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7.9 Common Interest. All information exchanged between the Parties regarding the prosecution, maintenance, enforcement and defense of Patents under this ARTICLE 7 will be deemed to be Confidential Information of the disclosing Party. In addition, the Parties acknowledge and agree that, with regard to such prosecution, ... |
7.10 Third Party Rights. Each Party's rights under this ARTICLE 7 with respect to the prosecution and enforcement of any Licensor Patent that is (a) a University Patent Right, are subject to the rights of the Regents of the University of Michigan as set forth in Article 7 and Article 8 of the UOFM License Agreement, no... |
ARTICLE 8 PHARMACOVIGILANCE AND SAFETY |
8.1 Pharmacovigilance. Within ninety (90) days after the License Option Exercise Closing Date, the Parties shall enter into an agreement to initiate a process for the exchange of adverse event safety data in a mutually agreed format, including postmarketing spontaneous reports received by the Party or its Affiliates in... |
8.2 Global Safety Database. Licensor shall initially set up, hold and maintain (at its sole cost and expense) the global safety database for Licensed Antibodies and Licensed Products with respect to safety data obtained in connection with the Initial Development Activities. Within thirty (30) days after the License Opt... |
8.3 Data Privacy and Security. |
8.3.1 For all Personal Data collected, Processed, hosted, or transmitted in performance by Licensor of this Agreement, including in connection with the conduct of the Initial Development Activities, Licensor shall (or shall obligate any applicable Third Party Providers to): |
(i) comply at all times with the Data Security and Privacy Laws; |
(ii) to the extent permitted by Applicable Law, notify AbbVie, as soon as practicable and in any event prior to making the relevant disclosure, if it is obliged to make a disclosure of the Personal Data under Applicable Law; |
(iii) make timely notification to, and obtain any necessary authorizations from, any applicable Regulatory Authority where required under applicable Data Security and Privacy Laws of its collection and other Processing of Personal Data in order to comply with its obligations under this Agreement; |
(iv) at all times, act in a manner such that it is not subject to any prohibition or restriction that (i) prevents or restricts it from disclosing or transferring the Personal Data to AbbVie, as required under this Agreement; or (ii) prevents or restricts either Party from Processing the Personal Data as envisaged unde... |
(v) ensure that to the extent applicable to Licensor's activities hereunder, all fair Processing and required notices have been obtained and are maintained and are sufficient in scope, and that Licensor has an appropriate legal basis under Data Security and Privacy Laws, to enable Licensor to Process the Personal Data ... |
(vi) implement and maintain reasonable administrative, technical, and physical safeguards designed to (i) maintain the security and confidentiality of the Personal Data; (ii) protect against reasonably anticipated threats or hazards to the security or integrity of the Personal Data; and (iii) protect against unauthoriz... |
(vii) notify AbbVie promptly, and in any event within forty-eight (48) hours of receipt of (i) any correspondence from a data protection regulator in relation to the Processing of Personal Data related to this Agreement, or (ii) a request or notice from a data subject exercising his rights under the Data Security and P... |
(viii) refrain from taking actions related to the Processing of the Personal Data that would be reasonably likely to damage or impair AbbVie's reputation. |
8.3.2 Data Agreements. At the reasonable request of AbbVie, the Parties shall cooperate to enter into any necessary joint controller agreements or controller-processor agreements with respect to such Personal Data as necessary to comply with Applicable Law. |
8.4 Security Breach Notification. Licensor shall notify AbbVie by email to csirt@abbvie.com as soon as practicable upon learning of any actual or suspected misappropriation or unauthorized access to, or disclosure or use of the Personal Data collected, Processed, hosted, or transmitted in performance by Licensor of th... |
ARTICLE 9 CONFIDENTIALITY AND NON-DISCLOSURE |
9.1 Product Information. Licensor recognizes that by reason of AbbVie's status as an exclusive optionee pursuant to the grants under Section 3.2.3, AbbVie has an interest in Licensor maintaining the confidentiality of certain information of Licensor. Accordingly, following the License Option Exercise Closing Date and f... |
9.2 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 P... |
9.2.1 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; |
9.2.2 has 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 Documentation (excluding clinical protocols) or Joint Know-How; |
9.2.3 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; |
9.2.4 is generally made available to Third Parties by the disclosing Party without restriction on disclosure; or |
9.2.5 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 Documentation (excluding clinical protocols). |
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... |
9.3 Permitted Disclosures. Each Party may disclose Confidential Information to the extent that such disclosure is: |
9.3.1 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 or local governmental body of competent jurisdiction, (including by r... |
9.3.2 made by or on behalf of the receiving Party to the Regulatory Authorities as required in connection with any filing, application or request for Regulatory Approval of a Licensed Product in accordance with the terms of this Agreement; provided, that reasonable measures shall be taken to assure confidential treatme... |
9.3.3 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 in accordance with the terms of this Agreement; provided, that reasonable measures shall be taken to assure confidential treatment of suc... |
9.3.4 made to its or its Affiliates' financial and legal advisors who have a need to know such disclosing Party's Confidential Information and are either under professional codes of conduct giving rise to expectations of confidentiality and non-use or under written agreements of confidentiality and non-use, in each cas... |
9.3.5 made by the receiving Party or its Affiliates to potential or actual investors or acquirers as may be necessary in connection with their evaluation of such potential or actual investment or acquisition; provided, that such Persons shall be subject to obligations of confidentiality and non-use with respect to such... |
9.3.6 made by AbbVie or its Affiliates or Sublicensees 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 connection with the Exploitation of the Lice... |
9.3.7 made by Licensor or its Affiliates after receiving advanced approval from AbbVie, with such approval not to be unreasonably withheld, conditioned or delayed, to its or their advisors, consultants, clinicians, vendors, service providers, contractors, or other Third Parties as may be necessary or useful in connecti... |
9.4 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 the Regents of the University of Michigan or any of its affiliates) (or any abbreviation or adaptation thereof) in any publication, press releas... |
9.5 Public Announcements. Neither Party shall issue any other public announcement, press release, or other public disclosure regarding this Agreement or its subject matter without the other Party's prior written consent, except for any such disclosure that is, in the opinion of the disclosing Party's counsel, required ... |
9.6 Publications. The Parties acknowledge that scientific publications must be strictly monitored to prevent any adverse effect from premature publication of results of the activities contemplated hereunder. Accordingly, Licensor shall not publish, present, or otherwise disclose, and shall cause its Affiliates and Thir... |
9.7 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 T... |
9.8 Survival. All Confidential Information shall continue to be subject to the terms of this Agreement for the period set forth in Section 9.2. |
ARTICLE 10 REPRESENTATIONS AND WARRANTIES |
10.1 Mutual Representations and Warranties. Licensor and AbbVie each represents and warrants to the other, as of the Effective Date, as follows: |
10.1.1 Organization. It is duly incorporated, validly existing, and in good standing under the laws of the jurisdiction of its incorporation, and has all requisite corporate power and authority, to execute, deliver, and perform this Agreement. |
10.1.2 Authorization. The execution and delivery of this Agreement and the performance by it of the transactions contemplated hereby have been duly authorized by all necessary corporate action, and do not violate (a) such Party's charter documents, bylaws, or other organizational documents, (b) in any material respect,... |
10.1.3 Binding Agreement. This Agreement is a legal, valid, and binding obligation of such Party enforceable against it in accordance with its terms and conditions, subject to the effects of bankruptcy, insolvency, or other laws of general application affecting the enforcement of creditor rights, judicial principles af... |
10.1.4 No Inconsistent Obligation. 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. |
10.2 Additional Representations and Warranties of Licensor. Licensor further represents and warrants to AbbVie, as of the Effective Date, that except as set forth in the corresponding numbered section of the disclosure schedule attached hereto as Schedule 10.2 (the "Disclosure Schedule"), as follows: |
10.2.1 All Licensor Patents existing as of the Effective Date are listed on the Disclosure Schedule (the "Existing Patents"). All Existing Patents that are Owned Patents and, to Licensor's Knowledge, all Existing Patents that are In-Licensed Patents, are subsisting and, to Licensor's Knowledge, all Existing Patents are... |
10.2.2 There are no judgments, or settlements against, or amounts with respect thereto, owed by Licensor or any of its Affiliates relating to the Existing Patents, or the Licensor Know-How. No claim or litigation has been brought or threatened in writing or any other form by any Person alleging, and Licensor has no Kno... |
10.2.3 Licensor is (a) the sole and exclusive owner of the entire right, title and interest in the Existing Patents listed on the Disclosure Schedule (the "Owned Patents") and the Licensor Know-How (other than know-how that is not owned by Licensor but that is Controlled by Licensor through any agreement from any Third... |
10.2.4 To Licensor's Knowledge, Licensor has the right to use and license to AbbVie all Information and Patents or which it is aware and that are necessary to Develop, Manufacture and Commercialize the Humanized 5H10 Antibody as contemplated herein. The Licensor Patents and Licensor Know-How are not subject to any lice... |
10.2.5 As of the Effective Date, none of Licensor or its Affiliates and, to Licensor's Knowledge, any Third Party is in breach of any Licensor In-License Agreement that would permit the termination of or withholding of rights under any such agreement. |
10.2.6 Prior to the Effective Date, neither Licensor nor any of its Affiliates has previously entered into any agreement, whether written or oral, with respect to the assignment, transfer, license, conveyance or encumbrance of, or otherwise assigned, transferred, licensed, conveyed or encumbered its right, title, or in... |
10.2.7 True, complete, and correct copies of: (a) the file wrapper and other documents and materials relating to the prosecution, defense, maintenance, validity, and enforceability of the Existing Patents, the In-Licensed Patents and Licensor In-License Agreements; and (b) all material adverse information with respect ... |
10.2.8 To Licensor's Knowledge, in respect of the pending patent applications included in the Existing Patents, Licensor and its Affiliates have presented all relevant references, documents, or information of which it and the inventors are aware to the relevant patent examiner at the relevant patent office. |
10.2.9 The Existing Patents represent all Patents within Licensor's or its Affiliates' Control relating to the Licensed Antibodies or the Licensed Products, or the Exploitation thereof, as of the Effective Date. There is no Information Controlled by Licensor or any of its Affiliates as of the Effective Date that relate... |
10.2.10 To Licensor's Knowledge, each of the Existing Patents 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 is issued or such application is pending. |
10.2.11 Each Person who has or has had any rights in or to any Owned Patents or any Licensor Know-How that is owned by or purported to be owned by Licensor, including any current or former officer, employee, agent or consultant of Licensor or any of its Affiliates, has assigned and has executed an agreement assigning i... |
10.2.12 All rights in all inventions and discoveries, made, developed, or conceived by any employee or independent contractor of Licensor or any of its Affiliates during the course of their employment (or other retention) by Licensor or such Affiliate, and included in Licensor Know-How or that are the subject of one (1... |
10.2.13 Licensor has obtained the right (including under any Patents and other intellectual property rights) to use all Information and all other materials (including any formulations and manufacturing processes and procedures) developed or delivered by any Third Party (including, for clarity, any Third Party subcontra... |
10.2.14 Licensor has taken reasonable steps consistent with those of a Capable Biotech Company to prevent the unauthorized use or disclosure of the Licensor Know-How, including by disclosing such Licensor Know-How in a manner intended to ensure that such Licensor Know-How has been kept confidential and that such Licens... |
10.2.15 Licensor has made available to AbbVie all Regulatory Documentation (if any) existing as of the Effective Date, and all such Regulatory Documentation (if any) is, to Licensor's Knowledge, true, complete, and correct in all material respects. Neither Licensor nor any of its Affiliates has any Knowledge of any sci... |
10.2.16 Neither Licensor nor any of its Affiliates, nor any of its or their respective officers, employees, or agents has made an untrue statement of material fact or fraudulent statement to the FDA or any other Regulatory Authority with respect to the Development of the Licensed Antibodies or the Licensed Products, fa... |
10.2.17 Licensor and its Affiliates have conducted, and to Licensor's Knowledge their respective contractors and consultants have conducted, all Development of the Licensed Antibodies or the Licensed Products that they have conducted prior to the Effective Date in accordance with Applicable Law. Licensor has obligated ... |
10.2.18 Other than as provided for in the agreements listed in clauses (a) through (c) of Section 1.87, there are no amounts that will be required to be paid to a Third Party as a result of the Exploitation of the Licensed Antibodies or Licensed Products that arise out of any agreement to which Licensor or any of its A... |
10.2.19 Neither Licensor nor any of its employees nor, to Licensor's Knowledge, agents performing hereunder, have ever been, are currently, or are the subject of a proceeding that could lead to it or such employees or agents becoming, as applicable, a Debarred Entity or Debarred Individual, an Excluded Entity or Exclud... |
(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 Drug Approval 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. |
(v) "FDA's Disqualified/Restricted List" is the list of clinical investigators restricted from receiving investigational drugs, biologics, or devices if the FDA has determined that the investigators have repeatedly or deliberately failed to comply with regulatory requirements for studies or have submitted false Informa... |
10.2.20 Licensor and its Affiliates (a) have complied and shall comply with all Applicable Law governing bribery, money laundering, and other corrupt practices and behavior (including, as applicable, the U.S. Foreign Corrupt Practices Act and UK Bribery Act) and (b) shall not, directly or indirectly, offer, give, pay, ... |
10.2.21 Licensor and its Affiliates have and undertake that they shall continue to update and maintain during the Term an internal compliance program under which Licensor (or its Affiliates') employees are required to comply with all Applicable Law. |
10.2.22 Other than with respect to the University Patent Rights, the inventions claimed or covered by the Existing Patents (a) were not conceived, reduced to practice, discovered, developed, or otherwise made in connection with any research activities funded, in whole or in part, by the federal government of the United... |
10.2.23 A true, complete, and correct copy of (a) the UOFM License Agreement and (b) the Abzena Agreement, in each case of (a) and (b), as amended, have been provided or made available to AbbVie prior to the Effective Date. |
10.2.24 The representations and warranties of Licensor in this Agreement, and the Information, documents and materials furnished to AbbVie in response to AbbVie's written requests for due diligence information prior to the Effective Date, do not, taken as a whole, and to Licensor's Knowledge (a) contain any untrue stat... |
10.2.25 Licensor is the beneficial owner of the payments provided hereunder and is a resident of the United States by virtue of the Applicable Law of the United States, is classified as a limited liability company taxable as a partnership for United States tax purposes, and does not have a fixed base, office or permane... |
10.3 Covenants of Licensor. Licensor covenants to AbbVie as follows: |
10.3.1 During the Term, neither Licensor nor any of its Affiliates shall encumber or diminish the rights granted to AbbVie hereunder with respect to the Licensor Patents, including by not (a) knowingly committing any acts or permitting the occurrence of any omissions that would cause the breach or termination or loss o... |
10.3.2 Licensor and its Affiliates will employ Persons with appropriate education, knowledge and experience to conduct and to oversee the Initial Development Activities. |
10.3.3 Licensor will obtain from each of its Affiliates, sublicensees, subcontractors, employees and agents who are participating in the Exploitation of the Licensed Antibodies or Licensed Products or who otherwise have access to any AbbVie Information or other Confidential Information of AbbVie under this Agreement, r... |
10.3.4 With respect to supplies of Licensed Antibodies, Licensed Products or placebos Manufactured and supplied by or on behalf of Licensor pursuant to Section 3.4, and subject to that certain side letter agreement between the Parties dated on or about the Effective Date, Licensor agrees to ensure that, and shall oblig... |
10.3.5 Licensor and its Affiliates will regularly train their respective employees and agents on the requirements of Licensor's compliance program and compliance with applicable anti-bribery and anti-corruption laws. Licensor will use all reasonable efforts to ensure that any Third Party's employees and agents providin... |
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... |
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... |
11.3 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... |
11.4 Control of Defense. |
11.4.1 In General. Subject to the provisions of Sections 7.4 (if applicable), 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 No... |
11.4.2 Right to Participate in Defense. Without limiting Section 11.4.1, 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 ... |
11.4.3 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, and as to which the indemnifying Party shall have acknowledged in writing the obligati... |
11.4.4 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... |
11.4.5 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 ... |
11.5 Special, Indirect, and Other Losses. EXCEPT (A) FOR WILLFUL MISCONDUCT OR GROSS NEGLIGENCE, (B) FOR A PARTY'S BREACH OF ITS OBLIGATIONS UNDER ARTICLE 9 OR SECTION 5.7, (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... |
11.6 Insurance. Each Party 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 each Party's own participation under this Agreement,... |
11.6.1 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 One Million Dollars ($1,000,000) 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 Four Million Dollars ($4,000,000) in the aggregate. General Liability Insurance shall include, at a minimum, Professional Liability and Clinical Trial Insurance. The limits may be met with a combination of primar... |
(d) Prior to any distribution or Commercialization of any Licensed Product hereunder, AbbVie will, at its own expense, procure product liability insurance when applicable that is consistent with normal business practices of prudent companies similarly situated to AbbVie. |
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