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9.2 AbbVie Patents. AbbVie shall have the sole right, but not the obligation, to prepare, file, prosecute, defend, maintain, and enforce any Patent Right which covers, among other matters, Know-How owned or otherwise controlled by AbbVie or its Affiliates pertaining to Royalty-Bearing Compounds, Royalty-Bearing Product... |
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9.3 Patent Prosecution and Maintenance. |
9.3.1 Anima Prosecution of Collaboration Patents. During the Term, neither Anima nor its Affiliates will, or will enable any Third Party without AbbVie's prior written approval to, prepare, file, or prosecute any patent application within the Collaboration Patents or otherwise relating to Collaboration Know-How, other ... |
9.3.2 AbbVie Prosecution of Anima Collaboration Patents. Promptly following the License Option Effective Date with respect to a Target Program Slot: (a) Anima shall provide AbbVie with all reasonable assistance and cooperation for AbbVie to assume responsibility for and control over the preparation, filing, prosecution... |
9.3.3 Anima Improvement Patents. Anima shall have the sole and exclusive right, but not the obligation, to prepare, file, prosecute, defend, and maintain the Anima Improvement Patents worldwide, at Anima's sole cost and expense. |
9.3.4 Cooperation. Anima agrees to cooperate fully with AbbVie in the preparation, filing, prosecution, defense, and maintenance of the Anima Collaboration Patents, at its own cost and expense. Such cooperation shall include: |
(a) executing all papers and instruments, or requiring its employees or contractors to execute such papers and instruments, as applicable, so as to: (i) effectuate the ownership of intellectual property set forth in Section 9.1 (Ownership of Intellectual Property; Disclosure); (ii) enable AbbVie to apply for and to pro... |
(b) consistent with this Agreement, assisting in any license registration processes with applicable Governmental Authorities that may be available in the Territory for the protection of a Party's interests in this Agreement; and |
(c) promptly informing AbbVie of any matters coming to Anima's attention that may materially affect the preparation, filing, prosecution, defense, or maintenance of any such Anima Collaboration Patents in the Territory. |
9.3.5 Patent Term Extension and Supplementary Protection Certificate. AbbVie shall have the sole right to make decisions regarding, and AbbVie shall have the sole right to apply for, patent term extensions in the Territory, including in the United States with respect to extensions pursuant to 35 U.S.C. § 156 et. seq. a... |
9.3.6 Patent Listings. AbbVie shall have the sole right to determine and make all patent listings and filings with Governmental Authorities in the Territory with respect to the Anima Collaboration Patents. |
9.4 Enforcement of Licensed IP. |
9.4.1 Enforcement. Each Party shall promptly notify the other Party in writing of any alleged or threatened infringement of the Licensed IP by a Third Party in the Territory of which such Party becomes aware based on the development, commercialization, or other exploitation of, or an application to register or market, ... |
9.4.2 Recovery. Unless otherwise agreed by the Parties in writing, the amount of any recovery from a proceeding brought under Section 9.4.1 (Enforcement) (whether by way of settlement or otherwise) shall first be applied to the internal and out-of-pocket costs and expenses of the Parties with respect to such action (wh... |
9.5 Infringement Claims by Third Parties. If the Manufacture, sale, or use of a Royalty-Bearing Compound or Royalty-Bearing Product in the Territory pursuant to this Agreement results in, or may result in, any claim, suit, or proceeding by a Third Party alleging infringement by a Party (or its Affiliates) (a "Third Par... |
9.6 Invalidity or Unenforceability Defenses or Actions. |
9.6.1 Notice. Each Party shall promptly notify the other Party in writing of any alleged or threatened assertion of invalidity or unenforceability of any of the Anima Collaboration Patents by a Third Party, in each case in the Territory and of which such Party becomes aware. |
9.6.2 Anima Collaboration Patents. Following the License Option Effective Date with respect to a Target Program Slot, AbbVie shall have the sole and exclusive right, but not the obligation, to defend and control the defense of the validity, patentability, and enforceability of all Anima Collaboration Patents at its own... |
9.6.3 Cooperation. Anima shall assist and cooperate with AbbVie as AbbVie may reasonably request from time to time in connection with its activities set forth in this Section 9.6 (Invalidity or Unenforceability Defenses or Actions), including by providing access to relevant documents and other evidence, and making its ... |
9.6.4 Costs and Expenses. AbbVie shall be entitled to offset up to fifty percent (50%) of the reasonable out-of-pocket costs of defending a claim, suit, or proceeding under this Section 9.6 (Invalidity or Unenforceability Defenses or Actions) in a given Calendar Quarter from any of (a) AbbVie's milestone payments under... |
9.7 Third Party Licenses. If in the reasonable opinion of AbbVie, the Development, Manufacture, Commercialization, or other Exploitation of any Royalty-Bearing Compound or Royalty-Bearing Product by AbbVie, any of its Affiliates, or any of its or their Sublicensees infringes or misappropriates any Patent Right, trade s... |
9.8 Product Trademarks. Following AbbVie's exercise of the applicable License Option, as between the Parties, AbbVie shall have the sole and exclusive right to determine and shall own all right, title, and interest in and to the Trademarks that are used in connection with any Royalty-Bearing Product anywhere in the wor... |
9.9 Inventor's Remuneration. Each Party shall be solely responsible for any remuneration that may be due such Party's inventors under any applicable inventor remuneration laws, including under Section 134 of the Israeli Patent Law-1967. |
9.10 International Nonproprietary Name. As between the Parties, AbbVie shall have the sole right and responsibility to select the International Nonproprietary Name or other name or identifier for any Royalty-Bearing Compound or Royalty-Bearing Product. AbbVie shall have the sole right and responsibility to apply for su... |
ARTICLE 10 CONFIDENTIALITY |
10.1 Product Information. Anima recognizes that by reason of AbbVie's rights under this Agreement, AbbVie has an interest in Anima's maintaining the confidentiality of certain information of Anima. Accordingly, during the Term, Anima shall, and shall cause its Affiliates and its and their respective officers, directors... |
10.2 Confidentiality Obligations. At all times during the Term and for a period of ten (10) years following termination or expiration of this Agreement in its entirety, each Party shall, and shall cause its officers, directors, employees, and agents to, keep confidential and not publish or otherwise disclose to a Third... |
10.2.1 has been published by a Third Party or otherwise is or hereafter becomes part of the public domain by public use, publication, general knowledge, or the like through no wrongful act, fault, or negligence on the part of the receiving Party; |
10.2.2 had been in the receiving Party's possession prior to disclosure by the disclosing Party without any obligation of confidentiality with respect to such information; provided that the foregoing exception shall not apply with respect to Regulatory Filings; |
10.2.3 is subsequently received by the receiving Party from a Third Party without restriction and without breach of any agreement between such Third Party and the disclosing Party; |
10.2.4 is generally made available to Third Parties by the disclosing Party without restriction on disclosure; or |
10.2.5 has been independently developed by or for the receiving Party without reference to, or use or disclosure of, the disclosing Party's Confidential Information; provided that the foregoing exception shall not apply with respect to Regulatory Filings. |
Specific aspects or details of Confidential Information shall not be deemed to be within the public domain or in the possession of the receiving Party merely because the Confidential Information is embraced by more general information in the public domain or in the possession of the receiving Party. Further, any combin... |
10.3 Permitted Disclosures. |
10.3.1 Each Party may disclose the Confidential Information of the other Party to the extent that such disclosure is: |
(a) in the reasonable opinion of the receiving Party's legal counsel, required to be disclosed pursuant to law, regulation, or a valid order of a court of competent jurisdiction or other supra-national, federal, national, regional, state, provincial, and local governmental body of competent jurisdiction (including by r... |
(b) made by or on behalf of the receiving Party to the Regulatory Authorities as required in connection with any filing, application, or request for any Regulatory Approval in accordance with the terms of this Agreement; provided that the receiving Party shall take reasonable measures to assure confidential treatment o... |
(c) made by or on behalf of the receiving Party to a patent authority as may be necessary or reasonably useful for purposes of preparing, obtaining, defending, or enforcing a Patent Right in accordance with the terms of this Agreement; provided that the receiving Party shall take reasonable measures to assure confident... |
10.3.2 AbbVie or its Affiliates or Sublicensees may disclose the Confidential Information of Anima to its or their advisors, consultants, clinicians, vendors, service providers, contractors, existing or prospective collaboration partners, licensees, sublicensees, or other Third Parties as may be necessary or useful in ... |
10.3.3 Anima or its Affiliates may, after receiving advance approval from AbbVie, such approval not to be unreasonably withheld, conditioned, or delayed, disclose the Confidential Information of AbbVie to its advisors, consultants, clinicians, vendors, service providers, contractors, and the like to the extent necessar... |
10.3.4 Each Party may disclose the existence and terms of this Agreement to the extent that such disclosure is: |
(a) made by the receiving Party (and where the receiving Party is AbbVie, its Affiliates) to their respective financial and external legal advisors who have a need to know the existence and terms of this Agreement and are either under professional codes of conduct giving rise to expectations of confidentiality and non-... |
(b) made by the receiving Party (and where the receiving Party is AbbVie, its Affiliates) to potential or actual investors or acquirers as may be necessary in connection with their evaluation of a potential or actual investment or acquisition; provided that such Persons shall be subject to obligations of confidentialit... |
10.3.5 Notwithstanding any provision to the contrary in this Agreement, Anima shall not, and shall cause its Affiliates not to, disclose any Collaboration Target or Reserved Target to any Third Party except (a) to a Third Party subcontractor of Anima solely for the purpose of performing activities under this Agreement ... |
10.4 Use of Name. Except as expressly provided herein, neither Party shall mention or otherwise use the name, logo, or Trademark of the other Party or any of its Affiliates (or any abbreviation or adaptation thereof) in any publication, press release, marketing and promotional material, or other form of publicity witho... |
10.5 Public Announcements. The Parties have agreed upon the content of a press release which shall be issued substantially in the form attached hereto as Schedule 10.5 (Public Announcement), the release of which the Parties shall coordinate in order to accomplish such release at a time mutually agreed by the Parties. N... |
10.6 Publications. Anima shall not publish, present, or otherwise disclose, and shall cause its Affiliates and any Third Party subcontractors and its and their employees and agents not to disclose any information relating to (a) any activities under a Collaboration Plan (including, for clarity, any lead generation acti... |
10.7 Return of Confidential Information. Upon the effective date of the termination of this Agreement for any reason, either Party may request in writing, and the other Party shall either, with respect to Confidential Information (in the event of termination of this Agreement with respect to one (1) or more Terminated ... |
10.8 Survival. All Confidential Information shall continue to be subject to the terms of this Agreement for the period set forth in Section 10.2 (Confidentiality Obligations). |
ARTICLE 11 REPRESENTATIONS AND WARRANTIES |
11.1 Representations and Warranties of Both Parties. Each Party hereby represents and warrants to the other Party, as of the Effective Date, that: |
11.1.1 such Party is duly organized, validly existing, and in good standing under the Laws of the jurisdiction of its incorporation and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof; |
11.1.2 such Party has taken all necessary action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder; |
11.1.3 this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, and binding obligation, enforceable against it in accordance with the terms hereof, subject to the effects of bankruptcy, insolvency, or other laws of general application affecting the enforcement of cred... |
11.1.4 the execution, delivery, and performance of this Agreement by such Party do not conflict with and do not violate: (a) such Party's charter documents, bylaws, or other organizational documents; (b) in any material respect, any agreement or any provision thereof, or any instrument or understanding, oral or written... |
11.1.5 it is not under any obligation, contractual or otherwise, to any Person that conflicts with or is inconsistent in any material respect with the terms of this Agreement or that would impede the diligent and complete fulfillment of its obligations hereunder. |
11.2 Representations, Warranties, and Covenants, as applicable, of Anima. Anima hereby represents, warrants, and covenants, as applicable, to AbbVie, as of (a) the Effective Date, and (b) the date(s) on which AbbVie exercises a License Option, except in each case ((a) and (b)) as set forth in the corresponding section ... |
11.2.1 Other than (a) Anima Biotech Ltd., a company incorporated in Israel and, (b) Anima Biotech DMCC, a company incorporated in the United Arab Emirates and (c) Anima Biotech UK Limited, a company incorporated in the United Kingdom, Anima has never had and does not as of such date have any Affiliates. True, complete,... |
11.2.2 Anima (a) has the right to grant the licenses specified herein and (b) has the right to use all Anima Background Know-How and Anima Background Patents necessary for Anima to fulfill its obligations hereunder; |
11.2.3 Anima solely owns the Anima Background Know-How and Anima Background Patents. As of the Effective Date, there are no licenses or other agreements between Anima or its Affiliate, on one hand, and a Third Party, on the other hand, under which AbbVie is granted a sublicense or other right under this Agreement, incl... |
11.2.4 The In-License Agreements do not and will not create any obligation upon AbbVie to any Third Party. No license or agreement to which Anima or any of its Affiliates is a party creates or imposes any financial obligation upon AbbVie to a Third Party. There are no amounts that will be required to be paid to a Third... |
11.2.5 All Anima Background Patents existing as of such date (the "Existing Patent Rights") are listed on Schedule 1.13 (Existing Patents), and all issued patents included in the Existing Patent Rights are (a) subsisting and are not invalid or unenforceable, in whole or in part, (b) solely and exclusively owned or lice... |
11.2.6 To Anima's Knowledge, no compound in the Anima Compound Library has been included in any unblinded compound library screened by or on behalf of Anima or its Affiliates prior to the Effective Date; |
11.2.7 True, complete, and correct copies of all In-License Agreements (subject to redaction of confidential and commercially sensitive information that is not relevant for AbbVie to determine its rights and obligations hereunder) have been provided to AbbVie; |
11.2.8 All of the Existing In-License Agreements existing as of the Effective Date are listed on Schedule 1.72 (Existing In-License Agreements) and (a) the licenses granted to Anima or its Affiliates in the In-License Agreements are in full force and effect, (b) to Anima's Knowledge, there are no challenges to or viola... |
11.2.9 The Existing Patent Rights represent all Patent Rights that Anima or its Affiliates own or Control that claim any Anima Background Know-How that Anima intends to use in conducting its obligations under this Agreement; |
11.2.10 Neither Anima nor any of its Affiliates has entered into any agreement, whether written or oral, (excluding agreements described in Section 11.2 (Representations, Warranties, and Covenants, as applicable, of Anima) and excluding confidentiality and non-disclosure agreements entered into in the normal course) th... |
11.2.11 No claim or litigation has been brought or asserted (and Anima has no Knowledge of any claim, whether or not brought or asserted) by any Person alleging that the Existing Patent Rights are invalid or unenforceable or the conception, development, reduction to practice, disclosing, copying, making, assigning, or ... |
11.2.12 To Anima's Knowledge, no Person is infringing or threatening to infringe, or misappropriating or threatening to misappropriate, the Existing Patent Rights or the Anima Background Know-How; |
11.2.13 To Anima's Knowledge, each of the Existing Patent Rights properly identifies each and every inventor of the claims thereof as determined in accordance with the laws of the jurisdiction in which such Existing Patent Right is issued or such application is pending; |
11.2.14 There are no pending or, to Anima's Knowledge, alleged or threatened, (a) inter partes reviews, post-grant reviews, interferences, re-examinations, or oppositions involving the Existing Patent Rights that are in or before any patent authority (or other Governmental Authority performing similar functions) or (b)... |
11.2.15 Each Person who has or has had any rights in or to any Existing Patent Rights or any Anima Background Know-How has assigned and has executed an agreement assigning its entire right, title, and interest in and to such Existing Patent Rights or Anima Background Know-How to Anima or its Affiliate; |
11.2.16 All works of authorship and all other materials subject to copyright protection included in Anima Background Know-How are original and were either created by employees of Anima or its Affiliates within the scope of their employment or are otherwise works made for hire, or all right, title, and interest in and t... |
11.2.17 Except as set forth in Schedule 11.2 (Anima Disclosure Schedule), to Anima's Knowledge, the inventions claimed by the Existing Patent Rights are not the subject of any licenses, options, or other rights of any Governmental Authority, within or outside the United States, due to such Governmental Authority's fund... |
11.2.18 The confidential Anima Background Know-How has been kept confidential or has been disclosed to Third Parties only under terms of confidentiality. To the Knowledge of Anima and its Affiliates, no breach of such confidentiality has been committed by any Third Party; |
11.2.19 None of the Anima Platform Technology, the UPenn Technology, or any other Patent Right or Know-How to which Anima or its Affiliates has rights but is not licensed to AbbVie hereunder is or will be, necessary to Exploit the data, information, or compounds to be provided in any License Option Exercise Data Packag... |
11.2.20 Anima and its Affiliates and their respective subcontractors have not disclosed and will not disclose any UPenn Technology to AbbVie or to any of AbbVie's Affiliates or Sublicensees, in any form, including in any License Option Exercise Data Package (including any Hit Validation Data Package or Lead Optimizatio... |
11.2.21 Neither Anima nor its Affiliates is a party to any agreement with the Israel Innovation Authority or any other Governmental Authority in Israel that refers or relates to the Anima Background Patents, Anima Background Know-How, Anima Improvements, Licensed IP, any Collaboration Target, or any activity contemplat... |
11.2.22 To Anima's Knowledge, none of the Anima Background Patents and Anima Background Know-How is subject to any restriction that would require any Development, Manufacturing, or Commercialization activities under this Agreement to occur in a certain location or otherwise restrict the conduct of such activities with ... |
11.2.23 Anima and its Affiliates have conducted and will conduct, and their respective contractors and consultants have conducted and will conduct, all Development activities allocated to Anima hereunder in accordance with applicable Law in all material respects. Anima and its Affiliates have employed (and, with respec... |
11.2.24 Anima and its Affiliates have not, and shall not during the Term of this Agreement, Process or provide to AbbVie or any of its Affiliates any Personal Data in connection with the activities under this Agreement; |
11.2.25 In the last five (5) years, Anima has not received written notice of any alleged material violation from a Governmental Authority or other Third Party of any Data Security and Privacy Laws and has no Knowledge of facts that would give rise to such a violation. Anima is not under investigation by any Governmenta... |
11.2.26 The execution, delivery, and performance of this Agreement and the other agreements and instruments contemplated hereby, and the consummation of the transactions contemplated hereunder, complies with Data Security and Privacy Laws; |
11.2.27 Except as set forth on Schedule 11.2 (Anima Disclosure Schedule), (a) patient information or patient-derived materials were not used in the development, invention, or generation of Anima Background Know-How or Anima Background Patents, (b) neither patient information nor patient-derived materials will be used i... |
11.2.28 Neither Anima nor any of its Affiliates, nor any of its or their respective officers, employees, or agents has (a) committed an act, (b) made a statement, or (c) failed to act or make a statement that, in any case ((a), (b), and (c)), (i) would be or create an untrue statement of material fact or fraudulent sta... |
11.2.29 Anima shall cause all Persons who perform Development activities (including regulatory activities) for Anima under this Agreement or who conceive, discover, develop, or otherwise make any Know-How or Patent Rights by or on behalf of Anima or its Affiliates or its or their (sub)licensees under or in connection w... |
11.2.30 Anima will not grant any license relating to the Licensed IP, Anima Background Patents, Anima Background Know-How, or Anima Improvements that would conflict with the rights or licenses granted to AbbVie hereunder; |
11.2.31 To Anima's Knowledge, no government authorization, consent, approval, license, exemption of, or filing or registration with any court or governmental department, commission, board, bureau, agency, or instrumentality, domestic or foreign, under any applicable Laws currently in effect, is or will be necessary for... |
11.2.32 Anima and its Affiliates have not ever been and are not currently the subject of a proceeding that could lead to it or its Affiliates becoming a Debarred Entity, Excluded Entity, or Convicted Entity and Anima and its Affiliates will not use in any capacity, in connection with the obligations to be performed und... |
11.3 Compliance with Applicable Law. Each Party hereby covenants to the other Party that in performing its obligations or exercising its rights under this Agreement, such Party, its Affiliates, and its and their (sub)licensees/Sublicensees (other than Dispute Settlement Sublicensees), shall comply with all applicable L... |
11.4 Additional Covenants of Anima. During the Term, Anima shall not, and shall cause its Affiliates not to, (a) knowingly misappropriate or willfully infringe any valid and enforceable intellectual property rights of a Third Party in connection with the activities allocated to Anima under this Agreement, (b) enter int... |
11.5 Anti-Bribery and Anti-Corruption Compliance. Each Party represents, warrants, and covenants to the other Party in connection with this Agreement that it and its Affiliates (a) have complied and will comply with all applicable Laws, rules, regulations, and industry codes governing bribery, money laundering, and oth... |
11.6 Disclaimer. Except as otherwise expressly set forth in this Agreement, NEITHER PARTY MAKES ANY REPRESENTATION OR EXTENDS ANY WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY THAT ANY PATENT RIGHTS ARE VALID OR ENFORCEABLE, AND EXPRESSLY DISCLAIMS ALL IMPLIED WARRANTIES OF MERCHANTABILITY, FI... |
ARTICLE 12 INDEMNIFICATION; INSURANCE |
12.1 Indemnification by AbbVie. Subject to Section 12.3 (Procedure), AbbVie shall indemnify, hold harmless, and defend Anima and its Affiliates, and its or their respective directors, officers, employees, and agents, from and against any and all liabilities, damages, losses, costs, and expenses, including the reasonabl... |
12.1.1 the negligence, recklessness, or willful misconduct of AbbVie, any of its Affiliates, or any Sublicensee, or its or their respective directors, officers, employees, or agents, in connection with performance of AbbVie's obligations or exercise of AbbVie's rights under this Agreement; |
12.1.2 any breach of this Agreement, including any representation or warranty or covenant, by AbbVie; or |
12.1.3 the Development, Commercialization, Manufacture, or other Exploitation conducted by or on behalf of AbbVie, any of its Affiliates, or any Sublicensee following AbbVie's exercise of the applicable License Option of any Royalty-Bearing Product or Royalty-Bearing Compound (excluding any Exploitation carried out by ... |
except, in each case (Section 12.1.1, Section 12.1.2, and Section 12.1.3), to the extent that Anima has an obligation to indemnify AbbVie for Losses pursuant to Section 12.2 (Indemnification by Anima), as to which Losses each Party shall indemnify the other to the extent of their respective liability for such Losses. |
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