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(c) Upon AbbVie's exercise of the SST Option, the TD-JRC shall promptly prepare and approve a SST Switch Plan in accordance with the terms of Section 6.1.2; |
(d) Upon the TD-JRC's approval of the SST Switch Plan, Calibr shall complete the tasks set forth in the SST Switch Plan (provided that if Calibr's failure to complete a task is solely due to AbbVie's failure to perform any activities allocated to AbbVie under this Agreement, then such failure shall not constitute a bre... |
(e) Calibr shall conduct its activities under the SST Switch Plan in accordance with this Article 2 and the other terms and conditions of this Agreement. |
(f) Calibr shall prepare, obtain and maintain INDs for the SST Switch Products for the performance of the Phase I Clinical Trial under the SST Switch Plan and conduct communications with the applicable Regulatory Authorities with respect to such INDs; provided that the form and content of all such INDs and related comm... |
2.1.10 Wind-Down. If the Phase I Clinical Trial under the PRLR Switch Plan or the SST Switch Plan, as applicable, is wound-down prior to completion of such Phase I Clinical Trial, the Parties shall coordinate in good faith to enable Calibr to wind-down such Phase I Clinical Trial, including amending the PRLR Switch Pla... |
2.2 CD19 Program. |
2.2.1 CD19 Diligence. Calibr shall complete the tasks set forth in the CD19 Plan and shall use Commercially Reasonable Efforts to (a) achieve the objectives of the CD19 Plan as soon as reasonably practicable and (b) prepare and deliver to AbbVie (i) the CD19 Data Package in accordance with the timeline set forth in the... |
2.2.2 CD19 Autoimmune Option. AbbVie shall have the right to exercise the CD19 Autoimmune Option by providing Calibr written notice of such exercise before the first (1st) anniversary of the A&R Effective Date. Once AbbVie has exercised the CD19 Autoimmune Option, the CD19-JDC shall approve an amendment to the CD19 Pla... |
2.2.3 CD19 Pre-Option Regulatory Responsibility. Unless and until AbbVie exercises the CD19 License Option, Calibr shall have the sole right to prepare, obtain and maintain INDs for the CD19 Products and to conduct communications with the applicable Regulatory Authorities with respect to such INDs; provided, that the f... |
2.3 Platform Improvement Program. |
2.3.1 Principal Objectives. The principal objective of the activities under the Platform Improvement Plan (the "Platform Research Activities") is for Calibr to generate Platform Improvements, including the Development of Switch modalities compatible with patient-friendly dosing schedules (including mRNA-based Switches)... |
2.3.2 Platform Improvement Diligence. Calibr shall complete the Platform Research Activities set forth in the research plans attached hereto as Schedule 2.3.2-a (the "mRNA Work Plan") and Schedule 2.3.2-b (the "In-Situ Work Plan" and, together with the mRNA Work Plan, the "Platform Improvement Plan") as the same may be... |
2.4 Review of Plans. |
2.4.1 Platform and Target Plans. The TD-JRC shall review the Target Research Plan, PRLR Switch Plan, SST Switch Plan, if applicable, and Platform Improvement Plan at least quarterly and at other times as required by the Target Research Plan, PRLR Switch Plan, SST Switch Plan, if applicable, or Platform Improvement Plan... |
2.4.2 CD19 Plan. The CD19-JDC shall review the CD19 Plan at least quarterly for the purpose of considering appropriate amendments thereto, and either Party, through its representatives on the CD19-JDC, may propose amendments to the CD19 Plan at any time. No amendment to the CD19 Plan shall be effective unless and until... |
2.5 Research Program Manufacturing and Supply. |
2.5.1 Switch Manufacturing. Unless otherwise agreed by the TD-JRC, AbbVie shall be solely responsible for the Manufacture and supply of all pre-clinical and clinical requirements of Switches, placebos with respect thereto and all components of the foregoing, in all cases, as necessary for Calibr to perform its obligati... |
2.5.2 sCAR-T Manufacturing. Calibr shall be solely responsible for the Manufacture and supply all requirements of sCAR-Ts, placebos with respect thereto and all components of the foregoing, in all cases, as necessary for Calibr to perform its obligations under the Target Research Plan in accordance with the terms hereo... |
2.5.3 Clinical Trial Product Warranty. Calibr represents and warrants that any sCAR-Ts Manufactured by Calibr for use in a Phase I Clinical Trial under the CD19 Plan, the SST Switch Plan or the PRLR Switch Plan, (a) shall be Manufactured in accordance with Applicable Law, including current good manufacturing practices ... |
2.5.4 Delivery of Existing Inventory; Manufacturing Assistance. With respect to each Research Target Product, upon AbbVie's request, Calibr shall, at its sole cost and expense, deliver to AbbVie reasonable quantities of sCAR-Ts and reagents (including Lentivirus, Switch and other analytical reagents), in both research ... |
2.6 Performance of Development Activities. |
2.6.1 General. Under the direction and supervision of the TD-JRC or CD19-JDC, as applicable, each Party shall perform all of its Development activities set forth in the Target Research Plan or, solely with respect to Calibr, the Platform Improvement Plan, CD19 Plan, PRLR Switch Plan or SST Switch Plan, as applicable, i... |
2.6.2 Subcontracting. Calibr shall have the right to subcontract its Development and Manufacturing activities under this Agreement to a Third Party to the extent expressly provided for in the Target Research Plan, Platform Improvement Plan, CD19 Plan, PRLR Switch Plan or SST Switch Plan, as applicable, or with the appr... |
2.6.3 Key Personnel. The scientific and technical personnel of Calibr considered by AbbVie to be critical for the conduct of the Development activities under the Target Research Plan, Platform Improvement Plan, CD19 Plan, PRLR Switch Plan or SST Switch Plan, (the "Key Personnel") are set forth on Schedule 2.6.3. To the... |
2.6.4 Research Program Records. Calibr shall, and shall cause its Affiliates and subcontractors to, maintain, in good scientific manner, complete and accurate books and records pertaining to its Development activities hereunder in sufficient detail to verify compliance with its obligations under this Agreement and whic... |
2.7 AbbVie Materials. From time to time during the Term, AbbVie may supply biological materials ("AbbVie Materials") to Calibr for use in connection with performing Development activities under the Target Research Plan. In connection therewith, Calibr agrees that (a) it shall not use the AbbVie Materials for any purpos... |
2.8 Calibr Development Costs. Subject to this Section 2.8, AbbVie shall reimburse Calibr for the Calibr Development Costs actually incurred by Calibr after (a) the Original Effective Date in connection with the performance of Development activities in accordance with the Target Research Plan (which Target Research Plan... |
2.8.1 Budget Overages. Calibr shall promptly inform AbbVie upon Calibr determining that Calibr is likely to overspend on either of the budgeted FTE Costs component or the budgeted Out-of-Pocket Costs component of the Calibr Development Costs set forth in the Target Research Plan, PRLR Switch Plan or SST Switch Plan, as... |
2.8.2 Development Cost Payments. Within forty-five (45) days after the end of each Calendar Quarter in which Calibr is performing any Development activities under the Target Research Plan, PRLR Switch Plan or SST Switch Plan, as applicable, Calibr shall provide to the TD-JRC and AbbVie an invoice setting forth the Cali... |
2.9 Information and Reports. |
2.9.1 Development Reports. Within thirty (30) days after the end of each Calendar Quarter, Calibr shall provide to the TD-JRC or the CD19-JDC, as applicable, a detailed report regarding its applicable Development activities hereunder (including with respect to CD19, PRLR and the Second Solid Tumor Target after the Init... |
2.9.2 Decision Points. With respect to each Decision Point for a Research Target, within thirty (30) days after completing all of the Development activities for the Research Target Products Directed to such Research Target set forth in the Target Research Plan for completion prior to such Decision Point, Calibr shall p... |
(a) Following the completion of in vitro characterization of the Switch Directed to the applicable Research Target and prior to initiating in vivo studies for a Research Target Product for such Research Target, the TD-JRC shall evaluate whether to move forward with in vivo studies with respect to such Research Target P... |
(b) Following the completion of in vivo efficacy studies and prior to initiating IND Enabling Studies for a Research Target Product, the TD-JRC shall evaluate whether to move forward with candidate selection activities with respect to such Research Target Product; and |
(c) Following the conduct of candidate selection activities for a Research Target product, the TD-JRC shall evaluate whether to move forward with GLP Toxicology Studies based on the Data Package provided by Calibr with respect to the applicable Research Target. |
2.9.3 Additional Information Exchange. In addition to the reports provided pursuant to Section 2.9.1 and Section 2.9.2, Calibr promptly shall provide to AbbVie any material Information Controlled by Calibr (including all research, analyses and other Information, copies of all correspondence to and from any Regulatory A... |
2.10 Data Packages. |
2.10.1 Research Target Data Package. |
(a) Subject to Section 5.1.4(a) and Section 2.10.1(b), with respect to each Research Target or Additional Gene, within thirty (30) days after the completion of the Development activities set forth in the Target Research Plan with respect to all of the Research Target Product(s) Directed to such Research Target or incor... |
(b) Notwithstanding Section 2.10.1(a), (i) within thirty (30) days after the completion of the Development activities set forth in the PRLR Switch Plan or SST Switch Plan, as applicable, Calibr shall deliver to AbbVie the PRLR Phase I Data Package or SST Phase I Data Package, as applicable, and provide AbbVie with elec... |
2.10.2 CD19 Data Packages. Within thirty (30) days after the completion of the Development activities set forth in (a) the CD19 Plan (excluding the CD19 Autoimmune Subplan, if applicable), Calibr shall deliver to AbbVie the CD19 Data Package and (b) if AbbVie exercises the CD19 Autoimmune Option, the CD19 Autoimmune Su... |
2.10.3 ROFN Data Package. Within thirty (30) days after AbbVie provides Calibr with a ROFN Notice with respect to an Existing Target, Calibr shall deliver to AbbVie the Data Package with respect to such Existing Target and provide AbbVie with electronic access to all data generated in connection with the Development of... |
2.10.4 Data Package Review. With respect to each Reviewable Data Package, AbbVie shall have thirty (30) days after the date Calibr provides such Reviewable Data Package in which to review such Reviewable Data Package, and, if AbbVie believes in good faith that any of the data or information required to be included in s... |
2.10.5 Additional CD19 Information Delivery. In addition to the CD19 Data Package and CD19 Autoimmune Data Package, if applicable, during the CD19 License Option Period, Calibr promptly shall provide to AbbVie any additional Information related to CD19 and any CD19 Product that Calibr or any of its Affiliates owns or C... |
2.10.6 Additional Platform Acquisition Information Delivery. In addition to the Data Packages for each of the Research Targets, during the Platform Option Period, Calibr promptly shall provide to AbbVie any additional Information related to the sCAR-T Platform, Switches or Research Targets that Calibr or any of its Aff... |
2.10.7 Additional ROFN Information Delivery. In addition to the Data Packages for each of the Existing Targets, during the applicable AbbVie Consideration Period, Calibr promptly shall provide to AbbVie any additional Information related to the applicable Existing Target that Calibr or any of its Affiliates owns or Con... |
2.10.8 Limitations. For purposes of Section 2.10.5, Section 2.10.6 and Section 2.10.7 "additional Information" shall be Information then in existence and in the Control of Calibr, the provision of which shall not require the conduct by Calibr of any additional Development activities or any additional analyses other tha... |
2.11 Transition of Research Target Products. With respect to each Research Target, upon the earlier of (a) (i) with respect to each Research Target other than PRLR and the Second Solid Tumor Target, the Acceptance Date for the Data Package with respect to such Research Target, (ii) with respect to PRLR, the first date ... |
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... |
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