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1.286 "Third Party Agreement" has the meaning set forth in Section 8.9. |
1.287 "Third Party Claims" has the meaning set forth in Section 11.1. |
1.288 "Third Party Infringement Claim" has the meaning set forth in Section 8.8.1. |
1.289 "Third Party Payments" has the meaning set forth in Section 8.9. |
1.290 "Third Party Right" has the meaning set forth in Section 8.9. |
1.291 "Trademark" means any word, name, symbol, color, shape, designation or any combination thereof, including any trademark, service mark, trade name, brand name, sub-brand name, trade dress, product configuration, program name, delivery form name, certification mark, collective mark, logo, tagline, slogan, design or... |
1.292 "Unavailable Target" means a Target with respect to which Calibr has granted rights to a Third Party, or owes obligations to a Third Party, which rights or obligations are inconsistent with the rights AbbVie would have, and the obligations Calibr would have, under this Agreement if such Target were to become a Re... |
1.293 "United States" or "U.S." means the United States of America and its territories. |
1.294 "Updated A&R Disclosure Schedules" has the meaning set forth in Section 10.2.6(b). |
1.295 "Updated CD19 Disclosure Schedules" has the meaning set forth in Section 10.2.6(c). |
1.296 "Updated Disclosure Schedules" means any of the Updated A&R Disclosure Schedules, Updated Effective Date Disclosure Schedules, the Updated CD19 Disclosure Schedules, the Updated Platform Disclosure Schedules or the Updated ROFN Disclosure Schedules. |
1.297 "Updated Effective Date Disclosure Schedules" has the meaning set forth in Section 10.2.6(a). |
1.298 "Updated Platform Disclosure Schedules" has the meaning set forth in Section 10.2.6(e). |
1.299 "Updated ROFN Disclosure Schedules" has the meaning set forth in Section 10.2.6(d). |
1.300 "Valid Claim" means, (a) a claim of any issued Patent that has not (i) expired or been subject to an irretrievable lapse, abandonment, revocation, dedication to the public or disclaimer or (ii) become subject to a holding, finding or decision of invalidity, unenforceability or non-patentability by a court, govern... |
1.301 "Valuation Expert" has the meaning set forth in Section 2.1.6(c). |
1.302 "Valuation Notice" has the meaning set forth in Section 2.1.6(c). |
1.303 "Voting Stock" has the meaning set forth in the definition of Change of Control. |
1.304 "Wellcome" means The Wellcome Trust Limited. |
1.305 "Wellcome Agreement" means that certain Not-for-Profit Funding Agreement (Translation Fund) between California Institute for Biomedical Research and The Wellcome Trust Limited, dated June 30, 2017. |
1.306 "Withholding Party" has the meaning set forth in Section 7.13.1. |
1.307 "Working Group" has the meaning set forth in Section 6.5. |
ARTICLE 2 RESEARCH AND DEVELOPMENT PROGRAMS |
2.1 Target Program. |
2.1.1 Principal Objectives. The principal objective of the activities under the Target Research Plan is for the Parties to use the sCAR-T Platform to generate and Develop at least one (1) Research Target Product Directed to each Research Target identified by AbbVie and included under this Agreement. In accordance with ... |
2.1.2 Diligence. Calibr shall complete the tasks set forth in the Target Research 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 breach of this Agreement) and shall ... |
2.1.3 Selected Targets. Within sixty (60) days following the Original Effective Date, AbbVie shall identify in writing to Calibr up to five (5) Targets to be included in the Target Research Plan (each, a "Selected Target") and the initial indications with respect thereto to be included in the Target Research Plan; prov... |
2.1.4 Failed Targets; Substitute Targets. |
(a) Calibr shall promptly notify AbbVie and the TD-JRC of each Selected Target that satisfies the Failed Target Criteria prior to the initiation of the first GLP Toxicology Study for a Research Target Product Directed to such Selected Target (such notice, a "Failed Target Notice" and such Selected Target, a "Failed Tar... |
(b) With respect to each Failed Target, AbbVie shall have the right within sixty (60) days following receipt of the Failed Target Notice for such Failed Target (or, if Calibr does not provide a Failed Target Notice for such Failed Target, the determination that such Failed Target is a Failed Target pursuant to Section ... |
(c) Upon AbbVie's provision of a Substitution Notice for a Substitute Target, (i) such Substitute Target shall be deemed a Research Target and (ii) all activities under this Agreement with respect to the Failed Target shall cease. Promptly after providing a Substitution Notice for a Substitute Target, AbbVie shall prop... |
2.1.5 Target Options. |
(a) Calibr hereby grants to AbbVie a fully paid-up and irrevocable option for the right to select, at any time during the Option Target Period by providing written Exercise Notice thereof to Calibr, up to five (5) additional Targets that are not (i) Unavailable Targets or (ii) Existing Targets (each of such five (5) ad... |
(b) Promptly after the Option Effective Date with respect to the Target Option for an Option Target, AbbVie shall propose an amendment to the Target Research Plan for the TD-JRC to review and approve in accordance with the terms of Section 6.1.1 to include activities to generate and Develop at least one (1) unique Rese... |
2.1.6 Right of First Negotiation for Existing Targets. |
(a) With respect to each Existing Target, during the New Platform Exclusivity Period, Calibr hereby grants to AbbVie a fully-paid up, irrevocable (subject to Section 12.2) and exclusive right of first negotiation to obtain an exclusive (even as to Calibr and its Affiliates, other than for purposes of Calibr performing ... |
(b) AbbVie shall have the right to exercise the Existing Target ROFN with respect to an Existing Target at any time during the New Platform Exclusivity Period by giving Calibr written notice of such exercise (a "ROFN Notice"). If AbbVie provides a ROFN Notice for an Existing Target during the New Platform Exclusivity P... |
(c) If AbbVie provides Calibr a ROFN Notice with respect to an Existing Target during the New Platform Exclusivity Period, and the Parties do not agree on the Existing Target Economic Terms for such Existing Target within one hundred eighty (180) days after AbbVie provides Calibr such ROFN Notice (provided, that if the... |
(d) AbbVie shall have the right, upon written notice to Calibr within thirty (30) days after the Valuation Expert notifies the Parties of the Determined Existing Target Economic Terms (such period, the "AbbVie Consideration Period"), to elect to accept the Determined Existing Target Economic Terms, in which case, upon ... |
(e) If any Existing Target is included in the scope of this Agreement as an Included Existing Target pursuant to this Section 2.1.6, then notwithstanding anything to the contrary in this Section 2.1.6 or in Section 5.2, following such inclusion, AbbVie shall use Commercially Reasonable Efforts to obtain Regulatory Appr... |
(f) If, with respect to an Existing Target, AbbVie (i) does not elect, pursuant to Section 2.1.6, to submit such dispute with respect to the Existing Target Economic Terms for such Existing Target to a Valuation Expert or (ii) if AbbVie does not elect to accept the Determined Existing Target Economic Terms during the A... |
2.1.7 Gatekeeper Process. |
(a) At any time during the Term, AbbVie may, at AbbVie's sole cost and expense, choose to engage an independent Third Party that is mutually agreeable to the Parties; provided, that Calibr shall not unreasonably condition, withhold or delay its agreement, which Third Party will be responsible for reviewing and maintain... |
(b) In order to facilitate the determination of whether or not a given Target nominated by AbbVie (i) as a Research Target (either as a Selected Target, Option Target, or Substitute Target) would not be an AbbVie Target as of its Inclusion Date or (ii) as an Option Target or a Substitute Target, is an Unavailable Targe... |
(c) Before nominating a Target as a Selected Target, Substitute Target or Option Target, AbbVie may notify the Gatekeeper in writing of its potential interest in selecting such Target as a Selected Target, Substitute Target or Option Target, as applicable, and the Gatekeeper shall (i) without revealing the identity of ... |
(d) In the event AbbVie disputes whether the inclusion of a Target on the Targets List is appropriate, then such dispute will be resolved in accordance with Section 13.5, and Calibr shall have the burden of showing that such Target was correctly included on the Target List at the relevant time it was placed on the Targ... |
2.1.8 PRLR Switch Program. |
(a) Calibr shall complete the tasks set forth in the PRLR 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 breach of this Agreement) and shall use Commercially ... |
(b) Calibr shall prepare, obtain and maintain INDs for the PRLR Switch Products for the performance of the Phase I Clinical Trial under the PRLR 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 co... |
2.1.9 Second Solid Tumor Switch Program. |
(a) Upon AbbVie's request, the TD-JRC shall prepare and approve the SST Initial Research Plan, as contemplated in Section 6.1.1; |
(b) AbbVie shall have the right to exercise the SST Option by providing Calibr written notice of such exercise within thirty (30) days after the Acceptance Date for the Data Package with respect to the SST Initial Research Plan. |
(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 ... |
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