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9.3.1. in the reasonable opinion of the receiving Party's legal counsel, required to be disclosed pursuant to Applicable Law (including by reason of filing with securities regulators, but subject to Section 9.5 (Public Announcements)); provided that the receiving Party shall first have given prompt written notice (and ... |
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 Confid... |
9.3.3. made by or on behalf of the receiving Party to a patent authority as may be reasonably necessary or 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 su... |
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 ca... |
9.3.5. 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 Lic... |
9.3.6. made by HotSpot or its Affiliates to its or their advisors, consultants, clinicians, vendors, service providers, contractors, and the like to the extent necessary in assisting with HotSpot's activities contemplated by this Agreement; provided that such Persons shall be subject to obligations of confidentiality a... |
9.3.7. made by HotSpot or its Affiliates to potential or actual investors, financing sources, or potential or actual assignees of HotSpot's or its Affiliates' right to receive any royalty or other payment under this Agreement, or HotSpot's or its Affiliates' obligation to make any payment under the cost-sharing provisi... |
(a) all such Persons to which disclosures are made pursuant to this Section 9.3.7 (Permitted Disclosures) shall be subject to obligations of confidentiality and non-use with respect to such Confidential Information of AbbVie substantially similar to the obligations of confidentiality and non-use of HotSpot pursuant to ... |
(b) the disclosure is limited solely to disclosure of this Agreement as redacted for information not relevant to such potential or actual investor, financing source, or assignee, including redactions with respect to the contents of the Development Plan and Budget; and |
9.3.8. made by HotSpot or its Affiliates to potential or actual collaboration partners for a Collaboration Target agonist collaboration; provided that the disclosure is limited solely to disclosure HotSpot Program Data that relates specifically to the Collaboration Target, but not the Compounds or the Products, and fur... |
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 witho... |
9.5. Public Announcements. Except as otherwise contemplated by this Section 9.5 (Public Announcements) and Section 9.6 (Publications), 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... |
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 Development Plan Activities hereunder. Accordingly, HotSpot shall not publish, present, or otherwise disclose, and shall cause its Affiliates and ... |
9.7. Return of Confidential Information. Upon the effective date of the termination (but not, for clarity, expiration) 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 res... |
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. HotSpot and AbbVie each represents and warrants to the other, as of the Effective Date, as follows: |
10.1.1. Organization. It is a corporation 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 a... |
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 HotSpot. HotSpot further represents and warrants to AbbVie, as of (a) the Effective Date, except as disclosed on Schedule 10.2 (Disclosures to Additional Representations and Warranties of HotSpot), and (b) the date on which HotSpot delivers to AbbVie each final and com... |
10.2.1. To HotSpot's Knowledge: all HotSpot Patents are subsisting and are not invalid or unenforceable, in whole or in part; are being diligently prosecuted in the respective patent offices in the Territory in accordance with Applicable Law; and all applicable fees have been paid on or before the due date for payment.... |
10.2.2. There are no claims, judgments, or settlements against, or amounts with respect thereto, owed by HotSpot (including any of its predecessors in interest) or any of its Affiliates relating to the HotSpot Patents or the HotSpot Know-How. HotSpot (including any of its predecessors in interest) has not received any ... |
10.2.3. To HotSpot's Knowledge, the conduct of the Development Plan Activities and AbbVie's Exploitation of Compounds and Products as contemplated herein will not violate, infringe, or otherwise conflict or interfere with any Patent right of any Person. The conduct of the Development Plan Activities and AbbVie's Exploi... |
10.2.4. The (a) conception, development, and reduction to practice of the HotSpot Patents and HotSpot Know-How, (b) Exploitation of HotSpot Existing Compounds and Research Compounds, and (c) the development of the HotSpot Platform Technology, the HotSpot Existing Compounds, Research Compounds, the Powder Libraries, Ser... |
10.2.5. Except as disclosed on Schedule 1.92 (Existing HotSpot Patents), HotSpot is (a) the sole and exclusive owner of the entire right, title and interest in the Existing HotSpot Patents listed on Schedule 1.92, Part A (Existing HotSpot Patents) (the "Owned Patents") and the HotSpot Know-How, and (b) the sole and exc... |
10.2.6. HotSpot has the right to use all Information and Patents necessary to conduct all Development Plan Activities for which it is responsible to perform. |
10.2.7. As of the Effective Date, HotSpot is not a party to any In-License Agreement. Neither HotSpot (including any predecessor in interest), its Affiliates nor, to HotSpot's Knowledge, any Third Party, is in breach of any In-License Agreement and any In-License Agreement executed after the Effective Date (if any) is ... |
10.2.8. Neither HotSpot (including any predecessor in interest) nor any of its Affiliates has 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... |
10.2.9. The Existing HotSpot Patents represent all Patents within HotSpot's or its Affiliates' Control that are necessary or reasonably useful to Exploit the Compounds and the Products. To HotSpot's Knowledge, there is no Information Controlled by HotSpot or any of its Affiliates that is necessary or reasonably useful ... |
10.2.10. Except as set forth on Schedule 10.2, each Person who has or has had any rights in or to any (i) Owned Patents, (ii) HotSpot Know-How, (iii) Collaboration DELs, (iv) any proprietary (i.e., non-commercially available) compound or other invention made by employees of HotSpot (including any predecessor in interes... |
10.2.11. HotSpot has the right (including under any Patents and other intellectual property rights) to use all Information, HotSpot Program Data, and all other materials (including any formulations and Manufacturing Processes and procedures) developed or delivered by any Third Party under any agreements between HotSpot... |
10.2.12. HotSpot (including any predecessor in interest) has used Commercially Reasonable Efforts to keep HotSpot Know-How confidential and to disclose the same to Third Parties only under terms of confidentiality consistent with industry practice. HotSpot has not disclosed any HotSpot Know-How to a Third Party absent ... |
10.2.13. The inventions claimed or covered by the HotSpot Patents or that are within the HotSpot Know-How (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 States or any ag... |
10.2.14. To the extent not publicly available, HotSpot has made available to AbbVie 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 HotSpot Patents; (b) all In-License Agreements; and (c)... |
10.2.15. Neither HotSpot nor any of its Affiliates, nor any of its or their respective officers, employees, or agents has (a) made an untrue statement of material fact or fraudulent statement to the FDA or any other Regulatory Authority with respect to the Exploitation of the Compounds or the Products, (b) failed to di... |
10.2.16. None of the Scheduled Deliverables, nor any technology or trade secrets of a Third Party generated under or provided in connection with the Scheduled Third Party Agreement, have been or will be used to generate or otherwise Exploit Compounds or Products, or to generate, create, or develop any HotSpot Patents, ... |
10.2.17. The Processing of Personal Data by HotSpot (including any transfer of Personal Data across national borders) in connection with the Compounds and Products is and has been in compliance with (a) Data Security and Privacy Laws in all countries and jurisdictions in the Territory, (b) all privacy related consents ... |
10.2.18. In the last five (5) years, HotSpot (including any predecessor in interest) has not received written notice of any alleged material violation from a Regulatory Authority or other Third Party of any Privacy and Data Security Obligations by HotSpot (including any predecessor in interest) and has no Knowledge of ... |
10.2.19. 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 the Privacy and Data Security Obligations. HotSpot has the full right and authority to provide to AbbVie the Per... |
10.2.20. HotSpot (including any predecessor in interest) has developed (a) the HotSpot Platform Technology, (b) the HotSpot Existing Compounds, (c) the Powder Libraries, (d) Series 1, Series 2/3, Series 4, (e) the Collaboration DELs (excluding Project DELs), and (f) HotSpot's deconvolution software independent of, and ... |
10.2.21. None of the HotSpot Existing Compounds are or have ever been included in any of the Project DELs. |
10.2.22. The following compound series were conceived on or about the following dates (a) Series 1 on or about March 13, 2021, (b) Series 2/3 on or about August 5, 2020, and (c) Series 4 on or about March 16, 2022. |
10.2.23. None of the Project DELs have been used, accessed, or screened by or on behalf of HotSpot (including any predecessor in interest) for targets in the Scheduled Third Party Exclusive Field. |
10.2.24. HotSpot (including any predecessor in interest)'s use, access, or screening of Project DELs for compounds (including degraders) Directed To the Collaboration Target has not and will not violate the covenant to refrain from screening in the Scheduled Third Party Exclusive Field pursuant to Section 3.4 of the Sc... |
10.2.25. HotSpot has developed, created, or conceived (a) Series 1 solely by screening DELs that are not Project DELs, and (b) Series 2/3 and Series 4 solely by screening the Powder Libraries. |
10.2.26. HotSpot's deconvolution software has been developed by HotSpot (including any predecessor in interest) and has not been developed by or on behalf of a Third Party. Neither the Scheduled Third Party nor any of its employees are or would be deemed an inventor or owner of (a) the Collaboration DELs, (b) any inven... |
10.2.27. HotSpot has provided to AbbVie true and complete copies of all material documentation and records with respect to the development, creation, conception, and reduction to practice of Series 1, Series 2/3, and Series 4, and any compound libraries related thereto. |
10.3. Additional Covenants of HotSpot. HotSpot agrees that, during the Term, HotSpot shall, and shall cause its Affiliates and any Third Party performing the Development Plan Activities on its behalf, to: |
10.3.1. not grant any license relating to the HotSpot Know-How or HotSpot Patents that would conflict with the rights or licenses granted or to be granted to AbbVie hereunder; |
10.3.2. (a) not encumber or diminish the rights granted to AbbVie hereunder with respect to the HotSpot Know-How and HotSpot Patents, including by not committing any acts or permitting the occurrence of any omissions that would cause the termination of any In-License Agreement, (b) dispose of any HotSpot Know-How and H... |
10.3.3. promptly provide AbbVie with notice of any written allegation that HotSpot has materially breached any In-License Agreement; |
10.3.4. make available to AbbVie true, complete, and correct copies of any Regulatory Documentation, In-License Agreements, HotSpot Know-How, and HotSpot Program Data regarding or related to the Compounds or the Products, or Exploitation thereof; |
10.3.5. not (a) misappropriate any valid and enforceable intellectual property rights of a Third Party in connection with any Development Plan Activities, or (b) enter into any agreement, whether written or oral, with respect to, or otherwise assign, transfer, license, convey or otherwise encumber any intellectual prop... |
10.3.6. obtain from each of its Affiliates, sublicensees, employees and agents who are participating in the Exploitation of the Compounds or Products or who otherwise have access to any AbbVie Know-How or other Confidential Information of AbbVie, rights to any and all Information that is necessary or reasonably useful ... |
10.3.7. conduct, and cause their respective contractors and consultants to conduct, all Development of any Compounds or Products in accordance with, as applicable, GLP, GCP, Applicable Law, and the Development Plan and Budget; |
10.3.8. employ Persons with appropriate education, knowledge, and experience to conduct and to oversee the conduct of those Development Plan Activities for which such Persons are responsible; |
10.3.9. continue to update and maintain during the Research Term an internal compliance program under which HotSpot (or its Affiliates') employees are required to comply with all Applicable Law, including applicable local and international anti-bribery and anti-corruption laws and regulations; |
10.3.10. in the event the consummation of the Agreement and the transactions contemplated herein require HotSpot to transfer Personal Data across national borders, ensure the lawful export of Personal Data, the terms of which may be outlined in a separate agreement between AbbVie and HotSpot; and |
10.3.11. incur or permit to exist, with respect to any HotSpot Patents, Joint Patents, or HotSpot Know-How, any lien, encumbrance, charge, security interest, mortgage, liability, or other restriction (including in connection with any indebtedness) that would conflict with or have an adverse impact on any of the rights ... |
10.3.12. none of the HotSpot personnel that will perform any of the Development Plan Activities will use or access the Scheduled Deliverables or related deconvolution software provided to HotSpot by the Scheduled Third Party in the course of performing such Development Plan Activities; |
10.3.13. HotSpot shall ensure it has sufficient funds to complete all Development Plan Activities successfully and in accordance with the timelines set forth in the Development Plan and Budget (e.g., by maintaining appropriate internal budgets); |
10.3.14. all individuals engaged by or on behalf of HotSpot to perform activities under the Scheduled Third Party Agreement or who otherwise used, accessed, or had access to any technology or Third Party's trade secrets generated under or provided in connection with the Scheduled Third Party Agreement, or otherwise pro... |
10.3.15. during the time period between the date on which AbbVie delivers the License Option Exercise Notice and the License Option Exercise Date, HotSpot shall promptly inform AbbVie in writing if HotSpot or any of its Affiliates becomes aware that any of the representations and warranties made by HotSpot pursuant to ... |
10.4. Debarment and Exclusion. Neither HotSpot (including any predecessor in interest) nor its Affiliates have ever been, are not currently, nor are they the subject of a proceeding that could lead to it or its Affiliates becoming, a Debarred Entity, Excluded Entity or Convicted Entity, and it and its Affiliates will n... |
10.4.1. 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. |
10.4.2. 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 such corporation, partnership, or association. |
10.4.3. 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 o... |
10.4.4. 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. |
10.4.5. "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 Inf... |
10.5. Anti-Bribery and Anti-Corruption Compliance. HotSpot (including any predecessor in interest) 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... |
10.6. Bring Down Limitations. The disclosures set forth in any Disclosure Letter will be limited to (a) updating Schedule 10.2 (Additional Representations and Warranties of HotSpot), and (b) any matter (i) existing as of the Effective Date, which, if known at the Effective Date, would have been required to be set forth... |
10.7. 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, O... |
ARTICLE 11 INDEMNITY |
11.1. Indemnification of HotSpot. AbbVie shall indemnify HotSpot, its Affiliates and its and their respective directors, officers, employees, and agents (the "HotSpot Indemnitees"), and defend and save each of them harmless, from and against any and all losses, damages, liabilities, penalties, costs, and expenses (incl... |
11.1.1. the breach by AbbVie or its Affiliates of this Agreement; |
11.1.2. the negligence 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; |
11.1.3. subject to Section 11.4 (Certain Losses), the conduct of any Development Plan Activities performed by or on behalf of AbbVie; or |
11.1.4. subject to Section 11.4 (Certain Losses), the Exploitation of any Licensed Compound or Licensed Product in the Territory by or on behalf of AbbVie following the License Option Effective Date; |
except, in the case of Sections 11.1.1 through 11.1.4 (Indemnification of HotSpot), for those Losses for which HotSpot, 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 r... |
11.2. Indemnification of AbbVie. HotSpot 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... |
11.2.1. the breach by HotSpot or its Affiliates of this Agreement; |
11.2.2. the negligence or willful misconduct on the part of HotSpot or its Affiliates or its or their respective directors, officers, employees, and agents in performing its obligations under this Agreement; |
11.2.3. the use of HotSpot's Corporate Name in connection with the Commercialization of any Licensed Compound or Licensed Products in the Territory as permitted under this Agreement; |
11.2.4. subject to Section 11.4 (Certain Losses), the conduct of any Development Plan Activities or other Exploitation of any Compound or Product in the Territory by or on behalf of HotSpot (i) prior to the Effective Date, (ii) during the Term, prior to the License Option Effective Date, or (iii) on or after the Licens... |
11.2.5. the Exploitation of any Licensed Compound or Licensed Products in the Terminated Territory by or on behalf of HotSpot, as the case may be; |
except, in the case of Sections 11.2.1 through 11.2.5 (Indemnification of AbbVie) above for those Losses for which AbbVie, in whole or in part, has an obligation to indemnify HotSpot pursuant to Section 11.1 (Indemnification of HotSpot) hereof, as to which Losses each Party shall indemnify the other to the extent of th... |
11.3. Special Indemnity. Without limiting HotSpot's obligations under Section 11.2 (Indemnification of AbbVie), HotSpot shall indemnify the AbbVie Indemnitees, and defend and save each of them harmless, from and against any and all Losses, incurred by or rendered against the AbbVie Indemnitees, arising from or occurrin... |
11.4. Certain Losses. |
11.4.1. Notwithstanding the foregoing Section 11.2 (Indemnification of AbbVie), if HotSpot has exercised the Cost-Sharing Option, any Losses, other than those Losses in Article 8 (Intellectual Property) or for which indemnification is provided in Section 11.1 (Indemnification of HotSpot), Section 11.2 (Indemnification ... |
11.4.2. AbbVie may treat any Losses arising from a Third-Party Infringement Claim for which it indemnifies HotSpot pursuant to Section 11.1 (Indemnification of HotSpot) as amounts paid by AbbVie to a Third Party in consideration for a license of Third Party Patents that are necessary or reasonably useful to Exploit any... |
11.5. Notice of Claims. 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 "Inde... |
11.6. Control of Defense of Third-Party Claims. |
11.6.1. In General. Subject to the provisions of Section 8.5 (Infringement Claims by Third Parties), Section 8.6 (Invalidity or Unenforceability Defenses or Actions) and Section 8.7 (Product Trademarks), at its option, the indemnifying Party may assume the defense of any Third-Party Claim by giving written notice to th... |
11.6.2. Right to Participate in Defense. Without limiting Section 11.6.1 (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... |
11.6.3. 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 obligat... |
11.6.4. 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 ... |
11.6.5. Expenses. Unless as otherwise provided in this Article 11 (Indemnity), 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 indem... |
11.7. 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 6.9 (EXCLUSIVITY), (C) LOSSES SUBJECT TO AN INDEMNIFICATION CLAIM UNDER SECTION 11.3 (SPECIAL INDEMNITY), (D) AS PROVIDED UNDER SECTIO... |
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