Additional Representations, Warranties and Covenants of Licensor. In addition to the representations, warranties and covenants made by Licensor elsewhere in this Agreement, Licensor hereby represents, warrants and covenants as of the Effective Date that (i) The Licensor Technology constitutes all of the intellectual property owned or Controlled by Licensor that would, but for the rights granted to Licensee pursuant to this Agreement, be infringed or misappropriated by the exercise by Licensee of its rights under this Agreement. (ii) As of the Effective Date, (i) the Licensor Patent Rights exist and are not invalid or unenforceable, in whole or in part, (ii) Licensor is the sole and exclusive owner of all right, title and interest in and to the Licensor Technology, and (iii) the Licensor Technology is free and clear of any liens, charges and encumbrances. As of the Effective Date Licensor has no knowledge of any claim made against it (x) asserting the invalidity, misuse, unregisterability or unenforceability of any of the Licensor Patent Rights or (y) challenging Licensor’s Control of the Licensor Technology or making any adverse claim of ownership of the Licensor Technology. (iii) As of the Effective Date, no regulatory activities related to the Licensed Product are being or have been undertaken by or on behalf of Licensor in the Territory. (iv) As of the Effective Date there are no agreements between Licensor and Third Parties pursuant to which Licensor has rights and/or obligations with respect to any Licensor Technology that it is sublicensing to Licensee under this Agreement (“Third Party Agreements”). If at any time during the Term Licensor enters into any Third Party Agreements, Licensor will ensure that it is able to grant, and will maintain the ability to grant throughout the Term the License and other rights granted under this Agreement to all the Licensor Technology. (v) As of the Effective Date, (i) Licensor has no knowledge of any Patent Rights (other than the Licensor Patent Rights) that may be infringed by the manufacture, use or sale of Licensed Products, (ii) no claim of infringement of the Patent Rights of any Third Party that has been made nor, to Licensor’s knowledge, is threatened against Licensor or any of its Affiliates with respect to the development, manufacture, sale or use of Licensed Products, and (iii) Licensor has no knowledge of other claims, judgments or settlements against or owed by Licensor or to which Licensor is a party or pending or threatened claims or litigation, in either case relating to any Licensed Product. As of the Effective Date, Licensor has no knowledge that Licensor or any of its Affiliates or their respective current or former employees has misappropriated any of the Licensor Know How from any Third Party, and Licensor has no knowledge of any claim by a Third Party that such misappropriation has occurred. - 51 - of - 75 - (vi) As of the Effective Date, Licensor has no knowledge of any activities by Third Parties that would constitute infringement or misappropriation of the Licensor Technology. (vii) As of the Effective Date, and to Licensor’s knowledge, the Exploitation of the Licensed Product by or on behalf of Licensor or its Affiliates has been conducted in accordance with all applicable Laws and Regulations in the past and Licensor will implement and comply with corporate policies so that all Exploitation of the Licensed Product by or on behalf of Licensor or its Affiliates in the Field outside the Territory or outside the Field will be conducted in accordance with applicable Laws and Regulations in the future. (viii) Neither Licensor nor any of its Affiliates has been Debarred and, in the course of its research, development or manufacture of products, Licensor, its Affiliates, their respective officers, and any person or entity engaged by Licensor or its Affiliates, have not used, and during the Term will not use in performing any activities pursuant to this Agreement, any person or entity who is or has been Debarred by the FDA or equivalent regulatory authorities or who, to the best knowledge of Licensor, its Affiliates or any such person or entity engaged by Licensor or its Affiliates, is the subject of Debarment proceedings by the FDA or equivalent regulatory authorities. Licensor agrees to notify Licensee in writing immediately if Licensor or its Affiliates, or any of their respective officers, or any person or entity used by Licensor or its Affiliates under this Agreement, is subject to any of the foregoing, or if any action, suit, claim, investigation, or proceeding relating to the foregoing is pending, or to the best knowledge of Licensor, its Affiliates or any such person or entity engaged by Licensor or its Affiliates, is threatened. (ix) As of the Effective Date, to Licensor’s knowledge, Licensor and its Affiliates have the financial and organizational capabilities and experience to perform Licensor’s obligations under this Agreement and Licensor and its Affiliates will maintain financial and organizational capabilities to perform Licensor’s obligations under this Agreement. (x) Licensor will grant sublicenses to the Licensee Technology in strict compliance with the provisions set forth in Section 2.9.
Appears in 2 contracts
Samples: Exclusive License and Collaboration Agreement (Nanobiotix S.A.), Exclusive License and Collaboration Agreement (Nanobiotix S.A.)
Additional Representations, Warranties and Covenants of Licensor. In addition to the representations, warranties and covenants made by Licensor elsewhere in this Agreement, Licensor hereby represents, represents and warrants and covenants as of the Effective Date and, to the extent applicable, covenants, to Licensee that:
(i) The 10.2.1 Licensor Technology constitutes all has not filed any Marketing Authorization Applications with a Governmental Authority for the sale of the intellectual property owned or Controlled by Licensor that would, but for the rights granted to Licensee pursuant to this Agreement, be infringed or misappropriated by the exercise by Licensee of its rights under this AgreementProduct.
(ii) As of the Effective Date, (i) the Licensor Patent Rights exist and are not invalid or unenforceable, in whole or in part, (ii) 10.2.2 Licensor is the sole and exclusive owner of all right, title and interest in and to the Licensor Technology, Patents and (iii) owner or licensee of the Licensor Technology is Know-How and has full right and power to grant the licenses set forth in ARTICLE 2, free and clear of any liensadverse assignment, charges grant, restriction on use or other encumbrances inconsistent with such grant, in the manner, for the duration of and encumbrances. As to the extent set forth in this Agreement, except such non-exclusive rights as have been granted to Third Parties solely to perform their obligations to Licensor under the On-Going Agreements or in connection with the performance of the Effective Date On-Going Studies or POC Study.
10.2.3 Licensor has no knowledge of complied with all Applicable Laws in all material respects, including any claim made against it (x) asserting disclosure requirements, in connection with the invalidityfiling, misuse, unregisterability or unenforceability of any prosecution and maintenance of the Licensor Patent Rights Patents owned by Licensor.
10.2.4 Neither Licensor nor, to the knowledge of Licensor, its subcontractors, has received written notice of any action, suit, investigation or (y) challenging proceedings pending before or threatened by any Governmental Authority with respect to the Compound and/or the Product.
10.2.5 To the best of Licensor’s Control knowledge, the use and practice of the Licensor Technology or making any adverse claim of ownership and the Development, Manufacture, and Commercialization of the Compound and Product (as the Product and Compound (i) are described and/or claimed in the Licensor Technology.
Patents and (iiiii) As of the Effective Date, no regulatory activities related to the Licensed Product are being or have been undertaken Developed and Manufactured by or on behalf of Licensor in the Territory.
(iv) As of the Effective Date there are no agreements between Licensor and Third Parties pursuant to which Licensor has rights and/or obligations with respect to any Licensor Technology that it is sublicensing to Licensee under this Agreement (“Third Party Agreements”). If at any time during the Term Licensor enters into any Third Party Agreements, Licensor will ensure that it is able to grant, and will maintain the ability to grant throughout the Term the License and other rights granted under this Agreement to all the Licensor Technology.
(v) As as of the Effective Date, (i) Licensor has no knowledge do not infringe the intellectual property rights of any Patent Rights (other than the Licensor Patent Rights) that may be infringed by the manufacture, use or sale of Licensed Products, (ii) no claim of infringement of the Patent Rights of any Third Party that has been made nor, to Licensor’s knowledge, is threatened against Licensor or any of its Affiliates with respect to the development, manufacture, sale or use of Licensed Products, and (iii) Licensor has no knowledge of other claims, judgments or settlements against or owed by Licensor or to which Licensor is a party or pending or threatened claims or litigation, in either case relating to any Licensed Product. As of the Effective Date, Licensor has no knowledge that Licensor or any of its Affiliates or their respective current or former employees has misappropriated any of the Licensor Know How from any Third Party, and Licensor has no knowledge of any claim by a Third Party has made any assertion in writing to the contrary.
10.2.6 To Licensor’s knowledge, (i) no Third Party is infringing any Licensor Patents], and (ii) [no Third Party has challenged the scope, duration, validity, enforceability, priority, or Licensor’s right to use or license any Licensor Patent.
10.2.7 Other than the Licensor Patents and Licensor Know-How, (i) none of Licensor nor any of its Affiliates nor employees owns or holds any rights with respect to any Patent or Know-How that such misappropriation has occurred. - 51 - is necessary for, or would be infringed by, the Development, Manufacture or Commercialization of - 75 -
the Compound or Royalty Products, and (viii) As none of Licensor’s subcontractors owns or holds any rights with respect to any issued Patent that is necessary for, or would be infringed by, the Development, Manufacture or Commercialization of the Compound or Product (as the Product and Compound (x) are described and/or claimed in the Licensor Patents and (y) are being Developed and Manufactured by or on behalf of Licensor as of the Effective Date).
10.2.8 Except with respect to Licensor Know-How that was generated prior to Licensor coming to Control the Compound and Product and that was never in Licensor’s possession (“External Know-How”), all Licensor has no knowledge of any activities by Third Parties that would constitute infringement or misappropriation Know-How existing as of the Effective Date has been made available to Licensee, or will be made available to Licensee in accordance with the Technology Transfer Plan, and, to Licensor’s best knowledge, is free from any material inaccuracies. If Licensee or Licensor Technology.
(vii) As becomes aware of the existence of such External Know-How after the Effective Date, then upon request by Licensee, Licensor shall provide reasonable assistance to Licensee in locating and acquiring access to Licensor’s knowledge, such External Know-How from the Exploitation entity in possession of such External Know-How.
10.2.9 None of the Licensed Product Confidential Information relating to Licensor Know-How has been disclosed to any Third Party other than under written confidentiality and non-use commitments.
10.2.10 To the best of the knowledge of Licensor, all raw data developed by or on behalf of Licensor or its Affiliates has been conducted in accordance with all applicable Laws and Regulations in supporting Licensor Know-How or otherwise relating to the past Compound or the Product are available and Licensor will implement and comply with corporate policies so that all Exploitation free from any material inaccuracies.
10.2.11 To Licensor’s best knowledge, none of the Licensed Product by or on behalf of Licensor or its Affiliates in the Field outside the Territory or outside the Field will be conducted in accordance with applicable Laws materials and Regulations in the future.
(viii) Neither Licensor nor any of its Affiliates has been Debarred and, documents provided to Licensee in the course of its researchLicensee’s due diligence preceding execution of this Agreement contained any untrue statement of material fact.
10.2.12 Licensor has informed Licensee of any pre-clinical or clinical data or information concerning the Compound and/or the Product and that to the knowledge of Licensor reasonably suggests that there may exist quality, development or manufacture toxicity, safety and/or efficacy concerns which may materially impair the safety of products, Licensor, its Affiliates, their respective officersthe Compound and/or the Product.
10.2.13 Licensor has conducted all Development of the Compound and the Product prior to the Effective Date in accordance with sound and ethical business and scientific practices, and any person or entity engaged by Licensor or its Affiliatesin compliance with all Applicable Law, have not usedincluding GCPs and GLPs, and during also including all applicable data privacy and data protection laws. In addition, Licensor has not used in any capacity, in connection with the Term will not use in performing Development of the Compound and the Product prior to the Effective Date, any activities Person who has been debarred pursuant to this AgreementSection 306 of the FD&C Act (or similar Applicable Law outside of the U.S.), any person or entity who is or has been Debarred by the FDA or equivalent regulatory authorities or who, to the best knowledge of Licensor, its Affiliates or any such person or entity engaged by Licensor or its Affiliates, is the subject of Debarment proceedings by the FDA or equivalent regulatory authorities. a conviction described in such section, and Licensor agrees to notify shall inform Licensee in writing immediately if Licensor or its Affiliates, it or any Person who has performed any such Development is debarred or is the subject of their respective officers, a conviction described in Section 306 (or any person or entity used by Licensor or its Affiliates under this Agreement, is subject to any similar Applicable Law outside of the foregoingU.S.), or if any action, suit, claim, investigation, investigation or legal administrative proceeding relating to the foregoing is pending, or to the best knowledge of Licensor, its Affiliates or any such person or entity engaged by Licensor or its Affiliates, is threatened.
(ix) As of the Effective Datepending or, to Licensor’s knowledge, is threatened, relating to the debarment of Licensor and or any Person used in any capacity by Licensee in connection with such Development.
10.2.14 Licensor has received no notice from S*BIO that it is in breach of any of its Affiliates have the financial and organizational capabilities and experience to perform Licensor’s obligations under this the S*BIO Agreement, and, as of the Effective Date, Licensor is not aware of any breach of the S*BIO Agreement nor of any other circumstance on which Licensor might cease to hold and enjoy the rights granted to it with respect to Licensor Technology under the S*BIO Agreement, and Licensor shall not amend, modify or waive any of its rights under the S*BIO Agreement in a manner that would have an adverse effect on the interests of Licensee hereunder without the prior written consent of Licensee.
10.2.15 Other than as has been made available to Licensee via [*CONFIDENTIAL*], and with the sole exceptions of that certain agreement in negotiation with [*CONFIDENTIAL*] and that certain [*CONFIDENTIAL*], there are no binding contracts or agreements to which Licensor is a Party, other than the S*BIO Agreement and Licensor and its Affiliates will maintain financial and organizational capabilities to perform Licensor’s obligations under this Agreementthe On-Going Agreements, [*CONFIDENTIAL*].
(x) Licensor will grant sublicenses to the Licensee Technology in strict compliance with the provisions set forth in Section 2.9.
Appears in 2 contracts
Samples: License, Development and Commercialization Agreement (MEI Pharma, Inc.), License, Development and Commercialization Agreement (MEI Pharma, Inc.)
Additional Representations, Warranties and Covenants of Licensor. In addition to the representations, warranties and covenants made by Licensor elsewhere in this Agreement, Licensor hereby represents, warrants warrants, and covenants (as applicable) to Licensee that, unless otherwise provided below, as of the Effective Date:
(a) Licensor solely owns or has a license under the Licensed Patents set forth in Exhibit A, free and clear of all liens, and has the right to grant to Licensee the licenses and rights as purported to be granted hereunder;
(b) Licensor has not granted, and Licensor will not grant during the Term, any license or right in the Licensed Technology that is inconsistent with the licenses and rights granted to Licensee under this Agreement;
(c) Licensor and its Affiliates will have provided the Licensee [***] and, to the knowledge of Licensor, [***];
(d) Licensor and its Affiliates have not received any written notice from any Third Party asserting or alleging that the Development or manufacture of the Product has infringed or misappropriated the intellectual property rights of such Third Party;
(e) there are no pending or, to the knowledge of Licensor and its Affiliates, alleged or threatened, adverse actions, suits, proceedings, or claims against Licensor or its Affiliates involving the Development, manufacture or Commercialization of the Product;
(f) Licensor and its Affiliates have no knowledge of any infringement or misappropriation of any Licensed Technology by any Third Party;
(g) to Licensor’s knowledge, Exhibit A includes all Patent Rights owned or controlled by Licensor and its Affiliates as of the Effective Date thatthat are necessary to Develop, manufacture, or Commercialize the Product in the Field in the Territory, as the Product exists as of the Effective Date;
(h) there is no pending or, or to the knowledge of Licensor and its Affiliates, alleged or threatened, re-examination, opposition, interference, or litigation, or any written communication alleging that any Licensed Patent is invalid or unenforceable anywhere in the world;
(i) The Licensor Technology constitutes all of the intellectual property owned or Controlled by Licensor that would, but for the rights granted to Licensee pursuant to this Agreement, be infringed or misappropriated by the exercise by Licensee of its rights under this Agreement.
(ii) As of the Effective Date, (i) the Licensor Patent Rights exist and are not invalid or unenforceable, in whole or in part, (ii) Licensor is the sole and exclusive owner of all right, title and interest in and to the Licensor Technology, and (iii) the Licensor Technology is free and clear of any liens, charges and encumbrances. As of the Effective Date Licensor has no knowledge of any claim made against it (x) asserting the invalidity, misuse, unregisterability or unenforceability of any of the Licensor Patent Rights or (y) challenging Licensor’s Control of the Licensor Technology or making any adverse claim of ownership of the Licensor Technology.
(iii) As of the Effective Date, no regulatory activities related to the Licensed Product are being or have been undertaken by or on behalf of Licensor in the Territory.
(iv) As of the Effective Date there are no agreements between Licensor and Third Parties pursuant to which Licensor has rights and/or obligations with respect to any Licensor Technology that it is sublicensing to Licensee under this Agreement (“Third Party Agreements”). If at any time during the Term Licensor enters into any Third Party Agreements, Licensor will ensure that it is able to grant, and will maintain the ability to grant throughout the Term the License and other rights granted under this Agreement to all the Licensor Technology.
(v) As of the Effective Date, (i) Licensor has no knowledge of any Patent Rights (other than the Licensor Patent Rights) that may be infringed by the manufacture, use or sale of Licensed Products, (ii) no claim of infringement of the Patent Rights of any Third Party that has been made nor, to Licensor’s knowledge, is threatened against Licensor or any of its Affiliates with respect to the development, manufacture, sale or use of Licensed Products, and (iii) Licensor has no knowledge of other claims, judgments or settlements against or owed by Licensor or to which Licensor is a party or pending or threatened claims or litigation, in either case relating to any Licensed Product. As of the Effective Date, Licensor has no knowledge that Licensor or any of its Affiliates or their respective current or former employees has misappropriated any of the Licensor Know How from any Third Party, and Licensor has no knowledge of any claim by a Third Party that such misappropriation has occurred. - 51 - of - 75 -
(vi) As of the Effective Date, Licensor has no knowledge of any activities by Third Parties that would constitute infringement or misappropriation of the Licensor Technology.
(vii) As of the Effective Date, and to Licensor’s knowledge, the Exploitation of the Licensed Product by or on behalf of Licensor or its Affiliates has been conducted in accordance with all applicable Laws and Regulations in the past and Licensor will implement and comply with corporate policies so that all Exploitation of the Licensed Product by or on behalf of Licensor or its Affiliates in the Field outside the Territory or outside the Field will be conducted in accordance with applicable Laws and Regulations in the future.
(viii) Neither Licensor nor any of its Affiliates has been Debarred and, in the course of its research, development or manufacture of products, Licensor, its Affiliates, their respective officers, and any person or entity engaged by Licensor or its Affiliates, have not used, and during the Term will not use in performing any activities pursuant to this Agreement, any person or entity who is or has been Debarred by the FDA or equivalent regulatory authorities or who, to the best knowledge of Licensor, its Affiliates or any such person or entity engaged by Licensor or its Affiliates, is the subject of Debarment proceedings by the FDA or equivalent regulatory authorities. Licensor agrees to notify Licensee in writing immediately if Licensor or its Affiliates, or any of their respective officers, or any person or entity used by Licensor or its Affiliates under this Agreement, is subject to any of the foregoing, or if any action, suit, claim, investigation, or proceeding relating to the foregoing is pending, or to the best knowledge of Licensor, its Affiliates or any such person or entity engaged by Licensor or its Affiliates, is threatened.
(ix) As of the Effective Date, to Licensor’s knowledge, Licensor and its Affiliates (including their contractors) have complied with all applicable Laws in connection with the financial and organizational capabilities and experience Development of the Product; and
(j) to perform Licensor’s obligations under this knowledge, Licensor has not committed a material breach of the Inserm License Agreement, the Inserm License Agreement is in full force and effect and Licensor has the full right and its Affiliates will maintain financial and organizational capabilities authority to perform Licensor’s obligations grant to Licensee the sublicense under the rights granted to Licensor under the Inserm License Agreement that Licensor purports to grant to Licensee under this Agreement.
(x) Licensor will grant sublicenses to the Licensee Technology in strict compliance with the provisions set forth in Section 2.9.
Appears in 1 contract
Additional Representations, Warranties and Covenants of Licensor. In addition to the representations, warranties and covenants made by Licensor elsewhere in this Agreement, Licensor hereby represents, warrants and covenants as to Myriad that:
(a) Licensor is a corporation duly organized, validly existing and in good standing under the laws of the Effective Date that
(i) The Licensor Technology constitutes all of state in which it is incorporated, and it has full corporate power and authority and the intellectual legal right to own and operate its property owned or Controlled and assets and to carry on its business as it is now being conducted and as is contemplated to be conducted by Licensor that would, but for the rights granted to Licensee pursuant to this Agreement, be infringed or misappropriated by the exercise by Licensee of its rights under this Agreement.
(iib) As Licensor has successfully conducted and completed the clinical portion (but not all related documentation) of four (4) clinical trials with respect to the Licensed Product. Licensor has conducted, or has caused its contractors or consultants to conduct, any and all preclinical and clinical studies related to the Licensed Compound and the Licensed Product in accordance with applicable known or published standards of the FDA. Licensor has employed individuals of appropriate education, knowledge, and experience to conduct or to oversee the conduct of the preclinical and clinical studies with respect to the Licensed Product performed as of the Effective Date, .
(ic) the Licensor Patent Rights exist has not been debarred and are is not invalid or unenforceablesubject to debarment and Licensor has not used in any capacity, in whole connection with the development of the Licensed Compound, any person 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 part, such section.
(iid) Licensor is the sole exclusive licensee of the Patent Rights listed on Exhibit 1 attached hereto. True and exclusive owner correct copies of all rightlicense agreements between Licensor and any Third Party regarding the Patents Rights listed on Exhibit 1, title and interest in and as amended to the date hereof, have been provided to Myriad. The Patent Rights listed on Exhibit 1 constitute all of the Patent Rights that Licensor Technologyand its Affiliates own, and have under license or have a right to acquire (iiiby option or otherwise) that are necessary or useful for, or otherwise related to, the research, development, modification, improvement, Manufacture, use, import, or sale of the Licensed Compound or the Licensed Product or the use of the Manufacturing Processes. During the term of this Agreement, Licensor Technology is free and clear shall use its best efforts not to encumber or diminish the rights granted to Myriad hereunder, including, without limitation, by not committing any acts or permitting the occurrence of any liens, charges and encumbrancesomissions that would cause the breach or termination of any In-License Agreement. Licensor shall promptly provide Myriad with notice of any alleged breach of any In-License Agreement. As of the Effective Date date hereof, Licensor has no knowledge of any claim made against it (x) asserting the invalidity, misuse, unregisterability or unenforceability of any is not in breach of the Licensor Patent Rights or (y) challenging Licensor’s Control of the Licensor Technology or making any adverse claim of ownership of the Licensor Technology.
(iii) As of the Effective Date, no regulatory activities related to the Licensed Product are being or have been undertaken by or on behalf of Licensor in the Territory.
(iv) As of the Effective Date there are no agreements between Licensor and Third Parties pursuant to which Licensor has rights and/or obligations with respect to any Licensor Technology that it is sublicensing to Licensee under this Agreement (“Third Party Agreements”). If at any time during the Term Licensor enters into any Third Party Agreements, Licensor will ensure that it is able to grant, and will maintain the ability to grant throughout the Term the LLUMC License and other rights granted under this Agreement to all the Licensor Technology.
(v) As of the Effective Date, (i) Licensor has no knowledge of any Patent Rights (other than the Licensor Patent Rights) that may be infringed by the manufacture, use or sale of Licensed Products, (ii) no claim of infringement of the Patent Rights of any Third Party that has been made nor, to Licensor’s knowledge, is threatened against Licensor or any of its Affiliates with respect to the development, manufacture, sale or use of Licensed Products, and (iii) Licensor has no knowledge of other claims, judgments or settlements against or owed by Licensor or to which Licensor is a party or pending or threatened claims or litigation, in either case relating to any Licensed Product. As of the Effective Date, Licensor has no knowledge that Licensor or any of its Affiliates or their respective current or former employees has misappropriated any of the Licensor Know How from any Third Party, and Licensor has no knowledge of any claim by a Third Party that such misappropriation has occurred. - 51 - of - 75 -
(vi) As of the Effective Date, Licensor has no knowledge of any activities by Third Parties that would constitute infringement or misappropriation of the Licensor Technology.
(vii) As of the Effective Date, and to Licensor’s knowledge, the Exploitation of the Licensed Product by or on behalf of Licensor or its Affiliates has been conducted in accordance with all applicable Laws and Regulations in the past and Licensor will implement and comply with corporate policies so that all Exploitation of the Licensed Product by or on behalf of Licensor or its Affiliates in the Field outside the Territory or outside the Field will be conducted in accordance with applicable Laws and Regulations in the future.
(viii) Neither Licensor nor any of its Affiliates has been Debarred and, in the course of its research, development or manufacture of products, Licensor, its Affiliates, their respective officers, and any person or entity engaged by Licensor or its Affiliates, have not used, and during the Term will not use in performing any activities pursuant to this Agreement, any person or entity who is or has been Debarred by the FDA or equivalent regulatory authorities or who, to the best knowledge of Licensor, its Affiliates or any such person or entity engaged by Licensor or its Affiliates, is the subject of Debarment proceedings by the FDA or equivalent regulatory authorities. Licensor agrees to notify Licensee in writing immediately if Licensor or its Affiliates, or any of their respective officers, or any person or entity used by Licensor or its Affiliates under this Agreement, is subject to any of the foregoing, or if any action, suit, claim, investigation, or proceeding relating to the foregoing is pending, or to the best knowledge of Licensor, its Affiliates or any such person or entity engaged by Licensor or its Affiliates, is threatened.
(ix) As of the Effective Date, to Licensor’s knowledge, Licensor and its Affiliates have the financial and organizational capabilities and experience to perform Licensor’s obligations under this Agreement and Licensor and its Affiliates will maintain financial and organizational capabilities to perform Licensor’s obligations under this Agreement.
(x) Licensor will grant sublicenses to the Licensee Technology in strict compliance with the provisions set forth in Section 2.9.
Appears in 1 contract
Samples: License and Collaboration Agreement (Myriad Genetics Inc)
Additional Representations, Warranties and Covenants of Licensor. In addition Licensor represents and warrants to the representations, warranties and covenants made by Licensor elsewhere in this Agreement, Licensor hereby represents, warrants and covenants AUM as of the Effective Date that:
(a) 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 of any Person; no such claims have been asserted or are threatened; and to the best of Licensor’s knowledge and belief after making reasonable enquiry, no circumstances exist which might reasonably lead to such a claim;
(b) The Licensor Technology constitutes 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;
(c) The Licensor Patents set out in Schedule 2 constitute all of the intellectual property Patent Rights owned or Controlled by Licensor that would, but for the rights granted to Licensee pursuant to this Agreement, be infringed or misappropriated by the exercise by Licensee of its rights under this Agreement.
(ii) As of the Effective Date, (i) the Licensor Patent Rights exist and are not invalid or unenforceable, in whole or in part, (ii) Licensor is the sole and exclusive owner of all right, title and interest in and to the Licensor Technology, and (iii) the Licensor Technology is free and clear of any liens, charges and encumbrances. As of as at the Effective Date Licensor has no knowledge of any claim made against it (x) asserting that pertain to the invalidityresearch, misuseDevelopment, unregisterability or unenforceability of any manufacture, use and Commercialization of the Licensor Patent Rights or (y) challenging Licensed Products in the Field and in the Territory as currently envisioned and are each owned by the Licensor’s Control of the Licensor Technology or making any adverse claim of ownership of the Licensor Technology.;
(iiid) As of the Effective Date, no regulatory activities related to the Licensed Product are being The Licensor Know-How set out in Schedule 2 constitutes all Know-How owned or have been undertaken Controlled by or on behalf of Licensor in the Territory.
(iv) As of as at the Effective Date there are no agreements between Licensor and Third Parties pursuant that is material to which Licensor has rights and/or obligations with respect to any Licensor Technology that it is sublicensing to Licensee under this Agreement (“Third Party Agreements”). If at any time during the Term Licensor enters into any Third Party Agreementsresearch, Licensor will ensure that it is able to grantDevelopment, and will maintain the ability to grant throughout the Term the License and other rights granted under this Agreement to all the Licensor Technology.
(v) As of the Effective Date, (i) Licensor has no knowledge of any Patent Rights (other than the Licensor Patent Rights) that may be infringed by the manufacture, use or sale of Licensed Products, (ii) no claim of infringement and Commercialization of the Patent Rights of any Third Party that has been made nor, Licensed Products in the Field and in the Territory as currently envisioned and is owned by the Licensor;
(e) There are no scientific or clinical facts known to Licensor’s knowledge, is threatened against Licensor or any of its Affiliates with respect that would materially and adversely affect the safety or efficacy of the Compounds that have not been disclosed to the development, manufacture, sale or use of Licensed Products, and AUM by Licensor; and
(iiif) Licensor has no knowledge of other claims, judgments or settlements against or owed by Licensor or to which Licensor is a party or pending or threatened claims or litigation, in either case relating person to any Licensed Product. As whom an offer of the Effective DateShares may be made without disclosure under a prospectus, Licensor has no knowledge that Licensor information memorandum or any of its Affiliates or their respective current or former employees has misappropriated any of other disclosure document under all laws applicable to Licensor and the Licensor Know How from any Third Partyoffer. Further, and Licensor has no knowledge of any claim by a Third Party that such misappropriation has occurred. - 51 - of - 75 -
(vi) As of the Effective Date, Licensor has no knowledge of any activities by Third Parties that would constitute infringement or misappropriation of the Licensor Technology.
(vii) As of the Effective Date, and to Licensor’s knowledge, the Exploitation of the Licensed Product by or on behalf of Licensor or its Affiliates has been conducted in accordance with all applicable Laws and Regulations in the past and Licensor will implement and comply with corporate policies so that all Exploitation of the Licensed Product by or on behalf of Licensor or its Affiliates in the Field outside the Territory or outside the Field will be conducted in accordance with applicable Laws and Regulations in the future.
(viii) Neither Licensor nor any of its Affiliates has been Debarred and, in the course of its research, development or manufacture of products, Licensor, its Affiliates, their respective officers, and any person or entity engaged by Licensor or its Affiliates, have not used, and during the Term will not use in performing any activities pursuant to this Agreement, any person or entity who is or has been Debarred by the FDA or equivalent regulatory authorities or who, to the best knowledge of Licensor, its Affiliates or any such person or entity engaged by Licensor or its Affiliates, is the subject of Debarment proceedings by the FDA or equivalent regulatory authorities. Licensor agrees to notify Licensee in writing immediately if Licensor or its Affiliates, or any of their respective officers, or any person or entity used by Licensor or its Affiliates under this Agreement, is subject to any Exhibit B, each Licensor subscribes for the Shares relying entirely upon their independent appraisal and assessment of the foregoing, or if any action, suit, claim, investigation, or proceeding relating to the foregoing is pending, or to the best knowledge of Licensor, its Affiliates or any such person or entity engaged by Licensor or its Affiliates, is threatenedall relevant matters.
(ix) As of the Effective Date, to Licensor’s knowledge, Licensor and its Affiliates have the financial and organizational capabilities and experience to perform Licensor’s obligations under this Agreement and Licensor and its Affiliates will maintain financial and organizational capabilities to perform Licensor’s obligations under this Agreement.
(x) Licensor will grant sublicenses to the Licensee Technology in strict compliance with the provisions set forth in Section 2.9.
Appears in 1 contract
Additional Representations, Warranties and Covenants of Licensor. In addition Licensor further represents and warrants to AbbVie, as of the representationsEffective Date, warranties and covenants made by as follows:
11.2.1 All Licensor elsewhere in this Agreement, Licensor hereby represents, warrants and covenants Background Patents existing as of the Effective Date that
are listed on Schedule 11.2.1 (i) The Licensor Technology constitutes the “Existing Patents”). To the Knowledge of Licensor, all of the intellectual property owned or Controlled by Licensor that would, but for the rights granted to Licensee pursuant to this Agreement, be infringed or misappropriated by the exercise by Licensee of its rights under this Agreement.
(ii) As of the Effective Date, (i) the Licensor Patent Rights exist Existing Patents are subsisting and are not invalid or unenforceable, in whole or in part.
11.2.2 There are no claims, judgments, or settlements against, or amounts with respect thereto, owed by Licensor or any of its Affiliates relating to the Existing Patents, or the Licensor Background Know-How. No 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 (iia) the Existing Patents or the Licensor Background Know-How are invalid or unenforceable, or (b) the Development, Manufacturing or Commercialization of the Discovery Probodies as contemplated herein, in each case as a result of such Discovery PDCs or Licensed Products containing a Discovery Probody (other than the Discovery Antibody portion thereof), does or will violate, infringe, misappropriate or otherwise conflict or interfere with, any Patent or other intellectual property or proprietary right of any Person.
11.2.3 Licensor is (a) the sole and exclusive owner or, where noted, co-owner of all the entire right, title and interest in the Existing Patents listed on Schedule 11.2.1, Part A (the “Owned Patents”) and to the Licensor TechnologyBackground Know-How and (b) the sole and exclusive licensee of the Existing Patents listed on Schedule 11.2.1, Part B (the “In-Licensed Patents”), in each case (a) and (b) free of any encumbrance, lien, or claim of ownership by any Third Party.
11.2.4 To Licensor’s Knowledge, Licensor has the right to (a) use all Information, and Patents necessary to conduct the Discovery Research Plan, and (iiib) the Licensor Technology is free permit AbbVie to use all such Information and clear of any liens, charges and encumbrances. As of the Effective Date Licensor has no knowledge of any claim made against it (x) asserting the invalidity, misuse, unregisterability or unenforceability of any of the Licensor Patent Rights or (y) challenging Licensor’s Control of the Licensor Technology or making any adverse claim of ownership of the Licensor TechnologyPatents to conduct its Development activities under this Agreement.
(iii) As of the Effective Date11.2.5 Except as expressly allowed under ARTICLE 2, no regulatory activities related to the Licensed Product are being or have been undertaken by or on behalf of neither Licensor in the Territory.
(iv) As of the Effective Date there are no agreements between Licensor and Third Parties pursuant to which Licensor has rights and/or obligations with respect to any Licensor Technology that it is sublicensing to Licensee under this Agreement (“Third Party Agreements”). If at any time during the Term Licensor enters into any Third Party Agreements, Licensor will ensure that it is able to grant, and will maintain the ability to grant throughout the Term the License and other rights granted under this Agreement to all the Licensor Technology.
(v) As of the Effective Date, (i) Licensor has no knowledge of any Patent Rights (other than the Licensor Patent Rights) that may be infringed by the manufacture, use or sale of Licensed Products, (ii) no claim of infringement of the Patent Rights of any Third Party that has been made nor, to Licensor’s knowledge, is threatened against Licensor or nor any of its Affiliates have encumbered or diminished, and during the Term, neither Licensor nor any of its Affiliates shall, encumber or diminish, the rights granted to AbbVie hereunder with respect to the developmentLicensor Background Patents or Licensor Program Patents, manufactureincluding by (a) committing any acts or permitting the occurrence of any omissions that would cause the breach or termination of any Licensor In-License Agreement, sale or use (b) amending or otherwise modifying or permitting to be amended or modified, any Licensor In-License Agreement, where such amendment or modification would adversely affect the rights granted to AbbVie hereunder. Licensor shall promptly provide AbbVie with notice of Licensed Productsany alleged, and (iii) threatened, or actual material breach of any Licensor has no knowledge of other claims, judgments or settlements against or owed by Licensor or to which Licensor is a party or pending or threatened claims or litigation, in either case relating to any Licensed ProductIn-License Agreement. As of the Effective Date, Licensor has no knowledge that Licensor or any of its Affiliates or their respective current or former employees has misappropriated any of the Licensor Know How from any Third Party, and Licensor has no knowledge of any claim by a Third Party that such misappropriation has occurred. - 51 - of - 75 -
(vi) As of the Effective Date, Licensor has no knowledge of any activities by Third Parties that would constitute infringement or misappropriation of the Licensor Technology.
(vii) As of the Effective Date, and to Licensor’s knowledge, the Exploitation of the Licensed Product by or on behalf of Licensor or its Affiliates has been conducted in accordance with all applicable Laws and Regulations in the past and Licensor will implement and comply with corporate policies so that all Exploitation of the Licensed Product by or on behalf of Licensor or its Affiliates in the Field outside the Territory or outside the Field will be conducted in accordance with applicable Laws and Regulations in the future.
(viii) Neither Licensor nor any of its Affiliates has been Debarred and, in the course of its research, development or manufacture of products, Licensor, its Affiliates, their respective officers, and any person or entity engaged by Licensor or its Affiliates, have not used, and during the Term will not use in performing any activities pursuant to this Agreement, any person or entity who is or has been Debarred by the FDA or equivalent regulatory authorities or who, to the best knowledge none of Licensor, its Affiliates or any such person or entity engaged by Licensor or its Affiliates, is the subject of Debarment proceedings by the FDA or equivalent regulatory authorities. Licensor agrees to notify Licensee in writing immediately if Licensor or its Affiliates, or any of their respective officers, or any person or entity used by Licensor or its Affiliates under this Agreement, is subject to any of the foregoing, or if any action, suit, claim, investigation, or proceeding relating to the foregoing is pending, or to the best knowledge of Licensor, its Affiliates or any such person or entity engaged by Licensor or its Affiliates, is threatened.
(ix) As of the Effective Dateand, to Licensor’s knowledgeKnowledge, none of the counterparties thereto is in breach of any Licensor In-License Agreement. No party to any Licensor In-License Agreement has threatened to terminate, or has otherwise alleged any material breach under, such agreement. Each Licensor In-License Agreement is in full force and effect in accordance with its terms.
11.2.6 The Existing Patents are being diligently prosecuted in the respective patent offices in the Territory in accordance with Applicable Law. The Existing Patents have been filed and maintained properly and correctly and all applicable fees have been paid on or before the due date for payment.
11.2.7 Neither Licensor nor its Affiliates has, and neither will during the Term, enter into any agreements or grant any right, title, or interest to any Person that is inconsistent with the rights and licenses granted to AbbVie under this Agreement.
11.2.8 True, complete, and correct copies of all existing Licensor In-License Agreements have been provided or made available to AbbVie prior to the Effective Date. Except for the UCSB Agreement, there is no other agreement pursuant to which Licensor in-licenses any other Existing Patent.
11.2.9 To Licensor’s Knowledge, no Person is infringing or threatening to infringe or misappropriating or threatening to misappropriate the Existing Patents or the Licensor Background Know-How.
11.2.10 In respect of the pending patent applications included in the Existing Patents, Licensor and its Affiliates have presented all references, documents, or information of which it and the financial inventors are aware and organizational capabilities and experience is otherwise material to perform patentability to the relevant patent examiner at the relevant patent office.
11.2.11 To Licensor’s obligations under this Agreement Knowledge, the conduct of the Discovery Research Plan and AbbVie’s Development, Manufacture and Commercialization of the Licensed Products as contemplated herein will not infringe any Patent or other intellectual property or
11.2.12 To Licensor’s Knowledge, the conception, development, and reduction to practice of the Existing Patents, and Licensor and its Affiliates will maintain financial and organizational capabilities to perform Background Know-How existing as of the Effective Date have not constituted or involved the misappropriation of trade secrets or other rights or property of any Person.
11.2.13 The Existing Patents represent all Patents within Licensor’s obligations under this Agreement.
(x) Licensor will grant sublicenses or its Affiliates’ ownership or Control relating to the Licensee Technology in strict compliance with Discovery PDCs or the provisions set forth in Section 2.9Licensed Products, or the Exploitation thereof, as of the Effective Date.
Appears in 1 contract
Samples: Discovery Collaboration and License Agreement (CytomX Therapeutics, Inc.)
Additional Representations, Warranties and Covenants of Licensor. In addition to the representations, warranties and covenants made by Licensor elsewhere in this Agreement, Licensor hereby represents, warrants and covenants as to Myriad that:
(a) Licensor is a corporation duly organized, validly existing and in good standing under the laws of the Effective Date that
(i) The Licensor Technology constitutes all of state in which it is incorporated, and it has full corporate power and authority and the intellectual legal right to own and operate its property owned or Controlled and assets and to carry on its business as it is now being conducted and as is contemplated to be conducted by Licensor that would, but for the rights granted to Licensee pursuant to this Agreement, be infringed or misappropriated by the exercise by Licensee of its rights under this Agreement.
(iib) As Licensor has successfully conducted and completed the clinical portion (but not all related documentation) of four (4) clinical trials with respect to the Licensed Product. Licensor has conducted, or has caused its contractors or consultants to conduct, any and all preclinical and clinical studies related to the Licensed Compound and the Licensed Product in accordance with applicable known or published standards of the FDA. Licensor has employed individuals of appropriate education, knowledge, and experience to conduct or to oversee the conduct of the preclinical and clinical studies with respect to the Licensed Product performed as of the Effective Date, .
(ic) the Licensor Patent Rights exist has not been debarred and are is not invalid or unenforceablesubject to debarment and Licensor has not used in any capacity, in whole connection with the development of the Licensed Compound, any person 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 part, such section.
(iid) Licensor is the sole exclusive licensee of the Patent Rights listed on Exhibit 1 attached hereto. True and exclusive owner correct copies of all rightlicense agreements between Licensor and any Third Party regarding the Patents Rights listed on Exhibit 1, title and interest in and as amended to the date hereof, have been provided to Myriad. The Patent Rights listed on Exhibit 1 constitute all of the Patent Rights that Licensor Technologyand its Affiliates own, and have under license or have a right to acquire (iiiby option or otherwise) that are necessary or useful for, or otherwise related to, the research, development, modification, improvement, Manufacture, use, import, or sale of the Licensed Compound or the Licensed Product or the use of the Manufacturing Processes. During the term of this Agreement, Licensor Technology is free and clear shall use its best efforts not to encumber or diminish the rights granted to Myriad hereunder, including, without limitation, by not committing any acts or permitting the occurrence of any liens, charges and encumbrancesomissions that would cause the breach or termination of any In-License Agreement. Licensor shall promptly provide Myriad with notice of any alleged breach of any In-License Agreement. As of the Effective Date date hereof, Licensor is not in breach of the LLUMC License Agreement.
(e) There are no claims, judgments, or settlements relating to the Licensor Patents or the Licensor Know-How to be paid by Licensor, and no claim has no knowledge of been brought by any claim made against it (x) asserting person or entity alleging that the invalidityLicensor Patents, misusethe Licensor Know-How, unregisterability or unenforceability of any the disclosing, copying, making, licensing, or selling of the Licensor Patent Rights Patents or Licensor Know-How, or products and services embodying the Licensor Patents, or Licensor Know-How, including, without limitation, the Licensed Compound, the Licensed Product, and the Manufacturing Processes, violates, infringes, or otherwise conflicts or interferes with any intellectual property or proprietary right of any Third Party.
(yf) challenging Licensor’s Control Licensor has not previously assigned, transferred, conveyed or otherwise encumbered any right, title or interest in or to the Licensor Patents or the Licensor Know-How and has not granted to any Third Party any license to use the Licensor Patents or the Licensor Know-How in any manner, or any covenant not to xxx for any such use of the Licensor Technology Patents or making any adverse claim of ownership of the Licensor TechnologyKnow-How.
(iii) As of the Effective Date, no regulatory activities related to the Licensed Product are being or have been undertaken by or on behalf of Licensor in the Territory.
(iv) As of the Effective Date there are no agreements between Licensor and Third Parties pursuant to which Licensor has rights and/or obligations with respect to any Licensor Technology that it is sublicensing to Licensee under this Agreement (“Third Party Agreements”). If at any time during the Term Licensor enters into any Third Party Agreements, Licensor will ensure that it is able to grant, and will maintain the ability to grant throughout the Term the License and other rights granted under this Agreement to all the Licensor Technology.
(v) As of the Effective Date, (ig) Licensor has no knowledge does not know of any Patent Rights (other than the Licensor Patent Rights) that may be infringed by the manufacture, use or sale of Licensed Products, (ii) no claim of infringement of the Patent Rights of any Third Party that has been made nor, to Licensor’s knowledge, is threatened against Licensor or any of its Affiliates with respect to the development, manufacture, sale or use of Licensed Products, and (iii) Licensor has no knowledge of other claims, judgments or settlements against or owed by Licensor or to which Licensor is a party or pending or threatened claims or litigation, in either case relating to any Licensed Product. As of the Effective Date, Licensor has no knowledge that Licensor or any of its Affiliates or their respective current or former employees has misappropriated any of the Licensor Know How from any Third Party, and Licensor has no knowledge of any claim by a Third Party that such misappropriation has occurred. - 51 - of - 75 -
(vi) As of the Effective Date, Licensor has no knowledge of any activities by Third Parties that would constitute infringement or misappropriation of the Licensor TechnologyPatents or the Licensor Know-How.
(viih) As of the Effective DateEXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, and to Licensor’s knowledgeLICENSOR DISCLAIMS ALL WARRANTIES WHATSOEVER, the Exploitation of the Licensed Product by or on behalf of Licensor or its Affiliates has been conducted in accordance with all applicable Laws and Regulations in the past and Licensor will implement and comply with corporate policies so that all Exploitation of the Licensed Product by or on behalf of Licensor or its Affiliates in the Field outside the Territory or outside the Field will be conducted in accordance with applicable Laws and Regulations in the futureWITH RESPECT TO THE LICENSED TECHNOLOGY, EITHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES AS TO THE MERCHANTABILITY, OR FITNESS FOR A PARTICULAR PURPOSE, VALIDITY OF PATENT CLAIMS, ISSUED OR PENDING, OR THAT THE MANUFACTURE, USE OR SALE OF THE LICENSED PRODUCT WILL NOT INFRINGE ANY PATENT, COPYRIGHT, TRADEMARK, OR OTHER RIGHTS. MYRIAD TAKES THE LICENSED COMPOUND "AS-IS" "WITH ALL FAULTS," AND "WITH ALL DEFECTS" AND EXPRESSLY WAIVES ALL RIGHTS TO MAKE ANY CLAIM WHATSOEVER AGAINST LICENSOR FOR ALL WARRANTY OF ANY KIND RELATING TO THE LICENSED COMPOUND, SUBJECT TO THE REPRESENTATIONS MADE IN SECTIONS 9.1 AND 9.3(a)-(g).
(viii) Neither Licensor nor any of its Affiliates has been Debarred and, in the course of its research, development or manufacture of products, Licensor, its Affiliates, their respective officers, and any person or entity engaged by Licensor or its Affiliates, have not used, and during the Term will not use in performing any activities pursuant to this Agreement, any person or entity who is or has been Debarred by the FDA or equivalent regulatory authorities or who, to the best knowledge of Licensor, its Affiliates or any such person or entity engaged by Licensor or its Affiliates, is the subject of Debarment proceedings by the FDA or equivalent regulatory authorities. Licensor agrees to notify Licensee in writing immediately if Licensor or its Affiliates, or any of their respective officers, or any person or entity used by Licensor or its Affiliates under this Agreement, is subject to any of the foregoing, or if any action, suit, claim, investigation, or proceeding relating to the foregoing is pending, or to the best knowledge of Licensor, its Affiliates or any such person or entity engaged by Licensor or its Affiliates, is threatened.
(ix) As of the Effective Date, to Licensor’s knowledge, Licensor and its Affiliates have the financial and organizational capabilities and experience to perform Licensor’s obligations under this Agreement and Licensor and its Affiliates will maintain financial and organizational capabilities to perform Licensor’s obligations under this Agreement.
(x) Licensor will grant sublicenses to the Licensee Technology in strict compliance with the provisions set forth in Section 2.9.
Appears in 1 contract
Additional Representations, Warranties and Covenants of Licensor. In addition to the representations, warranties and covenants made by Licensor elsewhere in this Agreement, Licensor hereby represents, warrants and covenants covenant to Licensee that as of the Effective Date thator during such period specifically referenced herein:
(ia) The Licensor Technology constitutes all is the sole owner of the intellectual property owned or Licensed Technology, and it has the right under the Licensed Technology to grant the licenses to Licensee as purported to be granted pursuant to this Agreement;
(b) Exhibit D lists all Patents Controlled by Licensor and its Affiliates that wouldare necessary or useful for the Development, but for Commercialization and Manufacturing of the Licensed Compounds and Licensed Products in the Territory;
(c) Licensor has not granted (and shall not grant during the Term) any right to any Third Party under the Licensed Technology that would conflict with the rights granted to Licensee hereunder;
(d) Licensor has not, and will not, during the Term, cause a Lien to be put on the Licensed Technology or use this Agreement for collateral or security for a loan except with the prior written consent of Licensee acting reasonably;
(e) During the Development Program Term, Licensor will notify Licensee of any meetings related to the development of the Licensed Product or Licensed Compound with key vendors, or consultants as determined by the JDC, and provide Licensee’s representatives on the JDC or designees thereof, with the ability to observe and participate in such meetings at their request;
(f) to its Knowledge, the Development, Manufacturing and Commercialization, of the Licensed Compounds or Licensed Products contemplated by the Parties as of the Effective Date does not infringe any intellectual property of any Third Party in the Territory;
(g) Until Proof of Concept is achieved, all amounts submitted by Licensor for advancement and/or reimbursement pursuant to this Agreement, Section 5.04 will either: (i) be infringed promptly paid or misappropriated by the exercise by Licensee of its rights under this Agreement.
(ii) As of the Effective Datewill have been paid, in such amount and to such party as described in Licensor’s statements provided to Licensee pursuant to Section 5.04(d); and
(ih) no claim or action has been brought against Licensor or, to Licensor’s Knowledge, threatened in writing to Licensor, by any Third Party alleging that (1) the Licensor Patent Rights exist and Licensed Patents are not invalid or unenforceable, in whole or in part, (ii) Licensor is the sole and exclusive owner of all right, title and interest in and to the Licensor Technology, and (iii2) the Licensor Technology is free and clear of any liens, charges and encumbrances. As use of the Effective Date Licensor has no knowledge of any claim made against it (x) asserting the invalidity, misuse, unregisterability Licensed Compound or unenforceability of any of the Licensor Patent Rights or (y) challenging Licensor’s Control of the Licensor Technology or making any adverse claim of ownership of the Licensor Technology.
(iii) As of the Effective Date, no regulatory activities related to the Licensed Product are being infringes the Patents or have been undertaken by or on behalf of Licensor in misappropriates the Territory.
(iv) As of the Effective Date there are no agreements between Licensor and Third Parties pursuant to which Licensor has rights and/or obligations with respect to any Licensor Technology that it is sublicensing to Licensee under this Agreement (“Third Party Agreements”). If at any time during the Term Licensor enters into any Third Party Agreements, Licensor will ensure that it is able to grant, and will maintain the ability to grant throughout the Term the License and other rights granted under this Agreement to all the Licensor Technology.
(v) As of the Effective Date, (i) Licensor has no knowledge of any Patent Rights (other than the Licensor Patent Rights) that may be infringed by the manufacture, use or sale of Licensed Products, (ii) no claim of infringement of the Patent Rights Patents of any Third Party that has been made nor, and (ii) to Licensor’s knowledgeKnowledge, is threatened no interference, opposition, cancellation or other protest proceeding has been filed against Licensor or any of its Affiliates with respect to the development, manufacture, sale or use of Licensed Products, and (iii) Licensor has no knowledge of other claims, judgments or settlements against or owed by Licensor or to which Licensor is a party or pending or threatened claims or litigation, in either case relating to any Licensed Product. As of the Effective Date, Licensor has no knowledge that Licensor or any of its Affiliates or their respective current or former employees has misappropriated any of the Licensor Know How from any Third Party, and Licensor has no knowledge of any claim by a Third Party that such misappropriation has occurred. - 51 - of - 75 -
(vi) As of the Effective Date, Licensor has no knowledge of any activities by Third Parties that would constitute infringement or misappropriation of the Licensor TechnologyPatent.
(vii) As of the Effective Date, and to Licensor’s knowledge, the Exploitation of the Licensed Product by or on behalf of Licensor or its Affiliates has been conducted in accordance with all applicable Laws and Regulations in the past and Licensor will implement and comply with corporate policies so that all Exploitation of the Licensed Product by or on behalf of Licensor or its Affiliates in the Field outside the Territory or outside the Field will be conducted in accordance with applicable Laws and Regulations in the future.
(viii) Neither Licensor nor any of its Affiliates has been Debarred and, in the course of its research, development or manufacture of products, Licensor, its Affiliates, their respective officers, and any person or entity engaged by Licensor or its Affiliates, have not used, and during the Term will not use in performing any activities pursuant to this Agreement, any person or entity who is or has been Debarred by the FDA or equivalent regulatory authorities or who, to the best knowledge of Licensor, its Affiliates or any such person or entity engaged by Licensor or its Affiliates, is the subject of Debarment proceedings by the FDA or equivalent regulatory authorities. Licensor agrees to notify Licensee in writing immediately if Licensor or its Affiliates, or any of their respective officers, or any person or entity used by Licensor or its Affiliates under this Agreement, is subject to any of the foregoing, or if any action, suit, claim, investigation, or proceeding relating to the foregoing is pending, or to the best knowledge of Licensor, its Affiliates or any such person or entity engaged by Licensor or its Affiliates, is threatened.
(ix) As of the Effective Date, to Licensor’s knowledge, Licensor and its Affiliates have the financial and organizational capabilities and experience to perform Licensor’s obligations under this Agreement and Licensor and its Affiliates will maintain financial and organizational capabilities to perform Licensor’s obligations under this Agreement.
(x) Licensor will grant sublicenses to the Licensee Technology in strict compliance with the provisions set forth in Section 2.9.
Appears in 1 contract
Samples: Research Collaboration and License Agreement (Palisade Bio, Inc.)