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2.11.1 upon AbbVie's request, Calibr shall cooperate with AbbVie to facilitate orderly transition of the Development activities under the relevant Target Program to AbbVie, including by, to the extent permitted under the relevant agreement, assigning to AbbVie any agreements to the extent relating to the Development or... |
2.11.2 Calibr shall transfer to AbbVie copies of all data, reports, records, materials and other information arising out of the Development activities to the extent relating to each then existing Research Target Product Directed to such Research Target or any Manufacturing activities with respect thereto, including all... |
2.11.3 Calibr shall transfer to AbbVie all of its then-existing inventory of each Research Target Product Directed to such Research Target and specifically related components thereof, and Calibr shall deliver such inventory to AbbVie DPP basis (as defined in Incoterms 2010) at a location designated by AbbVie. Calibr re... |
2.11.4 Calibr shall, and hereby does, assign to AbbVie all of its right, title, and interest in and to all Regulatory Documentation solely relating to any Research Target Product Directed to such Research Target and Calibr shall provide AbbVie copies of all Regulatory Documentation relating to any Research Target Produ... |
2.11.5 At AbbVie's request and at AbbVie's cost for reasonable and documented costs, Calibr shall duly execute and deliver or cause to be duly executed and delivered, such instruments and shall do and cause to be done such acts and things, including the filing of such assignments, agreements, documents and instruments,... |
2.11.6 upon AbbVie's request, within thirty (30) days of such request, the Parties shall negotiate in good faith and agree to a transition plan to transfer to AbbVie all Development activities for such Research Target Products as efficiently as possible. Without limiting its obligations under Section 2.11.1 through Sec... |
ARTICLE 3 EXCLUSIVE LICENSE OPTIONS |
3.1 CD19 License Option. |
3.1.1 CD19 Option Grant. Calibr hereby grants to AbbVie a fully paid-up, irrevocable (subject to Section 12.2) and exclusive option to obtain an exclusive right and license (even as to Calibr and its Affiliates) to Exploit CD19 Products under Section 4.1.2 ("CD19 License Option"). |
3.1.2 CD19 Option Exercise. AbbVie shall have the right to exercise the CD19 License Option at any time during the CD19 License Option Period by giving Calibr written notice of such exercise. Within thirty (30) days following the Option Effective Date with respect to the CD19 License Option, AbbVie shall pay to Calibr,... |
3.1.3 CD19 Licensed Products Responsibility. From and after the Option Effective Date for the CD19 License Option, AbbVie shall have the sole right to conduct, or have conducted Development and Commercialization activities relating to the CD19 Licensed Product(s); provided, that if as of the Option Effective Date for t... |
3.1.4 Transition of CD19 Activities. Upon the Option Effective Date for the CD19 License Option, and without additional consideration to Calibr: |
(a) Upon AbbVie's request, Calibr shall cooperate with AbbVie to facilitate orderly transition of the Development activities for CD19 Products to AbbVie, including by, to the extent permitted under the relevant agreement, assigning to AbbVie any agreements to the extent relating to the research, Development or Manufact... |
(b) Calibr shall transfer to AbbVie (i) copies of all data, reports, records, materials and other information arising out of the activities under the CD19 Plan or any Manufacturing activities specifically related thereto, including all non-clinical and clinical data relating to any CD19 Licensed Product arising therefr... |
(c) Calibr shall transfer to AbbVie all of its then-existing inventory of all CD19 Licensed Product(s) produced in accordance with the CD19 Plan, and Calibr shall deliver such inventory to AbbVie DPP basis (as defined in Incoterms 2010) at a location designated by AbbVie. Calibr represents and warrants that such CD19 L... |
(d) Calibr shall, and hereby does, assign to AbbVie all of its right, title, and interest in and to all Regulatory Documentation (including all INDs) relating to any CD19 Licensed Product, and Calibr shall deliver such Regulatory Documentation to AbbVie within thirty (30) days after the Option Effective Date for the CD... |
(e) without limiting Section 3.1.4(b)(ii), Calibr shall assist and cooperate with AbbVie, as AbbVie may reasonably request in the transition of the prosecution, maintenance, enforcement and defense of the Calibr CD19 Patents from Calibr to AbbVie; and |
(f) at AbbVie's request and at AbbVie's cost for reasonable and documented costs, Calibr shall duly execute and deliver or cause to be duly executed and delivered, such instruments and shall do and cause to be done such acts and things, including the filing of such assignments, agreements, documents and instruments, as... |
3.2 Platform Option. |
3.2.1 Platform Option Grant. Calibr hereby grants to AbbVie a fully paid-up, irrevocable (subject to Section 12.2) and exclusive option to obtain an exclusive right and license (even as to Calibr and its Affiliates) to Exploit the sCAR-T Platform and any sCAR-T or other pharmaceutical product incorporating the sCAR-T P... |
3.2.2 Platform Option Exercise. AbbVie shall have the right to exercise the Platform Option at any time during the Platform Option Period by giving Calibr written notice of such exercise. AbbVie shall have the option to extend the New Platform Exclusivity Period for an additional twelve (12)-month period by providing w... |
3.2.3 Platform Product Responsibility. From and after the Option Effective Date for the Platform Option, AbbVie shall have the sole right to conduct, or have conducted, Development and Commercialization activities relating to the Licensed Products and sCAR-T Platform; provided, that if as of the Option Effective Date f... |
3.2.4 From and after the Option Effective Date for the Platform Option, the Platform Option exercise fee and the Earnout Payments shall be in lieu of any Milestone Payments or royalties set forth in this Agreement. |
3.2.5 Transition of Platform Activities. Upon the Option Effective Date for the Platform Option, and without additional consideration to Calibr: |
(a) upon AbbVie's request, Calibr shall cooperate with AbbVie to facilitate orderly transition of the all activities relating to the sCAR-T Platform, including by, to the extent permitted under the relevant agreement, assigning to AbbVie any agreements relating to the research, Development or Manufacture of any Researc... |
(b) Calibr shall transfer to AbbVie (i) copies of all data, reports, records, materials and other information to the extent relating to the sCAR-T Platform or any Research Target Product, CD19 Product or Existing Target Product or any Manufacturing activities with respect thereto, including all non-clinical and clinica... |
(c) Calibr shall transfer to AbbVie all of its then-existing inventory of all Research Target Product(s), CD19 Products and Existing Target Products and components of sCAR-T Platforms, and Calibr shall deliver such inventory to AbbVie DPP basis (as defined in Incoterms 2010) at a location designated by AbbVie. Calibr r... |
(d) Calibr shall, and hereby does, assign to AbbVie all of its right, title, and interest in and to all Regulatory Documentation (including all INDs) relating to the sCAR-T Platform or any Research Target Product, CD19 Product or Existing Target Product, and Calibr shall deliver such Regulatory Documentation to AbbVie ... |
(e) without limiting Section 3.2.5(b)(ii), Calibr shall assist and cooperate with AbbVie, as AbbVie may reasonably request in the transition of the prosecution, maintenance, enforcement and defense of the Option Patents from Calibr to AbbVie; |
(f) Calibr shall duly execute and deliver or cause to be duly executed and delivered, such instruments and shall do and cause to be done such acts and things, including the filing of such assignments, agreements, documents and instruments, as may be necessary under or as AbbVie may reasonably request in connection with... |
(g) within thirty (30) days after such exercise, the Parties shall negotiate in good faith and agree to a transition plan to transfer to AbbVie all Development activities for the Research Target Products, Existing Target Products and the sCAR-T Platform as efficiently as possible. Without limiting its obligations under... |
3.2.6 For clarity, if AbbVie elects not to exercise the Platform Option during the Platform Option Period, then after the expiration of the Platform Option Period: |
(a) AbbVie shall retain the rights granted to AbbVie pursuant to Section 4.1.1 with respect to each Research Target, including with respect to the use of any Platform Improvements for such Research Targets; |
(b) AbbVie shall have no additional rights to identify additional Selected Targets pursuant to Section 2.1.3 or select any Substitute Targets pursuant to Section 2.1.4(b); |
(c) Calibr shall retain and AbbVie would have no rights to Exploit the sCAR-T Platform (including any Platform Improvements acquired (whether by license or otherwise), or conceived, discovered, developed or otherwise made before or during the New Platform Exclusivity Period) for any Targets other than Selected Targets ... |
3.3 Calibr Cost-Sharing Option. |
3.3.1 Cost-Share Option. Subject to Section 4.7.5, on a Licensed Product-by-Licensed Product basis, AbbVie hereby grants to Calibr an exclusive option with respect to such Licensed Product to pay for twenty-five percent (25%) of the AbbVie Development Costs with respect to such Licensed Product in the Territory, in exc... |
3.3.2 Development Cost Plan. With respect to each Research Target and, if AbbVie exercises the CD19 License Option, CD19, within forty-five (45) days after (a) the Acceptance Date for each Data Package with respect to a Research Target or (b) the Option Effective Date for the CD19 License Option, if applicable, AbbVie ... |
3.3.3 Cost-Share Option Exercise. Subject to the proviso in Section 3.3.1, Calibr may exercise the Cost-Sharing Option with respect to a Licensed Product by providing to AbbVie an Exercise Notice relating thereto at any time during the Cost-Sharing Option Period with respect to such Licensed Product (each Licensed Prod... |
3.3.4 Cost-Sharing. If Calibr exercises its Cost-Sharing Option with respect to one (1) or more Cost-Share Products, unless and until AbbVie exercises the Platform Option, within forty-five (45) days after the end of each Calendar Quarter in which AbbVie is performing any Development activities with respect to a Cost-S... |
3.3.5 Discontinuation of Cost Share. At any time following the exercise of the Cost-Sharing Option for a Cost-Share Product, Calibr shall have a one-time right, by providing written notice to AbbVie, to elect to discontinue its sharing of the AbbVie Development Costs for any Cost-Share Product, in which case, (a) if su... |
ARTICLE 4 GRANT OF RIGHTS; EXCLUSIVITY |
4.1 Grants to AbbVie. Subject to Section 4.4 and Section 4.5, Calibr (on behalf of itself and its Affiliates) hereby grants to AbbVie and its Affiliates: |
4.1.1 with respect to each Research Target, as of the Inclusion Date for such Research Target, (a) an exclusive (even as to Calibr and its Affiliates), royalty-bearing (in accordance with Section 7.6 unless and until AbbVie exercises the Platform Option) license (or sublicense), with the right to grant sublicenses in a... |
4.1.2 upon the Option Effective Date for the CD19 License Option, (a) an exclusive (even as to Calibr and its Affiliates), royalty-bearing (in accordance with Section 7.6 unless and until AbbVie exercises the Platform Option) license (or sublicense), with the right to grant sublicenses in accordance with Section 4.4, u... |
4.1.3 upon the Option Effective Date for the Platform Option, (a) an exclusive (even as to Calibr and its Affiliates), fully paid-up (subject to the Earnout Payments in Section 7.8), irrevocable, perpetual license (or sublicense), with the right to grant sublicenses in accordance with Section 4.4, under the Calibr IP a... |
4.1.4 a non-exclusive license, with the right to grant sublicenses in accordance with Section 4.4, to use Calibr's Corporate Names solely as required by Applicable Law to Exploit any Licensed Product in the Field in the Territory and for no other purpose. |
Upon AbbVie's request, Calibr shall take such steps as are necessary under Applicable Law, including issuing letters to any applicable Regulatory Authority, to grant the rights of reference described in this Section 4.1. |
4.2 Improvements to sCAR-T Platform. |
4.2.1 Notice of Platform Improvements. Calibr shall notify AbbVie in writing of any Information or invention that Calibr reasonably determines is a Platform Improvement to which AbbVie would have a license, promptly after the acquisition, reduction to practice, discovery, development or making of the same and shall pro... |
4.2.2 Exclusion Option. AbbVie shall have the right, on written notice to Calibr during the three hundred sixty five (365)-day period following the disclosure of any Platform Improvement pursuant to Section 4.2.1 to exclude such Platform Improvement from the license grants hereunder with respect to all Targets after wh... |
4.2.3 Platform Improvement Assistance. Upon request by AbbVie, Calibr shall provide AbbVie with all reasonable assistance required in order to transfer to AbbVie any Platform Improvement to which AbbVie retains a license, including all materials, data, methods, processes, documentation and other Information related the... |
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; |
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