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Each Party shall at all times maintain in force any insurance policy that is required by any Applicable Law that may govern or have jurisdiction over any provision of this Agreement and at all times remain fully compliant with any such Applicable Law. |
11.6.2 Certificates of Insurance. Upon request by a Party, the other Party shall provide Certificates of Insurance evidencing compliance with this Section 11.6. The insurance policies shall be under an occurrence form, but if only a claims-made form is available to a Party, then such Party shall continue to maintain su... |
11.6.3 Self-Insurance. Notwithstanding the foregoing, AbbVie may self-insure, in whole or in part, the insurance requirements described above. |
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 (a) the date of expiration of the last Royalty Term for the last Licensed Product, or (b) the expiration of the License Option Period and the failure of AbbVie... |
12.1.2 Effect of Expiration of the Term. Following the expiration of the Term pursuant to clause (a) (but not clause (b)) of Section 12.1.1, the grants in Section 5.1.2 shall become non-exclusive, fully-paid, 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... |
12.2.2 Material Breach Related to Diligence. 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 Development or Commercialization diligence obligations under Section 3.3, Licensor shall not have the right to terminate this Agreement in it... |
12.2.3 Invocation of Termination for Material Breach. Notwithstanding the foregoing, the Parties agree that termination pursuant to this Section 12.2 is a remedy to be invoked only if the applicable material breach is not (a) cured in accordance with Section 12.2.1 (including the timeframes set forth therein), (b) reme... |
12.3 Additional Termination Rights by AbbVie. |
12.3.1 Safety Issues. AbbVie may terminate this Agreement in its entirety effective immediately upon written notice to Licensor 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 seriou... |
12.3.2 For Convenience. AbbVie may terminate this Agreement in its entirety, or on a country-by-country or other jurisdiction-by-jurisdiction basis, for any or no reason, (a) upon ninety (90) days' prior written notice to Licensor at any time prior to the License Option Exercise Closing Date or (b) upon one hundred and... |
12.4 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 (90... |
12.5 AbbVie Cessation of Development and Commercialization. If, at any time following the exercise by AbbVie of its right under Section 12.7.2 or 12.7.3 in accordance with the terms therein, AbbVie has ceased Development and Commercialization of all Licensed Products throughout the Territory for twenty-four (24) consec... |
12.6 Rights in Bankruptcy. |
12.6.1 Applicability of 11 U.S.C. § 365(n). All rights and licenses (collectively, the "Intellectual Property") 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, for purpo... |
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 In the event of a termination of this Agreement in its entirety by AbbVie pursuant to Section 12.3.2 or by Licensor pursuant to Section 12.2.1, 12.4, or 12.5: |
(a) all rights and licenses granted by Licensor hereunder shall immediately terminate; |
(b) all rights and licenses granted by AbbVie hereunder shall immediately terminate; and |
(c) subject to Section 12.10, if AbbVie exercised its License Option prior to such termination, AbbVie shall, and hereby does effective as of the effective date of termination, grant Licensor an exclusive option to acquire an exclusive or non-exclusive (as agreed by the Parties), royalty-bearing license, with the right... |
(d) In the event of a termination of this Agreement in its entirety by AbbVie pursuant to Section 12.2.1 or 12.4, all rights and licenses granted by AbbVie and Licensor hereunder shall immediately terminate. |
12.7.2 If AbbVie has the right to terminate this Agreement in its entirety pursuant to Section 12.2.1 (i.e., by mutual agreement or as may be finally determined by an Adverse Ruling), for an uncured material breach by Licensor that occurs prior to the exercise of the License Option, then within ninety (90) days followi... |
(a) AbbVie may exercise its step-in right for all Initial Development Activities under Section 3.1.2 and the license set forth in Section 5.1.1 shall be maintained in full force and effect; |
(b) Licensor's obligations under this Agreement will remain in force, provided that if AbbVie exercises its step-in rights under Section 3.1.2, Licensor will have no further obligations under this Agreement to perform any activities in connection with the Development of Licensed Antibodies and Licensed Products, includ... |
(c) AbbVie may disband the JGC; |
(d) Licensor shall continue to perform its obligations with respect to Licensor Patents pursuant to ARTICLE 7; |
(e) AbbVie shall notify Licensor promptly following the date upon which the full clinical study report is available for both the Phase I/IA Trial and Phase I/IB Trial (the "CSR Notification Date"), and AbbVie shall have a period of ninety (90) days following the CSR Notification Date in which to exercise the License Op... |
(f) If AbbVie delivers a License Option Exercise Notice within the Post CSR Option Period, (i) Section 3.2.4 shall apply, (ii) AbbVie shall pay the fee for exercise of the License Option in accordance with Section 6.2, provided that, on AbbVie's request the Parties shall negotiate in good faith for a period of sixty (6... |
(g) Following the License Option Exercise Closing Date, all provisions of this Agreement with respect to AbbVie's rights and obligations following the exercise of the License Option shall apply; provided that (i) AbbVie shall have no further diligence obligations with respect to the Development or Commercialization of ... |
(h) If the Post CSR Option Period expires without AbbVie delivering a License Option Exercise Notice, then all rights and licenses granted by Licensor hereunder shall immediately terminate, and AbbVie shall have no further rights in connection with Licensed Antibodies and Licensed Products. |
12.7.3 If AbbVie has the right to terminate this Agreement in its entirety pursuant to Section 12.2.1 (i.e., by mutual agreement or as may be finally determined by an Adverse Ruling), for an uncured material breach that occurs following the License Option Exercise Closing Date, if then within ninety (90) days following... |
(a) all rights and licenses granted by AbbVie hereunder shall immediately terminate; |
(b) Licensor's obligations under this Agreement will remain in force, provided that Licensor will have no further obligations under this Agreement with respect to the performance of activities in connection with the Development of Licensed Antibodies and Licensed Products, including any obligations under ARTICLE 3; |
(c) Licensor will continue to perform its obligations with respect to Licensor Patents pursuant to ARTICLE 7; and |
(d) all provisions of this Agreement with respect to AbbVie's rights and obligations shall apply, provided that (i) AbbVie shall have no diligence obligations with respect to the Development or Commercialization of the Licensed Antibodies or Licensed Products pursuant to Section 3.3 or Section 4.2, (ii) all rights and ... |
12.8 Termination of Terminated Territory. In the event of a termination of this Agreement with respect to a country or other jurisdiction by AbbVie pursuant to Section 12.3.2 or with respect to a Terminated Territory by Licensor pursuant to Section 12.2.1 (but not in the case of any termination of this Agreement in its... |
12.8.1 the term "Territory" shall be automatically amended to exclude the Terminated Territory and all rights and licenses granted by Licensor hereunder (a) shall automatically be deemed to be amended to exclude, if applicable, the right to market, promote, detail, distribute, import, sell, offer for sale, file any Dru... |
12.8.2 subject to Section 12.10, if AbbVie exercised its License Option prior to such termination, AbbVie shall, and hereby does effective as of the effective date of termination, grant Licensor an exclusive option to acquire, subject to AbbVie's reasonable discretion, a co-exclusive or non-exclusive, royalty-bearing l... |
12.9 Transition Agreement. |
12.9.1 In the event of termination of this Agreement, whether in its entirety or with respect to the Terminated Territory, Licensor and AbbVie shall negotiate in good faith the terms and conditions of a written transition agreement (the "Transition Agreement") pursuant to which AbbVie and Licensor will effectuate and c... |
12.9.2 The Transition Agreement shall provide that in the event of a termination of this Agreement in its entirety by AbbVie pursuant to Section 12.3 or by Licensor pursuant to Section 12.2.1, 12.4 or 12.5, AbbVie shall: |
(a) where permitted by Applicable Law, grant to Licensor a right to reference to all Regulatory Documentation then owned by AbbVie and in its name applicable to the Licensed Products in the Territory that are the subject of the license grant in Section 12.7.1(c); |
(b) notify the applicable Regulatory Authorities and take any other action reasonably necessary to effect the transfer set forth in clause (a) above; |
(c) unless expressly prohibited by any Regulatory Authority, transfer control to Licensor of all Clinical Studies being conducted by AbbVie as of the effective date of termination and continue to conduct such Clinical Studies, at Licensor's cost, for up to six (6) months to enable such transfer to be completed without ... |
(d) assign (or cause its Affiliates to assign) to Licensor all agreements with any Third Party with respect to the conduct of Clinical Studies for the Licensed Products, including agreements with contract research organizations, clinical sites, investigators and manufacturing providers, unless, with respect to any such... |
12.9.3 The Transition Agreement shall provide that in the event of a termination of this Agreement with respect to a country or other jurisdiction by AbbVie pursuant to Section 12.3 or with respect to a Terminated Territory by Licensor pursuant to Section 12.2.1 (but not in the case of any termination of this Agreement... |
(a) where permitted by Applicable Law, transfer to Licensor all of its right, title, and interest in the Regulatory Approval then owned by AbbVie and in its name that is solely applicable to the Terminated Territory and to the Licensed Products that are the subject of the license grant in Section 12.8.2, as such Regula... |
(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 Licensor a right of reference to all Regulatory Documentation then owned by AbbVie and in AbbVie's name that are necessary or reasonably useful for Licensor, any of its Affiliates or sublicensees to Develop or Commercialize any Licensed Products that are the subject of the license grant in Section 12.8.2, as ... |
12.10 Reverse Royalty. If this Agreement is terminated in its entirety or with respect to one (1) or more Terminated Territories, and in connection therewith, Licensor exercises either its Grantback Option or its Terminated Territory Grantback Option, pursuant to Section 12.7 or 12.8, in consideration of the licenses g... |
12.11 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. |
12.12 Accrued Rights; Surviving Obligations. |
12.12.1 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. Such termination or exp... |
12.12.2 Notwithstanding the termination of AbbVie's licenses and other rights under this Agreement or with respect to a country or other jurisdiction, as the case may be, AbbVie shall have the right for up to one (1) year after the effective date of such termination with respect to each country or other jurisdiction wi... |
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 (a) such failure or delay is caused by or results from events beyond the reasonable co... |
13.2 Change in Control of Licensor. |
13.2.1 Licensor (or its successor) shall provide AbbVie with written notice of any Change in Control of Licensor within two (2) Business Days following the closing date of such transaction. |
13.2.2 In the event of a Change in Control of Licensor, AbbVie shall have the right, in its sole and absolute discretion, by written notice delivered to Licensor (or its successor) at any time during the one hundred eighty (180) days following the written notice contemplated by Section 13.2.1, to (a) terminate any or a... |
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. |
13.4.1 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 any of its ri... |
13.4.2 The rights to Information, Patents, materials and other intellectual property: (a) Controlled by a Third Party permitted assignee of a Party, which Information, Patents, materials and other intellectual property were Controlled by such assignee immediately prior to such assignment; or (b) Controlled by an Affili... |
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 Governing Law, Jurisdiction and Service. |
13.6.1 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 in... |
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 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 2.2.3, 6.14 or 13.11, if a dispute arises between the Parties in connection with or relating to this Agreement or any document or instrument delivered in connection herewith (a "Dispute"), it shall be resolved pursuant to this ... |
13.7.1 General. Any Dispute shall first be referred to the Senior Officers of the Parties, who shall confer in good faith on the resolution of the issue. Any final decision mutually agreed to by the Senior Officers shall be conclusive and binding on the Parties. If the Senior Officers are not able to agree on the resol... |
13.7.2 Intellectual Property Disputes. In the event that a Dispute arises with respect to the validity, enforceability, scope or patentability of any Patent, Trademark or other intellectual property rights, and such Dispute cannot be resolved in accordance with Section 13.7.1, unless otherwise agreed by the Parties in ... |
13.7.3 ADR. Any ADR proceeding under this Agreement shall take place pursuant to the procedures set forth on Schedule 13.7.3. |
13.7.4 Adverse Ruling. Any determination pursuant to this Section 13.7 that a Party is in material breach of its material 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, nothing in this Section 13.7 shall preclude either Party from seeking interim or provisional relief, including a temporary restraining order, preliminary injunction or other interim equitable relief concerning a Dispute, if necessary to protect the... |
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 transmis... |
13.8.2 Address for Notice. |
If to AbbVie, to: |
AbbVie Inc. |
1 North Waukegan Road |
North Chicago, Illinois 60064 United States |
Attention: Vice Chairman, External Affairs, Chief Legal Officer and Corporate Secretary |
Facsimile: (847) 935-3294 |
with a copy (which shall not constitute notice) to: |
Baker McKenzie |
452 Fifth Avenue |
New York, NY 10018 United States |
Attention: Denis Segota |
Facsimile: (212) 310-1816 |
If to Licensor, to: |
Opsidio, LLC |
121 Pennswood Rd |
Bryn Mawr, PA 19010 |
Fax is N/A |
Attention: CEO |
with a copy (which shall not constitute notice) to: |
Cooley LLP |
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