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4.3 Grants to Calibr; AbbVie Platform Improvements. Subject to Section 4.5 and Section 4.7, AbbVie hereby grants to Calibr and its Affiliates, during the performance of Calibr's Development activities under the Target Research Plan, Platform Improvement Plan, PRLR Switch Plan, SST Switch Plan or the CD19 Plan, a non-ex... |
4.4 Sublicenses. AbbVie shall have the right to grant sublicenses and further rights of reference, through multiple tiers of Sublicensees, under and limited to the scope of the licenses and rights of reference granted in Section 4.1 to its Affiliates and other Third Parties. Each sublicense with a Third Party shall be ... |
4.5 Retention of Rights. |
4.5.1 Reservation of Rights. Notwithstanding the exclusive licenses granted above, Calibr retains the right under the Calibr IP and Calibr's interests in the Joint IP, if any, to perform its obligations under this Agreement, including as set forth in, and subject to, the Target Research Plan, the CD19 Plan, the PRLR Sw... |
4.5.2 Non-Calibr Components. For clarity, and notwithstanding the foregoing Section 4.1, Calibr does not grant, and AbbVie does not receive, any rights under the Calibr IP licensed in Section 4.1 to the extent any such Calibr IP claims any Active Agent. |
4.5.3 No Implied Rights. Except as expressly provided herein, AbbVie grants no other right or license, including any rights or licenses to the AbbVie IP or AbbVie's interest in the Joint IP, if any, or any other Patent or intellectual property rights not otherwise expressly granted herein. |
4.6 Confirmatory Patent License. Calibr shall, if requested to do so by AbbVie and at AbbVie's cost and expense, immediately enter into confirmatory license agreements in such form as may be reasonably requested by AbbVie for purposes of recording the licenses granted under this Agreement with such patent offices in th... |
4.7 Exclusivity. |
4.7.1 Target Exclusivity. |
(a) With respect to each Category 1 Target during the period beginning on the Inclusion Date for such Category 1 Target and ending on the last day of the Term, Calibr shall not, and shall cause its Affiliates not to (except with respect to Development activities conducted under this Agreement in accordance with the Tar... |
(b) With respect to each Category 2 Target during the period beginning on the Inclusion Date for such Category 2 Target and ending on the last day of the Term, Calibr shall not, and shall cause its Affiliates not to (except with respect to Development activities conducted under this Agreement in accordance with the Tar... |
(c) With respect to each AbbVie Target, during the period beginning on the Inclusion Date for such AbbVie Target and ending on the first to occur of (i) the fifth (5th) anniversary of the last day of the Term and (ii) the date that such Target no longer meets the qualifications for an AbbVie Target, Calibr shall not, a... |
4.7.2 CD19 Exclusivity. Subject to Section 4.7.4, Calibr shall not, and shall cause its Affiliates not to: (a) Exploit or (b) license, authorize, appoint or otherwise assist or enable any Third Party to Exploit, in either case ((a) or (b)), any CD19 Product until (i) if AbbVie does not exercise the CD19 License Option,... |
4.7.3 Platform Exclusivity. Subject to Section 4.7.4, during the New Platform Exclusivity Period, Calibr shall not, and shall cause its Affiliates not to: (a) Exploit or (b) license, authorize, appoint or otherwise assist or enable any Third Party to Exploit, in either case ((a) or (b)), any product or process that use... |
4.7.4 Academic Collaborations. Notwithstanding Section 4.7.2 and Section 4.7.3, Calibr shall have the right to license, authorize, appoint, and otherwise assist or enable any academic institution, nonprofit organization (including nonprofit foundations) or government agency to perform non-commercial research activities... |
4.7.5 Calibr Change of Control. |
(a) Calibr (or its successor) shall provide AbbVie with written notice of any Change of Control of Calibr within two (2) Business Days following the earlier of the first public announcement of the execution of any agreement with respect to such Change of Control and the closing date of such Change of Control. In the ev... |
(b) If AbbVie elects, pursuant to Section 4.7.5(a)(i)(A) to undertake activities then being performed by Calibr, Calibr shall perform a technology transfer of those portions of the sCAR-T Platform and all Calibr Know-How reasonably necessary to enable AbbVie to conduct the activities under such Target Research Plan, th... |
4.7.6 Acknowledgement. Calibr acknowledges and agrees that (a) this Section 4.7 has been negotiated by the Parties, (b) the geographical and time limitations on activities set forth in this Section 4.7 are agreed as necessary for the adequate protection of the activities under this Agreement and (c) AbbVie would not ha... |
ARTICLE 5 DEVELOPMENT AND COMMERCIALIZATION BY ABBVIE |
5.1 In General. |
5.1.1 Licensed Products Prior to Platform Option Exercise. With respect to each Research Target, as of the Inclusion Date for such Research Target, subject to Calibr's obligations under Article 2 with respect to the Target Research Plan, PRLR Switch Plan or SST Switch Plan, AbbVie (itself or through its Affiliates or i... |
5.1.2 CD19 Licensed Products. From and after the Option Effective Date for the CD19 License Option, AbbVie (itself or through its Affiliates or its or their Sublicensees), at its sole cost and expense (subject to Calibr's exercise of the Cost-Sharing Option), shall, as between the Parties, have the sole right to furthe... |
5.1.3 Licensed Products Post Platform Option Exercise. From and after the Option Effective Date for the Platform Option, AbbVie (itself or through its Affiliates or its or their Sublicensees), at its sole cost and expense, shall, as between the Parties, have the sole right to further Develop, Manufacture, Commercialize... |
5.1.4 Early Assumption of Development Activities. At any time after the A&R Effective Date, AbbVie shall have the right, at AbbVie's sole election upon written notice to Calibr, to assume control of Calibr's Development activities (a) with respect to each Research Target, under the Target Research Plan with respect to ... |
5.2 Diligence. From and after the Acceptance Date for each Selected Target and any Substitute Target and subject to Calibr's performance of its obligations under the PRLR Switch Plan or SST Switch Plan, if applicable, and technology transfer obligations pursuant to Section 5.3, unless and until AbbVie exercises the Pla... |
5.3 Manufacturing Technology Transfer. |
5.3.1 Overview. With respect to each Technology Transfer Product, upon AbbVie's written request in accordance with this Section 5.3, Calibr shall effect a full transfer to AbbVie or its designee (which designee may be an Affiliate or a Third Party manufacturer) of all Information relating to the then-current process fo... |
5.3.2 Manufacturing Transfer Assistance. With respect to each Manufacturing Technology Transfer, Calibr shall provide, and shall cause its Affiliates to provide and, in the case of Third Party manufacturers, use reasonable efforts to cause such Third Party(ies) to provide, all reasonable assistance requested by AbbVie ... |
5.3.3 Manufacturing Information Transfer. Calibr shall make available, and shall cause its Affiliates and use reasonable efforts to cause the relevant Third Party manufacturers to make available, to AbbVie (or its Affiliate or designated Third Party manufacturer, as applicable) from time to time as AbbVie may request, ... |
5.3.4 Delivery of Existing Material. Calibr shall assign, upon AbbVie's written request in accordance with this Section 5.3, to AbbVie all of its right, title and interest in and to, and shall deliver to AbbVie, all cell banks (including master cell banks and working cell banks), sCAR-T cells and reagents (including Le... |
5.3.5 General Training Assistance. Calibr shall cause all appropriate employees and representatives of Calibr, its Affiliates to meet, and shall use reasonable efforts to cause its Third Party manufacturers to meet, with employees or representatives of AbbVie (or its Affiliate or designated Third Party manufacturer, as... |
5.3.6 Quality Control Assistance. Without limiting the generality of Section 5.3.5, Calibr shall cause all appropriate analytical and quality control laboratory employees and representatives of Calibr, its Affiliates and, shall use reasonable efforts to cause appropriate analytical and quality control laboratory employ... |
5.3.7 Licenses and Permits. Calibr shall take such steps, and shall cause its Affiliates and Third Party manufacturers to take such steps, as are reasonably necessary or useful to assist AbbVie (or its Affiliate or designated Third Party manufacturer, as applicable) in obtaining any necessary licenses, permits or appro... |
5.3.8 Further Assurances. Calibr shall provide, and shall cause its Affiliates and Third Party manufacturers to provide, such other assistance as AbbVie (or its Affiliate or designated Third Party manufacturer, as applicable) may reasonably request to enable AbbVie (or its Affiliate or designated Third Party manufactur... |
5.3.9 Limitations. In connection with any of the foregoing obligations in this Section 5.3 with respect to any Technology Transfer Product, Calibr's obligations to provide personnel and support shall be limited to an aggregate of five hundred (500) FTE hours (which shall be free of charge to AbbVie). Thereafter, if req... |
5.4 Subcontracting; Distributors. AbbVie shall have the right to subcontract any of its Development, Manufacturing or Commercialization activities to a Third Party (including by appointing one (1) or more contract sales forces, co-promotion partners or Distributors); provided, that no such permitted subcontracting shal... |
5.5 Development and Commercialization Reports. Unless AbbVie has exercised the Platform Option, during the Royalty Term for a Licensed Product, or if AbbVie does exercise the Platform Option, until the last Earnout Payment becomes payable, AbbVie shall provide reports to Calibr summarizing in reasonable detail AbbVie's... |
5.6 Regulatory Activities. AbbVie shall, as between the Parties, have the sole right to prepare, obtain and maintain BLAs (including the setting of the overall regulatory strategy therefor), other Regulatory Approvals and other submissions and to conduct communications with the Regulatory Authorities in the Territory f... |
ARTICLE 6 JOINT GOVERNANCE COMMITTEES |
6.1 Target Discovery Joint Research Committee. Within fifteen (15) days after the Original Effective Date, the Parties shall establish a joint target discovery joint research committee (the "TD-JRC"), which shall consist of three (3) representatives from each Party, each with the requisite experience and seniority to e... |
6.1.1 prepare and approve the SST Initial Research Plan if requested by AbbVie; |
6.1.2 prepare and approve the SST Switch Plan if AbbVie exercises the SST Option; |
6.1.3 review and approve any amendments or updates to the Target Research Plan (including the PRLR Interim Research Plan or SST Initial Research Plan), PRLR Switch Plan, SST Switch Plan or Platform Improvement Plan; |
6.1.4 consider and collaboratively determine the direction of the Development with respect to the composition of each Research Target Product and the Research Target(s) to which each Research Target Products shall be Directed to; |
6.1.5 consider and collaboratively determine potential armoring strategies for Research Target Products based on the current scientific art, including determining the direction of the Development with respect to the use or addition of Additional Genes in connection with one or more Research Target Products under the Ta... |
6.1.6 direct and monitor Calibr's Development activities under the Target Research Plan, Platform Improvement Plan, PRLR Switch Plan and SST Switch Plan (including clinical and regulatory decisions with respect to the PRLR Switch Plan and SST Switch Plan, if applicable) and review Calibr's progress against the Target R... |
6.1.7 with respect to each Decision Point for each Research Target, determine whether the Development of the Research Target Products directed to such Research Target should proceed; |
6.1.8 review and discuss Calibr's Development activities with respect to products containing Calibr Components Directed to any Existing Target; |
6.1.9 review and discuss AbbVie's Development activities with respect to the Licensed Products; |
6.1.10 review and discuss the Manufacturing of the Licensed Products; and |
6.1.11 perform such other functions as are set forth herein, if and as applicable, or as the Parties may mutually agree in writing. |
6.2 CD19 Platform Proof-of-Principle Joint Development Committee. Within fifteen (15) days after the Original Effective Date, the Parties shall establish a CD19 joint development committee (the "CD19-JDC"), which shall consist of three (3) representatives from each Party, each with the requisite experience and seniorit... |
6.2.1 review and approve any amendments or updates to the CD19 Plan; |
6.2.2 direct and supervise Calibr's Development activities under the CD19 Plan (including clinical and regulatory decisions with respect thereto) and review Calibr's progress against the CD19 Plan; |
6.2.3 review and discuss AbbVie's Development activities with respect to the CD19 Licensed Products after AbbVie exercises the CD19 License Option; |
6.2.4 review and discuss the Manufacturing of the CD19 Products under the CD19 Plan; |
6.2.5 discuss the utility in conducting ongoing stability studies for existing stored drug product based on AbbVie's then-current non-binding position regarding whether it intends to exercise the CD19 Autoimmune Option; and |
6.2.6 perform such other functions as are set forth herein, if and as applicable, or as the Parties may mutually agree in writing. |
6.3 General Provisions Applicable to a Committee. |
6.3.1 Meetings and Minutes. The TD-JRC and CD19-JDC (each, a "Committee") shall each meet quarterly or as otherwise agreed to by the Parties, with the location of in-person meetings alternating between a location designated by Calibr and a location designated by AbbVie, with AbbVie designating the place of the first me... |
6.3.2 Procedural Rules. Each Committee shall have the right to adopt such standing rules as shall be necessary for its work, to the extent that such rules are not inconsistent with this Agreement. A quorum of each Committee shall exist whenever there is present at a meeting at least one (1) representative appointed by ... |
6.3.3 Limitations on Authority. Without limitation to the foregoing, each Party hereby agrees that matters explicitly reserved to the consent, approval or other decision-making authority of one or both Parties, as expressly provided in this Agreement, are outside the jurisdiction and authority of any Committee, includi... |
6.3.4 Discontinuation; Disbandment. Each Committee shall continue to exist until the first to occur of: (a) the Parties mutually agreeing to disband such Committee, (b) AbbVie's request if AbbVie exercises the Platform Option, (c) upon AbbVie's request after the First Commercial Sale of the first (1st) Licensed Product... |
6.4 Decision-Making. Subject to the following provisions of this Section 6.4, each Committee shall take action by consensus of the representatives present at a meeting at which a quorum exists, with each Party having a single vote irrespective of the number of representatives of such Party in attendance, or by a writte... |
6.4.1 TD-JRC Final Decision Making Authority. With respect to issues within the jurisdiction of the TD-JRC, (a) for issues other than a Deadlocked Dispute or any dispute described in clause (b), AbbVie shall have final decision-making authority, (b) for issues regarding amendments to the Platform Improvement Plan that ... |
6.4.2 CD19-JDC Final Decision Making Authority. With respect to issues within the jurisdiction of the CD19-JDC, Calibr shall have final decision-making authority; provided, that: (a) the CD19-JDC shall approve the Initial CD19 Autoimmune Subplan as an amendment to the CD19 Plan upon AbbVie's exercise of the CD19 Autoim... |
6.5 Working Groups. From time to time, either Committee may establish and delegate duties within the scope of authority of such Committee to other committees or directed teams (each, a "Working Group") on an "as-needed" basis to oversee particular projects or activities. Each such Working Group shall be constituted and... |
6.6 Alliance Managers. Each Party shall appoint an individual who shall oversee contact between the Parties for all matters between meetings of the Committees and shall have such other responsibilities as the Parties may agree in writing after the Original Effective Date, which individual may be replaced at any time by... |
ARTICLE 7 PAYMENTS AND RECORDS |
7.1 Upfront Payments. Subject to the terms and conditions of this Agreement, no later than thirty (30) days after the Original Effective Date, AbbVie shall pay Calibr in consideration of the licenses and license options granted by Calibr to AbbVie hereunder a non-creditable, non-refundable payment of Fifty-Five Million... |
7.2 Platform Option Extension Fee. Subject to the terms and conditions of this Agreement, no later than thirty (30) days after the A&R Effective Date, AbbVie shall pay Calibr in consideration of the licenses and license options granted by Calibr to AbbVie hereunder a non-creditable, non-refundable payment of Forty-Four... |
7.3 Platform Extension Payment. If AbbVie provides written notice to Calibr in accordance with Section 3.2.2 at least ninety (90) days before the fifth (5th) anniversary of the A&R Effective Date of its desire to extend the New Platform Exclusivity Period by twelve (12) months, then AbbVie shall pay to Calibr within th... |
7.4 CD19 Autoimmune Option Fee. Within thirty (30) days after the CD19-JDC approves an amendment to the CD19 Plan to include the Initial CD19 Autoimmune Subplan in accordance with Section 2.2.2, AbbVie shall pay to Calibr, as partial consideration for the rights granted under this Agreement with respect to the CD19 Aut... |
7.5 Non-Platform Option Milestones. |
7.5.1 Research Target Milestones and CD19 Milestones. Unless and until AbbVie exercises the Platform Option, AbbVie shall make the following one-time milestone payments (each, a "Milestone Payment") to Calibr upon first achievement of the corresponding milestone events (each, a "Milestone Event") listed below. AbbVie s... |
[MILESTONE TABLE CONTENT APPEARS TO BE MISSING] |
7.5.2 Sales Milestones. On a Licensed Product-by-Licensed Product basis, unless AbbVie has exercised the Platform Option, AbbVie shall pay to Calibr a one-time, non-refundable, non-creditable milestone payment within forty five (45) days after the end of the Calendar Quarter in which worldwide annual Net Sales of a Lic... |
[SALES MILESTONE TABLE CONTENT APPEARS TO BE MISSING] |
7.5.3 Skipped Milestone Events. If a Milestone Event happens for a Licensed Product but such Licensed Product has not previously achieved all earlier Milestone Events (such as when a clinical development program does not include a Phase I Clinical Trial or Phase II Clinical Trial in a conventional progression or a Mile... |
7.6 Royalties. |
7.6.1 Royalty Rates. Subject to the remainder of this Section 7.6, and unless AbbVie has exercised the Platform Option, AbbVie shall pay to Calibr a royalty on annual (Calendar Year) aggregate Net Sales of each Licensed Product that is not a Cost-Share Product in the Territory during the applicable Royalty Term for suc... |
using such Licensed Product (or any Calibr Component included in such Licensed Product), which method covers an indication for which such Licensed Product has received Regulatory Approval in such country or (II) a method of making such Licensed Product (or any Calibr Component included in such Licensed Product), for co... |
(b) if in any country in the Territory during the Royalty Term in such country for a Licensed Product, a Biosimilar Product with respect to such Licensed Product is launched in such country, then; (i) starting with the Calendar Quarter in which unit sales of all Biosimilar Products for such Licensed Product in such cou... |
(c) except as otherwise provided in Section 7.6.4(d), if AbbVie enters into a Third Party Agreement in order to obtain a license or other right to a Third Party Right with respect to a Licensed Product in one (1) or more countries in the Territory pursuant to Section 8.9, other than any Third Party Rights with respect ... |
(d) if AbbVie enters into a Third Party Agreement in order to obtain a license or other right to a Third Party Right with respect to a Licensed Product in one (1) or more countries in the Territory pursuant to Section 8.9 that is necessary to avoid infringing or misappropriating a Patent, trade secret or other intellec... |
(e) if, during the Royalty Term for a Licensed Product, such Licensed Product is designated as a "selected drug" by the Secretary of the U.S. Department of Health and Human Services (in accordance with Section 1192(a) of the Social Security Act), and AbbVie is required to negotiate a maximum fair price (as defined in S... |
(f) AbbVie shall be entitled to the deductions set forth in Section 8.8.4, if applicable. |
Any reductions set forth in Section 7.6.4 shall be applied to the royalty rate payable to Calibr under Section 7.6.1, Section 7.6.2 or Section 7.7, as applicable, in the order in which the event triggering such reduction occurs. For purposes of this Section 7.6, the portion of Net Sales of a Licensed Product in each co... |
7.6.5 Cap on Reductions. In no event shall the royalty rate payable to Calibr under Section 7.6.1 or Section 7.6.2, as applicable, for a particular Licensed Product be reduced by more than fifty percent (50%) of what it would otherwise be in any Calendar Quarter as a result of the reductions set forth in Section 7.6.4(... |
7.13 Taxes. |
7.13.1 Withholding Taxes. If any amount to be paid to either Party hereunder is subject to any withholding or similar tax, the Parties shall use their commercially reasonable efforts to do all such acts and things and to sign all such documents as will enable them to take advantage of (a) any applicable double taxation... |
7.13.2 Indirect Taxes. All payments are exclusive of value added taxes, sales taxes, consumption taxes and other similar taxes (the "Indirect Taxes"). If any Indirect Taxes are chargeable in respect of any payments, the payor Party shall pay such Indirect Taxes at the applicable rate in respect of such payments followi... |
7.13.3 Changes in Domicile. Notwithstanding anything to the contrary in this Agreement, if the payor Party assigns, transfers or otherwise disposes of some or all of its rights and obligations to any Person and if, as a result of such action, the withholding or deduction of tax required by Applicable Laws with respect ... |
7.14 Interest on Late Payments. If any payment due to either Party under this Agreement is not paid when due, then the payor Party with respect thereto shall pay interest thereon (before and after any judgment) at a rate (with interest accruing on a daily basis) equal to the lesser of: (a) two hundred (200) basis point... |
7.15 Financial Records. AbbVie shall, and shall cause its Affiliates and its and their Sublicensees to, keep complete and accurate financial books and records pertaining to Net Sales, and Calibr shall, and shall cause its Affiliates and its and their (sub)licensees to, keep complete and accurate financial books and rec... |
7.16 Audit. |
7.16.1 Procedures. At the request of the other Party, each Party shall, and shall cause its Affiliates and its and their (sub)licensees to, permit an independent auditor designated by the other Party and reasonably acceptable to the audited Party, at reasonable times and upon reasonable notice, to audit the books and r... |
7.16.2 Audit Dispute. In the event of a dispute with respect to any audit under Section 7.16.1, the Parties shall work in good faith to resolve the dispute. If the Parties are unable to reach a mutually acceptable resolution of any such dispute within thirty (30) days after one Party notifies the other Party of such di... |
7.16.3 Confidentiality. The Receiving Party shall treat all information subject to review under this Article 7 in accordance with the confidentiality provisions of Article 9. The audited Party shall not be obligated to provide any information to the independent auditor pursuant to Section 7.16.1 or the Auditor pursuant... |
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