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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... |
7.17 Right to Offset. Each Party shall have the right to offset any (a) undisputed amount or (b) disputed amount once such dispute has been finally resolved pursuant to Section 13.5, in each case ((a) and (b)), owed by the other Party to such first Party under or in connection with this Agreement, including pursuant to... |
7.18 Diagnostic or Veterinary Products. The royalties in Section 7.6 or Section 7.7 shall apply to the Development and Commercialization of Licensed Products for diagnostic, veterinary or any other non-human use, or for uses solely for screening patients who have been diagnosed with a disease, state or condition for el... |
7.19 Financial Obligations under In-License Agreements. Unless otherwise agreed by the Parties, Calibr shall be responsible for all payments owed to Third Parties under the In-License Agreements or any other agreement (including funding agreements) to which it is a Party. |
ARTICLE 8 INTELLECTUAL PROPERTY |
8.1 Ownership of Intellectual Property. |
8.1.1 Ownership of IP. Subject to the license grants and other rights herein, including Calibr's assignment obligation under Section 8.1.3, as between the Parties, each Party shall own and retain all right, title and interest in and to any and all Information and inventions that are conceived, discovered, developed or ... |
8.1.2 Ownership of Joint IP. Subject to Section 8.1.3, as between the Parties, the Parties shall each own an equal, undivided interest in any and all: (a) Information and inventions that are conceived, discovered, developed or otherwise made under this Agreement jointly by or on behalf of Calibr or its Affiliates or it... |
8.1.3 Exceptions. Notwithstanding Section 8.1.1 and 8.1.2, as between the Parties, AbbVie shall own and retain all right, title and interest in and to any and all Information and inventions that are conceived, discovered, developed or otherwise made or acquired by or on behalf of either Party (or its Affiliates or its ... |
8.1.4 United States Law. The determination of whether Information and inventions are conceived, discovered, developed or otherwise made by a Party for the purpose of allocating proprietary rights (including Patent, copyright or other intellectual property rights) therein, shall, for purposes of this Agreement, be made ... |
8.1.5 Assignment Obligation. Each Party shall cause all Persons who perform Development activities, Manufacturing activities, Commercialization activities or regulatory activities for such Party under this Agreement or who conceive, discover, develop or otherwise make any Information or inventions by or on behalf of su... |
8.2 Control of Intellectual Property. Neither Party shall, and each Party shall cause its Affiliates not to, enter into or amend any agreement with a Third Party, or include in any such agreement or amendment any restrictive provisions, with an intent to limit its Control of, or to not Control, any Information, Patent ... |
8.3 Maintenance and Prosecution of Patents. |
8.3.1 Patent Prosecution and Maintenance of Joint Patents and Product Patents. As between the Parties, AbbVie shall have the first right, but not the obligation, using counsel of its own choice, to prepare, file, prosecute and maintain the Joint Patents and any Product Patent worldwide and to be responsible for any rel... |
8.3.2 Patent Prosecution and Maintenance of Calibr Patents Other Than Product Patents. Subject to the remainder of this Section 8.3.2, as between the Parties, Calibr shall have the sole right, but not the obligation, to prepare, file, prosecute and maintain the Calibr Patents (except those Calibr Patents that constitut... |
(a) With respect to Patents Controlled by Calibr or any of its Affiliates as of the Original Execution Date or at any time during the Term that are not Product Patents and are reasonably necessary or useful for the Exploitation of any products comprising sCAR-Ts, vectors encoding the chimeric proteins expressed by sCAR... |
(b) With respect to Patents Controlled by Calibr or any of its Affiliates as of the Original Execution Date or at any time during the Term that are not Product Patents and are reasonably necessary or useful for the Exploitation of any CD19 Products ("Calibr CD19 Patents"), (i) prior to AbbVie's exercise of the CD19 Lic... |
(c) While Calibr is the prosecuting Party for any Option Patents, Calibr shall periodically inform AbbVie of all material steps with regard to the preparation, filing, prosecution and maintenance of such Option Patents in the Territory, including by providing AbbVie with a copy of material communications to and from th... |
(d) Calibr shall use best efforts to ensure that any Calibr Patents being prepared, filed, prosecuted or maintained by Calibr are not Mixed Patents. Without limiting the foregoing, promptly after the Inclusion Date for a Target with respect to Licensed Products Directed to such Target or the Option Effective Date for t... |
(i) At AbbVie's request, Calibr shall instruct patent counsel for the Mixed Patents to, with respect to any substantive filings or responses with respect to any Mixed Patent, allow AbbVie or AbbVie's counsel to prepare the first draft of any portion thereof that is related to the Licensed Products or the Exploitation t... |
(ii) Calibr shall reasonably consider and not unreasonably reject the requests or suggestions of AbbVie with respect to (A) material communications to and from any patent authority regarding the Mixed Patents to the extent applicable to or potentially affecting claims relating to Licensed Products or the Exploitation t... |
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