Representations and Warranties by Licensor. Licensor represents and warrants to Licensee as of the Effective Date: 8.1.1 Licensor has the right, power, and authority to enter into this Agreement and to grant to Licensee the licenses specified in this Agreement; 8.1.2 This Agreement when executed shall become the legal, valid, and binding obligation of it, enforceable against it, in accordance with its terms; CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. 8.1.3 There are no actions, suits, proceedings, or arbitrations pending or, to Licensor’s knowledge, threatened against Licensor relating to the Licensed Research Patents that would be inconsistent with the rights granted to Licensee under this Agreement; 8.1.4 To Licensor’s Knowledge, Licensor has not received any written notice from the ReGenX Licensors informing Licensor that there are any actions, suits, proceedings, or arbitrations pending against the ReGenX Licensors relating to the Licensed Research Patents that would be inconsistent with the rights granted to Licensee under this Agreement; 8.1.5 To Licensor’s knowledge, (a) the Licensed Research Patents are solely owned by the Trustees of the University of Pennsylvania, and (b) no Third Party (other than the ReGenX Licensors) has any right, interest, or claim in or to such Licensed Research Patents with respect to the Disease Indications that are inconsistent with those granted to Licensee with respect to the Disease Indications; 8.1.6 To Licensor’s knowledge, GSK Agreement and Penn Agreement are in full force and effect; 8.1.7 To Licensor’s knowledge, no Third Party is infringing any of the Licensed Research Patents in a manner that is inconsistent with the scope of rights granted to Licensee with respect to the Disease Indications; and 8.1.8 Licensor has not received any written notice from any Third Party patentee alleging infringement of such Third Party’s patents by the practice of the Licensed Research Patents with respect to the Disease Indications.
Appears in 3 contracts
Sources: License Agreement (Voyager Therapeutics, Inc.), License Agreement (Voyager Therapeutics, Inc.), License Agreement (Voyager Therapeutics, Inc.)
Representations and Warranties by Licensor. Licensor represents and warrants to Licensee as of the Effective Date:
8.1.1 Licensor has the right, power, and authority to enter into this Agreement and to grant to Licensee the licenses rights specified in this Agreement;
8.1.2 This Agreement when executed shall become the legal, valid, and binding obligation of it, enforceable against it, in accordance with its terms; CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.;
8.1.3 There are no actions, suits, proceedings, or arbitrations pending or, to Licensor’s knowledge, threatened against Licensor relating to the Licensed Research Patents that would be inconsistent with the rights granted to Licensee under this Agreement;
8.1.4 To Licensor’s Knowledge, Licensor has not received any written notice from the ReGenX Licensors informing Licensor that there are any actions, suits, proceedings, or arbitrations pending against the ReGenX Licensors relating to the Licensed Research Patents that would be inconsistent with the rights granted to Licensee under this Agreement;
8.1.5 To Licensor’s knowledge, (a) the Licensed Research Patents are solely owned by the The Trustees of the University of Pennsylvania, and (b) no Third Party (other than the ReGenX REGENXBIO Licensors) has any right, interest, or claim in or to such Licensed Research Patents with respect to in the Disease Indications Field that are inconsistent with those granted to Licensee with respect to the Disease Indicationsunder this Agreement;
8.1.6 To Licensor’s knowledge, GSK Agreement and Penn Agreement are in full force and effect;
8.1.7 To Licensor’s knowledge, no Third Party is infringing any of the Licensed Research Patents in a manner that is inconsistent with the scope of rights granted to Licensee with respect to the Disease Indications; and
8.1.8 8.1.5 Licensor has not received any written notice from any Third Party patentee alleging infringement of such Third Party’s patents by the practice of the Licensed Research Patents with respect in the Field;
8.1.6 Licensor has not received any written notice from any of its licensors under the GSK Agreement or the Penn Agreement informing Licensor that there are any actions, suits, proceedings, or arbitrations pending against such licensors relating to the Disease IndicationsLicensed Patents that would impact activities under this Agreement; and
8.1.7 To Licensor’s knowledge, the GSK Agreement and the Penn Agreement are in full force and effect and Licensor is not in breach, and entering into this Agreement will not cause any breach, of any provisions thereof.
Appears in 2 contracts
Sources: License Agreement (Prevail Therapeutics Inc.), License Agreement (Prevail Therapeutics Inc.)
Representations and Warranties by Licensor. Licensor represents and warrants to Licensee as of the Effective Date:
8.1.1 Licensor has the right, power, and authority to enter into this Agreement and to grant to Licensee the licenses specified in this Agreement;
8.1.2 This Agreement when executed shall become the legal, valid, and binding obligation of it, enforceable against it, in accordance with its terms; CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.;
8.1.3 There are no actions, suits, proceedings, or arbitrations pending or, to Licensor’s knowledge, threatened against Licensor relating to the Licensed Research Patents that would be inconsistent with the rights granted to Licensee under this Agreement;
8.1.4 To Licensor’s Knowledge, Licensor has not received any written notice from the ReGenX Licensors informing Licensor that there are any actions, suits, proceedings, or arbitrations pending against the ReGenX Licensors relating to the Licensed Research Patents that would be inconsistent with the rights granted to Licensee under this Agreement;
8.1.5 To Licensor’s knowledge, (a) the Licensed Research Patents are solely owned by the Trustees of the University of Pennsylvania, and (b) no Third Party (other than the ReGenX Licensors) has any right, interest, or claim in or to such Licensed Research Patents with respect to the Disease Indications that are inconsistent with those granted to Licensee with respect to the Disease Indications;
8.1.6 To Licensor’s knowledge, GSK Agreement and Penn Agreement are in full force and effect;
8.1.7 To Licensor’s knowledge, no Third Party is infringing any of the Licensed Research Patents in a manner that is inconsistent with the scope of rights granted to Licensee with respect to the Disease Indications; and
8.1.8 Licensor has not received any written notice from any Third Party patentee alleging infringement of such Third Party’s patents by the practice of the Licensed Research Patents with respect to the Disease Indications**** CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
Appears in 2 contracts
Sources: License Agreement (REGENXBIO Inc.), License Agreement (REGENXBIO Inc.)
Representations and Warranties by Licensor. Licensor represents LICENSOR represents, warrants and warrants covenants to Licensee LICENSEE that:
(a) LICENSOR is the direct legal and beneficial owner of or Controls the Licensed Patents and owns or Controls all other IP in LICENSOR Product Technology and, to the Reasonably Best Knowledge of LICENSOR with respect to Know-How within the LICENSOR Product Technology, such Licensed Patents and IP are free and clear of all liens, charges and encumbrances;
(b) LICENSOR has obtained or will use Commercially Reasonable Efforts to obtain from all Third Parties that have performed or will perform Development and Manufacturing activities for Licensed Compound or Licensed Products on behalf of LICENSOR an assignment or license of IP developed in the course of such activities by such Third Parties sufficient to enable LICENSOR and LICENSEE to carry out their respective activities and perform their obligations under this Agreement;
(c) as of the Effective Date:, all of the Licensed Patents have been duly filed and prosecuted in the applicable countries in the Licensed Territory;
8.1.1 Licensor has (d) as of the rightEffective Date, powerall applicable filing, maintenance and other fees to pursue and maintain Licensed Patents have been timely paid, and authority to enter into this Agreement and to grant to Licensee the licenses specified in this Agreement;
8.1.2 This Agreement when executed shall become the legal, valid, and binding obligation of it, enforceable against it, in accordance with its terms; CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
8.1.3 There are no actions, suits, proceedings, or arbitrations pending or, to Licensor’s knowledge, threatened against Licensor relating to the Licensed Research Patents that would be inconsistent with the rights granted to Licensee under this Agreement;
8.1.4 To Licensor’s Knowledge, Licensor has not received any written notice from the ReGenX Licensors informing Licensor that there are any actions, suits, proceedings, or arbitrations pending against the ReGenX Licensors relating to the Licensed Research Patents that would be inconsistent with the rights granted to Licensee under this Agreement;
8.1.5 To Licensor’s knowledge, (a) the Licensed Research Patents are solely owned by the Trustees of the University of Pennsylvania, and (b) no Third Party (other than the ReGenX Licensors) has any right, interest, or claim in or to such Licensed Research Patents with respect to the Disease Indications that are inconsistent with those granted to Licensee with respect to the Disease Indications;
8.1.6 To Licensor’s knowledge, GSK Agreement and Penn Agreement are in full force and effect;
8.1.7 To Licensor(e) to LICENSOR’s knowledgeReasonably Best Knowledge, there is, as of the Effective Date, no Third Party is infringing pending or threatened re-examination, opposition, interference, inter partes review or claim challenging the inventorship, ownership, validity, enforceability or patentability of the Licensed Patents or other litigation or proceeding relating to any of the Licensed Research Patents;
(f) as of the Effective Date, to LICENSOR’s Reasonably Best Knowledge, there are no pending or threatened litigations or IP prosecution proceedings relating to any of Third Party Patents and other IP licensed to LICENSOR for the purposes of the Development, Manufacture or Commercialization of the Licensed Compound or Exiting Product;
(g) as of the Effective Date, to LICENSOR’s Reasonably Best Knowledge, the Development and Commercialization of the Licensed Compound in the Licensed Territory does not infringe any valid Patent or other IP of any Third Party;
(h) to LICENSOR’s Reasonably Best Knowledge, the conception, development and reduction to practice of the LICENSOR Product Technology has, as of the Effective Date, not constituted or involved, and will not constitute or involve the misappropriation of IP of any Third Party or the infringement of the Patents of any Third Party;
(i) as of the Effective Date, LICENSOR has not assigned, transferred, conveyed, granted rights to a Third Party or otherwise encumbered its right, title and interest in Licensed Patents in a manner that is inconsistent with the scope of rights License granted to Licensee with respect to the Disease Indicationsunder this Agreement; and
8.1.8 Licensor has not received any written notice from any Third Party patentee alleging infringement of such Third Party’s patents by (j) regulatory approvals necessary or favourable for the practice Commercialization of the Licensed Research Patents Compound and Licensed Products in the Field in the USA, EU, Switzerland and United Kingdom under the lead or control of, and as obtained by, LICENSOR under this Agreement have been and will be, during the Term, applied for and obtained in due processes in accordance with respect to the Disease Indicationsapplicable laws.
Appears in 1 contract
Representations and Warranties by Licensor. Licensor represents and warrants to Licensee as of the Effective Date:
8.1.1 8.2.1 Licensor has the right, power, and authority to enter into this Agreement and to grant to Licensee the licenses rights specified in this Agreement;
8.1.2 8.2.2 This Agreement when executed shall become the legal, valid, and binding obligation of it, enforceable against it, in accordance with its terms; CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.;
8.1.3 8.2.3 There are no actions, suits, proceedings, or arbitrations pending or, to Licensor’s knowledge, threatened against Licensor relating to the Licensed Research Patents that would be inconsistent with the rights granted to Licensee under this Agreement;
8.1.4 To Licensor’s Knowledge, Licensor has not received any written notice from the ReGenX Licensors informing Licensor that there are any actions, suits, proceedings, or arbitrations pending against the ReGenX Licensors relating to the Licensed Research Patents that would be inconsistent with the rights granted to Licensee under this Agreement;
8.1.5 8.2.4 To Licensor’s knowledge, (a) the Licensed Research Patents are solely owned by the The Trustees of the University of Pennsylvania, and (b) no Third Party (other than the ReGenX REGENXBIO Licensors) has any right, interest, or claim in or to such Licensed Research Patents with respect to in the Disease Indications Fields that are inconsistent with those granted to Licensee in the Fields under this Agreement (it being understood that the rights previously granted in the Conflicting License shall not be deemed to conflict with respect to the Disease Indicationslicenses granted under this Agreement);
8.1.6 To Licensor’s knowledge, GSK Agreement and Penn Agreement are in full force and effect;
8.1.7 To Licensor’s knowledge, no Third Party is infringing any of the Licensed Research Patents in a manner that is inconsistent with the scope of rights granted to Licensee with respect to the Disease Indications; and
8.1.8 8.2.5 Licensor has not received any written notice from any Third Party patentee alleging infringement of such Third Party’s patents by the practice of the Licensed Research Patents in the Fields; and
8.2.6 Licensor shall not, without the prior written consent of Licensee (such consent not to be unreasonably withheld or delayed), amend the Conflicting License in a manner that would materially and adversely affect Licensee’s rights and benefits under this Agreement during the term of this Agreement. ****Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the Disease Indications.omitted portions.21
Appears in 1 contract
Representations and Warranties by Licensor. Licensor hereby represents and warrants to Licensee Ventrus as of the Effective Date as follows:
(a) Exhibit C attached hereto sets forth a complete and accurate list of all Licensor Patents in existence as of the Effective Date:, indicating the owner or co-owners thereof if such Licensor Patent is not solely owned by Licensor;
8.1.1 (b) The Licensor Technology does not wrongfully incorporate any Intellectual Property owned or controlled by any Third Party;
(c) The University of Buffalo (and all relevant departments and offices therein, including, without limitation, the University of Buffalo Office of Science, Technology Transfer and Economic Outreach) has the right, power, waived in writing any and authority all claims of ownership in Licensor IP. TheraSyn has ownership interests in Licensor and is thereby entitled to enter into this Agreement royalty payments and to grant to Licensee the licenses specified in other consideration payable by Licensor from Licensor’s receipt of payments from Ventrus under this Agreement;
8.1.2 This Agreement when executed shall become (d) No portion of the legalLicensor IP was (i) created utilizing any University of Buffalo facility, validor (ii) invented during any period of time during which D▇. ▇▇▇▇▇▇▇▇ was devoted to the normal and assigned functions of teaching, university service, directing or conducting research on the University of Buffalo’s premises;
(e) Licensor is the sole and exclusive owner, or exclusive licensee, of all of the Licensor IP free from Encumbrances and is listed in the records of the appropriate governmental authorities as the sole and exclusive owner of record or exclusive licensee for each registration, grant and application included in the Licensor IP;
(f) all of Licensor’s and its Affiliates’ employees, officers, subcontractors, consultants, and binding obligation any other Person who has participated in any respect in the invention or authorship of itany Licensor IP have assigned to Licensor or its Affiliates, enforceable against itas applicable, in accordance all inventions made during the course of and as the result of such Person’s association with Licensor and are under written and existing obligations restricting disclosure and use by such Person of Licensor’s Confidential Information as well as confidential information of other parties (including Ventrus and its terms; CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933Affiliates) that such Person may receive, AS AMENDED.to the extent required to support Licensor’s obligations under this Agreement;
8.1.3 There are no actions(g) neither Licensor, suitsnor any Person(s) who have performed work related to the Licensor IP on behalf of Licensor, proceedings, is or arbitrations pending has been debarred under 21 U.S.C. Section 335a or, to Licensor’s knowledge, has engaged in any conduct that has resulted, or would reasonably be expected to result, in such debarment under applicable Law, including 21 U.S.C. Section 335a. No actions that would reasonably be expected to result in such debarment are pending or threatened against Licensor or any Person(s) who have performed work related to the Licensor IP on behalf of Licensor and, to Licensor’s knowledge, there are no facts that could reasonably give rise to such an action. To the actual knowledge of Licensor, no Person on any of the FDA clinical investigator enforcement lists (including, but not limited to, the (1) Disqualified/Totally Restricted List, (2) Restricted List and (3) Adequate Assurances List) will participate in the performance of any activities hereunder;
(h) Licensor has the right to grant to Ventrus the licenses under the Licensor IP that it purports to grant hereunder and has not granted any Third Party rights that would otherwise interfere or be inconsistent with Ventrus’ rights hereunder;
(i) Licensor has the right to use and disclose and to enable Ventrus to use and disclose (in each case under appropriate conditions of confidentiality) the Licensor Know-How free from Encumbrances;
(j) all application, registration, maintenance, and renewal fees in respect of the Licensor Patents have been paid and all necessary documents and certificates have been filed with the relevant agencies for the purpose of maintaining the Licensor Patents;
(k) Licensor has filed and prosecuted the patent applications within the Licensor Patent Rights in good faith and complied with its duties of disclosure with respect thereto and there are and have been no claims, challenges, oppositions, interference, or other proceedings regarding the prosecution of the Licensor Patents;
(l) Licensor has not committed any act, or omitted to commit any act, that may cause the Licensor Patent Rights to expire prematurely or be declared invalid or unenforceable;
(m) the Licensor IP comprises all of the Intellectual Property rights used by Licensor, its Affiliates, consultants, subcontractors, and sublicensees with respect to the Licensor Technology;
(n) to its knowledge, the making, use, sale, offering for sale, importing, exporting, or research, Development, Manufacture, and Commercialization of the Licensor Technology, exclusive of any drug or compound owned or controlled by a Third Party, does not infringe the Patent Rights or misappropriate the Know-How of any Third Party, nor has Licensor received any written notice alleging such infringement or misappropriation;
(o) Licensor has not initiated or been involved in any proceedings, actions, or claims in which it alleges that any Third Party is or was infringing or misappropriating any Licensor IP, nor have any such proceedings, actions or claims been threatened by Licensor, nor does Licensor know of any valid basis for any such proceeding;
(p) there are no pending, and, to Licensor’s knowledge, there are no threatened, actions, claims, or proceedings of any nature, civil, criminal, regulatory, or otherwise, in law or in equity, against Licensor or any of its Affiliates or licensees or, to the knowledge of Licensor, pending or threatened actions, claims, or proceedings of any nature, civil, criminal, regulatory, or otherwise, against any Third Party, in each case involving the Licensor IP or relating to the Licensed Research Patents transactions contemplated by this Agreement;
(q) Neither D▇. ▇▇▇▇▇▇▇▇ nor any employee or consultant of Licensor or its Affiliates involved in the research and Development of the Licensor Technology is subject to any agreement with any other Third Party which requires such employee or consultant to assign any interest in any Licensor IP to any Third Party (including, for the avoidance of doubt, the University of Buffalo);
(r) Licensor has disclosed to Ventrus all government funding relationships to which it is a party that would be inconsistent with result in rights to any Product residing in the U.S. Government, National Institutes of Health, National Institute for Drug Abuse or other Regulatory Authority, or other governmental authority;
(s) there are no agreements or arrangements to which Licensor or any of its Affiliates is a party that would limit the rights granted to Licensee Ventrus under this Agreement or that restrict or will result in a restriction on the Parties’ ability to perform activities contemplated by this Agreement;
8.1.4 To (t) the Licensor Know-How has not been used or disclosed by any Person except pursuant to valid and appropriate non-disclosure and/or license agreements that, to Licensor’s Knowledgeknowledge, have not been breached. Exhibit E attached hereto sets forth a complete and accurate list of all such non-disclosure and/or license agreements in existence as of Effective Date;
(u) Licensor has not permitted any of the Licensor Know-How to enter the public domain other than those publications listed on Exhibits F-1 and F-2 attached herewith that sets forth a complete and accurate list of all such publications, including publications of patents and patent applications by the relevant patent offices or by WIPO for PCT applications; and
(v) Licensor has disclosed or made available to Ventrus all material scientific and technical information known to it relating to the Licensor Technology, including the safety and efficacy of the Licensor Technology. The materials provided or made available to Ventrus do not contain an untrue statement of material fact or omit to state a material fact necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading. Notwithstanding anything to the contrary contained in this Agreement, Licensor has not received failed to disclose to Ventrus any written notice from the ReGenX Licensors informing fact or circumstance known to Licensor that there are any actions, suits, proceedings, or arbitrations pending against the ReGenX Licensors and relating to the Licensed Research Patents Licensor Technology that would be inconsistent reasonably material to Ventrus in connection with this Agreement or the rights granted to Licensee under this Agreement;
8.1.5 To Licensor’s knowledge, (a) the Licensed Research Patents are solely owned by the Trustees of the University of Pennsylvania, and (b) no Third Party (other than the ReGenX Licensors) has any right, interest, or claim in or to such Licensed Research Patents with respect to the Disease Indications that are inconsistent with those granted to Licensee with respect to the Disease Indications;
8.1.6 To Licensor’s knowledge, GSK Agreement and Penn Agreement are in full force and effect;
8.1.7 To Licensor’s knowledge, no Third Party is infringing any of the Licensed Research Patents in a manner that is inconsistent with the scope of rights granted to Licensee with respect to the Disease Indications; and
8.1.8 Licensor has not received any written notice from any Third Party patentee alleging infringement of such Third Party’s patents by the practice of the Licensed Research Patents with respect to the Disease Indicationstransactions contemplated herein.
Appears in 1 contract
Sources: License and Collaboration Agreement (Ventrus Biosciences Inc)
Representations and Warranties by Licensor. Licensor represents and warrants to Licensee Novartis, as of the Effective Date, that:
8.1.1 (a) Exhibit B sets forth a complete and accurate list of: (i) all Licensor Patent Rights in existence, indicating the owner, licensor or co-owner(s) thereof if such Licensor Patent Rights are not solely owned by Licensor; and (ii) all license, assignment, distribution or other agreements relating to the Licensor Patent Rights and Licensor Know-How;
(b) Licensor is the sole and exclusive owner, or exclusive licensee, of all of the Licensor Patent Rights free from Encumbrances and is listed in the records of the applicable governmental agencies as the exclusive licensee or sole and exclusive owner of record for each registration, grant and application included in the Licensor Patent Rights;
(c) Licensor has the rightobtained from all individuals who have been identified as inventors of any Licensor Patent Rights effective assignments of all ownership rights of such individuals in such Licensor Patent Rights, powereither pursuant to written agreement or by operation of law;
(d) All of its employees, officers, and authority consultants have executed agreements or have existing obligations under applicable laws requiring assignment to enter into this Agreement Licensor of all inventions made during the course of and as the result of their association with Licensor and obligating all such individuals to grant maintain as confidential Licensor’s Confidential Information as well as confidential information of other parties (including Novartis and its Affiliates) which such individual may receive, to Licensee the licenses specified in extent required to support Licensor’s obligations under this Agreement;
8.1.2 This Agreement when executed shall become (e) Licensor has the legalright to grant to Novartis the licenses under the Licensor Patent Rights and Licensor Know-How that it purports to grant hereunder;
(f) Licensor has the right to use and disclose and to enable Novartis to use and disclose (in each case, validunder appropriate conditions of confidentiality) the Licensor Know-How free from Encumbrances;
(g) to the knowledge of Licensor, the issued patents in the Licensor Patent Rights are valid and binding obligation of itenforceable without any Claims, enforceable against itchallenges, in accordance with its terms; CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933oppositions, AS AMENDED.
8.1.3 There are no nullity actions, suitsinterferences, inter-partes reexaminations, inter-partes reviews, post-grant reviews, derivation proceedings, or arbitrations other proceedings pending or threatened, and Licensor has filed and prosecuted patent applications within the Licensor Patent Rights in good faith and complied with all duties of disclosure with respect thereto; 264814036 v4 EXECUTION COPY CONFIDENTIAL INFORMATION
(h) to Licensor’s knowledge, Licensor has not committed any act, or omitted to commit any act, that may cause the Licensor Patent Rights to expire prematurely or be declared invalid or unenforceable;
(i) all application, registration, maintenance, other related fees and renewal fees in respect of the Licensor Patent Rights have been paid and all necessary documents and certificates have been filed with the relevant agencies for the purpose of obtaining or maintaining the Licensor Patent Rights;
(j) Licensor has not granted to any Third Party, including any academic organization or agency, any rights to the Licensed Compounds or any Product;
(k) the Licensor Technology comprises all of the intellectual property rights used by Licensor, its Affiliates, and their respective consultants and contractors (if applicable) in the Development of the Licensed Compounds subject to the limitations in the definition of Licensor Know-How;
(l) to Licensor’s knowledge, the Development, use, importation, offering for sale, sale, having sold or other Commercialization of the Licensed Compounds or Products do not infringe the Patent Rights or misappropriate the Know-How of any Third Party, nor has Licensor received any written notice alleging such infringement or misappropriation;
(m) Licensor has not initiated or been involved in any Claims in which it alleges that any Third Party is or was infringing or misappropriating any Licensor Technology, nor have any such Claims been threatened by Licensor, nor does Licensor know of any valid basis for any such Claims;
(n) no officer or employee of Licensor is subject to any agreement with any other Third Party which requires such officer or employee to assign any interest in any Licensor Technology relating to the Licensed Compounds or Products to any Third Party;
(o) Licensor has taken all reasonable precautions to preserve the confidentiality of the Licensor Know-How related to the composition of matter of the Licensed Compounds or resulting from the Research Program;
(p) Licensor has not entered into a government funding relationship that would result in rights to any Licensed Compounds or Products residing in the US Government, National Institutes of Health, National Institute for Drug Abuse or other agency, and the licenses granted hereunder are not subject to overriding obligations to the US Government as set forth in Public Law 96 517 (35 U.S.C. 200 204) or any similar obligations under the laws of any other country;
(q) Licensor has not granted any Third Party rights that would otherwise interfere or be inconsistent with Novartis’ rights hereunder, and there are no agreements or arrangements to which Licensor or any of its Affiliates is a party relating to the Products, Licensed Compounds, Licensor Patent Rights, or Licensor Know-How that would limit the rights granted to Novartis under this Agreement or that restrict or will result in a restriction on Novartis’ ability to Develop, manufacture, import, offer for sale, sell, have sold, or otherwise Commercialize the Licensed Compounds or the Products in the Territory; and
(r) neither Licensor nor any Person acting on its behalf has: (i) made an untrue statement of a material fact or fraudulent statement to the FDA, EMA or any other Regulatory Authority or with respect to any Regulatory Filing; or (ii) failed to disclose a material fact required to be disclosed to the FDA, EMA or any other Regulatory Authority, or committed any act, made a statement, or failed to make a statement that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA, EMA or any other Regulatory Authority 264814036 v4 EXECUTION COPY CONFIDENTIAL INFORMATION to invoke its policy regarding “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy;
(s) neither Licensor nor, to Licensor’s knowledge, any Person acting on its behalf is the subject of any pending or, to Licensor’s knowledge, threatened against Licensor relating to investigation by the Licensed Research Patents that would be inconsistent with the rights granted to Licensee under this AgreementFDA, EMA or any other Regulatory Authority;
8.1.4 To Licensor’s Knowledge, (t) Licensor has not received any written notice from the ReGenX Licensors informing Licensor that there are any actions, suits, proceedings, or arbitrations pending against the ReGenX Licensors relating to the Licensed Research Patents that would be inconsistent with the rights granted to Licensee under this Agreement;
8.1.5 To Licensor’s knowledge, (a) the Licensed Research Patents are solely owned by the Trustees of the University of Pennsylvanianot, and (b) no Third Party (other than the ReGenX Licensors) has any right, interest, or claim in or to such Licensed Research Patents with respect to the Disease Indications that are inconsistent with those granted to Licensee with respect to the Disease Indications;
8.1.6 To Licensor’s knowledge, GSK Agreement and Penn Agreement are in full force and effect;
8.1.7 To Licensor’s knowledge, no Third Party is infringing Parties have, altered, falsified, or otherwise manipulated any data generated or used in any clinical trials or other studies related to the development, use, handling, safety, efficacy, reliability or manufacturing of the Licensed Compounds or Products; and
(u) notwithstanding anything to the contrary contained in this Agreement, Licensor has not failed to disclose to Novartis any fact or circumstance known to Licensor or any of its Affiliates and relating to any of the Licensed Research Patents Compounds or the Products that would be reasonably material to Novartis in a manner that is inconsistent connection with this Agreement or the scope of rights granted to Licensee with respect to the Disease Indications; and
8.1.8 Licensor has not received any written notice from any Third Party patentee alleging infringement of such Third Party’s patents by the practice of the Licensed Research Patents with respect to the Disease Indicationstransactions contemplated herein.
Appears in 1 contract
Sources: License and Collaboration Agreement (Molecular Partners Ag)
Representations and Warranties by Licensor. Licensor represents and warrants to Licensee Novartis, as of the Effective Date, that:
8.1.1 (a) Exhibit B sets forth a complete and accurate list of: (i) all Licensor Patent Rights in existence, indicating the owner, licensor or co-owner(s) thereof if such Licensor Patent Rights are not solely owned by ▇▇▇▇▇▇▇▇; and (ii) all license, assignment, distribution or other agreements relating to the Licensor Patent Rights and Licensor Know-How;
(b) Licensor is the sole and exclusive owner, or exclusive licensee, of all of the Licensor Patent Rights free from Encumbrances and is listed in the records of the applicable governmental agencies as the exclusive licensee or sole and exclusive owner of record for each registration, grant and application included in the Licensor Patent Rights;
(c) ▇▇▇▇▇▇▇▇ has the rightobtained from all individuals who have been identified as inventors of any Licensor Patent Rights effective assignments of all ownership rights of such individuals in such Licensor Patent Rights, powereither pursuant to written agreement or by operation of law;
(d) All of its employees, officers, and authority consultants have executed agreements or have existing obligations under applicable laws requiring assignment to enter into this Agreement Licensor of all inventions made during the course of and as the result of their association with Licensor and obligating all such individuals to grant maintain as confidential Licensor’s Confidential Information as well as confidential information of other parties (including Novartis and its Affiliates) which such individual may receive, to Licensee the licenses specified in extent required to support Licensor’s obligations under this Agreement;
8.1.2 This Agreement when executed shall become (e) Licensor has the legalright to grant to Novartis the licenses under the Licensor Patent Rights and Licensor Know-How that it purports to grant hereunder;
(f) Licensor has the right to use and disclose and to enable Novartis to use and disclose (in each case, validunder appropriate conditions of confidentiality) the Licensor Know-How free from Encumbrances;
(g) to the knowledge of Licensor, the issued patents in the Licensor Patent Rights are valid and binding obligation of itenforceable without any Claims, enforceable against itchallenges, in accordance with its terms; CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933oppositions, AS AMENDED.
8.1.3 There are no nullity actions, suitsinterferences, inter-partes reexaminations, inter-partes reviews, post-grant reviews, derivation proceedings, or arbitrations other proceedings pending or threatened, and Licensor has filed and prosecuted patent applications within the Licensor Patent Rights in good faith and complied with all duties of disclosure with respect thereto; 264814036 v4 EXECUTION COPY CONFIDENTIAL INFORMATION
(h) to Licensor’s knowledge, Licensor has not committed any act, or omitted to commit any act, that may cause the Licensor Patent Rights to expire prematurely or be declared invalid or unenforceable;
(i) all application, registration, maintenance, other related fees and renewal fees in respect of the Licensor Patent Rights have been paid and all necessary documents and certificates have been filed with the relevant agencies for the purpose of obtaining or maintaining the Licensor Patent Rights;
(j) Licensor has not granted to any Third Party, including any academic organization or agency, any rights to the Licensed Compounds or any Product;
(k) the Licensor Technology comprises all of the intellectual property rights used by Licensor, its Affiliates, and their respective consultants and contractors (if applicable) in the Development of the Licensed Compounds subject to the limitations in the definition of Licensor Know-How;
(l) to Licensor’s knowledge, the Development, use, importation, offering for sale, sale, having sold or other Commercialization of the Licensed Compounds or Products do not infringe the Patent Rights or misappropriate the Know-How of any Third Party, nor has Licensor received any written notice alleging such infringement or misappropriation;
(m) Licensor has not initiated or been involved in any Claims in which it alleges that any Third Party is or was infringing or misappropriating any Licensor Technology, nor have any such Claims been threatened by Licensor, nor does Licensor know of any valid basis for any such Claims;
(n) no officer or employee of Licensor is subject to any agreement with any other Third Party which requires such officer or employee to assign any interest in any Licensor Technology relating to the Licensed Compounds or Products to any Third Party;
(o) Licensor has taken all reasonable precautions to preserve the confidentiality of the Licensor Know-How related to the composition of matter of the Licensed Compounds or resulting from the Research Program;
(p) Licensor has not entered into a government funding relationship that would result in rights to any Licensed Compounds or Products residing in the US Government, National Institutes of Health, National Institute for Drug Abuse or other agency, and the licenses granted hereunder are not subject to overriding obligations to the US Government as set forth in Public Law 96 517 (35 U.S.C. 200 204) or any similar obligations under the laws of any other country;
(q) Licensor has not granted any Third Party rights that would otherwise interfere or be inconsistent with Novartis’ rights hereunder, and there are no agreements or arrangements to which Licensor or any of its Affiliates is a party relating to the Products, Licensed Compounds, Licensor Patent Rights, or Licensor Know-How that would limit the rights granted to Novartis under this Agreement or that restrict or will result in a restriction on Novartis’ ability to Develop, manufacture, import, offer for sale, sell, have sold, or otherwise Commercialize the Licensed Compounds or the Products in the Territory; and
(r) neither Licensor nor any Person acting on its behalf has: (i) made an untrue statement of a material fact or fraudulent statement to the FDA, EMA or any other Regulatory Authority or with respect to any Regulatory Filing; or (ii) failed to disclose a material fact required to be disclosed to the FDA, EMA or any other Regulatory Authority, or committed any act, made a statement, or failed to make a statement that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA, EMA or any other Regulatory Authority 264814036 v4 EXECUTION COPY CONFIDENTIAL INFORMATION to invoke its policy regarding “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy;
(s) neither Licensor nor, to Licensor’s knowledge, any Person acting on its behalf is the subject of any pending or, to Licensor’s knowledge, threatened against Licensor relating to investigation by the Licensed Research Patents that would be inconsistent with the rights granted to Licensee under this AgreementFDA, EMA or any other Regulatory Authority;
8.1.4 To Licensor’s Knowledge, (t) Licensor has not received any written notice from the ReGenX Licensors informing Licensor that there are any actions, suits, proceedings, or arbitrations pending against the ReGenX Licensors relating to the Licensed Research Patents that would be inconsistent with the rights granted to Licensee under this Agreement;
8.1.5 To Licensor’s knowledge, (a) the Licensed Research Patents are solely owned by the Trustees of the University of Pennsylvanianot, and (b) no Third Party (other than the ReGenX Licensors) has any right, interest, or claim in or to such Licensed Research Patents with respect to the Disease Indications that are inconsistent with those granted to Licensee with respect to the Disease Indications;
8.1.6 To Licensor’s knowledge, GSK Agreement and Penn Agreement are in full force and effect;
8.1.7 To Licensor’s knowledge, no Third Party is infringing Parties have, altered, falsified, or otherwise manipulated any data generated or used in any clinical trials or other studies related to the development, use, handling, safety, efficacy, reliability or manufacturing of the Licensed Compounds or Products; and
(u) notwithstanding anything to the contrary contained in this Agreement, Licensor has not failed to disclose to Novartis any fact or circumstance known to Licensor or any of its Affiliates and relating to any of the Licensed Research Patents Compounds or the Products that would be reasonably material to Novartis in a manner that is inconsistent connection with this Agreement or the scope of rights granted to Licensee with respect to the Disease Indications; and
8.1.8 Licensor has not received any written notice from any Third Party patentee alleging infringement of such Third Party’s patents by the practice of the Licensed Research Patents with respect to the Disease Indicationstransactions contemplated herein.
Appears in 1 contract
Sources: License and Collaboration Agreement (Molecular Partners Ag)
Representations and Warranties by Licensor. Licensor represents and warrants to Licensee as of the Effective Date:
8.1.1 Licensor has the right, power, and authority to enter into this Agreement and to grant to Licensee the licenses rights specified in this Agreement;
8.1.2 This Agreement when executed shall become the legal, valid, and binding obligation of it, enforceable against it, in accordance with its terms; CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.;
8.1.3 There are no actions, suits, proceedings, or arbitrations pending or, to Licensor’s knowledge, threatened against Licensor relating to the Licensed Research Patents that would be inconsistent with the rights granted to Licensee under this Agreement;
8.1.4 To Licensor’s Knowledge, Licensor has not received any written notice from the ReGenX Licensors informing Licensor that there are any actions, suits, proceedings, or arbitrations pending against the ReGenX Licensors relating to the Licensed Research Patents that would be inconsistent with the rights granted to Licensee under this Agreement;
8.1.5 To Licensor’s knowledge, (a) the Licensed Research Patents are solely owned by the The Trustees of the University of Pennsylvania, and (b) no Third Party (other than the ReGenX REGENXBIO Licensors) has any right, interest, or claim in or to such Licensed Research Patents with respect to in the Disease Indications Field that are inconsistent with those granted to Licensee with respect to in the Disease IndicationsField under this Agreement;
8.1.6 To Licensor’s knowledge, GSK Agreement and Penn Agreement are in full force and effect;
8.1.7 To Licensor’s knowledge, no Third Party is infringing any of the Licensed Research Patents in a manner that is inconsistent with the scope of rights granted to Licensee with respect to the Disease Indications; and
8.1.8 8.1.5 Licensor has not received any written notice from any Third Party patentee alleging infringement of such Third Party’s patents by the practice of the Licensed Research Patents in the Field; and
8.1.6 To Licensor’s knowledge, Licensor does not Control as of the Effective Date any patent or patent application (other than the Licensed Patents (as defined in Section 1.17) that would necessarily be infringed by the use or sale of Licensed Vectors in the Field. If it is determined, in accordance with respect the procedure of this Section 8.1.6, that Licensor Controls as of the Effective Date a patent or patent application (other than the Licensed Patents) that would necessarily be infringed by the use or sale of Licensed Vectors in the Field, then Licensee’s sole remedy shall be the inclusion of the applicable patent or patent application as a “Licensed Patent” hereunder but solely to the Disease Indicationsextent of the claim(s) that would necessarily be infringed by the use or sale of Licensed Vectors. At any time during the term of this Agreement, Licensee may notify Licensor in writing of any such patent or patent application that Licensee believes should be included as a “Licensed Patent” pursuant to this Section 8.
Appears in 1 contract