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11.8. Insurance. HotSpot shall obtain and carry in full force and effect the minimum insurance requirements set forth herein from an insurance company properly licensed to provide the required insurance. Such insurance shall (a) be primary insurance with respect to HotSpot's own participation under this Agreement, (b) ... |
11.8.1. Types and Minimum Limits. The types of insurance, and minimum limits shall be: |
(a) Worker's compensation with statutory limits in compliance with the worker's compensation laws of the state or states in which the Party has employees in the United States (excluding Puerto Rico). |
(b) Employer's liability coverage with a minimum limit of Five Hundred Thousand Dollars ($500,000) per occurrence; provided that a Party has employees in the United States (excluding Puerto Rico). |
(c) General liability insurance with a minimum limit of (i) Two Million Five Hundred Thousand Dollars ($2,500,000) per occurrence and Five Million Dollars ($5,000,000) in the aggregate, as of the Effective Date, and (ii) Five Million Dollars ($5,000,000) per occurrence and Ten Million Dollars ($10,000,000) in the aggre... |
HotSpot shall at all times maintain in force any insurance policy that is required by Applicable Law which may govern or have jurisdiction over any provision of this Agreement and at all times remain fully compliant with any such Applicable Law. |
11.8.2. Certificates of Insurance. Upon request by AbbVie, HotSpot shall provide certificates of insurance evidencing compliance with the requirements of Section 11.8.1 (Types and Minimum Limits). The insurance policies shall be under an occurrence form, but if only a claims-made form is available to HotSpot, then HotS... |
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 earliest to occur of (a) the failure of AbbVie to pay the applicable Option Extension Payment within thirty (30) days after delivery of the applicable Lic... |
12.1.2. Effect of Expiration of the Term. Following the expiration of the Term pursuant to clause (c) (but not clauses (a) or (b)) of Section 12.1.1 (Term), the grants in Section 6.3 (Grants to AbbVie on the License Option Effective Date), shall become fully-paid, royalty-free, perpetual, and irrevocable, and shall con... |
12.2. Termination for Material Breach. |
12.2.1. Material Breach. If either Party (the "Non-Breaching Party") reasonably 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 providing sufficient factual detail of such mate... |
12.2.2. Material Breach Related to Diligence in Specific Countries. (a) If the material breach and failure to cure contemplated by Section 12.2.1 (Material Breach) is specifically with respect to AbbVie's diligence obligations under Section 5.2 (Diligence) only in the United States, then HotSpot shall not have the righ... |
12.2.3. Invocation of Termination for Material Breach. Notwithstanding the foregoing, the Parties agree that termination pursuant to this Section 12.2 (Termination for Material Breach) is a remedy to be invoked only if the breach is not (a) cured in accordance with Section 12.2.1 (Material Breach) (including the timefr... |
12.3. Additional Termination Rights by AbbVie. |
12.3.1. For Cause. AbbVie may terminate this Agreement in its entirety effective immediately upon written notice to HotSpot (a) pursuant to Section 10.4 (Debarment and Exclusion) or Section 10.5 (Anti-Bribery and Anti-Corruption Compliance), or (b) if AbbVie in good faith believes that it is not advisable for AbbVie to... |
12.3.2. For Convenience. AbbVie may terminate this Agreement (a) in its entirety, (b) solely with respect to the United States, or (c) solely with respect to Europe, for any or no reason, in each case ((a)-(c)) upon one hundred twenty (120) days' prior written notice to HotSpot. |
12.4. Termination for Failure or Delay to Obtain Antitrust Clearance. (a) AbbVie may terminate this Agreement in its entirety effective immediately upon written notice to HotSpot in the event that either Party receives a request for additional information under the HSR Act or if the transaction contemplated under this ... |
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 s... |
12.6. Rights in Bankruptcy. |
12.6.1. 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 ("Bankruptcy Code") to the maximum extent permitted by Applicable Law. All rights and licenses granted under or purs... |
12.6.2. 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 appropr... |
12.6.3. 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 ... |
12.7. Termination in Entirety. |
12.7.1. In the event of a termination of this Agreement in its entirety by either Party: |
(a) all rights and licenses granted by HotSpot hereunder shall immediately terminate; |
(b) all rights and licenses granted by AbbVie hereunder shall immediately terminate; |
(c) only if such termination is by AbbVie pursuant to Section 12.3.2 (For Convenience) or by HotSpot pursuant to Section 12.2.1 (Material Breach) or Section 12.5 (Termination for Insolvency), then, subject to Section 12.10 (Other Effects of Termination), AbbVie shall, and hereby does effective as of the effective date ... |
(d) if the AbbVie Grantback Know-How and AbbVie Grantback Patents do not include the process or formulation actually used by AbbVie as of the effective date of termination to Manufacture the Grantback Product because that process or formulation is AbbVie Platform Technology, and there is no reasonable substitute for su... |
(e) AbbVie shall, and hereby does, effective as of the effective date of termination, grant to HotSpot, automatically and without further action of the Parties, an exclusive license under the Product Trademarks to Exploit Grantback Products in the Terminated Territory; provided that HotSpot shall maintain the quality s... |
(f) only if such termination is by AbbVie pursuant to Section 12.2.1 (Material Breach), if HotSpot has previously exercised the Cost-Sharing Option, HotSpot shall pay, within sixty (60) days of the effective date of termination, its Pro Rata Percentage of all Deferred Shared Development Costs and all Additional Shared ... |
12.8. AbbVie Additional Remedy for HotSpot Material Breach. If, during the Term, AbbVie would have the right to terminate this Agreement in its entirety pursuant to Section 12.2.1 (Material Breach) (except insofar as AbbVie's right to terminate arises from HotSpot's material breach of its obligations under Section 5.3 ... |
(a) all licenses granted by AbbVie hereunder shall immediately terminate, except for those necessary for HotSpot to perform its obligations under this Agreement; |
(b) any (i) royalties, after giving effect to any deductions allowable hereunder that would have been due to HotSpot by AbbVie with respect to Licensed Products before election of the alternative remedy set forth in this Section 12.8 (AbbVie Additional Remedy for HotSpot Material Breach), (ii) Option Extension Payments... |
(c) HotSpot's rights to defer Deferred Shared Development Costs pursuant to Section 5.3.6 (HotSpot Cost-Sharing Option) and to defer AbbVie for Additional Shared Development Costs pursuant to clause (b) of Section 5.3.7 (HotSpot Cost-Sharing Option) shall terminate; |
(d) if HotSpot has previously exercised the Cost-Sharing Option, require HotSpot to pay, within sixty (60) days of such written notice of HotSpot, one hundred twenty-five percent (125%) of its Pro Rata Percentage of all Deferred Shared Development Costs and all Additional Shared Development Costs that were deferred pri... |
(e) terminate HotSpot's Cost-Sharing Option if not previously exercised by HotSpot. |
For clarity, if AbbVie exercises any of the alternative remedies set forth in this Section 12.8 (AbbVie Additional Remedy for HotSpot Material Breach), then all other rights and obligations of both Parties under this Agreement shall continue unaffected, unless and until this Agreement is subsequently terminated by eith... |
12.9. Termination of Terminated Territory. In the event of a termination of this Agreement with respect to a Terminated Territory by HotSpot pursuant to Section 12.2.2 (Material Breach Related to Diligence in Specific Countries) or by AbbVie pursuant to Section 12.3.2 (For Convenience) (but not in the case of any termi... |
12.9.1. all rights and licenses granted by HotSpot hereunder shall terminate in the Terminated Territory, and HotSpot shall, and hereby does, grant AbbVie a non-exclusive license, with the right to sublicense in accordance with Section 6.4 (Sublicenses), (a) under the HotSpot Know-How and HotSpot Patents to Manufacture... |
12.9.2. subject to Section 12.10 (Other Effects of Termination), AbbVie shall, and hereby does effective as of the effective date of termination, grant HotSpot an exclusive, royalty-bearing license, with the right to grant multiple tiers of sublicenses, under the AbbVie Grantback Patents, AbbVie Grantback Know-How, and... |
12.9.3. AbbVie shall, and hereby does effective as of the effective date of termination, grant HotSpot a non-exclusive license, with the right to sublicense, (a) under the AbbVie Grantback Patents, AbbVie Grantback Know-How, and AbbVie's rights under the Joint Patents to Manufacture any applicable Grantback Product in ... |
12.9.4. if the AbbVie Grantback Know-How and AbbVie Grantback Patents do not include the process or formulation actually used by AbbVie as of the effective date of termination to Manufacture the Grantback Product because that process or formulation is AbbVie Platform Technology, and there is no reasonable substitute fo... |
12.9.5. HotSpot shall have no obligations under Section 6.9.1 (HotSpot Exclusivity) in the Terminated Territory; |
12.9.6. AbbVie shall, and hereby does effective as of the effective date of termination, grant to HotSpot, automatically and without further action of the Parties, an exclusive license under all Product Trademark(s) that have been approved by or are pending approval by a Regulatory Authority in the Terminated Territory... |
12.9.7. HotSpot shall not, and shall not permit any of its Affiliates, and shall use commercially reasonable efforts not to permit any of its and their (sub)licensees, or distributors to, distribute, market, promote, offer for sale, or sell any Grantback Product (or Licensed Compound contained therein) directly or indi... |
12.9.8. From and after the effective date of termination of this Agreement with respect to such Terminated Territory, neither Party (or its Affiliates) shall do any act or fail to do any act that is within such Party's (or its Affiliates') control in connection with any Grantback Product (or Licensed Compound contained... |
12.10. Other Effects of Termination. |
12.10.1. In the event of a termination of this Agreement in its entirety by AbbVie pursuant to Section 12.3.2 (For Convenience) or by HotSpot pursuant to Sections 12.2.1 (Material Breach) or 12.5 (Termination for Insolvency) AbbVie shall (and shall cause its Affiliates to): |
(a) where permitted by Applicable Law, transfer to HotSpot all of AbbVie's and its Affiliates' right, title, and interest in all Regulatory Documentation then owned by AbbVie or its Affiliates, and in its or their name, applicable to the Grantback Products in the Territory that are the subject of the license grant in S... |
(b) notify the applicable Regulatory Authorities and take any other action reasonably necessary to effect the transfer set forth in clause (a) above; and |
(c) in HotSpot's sole discretion, either (i) subject to patient safety and other ethical considerations, wind-down any ongoing Clinical Studies being conducted by AbbVie or its Affiliates as of the effective date of termination in accordance with Applicable Law and at HotSpot's expense, or (ii) unless expressly prohibi... |
12.10.2. In the event of a termination of this Agreement with respect to a Terminated Territory by HotSpot pursuant to Section 12.2.2 (Material Breach Related to Diligence in Specific Countries) or by AbbVie pursuant to Section 12.3.2 (For Convenience) (but not in the case of any termination of this Agreement in its en... |
(a) where permitted by Applicable Law, transfer to HotSpot all of AbbVie's and its Affiliates' right, title, and interest in all Regulatory Approvals then owned by AbbVie or its Affiliates and then in its or their name that is solely applicable to the Terminated Territory and to the Grantback Products that are the subj... |
(b) notify the applicable Regulatory Authorities and take any other action reasonably necessary to effect the transfer set forth in clause (a) above; |
(c) grant HotSpot a right of reference to all Regulatory Documentation then owned by AbbVie or its Affiliates and in AbbVie's or its Affiliates' name that are not transferred to HotSpot pursuant to clause (a) above that are necessary or reasonably useful for HotSpot, any of its Affiliates or sublicensees to Develop or ... |
(d) following the conclusion of any Wind Down Period, if the effective date of termination occurred during the Cost-Sharing Period with respect to the applicable terminated Licensed Product, AbbVie and HotSpot shall calculate and perform a final sharing of Shared Development Costs pursuant to Section 5.3 (HotSpot Cost-... |
12.10.3. Promptly following termination of this Agreement (in its entirety or with respect to the Terminated Territory, as applicable) pursuant to Section 12.3 (Additional Termination Rights by AbbVie), Section 12.2.1 (Material Breach), Section 12.5 (Termination for Insolvency) or Section 12.9 (Termination of Terminate... |
12.11. Reverse Royalty. If this Agreement is terminated in its entirety or with respect to one (1) or more Terminated Territories, and in connection therewith, AbbVie grants to HotSpot a grantback license pursuant to Section 12.7.1(c) (Termination in Entirety) or 12.9.2 (Termination of Terminated Territory), in conside... |
12.11.1. If the Parties are unable to agree upon a commercially reasonable royalty within ninety (90) days after the effective date of termination, then upon either Party's written request made within fifteen (15) days after the expiration of such ninety (90)-day period, each Party shall provide the other Party in writ... |
12.11.2. Each Party shall submit to the Valuation Expert and the other Party (a) the Final Offer such Party provided to the other Party pursuant to Section 12.11.1 (Reverse Royalty) and such information concerning the commercially reasonable royalty as such Party may deem appropriate within fifteen (15) days after the ... |
12.12. 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. |
12.13. Accrued Rights; Surviving Obligations. |
12.13.1. Termination or expiration of this Agreement (either in its entirety or with respect to one (1) or more country(ies) or other jurisdiction(s)) or one (1) or more Product(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 expi... |
12.13.2. Notwithstanding the termination of AbbVie's licenses and other rights under this Agreement or with respect to a particular country or other jurisdiction, as the case may be, AbbVie shall have the right for one (1) year after the effective date of such termination with respect to the Terminated Territory to sel... |
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 contr... |
13.2. Change in Control of HotSpot. |
13.2.1. HotSpot (or its successor) shall provide AbbVie with written notice of any Change in Control of HotSpot within two (2) Business Days following the closing date of such transaction. |
13.2.2. In the event of a Change in Control of HotSpot, (i) HotSpot shall comply with the terms of Section 6.9.2 (Change in Control of HotSpot) and (ii) AbbVie shall have the right, in its sole and absolute discretion, by written notice delivered to HotSpot (or its successor) at any time during the one hundred eighty (... |
(a) undertake one (1) or more activities under the Development Plan and Budget solely and exclusively by itself (without any consultation with or approval by HotSpot) at HotSpot's sole cost and expense, provided that AbbVie shall (i) be solely responsible for any costs incurred in excess of the costs budgeted in the De... |
(b) require HotSpot to perform a one-time transfer of technology necessary for AbbVie to conduct the activities assumed by AbbVie in accordance with Section 13.2.2(a) (Change in Control of HotSpot), provided that AbbVie shall reimburse HotSpot for (i) HotSpot's and its Third Party contract manufacturers' FTE Costs in e... |
(c) diminish or terminate any provision of this Agreement providing for any delivery by AbbVie to HotSpot of Information relating to activities assumed by AbbVie in accordance with Section 13.2.2(a) (Change in Control of HotSpot), provided that AbbVie agrees to provide progress reports, including prompt written notice,... |
(d) terminate HotSpot's right to defer Deferred Shared Development Costs and Additional Shared Development Costs; and |
(e) require HotSpot to pay, within sixty (60) days of such Change in Control of HotSpot, one hundred twenty-five percent (125%) of its Pro Rata Percentage of all Deferred Shared Development Costs and all Additional Shared Development Costs that were deferred prior to the effective date of such Change in Control (and no... |
13.2.3. For any Change in Control of HotSpot, and for clarity in addition to the rights of AbbVie under Section 13.2.2 (Change in Control of HotSpot) for a Change in Control to a Large Pharmaceutical Company, HotSpot covenants: |
(a) there shall be no material change in the level or nature of efforts or resources expended by HotSpot and its Affiliates with respect to, or the qualifications and experience of, the personnel assigned to (including with respect to the allocation of their time to) the Development Plan Activities; |
(b) if such Change in Control occurs prior to expiration of the License Option Period, then, for a period not less than six (6) months from the Change in Control, each employee of HotSpot or any of its Affiliates who worked on the Development Plan Activities during the six (6) month-period immediately prior to the Chan... |
(c) HotSpot and the Acquiring Party will adopt reasonable procedures to be agreed upon in writing to prevent disclosure of Confidential Information of AbbVie. |
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. 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 operation of law or otherwise, this Agreement or an... |
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 Agre... |
13.6. Governing Law, Jurisdiction and Service. |
13.6.1. Governing Law. This Agreement and the performance, enforcement, breach and 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... |
13.6.2. Service. Each Party further agrees that service of any process, summons, notice or document by registered mail to its address set forth in Section 13.8.2 (Address for Notice) shall be effective service of process for any action, suit, or proceeding brought against it under this Agreement in any such court. |
13.7. Dispute Resolution. Except for disputes resolved by the procedures set forth in Section 2.3.4 (Decision Making), Section 7.17 (Audit Dispute) or Section 13.11 (Equitable Relief) and disputes regarding matters that are to be approved or decided by the JGC pursuant to Section 2.1.2 (Responsibilities), if a dispute ... |
13.7.1. General. Any Dispute shall first be referred to the Senior Officers of the Parties by written notice transmitted by either Party requesting the Dispute be referred to the Senior Officers, who shall confer in good faith on the resolution of the issue. Any final decision mutually agreed to by the Senior Officers ... |
13.7.2. Intellectual Property Disputes. If a Dispute arises with respect to the validity, scope, enforceability, inventorship or ownership of any Patent, Trademark, or other intellectual property rights, and such Dispute cannot be resolved in accordance with Section 13.7.1 (General), unless otherwise agreed by the Part... |
13.7.3. ADR. Any ADR proceeding under this Agreement shall take place pursuant to the procedures set forth in Schedule 13.7.3 (ADR Procedures). |
13.7.4. Adverse Ruling. Any determination pursuant to this Section 13.7 (Dispute Resolution) that a Party is in material breach of its obligations hereunder shall specify a (nonexclusive) set of actions to be taken to cure such material breach, if feasible. |
13.7.5. Interim Relief. Notwithstanding anything herein to the contrary and without limiting Section 13.11 (Equitable Relief), nothing in this Section 13.7 (Dispute Resolution) shall preclude either Party from seeking interim or provisional relief from any court of competent jurisdiction, including a temporary restrain... |
13.8. Notices. |
13.8.1. Notice Requirements. Any notice, request, demand, waiver, consent, approval, or other communication permitted or required under this Agreement shall be in writing, shall refer specifically to this Agreement and shall be deemed given only if (a) delivered by hand, (b) sent by facsimile transmission (with transmi... |
13.8.2. Address for Notice. |
If to AbbVie, to: |
AbbVie Global Enterprises LTD 16 Church Street Hamilton HM11 Bermuda Attention: |
with a copy (which shall not constitute notice) to: |
1 North Waukegan Road North Chicago, IL 60064 Attention: Vice Chairman, External Affairs, Chief Legal Officer and Corporate Secretary Facsimile: +1 847 935 3294 |
and: |
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