Common use of Xxxxxxx Representations and Warranties Clause in Contracts

Xxxxxxx Representations and Warranties. Xxxxxxx represents, warrants, and covenants that: (a) As of the Effective Date, it is the owner of all right, title, and interest in all Xxxxxxx Patents (including those listed on Schedule 1.41), Existing IND(s), Existing CTA(s), and related Regulatory Documentation free and clear of any liens, claims, or encumbrances, and it did not acquire such right, title and interest from any Third Party other than by assignment from employees of Xxxxxxx or its Affiliates pursuant to the terms of their employment; (b) As of the Effective Date, (1) neither Xxxxxxx nor any Affiliate thereof is a party to any contract, arrangement, or understanding relating to any Xxxxxxx Patent, Xxxxxxx Know-How, Existing IND(s), Existing CTA(s), or related Regulatory Documentation granting any Third Party any rights to develop or commercialize any Licensed Product; (2) neither Xxxxxxx nor any Affiliate thereof is aware of any ground rendering, or reasonably likely to render, the Xxxxxxx Patents invalid or unenforceable; (3) neither Xxxxxxx nor any Affiliate thereof is aware of any material defect regarding the preparation or prosecution of the Xxxxxxx Patents that would render such Xxxxxxx Patent invalid or unenforceable; (4) neither Xxxxxxx nor any Affiliate thereof is aware of the existence of any patent or other intellectual property right owned, licensed, or otherwise controlled by a Third Party that (i) would materially preclude the Parties from conducting Development and Commercialization of Licensed Products, or (ii) that would be infringed by the development, commercialization, use, manufacture, sale, or importation of any Licensed Product as contemplated by this Agreement; (5) neither Xxxxxxx nor any Affiliate thereof has received or is aware of any notice or other communication alleging that a Compound or any Licensed Product, or the use, manufacture, or sale thereof as contemplated by this Agreement, infringes or misappropriates the intellectual property rights of any Third Party; (c) During any portion of the term of this Agreement during which PPD has been granted rights under any Xxxxxxx Patents or Joint Patents, Xxxxxxx will not grant, any right to any Third Party that conflicts with the rights to the Xxxxxxx Patents or Joint Patents granted to PPD hereunder, or which would grant such Third Party the right to make, have made, use, sell, offer for sale, or import Licensed Products thereunder; (d) The Xxxxxxx Patents listed on Schedule 1.41 are, as of the Effective Date, the only Patents owned, licensed, or otherwise controlled by Xxxxxxx or any Affiliate thereof claiming a Compound, any Licensed Products, or the manufacture, use, or application of any of the foregoing; (e) No application for a patent filed by or on behalf of Xxxxxxx with respect thereto, and included within the Xxxxxxx Patents, has been abandoned or allowed to lapse; (f) With respect to the Xxxxxxx Patents, to its knowledge, as of the Effective Date: (i) none of the Xxxxxxx Patents is the subject of any pending interference, opposition, cancellation or other protest proceeding; and (ii) there are no claims pending, threatened, or previously made alleging infringement or misappropriation of any trade secrets of any Third Party; (g) To its knowledge, as of the Effective Date, the Existing IND(s) and Existing CTA(s) are and have been filed, updated, and maintained in accordance with applicable laws, rules, regulations, and guidelines, and neither Xxxxxxx nor any Affiliate thereof has received nor been the subject of, nor is aware of any information for which one would reasonably expect Xxxxxxx or any Affiliate thereof to receive or be the subject of, any correspondence or other action on the part of any regulatory authority which would or could reasonably be expected to have a material adverse effect on the Existing IND(s), Existing CTA(s), or Development of any Licensed Product; (h) As of the Effective Date, and except for the Existing IND(s) and Existing CTA(s), neither Xxxxxxx nor any of its Affiliates own, control, or have any rights to any Regulatory Approvals, Regulatory Filings, or other Regulatory Documentation regarding any Licensed Product and, to Xxxxxxx’x knowledge, no Licensed Product or other product incorporating a Compound has been approved by any regulatory authority in any jurisdiction for marketing or sale for human use; (i) As of the Effective Date, neither Xxxxxxx nor any Affiliate thereof has received from the FDA or any foreign regulatory authority any written notice regarding the approvability or approval of any Licensed Product. No Licensed Product has been withdrawn, suspended or discontinued by Xxxxxxx or any Affiliate thereof as a result of any action by the FDA or any foreign regulatory authority. (j) As of the Effective Date, Xxxxxxx does not own, license, or control any rights to any trademarks, service marks, or trade dress with respect to Licensed Products; (k) As of the Effective Date, (i) Xxxxxxx possesses the Existing Drug Material and owns all right, title, and interest to the Existing Drug Material, free and clear of all liens, claims, and encumbrances, and (ii) the Existing Drug Material has been manufactured in accordance with GMP and all applicable laws, rules, and regulations and conforms to the description thereof provided on Schedule 1.24, without material defect or contamination; and (l) As of the Effective Date, (1) Xxxxxxx has provided to PPD all the material data listed in Schedule 9.3(l), relating to efficacy and toxicity of the Compound and Licensed Products in Xxxxxxx’x possession or under Xxxxxxx’x control as of the Effective Date, respectively, (2) all such data is accurate, complete, and has been generated in accordance with commercially reasonable and generally accepted scientific standards (including, but not limited to, as reasonably appropriate, GLP and GCP), and (3) there is no additional preclinical or clinical data in the possession of Xxxxxxx or any Affiliate thereof that would reasonably be anticipated to materially and adversely affect PPD’s Development or Commercialization of the Licensed Product.

Xxxxxxx Representations and Warranties. Xxxxxxx represents, warrants, Xxxxxx represents and covenants warrants to the other Parties that: (a) As Xxxxxx is an individual; (b) to his Knowledge, Xxxxxx is not an inventor, nor does he own any interest in any patents or patent applications other than his ownership interest in the Patents that would be infringed by the making, having made, using, or selling of products claimed in the Patents as of the Effective Date, it or the otherwise practicing of any technology or inventions claimed in the Patents as of the Effective Date; (c) to his Knowledge, the making, having made, using, or selling of products claimed in the Patents as of the Effective Date, or the otherwise practicing of any technology or inventions claimed in the Patents as of the Effective Date, will not infringe any patent or any other rights of any Third Party (other than the Scripps Rights) or contribute to the infringement of other rights of any Third Party (other than the Scripps Rights) in the United States or elsewhere, and no claim, action or suit alleging any such infringement or contribution to infringement is pending (other than with respect to the owner Scripps Rights) or threatened (other than with respect to the Scripps Rights) in writing against Xxxxxx or his Affiliates; (d) his assignment to Pharmsynthez of all his right, title, and interest in all Xxxxxxx Patents (including those listed on Schedule 1.41), Existing IND(s), Existing CTA(s), and related Regulatory Documentation free and clear of any liens, claims, or encumbrances, and it did not acquire such right, title and interest from any Third Party other than by assignment from employees of Xxxxxxx or its Affiliates pursuant to the terms of their employment; (b) As of the Effective Date, (1) neither Xxxxxxx nor any Affiliate thereof Patents is a party to any contract, arrangement, or understanding relating to any Xxxxxxx Patent, Xxxxxxx Know-How, Existing IND(s), Existing CTA(s), or related Regulatory Documentation granting any Third Party any rights to develop or commercialize any Licensed Product; (2) neither Xxxxxxx nor any Affiliate thereof is aware of any ground rendering, or reasonably likely to render, the Xxxxxxx Patents invalid or unenforceable; (3) neither Xxxxxxx nor any Affiliate thereof is aware of any material defect regarding the preparation or prosecution of the Xxxxxxx Patents that would render such Xxxxxxx Patent invalid or unenforceable; (4) neither Xxxxxxx nor any Affiliate thereof is aware of the existence of any patent or other intellectual property right owned, licensed, or otherwise controlled by a Third Party that (i) would materially preclude the Parties from conducting Development valid and Commercialization of Licensed Products, or (ii) that would be infringed by the development, commercialization, use, manufacture, sale, or importation of any Licensed Product as contemplated by this Agreement; (5) neither Xxxxxxx nor any Affiliate thereof has received or is aware of any notice or other communication alleging that a Compound or any Licensed Product, or the use, manufacture, or sale thereof as contemplated by this Agreement, infringes or misappropriates the intellectual property rights of any Third Party; (c) During any portion of the term of this Agreement during which PPD has been granted rights under any Xxxxxxx Patents or Joint Patents, Xxxxxxx will not grant, any right to any Third Party that conflicts with the rights to the Xxxxxxx Patents or Joint Patents granted to PPD hereunder, or which would grant such Third Party the right to make, have made, use, sell, offer for sale, or import Licensed Products thereunder; (d) The Xxxxxxx Patents listed on Schedule 1.41 are, as of the Effective Date, the only Patents owned, licensed, or otherwise controlled by Xxxxxxx or any Affiliate thereof claiming a Compound, any Licensed Products, or the manufacture, use, or application of any of the foregoingbinding; (e) No application for upon the execution and delivery of this Agreement, this Agreement shall constitute a patent filed valid and binding obligation of Xxxxxx, enforceable against Xxxxxx in accordance with its terms, except to the extent enforceability is limited by bankruptcy, insolvency or on behalf of Xxxxxxx with respect thereto, similar laws affecting creditors’ rights and included within the Xxxxxxx Patents, has been abandoned remedies or allowed to lapseequitable principles; (f) With respect to the Xxxxxxx Patents, to its knowledge, as performance of the Effective Date: (i) none of the Xxxxxxx Patents is the subject Xxxxxx’x obligations under this Agreement will not result in a breach of any pending interference, opposition, cancellation material agreements or other protest proceeding; and (ii) there are no claims pending, threatened, or previously made alleging infringement or misappropriation of any trade secrets of any Third Partycontracts to which he is a party; (g) To its knowledgeXxxxxx has not and will not, as of during the Effective DateTerm, the Existing IND(s) and Existing CTA(s) are and have been filed, updated, and maintained in accordance enter into any material agreements or contracts that would be inconsistent with applicable laws, rules, regulations, and guidelines, and neither Xxxxxxx nor any Affiliate thereof has received nor been the subject of, nor is aware of any information for which one would reasonably expect Xxxxxxx or any Affiliate thereof to receive or be the subject of, any correspondence or other action on the part of any regulatory authority which would or could reasonably be expected to have a material adverse effect on the Existing IND(s), Existing CTA(s), or Development of any Licensed Product;his obligations under this Agreement; and (h) As of the Effective Date, this Agreement is fully binding and except for the Existing IND(s) and Existing CTA(s), neither Xxxxxxx nor any of its Affiliates own, control, or have any rights to any Regulatory Approvals, Regulatory Filings, or other Regulatory Documentation regarding any Licensed Product and, to Xxxxxxx’x knowledge, no Licensed Product or other product incorporating a Compound has been approved by any regulatory authority in any jurisdiction for marketing or sale for human use; (i) As of the Effective Date, neither Xxxxxxx nor any Affiliate thereof has received from the FDA or any foreign regulatory authority any written notice regarding the approvability or approval of any Licensed Product. No Licensed Product has been withdrawn, suspended or discontinued by Xxxxxxx or any Affiliate thereof as a result of any action by the FDA or any foreign regulatory authority. (j) As of the Effective Date, Xxxxxxx does not own, license, or control any rights to any trademarks, service marks, or trade dress with respect to Licensed Products; (k) As of the Effective Date, (i) Xxxxxxx possesses the Existing Drug Material and owns all right, title, and interest to the Existing Drug Material, free and clear of all liens, claims, and encumbrances, and (ii) the Existing Drug Material has been manufactured enforceable in accordance with GMP and all applicable laws, rules, and regulations and conforms to the description thereof provided on Schedule 1.24, without material defect or contamination; and (l) As of the Effective Date, (1) Xxxxxxx has provided to PPD all the material data listed in Schedule 9.3(l), relating to efficacy and toxicity of the Compound and Licensed Products in Xxxxxxx’x possession or under Xxxxxxx’x control as of the Effective Date, respectively, (2) all such data is accurate, complete, and has been generated in accordance with commercially reasonable and generally accepted scientific standards (including, but not limited to, as reasonably appropriate, GLP and GCP), and (3) there is no additional preclinical or clinical data in the possession of Xxxxxxx or any Affiliate thereof that would reasonably be anticipated to materially and adversely affect PPD’s Development or Commercialization of the Licensed Productits terms.

Xxxxxxx Representations and Warranties. Xxxxxxx represents, warrants, Xxxxxx represents and covenants warrants to the other Parties that: (a) As Xxxxxx is an individual; (b) to his Knowledge, Xxxxxx is not an inventor, nor does he own any interest in any patents or patent applications other than his ownership interest in the Patents that would be infringed by the making, having made, using, or selling of products claimed in the Patents as of the Effective Date, it or the otherwise practicing of any technology or inventions claimed in the Patents; (c) to his Knowledge, the making, having made, using, or selling of products claimed in the Patents as of the Effective Date, or the otherwise practicing of any technology or inventions claimed in the Patents as of the Effective Date, will not infringe any patent or any other rights of any Third Party (other than with respect to the Scripps Rights) or contribute to the infringement of other rights of any Third Party (other than with respect to the Scripps Rights) in the United States or elsewhere, and no claim, action or suit alleging any such infringement or contribution to infringement is pending (other than with respect to the owner Scripps Rights) or threatened (other than with respect to the Scripps Rights) in writing against Xxxxxx or his Affiliates; (d) his assignment to Scripps of all his right, title, and interest in all Xxxxxxx Patents (including those listed on Schedule 1.41), Existing IND(s), Existing CTA(s), and related Regulatory Documentation free and clear of any liens, claims, or encumbrances, and it did not acquire such right, title and interest from any Third Party other than by assignment from employees of Xxxxxxx or its Affiliates pursuant to the terms of their employment; (b) As of the Effective Date, (1) neither Xxxxxxx nor any Affiliate thereof Patents is a party to any contract, arrangement, or understanding relating to any Xxxxxxx Patent, Xxxxxxx Know-How, Existing IND(s), Existing CTA(s), or related Regulatory Documentation granting any Third Party any rights to develop or commercialize any Licensed Product; (2) neither Xxxxxxx nor any Affiliate thereof is aware of any ground rendering, or reasonably likely to render, the Xxxxxxx Patents invalid or unenforceable; (3) neither Xxxxxxx nor any Affiliate thereof is aware of any material defect regarding the preparation or prosecution of the Xxxxxxx Patents that would render such Xxxxxxx Patent invalid or unenforceable; (4) neither Xxxxxxx nor any Affiliate thereof is aware of the existence of any patent or other intellectual property right owned, licensed, or otherwise controlled by a Third Party that (i) would materially preclude the Parties from conducting Development valid and Commercialization of Licensed Products, or (ii) that would be infringed by the development, commercialization, use, manufacture, sale, or importation of any Licensed Product as contemplated by this Agreement; (5) neither Xxxxxxx nor any Affiliate thereof has received or is aware of any notice or other communication alleging that a Compound or any Licensed Product, or the use, manufacture, or sale thereof as contemplated by this Agreement, infringes or misappropriates the intellectual property rights of any Third Party; (c) During any portion of the term of this Agreement during which PPD has been granted rights under any Xxxxxxx Patents or Joint Patents, Xxxxxxx will not grant, any right to any Third Party that conflicts with the rights to the Xxxxxxx Patents or Joint Patents granted to PPD hereunder, or which would grant such Third Party the right to make, have made, use, sell, offer for sale, or import Licensed Products thereunder; (d) The Xxxxxxx Patents listed on Schedule 1.41 are, as of the Effective Date, the only Patents owned, licensed, or otherwise controlled by Xxxxxxx or any Affiliate thereof claiming a Compound, any Licensed Products, or the manufacture, use, or application of any of the foregoingbinding; (e) No application for upon the execution and delivery of this Agreement, this Agreement shall constitute a patent filed valid and binding obligation of Xxxxxx, enforceable against Xxxxxx in accordance with its terms, except to the extent enforceability is limited by bankruptcy, insolvency or on behalf of Xxxxxxx with respect thereto, similar laws affecting creditors’ rights and included within the Xxxxxxx Patents, has been abandoned remedies or allowed to lapseequitable principles; (f) With respect to the Xxxxxxx Patents, to its knowledge, as performance of the Effective Date: (i) none of the Xxxxxxx Patents is the subject Xxxxxx’x obligations under this Agreement will not result in a breach of any pending interference, opposition, cancellation material agreements or other protest proceeding; and (ii) there are no claims pending, threatened, or previously made alleging infringement or misappropriation of any trade secrets of any Third Partycontracts to which he is a party; (g) To its knowledgeXxxxxx has not and will not, as of during the Effective DateTerm, the Existing IND(s) and Existing CTA(s) are and have been filed, updated, and maintained in accordance enter into any material agreements or contracts that would be inconsistent with applicable laws, rules, regulations, and guidelines, and neither Xxxxxxx nor any Affiliate thereof has received nor been the subject of, nor is aware of any information for which one would reasonably expect Xxxxxxx or any Affiliate thereof to receive or be the subject of, any correspondence or other action on the part of any regulatory authority which would or could reasonably be expected to have a material adverse effect on the Existing IND(s), Existing CTA(s), or Development of any Licensed Product;his obligations under this Agreement; and (h) As of the Effective Date, this Agreement is fully binding and except for the Existing IND(s) and Existing CTA(s), neither Xxxxxxx nor any of its Affiliates own, control, or have any rights to any Regulatory Approvals, Regulatory Filings, or other Regulatory Documentation regarding any Licensed Product and, to Xxxxxxx’x knowledge, no Licensed Product or other product incorporating a Compound has been approved by any regulatory authority in any jurisdiction for marketing or sale for human use; (i) As of the Effective Date, neither Xxxxxxx nor any Affiliate thereof has received from the FDA or any foreign regulatory authority any written notice regarding the approvability or approval of any Licensed Product. No Licensed Product has been withdrawn, suspended or discontinued by Xxxxxxx or any Affiliate thereof as a result of any action by the FDA or any foreign regulatory authority. (j) As of the Effective Date, Xxxxxxx does not own, license, or control any rights to any trademarks, service marks, or trade dress with respect to Licensed Products; (k) As of the Effective Date, (i) Xxxxxxx possesses the Existing Drug Material and owns all right, title, and interest to the Existing Drug Material, free and clear of all liens, claims, and encumbrances, and (ii) the Existing Drug Material has been manufactured enforceable in accordance with GMP and all applicable laws, rules, and regulations and conforms to the description thereof provided on Schedule 1.24, without material defect or contamination; and (l) As of the Effective Date, (1) Xxxxxxx has provided to PPD all the material data listed in Schedule 9.3(l), relating to efficacy and toxicity of the Compound and Licensed Products in Xxxxxxx’x possession or under Xxxxxxx’x control as of the Effective Date, respectively, (2) all such data is accurate, complete, and has been generated in accordance with commercially reasonable and generally accepted scientific standards (including, but not limited to, as reasonably appropriate, GLP and GCP), and (3) there is no additional preclinical or clinical data in the possession of Xxxxxxx or any Affiliate thereof that would reasonably be anticipated to materially and adversely affect PPD’s Development or Commercialization of the Licensed Productits terms.

Xxxxxxx Representations and Warranties. Xxxxxxx represents, warrants, represents and covenants warrants that: : (a) As of the Effective DateXxxxxxx Services will be performed in a professional manner and Xxxxxxx will use its best efforts to conform to the performance criteria set forth in this Agreement, it is the owner of all rightin compliance with applicable federal, titlestate and local laws, regulations, rules, and interest in all Xxxxxxx Patents (including those listed on Schedule 1.41), Existing IND(s), Existing CTA(s), ordinances; and related Regulatory Documentation free and clear of any liens, claims, or encumbrances, and it did not acquire such right, title and interest from any Third Party other than by assignment from employees of Xxxxxxx or its Affiliates pursuant to the terms of their employment; (b) As of the Effective Dateall services will be performed by qualified, (1) neither Xxxxxxx nor any Affiliate thereof is a party to any contracttrained, arrangement, or understanding relating to any Xxxxxxx Patent, Xxxxxxx Know-How, Existing IND(s), Existing CTA(s), or related Regulatory Documentation granting any Third Party any rights to develop or commercialize any Licensed Productand properly equipped personnel; (2) neither Xxxxxxx nor any Affiliate thereof is aware of any ground rendering, or reasonably likely to render, the Xxxxxxx Patents invalid or unenforceable; (3) neither Xxxxxxx nor any Affiliate thereof is aware of any material defect regarding the preparation or prosecution of the Xxxxxxx Patents that would render such Xxxxxxx Patent invalid or unenforceable; (4) neither Xxxxxxx nor any Affiliate thereof is aware of the existence of any patent or other intellectual property right owned, licensed, or otherwise controlled by a Third Party that (i) would materially preclude the Parties from conducting Development and Commercialization of Licensed Products, or (ii) that would be infringed by the development, commercialization, use, manufacture, sale, or importation of any Licensed Product as contemplated by this Agreement; (5) neither Xxxxxxx nor any Affiliate thereof has received or is aware of any notice or other communication alleging that a Compound or any Licensed Product, or the use, manufacture, or sale thereof as contemplated by this Agreement, infringes or misappropriates the intellectual property rights of any Third Party; (c) During that it is not debarred, suspended, proposed for debarment, or declared ineligible by any portion of relevant governmental entity. Xxxxxxx represents that it has not offered (and will not offer during the term of this Agreement during which PPD has been granted rights under Agreement) any Xxxxxxx Patents compensation, reward, gift, favor, service, outside employment, reimbursement of expenses, loan, ownership interest, or Joint Patentsanything else of value, to any officer, employee, or faculty member of Rutgers as an inducement to enter into or renew this Agreement. Xxxxxxx will not grantnotify Rutgers of any changes in the conditions as represented in the foregoing, any right that might give the appearance of a conflict of interest. Xxxxxxx warrants and represents that it is financially responsible and experienced in and competent to any Third Party perform the type of work required hereunder. Each party represents that conflicts with the rights to the Xxxxxxx Patents or Joint Patents granted to PPD hereunder, or which would grant such Third Party the right to make, have made, use, sell, offer for sale, or import Licensed Products thereunder; (d) The Xxxxxxx Patents listed on Schedule 1.41 are, as best of the Effective Date, the only Patents owned, licensed, or otherwise controlled by Xxxxxxx or any Affiliate thereof claiming a Compound, any Licensed Products, or the manufacture, use, or application of any of the foregoing; (e) No application for a patent filed by or on behalf of Xxxxxxx with respect thereto, and included within the Xxxxxxx Patents, has been abandoned or allowed to lapse; (f) With respect to the Xxxxxxx Patents, to its knowledge, as any method of transmitting the programs to the other party will not introduce, any program, routine, subroutine or data (including malicious software or “malware,” viruses, worms and Trojan Horses) that are designed to disrupt the proper operation of the Effective Date: (i) none of the Xxxxxxx Patents is the subject of any pending interference, opposition, cancellation or other protest proceeding; and (ii) there are no claims pending, threatened, or previously made alleging infringement or misappropriation of any trade secrets of any Third Party; (g) To its knowledge, as of the Effective Date, the Existing IND(s) and Existing CTA(s) are and have been filed, updated, and maintained in accordance with applicable laws, rules, regulations, and guidelines, and neither Xxxxxxx nor any Affiliate thereof has received nor been the subject of, nor is aware of any information for which one would reasonably expect Xxxxxxx programs or any Affiliate thereof to receive other software or be the subject ofsystem used by that party. XXXXXXX MAKES NO OTHER WARRANTY, any correspondence or other action on the part of any regulatory authority which would or could reasonably be expected to have a material adverse effect on the Existing IND(s)EXPRESS OR IMPLIED, Existing CTA(s)WITH RESPECT TO ANY PRODUCTS OR SERVICES PROVIDED BY XXXXXXX HEREUNDER. XXXXXXX HEREBY DISCLAIMS ALL IMPLIED WARRANTIES AND CONDITIONS, or Development of any Licensed Product; (h) As of the Effective DateWHETHER STATUTORY, and except for the Existing IND(s) and Existing CTA(s)ARISING FROM COURSE OF DEALING, neither Xxxxxxx nor any of its Affiliates ownUSAGE OR TRADE PRACTICE, controlOR OTHERWISE, or have any rights to any Regulatory ApprovalsINCLUDING WITHOUT LIMITATION TERMS AS TO QUALITY, Regulatory FilingsMERCHANTABILITY, or other Regulatory Documentation regarding any Licensed Product andFITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT. XXXXXXX MAKES NO WARRANTY THAT THE XXXXXXX SERVICES OR RUTGERS’ USE THEREOF WILL BE UNINTERRUPTED OR ERROR- FREE. EXCEPT TO THE EXTENT OTHERWISE EXPRESSLY PROVIDED FOR IN THIS AGREEMENT, to Xxxxxxx’x knowledgeXXXXXXX DISCLAIMS ANY REPRESENTATION OR WARRANTY CONCERNING ANY PRESENT OR FUTURE USE, no Licensed Product or other product incorporating a Compound has been approved by any regulatory authority in any jurisdiction for marketing or sale for human use; (i) As of the Effective Date, neither Xxxxxxx nor any Affiliate thereof has received from the FDA or any foreign regulatory authority any written notice regarding the approvability or approval of any Licensed Product. No Licensed Product has been withdrawn, suspended or discontinued by Xxxxxxx or any Affiliate thereof as a result of any action by the FDA or any foreign regulatory authorityINTEGRATION OR COMPATIBILITY WITH ANY OTHER PRODUCTS OR SERVICES. (j) As of the Effective Date, Xxxxxxx does not own, license, or control any rights to any trademarks, service marks, or trade dress with respect to Licensed Products; (k) As of the Effective Date, (i) Xxxxxxx possesses the Existing Drug Material and owns all right, title, and interest to the Existing Drug Material, free and clear of all liens, claims, and encumbrances, and (ii) the Existing Drug Material has been manufactured in accordance with GMP and all applicable laws, rules, and regulations and conforms to the description thereof provided on Schedule 1.24, without material defect or contamination; and (l) As of the Effective Date, (1) Xxxxxxx has provided to PPD all the material data listed in Schedule 9.3(l), relating to efficacy and toxicity of the Compound and Licensed Products in Xxxxxxx’x possession or under Xxxxxxx’x control as of the Effective Date, respectively, (2) all such data is accurate, complete, and has been generated in accordance with commercially reasonable and generally accepted scientific standards (including, but not limited to, as reasonably appropriate, GLP and GCP), and (3) there is no additional preclinical or clinical data in the possession of Xxxxxxx or any Affiliate thereof that would reasonably be anticipated to materially and adversely affect PPD’s Development or Commercialization of the Licensed Product.

Xxxxxxx Representations and Warranties. Xxxxxxx representsrepresents and warrants to Cidara, warrants, and covenants as of the Execution Date that: (a) As of the Effective Dateto Xxxxxxx’x knowledge, it is the owner of all rightno Xxxxxxx Patents, title, and interest in all Xxxxxxx Joint Patents (including those listed on Schedule 1.41), Existing IND(s), Existing CTA(s), and related Regulatory Documentation free and clear of any liens, claims, or encumbrances, and it did not acquire such right, title and interest from any Third Party other than by assignment from employees of Xxxxxxx or its Affiliates pursuant to the terms of their employmentJoint Inventions exist; (b) As none of the Effective DateXxxxxxx Technology is licensed to Janssen or any Affiliate of Xxxxxxx by a Third Party, and no Third Party has any rights, title or interests in or to, or any license under, any of the Xxxxxxx Technology that would conflict with the rights and licenses granted to Xxxxxx xxxxxxxxx; (1c) to Xxxxxxx’x knowledge, neither Xxxxxxx nor any of its Affiliates is a party to any Third Party agreement (including with WuXi Biologics (Hong Kong) Limited or any of its Affiliates) under which any royalty or other payment obligations to any Third Party would accrue as a result of: (i) the Development or Commercialization of CD388, or of the CD388 Product used by or on behalf of Janssen or any Affiliate of Janssen in the conduct of the Collaboration Activities; or (ii) the Manufacture of CD388, or the CD388 Product used by or on behalf of Janssen or any Affiliate of Janssen in the conduct of the Collaboration Activities, in each case, as CD388 or such CD388 Product (as applicable) was Manufactured by or on behalf of Xxxxxxx or any of its Affiliates during the Collaboration Term; (d) Xxxxxxx has not previously (i) assigned, transferred, conveyed or granted any license or other rights under the Xxxxxxx Technology that would conflict with or limit the scope of any of the rights or licenses granted to Cidara hereunder, or (ii) granted to any Third Party or Affiliate any license or sublicense, or option or other right to obtain a license or sublicense, to Develop, Manufacture or Commercialize CD388 or a CD388 Product, other than to Third Party contractors for the purpose of performing Development or Manufacturing activities on Xxxxxxx’x behalf during the Collaboration Term; (e) neither Xxxxxxx nor any Affiliate thereof of its Affiliates has been a party to any, and is not a party to any contractpending, arrangementlitigation, or understanding relating to any and Xxxxxxx Patent, Xxxxxxx Know-How, Existing IND(s), Existing CTA(s), or related Regulatory Documentation granting has not received written notice from any Third Party any rights to develop Party, in each case, claiming that the Manufacture, use, sale, offer for sale or commercialize any Licensed Product; (2) neither Xxxxxxx nor any Affiliate thereof is aware import of any ground rendering, CD388 infringes or reasonably likely to render, would infringe the Xxxxxxx Patents invalid or unenforceable; (3) neither Xxxxxxx nor any Affiliate thereof is aware of any material defect regarding the preparation or prosecution of the Xxxxxxx Patents that would render such Xxxxxxx Patent invalid or unenforceable; (4) neither Xxxxxxx nor any Affiliate thereof is aware of the existence of any patent or other intellectual property right owned, licensed, or otherwise controlled by a Third Party that (i) would materially preclude the Parties from conducting Development and Commercialization of Licensed Products, or (ii) that would be infringed by the development, commercialization, use, manufacture, sale, or importation of any Licensed Product as contemplated by this Agreement; (5) neither Xxxxxxx nor any Affiliate thereof has received or is aware of any notice or other communication alleging that a Compound or any Licensed Product, or the use, manufacture, or sale thereof as contemplated by this Agreement, infringes or misappropriates the intellectual property rights of any Third Party; (cf) During any portion of the term of this Agreement during which PPD Xxxxxxx has been granted rights under any Xxxxxxx Patents or Joint Patents, Xxxxxxx will not grant, any right to any Third Party that conflicts with the rights to the Xxxxxxx Patents or Joint Patents granted to PPD hereunderobtained, or which would grant caused all Affiliates of Xxxxxxx, as applicable, to obtain, assignments from all natural persons involved in the performance by or on behalf of Janssen or any of its Affiliates of any Development or Manufacturing activities with respect to CD388 or a CD388 Product who were employees of Xxxxxxx or any of its Affiliates of Janssen at the time of performance of such Third Party activities, of all right, title and interest in and to all Xxxxxxx Know-How (including all Data, AVC Improvement Know-How and Manufacturing Improvement Know-How) generated or developed by such natural persons in the right to makeconduct of such activities, have made, use, sell, offer for sale, or import Licensed Products thereunderand all such assignments are valid and enforceable; (dg) The Xxxxxxx Patents listed on Schedule 1.41 arethere are no claims, as of the Effective Date, the only Patents owned, licensedjudgments, or otherwise controlled settlements against or pending with respect to any Xxxxxxx Know-How (including any Data, AVC Improvement Know-How or Manufacturing Improvement Know-How) generated or developed by or on behalf of Janssen or any of its Affiliates pursuant to the Collaboration Agreement, or amounts with respect thereto, owed by Xxxxxxx or any Affiliate thereof claiming a Compound, any Licensed Products, or the manufacture, use, or application of any of the foregoing; (e) No application for a patent filed by or on behalf of Xxxxxxx with respect theretoJanssen, and included within the Xxxxxxx Patents, has been abandoned or allowed to lapse; (f) With respect to the Xxxxxxx Patents, to its knowledge, as of the Effective Date: (i) none of the Xxxxxxx Patents is the subject of any pending interference, opposition, cancellation or other protest proceeding; and (ii) there are no claims pending, threatened, or previously made alleging infringement or misappropriation of any trade secrets of any Third Party; (g) To its knowledge, as of the Effective Date, the Existing IND(s) and Existing CTA(s) are and have been filed, updated, and maintained in accordance with applicable laws, rules, regulations, and guidelines, and neither Xxxxxxx nor any Affiliate thereof has received nor been the subject of, nor is aware of any information for which one would reasonably expect Xxxxxxx or any Affiliate thereof to receive or be the subject of, any correspondence or other action on the part of any regulatory authority which would or could reasonably be expected to have a material adverse effect on the Existing IND(s), Existing CTA(s), or Development of any Licensed Product; (h) As of the Effective Date, and except for the Existing IND(s) and Existing CTA(s), neither Xxxxxxx nor any of its Affiliates own, control, or have has received written notice threatening any rights to any Regulatory Approvals, Regulatory Filings, or other Regulatory Documentation regarding any Licensed Product such claim; and, to Xxxxxxx’x knowledge, no Licensed Product or other product incorporating a Compound has been approved by any regulatory authority in any jurisdiction for marketing or sale for human use; (ih) As of the Effective Date, neither Xxxxxxx nor any Affiliate thereof of its Affiliates has received from the FDA been debarred or suspended under 21 U.S.C. § 335(a) or § 335(b) or any foreign regulatory authority any written notice regarding equivalent thereof, or is the approvability or approval subject of any Licensed Product. No Licensed Product has been withdrawn, suspended or discontinued by Xxxxxxx or any Affiliate thereof as a result of any action by the FDA conviction described in such section or any foreign regulatory authorityequivalent thereof. (j) As of the Effective Date, Xxxxxxx does not own, license, or control any rights to any trademarks, service marks, or trade dress with respect to Licensed Products; (k) As of the Effective Date, (i) Xxxxxxx possesses the Existing Drug Material and owns all right, title, and interest to the Existing Drug Material, free and clear of all liens, claims, and encumbrances, and (ii) the Existing Drug Material has been manufactured in accordance with GMP and all applicable laws, rules, and regulations and conforms to the description thereof provided on Schedule 1.24, without material defect or contamination; and (l) As of the Effective Date, (1) Xxxxxxx has provided to PPD all the material data listed in Schedule 9.3(l), relating to efficacy and toxicity of the Compound and Licensed Products in Xxxxxxx’x possession or under Xxxxxxx’x control as of the Effective Date, respectively, (2) all such data is accurate, complete, and has been generated in accordance with commercially reasonable and generally accepted scientific standards (including, but not limited to, as reasonably appropriate, GLP and GCP), and (3) there is no additional preclinical or clinical data in the possession of Xxxxxxx or any Affiliate thereof that would reasonably be anticipated to materially and adversely affect PPD’s Development or Commercialization of the Licensed Product.