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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. |
12.2 Indemnification by Anima. Subject to Section 12.3 (Procedure), Anima shall indemnify, hold harmless, and defend AbbVie and its Affiliates, Sublicensees, and Distributors, and its and their respective directors, officers, employees, and agents, from and against any and all Losses to the extent arising out of or res... |
12.2.1 the negligence, recklessness, or willful misconduct of Anima or any of its Affiliates or subcontractors, or its or their respective directors, officers, employees, or agents, in connection with performance by or on behalf of Anima of Anima's obligations or exercise of Anima's rights under this Agreement; |
12.2.2 any breach of this Agreement, including any representation or warranty or covenant, by Anima; |
12.2.3 infringement or misappropriation of any Patent Rights or other intellectual property rights of any Third Party by the activities conducted by or on behalf of Anima or its Affiliates under this Agreement; or |
12.2.4 the Development, Commercialization, Manufacture, or other Exploitation of any Royalty-Bearing Product or Royalty-Bearing Compound by or on behalf of Anima or its Affiliates or (sub)licensees anywhere in the world after the Agreement has terminated (in whole or in part) with respect to such Royalty-Bearing Produc... |
except, in each case (Section 12.2.1, Section 12.2.2, Section 12.2.3, and Section 12.2.4), to the extent that AbbVie has an obligation to indemnify Anima for Losses pursuant to Section 12.1 (Indemnification by AbbVie), as to which Losses each Party shall indemnify the other to the extent of their respective liability f... |
12.3 Procedure. |
12.3.1 Notice. All indemnification claims in respect of a Party, its Affiliates or, in the case of AbbVie, its or their Sublicensees or Distributors, or its or their respective directors, officers, employees, and agents (each, an "Indemnitee") shall be made solely by such Party (the "Indemnified Party"). The Indemnifie... |
12.3.2 Control of Defense. |
(a) In General. Subject to the provisions of Sections 9.5 (Infringement Claims by Third Parties) and 9.6 (Invalidity or Unenforceability Defenses or Actions), at its option, the Indemnifying Party may assume the defense of any Third Party Claim by giving written notice to the Indemnified Party within thirty (30) days a... |
(b) Right to Participate in Defense. Without limiting Section 12.3.2(a) (In General), any Indemnified Party shall be entitled to participate in, but not control, the defense of such Third Party Claim and to employ counsel of its choice for such purpose; provided that such employment shall be at the Indemnified Party's ... |
(c) Settlement. With respect to any Losses relating solely to the payment of money damages in connection with a Third Party Claim and that shall not result in the Indemnified Party's becoming subject to injunctive or other relief or otherwise adversely affecting the business of the Indemnified Party in any manner, and ... |
(d) Cooperation. Regardless of whether the Indemnifying Party chooses to defend or prosecute any Third Party Claim, the Indemnified Party shall, and shall cause each Indemnitee to, cooperate in the defense or prosecution thereof and shall furnish such records, information, and testimony, provide such witnesses, and att... |
(e) Expenses. Except as provided above, the reasonable and verifiable costs and expenses, including fees and disbursements of counsel, incurred by the Indemnified Party in connection with any Third Party Claim shall be reimbursed on a Calendar Quarter basis in arrears by the Indemnifying Party, without prejudice to the... |
12.4 Insurance. Anima shall obtain and carry in full force and effect the minimum insurance requirements set forth herein from an insurance company properly licensed to provide the required insurance. Such insurance (a) shall be primary insurance with respect to Anima's participation under this Agreement, and (b) shall... |
12.4.1 Types and Minimum Limits. The types of insurance and minimum limits with respect to Anima shall include at least the following: |
(a) Worker's Compensation with statutory limits in compliance with the Worker's Compensation laws of Israel and of the state or states in which Anima has employees in the United States (excluding Puerto Rico). |
(b) Employer's liability coverage with a minimum limit of Five Hundred Thousand Dollars ($500,000) per occurrence; provided that Anima has employees in Israel or in the United States (excluding Puerto Rico). |
(c) General Liability Insurance with a minimum limit of Five Million Dollars ($5,000,000) per occurrence and Five Million Dollars ($5,000,000) in the aggregate. |
Anima shall at all times maintain in force any insurance policy that is required by any federal, state, national, or other such applicable Law that may govern or have jurisdiction over any provision of this Agreement and at all times remain fully compliant with any such applicable Law. |
12.4.2 Certificates of Insurance. Upon request by AbbVie, Anima shall provide Certificates of Insurance evidencing compliance with the above requirements of this Section 12.4 (Insurance). The insurance policies shall be under an occurrence form, but if only a claims-made form is available to AbbVie, then Anima shall co... |
12.4.3 Self-Insurance. Notwithstanding anything to the contrary in this Agreement, AbbVie may self-insure, in whole or in part. |
12.5 Limitation of Liability. EXCEPT (A) FOR A BREACH OF ARTICLE 8 (EXCLUSIVITY; CHANGE OF CONTROL) OR ARTICLE 10 (CONFIDENTIALITY), (B) AS PROVIDED UNDER SECTION 14.10 (EQUITABLE RELIEF), (C) TO THE EXTENT ANY SUCH DAMAGES ARE REQUIRED TO BE PAID TO A THIRD PARTY FOR CLAIMS THAT ARE SUBJECT TO INDEMNIFICATION UNDER TH... |
ARTICLE 13 TERM AND TERMINATION |
13.1 Term. This Agreement shall commence as of the Effective Date and, unless terminated earlier, shall continue in full force and effect until: (a) the expiration of the last-to-expire License Option Period, if AbbVie does not exercise its License Option with respect to any Target Program Slot; or (b) otherwise, the e... |
13.2 Termination. |
13.2.1 Termination for Cause. |
(a) Material Breach. If either Party (the "Non-Breaching Party") believes that the other Party (the "Breaching Party") has materially breached one (1) or more of its material obligations under this Agreement, then the Non-Breaching Party may deliver notice of such material breach to the Breaching Party (a "Default Noti... |
(b) Partial Terminations. Notwithstanding Section 13.2.1(a) (Material Breach), if any uncured material breach by AbbVie of any of its material obligations under this Agreement is with respect to: (i) one (1) or more, but not all, of the countries in the Territory, then Anima will not have the right to terminate this Ag... |
(c) Invocation of Termination for Material Breach. Notwithstanding the foregoing, the Parties agree that termination pursuant to this Section 13.2.1 (Termination for Cause) is a remedy to be invoked only if the breach cannot be adequately remedied through a combination of specific performance and the payment of money d... |
13.2.2 Termination by AbbVie. |
(a) AbbVie may terminate this Agreement on a Royalty-Bearing Product-by-Royalty-Bearing Product basis effective immediately upon written notice to Anima if AbbVie in good faith believes that it is not advisable for AbbVie to continue to Develop or Commercialize such Royalty-Bearing Product as a result of a perceived se... |
(b) AbbVie may terminate this Agreement (i) in its entirety at any time, or (ii) with respect to one (1) or more Collaboration Targets, Royalty-Bearing Products, or countries in the Territory, on a Collaboration Target-by-Collaboration Target, Royalty-Bearing Product-by-Royalty-Bearing Product, or country-by-country ba... |
13.2.3 Termination for Insolvency. In the event that either Party (or a parent of such Party) (a) files for protection under bankruptcy or insolvency Laws, (b) makes an assignment for the benefit of creditors, (c) appoints or suffers appointment of a receiver or trustee over substantially all of its property that is no... |
13.2.4 Termination for Debarment. AbbVie may terminate this Agreement pursuant to Section 11.2 (Representations, Warranties, and Covenants, as Applicable, of Anima). |
13.2.5 Termination for Anti-Bribery or Anti-Corruption Non-Compliance. AbbVie may terminate this Agreement in accordance with Section 11.5 (Anti-Bribery and Anti-Corruption Compliance). |
13.2.6 Termination for Failure or Delay to Obtain HSR Clearance. AbbVie may terminate this Agreement, on a Collaboration Target-by-Collaboration Target basis, with respect to such Collaboration Target upon written notice to Anima in the event that (a) either Party receives a Second Request following AbbVie's exercise o... |
13.3 Modification in Lieu of Termination. If, at any time during the Term, AbbVie has the right to terminate this Agreement pursuant to Section 13.2.1 (Termination for Cause), Section 13.2.3 (Termination for Insolvency), Section 13.2.4 (Termination for Debarment), or Section 13.2.5 (Termination for Anti-Bribery or Anti... |
13.3.1 the royalties payable by AbbVie to Anima pursuant to Section 7.8.1 (Royalty Rates) with respect to any Net Sales thereafter shall be based on royalty rates that are fifty percent (50%) of the applicable royalty rates set forth in Section 7.8.1 (Royalty Rates); |
13.3.2 the amount of any milestone payment payable by AbbVie to Anima under Section 7.6 (Development and Regulatory Milestone Payments) or Section 7.7 (Sales-Based Milestone Payments) for any milestone event achieved thereafter shall be reduced by fifty percent (50%) of the applicable amount set forth in Section 7.6 (D... |
13.3.3 AbbVie's obligations under Section 5.3 (AbbVie Diligence Obligation) shall terminate; and |
13.3.4 all other provisions of this Agreement shall remain in full force and effect without change. |
Notwithstanding the foregoing, if, at any time during the Term, AbbVie has the right to terminate this Agreement pursuant to Section 13.2.1 (Termination for Cause) for an uncured material breach by Anima of a material obligation that is not an Anima Severe Material Breach, then if AbbVie elects to continue this Agreeme... |
13.4 Effects of Termination. |
13.4.1 Without limiting any other legal or equitable remedies that either Party may have under this Agreement, in the event of a termination of (a) this Agreement in its entirety by AbbVie pursuant to Section 13.2.2 (Termination by AbbVie) or Section 13.2.6 (Termination for Failure or Delay to Obtain HSR Clearance), al... |
13.4.2 Without limiting any other legal or equitable remedies that either Party may have under this Agreement, in the event of a termination of this Agreement by Anima pursuant to Section 13.2.1 (Termination for Cause) or Section 13.2.3 (Termination for Insolvency), all rights and licenses granted by either Party to th... |
13.4.3 Without limiting any other legal or equitable remedies that either Party may have under this Agreement, in the event of a termination of this Agreement by AbbVie pursuant to Section 13.2.1 (Termination for Cause), Section 13.2.3 (Termination for Insolvency), Section 13.2.4 (Termination for Debarment), or Section... |
13.5 Effects of Termination in Terminated Territory. Without limiting any other legal or equitable remedies that either Party may have under this Agreement, in the event of a termination of this Agreement with respect to a country or other jurisdiction by AbbVie pursuant to this ARTICLE 13 (Term and Termination) (such ... |
13.6 Accrued Rights; Surviving Provisions of the Agreement. |
13.6.1 Accrued Rights. Termination or expiration of this Agreement either in its entirety or with respect to one (1) or more targets, countries, or Royalty-Bearing Products for any reason shall be without prejudice to any rights that shall have accrued to the benefit of either Party prior to such termination or expirat... |
13.6.2 Surviving Provisions of the Agreement. Without limiting Section 13.6.1 (Accrued Rights), the provisions of ARTICLE 1 (Definitions) (solely to the extent such definitions are used in other surviving provisions); Section 4.4 (No Other Rights); Section 4.7 (Rights in Bankruptcy); Section 6.5 (Records and Audits); S... |
13.6.3 Inventory Sell-Off. Notwithstanding the termination of AbbVie's licenses and other rights under this Agreement, AbbVie and its Affiliates and Sublicensees shall have the right for twelve (12) months after the effective date of such termination to sell or otherwise dispose of all Royalty-Bearing Products then in ... |
ARTICLE 14 MISCELLANEOUS |
14.1 Governing Law; Service. |
14.1.1 Governing Law. This Agreement and any dispute arising from the performance or breach hereof shall be governed by and construed and enforced in accordance with the Laws of the State of New York without reference to conflicts of laws principles; provided that all questions concerning (a) inventorship and ownership... |
14.1.2 Service. Each Party further agrees that service of any process, summons, notice, or document by certified mail to its address set forth in Section 14.5 (Notices) shall be effective service of process for any action, suit, or proceeding brought against it under this Agreement in any such court. |
14.2 Dispute Resolution. Except for disputes resolved by the procedures set forth in Section 3.5 (Decision-Making), Section 7.14.2 (Audit Dispute), or Section 14.10 (Equitable Relief), if a dispute arises between the Parties in connection with or relating to this Agreement or any document or instrument delivered in con... |
14.2.1 General. Any Dispute shall first be referred to the Executive Officers of the Parties, who shall confer in good faith on the resolution of the issue. Any final decision mutually agreed to by the Executive Officers shall be conclusive and binding on the Parties. If the Executive Officers are not able to agree on ... |
14.2.2 ADR. Subject to Section 14.2.1 (General) and Section 14.2.3 (Intellectual Property Disputes), any ADR proceeding under this Agreement shall take place pursuant to the procedures set forth in Schedule 14.2.2 (ADR Procedures) and subject to the Federal Arbitration Act. |
14.2.3 Intellectual Property Disputes. Unless otherwise agreed by the Parties in writing, a Dispute between the Parties relating to the validity, enforceability, or patentability of any Patent Right, Trademark, or other intellectual property rights, if not resolved in accordance with Section 14.2.1 (General), shall not... |
14.2.4 Adverse Ruling. Any determination pursuant to this Section 14.2 (Dispute Resolution) that a Party is in material breach of its material obligations hereunder shall specify a (nonexclusive) set of actions to be taken to cure such material breach, if feasible. |
14.2.5 Interim Relief. Notwithstanding anything herein to the contrary, nothing in this Section 14.2 (Dispute Resolution) shall preclude either Party from seeking interim or provisional relief, including a temporary restraining order, preliminary injunction, or other interim equitable relief concerning a Dispute, if ne... |
14.2.6 Monetary Damages. Notwithstanding anything herein to the contrary, including any designation of a payment as "non-refundable" or "non-creditable," in the event of a Dispute, the Parties may consider payments made by AbbVie under this Agreement when determining the amount of monetary damages due to AbbVie. |
14.3 Assignment. |
14.3.1 This Agreement may not be assigned or otherwise transferred, nor may any right or obligation hereunder be assigned or transferred (except as provided in Sections 4.2 (Sublicensing Rights), 6.3 (Performance by Affiliates and Sublicensees), or 6.4 (Subcontracting)), whether by operation of law or otherwise, in who... |
14.3.2 AbbVie agrees that, notwithstanding any provision of this Agreement to the contrary, if Anima undergoes a Change of Control, then AbbVie will not have any rights under this Agreement to any Patent Right, Know-How, or other intellectual property or other proprietary rights that are owned or otherwise Controlled b... |
14.4 Force Majeure. Except for the payment of money, neither Party shall be held liable or responsible to the other Party or be deemed to have defaulted under or breached this Agreement for failure or delay in fulfilling or performing any term of this Agreement when such failure or delay is caused by or results from ev... |
14.5 Notices. Any notice, request, demand, waiver, consent, approval, or other communication permitted or required under this Agreement shall be in writing, shall refer specifically to this Agreement, and shall be deemed given only if (a) delivered by hand, (b) sent by facsimile transmission (with transmission confirme... |
If to Anima, addressed to: Anima Biotech Inc. 75 Claremont Rd, Ste 102 Bernardsville, NJ 07924, USA Attention: Chief Executive Officer |
with a copy (which shall not constitute notice) to: Yochi.slonim@animabiotech.com |
If to AbbVie, addressed to: AbbVie Global Enterprises Ltd. c/o Harbour Fiduciary Services Ltd. Thistle House, 4 Burnaby Street Hamilton Pembroke HM 11 Bermuda |
with a copy (which shall not constitute notice) to: AbbVie Inc. 1 North Waukegan Road North Chicago, IL 60064 Facsimile: +1 847 935 3294 Attn: Executive Vice President, General Counsel, and Secretary |
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