutes trade secrets under applicable Law and has required all reasonable actions necessary or appropriate employees, consultants and independent contractors to preserve execute binding and enforceable agreements requiring all such employees, consultants and independent contractors to maintain the confidentiality of all trade secrets, proprietary and other confidential information material to Licensor Technologysuch Licensed Know-How;
8.2.11 to the knowledge of Licensor, the Exploitation of the Licensed Compounds and Licensed Products, and the use, practice or application of the Licensed Technology as contemplated under this Agreement, does not and will not (fi) Neither Licensor nor infringe any Affiliate thereof is aware Patent of any Third Party activities which existing as of the Execution Date (or, with respect to any pending patent application existing as of the Execution Date, would constitute misappropriation not infringe such patent if it were to issue without modification) or infringement (ii) misappropriate the Know-How or other intellectual property of any Third Party. No Third Party has made any claim or threatened in writing to Licensor Technology
(g) The Licensor Patents constitute all Patent Rights owned or Controlled by Licensor that pertain directly and particularly its Affiliates to the research, Development, manufacture, use and Commercialization make any claim alleging either of the Licensed Products; andforegoing ((i) or (ii));
(h) To 8.2.12 to Licensor’s knowledge, no Third Party is infringing or threatening to infringe, or misappropriating or threatening to misappropriate, any of the Licensed Technology;
8.2.13 Licensor has filedprepared, pursued maintained and retained all Regulatory Documentation for the Licensed Products pursuant to and in accordance in all material respects with all applicable Law, including, as applicable, GLP, and Licensor has not, to its knowledge, made any false and misleading statements in connection with submitting or maintained obtaining such Regulatory Documentation;
8.2.14 Licensor has conducted, and has used reasonable efforts to cause its contractors and consultants to conduct, the Exploitation of the Licensed Compounds and Licensed Products in accordance in all material respects with applicable Law, professional scientific standards, accepted ethical standards, including, as applicable, GCP, GMP and GLP, and applicable experimental protocols, procedures and controls;
8.2.15 no adverse event involving human subjects has occurred in connection with any study, test, pre-clinical trial or threatened Clinical Study of a Licensed Compound or Licensed Product;
8.2.16 all personal data and biological specimens collected from or disclosed by human subjects in writing Clinical Studies of the Licensed Products has been collected, used, processed and disclosed in compliance with applicable Law, and Licensor has secured all patient consents reasonably required to filedisclose such personal data and biological specimens to Xxxxxxx in accordance with this Agreement; CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, pursue or maintain any AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
8.2.17 there is no claim, lawsuitaction, chargesuit, complaint arbitration, inquiry, audit or investigation by or before any Governmental Authority pending or, to the knowledge of Licensor, threatened against Licensor or its Affiliates, or involving any of the Licensed Compounds or Licensed Products. There is no award, stay, writ, judgement, injunction, decree or similar order of any Governmental Authority outstanding or, to Licensor’s knowledge, pending, with respect to Licensor or its Affiliates, or involving any of the Licensed Compounds or Licensed Products;
8.2.18 neither Licensor nor any of its Affiliates is or has been a party to any agreement with a Governmental Authority pursuant to which such Governmental Authority provided or may provide funding for the Development of any Licensed Compound or Licensed Product. None of the Licensed Patents or Licensed Know-How are or include any invention that was conceived or first actually reduced to practice in the performance of work under a funding agreement between Licensor and the U.S. government or any other action alleging Governmental Authority;
8.2.19 Schedule 1.29 sets forth a true and complete list of all agreements whereby Licensor or any of its Affiliates has in-licensed any Licensed Technology or any other rights that are relevant to the Licensed Compounds or Licensed Products;
8.2.20 neither Licensor nor any of its Affiliates is party to any agreement with a Third Party in effect on the Execution Date pursuant to which Licensor Technology (or its respective Affiliates) is invalid obligated to pay any amount to such Third Party with respect to the Exploitation of Licensed Compounds or unenforceableLicensed Products;
8.2.21 Licensor has provided to Xxxxxxx, prior to the Execution Date, true, complete and correct copies of all material agreements related to the Licensed Compounds or the Licensed Products;
8.2.22 Exhibits 1.56(a) and 1.56(b) collectively set forth all small molecules that have been demonstrated by or on behalf of Licensor to [***] prior to the Execution Date; and
8.2.23 Licensor has made available to Xxxxxxx all material information in Licensor’s or its Affiliate’s control relating to the Licensed Compounds or Licensed Products, including complete and correct copies of the following, if any: (a) adverse event reports; (b) clinical study reports and material study data; and (c) Regulatory Authority inspection reports, notices of adverse findings, warning letters, regulatory filings and other material correspondence with Regulatory Authorities.
Appears in 1 contract