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8.1.1 Anima Exclusivity Obligation. |
(a) Reserved Targets. During the period beginning on the Effective Date and ending on the earlier of (i) the five- (5-) year anniversary thereof or (ii) if AbbVie does not exercise its License Option with respect to any Collaboration Target during the applicable License Option Period, the date of expiration of the last... |
(b) Collaboration Targets for which License Option has not been Exercised. On a Collaboration Target-by-Collaboration Target basis, during the period beginning on the Effective Date and ending on the expiration of the applicable License Option Period with respect to each Collaboration Target for which AbbVie does not e... |
(c) Collaboration Targets for which License Option is Exercised. |
(i) Solely in the U.S., on a Collaboration Target-by-Collaboration Target basis, during the period beginning on the Effective Date and ending on the five- (5-) year anniversary of the expiration or termination of this Agreement in its entirety, with respect to each Collaboration Target for which AbbVie exercises its Li... |
(ii) Anywhere in the Territory other than the U.S., the following terms shall apply to each Collaboration Target for which AbbVie exercises its License Option during the applicable License Option Period in accordance with the terms of this Agreement: |
A. Development Exclusivity Obligation. On a Collaboration Target-by-Collaboration Target basis, neither Anima nor its Affiliates shall, directly or indirectly: (w) conduct any screening or other research activities with respect to such Collaboration Target; (x) intentionally generate data with respect to such Collabora... |
B. Commercialization Exclusivity Obligation. On a Collaboration Target-by-Collaboration Target basis, during the period beginning on the date of the first Regulatory Approval of a Royalty-Bearing Product Directed To such Collaboration Target anywhere in the Territory other than the U.S. and ending on the five- (5)- yea... |
(d) Compound Library. In screening activities outside and independent of its collaboration with AbbVie under this Agreement, Anima and its Affiliates shall exclude from compound libraries of Anima and any un-blinded compound library of a Third Party all compounds that immediately prior to starting such screen are inclu... |
(e) ADCs. Anima shall not, and shall cause its Affiliates not to, conduct activities with respect to any ADC included in any License Option Exercise Data Package (including, for clarity, any in-process draft thereof) outside this Agreement, including in connection with Anima's or its Affiliate's independent research or... |
(f) The provisions of this Section 8.1.1 (Anima Exclusivity Obligation) and Section 4.1.1(b) (Commercial Licenses) shall not restrict: |
(i) Anima or its Affiliates (A) from directly or indirectly conducting activities with respect to a molecule, compound, product, or other therapeutic agent (other than any ADC included in any License Option Exercise Data Package (including, for clarity, any in-process draft thereof)) pursuant to an agreement with a Thi... |
(ii) Anima or its Affiliates from directly or indirectly conducting, under an independent internal research program (i.e., not a program pursuant to an agreement with a Third Party, which is covered by the foregoing Section 8.1.1(f)(i)) not related to a target that is a Collaboration Target or Reserved Target, activiti... |
(iii) Anima or its Affiliates from granting licenses (including exclusive licenses for any purpose) to a Third Party under any Intellectual Property rights relating to any molecule, compound, product, or other therapeutic agent (other than any ADC included in any License Option Exercise Data Package (including, for cla... |
(iv) the manner in which Anima's or its Affiliates' Third Party collaboration partners Exploit any molecule, compound, product, or other therapeutic agent (other than any ADC included in any License Option Exercise Data Package (including, for clarity, any in-process draft thereof)) independently generated in the cours... |
(g) For clarity, a target shall not be a "Collaboration Target" under this Agreement (and as such shall not be subject to the exclusivity set forth in Section 8.1.1(b) (Collaboration Targets for which License Option has not been Exercised)) following expiration or termination of this Agreement with respect to such targ... |
8.1.2 Effect of Change of Control of Anima. Notwithstanding the provisions of Section 8.1.1 (Anima Exclusivity Obligation), if Anima undergoes a Change of Control during the Term and, as of immediately prior to the closing of such Change of Control, any Person that becomes an Independent Affiliate of Anima upon such Ch... |
8.2 Change of Control of Anima. If Anima undergoes a Change of Control during the Term, then: |
(a) Anima shall notify AbbVie thereof immediately upon the closing of the Change of Control; |
(b) Anima shall comply with the terms of Section 8.1.2 (Effect of Change of Control of Anima); |
(c) AbbVie shall have the right, in its sole and absolute discretion, by written notice delivered to Anima (or its successor) at any time within one hundred eighty (180) days following the written notice contemplated by the foregoing clause (a), to: (i) terminate any or all provisions of this Agreement providing for an... |
(d) Anima covenants that, subject to the foregoing clause (c), there shall be no material change in the level or nature of efforts or resources expended by Anima and its Affiliates or the qualifications and experience of Anima's assigned personnel (including with respect to the allocation of their time), in each case, ... |
ARTICLE 9 INTELLECTUAL PROPERTY RIGHTS |
9.1 Ownership of Intellectual Property; Disclosure. |
9.1.1 Ownership. Subject to the license grants and other rights herein, as between the Parties: (a) all right, title, and interest in and to all (i) Know-How that is conceived, reduced to practice, generated, discovered, developed, or otherwise made solely by or on behalf of Anima (or its Affiliates) in the course of a... |
9.1.2 United States Law. The determination of whether Know-How is conceived, reduced to practice, generated, discovered, developed, or otherwise made by or on behalf of a Party or its Affiliates for the purpose of allocating proprietary rights (including patent, copyright, or other intellectual property rights) therein... |
9.1.3 Disclosure of Inventions. During the Term, Anima shall, and shall cause its Affiliates, subcontractors, and (sub)licensees to, promptly disclose in writing to AbbVie the conception, reduction to practice, generation, discovery, development, or making of any Collaboration Know-How by Anima or any of its Affiliates... |
9.1.4 Control of Intellectual Property. Anima and its Affiliates shall not enter into or amend any agreement with a Third Party, or include in any such agreement or amendment any restrictive provisions, that limit its Control of any Licensed IP that would be subject to the license grants in Section 4.1 (Licenses to Abb... |
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)... |
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