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10.2.25 To the Knowledge of Heptares neither Heptares 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, failed to disclose a material fact required to be disclos... |
10.2.26 Neither Heptares nor any of its Affiliates has any Knowledge of anything that could adversely affect the acceptance, or the subsequent approval, by any Regulatory Authority of any filing, application or request for any Regulatory Approval for a Compound or a Product. |
10.2.27 Neither Heptares 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 the obligations to b... |
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. |
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. |
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 Health... |
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. |
"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 Information... |
10.2.28 The inventions claimed or covered by the Existing Patents (a) were not conceived, reduced to practice, discovered, developed, or otherwise made in connection with any research activities funded, in whole or in part, by the federal government of the United States or any agency thereof, (b) are not a "subject inv... |
10.2.29 The representations and warranties of Heptares in this Agreement, and 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 mater... |
10.2.30 Heptares has made (and will make) available to AbbVie all Heptares Know-How and other Information in its Control specifically related to the Compounds and the Products and all such Heptares Know-How and other Information are (and, if made available after the Effective Date, will be) true, complete, and correct. |
10.3 Mutual Covenants. Each Party agrees that it will undertake and shall continue to update and maintain during the Term an internal compliance program under which each such Party's (or its Affiliates') employees are required to comply with all Applicable Law, including applicable local and international anti-bribery ... |
10.4 Additional Covenants of Heptares. Heptares agrees that, during the Term, Heptares shall, and shall cause its Affiliates to: |
10.4.1 not grant any license relating to the Licensed Technology that would conflict with the rights or licenses granted or to the granted to AbbVie hereunder; |
10.4.2 (a) not encumber or diminish the rights granted to AbbVie hereunder with respect to the Heptares Know-How or Heptares Patents, including by not committing any acts or permitting the occurrence of any omissions that would cause the breach or termination of any In-License Agreement, or (b) without AbbVie's prior w... |
10.4.3 promptly provide AbbVie with notice of any alleged, threatened, or actual breach of any In-License Agreement; |
10.4.4 conduct, and their respective contractors and consultants will conduct, all Development of any Compounds or Products in accordance with GLP and GCP, as applicable, and Applicable Law. Heptares and its Affiliates shall employ Persons with appropriate education, knowledge and experience to conduct and to oversee t... |
10.4.5 subject to Section 3.13.2, with respect to supplies of Compound, Product, comparators, co-administered agents or placebo Manufactured and supplied by or on behalf of Heptares pursuant to Section 3.13, (a) all such Compound, Product, comparators, co-administered agents and placebo shall be in conformity with the ... |
10.5 Anti-Bribery and Anti-Corruption Compliance. Each Party 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... |
10.6 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... |
10.7 Bring Down Limitations. The disclosures set forth in any updated Schedule 10.2 (an "Updated Disclosure Schedule") shall be limited to (a) disclosures required in connection with those certain representations and warranties set forth on Schedule 10.7, and (b) the Updated Existing Patents. The Parties agree that any... |
ARTICLE 11 INDEMNITY |
11.1 Indemnification of Heptares. AbbVie shall indemnify Heptares, its Affiliates and its and their respective directors, officers, employees, and agents (the "Heptares Indemnitees") and defend and save each of them harmless, from and against any and all losses, damages, liabilities, penalties, costs, and expenses (inc... |
11.1.1 the breach by AbbVie 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; or |
11.1.3 the Exploitation by AbbVie of Licensed Products in the Territory after the applicable License Option Effective Date and during the Term; |
except in the case of Section 11.1.1 through 11.1.3, for those Losses for which Heptares, 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. Heptares 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 Heptares of this Agreement; |
11.2.2 the negligence, reckless conduct or willful misconduct on the part of Heptares or its Affiliates or its or their respective directors, officers, employees, and agents in performing its obligations under this Agreement; |
11.2.3 the Exploitation of any Licensed Compound or Licensed Products or use of any Product Trademark in or for the benefit of the Terminated Territory; |
11.2.4 the Exploitation of any (i) Reserved Compounds or Reserved Products (in the event AbbVie does not deliver an applicable Reserved Option Program Activation Notice), and (ii) Option Compounds or Option Products (in the event AbbVie does not exercise the applicable License Option) during or after the Term, anywhere... |
11.2.5 the Exploitation of (i) any Grantback Product in the Terminated Territory, and (ii) any Licensed Compound or Licensed Product anywhere in the world after the Term, in each case, by or on behalf of Heptares. |
except, in the case of Section 11.2.1 through 11.2.3 above for those Losses for which AbbVie, in whole or in part, has an obligation to indemnify Heptares pursuant to 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 "Indemni... |
11.4 Control of Defense. |
11.4.1 In General. Subject to the provisions of Sections 8.4, 8.5 and 8.7, 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 Notice. The assump... |
11.4.2 Right to Participate in Defense. Without limiting Section 11.4.1, any Indemnified Party shall be entitled to participate in, but not control, the defense of such Third Party Claim and to employ counsel of its choice for such purpose; provided, that such employment shall be at the Indemnified Party's own expense ... |
11.4.3 Settlement. With respect to any Losses relating solely to the payment of money damages in connection with a Third Party Claim and that shall not result in the Indemnified Party's becoming subject to injunctive or other relief, and as to which the indemnifying Party shall have acknowledged in writing the obligati... |
11.4.4 Cooperation. Regardless of whether the indemnifying Party chooses to defend or prosecute any Third Party Claim, the Indemnified Party shall, and shall cause each indemnitee to, cooperate in the defense or prosecution thereof and shall furnish such records, information and testimony, provide such witnesses and at... |
11.4.5 Expenses. Except as provided above, the reasonable and verifiable costs and expenses, including fees and disbursements of counsel, incurred by the Indemnified Party in connection with any Third Party Claim shall be reimbursed on a Calendar Quarter basis in arrears by the indemnifying Party, without prejudice to ... |
11.5 Special, Indirect, and Other Losses. EXCEPT (A) FOR WILLFUL MISCONDUCT, (B) FOR A PARTY'S BREACH OF ITS OBLIGATIONS UNDER ARTICLE 9 OR SECTION 6.9, (C) AS PROVIDED UNDER SECTION 13.11, AND (D) TO THE EXTENT ANY SUCH DAMAGES ARE REQUIRED TO BE PAID TO A THIRD PARTY AS PART OF A CLAIM FOR WHICH A PARTY PROVIDES INDE... |
11.6 Insurance. |
11.6.1 Each Party shall, at its own expense, procure and maintain during the Term and for a period of five (5) years thereafter, insurance policy/policies, including product liability insurance, adequate to cover its obligations hereunder and which are consistent with normal business practices of prudent companies simi... |
11.6.2 Notwithstanding the foregoing, AbbVie may self-insure, in whole or in part, the insurance requirements described in Section 11.6.1. |
ARTICLE 12 TERM AND TERMINATION |
12.1 Term. |
12.1.1 Term. This Agreement shall commence on the Effective Date and, unless earlier terminated in accordance herewith, shall continue in force and effect until the date of expiration of the last Royalty Term for the last Licensed Product for the last country (such period, the "Term"). |
12.1.2 Effect of Expiration of the Term. Following the expiration of the Term, and on a Program-by-Program and country or other jurisdiction-by-country or other jurisdiction, the grants in Section 6.1 shall become non-exclusive, perpetual, fully-paid, unrestricted, royalty-free and irrevocable. |
12.2 Termination for Material Breach. |
12.2.1 Material Breach. 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 N... |
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12.2.2 Material Breach Related to Specific Countries. Notwithstanding Section 12.2.1, if the material breach and failure to cure contemplated by Section 12.2.1 is with respect to AbbVie's diligence obligations under Section 5.2, as applicable, with respect to fewer than all of the countries in the Territory, Heptares s... |
12.3 Additional Termination Rights by AbbVie. |
12.3.1 For Cause. AbbVie may terminate this Agreement in its entirety effective immediately upon thirty (30) days' written notice to Heptares if AbbVie in good faith believes that it is not advisable for AbbVie to continue to Exploit the Compounds or Products as a result of a serious safety issue regarding the use of a... |
12.3.2 For Convenience. AbbVie may terminate this Agreement in its entirety, or on a Program-by-Program and country or other jurisdiction-by-country or other jurisdiction basis for any or no reason, upon ninety (90) days' prior written notice to Heptares. |
12.3.3 For Termination of the License Option. |
Either Party may terminate this Agreement in its entirety effective immediately upon written notice to the other Party if the last-to-expire License Option terminates pursuant to Section 4.4.4 in circumstances in which AbbVie has not delivered a License Option Exercise Notice for any License Option pursuant to Section ... |
AbbVie may terminate this Agreement in its entirety or on a Program-by-Program basis effective immediately upon written notice to Heptares in the event that (a) either Party receives a second request for additional information under the HSR Act (a "Second Request") or (b) the License Option Effective Date has not occur... |
12.4 AbbVie Cessation of Development and Commercialization. If at any time during the Term following the exercise of a License Option, AbbVie has ceased Development and Commercialization of all Licensed Products with respect to such Licensed Program throughout the Territory for twenty-four (24) consecutive months and s... |
12.5 Termination for Insolvency. If 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) days after su... |
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12.6 Rights in Bankruptcy. |
12.6.1 Applicability of 11 U.S.C. § 365(n). All rights and licenses (collectively, the "Intellectual Property Rights") 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, fo... |
12.6.2 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... |
12.7 Termination in Entirety. |
12.7.1 Subject to this Section 12.7.1, in the event of a termination of this Agreement in its entirety by either Party: |
(a) all licenses and other rights granted by Heptares pursuant to Section 6.1 shall immediately terminate; |
(b) all licenses and other rights granted by AbbVie pursuant to Section 6.3 shall immediately terminate; |
(c) except in the case of termination by AbbVie pursuant to Section 12.2.1, 12.3.1 or 12.5, if the effective date of such termination is prior to the License Option Effective Date of any Option Program, then AbbVie shall, and hereby does effective as of the effective date of termination, grant Heptares an exclusive, ro... |
(d) except in the case of termination by AbbVie pursuant to Section 12.2.1, 12.3.1 or 12.5, if the effective date of such termination is on or after a License Option Effective Date, then, subject to Section 12.10 and solely with respect to the Licensed Programs, AbbVie shall, and hereby does effective as of the effecti... |
(e) the covenants granted by Heptares to AbbVie in Section 6.9 shall immediately terminate. |
12.7.2 If AbbVie has the right to terminate this Agreement in its entirety pursuant to Section 12.2.1 (solely with respect to Heptares' breaches under Section 6.9, ARTICLE 8, ARTICLE 9, ARTICLE 11, and Section 13.11) or Section 12.5, AbbVie may, in lieu of termination, elect (in its sole discretion) by written notice t... |
(a) all licenses and other rights granted by AbbVie pursuant to Section 6.3 shall immediately terminate; |
(b) any amounts, after giving effect to any deductions allowable hereunder, that would have been due to Heptares by AbbVie with respect to Licensed Product after such termination shall be reduced by thirty percent (30%) and paid to Heptares in accordance with the payment provisions of this Agreement; |
(c) AbbVie's obligations pursuant to Sections 5.1 shall terminate; |
(d) AbbVie shall have the right to disband the JGC and terminate the activities of the JGC and thereafter undertake all activities assigned by this Agreement to the JGC solely and exclusively by itself, provided that AbbVie shall not have a license to the Heptares Platform or any Heptares Patents or Heptares Know-How r... |
The remedies set forth in this Section 12.7.2 shall be without limitation to any other rights or remedies that may be available to AbbVie under this Agreement or at law or in equity. |
12.8 Termination of Terminated Territory. In the event of a termination of this Agreement with respect to a country by AbbVie pursuant to Section 12.3.2 or with respect to a Terminated Territory by Heptares pursuant to Section 12.2.2 (but not in the case of any termination of this Agreement in its entirety): |
12.8.1 all licenses and other rights granted by Heptares pursuant to Section 6.1 (a) shall automatically be deemed to be amended to exclude, if applicable, the right to market, promote, detail, distribute, import, sell, offer for sale, submit any Drug Approval Application for, or seek any Regulatory Approval such Licen... |
12.8.2 AbbVie and Heptares shall negotiate in good faith the terms and conditions of a written grantback agreement ("Grantback Agreement") pursuant to which, subject to Section 12.10, AbbVie shall grant to Heptares an exclusive, royalty-bearing license, with the right to grant multiple tiers of sublicenses, under the A... |
12.8.3 Exploitation of the terminated Licensed Products in the Terminated Territory by Heptares shall not breach Section 6.9.1; |
12.8.4 Subject to Applicable Law, Heptares shall not, and shall not permit any of its Affiliates or any of its and their licensees, sublicensees or distributors to, distribute, market, promote, offer for sale or sell any terminated Licensed Product directly or indirectly (a) to any Person for use outside the Terminated... |
12.8.5 Heptares shall not do any act or fail to do any act in connection with any terminated Licensed Compound or terminated Licensed Product in the Terminated Territory for such terminated Licensed Compound or terminated Licensed Product that would reasonably be expected to have an adverse impact on the Exploitation o... |
12.9 Transition Agreement and Other Performance Obligations. |
12.9.1 In the event of termination of this Agreement, whether in its entirety or with respect to the Terminated Territory or one or more Licensed Products, solely in those circumstances in which AbbVie is required to grant to Heptares a license pursuant to Section 12.7.1(d) or 12.7.1(c), or pursuant to Section 12.8.2: |
(a) unless otherwise required by AbbVie's then-current policies or Applicable Law, at AbbVie's election, AbbVie shall transfer control to Heptares of all Clinical Studies with respect to the applicable Grantback Products and continue to Conduct such Clinical Studies, at Heptares' cost, for up to six (6) months to enabl... |
(b) Heptares and AbbVie shall negotiate in good faith the terms and conditions of a written transition agreement (the "Transition Agreement") pursuant to which AbbVie and Heptares will effectuate and coordinate a smooth and efficient transition of relevant obligations and rights to Heptares as reasonably necessary for ... |
12.9.2 The Transition Agreement shall provide that in the event of a termination of this Agreement in its entirety or with respect to one or more applicable Grantback Products worldwide (i) by AbbVie pursuant to Section 12.3.2, (ii) by Heptares in its entirety or with respect to one or more applicable Grantback Product... |
(a) where permitted by Applicable Law, transfer to Heptares all of its right, title, and interest in all Regulatory Documentation then owned by AbbVie and in its name applicable to the extent specifically related to the applicable Grantback Products (not related to any other Licensed Compounds, Licensed Products, other... |
(b) notify the applicable Regulatory Authorities and take any other action reasonably necessary to effect the transfer set forth in clause (a) above; |
(c) set forth terms and conditions consistent with Section 12.9.1(a) with respect to Clinical Studies with respect to the applicable Licensed Products being Conducted by AbbVie as of the effective date of termination; and |
(d) set forth terms and conditions to address any finished or in-process inventory of the applicable Grantback Products. |
12.9.3 The Transition Agreement shall provide that in the event of a termination of this Agreement with respect to a country by AbbVie pursuant to Section 12.3.2 or with respect to a Terminated Territory by Heptares pursuant to Section 12.2.2 (but not in the case of any termination of this Agreement in its entirety), A... |
(a) where permitted by Applicable Law, transfer to Heptares all of its right, title, and interest in all Regulatory Approval(s) then owned by AbbVie and in its name that is solely applicable to the Terminated Territory and to the applicable Grantback Products (and not related to any other Licensed Compounds, Licensed P... |
(b) notify the applicable Regulatory Authorities and take any other action reasonably necessary to effect the transfer set forth in clause (a) above; |
(c) set forth terms and conditions consistent with Section 12.9.1(a) with respect to Clinical Studies with respect to the applicable Grantback Products being Conducted by AbbVie as of the effective date of termination; |
(d) grant Heptares a right of reference to all Regulatory Documentation then owned by AbbVie and in AbbVie's name that are not transferred to Heptares pursuant to clause (a) above that are necessary or useful for Heptares, any of its Affiliates or sublicensees to Develop or Commercialize any applicable Grantback Produc... |
(e) set forth terms and conditions to address any finished or in-process inventory of the applicable Grantback Products. |
12.10 Reverse Royalty. If this Agreement is terminated in its entirety or with respect to a Licensed Product in one (1) or more Terminated Territories, and in connection therewith, AbbVie grants to Heptares a grantback license pursuant to Section 12.7.1(d) in consideration of the licenses granted and other consideratio... |
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