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9.1.2 Data Agreements; Data Export. 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. In the event Parvus needs to transfer EEA or UK P... |
9.1.3 Security Breach Notification. Parvus shall notify AbbVie without undue delay 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 Parvus of any Research and Development Plan Ac... |
ARTICLE 10 CONFIDENTIALITY AND NON-DISCLOSURE |
10.1 Product Information Confidentiality Obligations. During the Term, Parvus shall, and shall cause its Affiliates and its and their respective officers, directors, employees, and agents to, keep completely confidential, and not publish or otherwise disclose, and not use directly or indirectly for any purpose other th... |
10.2 General Confidentiality Obligations. At all times during the Term and for a period of ten (10) years (or, with respect to Confidential Information that constitute trade secrets under Applicable Law, for so long as such Confidential Information is reasonably deemed a trade secret under Applicable Law) following ter... |
10.2.1 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; |
10.2.2 has been in the receiving Party's or its Affiliates' lawful possession prior to disclosure by the disclosing Party without any obligation of confidentiality with respect to such information; |
10.2.3 is subsequently received by the receiving Party or its Affiliates from a Third Party without restriction and without breach of any agreement between such Third Party and the disclosing Party; |
10.2.4 that is generally made available to Third Parties by the disclosing Party or its Affiliates without restriction on disclosure; or |
10.2.5 has been independently developed by or for the receiving Party without reference to, or use or disclosure of, the disclosing Party's Confidential Information. |
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... |
10.3 Permitted Disclosures. Each Party may disclose Confidential Information to the extent that such disclosure is: |
10.3.1 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... |
10.3.2 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... |
10.3.3 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 suc... |
10.3.4 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... |
10.3.5 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... |
10.3.6 made by Parvus or its Affiliates to its or their advisors, consultants, clinicians, vendors, service providers, contractors, and the like to the extent necessary in assisting with Parvus' activities contemplated by this Agreement; provided, that (a) such Persons shall be subject to obligations of confidentiality... |
10.4 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... |
10.5 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... |
10.6 Publications. The Parties acknowledge that scientific publications must be strictly monitored to prevent any adverse effect from premature publication of results of the Research and Development Plan Activities and other activities undertaken in connection with the Exploitation of Licensed Compounds, Licensed Produ... |
10.7 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... |
10.8 Survival. All Confidential Information shall continue to be subject to the terms of this Agreement for the period set forth in Section 10.2 (General Confidentiality Obligations). |
ARTICLE 11 REPRESENTATIONS AND WARRANTIES |
11.1 Mutual Representations and Warranties. Parvus and AbbVie each represents and warrants to the other, as of the Effective Date, as follows: |
11.1.1 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. |
11.1.2 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,... |
11.1.3 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... |
11.1.4 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. |
11.2 Additional Representations and Warranties of Parvus. Parvus further represents and warrants to AbbVie, as of (a) the Effective Date, except as disclosed on Schedule 11.2 (Disclosures to Additional Representations and Warranties of Parvus), and (b) the date on which Parvus delivers to AbbVie each final and complete... |
11.2.1 All Parvus Licensed Patents are subsisting and (a) to the Knowledge of Parvus, are not invalid or unenforceable, in whole or in part, (b) are being diligently prosecuted in the respective patent offices in the Territory in accordance with Applicable Law, and (c) have been filed and maintained properly and correc... |
11.2.2 There are no claims, judgments, or settlements against, or amounts with respect thereto, owed by Parvus or any of its Affiliates relating to the Parvus Licensed Patents, or the Parvus Licensed Know-How. No claim or litigation has been brought or threatened in writing by any Person alleging, and Parvus has no Kno... |
11.2.3 To the Knowledge of Parvus, the conduct of the Research and Development Plan Activities and the Exploitation of PVT401 and Licensed Products comprising or containing PVT401 as contemplated herein will not violate, infringe misappropriate or otherwise conflict or interfere with any Patent or other intellectual pr... |
11.2.4 The conception, development, and reduction to practice of the Parvus Licensed Patents and Parvus Licensed Know-How existing as of the Effective Date have not constituted or involved the misappropriation of trade secrets or other rights or property of any Person. For clarity, the foregoing shall not be construed ... |
11.2.5 Parvus is (a) the sole and exclusive owner of the entire right, title and interest in the Parvus Licensed Patents listed on Schedule 1.166, Part A (the "Owned Patents") and the Parvus Licensed Know-How and (b) the sole and exclusive licensee of the Parvus Licensed Patents listed on Schedule 1.166, Part B (the "I... |
11.2.6 Parvus has the right to use all Information and Patents necessary to conduct all Research and Development Plan Activities for which it is responsible to perform. The Parvus Licensed Patents and Parvus Licensed Know-How are not subject to any license or other agreement to which Parvus or any of its Affiliates is ... |
11.2.7 Neither Parvus nor its Affiliates, nor to the Knowledge of Parvus, any Third Party, is in breach of any In-License Agreement and each In-License Agreement is in full force and effect. |
11.2.8 Neither Parvus 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 interest in or to the Parvus Lice... |
11.2.9 The Parvus Licensed Patents represent all Patents within Parvus' or its Affiliates' Control relating to the Licensed Compounds and the Licensed Products, or the Exploitation thereof as contemplated by Parvus as of the Effective Date and the date on which Parvus delivers to AbbVie each final and complete Informat... |
11.2.10 Each Person who has or has had any ownership rights in or to any Parvus Licensed Patents or any Parvus Licensed Know-How, has assigned and has executed an agreement assigning its entire right, title, and interest in and to such Parvus Licensed Patents and Parvus Licensed Know-How to Parvus or its licensor under... |
11.2.11 Parvus or its Affiliates have obtained the right (including under any Patents and other intellectual property rights) to use all Information and all other materials developed or delivered by any Third Party under any agreements between Parvus or its Affiliates and any such Third Party with respect to the Licens... |
11.2.12 The Parvus Licensed Know-How has been kept confidential by Parvus and its Affiliates or has been disclosed by Parvus or its Affiliates to Third Parties only under terms of confidentiality. To the Knowledge of Parvus and its Affiliates, no breach of such confidentiality has been committed by any Third Party. |
11.2.13 The inventions claimed or covered by the Parvus Licensed Patents or that are within the Parvus Licensed 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 S... |
11.2.14 Parvus has made available to AbbVie true, complete, and correct copies of: (a) the file wrapper (other than items publicly available in the United States) and other documents and materials relating to the prosecution, defense, maintenance, validity, and enforceability of the Parvus Licensed Patents; (b) all In-... |
11.2.15 Neither Parvus 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 Exploitation of the Licensed Compounds or the Licensed Products, fail... |
11.2.16 Except pursuant to any In-License Agreement and agreements with vendors and services providers, Parvus will not be required to pay any amount to a Third Party under an agreement with such Third Party as a result of the Exploitation of any Licensed Compound, Licensed Product or Unique Component. |
11.2.17 Parvus and its Affiliates have an internal compliance program under which Parvus (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. |
11.2.18 Parvus and its Affiliates have complied and shall comply with all Applicable Law, including applicable local and international anti-bribery and anti-corruption laws and regulations. |
11.2.19 Parvus' and its Affiliates' respective employees and agents are regularly trained, and will continue to be regularly trained, on the requirements of its compliance program and compliance with applicable anti-bribery and anti-corruption laws. |
11.2.20 The execution, delivery and performance of this Agreement and the other agreements and instruments contemplated hereby, and the consummation of the transactions contemplated hereunder complies with Data Security and Privacy Laws in all countries and jurisdictions in the Territory, all privacy related consents a... |
11.2.21 Parvus is and has been in compliance in all material respects with all Privacy and Security Obligations relating to Data Breach reporting and notification obligations. |
11.2.22 Parvus has not received written notice of any actual or suspected misappropriation or unauthorized access to, or disclosure or use of, the Personal Data collected, Processed, hosted or transmitted by or on behalf of Parvus in connection with the Licensed Compounds or Licensed Products. |
11.2.23 In the last five (5) years, Parvus 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 any such violation and, to its Knowledge, is not under investigation by any Regulatory Authority f... |
11.2.24 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) omit to state any material fact necessary to make the statements or facts contained therein, ... |
11.2.25 Parvus has provided to AbbVie copies of (i) the UTI/MGH License, (ii) the License and Collaboration Agreement, by and between Genentech, Inc. and Parvus, dated May 13, 2019 (the "Genentech License"), (iii) the letter dated March 19, 2021 providing notice of termination of the Genentech License and (iv) the lett... |
11.2.26 No counterparty under either the Genentech License or the Novartis License has any surviving rights or licenses, and Parvus has no surviving obligations to such counterparties under or with respect to Patents or Information owned by Parvus, in each case related to the Parvus Platform Technology, Licensed Compou... |
11.2.27 No intellectual property related to the Parvus Platform Technology, Licensed Compounds or Licensed Products and licensed to AbbVie under this Agreement was generated under either the Genentech License or the Novartis License. |
11.3 Additional Covenants of Parvus. Parvus agrees that, during the Term, Parvus shall, and shall cause its Affiliates and any Third Party performing the Research and Development Plan Activities on its behalf to: |
11.3.1 not grant any license relating to the Parvus Licensed Know-How or Parvus Licensed Patents that will conflict with the rights or licenses granted or to be granted to AbbVie hereunder; |
11.3.2 (a) not encumber or diminish the rights granted to AbbVie hereunder with respect to the Parvus Licensed Know-How and Parvus Licensed Patents, including by not committing any acts or permitting the occurrence of any omissions that will cause the breach or termination of any In-License Agreement, (b) dispose of an... |
11.3.3 promptly provide AbbVie with notice of any alleged, threatened, or actual breach of any In-License Agreement; |
11.3.4 make available to AbbVie in accordance with this Agreement copies of any Regulatory Documentation, In-License Agreements, Parvus Licensed Know-How and other Information in its Control regarding or related to the Licensed Compounds or the Licensed Products, or Exploitation thereof, which copies shall be true, com... |
11.3.5 not (a) knowingly misappropriate any valid and enforceable intellectual property rights of a Third Party in connection with any Research and Development Plan Activities and (b) enter into any agreement, whether written or oral, with respect to, or otherwise assign, transfer, license, convey or otherwise encumber... |
11.3.6 with respect to supplies of Program Materials Manufactured and supplied by or on behalf of Parvus pursuant to this Agreement, ensure that (a) all Program Materials are in conformity with the applicable specifications for such Program Materials; (b) such Program Materials have been |
CONFIDENTIAL 81 |
Manufactured in conformance with GMP (to the extent such conformance is required for the intended use of such Program Materials), all other Applicable Law, this Agreement, and any applicable quality agreement; (c) such Program Materials have been Manufactured in facilities that are in compliance with Applicable Law at ... |
11.3.7 obtain from each of its Affiliates, sublicensees, employees and agents who are participating in the Research and Development Plan Activities of the Licensed Compounds or Licensed Products or who otherwise have access to any AbbVie Know-How or other Confidential Information of AbbVie, rights to any and all Inform... |
11.3.8 conduct, and cause their respective contractors and consultants to conduct, all Development of any Licensed Compounds or Licensed Products in accordance with GLP, GCP, Applicable Law, and the Research and Development Plan; |
11.3.9 employ Persons with appropriate education, knowledge and experience to conduct and to oversee the conduct of the Research and Development Plan Activities with respect to the Licensed Compounds and Licensed Products; |
11.3.10 continue to update and maintain during the Term an internal compliance program under which Parvus (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; |
11.3.11 upon reasonable request by AbbVie, cause Third Party's employees and agents providing services on behalf of Parvus pursuant to this Agreement to attend training provided by AbbVie on applicable anti-bribery and anti-corruption laws and the requirements of this Agreement; |
11.3.12 Parvus shall ensure it has sufficient funds to complete all Research and Development Plan Activities; |
11.3.13 Parvus shall ensure that UTI, MGH and Parvus amend the UTI/MGH License, as follows: (a) within sixty (60) days of the Effective Date, amend (i) Exhibit I (Patent Rights) to include within Patent Rights (as defined thereunder) any and all Parvus Licensed Patents, existing as of the Effective Date, that were conc... |
11.3.14 in the event the consummation of the Agreement and the transactions contemplated herein require Parvus 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 Parvus. |
CONFIDENTIAL 82 |
11.4 Debarment and Exclusion. Neither Parvus 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 not use in any capacity, in connection with t... |
11.4.1 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. |
11.4.2 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. |
11.4.3 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 of... |
11.4.4 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. |
11.4.5 "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 Info... |
11.5 Anti-Bribery and Anti-Corruption Compliance. Parvus and its Affiliates (a) have complied with 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) have not... |
11.6 Bring Down Limitations. Any disclosure set forth in any Disclosure Letter provided after the Effective Date shall be a specific disclosure of any matter arising after the Effective Date which, if existing at the Effective Date, would have been required to be set forth or described in Schedule 11.2 (Disclosures to ... |
11.7 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 SUCH OTHER WARRANTIES, WHETHER WRITTEN OR ORA... |
ARTICLE 12 INDEMNITY |
12.1 Indemnification of Parvus. AbbVie shall indemnify Parvus, its Affiliates and its and their respective directors, officers, employees, and agents (the "Parvus Indemnitees") and defend and save each of them harmless, from and against any and all losses, damages, liabilities, penalties, costs, and expenses (including... |
12.1.1 the breach by AbbVie or its Affiliates of this Agreement; |
12.1.2 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; |
12.1.3 the conduct of any Research and Development Plan Activities or other Exploitation of any Licensed Compound or Licensed Product in the Territory by or on behalf of AbbVie, its Affiliates, or its or their Sublicensees or Distributors; or |
except, in the case of Sections 12.1.1 – 12.1.3 (Indemnification of Parvus), for those Losses for which Parvus, in whole or in part, has an obligation to indemnify AbbVie pursuant to Section 12.2 (Indemnification of AbbVie) hereof, as to which Losses each Party shall indemnify the other to the extent of their respectiv... |
12.2 Indemnification of AbbVie. Parvus 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 o... |
12.2.1 the breach by Parvus or its Affiliates of this Agreement; |
12.2.2 the negligence or willful misconduct on the part of Parvus or its Affiliates or its or their respective directors, officers, employees, and agents in performing its obligations under this Agreement; |
12.2.3 the conduct of any Research and Development Plan Activities or other Exploitation of any Licensed Compound or Licensed Product in the Territory by or on behalf of Parvus (a) prior to the Effective Date, (b) during the Term, prior to the License Option Effective Date, or (c) on or after the License Option Effecti... |
12.2.4 the Exploitation by Parvus or its Affiliates or its or their sublicensees of any Grantback Product in the Terminated Territory; |
except, in the case of Sections 12.2.1 – 12.2.4 (Indemnification of AbbVie) above, for those Losses for which AbbVie, in whole or in part, has an obligation to indemnify Parvus pursuant to Section 12.1 (Indemnification of Parvus) hereof, as to which Losses each Party shall indemnify the other to the extent of their res... |
12.3 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... |
12.4 Control of Defense. |
12.4.1 In General. Subject to the provisions of Sections 8.4 (Infringement Claims by Third Parties), 8.5 (Invalidity or Unenforceability Defenses or Actions) and 8.6 (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... |
12.4.2 Right to Participate in Defense. Without limiting Section 12.4.1 (Control of Defense—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 I... |
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