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Common use of Property Matters Clause in Contracts

Property Matters. (a) Schedule 4.10(a) sets forth an accurate and complete list of the Owned Included Product Patent Rights and to the Knowledge of the Company the Licensed Included Product Patent Rights. For each Patent set forth on Schedule 4.10(a) the Company has indicated: (i) the application number; (ii) the patent or registration number, if any; (iii) the country or other jurisdiction where the Patent Right was issued, registered, or filed; (iv) the scheduled expiration date of any issued Patent Right, including a notation if such scheduled expiration date includes a term extension or supplementary protection certificate; and (v) the registered owner thereof. (b) The Company (or the Company Party indicated on Schedule 4.10(a)) is the sole and exclusive owner of the entire right, title and interest in each of the Owned Included Product Patent Rights. Other than Permitted Liens, the Owned Included Product Patent Rights are not subject to any encumbrance, Lien or claim of ownership by any Third Party, and to the Knowledge of the Company there are no facts that would preclude the Company from having unencumbered title to the Owned Included Product Patent Rights. No Company Party has received any written notice of any claim by any Third Party challenging Company Parties’ ownership of the Owned Included Product Patent Rights. (c) Except as set forth on Schedule 4.10(c), each inventor named on the Owned Included Product Patent Rights, has executed a Contract assigning their entire right, title and interest in and to such Patent Rights and the inventions embodied, described and/or claimed therein, to the Company (or the respective Company Party indicated on Schedule 4.10(a)), and each such Contract has been duly recorded at the United States Patent and Trademark Office. (d) To the Knowledge of the Company, no issued Owned Included Product Patent Right has lapsed, expired or otherwise been terminated and no Owned Included Product Patent Right applications have lapsed, expired, been abandoned or otherwise been terminated, other than by operation of law or in the ordinary course of patent prosecution. (e) To the Knowledge of the Company, there are no unpaid maintenance fees, annuities or other like payments that are overdue with respect to any of the Owned Included Product Patent Rights. (f) To the Knowledge of the Company, each of the Owned Included Product Patent Rights correctly identifies each and every inventor of the claims thereof as determined in accordance with Applicable Law. Each such inventor has executed an assignment assigning their entire right, title and interest in and to such Included Product Patent Rights and the inventions embodied, described and/or claimed therein, to the Company or to an entity that has in turn executed an assignment assigning their entire right, title and interest in and to such Patent Rights and the inventions embodied, described and/or claimed therein, to the Company, and each such assignment has been duly recorded at the United States Patent and Trademark Office. To the Knowledge of the Company, there is no Person who is or claims to be an inventor of any of the Owned Included Product Patent Rights who is not a named inventor thereof. No Company Party has received from any Person who is not a named inventor of any of the Owned Included Product Patent Rights written notice in which such Person claims to be an inventor of any of the Owned Included Product Patent Rights. ​ (g) To the Knowledge of the Company, each of the Owned Included Product Patent Rights and each of the claims thereof is valid, enforceable and subsisting. No Company Party has received any opinion of counsel that any of the Owned Included Product Patent Rights or any claims thereof are invalid or unenforceable. No Company Party has received written notice of any claim by any Third Party challenging the validity or enforceability of any of the Owned Included Product Patent Rights or any claims thereof. (h) To the Knowledge of the Company, each individual associated with the filing and prosecution of the Owned Included Product Patent Rights has complied in all material respects with all applicable duties of candor and good faith in dealing with any Patent Office, including any duty to disclose to any Patent Office all information known by such individual to be material to patentability of each such Patent Right, in those jurisdictions where such duties exist. (i) There is at least one valid claim in the Owned Included Product Patent Rights that would be infringed by the Company’s or any Subsidiary’s Commercialization of ZTALMY but for the Company’s and the Subsidiaries’ rights in such Patent Rights. Each of claims 1-18, 20-22, 24-28, 34-38, 40-47, and 49-55 of U.S. Patent No. 8,318,714 are Valid Claims and Cover ZTALMY. The application for Patent Term Extension for U.S. Patent No. 8,318,714 was timely filed and in accordance with all Applicable Laws, is accurate and complete in all material respects. The Company exercised due diligence in the development of ZTALMY during the entire period of time extending from its acquisition of IND No. 044020 for ZTALMY on February 8, 2005 through and to the approval of the NDA for ZTALMY (NDA No. 215904) on June 1, 2022. To the Company’s Knowledge, the Company’s predecessors in interest CoCensys, Inc. and Purdue Pharma, Inc. exercised due diligence in the development of ZTALMY during the entire period of time extending from the effective date of IND No. 044020, which was no later than March 28, 1994, through and to the sale of IND No. 044020 to the Company on February 8, 2005. (j) Except for information disclosed to the applicable Patent Office during prosecution of the Owned Included Product Patent Rights, and to the Knowledge of the Company, there are no patents, published patent applications, articles, abstracts, disclosures, sales, offers for sale or other prior art deemed material to patentability of any of the inventions claimed in such Owned Included Product Patent Rights, or that would otherwise reasonably be expected to materially adversely affect the validity or enforceability of any of the claims of such Owned Included Product Patent Rights. (k) There is no pending or, to the Knowledge of the Company, threatened opposition, interference, reexamination, injunction, claim, suit, action, citation, summons, subpoena, hearing, inquiry, investigation (by the International Trade Commission or otherwise), complaint, arbitration, mediation, demand, decree or other dispute, disagreement, proceeding, claim, inter-partes review, post-grant review, or Paragraph IV Certification (collectively, “Disputes”) challenging the legality, validity, enforceability, ownership or infringement of any of the Owned Included Product Patent Rights or that could reasonably be expected to result in any Set-off against the payments due to the Investor under this Agreement. There are no Disputes by or with any Third Party against the Company or any of its Subsidiaries involving the Owned included Product Patents, ZTALMY or any other Included Product currently being Developed by or on behalf of the Company. The Owned Included Product Patent Rights are not subject to any ​ outstanding injunction, judgment, order, decree, ruling, challenge, settlement or other disposition of a Dispute. (l) Except as set forth on Schedule 4.10(l), there is no pending or, to the Knowledge of the Company, threatened, and no event has occurred or circumstance exists that (with or without notice or lapse of time, or both) would result in or serve as a basis for any, action, suit or proceeding, or any investigation or claim, and the Company has not received any written notice of the foregoing, that claims that the manufacture, use, marketing, sale, offer for sale, importation or distribution of ZTALMY or any other Included Product currently being Developed by or on behalf of the Company infringes on any Patent or other intellectual property rights of any other Person or constitutes misappropriation of any other Person’s trade secrets or other intellectual property rights. (m) To the Knowledge of the Company, none of the conception, development and reduction to practice of the inventions claimed in the Owned Included Product Patent Rights has constituted or involved the misappropriation of trade secrets or other rights or property of any Third Party. (n) No Company Party has filed any disclaimer, other than a terminal disclaimer, or made or permitted any other voluntary reduction in the scope of any Owned Included Product Patent Rights. (o) To the Knowledge of the Company, no valid Third Party Patent has been, or is, or will be, infringed by the Company’s current or proposed Commercialization of ZTALMY or any other Included Product currently being clinically Developed by or on behalf of the Company. To the Knowledge of the Company, no valid Third Party Patent would limit or prohibit in any material respect the Company’s Commercialization of ZTALMY or any other Included Product currently being clinically Developed by or on behalf of the Company as currently proposed. The Company has not received any written notice of any claim by any Third Party asserting that the Company’s Commercialization of ZTALMY or any other Included Product currently being Developed by or on behalf of the Company infringes or, upon Commercialization, could infringe such Third Party’s Patents. The Company has not received any opinion of counsel regarding infringement or non-infringement of any Third Party Patent by the Company’s Commercialization of ZTALMY or any other Included Product currently being Developed by or on behalf of the Company. (p) Except as set forth on Schedule 4.10(p), to the Knowledge of the Company, there are no pending, published patent applications owned by any Third Party, which the Company Parties do not have the right to use, which if issued, would limit or prohibit in any material respect the Company’s Parties’ Commercialization of ZTALMY or any other Included Product currently being Developed by or on behalf of the Company. (q) To the Knowledge of the Company, no Third Party is infringing any of the issued Owned Included Product Patent Rights. No Company Party has provided written notice to a Third Party claiming that the Third Party is infringing any Included Product Patent Rights. ​ (r) Schedule 4.10(r) sets forth all Trademarks material to Company Parties’ Commercialization of any Included Product. (s) The Owned Included Product Patent Rights and the Licensed Included Product Patent Rights licensed to Company under the License Agreements (Schedule 1.1-3) constitute all of the Patents owned or controlled by the Company or any of the Company’s Affiliates that relate to the Included Products.

Appears in 1 contract

Samples: Revenue Interest Financing Agreement (Marinus Pharmaceuticals, Inc.)

Property Matters. (a) Schedule 4.10(a) sets forth an accurate and complete list of the Owned Included Product Patent Rights owned by or exclusively licensed to any Company Party, including the complete and to the Knowledge accurate list of the Company the Licensed Included Product Yutrepia Patent Rights. For each Patent Right set forth on Schedule 4.10(a) the Company has indicated: (i) the application number; (ii) the patent or registration number, if any; (iii) the country or other jurisdiction where the Patent Right was issued, registered, or filed; (iv) the scheduled expiration date of any issued Patent Right, including a notation if such scheduled expiration date includes a term extension or supplementary protection certificate; and (v) the registered owner thereof. (b) The Company (or the Company Party indicated on Schedule 4.10(a)) is the sole and exclusive owner of the entire right, title and interest in each of the Owned Included Product Patent Rights. Other than Permitted Liens, the The Owned Included Product Patent Rights are not subject to any encumbrance, Lien or claim of ownership by any Third Party, other than a Permitted License, and to the Knowledge of the Company Company, there are no facts that would preclude the relevant Company Party from having unencumbered title to the Owned Included Product Patent Rights. No Company Party has received any written notice of any claim by any Third Party challenging Company Parties’ the ownership of the rights of the Company Parties in and to the Owned Included Product Patent Rights. (c) Except as set forth on Schedule 4.10(c)To the Knowledge of the Company, each Person who has or has had any rights in or to the Patent Rights, including each inventor named on the Owned Included Product such Patent Rights, has executed a Contract assigning their entire right, title and interest in and to such Patent Rights and the inventions embodied, described and/or claimed therein, to the Company (or the respective Company Party indicated on Schedule 4.10(a))owner thereof, and each such Contract has been duly recorded at the United States Patent and Trademark Office. (d) To the Knowledge of the Company, no issued Owned Included Product Patent Right has lapsed, expired or otherwise been terminated and no Owned Included Product terminated. No patent applications included in the Patent Right applications Rights have lapsed, expired, been abandoned or otherwise been terminated, in each case other than (i) by LEGAL 4875-0317-8306v.49 ​ operation of law or law, (ii) in the course of patent prosecution under the ordinary course of patent prosecutionbusiness, or (iii) due to strategic abandonment, expiration, or termination. (e) To the Knowledge of the Company, there There are no unpaid maintenance fees, annuities or other like payments that are overdue with respect to any the Patent Rights as of the Owned Included Product Patent RightsEffective Date for which any Company Party is responsible for payment. (f) To the Knowledge of the Company, each of the Owned Included Product Patent Rights correctly identifies each and every inventor of the claims thereof as determined in accordance with Applicable Law. Each such inventor has executed an assignment assigning their entire right, title and interest the Laws of the jurisdiction in and to such Included Product Patent Rights and the inventions embodied, described and/or claimed therein, to the Company or to an entity that has in turn executed an assignment assigning their entire right, title and interest in and to which such Patent Rights and the inventions embodied, described and/or claimed therein, to the Company, and each such assignment has been duly recorded at the United States Patent and Trademark OfficeRight was issued or is pending. To the Knowledge of the Company, there is no not any Person who is or claims to be an inventor of any of the Owned Included Product Patent Rights who is not a named inventor thereof. No Company Party has received any notice from any Person who is not a named inventor of any of the Owned Included Product Patent Rights written notice in which such Person or claims to be an inventor of any of the Owned Included Product Patent Rights. ​Rights who is not a named inventor thereof. (g) To the Knowledge of the Company, each of the Owned Included Product Patent Rights and each of the claims thereof therein is valid, enforceable and subsisting. No Company Party has received any opinion of counsel that any of the Owned Included Product Patent Rights or any claims thereof are is invalid or unenforceable. No Company Party has received written any notice of any claim by any Third Party challenging the validity or enforceability of any of the Owned Included Product Patent Rights or any claims thereofRights. (h) To the Knowledge of the Company, each individual associated with the filing and prosecution of the Owned Included Product Patent Rights has complied in all material respects with all applicable duties of candor and good faith in dealing with any Patent Office, including any duty to disclose to any Patent Office all information known by such individual to be material to patentability of each such Patent Right, in those jurisdictions where such duties exist. (i) There is at least one valid claim in each of the Owned Included Product Patent Rights set forth on Schedule 4.10(i) that would be infringed by any member of the Company’s or any SubsidiaryCompany Group’s Commercialization of ZTALMY the Included Products (other than the Sandoz Product) but for such member of the CompanyCompany Group’s and the Subsidiaries’ rights in such Patent Rights. Each of claims 1-18, 20-22, 24-28, 34-38, 40-47, and 49-55 of U.S. Patent No. 8,318,714 are Valid Claims and Cover ZTALMY. The application for Patent Term Extension for U.S. Patent No. 8,318,714 was timely filed and in accordance with all Applicable Laws, is accurate and complete in all material respects. The Company exercised due diligence in the development of ZTALMY during the entire period of time extending from its acquisition of IND No. 044020 for ZTALMY on February 8, 2005 through and to the approval of the NDA for ZTALMY (NDA No. 215904) on June 1, 2022. To the Company’s Knowledge, the Company’s predecessors in interest CoCensys, Inc. and Purdue Pharma, Inc. exercised due diligence in the development of ZTALMY during the entire period of time extending from the effective date of IND No. 044020, which was no later than March 28, 1994, through and to the sale of IND No. 044020 to the Company on February 8, 2005. (j) Except To the Knowledge of the Company, except for information disclosed to the applicable Patent Office during prosecution of the Owned Included Product Patent Rights, and to the Knowledge of the Company, there are no patents, published patent applications, articles, abstracts, disclosures, sales, offers for sale abstracts or other prior art deemed material to patentability of any of the inventions claimed in such Owned Included Product Patent Rights, or that would otherwise reasonably be expected to materially adversely affect the validity or enforceability of any of the claims of such Owned Included Product Patent Rights. (k) There is no pending or, to the Knowledge of the Company, threatened opposition, interference, reexamination, injunction, claim, suit, action, citation, summons, subpoena, hearing, inquiry, investigation (by the International Trade Commission or otherwise), complaint, arbitration, mediation, demand, decree or other dispute, disagreement, proceeding, claim, inter-claim or inter partes review, post-grant review, or Paragraph IV Certification review (other than standard patent prosecution before a Patent Office) (collectively, “Disputes”) challenging the legality, validity, enforceability, enforceability or ownership or infringement of any of the Owned Included Product Patent Rights or that could reasonably be expected to result in any Set-off against the payments due to the Investor Representative under this Agreement. There To the Knowledge of the Company, there are no Disputes by or with any Third Party against the any Company or any of its Subsidiaries Party involving the Owned included Product Patents, ZTALMY or any other Included Product currently being Developed by or on behalf of the CompanyProduct. The Owned Included Product Patent LEGAL 4875-0317-8306v.49 ​ Rights are not subject to any outstanding injunction, judgment, order, decree, ruling, challengechange, settlement or other disposition of a Dispute. (l) Except as set forth on Schedule 4.10(l), there is no pending or, to To the Knowledge of the Company, and except as separately disclosed to Investor Representative, there is no pending or threatened, and no event has occurred or circumstance exists that (with or without notice or lapse of time, or both) would result in or serve as a basis for any, action, suit or proceeding, or any investigation or claim, and none of the Company has not Group members have received any written notice of the foregoing, that claims that the manufacture, use, marketing, sale, offer for sale, importation or distribution of ZTALMY or any other the Included Product as currently being Developed by or on behalf of the Company contemplated infringes on any Patent or other intellectual property rights of any other Person or constitutes misappropriation of any other Person’s trade secrets Trade Secrets or other intellectual property rights. (m) To the Knowledge of the Company, none of the conception, development and reduction to practice of the inventions claimed in the Owned Included Product Patent Rights has constituted or involved the misappropriation of trade secrets Trade Secrets or other rights or property of any Third Party. (n) No Company Party has filed any disclaimer, other than a terminal disclaimer, or made or permitted any other voluntary reduction in the scope of any Owned Included Product Patent RightsRight. (o) To the Knowledge of the Company, no valid Third Party Patent has been, or is, or will be, or are, infringed by the Company’s current or proposed Commercialization of ZTALMY or any other Included Product currently being clinically Developed by or on behalf member of the Company. To the Knowledge of the Company, no valid Third Party Patent would limit or prohibit in any material respect the CompanyCompany Group’s Commercialization of ZTALMY or any other the Included Product Products as the Commercialization of such Included Products is currently being clinically Developed by or on behalf contemplated as of the date the representation is made. Except with respect to the Asserted Patents, none of the Company as currently proposed. The Company has not Group members have received any written notice of any claim by any Third Party asserting that any member of the CompanyCompany Group’s Commercialization of ZTALMY or any other Included Product currently being Developed by or on behalf of the Company infringes or, upon Commercialization, could infringe such Third Party’s Patent. Except with respect to the Asserted Patents. The , none of the Company has not Group members have received any opinion of counsel regarding infringement or non-infringement of any Third Party Patent Patents by any member of the CompanyCompany Group’s Commercialization of ZTALMY or any other Included Product currently being Developed by or on behalf of the CompanyProduct. (p) Except as set forth on Schedule 4.10(p), to To the Knowledge of the Company, there are no pending, published patent applications owned by any Third Party, which the Company Parties Group members do not have the right to use, which and which, if issuedissued in their current form, would could limit or prohibit in any material respect any member of the CompanyCompany Group’s Parties’ Commercialization of ZTALMY or any other Included Product currently being Developed by or on behalf of the CompanyProduct. (q) To the Knowledge of the Company, no Third Party is infringing any of the issued Owned Included Product Patent Rights. No Company Party has provided written notice to a put any Third Party claiming that the Third Party is infringing on notice of infringement of any Included Product of such Patent Rights. ​. (r) Schedule 4.10(r) sets forth all Copyrights, Trademarks and Domain Names owned or exclusively licensed to any Company Party and material to any member of the Company Parties’ Group’s Commercialization of any Included Product. (s) The Owned Included Product To the Knowledge of the Company, the Patent Rights and the Licensed Included Product Patent Rights licensed to Company under the License Agreements (set forth on Schedule 1.1-34.10(a) constitute include all of the Patents owned or exclusively licensed and controlled by any member of the Company Group or any of the CompanyCompany Group’s Affiliates that relate to are necessary for the sale of the Included Products.Products in the United States. LEGAL 4875-0317-8306v.49 ​

Appears in 1 contract

Samples: Revenue Interest Financing Agreement (Liquidia Corp)

Property Matters. (a) Schedule 4.10(a) To the Knowledge of Seller, Exhibit E sets forth an accurate and complete list of the Owned Included all Product Patent Rights and Patents licensed to pursuant to the Knowledge of the Company the Licensed Included License Agreements, including for each such Product Patent Rights. For each Patent set forth on Schedule 4.10(a) the Company has indicatedPatent: (i) the application number; jurisdictions in which such Product Patent is pending, allowed, granted or issued, (ii) the patent number or registration pending patent application serial number, if any; (iii) the country or other jurisdiction where the Patent Right was issuedfiling date of such Product Patent, registered, or filed; and (iv) the scheduled expiration date owner of any issued Patent Right, including a notation if such scheduled expiration date includes a term extension or supplementary protection certificate; and (v) the registered owner thereofProduct Patent. (b) The Company To the Knowledge of Seller, the Product Patents listed or required to be listed on Section 3.11(a) of Exhibit E are valid and enforceable, and in full force and effect. To the Knowledge of Seller, each claim of any such issued Product Patent is a Valid Claim. (or c) To the Company Party indicated on Schedule 4.10(a)) Knowledge of Seller, except as provided for in the License Agreements and the Revenue Participation Agreement, Seller is the sole and exclusive owner or exclusive licensor of the entire all right, title and interest in each of the Owned Included Product Patent RightsPatents. Other than Permitted LiensSeller has not pledged, the Owned Included Product Patent Rights are not subject assigned, sold, licensed, conveyed, granted, or otherwise transferred any rights to any encumbranceof [*] = Certain confidential information contained in this document, Lien marked by brackets, has been omitted because it is both (i) not material and (ii) is the type that the registrant treats as private or claim of ownership by confidential. ​ the Product Patents to any Third Party, and Person other than pursuant to the Knowledge of Revenue Participation Agreement and the Company there are no facts that would preclude the Company from having unencumbered title licenses granted to (i) Day One pursuant to the Owned Included Product Patent Rights. No Company Party has received any written notice of any claim by any Third Party challenging Company Parties’ ownership of the Owned Included Product Patent Rights. Day One License Agreement and (cii) Except as set forth on Schedule 4.10(c), each inventor named on the Owned Included Product Patent Rights, has executed a Contract assigning their entire right, title and interest in and to such Patent Rights and the inventions embodied, described and/or claimed therein, Denovo pursuant to the Company (or the respective Company Party indicated on Schedule 4.10(a)), and each such Contract has been duly recorded at the United States Patent and Trademark OfficeDenovo License Agreement. (d) To the Knowledge of the Company, no issued Owned Included Product Patent Right has lapsed, expired or otherwise been terminated and no Owned Included Product Patent Right applications have lapsed, expired, been abandoned or otherwise been terminated, other than by operation of law or in the ordinary course of patent prosecution. Seller: (ei) To the Knowledge of the Company, there are no unpaid maintenance fees, annuities or other like payments renewal fees payable to any Third Party that currently are overdue with respect to for any of the Owned Included Product Patent Rights. (f) To the Knowledge of the Company, each of the Owned Included Product Patent Rights correctly identifies each and every inventor of the claims thereof as determined in accordance with Applicable Law. Each such inventor has executed an assignment assigning their entire right, title and interest in and to such Included Product Patent Rights and the inventions embodied, described and/or claimed therein, to the Company Patents listed or to an entity that has in turn executed an assignment assigning their entire right, title and interest in and to such Patent Rights and the inventions embodied, described and/or claimed therein, to the Company, and each such assignment has been duly recorded at the United States Patent and Trademark Office. To the Knowledge of the Company, there is no Person who is or claims required to be an inventor listed on Section 3.11(a) of any of the Owned Included Exhibit E, (ii) no Product Patent Rights who is not a named inventor thereof. No Company Party has received from any Person who is not a named inventor of any of the Owned Included Product Patent Rights written notice in which such Person claims Patents listed or required to be an inventor listed on Section 3.11(a) of any of the Owned Included Product Patent Rights. ​ Exhibit E have lapsed or been abandoned, cancelled or expired, (giii) To the Knowledge of the Company, each of the Owned Included Product Patent Rights and each of the claims thereof is valid, enforceable and subsisting. No Company Party has received any opinion of counsel that any of the Owned Included Product Patent Rights or any claims thereof are invalid or unenforceable. No Company Party has received written notice of any claim by any Third Party challenging the validity or enforceability of any of the Owned Included Product Patent Rights or any claims thereof. (h) To the Knowledge of the Company, each individual associated with the filing and prosecution of the Owned Included Patents, including the named inventors of the Product Patent Rights has Patents complied in all material respects with all applicable duties of candor and good faith in dealing with any Patent Office, including any duty to disclose to any Patent Office all information known by such individual inventors to be material to the patentability of each such Patent Rightof the Product Patents (including any relevant prior art), in each case, in those jurisdictions where such duties exist. (i) There is at least one valid claim in the Owned Included Product Patent Rights that would be infringed by the Company’s or any Subsidiary’s Commercialization of ZTALMY but for the Company’s and the Subsidiaries’ rights in such Patent Rights. Each of claims 1-18, 20-22, 24-28, 34-38, 40-47, and 49-55 of U.S. Patent No. 8,318,714 are Valid Claims and Cover ZTALMY. The application for Patent Term Extension for U.S. Patent No. 8,318,714 was timely filed and in accordance with all Applicable Laws, (iv) there is accurate and complete in all material respects. The Company exercised due diligence in the development of ZTALMY during the entire period of time extending from its acquisition of IND No. 044020 for ZTALMY on February 8, 2005 through and no Person who is or claims to the approval of the NDA for ZTALMY (NDA No. 215904) on June 1, 2022. To the Company’s Knowledge, the Company’s predecessors in interest CoCensys, Inc. and Purdue Pharma, Inc. exercised due diligence in the development of ZTALMY during the entire period of time extending from the effective date of IND No. 044020, which was no later than March 28, 1994, through and to the sale of IND No. 044020 to the Company on February 8, 2005. (j) Except for information disclosed to the applicable Patent Office during prosecution of the Owned Included Product Patent Rights, and to the Knowledge of the Company, there are no patents, published patent applications, articles, abstracts, disclosures, sales, offers for sale or other prior art deemed material to patentability be an inventor of any of the inventions claimed Product Patents who is not a named inventor thereof. (e) To the Knowledge of Seller, Seller has not been involved in such Owned Included Product Patent Rightsany interference, re-examination, opposition, derivation or that would otherwise reasonably be expected to materially adversely affect the validity or enforceability of other post-grant proceedings involving any of the claims of such Owned Included Product Patent RightsPatents. (kf) There is no pending orWith the exception of: (i) ex parte patent prosecution with respect to the Product Patents and (ii) and proceedings before any Regulatory Agency with respect to the Products being prosecuted by Seller or a Licensee, to the Knowledge of the CompanySeller, threatened there is no opposition, interference, reexamination, derivation or other post-grant proceeding, injunction, claim, suit, action, citation, summonssummon, subpoena, hearing, inquiry, investigation (by the International Trade Commission or otherwise), complaint, arbitration, mediation, demand, decree or other dispute, disagreement, proceeding, claim, inter-partes review, post-grant review, proceeding or Paragraph IV Certification claim (collectively, “Disputes”) pending or, to the Knowledge of Seller, threatened, challenging the legality, validity, enforceability, enforceability or ownership of or infringement of otherwise relating to any of the Owned Included Product Patent IP Rights (including the Product Patents) or that could reasonably be expected give rise to result in any Set-off against the payments due to the Investor under this AgreementPurchased Royalty Payments. There are no Disputes by pending, or with to the Knowledge of Seller, threatened, involving Seller and any Third Party Product, or, to the Knowledge of Seller, pending or threatened against any other Person (including Day One, Denovo and any Sublicensees) and relating to any Product. To the Company or Knowledge of Seller, neither any of its Subsidiaries involving the Owned included Product IP Rights (including the Patents, ZTALMY or ) nor any other Included Product currently being Developed by or on behalf of the Company. The Owned Included Product Patent Rights are not Products is subject to any outstanding injunction, judgment, order, decree, ruling, challenge, settlement or other disposition of a Dispute. Seller has not commissioned, nor has it received, any written legal opinion that alleges that an issued Patent within the Product Patents is invalid or unenforceable. (lg) Except as set forth on Schedule 4.10(l)To the Knowledge of Seller, there is no pending or, to the Knowledge of the Company, or threatened, and no event has occurred or circumstance exists that (with or without notice or lapse of time, or both) would result in could reasonably be expected to give rise to or serve as a basis for any, action, suit or proceeding, or any investigation or claim, and the Company has not received claim by any written notice of the foregoing, Person that claims that the development, manufacture, use, marketing, sale, offer for sale, importation or distribution of ZTALMY any Product does or any other Included Product currently being Developed by or on behalf of the Company infringes could infringe on any Patent or other intellectual property rights of any other Person or constitutes constitute misappropriation of any other Person’s trade secrets or other intellectual property rights. To the Knowledge of Seller, neither Seller nor any Licensee has received any written notice asserting or claiming any such infringement or misappropriation in respect of any Product. To the Knowledge of Seller, there are [*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) is the type that the registrant treats as private or confidential. ​ no issued Patents owned by any Third Party that limit or would be infringed by or otherwise violated by the development, manufacture, use, marketing, sale, offer for sale, importation or distribution of any Product. (mh) To the Knowledge of the CompanySeller, none no Person has infringed or otherwise violated, or is infringing or otherwise violating, any Product IP Rights. Seller has not received any notice of the conception, development and reduction to practice of the inventions claimed in the Owned Included Product Patent Rights has constituted or involved the misappropriation of trade secrets or other rights or property infringement of any Third Party. (n) No Company Party has filed any disclaimer, other than a terminal disclaimer, or made or permitted any other voluntary reduction in the scope of any Owned Included Product Patent IP Rights. (oi) To the Knowledge of Seller, each of Seller and Day One and Denovo, has taken all reasonable precautions to protect the Companysecrecy, no valid Third Party Patent has been, or is, or will be, infringed by confidentiality and/or value of any Trade Secrets included among the Company’s current or proposed Commercialization of ZTALMY or Product IP Rights and any other Included Product currently being clinically Developed by or on behalf IP Rights that are of the Company. To the Knowledge of the Company, no valid Third Party Patent would limit or prohibit in a confidential and proprietary nature (including any material respect the Company’s Commercialization of ZTALMY or any other Included Product currently being clinically Developed by or on behalf of the Company as currently proposed. The Company has not received any written notice of any claim by any Third Party asserting that the Company’s Commercialization of ZTALMY or any other Included Product currently being Developed by or on behalf of the Company infringes or, upon Commercialization, could infringe such Third Party’s Patents. The Company has not received any opinion of counsel regarding infringement or nonknow-infringement of any Third Party Patent by the Company’s Commercialization of ZTALMY or any other Included Product currently being Developed by or on behalf of the Companyhow). (p) Except as set forth on Schedule 4.10(p), to the Knowledge of the Company, there are no pending, published patent applications owned by any Third Party, which the Company Parties do not have the right to use, which if issued, would limit or prohibit in any material respect the Company’s Parties’ Commercialization of ZTALMY or any other Included Product currently being Developed by or on behalf of the Company. (qj) To the Knowledge of Seller, except for the CompanyProduct Patents, no Third Party is infringing neither Seller nor any of Seller’s Affiliates owns or licenses any Patents that, absent a license, would be infringed by the issued Owned Included Product Patent Rights. No Company Party has provided written notice to a Third Party claiming that the Third Party is infringing any Included Product Patent Rights. ​ (r) Schedule 4.10(r) sets forth all Trademarks material to Company Parties’ Commercialization development, manufacture, use, sale, offer for sale or importation of any Included Product. (sk) The Owned Included To the Knowledge of Seller, Seller has not commissioned, nor has it received, any written legal opinion relating to any Product Patent Rights and the Licensed Included or Product Patent Rights licensed to Company under the License Agreements (Schedule 1.1Patent, including any freedom-3) constitute all of the Patents owned to-operate, product clearance, patentability or controlled by the Company or any of the Company’s Affiliates that relate to the Included Productsright-to-use opinion.

Appears in 1 contract

Samples: Royalty Purchase Agreement (XOMA Corp)

Property Matters. (a) Section 3.11(a) of the Disclosure Schedule 4.10(a) sets forth an accurate and complete list of the Owned Included Product all issued Patents and pending Patent Rights and to the Knowledge of the Company the Licensed Included Product Patent Rightsapplications. For each Patent set forth listed on Section 3.11(a) of the Disclosure Schedule 4.10(a) the Company Seller has indicated: indicated (i) the application number; countries in which such Patent is pending, allowed, granted or issued, (ii) including a notation of any term extensions, the patent or registration number and/or patent application serial number, if any; (iii) the country or other jurisdiction where the Patent Right was issued, registered, or filed; (iv) the scheduled expiration date of any each such issued Patent RightPatent, including a notation if such (iv) the expected scheduled expiration date includes a term extension or supplementary protection certificate; of each Patent issuing from such pending Patent application once issued and (v) the registered owner thereof. (b) The Company (or the Company Party indicated on Schedule 4.10(a)) is the sole and exclusive owner of the entire right, title and interest in each of the Owned Included Product Patent Rights. Other than Permitted Liens, the Owned Included Product Patent Rights are not subject to any encumbrance, Lien or claim of ownership by any Third Party, and to the Knowledge Patents listed on Section 3.11(a) of the Company there are no facts that would preclude the Company from having unencumbered title to the Owned Included Product Patent Rights. No Company Party has received any written notice of any claim by any Third Party challenging Company Parties’ ownership Disclosure Schedule and each of the Owned Included Product Patent Rightsinventions claimed in such Patents. (c) Except To the Knowledge of the Seller, in each Patent listed on Section 3.11(a) of the Disclosure Schedule, there is at least one valid claim (treating pending claim as set forth if issued) that would be infringed by the Exploitation of the Maruishi Licensed Products or Vifor Licensed Products, as applicable. (d) There are no unpaid maintenance or renewal fees payable by the Seller to any Third Party that currently are overdue for any of the Patents. No Patents listed on Section 3.11(a) of the Disclosure Schedule 4.10(c)have lapsed or been abandoned, cancelled or expired. (e) To the Knowledge of the Seller, each Person who has or has had any rights in or to the Patents, including each inventor named on the Owned Included Product Patent RightsPatents, has executed a Contract contract assigning their his, her or its entire right, title and interest in and to such Patent Rights Patents and the inventions embodied, described and/or and or claimed therein, to the Company (or the respective Company Party indicated on Schedule 4.10(a))owner thereof, and each such Contract contract has been duly recorded at in each Patent Office wherein it would be necessary or advisable, as determined by the United States Patent and Trademark Office. (d) To the Knowledge of the CompanySeller in its commercially reasonable judgement, no issued Owned Included Product Patent Right has lapsed, expired or otherwise been terminated and no Owned Included Product Patent Right applications have lapsed, expired, been abandoned or otherwise been terminated, other than by operation of law or in the ordinary course of patent prosecution. (e) To the Knowledge of the Company, there are no unpaid maintenance fees, annuities or other like payments that are overdue with respect to any of the Owned Included Product Patent Rightsdocument such assignment. (f) To the Knowledge of the Company, each of the Owned Included Product Patent Rights correctly identifies each and every inventor of the claims thereof as determined in accordance with Applicable Law. Each such inventor has executed an assignment assigning their entire right, title and interest in and to such Included Product Patent Rights and the inventions embodied, described and/or claimed therein, to the Company or to an entity that has in turn executed an assignment assigning their entire right, title and interest in and to such Patent Rights and the inventions embodied, described and/or claimed therein, to the Company, and each such assignment has been duly recorded at the United States Patent and Trademark Office. To the Knowledge of the Company, there is no Person who is or claims to be an inventor of any of the Owned Included Product Patent Rights who is not a named inventor thereof. No Company Party has received from any Person who is not a named inventor of any of the Owned Included Product Patent Rights written notice in which such Person claims to be an inventor of any of the Owned Included Product Patent Rights. ​ (g) To the Knowledge of the Company, each of the Owned Included Product Patent Rights and each of the claims thereof is valid, enforceable and subsisting. No Company Party has received any opinion of counsel that any of the Owned Included Product Patent Rights or any claims thereof are invalid or unenforceable. No Company Party has received written notice of any claim by any Third Party challenging the validity or enforceability of any of the Owned Included Product Patent Rights or any claims thereof. (h) To the Knowledge of the CompanySeller, each individual associated with the filing and prosecution of the Owned Included Product Patent Rights Patents, including the named inventors of the Patents, has complied in all material respects with all applicable duties of candor and good faith in dealing with any Patent Office, including any duty to disclose to any Patent Office all information known by such individual inventors to be material to the patentability of the Patents (including any relevant prior art), in each such Patent Rightcase, in those jurisdictions where such duties exist. (ig) There is at least one valid claim in the Owned Included Product Patent Rights that would be infringed by the Company’s or any Subsidiary’s Commercialization of ZTALMY but for the Company’s and the Subsidiaries’ rights in such Patent Rights. Each of claims 1-18, 20-22, 24-28, 34-38, 40-47, and 49-55 of U.S. Patent No. 8,318,714 are Valid Claims and Cover ZTALMY. The application for Patent Term Extension for U.S. Patent No. 8,318,714 was timely filed and in accordance with all Applicable Laws, is accurate and complete in all material respects. The Company exercised due diligence in the development of ZTALMY during the entire period of time extending from its acquisition of IND No. 044020 for ZTALMY on February 8, 2005 through and Subsequent to the approval issuance of each Patent, neither the NDA for ZTALMY (NDA No. 215904) on June 1Seller nor, 2022. To the Company’s Knowledge, the Company’s predecessors in interest CoCensys, Inc. and Purdue Pharma, Inc. exercised due diligence in the development of ZTALMY during the entire period of time extending from the effective date of IND No. 044020, which was no later than March 28, 1994, through and to the sale of IND No. 044020 to the Company on February 8, 2005. (j) Except for information disclosed to the applicable Patent Office during prosecution of the Owned Included Product Patent Rights, and to the Knowledge of the CompanySeller, there are no patentsany Counterparty, published patent applications, articles, abstracts, disclosures, sales, offers for sale has filed any disclaimer or made or permitted any other prior art deemed material to patentability of any of voluntary reduction in the inventions claimed in such Owned Included Product Patent Rights, or that would otherwise reasonably be expected to materially adversely affect the validity or enforceability of any of the claims scope of such Owned Included Product Patent RightsPatent. (kh) There is no pending or, to the Knowledge of the CompanySeller, threatened opposition, interference, reexamination, injunction, claim, suit, action, citation, summonssummon, subpoena, hearing, inquiry, investigation (by the International Trade Commission or otherwise), complaint, arbitration, mediation, demand, decree or other dispute, disagreement, proceeding, claim, inter-partes review, post-grant review, proceeding or Paragraph IV Certification claim (collectively, “Disputes”) challenging the legality, validity, enforceabilityscope, enforceability or ownership or infringement of any of the Owned Included Product Patent Intellectual Property Rights or that could reasonably be expected would give rise to result in any Set-off Royalty Reduction against the payments due to the Investor Seller under this Agreementthe Covered License Agreements. To the Knowledge of the Seller, there are no pending or threatened Disputes by any Counterparty, or their Affiliates or sublicensees, challenging the legality, validity, scope, enforceability or ownership of any of the Intellectual Property Rights or that would give rise to any Royalty Reduction against the payments due to the Seller under the Covered License Agreements. There are no Disputes by or with any Third Party against the Company Seller or, to the Knowledge of the Seller, any Counterparty or any of its Subsidiaries sublicensees involving the Owned included Product Patents, ZTALMY or any other Included Product currently being Developed by or on behalf of the CompanyLicensed Products. The Owned Included Product Patent Intellectual Property Rights are not subject to any outstanding injunction, judgment, order, decree, ruling, challengechange, settlement or other disposition of a Dispute. There are no ​ ​ proceedings, other than proceedings in the ordinary course of patent prosecution with respect to the Patents listed on Section 3.11(a) of the Disclosure Schedule. (li) Except as set forth on Schedule 4.10(l), there There is no pending oraction, suit, proceeding, investigation or claim and, to the Knowledge of the CompanySeller, threatenedthere is no threatened action, and suit, proceeding, investigation or claim, and, to the Knowledge of the Seller, no event has occurred or circumstance exists that (with or without notice or lapse of time, or both) would result in reasonably be expected to give rise to or serve as a basis for any, any action, suit or suit, proceeding, or any investigation or claim, and the Company has not received claim by any written notice of the foregoing, Person that claims that the manufacture, use, marketing, sale, offer for sale, importation or distribution of ZTALMY any Licensed Product does or any other Included Product currently being Developed by or on behalf of the Company infringes could infringe on any Patent patent or other intellectual property rights of any other Person Third Party or constitutes constitute misappropriation of any other Person’s trade secrets or other intellectual property rights. (mj) To the Knowledge of the CompanySeller, none of the conceptionthere are no patents issued, development and reduction no pending patent applications with claims reasonably likely to practice of the inventions claimed in the Owned Included Product Patent Rights has constituted or involved the misappropriation of trade secrets or other rights or property of issue, owned by any Third Party, that Maruishi or Vifor, as applicable, do not have a right to use (i) that would be infringed by Xxxxxxxx’s or Vifor’s Exploitation of a Licensed Product in the Territory, as applicable, but for Xxxxxxxx’s and Vifor’s rights in such patents and patent applications, or (ii) that would give rise to any Royalty Reduction against the payments due to the Seller under the Covered License Agreements. (nk) No Company Party has filed any disclaimer, other than a terminal disclaimer, or made or permitted any other voluntary reduction in the scope of any Owned Included Product Patent RightsKORSUVATM and KAPRUVIATM are each Licensed Products. (ol) To the Knowledge of the CompanySeller, there is no valid Third Party Patent has been, or is, or will be, infringed by the Company’s current or proposed Commercialization of ZTALMY or Person infringing any other Included Product currently being clinically Developed by or on behalf of the Company. To Intellectual Property Rights, and neither the Knowledge Seller nor the Company has received any notice under any of the CompanyCovered License Agreements or put any Person on notice, no valid Third Party Patent would limit of actual or prohibit in any material respect the Company’s Commercialization of ZTALMY or any other Included Product currently being clinically Developed by or on behalf of the Company as currently proposed. The Company has not received any written notice of any claim by any Third Party asserting that the Company’s Commercialization of ZTALMY or any other Included Product currently being Developed by or on behalf of the Company infringes or, upon Commercialization, could infringe such Third Party’s Patents. The Company has not received any opinion of counsel regarding infringement or non-alleged infringement of any Third Party Patent by the Company’s Commercialization of ZTALMY or any other Included Product currently being Developed by or on behalf of the CompanyIntellectual Property Rights. (pm) Except as set forth on Schedule 4.10(p)Each of the Seller and the Company and, to the Knowledge of the CompanySeller, there are no pendingeach of Maruishi and Vifor has taken all reasonable precautions to protect the secrecy, published patent applications owned by any Third Party, which the Company Parties do not have the right to use, which if issued, would limit or prohibit in any material respect the Company’s Parties’ Commercialization of ZTALMY or any other Included Product currently being Developed by or on behalf confidentiality and/or value of the Companyapplicable Know-How. (qn) The Intellectual Property Rights constitute all of the intellectual property owned or licensed by the Seller or the Company or any of their Affiliates that is, to the Seller’s Knowledge, necessary or useful for the manufacture, use or sale of the Licensed Products in the Territory. (o) No legal opinion concerning or with respect to any Third Party intellectual property rights relating to the Licensed Products, including any freedom-to-operate, product clearance, patentability, validity or right-to-use opinion, has been delivered to the Seller. (p) To the Knowledge of the CompanySeller, there is no Third Party Person who is infringing or claims to be an inventor under any Patent who is not a named inventor thereof and the list of inventors named in each issued and unexpired Patent listed on Section 3.11(a) of the issued Owned Included Product Patent Rights. No Company Party has provided written notice to a Third Party claiming that the Third Party Disclosure Schedule is infringing any Included Product Patent Rights. ​ (r) Schedule 4.10(r) sets forth all Trademarks material to Company Parties’ Commercialization of any Included Productcurrent and complete. (s) The Owned Included Product Patent Rights and the Licensed Included Product Patent Rights licensed to Company under the License Agreements (Schedule 1.1-3) constitute all of the Patents owned or controlled by the Company or any of the Company’s Affiliates that relate to the Included Products.

Appears in 1 contract

Samples: Purchase and Sale Agreement (Cara Therapeutics, Inc.)

Property Matters. (a) Schedule 4.10(a) sets forth an accurate and complete list of sets forth a complete and accurate list of Patent Rights, including the complete and accurate list of the Owned Included Product Imcivree Patent Rights Rights, and to the Knowledge of the Company the exclusively in-licensed Licensed Included Product Imcivree Patent Rights. For each Patent set forth on Schedule 4.10(a) the Company has indicated: (i) the application numbernumber (if any); (ii) the patent or registration number, if any; (iii) the country or other jurisdiction where the Patent Right was issued, registered, or filed; (iv) the scheduled expiration date of any issued Patent Right, including a notation if such scheduled expiration date includes a term extension or supplementary protection certificate; and (v) the registered owner thereof. (b) The Company (or Except as disclosed on Schedule 4.10(b), the Company Party indicated on Schedule 4.10(a)) is the sole and exclusive owner of the entire right, title and interest in each of the Owned Included Product Imcivree Patent Rights. Other than Permitted Liens, the The Owned Included Product Imcivree Patent Rights are not subject to any encumbrance, Lien or claim of ownership by any Third Party, and to the Knowledge of the Company Company, there are no facts that would preclude the Company from having unencumbered title to the Owned Included Product such Patent Rights. No Company Party has ​ ​ ​ received any written notice of any claim by any Third Party challenging Company Parties’ the ownership of the rights of the Company in and to the Owned Included Product Imcivree Patent Rights. (c) Except as set forth on Schedule 4.10(c)To the Knowledge of the Company, each Person who has or has had any rights in or to the Owned Imcivree Patent Rights, and to the Knowledge of the Company, with respect to the exclusively in-licensed Licensed Imcivree Patent Rights, including each inventor named on the Owned Included Product such Patent Rights, has executed a Contract assigning their entire right, title and interest in and to such Patent Rights and the inventions embodied, described and/or claimed therein, to the Company (or owner thereof, and each such Contract that relate to the respective Company Party indicated on Schedule 4.10(a))Owned Imcivree Patent Rights, and to the Knowledge of the Company, with respect to the exclusively in-licensed Licensed Imcivree Patent Rights, has been duly recorded at the United States Patent and Trademark Office and each such Contract has been duly recorded at the United States Patent and Trademark OfficeOffice as of the Closing Date. (d) To the Knowledge of the Company, no issued Owned Included Product Imcivree Patent Right has lapsed, expired or otherwise been terminated and no Owned Included Product Imcivree Patent Right applications have lapsed, expired, been abandoned or otherwise been terminated, in each case, other than by operation of law or in the ordinary course of patent prosecutionlaw. (e) To the Knowledge of the Company, there are no unpaid maintenance fees, annuities or other like payments that are overdue with respect to any the Owned Imcivree Patent Rights required to be paid as of the Owned Included Product Closing Date, and to the Knowledge of the Company, with respect to the exclusively in-licensed Licensed Imcivree Patent Rights. (f) To the Knowledge of the Company, the Company has a valid license to each of the in-licensed Licensed Imcivree Patent Rights, in each case pursuant to the terms of the applicable License Agreement. (g) To the Knowledge of the Company, each of the Owned Included Product Imcivree Patent Rights Rights, and to the Knowledge of the Company, with respect to the exclusively in-licensed Licensed Imcivree Patent Rights, correctly identifies each and every inventor of the claims thereof as determined in accordance with Applicable Law. Each such inventor has executed an assignment assigning their entire right, title and interest the Laws of the jurisdiction in and to such Included Product Patent Rights and the inventions embodied, described and/or claimed therein, to the Company or to an entity that has in turn executed an assignment assigning their entire right, title and interest in and to which such Patent Rights and the inventions embodied, described and/or claimed therein, to the Company, and each such assignment has been duly recorded at the United States Patent and Trademark OfficeRight was issued or is pending. To the Knowledge of the Company, there is no not any Person who is or claims to be an inventor of any of the Owned Included Product Imcivree Patent Rights or any exclusively in-licensed Licensed Imcivree Patent Rights, who is not a named inventor thereof. No Company Party has received any notice from any Person who is not a named inventor of any of the Owned Included Product Patent Rights written notice in which such Person or claims to be an inventor of any of the Owned Included Product Imcivree Patent Rights. ​Rights who is not a named inventor thereof. (gh) To the Knowledge of the Company, each of the Owned Included Product Imcivree Patent Rights and each of the claims thereof exclusively in-licensed Licensed Imcivree Patent Rights is valid, enforceable and subsisting. No Company Party has received any opinion of counsel that any of the Owned Included Product Imcivree Patent Rights or any claims thereof are exclusively in-licensed Licensed Imcivree Patent Rights is invalid or unenforceable. No Company Party has received written any notice of any claim by any Third Party challenging the validity or enforceability of any of the Owned Included Product Imcivree Patent Rights or any claims thereofexclusively in-licensed Licensed Imcivree Patent Rights. (hi) To the Knowledge of the Company, each individual associated with the filing and prosecution of the Owned Included Product Imcivree Patent Rights or exclusively in-licensed Licensed Imcivree Patent Rights for which Company controls has complied in all material respects with all applicable duties of candor and good faith in dealing with any Patent Office, including any duty to disclose to any Patent Office all information known by such individual to be material to patentability of each such Owned Imcivree Patent RightRight or exclusively in-licensed Licensed Imcivree Patent Rights, in those jurisdictions where such duties exist. (ij) There is at least one valid claim in each of the Owned Included Product Imcivree Patent Rights listed in the Orange Book that would be infringed by the Company’s or any Subsidiary’s Commercialization of ZTALMY Imcivree but for the Company’s and the Subsidiaries’ rights in such Patent Rights. Each of claims 1-18, 20-22, 24-28, 34-38, 40-47, and 49-55 of U.S. Patent No. 8,318,714 are Valid Claims and Cover ZTALMY. The application for Patent Term Extension for U.S. Patent No. 8,318,714 was timely filed and in accordance with all Applicable Laws, is accurate and complete in all material respects. The Company exercised due diligence in the development of ZTALMY during the entire period of time extending from its acquisition of IND No. 044020 for ZTALMY on February 8, 2005 through and to the approval of the NDA for ZTALMY (NDA No. 215904) on June 1, 2022. To the Company’s Knowledge, the Company’s predecessors in interest CoCensys, Inc. and Purdue Pharma, Inc. exercised due diligence in the development of ZTALMY during the entire period of time extending from the effective date of IND No. 044020, which was no later than March 28, 1994, through and to the sale of IND No. 044020 to the Company on February 8, 2005. (jk) Except To the Knowledge of the Company, except for information disclosed to the applicable Patent Office during prosecution of the Owned Included Product Imcivree Patent Rights, and to the Knowledge of the Company, there are no patents, published patent applications, articles, abstracts, disclosures, sales, offers for sale abstracts or other prior art deemed material to patentability of any of the inventions claimed in such the issued Owned Included Product Imcivree Patent Rights, or that would otherwise reasonably be expected to materially adversely affect the validity or enforceability of any of the claims of such the issued Owned Included Product Imcivree Patent Rights. (kl) There is no pending or, to the Knowledge of the Company, threatened opposition, interference, reexamination, injunction, claim, suit, action, citation, summons, subpoena, hearing, inquiry, investigation (by the International Trade Commission or otherwise), complaint, arbitration, mediation, demand, decree or other dispute, disagreement, proceeding, claimclaim or inter partes review (in each case, inter-partes review, post-grant review, or Paragraph IV Certification other than standard patent prosecution before a Patent Office) (collectively, “Disputes”) challenging the legality, validity, enforceability, enforceability or ownership or infringement of any of the Owned Included Product Patent Rights or that could reasonably set forth on Schedule 4.10 as may be expected updated from time to result in any Set-off against time. To the payments due to Knowledge of the Investor under this Agreement. There Company, there are no Disputes by or with any Third Party against the Company or any of its Subsidiaries involving the Owned included Product Patents, ZTALMY Imcivree Patent Rights or any other Patent Rights related to an Included Product currently being Developed that are owned or controlled by or on behalf Company. To the Knowledge of the Company. The Owned Included Product Company the Patent Rights set forth on Schedule 4.10 are not subject to any outstanding injunction, judgment, order, decree, ruling, challengechange, settlement or other disposition Disposition of a Dispute. (lm) Except as set forth on Schedule 4.10(l), there is no pending or, to To the Knowledge of the Company, and except as separately disclosed to Investor Representative, there is no pending or threatened, and no event has occurred or circumstance exists that (with or without notice or lapse of time, or both) would result in or serve as a basis for any, action, suit or proceeding, or any investigation or claim, and the Company has not received any written notice of the foregoing, that claims that the manufacture, use, marketing, sale, offer for sale, importation or distribution of ZTALMY or any other the Included Product as currently being Developed by or on behalf of the Company contemplated infringes on any Patent Rights or other intellectual property Intellectual Property rights of any other Person or constitutes misappropriation of any other Person’s trade secrets or other intellectual property rightsTrade Secrets. (mn) To the Knowledge of the Company, none of the conception, development and reduction to practice of the inventions claimed in the Owned Included Product Imcivree Patent Rights or exclusively in-licensed Licensed Imcivree Patent Rights for which Company controls has constituted or involved the misappropriation of trade secrets or other rights or property of any Third Party.Trade Secrets. ​ ​ (no) No Company Party has filed any disclaimer, other than a terminal disclaimer, or made or permitted any other voluntary reduction in the scope of any Owned Included Product Imcivree Patent RightsRight. (op) To the Knowledge of the Company, no valid Third Party Patent has been, or is, or will be, infringed by the Company’s current or proposed Commercialization of ZTALMY or any other Included Product currently being clinically Developed by or on behalf of the Company. To the Knowledge of the Company, no valid Third Party Patent would limit or prohibit in any material respect the Company’s Commercialization of ZTALMY or any other Included Product currently being clinically Developed by or on behalf of the Company as currently proposedImcivree. The Company has not received any written notice of any claim by any Third Party asserting that the Company’s Commercialization of ZTALMY or any other Included Product currently being Developed by or on behalf of the Company infringes or, upon Commercialization, could infringe such Third Party’s Patentspatents. The Company has not received any written opinion of counsel regarding infringement or non-infringement of any Third Party Patent by the Company’s Commercialization of ZTALMY or any other Included Product currently being Developed by or on behalf of the CompanyProduct. (pq) Except as set forth on Schedule 4.10(p), to To the Knowledge of the Company, there are no pending, published patent applications with claims reasonably likely to issue which are owned by any Third Party, which the Company Parties do does not have the right to use, which if issuedissued with claims reasonably likely to issue, would limit or prohibit in any material respect the Company’s Parties’ Commercialization of ZTALMY or any other Included Product currently being Developed by or on behalf of the CompanyImcivree. (qr) To the Knowledge of the Company, no Third Party is infringing any of the issued Owned Included Product Imcivree Patent Rights or exclusively in-licensed Licensed Imcivree Patent Rights. No Company Party has provided written notice to a put any Third Party claiming that on notice of any infringement of the Third Party is infringing any Included Product issued Patent Rights Owned Imcivree Patent Rights or exclusively in-licensed Licensed Imcivree Patent Rights. ​. (rs) Schedule 4.10(r) sets forth all Trademarks lists Copyrights, Trademarks, Trade Secrets or net names material to Company Parties’ Commercialization of any Included ProductProduct that are owned or exclusively in-licensed to Company. (st) The Owned Included Product To the Knowledge of the Company, the Imcivree Patent Rights and the Licensed Included Product Patent Rights licensed to Company under the License Agreements (Schedule 1.1-3) constitute all of the Patents owned or controlled by the Company or any of the Company’s Affiliates that relate necessary for the sale of the Imcivree in the U.S., the EEA, China, South Korea and Japan. (u) The Company is the sole and exclusive owner of all the rights, title and interests to any and all inventions relating to Bardet-Biedl Syndrome disclosed in the Included ProductsPatent Rights identified by the Company’s patent family reference number 7005.

Appears in 1 contract

Samples: Revenue Interest Financing Agreement (Rhythm Pharmaceuticals, Inc.)