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(i) A "Debarred Individual" is an individual who has been debarred by the FDA pursuant to 21 U.S.C. § 335a (a) or (b) from providing services in any capacity to a Person that has an approved or pending drug or biological product application. |
(ii) A "Debarred Entity" is a corporation, partnership or association that has been debarred by the FDA pursuant to 21 U.S.C. § 335a (a) or (b) from submitting or assisting in the submission of any abbreviated drug application, or a subsidiary or affiliate of a Debarred Entity. |
(iii) An "Excluded Individual" or "Excluded Entity" is (A) an individual or entity, as applicable, who has been excluded, debarred, suspended or is otherwise ineligible to participate in federal health care programs such as Medicare or Medicaid by the Office of the Inspector General (OIG/HHS) of the U.S. Department of ... |
(iv) A "Convicted Individual" or "Convicted Entity" is an individual or entity, as applicable, who has been convicted of a criminal offense that falls within the ambit of 21 U.S.C. § 335a (a) or 42 U.S.C. § 1320a - 7(a), but has not yet been excluded, debarred, suspended or otherwise declared ineligible. |
10.2.23 The inventions claimed or covered by the Existing Patents (a) were not conceived, discovered, developed, or otherwise made in connection with any research activities funded, in whole or in part, by the federal government of the United States or any agency thereof, and (b) are not a "subject invention" as that t... |
10.2.24 During the period from the Execution Date until the Effective Date, Licensor and each of its Affiliates shall conduct its research and development with respect to the Licensed Antibody and the Licensed Products in the ordinary course. |
10.2.25 At the time of delivery of the PoC Trial Report, Licensor shall inform AbbVie in writing if Licensor or any of its Affiliates becomes aware that the representations and warranties made by Licensor herein (other than pursuant to Sections 10.2.9, 10.2.13, 10.2.14 and 10.2.17) as of the Execution Date are not true... |
10.2.26 To Licensor's Knowledge, the representations and warranties of Licensor in this Agreement, and the Information, documents and materials furnished to AbbVie in connection with its period of diligence prior to the Effective Date, do not, taken as a whole, (a) contain any untrue statement of a material fact, or (b... |
10.3 Additional Covenants of Licensor. Licensor further covenants to AbbVie as follows: |
10.3.1 During the Term, Licensor shall (a) not commit or omit any acts that would cause the breach or termination of any In-License Agreement, or (b) not amend or otherwise modify or permit to be amended or modified, any In-License Agreement, in each case in a manner that would encumber or diminish the rights granted t... |
10.3.2 Neither Licensor nor any of its Affiliates will enter into any assignment, transfer, license, conveyance or encumbrance of, or otherwise assign, transfer, license, convey or encumbered its right, title, or interest in or to the Existing Patents, Licensor Background Know-How, Regulatory Documentation or grant any... |
10.3.3 If Licensor secures a license to European Patent No. EP2625201B (including, if applicable, patents issuing thereon, foreign equivalents, or any patent claiming priority thereto), licensor shall ensure such license is sublicensable (through multiple tiers) to AbbVie under this Agreement at no cost to AbbVie and t... |
10.4 DISCLAIMER OF WARRANTIES. EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH HEREIN, NEITHER PARTY MAKES ANY REPRESENTATIONS OR GRANTS ANY WARRANTIES, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, AND EACH PARTY SPECIFICALLY DISCLAIMS ANY OTHER WARRANTIES, WHETHER WRITTEN OR ORAL, OR... |
ARTICLE 11. INDEMNITY |
11.1 Indemnification of Licensor. AbbVie shall indemnify Licensor, its Affiliates and its and their respective directors, officers, employees, and agents (the "Licensor Indemnitees") and defend and save each of them harmless, from and against any and all losses, damages, liabilities, penalties, costs, and expenses (inc... |
(a) the breach by AbbVie or its Affiliates of this Agreement; or |
(b) the negligence, reckless conduct or willful misconduct on the part of AbbVie or its Affiliates or their respective directors, officers, employees, and agents in performing its or their obligations under this Agreement. |
except in the case of clauses (a) and (b), for those Losses for which Licensor, in whole or in part, has an obligation to indemnify AbbVie pursuant to Section 11.2 hereof, as to which Losses each Party shall indemnify the other to the extent of their respective liability for such Losses. |
11.2 Indemnification of AbbVie. Licensor shall indemnify AbbVie, its Affiliates and its and their respective directors, officers, employees, and agents (the "AbbVie Indemnitees"), and defend and save each of them harmless, from and against any and all Losses in connection with any and all Third Party Claims incurred by... |
(a) the breach by Licensor or its Affiliates of this Agreement; |
(b) the negligence, reckless conduct or willful misconduct on the part of Licensor or its Affiliates or its or their respective directors, officers, employees, and agents in performing its obligations under this Agreement; |
(c) the use of Licensor's Corporate Name in connection with the Commercialization of the Licensed Antibodies or Licensed Products in the Territory as permitted under this Agreement; or |
(d) the Development, Commercialization, Manufacture, or other Exploitation of the Licensed Antibodies or the Licensed Products anywhere in the world prior to the Effective Date; |
(e) the Development, Commercialization, Manufacture, or other Exploitation of the Terminated Antibodies or Terminated Products anywhere in the world. |
except, in the case of clauses (a) through (c) above for those Losses for which AbbVie, in whole or in part, has an obligation to indemnify Licensor pursuant to Section 11.1 hereof, as to which Losses each Party shall indemnify the other to the extent of their respective liability for the Losses. |
11.3 Certain Losses. Any Losses, other than those Losses covered in ARTICLE 7, or which result from the unlawful conduct of a Party, or for which indemnification is otherwise provided in Section 11.1 or Section 11.2, in connection with any Third Party Claim brought against either Party resulting directly or indirectly ... |
11.4 Notice of Claim. All indemnification claims in respect of a Party, its Affiliates, or their respective directors, officers, employees and agents shall be made solely by such Party to this Agreement (the "Indemnified Party"). The Indemnified Party shall give the indemnifying Party prompt written notice (an "Indemni... |
11.5 Control of Defense. |
11.5.1 In General. Subject to the provisions of Sections 7.4, 7.5 and 7.6, 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 after the indemnifying Party's receipt of an Indemnification Claim Notice. The assump... |
11.5.2 Right to Participate in Defense. Without limiting Section 11.5.1, 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 own expense u... |
11.5.3 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 affect the business of the Indemnified Party in any manner, and ... |
11.5.4 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 at... |
11.5.5 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 ... |
11.6 Special, Indirect, and Other Losses. EXCEPT (A) FOR WILLFUL MISCONDUCT, (B) FOR A PARTY'S BREACH OF ITS OBLIGATIONS UNDER ARTICLE 9 OR SECTION 5.10, (C) AS PROVIDED UNDER SECTION 13.11, AND (D) TO THE EXTENT ANY SUCH DAMAGES ARE REQUIRED TO BE PAID TO A THIRD PARTY AS PART OF A CLAIM FOR WHICH A PARTY PROVIDES IND... |
11.7 Insurance. Each Party shall obtain and carry in full force and effect the minimum insurance requirements set forth herein. Such insurance (a) shall be primary insurance with respect to each Party's own participation under this Agreement, (b) shall be issued by a recognized insurer rated by A.M. Best "A-VII" (or it... |
11.7.1 Types and Minimum Limits. The types of insurance, and minimum limits shall be: |
(a) Worker's Compensation with statutory limits in compliance with the Worker's Compensation laws of the state or states in which the Party 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 a Party has employees in the United States (excluding Puerto Rico). |
(c) General Liability Insurance with a minimum limit of two million dollars ($2,000,000) per occurrence and five million dollars ($5,000,000) in the aggregate. Beginning at least thirty (30) days prior to the initiation of the PoC Study, General Liability Insurance shall include Professional Liability and Clinical Tria... |
11.7.2 Certificates of Insurance. Upon request by a Party, the other Party shall provide Certificates of Insurance evidencing compliance with this Section 11.7.2. The insurance policies shall be under an occurrence form, but if only a claims-made form is available to a Party, then such Party shall continue to maintain ... |
11.7.3 Self-Insurance. Notwithstanding the foregoing, AbbVie may self-insure, in whole or in part, the insurance requirements described above; provided that AbbVie continues to be investment grade determined by reputable and accepted financial rating agencies. |
ARTICLE 12. TERM AND TERMINATION |
12.1 Term. |
12.1.1 HSR and Other Governmental Filings. The Parties shall each, as soon as practicable prior to the Option Exercise Date, file or cause to be filed with the U.S. Federal Trade Commission and the U.S. Department of Justice and any relevant foreign governmental authority ("Governmental Authority") any notifications re... |
12.1.2 Term. Notwithstanding anything in this Agreement to the contrary, the exercise of the Option may not become effective until the expiration or earlier termination of the waiting period (or any extension thereof) under the HSR Act and any other applicable similar approvals or clearances (collectively, "Antitrust A... |
12.1.3 Effect of Expiration of the Term. Following the expiration of the Term with respect to a Collaboration Program, if AbbVie delivered an Exercise Notice at or prior to expiration of the Option Period for such Collaboration Program, and this Agreement has not terminated with respect to such Collaboration Program in... |
12.2 Termination for 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... |
12.3 Material Breach Related to Diligence in the Major Markets. Notwithstanding Section 12.2, if the material breach and failure to cure contemplated by Section 12.2 is with respect to a breach of AbbVie's Commercialization diligence obligations under Section 4.3 as they relate to AbbVie's conduct following the First C... |
12.4 Invocation of Termination for Material Breach. Notwithstanding the foregoing, the Parties agree that termination pursuant to Section 12.2 is a remedy to be invoked only if the breach cannot be adequately remedied through specific performance or the payment of money damages. |
12.5 For Convenience. Beginning twelve (12) months after the Effective Date, AbbVie may terminate this Agreement (a) in its entirety, (b) on Collaboration Program-by-Collaboration Program basis, or (c) on an AbbVie Opt In Product-by-AbbVie Opt In Product basis, for any or no reason, upon one ninety (90) days' prior wri... |
12.6 Termination for Insolvency. In the event that either 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 not discharged within ninety (90... |
12.7 Rights in Bankruptcy. |
12.7.1 Applicability of 11 U.S.C. § 365(n). All rights and licenses (collectively, the "Intellectual Property") granted under or pursuant to this Agreement, including all rights and licenses to use improvements or enhancements developed during the Term, are intended to be, and shall otherwise be deemed to be, for purpo... |
12.7.2 Rights of non-Debtor Party in Bankruptcy. If a bankruptcy proceeding is commenced by or against either Party under the Bankruptcy Code or any analogous provisions in any other country or jurisdiction, the non-debtor Party shall be entitled to a complete duplicate of (or complete access to, as appropriate) any In... |
12.8 Effects of Termination and Option Expiration. |
12.8.1 In the event of a (i) termination of this Agreement in its entirety or with respect to a Terminated Program by AbbVie pursuant to Section 12.5 or by Licensor pursuant to Section 12.2 or 12.6 or (ii) expiration of the Option Period for a Collaboration Program if AbbVie has not previously delivered an Exercise Not... |
(a) all rights and licenses granted by Licensor hereunder shall immediately terminate with respect to the Terminated Programs. |
(b) all rights and licenses granted by AbbVie (other than as set forth in this Article 12) shall immediately terminate with respect to the Terminated Programs. |
(c) subject to Section 12.10, solely with respect to the Terminated Programs, AbbVie shall, and hereby does effective as of the effective date of termination, grant Licensor a royalty-bearing (to the extent provided in Section 12.10) license, with the right to grant multiple tiers of sublicenses, under the AbbVie Grant... |
(d) to the extent that AbbVie has incorporated into the Terminated Antibody or Terminated Product any inventions constituting AbbVie Background Know-How (the "AbbVie Incorporated Background Know-How"), AbbVie shall, and hereby does effective as of the effective date of termination, grant Licensor a non-exclusive licens... |
(e) Notwithstanding paragraphs (c) and (d) above: (i) the licenses under Sections 12.8.1(c) above shall exclude any license or other rights with respect to (A) a Collaboration Program other than the Terminated Programs, (B) AbbVie Program Know-How pertaining to the Manufacture of Terminated Antibodies or Terminated Pro... |
(f) For clarity, upon such a termination: (a) in the event the Terminated Program is a Collaboration Program, the Collaboration Target for such Collaboration Program (the "Terminated Target") shall thereafter cease to be a Collaboration Target and (and such program shall cease to be a Collaboration Program), any Antibo... |
12.8.2 In the event of a termination of this Agreement in its entirety or with respect to a Terminated Program by AbbVie pursuant to Section 12.2 or 12.6: |
(a) all rights and licenses granted by AbbVie hereunder shall immediately terminate with respect to the Terminated Programs; and |
(b) all rights and licenses granted to AbbVie hereunder shall become exclusive or non-exclusive (at AbbVie's sole option), irrevocable, unrestricted, and perpetual rights and licenses, provided that the Parties shall mutually agree, in good faith, in writing the consideration Licensor shall receive for and the terms an... |
12.9 Transition. In the event of termination of this Agreement, whether in its entirety or with respect to a Terminated Program by AbbVie pursuant to Section 12.5 (including, for clarity, expiration of the Option with respect to the Terminated Program without AbbVie having delivered an Exercise Notice for such Terminat... |
12.9.1 Development. In the event AbbVie is conducting (or is having conducted on its behalf) any (a) on-going Clinical Studies of Licensed Antibody or Licensed Product (b) any ongoing pre-clinical studies and/or development of the Manufacturing Process (including without limitation, formulation studies, stability studi... |
12.9.2 Commercialization. To avoid disruption in the availability of Terminated Products to patients, if this Agreement is terminated after the First Commercial Sale of a Terminated Product, AbbVie, its Affiliates and its Sublicensees shall continue to distribute such Terminated Product, in accordance with the terms an... |
12.9.3 Regulatory Approvals, Regulatory Documentation and Product Trademarks. AbbVie shall assign (or cause to be assigned) to Licensor or its designee all Regulatory Approvals, Regulatory Documentation and Product Trademarks solely to the extent related to the Terminated Products, including any such Regulatory Documen... |
12.9.4 Supply Obligations. Upon Licensor's request, AbbVie shall either (a) to the extent allowable under such agreements, assign to Licensee or its Affiliates the portion of AbbVie's agreement(s) with its Third Party manufacturing provider related to the Terminated Antibodies, Terminated Products and placebo used in c... |
12.9.5 Information Transfer. AbbVie shall provide to Licensor the AbbVie Program Know-How, Regulatory Documentation, Clinical Data and other Information pertaining to the Terminated Program to the same degree and on a reciprocal basis as provided in Sections 3.5.3(a)-(d), 3.6.1, 3.6.2 and 3.8.3 (mutatis mutandis, as wo... |
12.9.6 Cooperation. Without limiting the foregoing, AbbVie shall use Commercially Reasonable Efforts to cooperate with Licensor and/or its designee to effect a smooth and orderly transition in the development, sale and ongoing marketing, promotion and commercialization of the Product in the Territory during the Develop... |
12.10 Reverse Royalty. If this Agreement is terminated in its entirety or with respect to a Terminated Program, and in connection therewith, AbbVie grants to Licensor a license pursuant to Section 12.8, in consideration of the licenses granted and other consideration provided to Licensor pursuant to Section 12.8, if Li... |
12.11 Remedies. Except as otherwise expressly provided herein, termination of this Agreement (either in its entirety or with respect to a Terminated Program) in accordance with the provisions hereof shall not limit remedies that may otherwise be available in law or equity. |
12.12 Accrued Rights; Surviving Obligations. |
12.12.1 Termination or expiration of this Agreement (either in its entirety or with respect to one (1) or more country(ies) or other jurisdiction(s)) for any reason shall be without prejudice to any rights that shall have accrued to the benefit of a Party prior to such termination or expiration. Such termination or exp... |
12.12.2 Notwithstanding the termination of AbbVie's licenses and other rights under this Agreement or with respect to a Terminated Program, AbbVie shall have the right for one (1) year after the effective date of such termination to sell or otherwise dispose of all Terminated Antibody or Terminated Product then in its ... |
ARTICLE 13. MISCELLANEOUS |
13.1 Force Majeure. 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 events beyond the reasonable contro... |
13.2 Change in Control of Licensor. |
13.2.1 Licensor (or its successor) shall provide AbbVie with written notice of any Change in Control of Licensor or Acquisition by Licensor within two (2) Business Days following the closing date of such transaction. |
(a) In the event of the Change in Control of Licensor, AbbVie shall have the right, in its sole and absolute discretion, by written notice delivered to Licensor (or its successor) at any time during the one hundred eighty (180) days following the written notice contemplated by Section 13.2.1, to require Licensor and th... |
(b) In addition to the rights set forth in Section 13.2.1(a), solely in the event of a Change in Control of Licensor pursuant to which a Significant Pharmaceutical Company acquires Control of Licensor, AbbVie shall have the right, in its sole discretion, to (i) disband each of the Joint Committees and terminate the act... |
13.3 Export Control. This Agreement is made subject to any restrictions concerning the export of products or technical information from the United States or other countries that may be imposed on the Parties from time to time. Each Party agrees that it will not export, directly or indirectly, any technical information ... |
13.4 Assignment. |
13.4.1 Without the prior written consent of the other Party, neither Party shall sell, transfer, assign, delegate (except as expressly permitted under this Agreement), pledge, or otherwise dispose of, whether voluntarily, involuntarily, by operation of law or otherwise, this Agreement or any of its rights or duties her... |
13.4.2 Without limiting Section 13.2 above, the rights to Information, materials and intellectual property: (a) Controlled by a Third Party permitted assignee of a Party, which Information, materials and intellectual property were Controlled by such assignee immediately prior to such assignment; or (b) Controlled by an... |
13.5 Severability. If any provision of this Agreement is held to be illegal, invalid, or unenforceable under any present or future law, and if the rights or obligations of either Party under this Agreement will not be materially and adversely affected thereby, (a) such provision shall be fully severable, (b) this Agree... |
13.6 Governing Law, Jurisdiction and Service. |
13.6.1 Governing Law. This Agreement or the performance, enforcement, breach or termination hereof shall be interpreted, governed by and construed in accordance with the laws of the State of Delaware, United States, excluding any conflicts or choice of law rule or principle that might otherwise refer construction or in... |
13.6.2 Service. Each Party further agrees that service of any process, summons, notice or document by registered mail to its address set forth in Section 13.8 shall be effective service of process for any action, suit, or proceeding brought against it under this Agreement in any such court. |
13.7 Dispute Resolution. Except for disputes resolved by the procedures set forth in Section 2.4.3, 6.14 or 13.11 or for which either Party has final decision making authority, if a dispute arises between the Parties in connection with or relating to this Agreement or any document or instrument delivered in connection ... |
13.7.1 General. Any Dispute shall first be referred to the Senior Officers of the Parties, who shall confer in good faith on the resolution of the issue. Any final decision mutually agreed to by the Senior Officers shall be conclusive and binding on the Parties. If the Senior Officers are not able to agree on the resol... |
13.7.2 Intellectual Property Disputes. In the event that a Dispute arises with respect to the validity, scope, enforceability, inventorship or ownership of any Patent, Trademark or other intellectual property rights, and such Dispute cannot be resolved in accordance with Section 13.7.1, unless otherwise agreed by the P... |
13.7.3 ADR. Any ADR proceeding under this Agreement shall take place pursuant to the procedures set forth on Schedule 13.7.3. |
13.7.4 Expert Arbitration. Any dispute expressly stated in this Agreement to be resolved pursuant to this Section 13.7.4 shall take place pursuant to the following procedures: |
(a) Arbitration Supervision. The expert arbitration shall be overseen by and conducted as a "baseball" form of binding arbitration by a single arbitrator selected in accordance with the procedure set forth in Schedule 13.7.3, and conducted pursuant to Schedule 13.7.3, except as modified under this Section 13.7.4 The ar... |
(b) Promptly following receipt of any notice requiring dispute resolution pursuant to this Section 13.7.4, the arbitrator may engage one or more experts to assist the arbitrator in resolving the issue under the supervision of an arbitrator as provided in Section 13.7.4(a), which experts shall be neutral and independent... |
13.7.5 Adverse Ruling. Any determination pursuant to this Section 13.7 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. |
13.7.6 Interim Relief. Notwithstanding anything herein to the contrary, nothing in this Section 13.7 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 necessary to protect the... |
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