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10.3 Additional Covenants of Calibr. |
10.3.1 Non-Infringement Covenant. From and after the Original Execution Date, Calibr shall not, and shall cause its Affiliates not to, (a) misappropriate, infringe or use without authorization any valid and enforceable intellectual property rights of a Third Party in connection with the performance of its activities un... |
10.3.2 Board of Director Conflicts of Interest. Calibr shall maintain and take steps to ensure compliance with one or more policies to identify, review and manage actual or potential conflicts of interest involving the members of its Board of Directors, officers and employees, including requiring members of the Board o... |
10.3.3 Scripps License Agreement. Within forty five (45) days after the Original Effective Date, The California Institute for Biomedical Research shall enter into an amendment in substantially the form attached hereto as Schedule 10.3.3 with The Scripps Research Institute. |
10.3.4 Merck. Calibr shall not, and shall cause its Affiliates not to, provide to Merck any Information regarding the sCAR-T Platform or any of the activities under this Agreement. |
10.3.5 Patent Management. At all times during the Term, except to the extent otherwise consented to by AbbVie in writing, such consent not to be unreasonably conditioned, withheld or delayed, Calibr shall (a) maintain patent protection on, and shall not decide not to pursue, discontinue its financial support for, aband... |
10.3.6 Wellcome Trust. Promptly after the Original Effective Date, Calibr shall use its best efforts to enter into an amendment with Wellcome, in a form reasonably acceptable to AbbVie, to amend the Wellcome Agreement to terminate Wellcome's rights under the Wellcome Agreement to (a) pursue, file, prosecute, protect, m... |
10.3.7 UCSD. Calibr shall not, and shall cause its Affiliates not to, use in connection with any activities under this Agreement any PCSD1 cells provided to Calibr or any of its Affiliates by the University of California, San Diego pursuant to that certain Material Transfer Agreement by and between Calibr and the Regen... |
10.3.8 Government Interest Matters. |
(a) Calibr shall, or shall use reasonable efforts to cause any applicable licensor to, take all actions necessary under the Bayh Dole Act to secure ownership of Patents that would constitute Calibr Patents that claim any Federally Funded Inventions for Calibr or its applicable licensor, including complying with all rep... |
(b) Calibr shall (i) not use or permit any funding or other resources of any Governmental Authority to be used in connection with the performance of any activities undertaken by or on behalf of Calibr under the Target Research Plan, the CD19 Plan, PRLR Switch Plan or SST Switch Plan, without the prior written consent o... |
(c) If any Licensed Product or any Calibr Component included in such Licensed Product becomes a "subject invention" as that term is described in 35 U.S.C. § 201(e) or is produced through the use of a "subject invention" including as a result of Calibr's failure to comply with the restrictions in Section 10.3.8(b), at A... |
10.3.9 Wellcome. Promptly after the Original Effective Date, Calibr shall negotiate with Wellcome and execute, as soon as practicable, a Revenue and Equity Sharing Agreement (as defined in the Wellcome Agreement) and, as soon as practicable thereafter, negotiate with Wellcome and execute an agreement setting forth the ... |
10.3.10 WuXi. Calibr shall make all payments necessary to obtain the assignment of intellectual property under any agreements relating to the sCAR-T technology between The California Institute for Biomedical Research and WuXi Advanced Therapies, including WO-001, dated May 31, 2018, subject to Calibr's withholding of a... |
10.4 Data Privacy and Security. For all Personal Data Processed by or on behalf of either Party or any of its Affiliates in performance of this Agreement, including, with respect to Calibr the conduct of the Phase I Clinical Trials under the PRLR Switch Plan, SST Switch Plan, CD19 Plan and in connection with the prepar... |
10.4.1 comply at all times with the applicable Data Protection Laws to which such Party is subject in accordance with Applicable Law; |
10.4.2 to the extent permitted by Applicable Law, notify the other Party, as soon as practicable and in any event prior to making the relevant disclosure, if it is obliged to make a disclosure of the Agreement Data under any statutory requirement; |
10.4.3 make timely notification to and obtain any necessary authorizations from any relevant data protection regulator where required under applicable Data Protection Laws of its collection and other Processing of Agreement Data in order to comply with its obligations under this Agreement; |
10.4.4 at all times, act in a manner such that it is not subject to any prohibition or restriction which shall (a) prevent or restrict it from disclosing or transferring the Agreement Data to the other Party as required under this Agreement or (b) prevent or restrict such other Party from Processing the Agreement Data ... |
10.4.5 ensure that all fair Processing notices or informed consents have been obtained and are maintained and are sufficient in scope to enable such Party to Process the Agreement Data as required in order to comply with its obligations under this Agreement to obtain the benefit of its rights and to fulfil its obligati... |
10.4.6 implement and maintain reasonable administrative, technical, organizational and physical safeguards designed to (a) maintain the security and confidentiality of all Agreement Data, (b) protect against reasonably anticipated threats or hazards to the security or integrity of Agreement Data and (c) protect against... |
10.4.7 notify the other Party promptly, and in any event within forty-eight (48) hours, of receipt of (a) any correspondence from a data protection regulator in relation to the Processing of Agreement Data related to this Agreement or (b) a request or notice from a data subject exercising his rights under applicable Da... |
10.4.8 refrain from taking actions related to the Processing of the Personal Data under this Agreement, which would be reasonably likely to damage or impair the other Party's reputation. |
10.5 Data Export. In the event that a Party needs to transfer Agreement Data originating from a Member State of the European Economic Area to an entity in a Third Country, such Party shall enter into then-applicable European Union standard contractual clauses or other required agreements under applicable Data Protectio... |
10.6 Debarment. Neither Party nor any of its Affiliates has been debarred or is subject to debarment and neither it nor any of its Affiliates will use in any capacity, in connection with the activities to be performed under this Agreement, any Person who has been debarred pursuant to Section 306 of the FFDCA or who is ... |
10.7 DISCLAIMER OF WARRANTIES. EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH HEREIN, NEITHER PARTY MAKES ANY REPRESENTATIONS OR GRANTS ANY WARRANTIES, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, AND EACH PARTY SPECIFICALLY DISCLAIMS ANY OTHER WARRANTIES, WHETHER WRITTEN OR ORAL OR ... |
10.8 Anti-Bribery and Anti-Corruption Compliance. Each Party represents, warrants, and covenants to the other Party in connection with this Agreement that such Party and its Affiliates (a) have complied and shall comply with all applicable laws, rules, regulations and industry codes governing bribery, money laundering,... |
ARTICLE 11 INDEMNITY |
11.1 Indemnification of Calibr. AbbVie shall indemnify Calibr, its Affiliates and its and their respective directors, officers, employees and agents (collectively, "Calibr Indemnitees"), and defend and save each of them harmless, from and against any and all losses, damages, liabilities, costs and expenses (including r... |
11.2 Indemnification of AbbVie. Calibr shall indemnify AbbVie, its Affiliates and its and their respective directors, officers, employees and agents (collectively, "AbbVie Indemnitees"), and defend (except as provided in Section 8.8.2) and save each of them harmless, from and against any and all Losses in connection wi... |
11.3 Indemnification Procedures. |
11.3.1 Notice of Claim. All indemnification claims in respect of an AbbVie Indemnitee or a Calibr Indemnitee shall be made solely by Calibr or AbbVie, as applicable (each of Calibr or AbbVie in such capacity, the "Indemnified Party"). The Indemnified Party shall give the indemnifying Party (each of Calibr or AbbVie in ... |
11.3.2 Control of Defense. At its option, the Indemnifying Party may assume the defense of any Third Party Claim, except for any Third Party Infringement Claim, the procedures for which are set forth in Section 8.8.2, by notifying the Indemnified Party in writing within thirty (30) days after the Indemnifying Party's r... |
11.3.3 Right to Participate in Defense. Any Indemnified Party shall be entitled to participate in, but not control, the defense of a Third Party Claim and to employ counsel of its choice for such purpose; provided, that such employment shall be at the Indemnified Party's sole cost and expense unless (a) the employment ... |
11.3.4 Settlement. With respect to any Third Party Claim for which the Indemnifying Party has assumed the defense of such Third Party Claim in accordance with Section 11.3.2 that relates solely to the payment of money damages in connection with such Third Party Claim and that will not result in any AbbVie Indemnitee or... |
11.3.5 Cooperation. Regardless of whether the Indemnifying Party chooses to defend or prosecute any Third Party Claim, the Indemnified Party shall, and shall cause each AbbVie Indemnitee or Calibr Indemnitee, as applicable, to, reasonably cooperate in the defense or prosecution thereof and shall furnish such records, i... |
11.3.6 Expenses. Except as provided above, the costs and expenses, including fees and disbursements of counsel, incurred by the Indemnified Party in connection with any claim shall be reimbursed on a Calendar Quarter basis by the Indemnifying Party, without prejudice to the Indemnifying Party's right to contest any Abb... |
11.4 Special, Indirect and Other Losses. EXCEPT (A) IN THE EVENT OF THE WILLFUL MISCONDUCT OR FRAUD OF A PARTY OR OF A PARTY'S BREACH OF ITS OBLIGATIONS UNDER ARTICLE 9 OR SECTION 4.7, (B) AS PROVIDED UNDER SECTION 13.10, AND (C) TO THE EXTENT ANY SUCH DAMAGES ARE REQUIRED TO BE PAID TO A THIRD PARTY AS PART OF A CLAIM... |
11.5 Insurance. |
11.5.1 Calibr's Insurance Obligations. Calibr shall maintain, at its cost, type and amounts of insurance covering its activities hereunder as is reasonable under the circumstances, including insurance as is normal and customary in the research-based pharmaceutical industry generally for parties similarly situated, incl... |
11.5.2 AbbVie's Insurance Obligations. AbbVie shall have and maintain and AbbVie hereby represents, warrants and covenants to Calibr that it does have and shall maintain during the Term a self-insurance plan, adequate insurance against liability and other risks associated with its and its Affiliates' and any Sublicense... |
ARTICLE 12 TERM AND TERMINATION |
12.1 Term and Expiration. |
12.1.1 This Agreement shall take effect automatically without further action of either Party on the A&R Effective Date. This Agreement shall continue in force and effect until the date of expiration or earlier termination in accordance herewith. |
12.1.2 If AbbVie has not exercised the Platform Option, this Agreement shall, unless earlier terminated in accordance herewith, continue in force and effect until the date of expiration of the last Royalty Term for the last Licensed Product. If AbbVie has not exercised the Platform Option prior to the expiration of the... |
12.1.3 If AbbVie exercises the Platform Option, upon payment by AbbVie to Calibr of the Platform Option exercise fee in accordance with Section 3.2.2, this Agreement may only be terminated upon written agreement of the Parties. |
12.2 Termination. Prior to AbbVie's exercise of the Platform Option and payment by AbbVie to Calibr of the Platform Option exercise fee in accordance with Section 3.2.2, this Agreement may be terminated as follows. |
12.2.1 Material Breach. |
(a) In the event that either Party (the "Breaching Party") materially breaches any of its material obligations under this Agreement, in addition to any other right and remedy the other Party (the "Non-Breaching Party") may have, the Non-Breaching Party may terminate this Agreement by providing ninety (90) days' (or six... |
(b) Notwithstanding Section 12.2.1(a), if any uncured material breach by AbbVie of any of its material obligations under this Agreement is with respect to (i) only one (1) of the countries in the Territory, Calibr shall not have the right to terminate this Agreement in its entirety, but shall have the right to terminat... |
12.2.2 Additional Termination Rights. |
(a) AbbVie may terminate this Agreement at any time during the Term immediately upon written notice to Calibr (i) in its entirety if AbbVie in good faith determines that it is not advisable for AbbVie to continue to Develop or Commercialize the Licensed Products due to documented safety concerns or (ii) with respect to... |
(b) AbbVie may terminate this Agreement, in its entirety or on a country-by-country basis, for any or no reason, upon one hundred and eighty (180) days' prior written notice to Calibr. |
(c) AbbVie may terminate this Agreement pursuant to Section 10.8. |
12.2.3 Termination for Insolvency. In the event that either Party (or, if applicable, a parent of such 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 pro... |
12.2.4 Termination for Patent Challenge. If, during the Term, AbbVie or any of its Affiliates or Sublicensees of Calibr Patents under this Agreement: (a) commences, knowingly assists, induces, knowingly facilitates or otherwise voluntarily participates in any action or proceeding (including any administrative proceedin... |
12.3 Rights in Bankruptcy. All rights and licenses granted under or pursuant to this Agreement by AbbVie or Calibr are and shall otherwise be deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code or any analogous provisions in any other country or jurisdiction, licenses of rights to "intellectual pro... |
12.4 Consequences of Termination. |
12.4.1 Consequences of Termination. If this Agreement is terminated in its entirety, or with respect to a country (such country(ies), each a "Terminated Territory") or a Licensed Product(s) (such Licensed Product(s), each a "Terminated Product"), then the following shall apply: |
(a) All rights and licenses granted by Calibr to AbbVie under Section 4.1.1, Section 4.1.2 (if AbbVie exercises the CD19 License Option) and Section 4.1.3 shall immediately terminate and all rights and licenses granted by AbbVie to Calibr under Section 4.3 shall immediately terminate (i) in the case where this Agreemen... |
(b) If this Agreement is terminated by AbbVie pursuant to Section 12.2.2(b) or by Calibr pursuant to Section 12.2.1, Section 12.2.3, or Section 12.2.4, AbbVie shall, with respect to each Licensed Product (or Terminated Product, if applicable) that is a Reversion Product, (i) assign to Calibr any Program Product Inventi... |
(c) If this Agreement is terminated by AbbVie pursuant to Section 12.2.2(b), then on a Reversion-Product-by-Reversion Product and Terminated Territory-by-Terminated Territory basis for a period of ten (10) years following the date of the First Commercial Sale of such Reversion Product, Calibr shall pay to AbbVie a roya... |
(d) If Calibr requests, AbbVie shall reasonably cooperate with Calibr to facilitate orderly transition to Calibr or its designee of the Development and Commercialization of Reversion Products, including by, to the extent permitted under the relevant agreement at the time of termination, assigning to Calibr any agreemen... |
(e) AbbVie shall transfer to Calibr or Calibr's designee copies of all data, reports, records and materials, including all non-clinical and clinical data solely relating to any Reversion Products and all adverse event or other safety data, in AbbVie's (or its Affiliate's) possession and Control to the extent that such ... |
(f) Unless AbbVie terminated this Agreement pursuant to Section 12.2.2(a), AbbVie and Calibr shall promptly negotiate in good faith the terms and conditions of a written transition agreement pursuant to which, at Calibr's cost and expense (or, with respect to clause (i) and (ii) below, at AbbVie's cost and expense if t... |
(g) If AbbVie, any of its Affiliates or any Sublicensee is Manufacturing a Reversion Product, then, at Calibr's request, AbbVie shall supply such Reversion Product to Calibr in such form, and such quantities, as AbbVie or such Affiliate or Sublicensee is then Manufacturing such Reversion Product for worldwide use or us... |
(h) AbbVie shall, upon Calibr's written request, transfer to Calibr any inventory of Reversion Products for worldwide use or use in the Terminated Territory, as applicable, owned or under AbbVie's or any of its Affiliates or Sublicensees control (i.e., being stored at a warehouse) as of the termination date at the actu... |
(i) If, at the time of such termination, AbbVie or any of its Affiliates are conducting clinical trials for a Reversion Product, (A) if this Agreement is terminated with respect to the entire Territory anywhere in the world or (B) if this Agreement is terminated with respect to a Terminated Territory, that is reasonabl... |
12.4.2 Additional Calibr Rights. |
(a) Additional Reversion Data. Upon any termination of this Agreement, in addition to those provisions surviving under Section 12.7 and without limiting Section 12.4.1, AbbVie shall, within forty-five (45) days following the effective date of termination provide a high level summary to Calibr of any AbbVie IP or other ... |
(b) Calibr Option. Calibr shall have the right for ninety (90) days following the delivery of the Reversion Data from AbbVie to Calibr to elect to negotiate with AbbVie in good faith, for a period not to exceed one hundred and eighty (180) days (or such longer term as may be mutually agreed by the Parties), commerciall... |
(c) Option Limitations. It is understood and agreed that, without limiting Section 12.4.1, AbbVie's election to grant or not grant Calibr any rights under the AbbVie IP pursuant to the negotiations set forth in this Section 12.4.2, including the scope or terms thereof, are solely at AbbVie's discretion and the terms of... |
12.5 AbbVie Rights in Lieu of Termination. If AbbVie has the right to terminate this Agreement pursuant to Section 12.2.1 (including as may be finally determined in accordance with Section 13.5), then within ninety (90) days following the expiration of the relevant cure period AbbVie may, by written notice to Calibr, a... |
12.5.1 AbbVie may assume all activities previously performed by Calibr under this Agreement as they relate to (a) if the breach affects one (1) or more Target Programs, the Licensed Product(s) within such Target Program(s) and (b) if the breach is of a general nature, all Licensed Products (such Licensed Product(s) in ... |
12.5.2 the financial provisions set forth in Article 7 will continue to apply with respect to AbbVie's payment obligations hereunder following AbbVie's delivery of its notice to exercise its alternative remedy pursuant to this Section 12.5 provided, that (a) the Milestone Payments payable by AbbVie to Calibr pursuant t... |
12.5.3 Calibr's obligation to pay for any AbbVie Development Costs pursuant to Section 3.3.4, if applicable, shall terminate with respect to any AbbVie Development Costs incurred after the date of such notice and Calibr shall not have the right to exercise any Cost-Sharing Option; |
12.5.4 (a) if the Impacted Products are all the Licensed Products under this Agreement, AbbVie's diligence obligations under Section 5.2 shall terminate and (b) if the Impacted Products are Directed to an Included Existing Target, AbbVie's diligence obligations under Section 2.1.6(e) with respect to such Included Exist... |
12.5.5 all other provisions of this Agreement shall remain in full force and effect without change. |
12.6 Remedies. Except as otherwise expressly provided herein, termination of this Agreement in accordance with the provisions hereof shall not limit remedies that may otherwise be available in law or equity. |
12.7 Accrued Rights; Surviving Obligations. |
12.7.1 Survival. Termination or expiration of this Agreement for any reason will be without prejudice to any rights that will have accrued to the benefit of a Party prior to such termination or expiration; provided, that except as set forth in this Section 12.7.1, in no event shall Calibr accrue any rights to, and AbbV... |
12.7.2 Wind-Down. Notwithstanding the termination of AbbVie's licenses and other rights under this Agreement, AbbVie will have the right (except in the case of termination by Calibr pursuant to Section 12.2.1, Section 12.2.3 or Section 12.2.4 or by AbbVie pursuant to Section 12.2.2(b), where such right shall require Ca... |
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 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 shall not, and shall cause its Affiliates not to, export, directly or indirectly, ... |
13.3 Assignment. |
13.3.1 Neither Party may assign its rights or, except as provided in Section 2.6.2 or Section 5.4 or Section 13.19, delegate its obligations under this Agreement, whether by operation of law or otherwise, in whole or in part without the prior written consent of the other Party, which consent shall not be unreasonably c... |
13.3.2 AbbVie and Calibr each agrees that, notwithstanding any provision of this Agreement to the contrary, in the event that a Third Party merges or consolidates with or acquires a Party or an Affiliate of a Party, or a Party or an Affiliate of a Party transfers to a Third Party all or substantially all of its assets ... |
13.4 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 Agreeme... |
13.5 Dispute Resolution. Except as otherwise provided in Section 2.1.6, Section 6.4, Section 7.16.2, Section 13.10 or Section 13.11, any dispute arises between the Parties in connection with or relating to this Agreement or any document or instrument delivered in connection herewith (a "Dispute"), shall be resolved pur... |
13.5.1 General. All Disputes shall first be referred to the Senior Officers, who shall confer in good faith on the resolution thereof. Any final decision mutually agreed to by the Senior Officers in writing shall be conclusive and binding on the Parties. If the Senior Officers are not able to agree on the resolution of... |
13.5.2 Intellectual Property Disputes. If a Dispute arises with respect 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 13.5.1, unless otherwise agreed by the Parties in writing,... |
13.5.3 Adverse Ruling. Any determination pursuant to this Section 13.5 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. |
13.5.4 Interim Relief. Notwithstanding anything herein to the contrary, nothing in this Section 13.5 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... |
13.6 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 inte... |
13.7 Notices. |
13.7.1 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 delivered by hand or sent by facsimile transmission (with transmission co... |
13.7.2 Address for Notice. |
If to AbbVie, to: AbbVie Global Enterprises Ltd. 4th Floor, Washington House 16 Church Street Hamilton HM 11 Bermuda with a copy (which shall not constitute notice) to: AbbVie Inc. 1 North Waukegan Road North Chicago, Illinois 60064 United States Attention: Executive Vice President, External Affairs, General Counsel an... |
13.8 Entire Agreement; Amendments. This Agreement, together with the Schedules attached hereto, sets forth and constitutes the entire agreement and understanding between the Parties with respect to the subject matter hereof and, subject to Section 13.19, supersedes all prior agreements, understandings, promises and rep... |
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