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10.2.15 Neither OSE 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, failed ... |
10.2.16 OSE and its Affiliates have conducted, and their respective contractors and consultants have conducted, all Development of the Licensed Antibodies prior to the Effective Date in accordance with Applicable Law, and with respect to any regulatory toxicology studies, in accordance with good laboratory practices. O... |
10.2.17 OSE has made available to AbbVie: (a) the file wrapper and other documents and materials relating to the prosecution, defense, maintenance, validity, and enforceability of the Existing Patents and (b) OSE Know-How including all material adverse information with respect to the safety and efficacy of the Licensed... |
10.2.18 There are no Regulatory Documentation relating to the Licensed Antibodies or the Licensed Products as of the Effective Date. To the extent that OSE comes into Control of any Regulatory Documentation relating to the Licensed Antibodies or the Licensed Products after the Effective Date during the Term, OSE will t... |
10.2.19 Neither OSE nor any of its Affiliates has any Knowledge of any scientific or technical facts or circumstances that would adversely affect the scientific, therapeutic, or commercial potential of the Licensed Antibodies or Licensed Products or that could adversely affect the acceptance, or the subsequent approval... |
10.2.20 OSE and its Affiliates have not 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 the obligations to be perform... |
(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 such a corporation, partnership, or association. |
(c) 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 H... |
(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. §132–a - 7(a), but has not yet been excluded, debarred, suspended, or otherwise declared ineligible. |
(e) "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... |
10.2.21 In connection with their Development activities relating to Licensed Antibodies, OSE 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 U... |
10.2.22 OSE and its Affiliates have and undertake that they shall continue to update and maintain during the Term an internal compliance program under which OSE (or its Affiliates') employees are required to comply with all Applicable Law, including applicable local and international anti-bribery and anti-corruption la... |
10.2.23 OSE's and its Affiliates' respective employees 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. |
10.2.24 The inventions claimed or covered by the Existing Patents or that are within OSE Know-How as of the Effective Date are not Federally Funded Inventions. |
10.2.25 OSE covenants that with respect to supplies of Licensed Antibody, Licensed Product, or placebos Manufactured and supplied by or on behalf of OSE pursuant to Section 3.4, (a) all such Licensed Antibody, Licensed Product, and placebo shall be in conformity with the applicable specifications for such Licensed Anti... |
10.2.26 The Processing of Personal Data by OSE (including any transfer of Personal Data across national borders) in connection with the Licensed Antibodies and Licensed Products is and has been in compliance with Data Security and Privacy Laws in all countries and jurisdictions in the Territory, all privacy related con... |
10.2.27 In the last five (5) years, OSE has not received written notice of any alleged material violation from a Regulatory Authority or other Third Party of any Privacy and Security Obligations. OSE is not under investigation by any Regulatory Authority for a violation of Data Security and Privacy Laws. |
10.2.28 Subject to AbbVie complying with Data Security and Privacy Laws, 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 Security Obligations. OSE has th... |
10.2.29 In the event the consummation of the Agreement and the transactions contemplated herein require OSE to transfer Personal Data across national borders, OSE shall ensure the lawful export of Personal Data, subject to AbbVie complying with Data Security and Privacy Laws, the terms of which may be outlined in a sep... |
10.2.30 Bring Down. During the period commencing on the Execution Date and ending at the Effective Date (the "Interim Period"), any updates (an "Updated Disclosure Schedule") to the representations and warranties provided by OSE with respect to any matter relating to Section 10.1 and Section 10.2 shall be limited to ma... |
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... |
10.4 Anti-Bribery and Anti-Corruption Compliance. AbbVie may terminate this Agreement in its entirety immediately on five (5) Business Days' written notice to OSE in the event that AbbVie receives any information that it in good faith determines to be evidence of an actual, alleged, or potential breach by OSE or its Af... |
ARTICLE 11 Indemnity |
11.1 Indemnification of OSE. AbbVie shall indemnify OSE, its Affiliates, and its and their respective directors, officers, employees, and agents (the "OSE Indemnitees") and defend and save each of them harmless, from and against any and all losses, damages, liabilities, penalties, costs, and expenses (including attorne... |
(a) the breach by AbbVie or its Affiliates of any of its representations or warranties set forth in 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; and |
(c) the Exploitation of any Licensed Products or the Licensed Antibodies or use of any Product Trademark in or for the Territory (excluding any Exploitation conducted by, or on behalf of or for, OSE or its Affiliates, including the Transition Activities); |
except, in the case of clauses (a) through (c), for those Losses for which OSE, in whole or in part, has an obligation to indemnify AbbVie pursuant to Section 11.2 hereof, as to which Losses each Party shall indemnify the other to the extent of their respective liability for such Losses. |
11.2 Indemnification of AbbVie. OSE 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 OSE or its Affiliates of any of its representations or warranties set forth in this Agreement; |
(b) the negligence, reckless conduct, or willful misconduct on the part of OSE or its Affiliates or its or their respective directors, officers, employees, and agents in performing its obligations under this Agreement; |
(c) the Exploitation of the Licensed Products or the Licensed Antibodies anywhere in the world (i) prior to the Effective Date, or (ii) the conduct of the Transition Activities, in each case by or on behalf of OSE; and |
(d) the Exploitation of any Reversion Products in the Territory. |
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 OSE pursuant to clause (a) or (b) of Section 11.1 hereof, as to which Losses each Party shall indemnify the other to the extent of their respective liability for the Losses. |
11.3 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 "Indemn... |
11.4 Control of Defense. |
11.4.1 In General. Subject to the provisions of Section 7.4, Section 7.5 and Section 7.7, 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 Not... |
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 (except as provided in Section 7.4, Section 7.5, and Section 7.7), the defense of such Third Party Claim and to employ counsel of its choice for such purpose; provided that... |
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. 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 a... |
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 AND (C) AS PROVIDED UNDER SECTION 13.12, AND (D) TO THE EXTENT ANY SUCH DAMAGES ARE REQUIRED TO BE PAID TO A THIRD PARTY AS PART OF A CLAIM FOR WHICH A PARTY PROVIDES INDEMNIFICATION ... |
11.6 Insurance. OSE shall have and maintain, at its sole cost and expense, an adequate liability insurance (including product liability insurance) to protect against potential liabilities and risk arising out of activities to be performed under this Agreement and any agreement related hereto and upon such terms (includ... |
11.6.1 Certificates of Insurance. Upon request by AbbVie, OSE shall provide certificates of insurance evidencing compliance with the above requirements in this Section 11.6. |
ARTICLE 12 Term and Termination |
12.1 HSR and Other Governmental Filings. The Parties shall each, as soon as practicable after the Execution Date, file or cause to be filed with the U.S. Federal Trade Commission and the U.S. Department of Justice and any relevant foreign governmental authority any notifications required to be filed under the HSR Act (... |
12.1.1 Antitrust Clearances. |
(a) Unless agreed otherwise by mutual consent, AbbVie and OSE shall use reasonable best efforts to prepare and file any filing required to obtain such antitrust clearance promptly after the Execution Date. Each Party shall use its best efforts to cooperate with the other Party and furnish to the other Party, or such Pa... |
(b) AbbVie and OSE shall each use reasonable best efforts to resolve as promptly as practicable any objections that may be asserted by any governmental authority with respect to the transactions contemplated under this Agreement. Notwithstanding the foregoing, nothing in this Section 12.1.1 or otherwise in this Agreeme... |
12.2 Term. |
12.2.1 Term. Notwithstanding anything in this Agreement to the contrary, this Agreement (other than this Article 12, which is binding and effective as of the Execution Date) shall not become effective until the expiration or earlier termination of the waiting period (or any extension thereof) under the HSR Act in the U... |
12.2.2 Effect of Expiration of the Term. Following the expiration of the Term, the grants in Section 5.1 shall become unrestricted, fully paid, royalty-free, perpetual, and irrevocable. |
12.3 Termination. |
12.3.1 Termination for Material Breach. |
(a) If either Party (the "Non-Breaching Party") believes that the other Party (the "Breaching Party") has materially breached one (1) or more of its material obligations under this Agreement, then the Non-Breaching Party may deliver notice of such material breach to the Breaching Party (a "Default Notice"). If the Brea... |
(b) The Parties agree that termination pursuant to this Section 12.3.1 is a remedy to be invoked only if the breach cannot be adequately remedied through a combination of specific performance and the payment of money damages. For clarity, OSE may not terminate this Agreement in whole or in part following the First Comm... |
12.3.2 Termination For Safety Concern. AbbVie may terminate this Agreement in its entirety in the event that AbbVie in good faith believes that it is not advisable for AbbVie to continue to Develop or Commercialize the Licensed Antibodies or Licensed Products as a result of a perceived serious safety issue regarding th... |
12.3.3 Termination For Convenience. AbbVie may terminate this Agreement in its entirety, or on a country or other jurisdiction-by-country or other jurisdiction basis, for any or no reason, upon ninety (90) days' prior written notice to OSE. |
12.3.4 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 (... |
12.3.5 Termination for Debarment or Anti-Bribery or Anti-Corruption Non-Compliance. AbbVie may terminate this Agreement in accordance with Section 10.2.20 or Section 10.4. |
12.4 Rights in Bankruptcy. |
12.4.1 The Parties intend to take advantage of the protections of Section 365(n) (or any successor provision) of the U.S. Bankruptcy Code or any analogous provisions in any other country or jurisdiction to the maximum extent permitted by Applicable Law. All rights and licenses granted under or pursuant to this Agreemen... |
12.4.2 In the event of the commencement of a bankruptcy proceeding by or against either Party under the U.S. Bankruptcy Code or any analogous provisions in any other country or jurisdiction, the Party that is not subject to such proceeding shall be entitled to a complete duplicate of (or complete access to, as appropri... |
12.4.3 Unless and until the subject Party rejects this Agreement, the subject Party shall perform this Agreement or provide the intellectual property (including all embodiments of such intellectual property) to the non-subject Party, and shall not interfere with the rights of the non-subject Party to such intellectual ... |
12.4.4 The Parties acknowledge and agree that payments made under Section 6.2 Section 6.3 and Section 6.4 are not intended to be and shall not (a) constitute royalties within the meaning of Section 365(n) of the U.S. Bankruptcy Code or any analogous provisions in any other country or jurisdiction or (b) relate to licen... |
12.5 Modification In Lieu of Termination. Without limiting any other remedies or termination rights hereunder, if, at any time after the Transition Term, (a) AbbVie has the right to terminate this Agreement pursuant and subject to Section 12.3.1 or Section 12.3.4 (other than for any breach related to the Transition Act... |
12.5.1 the royalties payable by AbbVie to OSE pursuant to Section 6.5 with respect to any Net Sales thereafter shall be reduced by a percentage equal to fifty percent (50%) of the applicable rate; |
12.5.2 the amount of any milestone payments payable by AbbVie to OSE pursuant to Section 6.2, Section 6.3 and Section 6.4 for any milestone event achieved thereafter shall be reduced by fifty percent (50%) of the applicable amount set forth in such Section; and |
12.5.3 all other provisions of this Agreement shall remain in full force and effect without change. |
12.6 Termination in Entirety. |
12.6.1 In the event of a termination of this Agreement in its entirety by AbbVie pursuant to Section 12.3.3 or by OSE pursuant to Section 12.3.1 or Section 12.3.4, AbbVie hereby grants to OSE an exclusive and irrevocable option to acquire an exclusive or non-exclusive (at AbbVie's sole election) license, with the right... |
12.6.2 In the event of a termination of this Agreement in its entirety by AbbVie pursuant to Section 12.3.1, Section 12.3.2, Section 12.3.3 or Section 12.3.4 or by OSE pursuant to Section 12.3.1 or Section 12.3.4: (a) all rights and licenses granted by OSE hereunder shall immediately terminate, (b) the receiving Party ... |
12.6.3 Without limiting any other remedies or termination rights hereunder, in the event of a termination of this Agreement in its entirety by AbbVie pursuant to Section 12.3.5 for breach of Section 10.2.20, all rights and licenses granted by OSE hereunder shall become irrevocable, unrestricted, and perpetual rights an... |
12.7 Termination of Terminated Territory. In the event of a termination of this Agreement with respect to a Terminated Territory by AbbVie pursuant to Section 12.3.3 or by OSE pursuant to Section 12.3.1 (but not in the case of any termination of this Agreement in its entirety): |
12.7.1 all rights and licenses granted by OSE hereunder (a) shall automatically be deemed to be amended to exclude, if applicable, the right to market, promote, detail, distribute, sell, offer for sale, file any Drug Approval Application for, or seek any Regulatory Approval for Licensed Antibodies and Licensed Products... |
12.7.2 AbbVie hereby grants to OSE an exclusive and irrevocable option to acquire an exclusive or non-exclusive (at AbbVie's sole election) license solely for Exploitation of the Licensed Antibody and Licensed Compound in the Terminated Territory, with the right to sublicense through multiple tiers, Patents and Know-Ho... |
12.8 Grantback Transition Agreement. |
12.8.1 In the event of any termination of this Agreement, whether in its entirety or with respect to the Terminated Territory, OSE and AbbVie shall negotiate in good faith the terms and conditions of a written transition agreement (the "Grantback Transition Agreement") pursuant to which AbbVie and OSE will effectuate a... |
(a) In the event of a termination of this Agreement in its entirety by AbbVie pursuant to Section 12.3.2 or Section 12.3.3 or by OSE pursuant to Section 12.3.1 or 12.3.4, the Grantback Transition Agreement shall provide that AbbVie shall (and shall cause its Affiliates to) where permitted by Applicable Law, transfer to... |
(b) In the event of a termination of this Agreement with respect to a country or other jurisdiction by AbbVie pursuant to Section 12.3.3 or by OSE pursuant to Section 12.3.1 (but not in the case of any termination of this Agreement in its entirety), the Transition Agreement shall: (x) include provisions regarding the m... |
12.9 Remedies. Except as otherwise expressly provided herein, termination of this Agreement (either in its entirety or with respect to one (1) or more country(ies) or other jurisdiction(s)) in accordance with the provisions hereof shall not limit remedies that may otherwise be available in law or equity. |
12.10 Accrued Rights; Surviving Obligations. |
12.10.1 Termination or expiration of this Agreement either in its entirety or with respect to one (1) or more country(ies) or other jurisdiction(s) for any reason shall be without prejudice to any rights that shall have accrued to the benefit of a Party prior to such termination or expiration; provided that in no event... |
12.10.2 Without limiting the foregoing, Section 6.1 through Section 6.13 (to the extent of accrued rights to payment that were not satisfied prior to expiration or termination), Section 6.15 (solely for a period not to exceed three (3) years after expiration or termination); Sections 7.1, and this Section 12.10.2, and ... |
12.10.3 Notwithstanding the termination of AbbVie's licenses and other rights under this Agreement, AbbVie shall have the right for one (1) year after the effective date of such termination with respect to the Terminated Territory to sell or otherwise dispose of all Licensed Antibodies and Licensed Products then in its... |
ARTICLE 13 MISCELLANEOUS |
13.1 Force Majeure. Neither Party shall be held liable or responsible to the other Party or be deemed to have defaulted under or breached this Agreement for failure or delay in fulfilling or performing any term of this Agreement when such failure or delay is caused by or results from events beyond the reasonable contro... |
13.2 Change in Control of OSE. |
13.2.1 OSE (or its successor) shall provide AbbVie with written notice of any Change in Control of OSE or Acquisition by OSE within two (2) Business Days following the closing date of such transaction. |
13.2.2 In the event that a Change in Control of OSE or Acquisition by OSE, results in OSE (or its successor) having rights or access any product that is an Antibody that binds to, inhibits or otherwise modulates ChemR23 and any fragments or altered, modified improved forms of such antibodies (a "Competing Product"), th... |
13.2.3 OSE covenants that, following a Change in Control of OSE, if the Change of Control occurs during the Transition Term, (a) there shall be no material change in the level or nature of efforts or resources expended by OSE and its Affiliates with respect to, or the qualifications and experience of the personnel assi... |
13.3 Export Control. This Agreement is made subject to any restrictions concerning the export of products or technical information from the United States or other countries that may be imposed on the Parties from time to time. Each Party agrees that it will not export, directly or indirectly, any technical information ... |
13.4 Assignment. Except as provided in Section 3.3 and Section 5.3, without the prior written consent of the other Party, such consent not to be unreasonably withheld, conditioned, or delayed, neither Party shall sell, transfer, assign, delegate, pledge, or otherwise dispose of, whether voluntarily, involuntarily, by o... |
13.4.1 The rights to Information, materials, Know-How and/or Patents: (a) Controlled by a Third Party permitted assignee or an Acquiror of a Party that were Controlled by such assignee or Acquiror immediately prior to such assignment, or thereafter if such Information, materials, Know-How and/or Patents become Controll... |
13.5 Severability. If any provision of this Agreement is held to be illegal, invalid, or unenforceable under any present or future law, and if the rights or obligations of either Party under this Agreement will not be materially and adversely affected thereby, (a) such provision shall be fully severable, (b) this Agree... |
13.6 Offsets. Each Party shall have the right to offset any (a) undisputed amount or (b) disputed amount once such dispute has been finally resolved pursuant to Section 13.8, in each case ((a) and (b)), owed by the other Party to such first Party under or in connection with this Agreement, including if such amount were... |
13.7 Governing Law, Jurisdiction, and Service. |
13.7.1 Governing Law. This Agreement or the performance, enforcement, breach, or termination hereof shall be interpreted, governed by, and construed in accordance with the laws of the State of New York, United States, excluding any conflicts or choice of law rule or principle that might otherwise refer construction or ... |
13.7.2 Service. Each Party further agrees that service of any process, summons, notice, or document by registered mail to its address set forth in Section 13.9.2 shall be effective service of process for any action, suit, or proceeding brought against it under this Agreement in any such court. |
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