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8.3 Security Breach Notification. Licensor shall notify AbbVie immediately upon learning of any actual or suspected misappropriation or unauthorized access to, or disclosure or use of Personal Data collected, Processed, hosted or transmitted in performance by Licensor of this Agreement, including the conduct of the Dev... |
ARTICLE 9 CONFIDENTIALITY AND NON-DISCLOSURE |
9.1 Product Information. Licensor recognizes that by reason of, inter alia, AbbVie's status as an exclusive optionee and licensee pursuant to the grants under Section 4.1 (AbbVie Option) and Section 4.4.1 (License Grants to AbbVie), AbbVie has an interest in Licensor's maintaining the confidentiality of certain informa... |
9.2 Confidentiality Obligations. At all times during the Term and for a period of ten (10) years following termination or expiration hereof 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 Party and no... |
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; |
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 that 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. |
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 such Confidential Information is embraced by more general information in the public domain or in the possession of the receiving Party. Further, any combi... |
9.3 Permitted Disclosures. Subject to Section 9.1 (Product Information), a receiving Party may disclose the disclosing Party's 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 and local governmental body of competent jurisdiction, (including by ... |
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 any Regulatory Approval in accordance with the terms of this Agreement; provided, that reasonable measures shall be taken to assure confidential treatment of such Confide... |
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 such... |
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 that is 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 Co... |
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 Licen... |
9.3.7 made by Licensor or its Affiliates, after receiving advance approval from AbbVie, to its or their advisors, consultants, clinicians, vendors, service providers, contractors and the like to the extent necessary in assisting with Licensor's activities contemplated by this Agreement; provided that such Persons shall... |
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 any abbreviation or adaptation thereof) in any publication, press release, marketing and promotional material, or other form of publicity, withou... |
9.5 Public Announcements. The Parties have agreed upon the content of a joint press release which shall be issued substantially in the form attached hereto as Schedule 9.5 (Press Release), the release of which the Parties shall coordinate in order to accomplish such release promptly upon execution of this Agreement. Ne... |
9.6 Publications. Each Party recognizes that the publication of papers regarding results of, and other information regarding, activities under this Agreement, including oral presentations and abstracts, may be beneficial to both Parties; provided such publications are subject to reasonable controls to protect Confident... |
9.7 Return of Confidential Information. Upon the effective date of the termination of this Agreement for any reason, a 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 countries, other ... |
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 (Confidentiality Obligations). |
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, and covenants, as follows: |
10.1.1 Organization. It is a duly organized, validly existing and in good standing under the laws of the jurisdiction of its organization, and has all requisite power and authority, corporate or otherwise, 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 affe... |
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, Warranties and Covenants of Licensor. Licensor further represents, warrants and covenants, as applicable, to AbbVie, as of (a) the Effective Date and (b) the Option Effective Date, except as set forth in the corresponding section of Schedule 10.2 (Licensor Disclosure Schedule) or of the... |
10.2.1 All Licensor Product Patents existing as of the Effective Date are listed on Schedule 10.2.1 (Existing Licensor Product Patents), which schedule shall be updated and delivered by Licensor to AbbVie in accordance with Section 4.2 (Option Exercise) to include all Licensor Product Patents existing as of the deliver... |
10.2.2 There are no claims, judgments or settlements against, or amounts with respect thereto, owed by Licensor or any of its Affiliates relating to (a) (i) as of the Effective Date, the Existing Regulatory Documentation, and (ii) as of the Option Effective Date, the Existing Regulatory Documentation or any Regulatory ... |
10.2.3 Licensor is the sole and exclusive owner of the entire right, title and interest in the Existing Patents and the Licensor Know-How free of any encumbrance, lien or claim of ownership by any Third Party. Licensor is entitled to grant the licenses specified herein. The grant of any license by Licensor specified he... |
10.2.4 Licensor has the right to use all Information and Patents necessary to Develop and Manufacture the Licensed Compound and the Licensed Products as contemplated under the Initial Development Plan and the aGVHD Clinical Study, and such Development and Manufacture are not subject to any other license or agreement to... |
10.2.5 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, Licensor Know-How and Regulatory Documentation. |
10.2.6 To Licensor's knowledge, true, complete and correct copies of: (a) the file wrapper, inventor assignment documents and other documents and materials relating to the prosecution, defense, maintenance, validity and enforceability of the Existing Patents; (b) (i) as of the Effective Date, all Existing Regulatory Do... |
10.2.7 Licensor and its Affiliates have generated, prepared, maintained and retained all Regulatory Documentation that is required to be maintained or retained pursuant to and in accordance with good laboratory and clinical practice and Applicable Law, and all such information is true, complete and correct and what it ... |
10.2.8 The Existing Patents represent all Patents that are owned or Controlled by Licensor or its Affiliates and cover or claim ALPN-101 or the Exploitation thereof. |
10.2.9 Each Person who has or has had any rights in or to any Existing Patents or any Licensor Know-How, has assigned and has executed an agreement assigning its entire right, title and interest in and to such Existing Patents and Licensor Know-How to Licensor. To Licensor's knowledge, no current officer, employee, age... |
10.2.10 To Licensor's knowledge, all works of authorship and all other materials subject to copyright protection included in Licensor Know-How are original and were either created by employees of Licensor or its Affiliates within the scope of their employment or are otherwise works made for hire, or all right, title an... |
10.2.11 The Licensor Know-How has been kept confidential by Licensor and its Affiliates or has been disclosed to Third Parties by Licensor and its Affiliates only under terms of confidentiality. To the knowledge of Licensor and its Affiliates, no breach of such confidentiality has been committed by any Third Party. |
10.2.12 Licensor has made (and shall make) available to AbbVie all Regulatory Documentation, Licensor Know-How and other Information in its possession or Control regarding or related to the Licensed Compound or the Licensed Products and all such Regulatory Documentation, Licensor Know-How and other Information are (and... |
10.2.13 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 Compound or the Licensed Products, fail... |
10.2.14 Licensor and its Affiliates have conducted, and their respective contractors and consultants have conducted, all Development of the Licensed Compound and the Licensed Products that they have conducted prior to the Effective Date in accordance with Applicable Law. Licensor has conducted, and has caused its contr... |
10.2.15 There are no amounts that shall be required to be paid to a Third Party in consideration for any rights as a result of the Development or Commercialization of Licensed Compound or the Licensed Products that arise out of any agreement to which Licensor or any of its Affiliates is a party. |
10.2.16 Licensor represents and warrants that it has not ever been, is not currently, nor is it the subject of a proceeding that could lead to it becoming a Debarred Entity, Excluded Entity or Convicted Entity and it shall not use in any capacity, in connection with the obligations to be performed under this Agreement,... |
(a) 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. |
(b) 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. |
(c) An "Excluded Individual" or "Excluded Entity" is (i) 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 He... |
(d) 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. |
10.2.17 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, p... |
10.2.18 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, including applicable local and international anti-bribery and anti-cor... |
10.2.19 If AbbVie so requests, Licensor covenants and agrees that Third Party employees and agents providing services on behalf of Licensor pursuant to this Agreement shall attend training provided by AbbVie on applicable anti-bribery and anti-corruption laws and the requirements of this Agreement. |
10.2.20 Licensor shall have obtained from each of its Affiliates, sublicensees, employees and agents, and from the employees and agents of its Affiliates, sublicensees and agents, who are participating in the Exploitation of the Licensed Compound or Licensed Products or who otherwise have access to any Confidential Inf... |
10.2.21 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 te... |
10.2.22 To Licensor's knowledge, the Processing of Personal Data by Licensor (including, without limitation, any transfer of Personal Data across national borders) in connection with the Licensed Compound and Licensed Products is and has been in compliance with Data Security and Privacy Laws in all countries and jurisd... |
10.2.23 In the last five (5) years, Licensor has not received written notice of any alleged material violation from a Regulatory Authority or other Third Party of any Privacy and Security Obligations and has no knowledge of facts that would give rise to such a violation. Licensor is not under investigation by any Regul... |
10.2.24 The execution, delivery and performance of this Agreement and the other agreements and instruments contemplated hereby, and the consummation of the transactions contemplated hereunder, comply with the Privacy and Security Obligations. Licensor has the full right and authority to provide to AbbVie the Personal D... |
10.2.25 In the event the consummation of the Agreement and the transactions contemplated herein require Licensor to transfer Personal Data across national borders, Licensor shall ensure the lawful export of Personal Data, the terms of which may be outlined in a separate agreement between AbbVie and Licensor. |
10.3 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 (includ... |
(a) the breach by AbbVie or its Affiliates of this Agreement; |
(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; |
(c) the Development, Manufacture or other Exploitation of the Licensed Compound or Licensed Products by AbbVie or its Affiliates or Sublicensees anywhere in the world following the Option Effective Date; and |
except, in the case of clauses (a) through (c) above, for those Losses for which Licensor, in whole or in part, has an obligation to indemnify AbbVie pursuant to Section 11.2 (Indemnification of AbbVie) hereof, as to which Losses each Party shall indemnify the other to the extent of their respective liability for such ... |
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 or... |
(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 conduct of the aGVHD Clinical Study at any time or the Development, Manufacture or other Exploitation of the Licensed Compound or Licensed Products by Licensor, Affiliates or its licensee anywhere in the world prior to the Option Effective Date; |
(d) the infringement of the Patent or other intellectual property or other proprietary rights of any Third Party as a result of the Exploitation of the Licensed Compound or Licensed Products by Licensor, its Affiliates or licensees prior to the Option Effective Date; and |
except, in the case of clauses (a) through (d) above, for those Losses for which AbbVie, in whole or in part, has an obligation to indemnify Licensor pursuant to Section 11.1 (Indemnification of Licensor) hereof, as to which Losses each Party shall indemnify the other to the extent of their respective liability for the... |
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 "Indemnif... |
11.4 Control of Defense. |
11.4.1 In General. Subject to the provisions of Sections 7.4 (Infringement Claims by Third Parties), 7.5 (Invalidity or Unenforceability Defenses or Actions) and 7.7 (Product Trademarks), at its option, the indemnifying Party may assume the defense of any Third Party Claim by giving written notice to the Indemnified Pa... |
11.4.2 Right to Participate in Defense. Without limiting Section 11.4.1 (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 ... |
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 or otherwise adversely affecting the business of the Indemnified Party in any manner, a... |
11.4.4 Cooperation. 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 attend such conferences, discovery proceedings, hearings, trials and appeals as may be reasonably req... |
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, (B) FOR A PARTY'S BREACH OF ITS OBLIGATIONS UNDER ARTICLE 9 (CONFIDENTIALITY AND NON-DISCLOSURE) OR SECTION 2.4 (EXCLUSIVITY), (C) AS PROVIDED UNDER SECTION 13.11 (EQUITABLE RELIEF) AND (D) TO THE EXTENT ANY SUCH DAMAGES ARE REQUIRED TO BE PAI... |
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 a 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 Five Million Dollars ($5,000,000) per occurrence and Ten Million Dollars ($10,000,000) in the aggregate. General Liability Insurance shall include, at a minimum, Professional Liability, Clinical Trial Insurance and, beginning at least thirty (30) days prior to Fir... |
Each Party 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. |
11.6.2 Certificates of Insurance. Upon request by a Party, the other Party shall provide Certificates of Insurance evidencing compliance with the above requirements in this Section 11.6 (Insurance). The insurance policies shall be under an occurrence form, but if only a claims-made form is available to a Party, then su... |
11.6.3 Self-Insurance. Notwithstanding the foregoing, AbbVie may self-insure, in whole or in part, the insurance requirements described above. |
ARTICLE 12 TERM AND TERMINATION |
12.1 Term. This Agreement shall commence on the Effective Date and, unless earlier terminated in accordance herewith, shall continue in force and effect until: (a) in the event that the Option is not exercised by AbbVie during the Option Exercise Period, the first day following the end of the Option Exercise Period or ... |
12.2 Termination for Material Breach. |
12.2.1 Material Breach. If a 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 Notice... |
12.2.2 Material Breach Related to Diligence in a Major Market. Notwithstanding Section 12.2 (Material Breach), if a material breach and failure to cure contemplated by Section 12.2 (Material Breach) is with respect to AbbVie's diligence obligations under Section 5.7 (AbbVie Diligence) with respect to any Major Market b... |
12.3 Termination Right by AbbVie For Convenience. AbbVie may terminate this Agreement in its entirety, or on a country-by-country or other jurisdiction-by-other jurisdiction basis, for any or no reason, upon ninety (90) days' prior written notice to Licensor. |
12.4 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... |
12.5 Rights in Bankruptcy. |
12.5.1 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... |
12.5.2 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... |
12.6 Termination for Failure or Delay to Obtain HSR Clearance. This Agreement shall terminate (a) upon notice given by AbbVie to Licensor in the event that either Party receives a second request for additional information under the HSR Act (a "Second Request") and AbbVie delivers such notice of termination within ten (... |
12.7 AbbVie Rights in Lieu of Termination. If, at any time during the Term, AbbVie has the right to terminate this Agreement pursuant to Section 12.2.1 (Material Breach) (subject to Licensor's rights to dispute any such breach claim therein and, if Licensor does exercise such dispute rights, effective only upon a Breac... |
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