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1.238 "Regulatory Authority" means any applicable supra-national, federal, national, regional, state, provincial or local regulatory agencies, departments, bureaus, commissions, councils or other government entities regulating or otherwise exercising authority with respect to the Exploitation of Licensed Products in th... |
1.239 "Regulatory Documentation" means: all (a) applications (including all INDs and BLAs), registrations, licenses, authorizations and approvals (including Regulatory Approvals) and (b) correspondence and reports submitted to or received from Regulatory Authorities (including minutes and official contact reports relat... |
1.240 "Regulatory Exclusivity Period" means, with respect to a Licensed Product or a CD19 Product in any country in the Territory, a period of exclusivity (other than Patent exclusivity) granted or afforded by Applicable Law or by a Regulatory Authority in such country that prevents a Third Party from referencing the L... |
1.241 "Research Target" means any Selected Target (unless and until it becomes a Failed Target), Substitute Target, Option Target or Included Existing Target, in each case from and after the applicable Inclusion Date with respect thereto. |
1.242 "Research Target Product" means a product generated and Developed by Calibr under the Target Research Plan, the PRLR Switch Plan or the SST Switch Plan and solely comprising: (a) an sCAR-T or a vector encoding the chimeric protein of an sCAR-T, and, if applicable, an Additional Gene expressed by such sCAR-T; and ... |
1.243 "Reversion Data" has the meaning set forth in Section 12.4.2(a). |
1.244 "Reversion Product" means a Licensed Product with respect to which this Agreement is terminated and that is or was the subject of Exploitation by or on behalf of AbbVie in the Territory as of the effective date of termination of this Agreement that (a) is not Directed to an AbbVie Target and (b) is solely compris... |
1.245 "Reviewable Data Package" means any Data Package, CD19 Data Package, CD19 Autoimmune Data Package, In-Situ Data Package, mRNA Data Package, PRLR Phase I Data Package, or SST Phase I Data Package. |
1.246 "ROFN Notice" has the meaning set forth in Section 2.1.6(b). |
1.247 "Royalty Term" means, with respect to each Licensed Product (unless and until AbbVie exercises the Platform Option) or CD19 Product and each country in the Territory, the time period commencing on the date of the First Commercial Sale of such Licensed Product or CD19 Product, as applicable, in such country and en... |
1.248 "sCAR-T" means, with respect to a Target(s), a chimeric antigen receptor T-cell expressing (a) a chimeric protein comprising (i) an extracellular domain that specifically binds to a Switch, (ii) a transmembrane region and (iii) an intracellular signaling domain and (b) optionally one (1) or more Additional Genes,... |
1.249 "sCAR-T Platform" means Calibr's cell therapy platform employing sCAR-Ts and Switches, including, subject to Section 4.2.1, any Platform Improvements. |
1.250 "sCAR-T Platform IP" means the sCAR-T Platform Know-How and sCAR-T Platform Patents. |
1.251 "sCAR-T Platform Know-How" means any Information Controlled by Calibr or any of its Affiliates as of the Original Execution Date or during the Term that is solely related to the sCAR-T Platform. For clarity, sCAR-T Platform Know-How shall not include any Information with respect to CD19, any Research Target or an... |
1.252 "sCAR-T Platform Patents" means any Patents Controlled by Calibr or any of its Affiliates as of the Original Execution Date or at any time during the Term that claim sCAR-T Platform Know-How. |
1.253 "Scripps-Research Personnel" means employees of The Scripps Research Institute that (a) are not employed through its Calibr-Division, (b) do not conduct any Development activities under this Agreement, including any activities in connection with any activities under the Target Research Plan, mRNA Work Plan, In-Si... |
1.254 "Second Solid Tumor Switch Program" means all Development activities pursuant to the SST Switch Plan for the Second Solid Tumor Target. |
1.255 "Second Solid Tumor Target" means LIV1 or BMPR1, as selected by AbbVie and notified to Calibr. |
1.256 "Selected Target" has the meaning set forth in Section 2.1.3. |
1.257 "Senior Officer" means, (a) with respect to Calibr, its Chief Operating Officer, and (b) with respect to AbbVie, its Chief Scientific Officer, or his or her designee. |
1.258 "Sole Inventions" has the meaning set forth in Section 8.1.1. |
1.259 "SST Initial Research Plan" means that portion of the Target Research Plan to be agreed and approved by the TD-JRC in accordance with Section 2.1.9 and 6.1.1 setting forth in reasonable detail the specific Development activities to be conducted by each Party with respect to the SST Switch Product up to the comple... |
1.260 "SST Option" means the option to require Calibr to conduct a Phase I Clinical Trial for a SST Switch Product. |
1.261 "SST Phase I Data Package" means a data package prepared by Calibr in a form reasonable under the circumstances setting forth the Development activities conducted by or on behalf of Calibr or its Affiliates under the SST Switch Plan, and Information generated in connection with the same, including: (a) a summary ... |
1.262 "SST Switch Plan" means the Development plan and budget with respect to the Phase I Clinical Trial of a SST Switch Product approved by the TD-JRC, which may include a path to a PRLR Switch Product and SST Switch Product combination study, as the same may be amended from time to time in accordance with the terms h... |
1.263 "SST Switch Product" means any biopharmaceutical product comprising (a) a sCAR-T or vector encoding the chimeric proteins expressed by a sCAR-T that is Directed to the Second Solid Tumor Target and (b) one (1) or more Switches Directed to the Second Solid Tumor Target. |
1.264 "Sublicensee" means a Person, other than an Affiliate or a Distributor, that is granted a sublicense by AbbVie or its Affiliate under the grants in Section 4.1, as provided in Section 4.3. |
1.265 "Substitute Target" has the meaning set forth in Section 2.1.4(b). |
1.266 "Substitution Date" means (a) with respect to a Failed Target, the date AbbVie provides Calibr the Substitution Notice selecting the Substitute Target with respect thereto and (b) with respect to a Substitute Target, the date AbbVie provides Calibr the Substitution Notice selecting such Substitute Target. Notwith... |
1.267 "Substitution Notice" has the meaning set forth in Section 2.1.4(b). |
1.268 "Switch" means any molecule (including an Antibody-Based Protein, a TCR-Based Protein, a ligand for a cell surface receptor or another Target-binding protein, active pharmaceutical ingredient, antibody, recombinant protein, gene, nucleic acid sequence, or small molecule-induced, pathway induced, or protein-induce... |
1.269 "Target" means a protein, polypeptide, or nucleic acid molecule, and all nucleic acids encoding such protein, polypeptide, or molecule, which includes each Research Target. |
1.270 "Target Licensed Product" has the meaning set forth in the definition of Licensed Product. |
1.271 "Target Option" has the meaning set forth in Section 2.1.5(a). |
1.272 "Target Program" means, with respect to a Research Target, all Development activities pursuant to the Target Research Plan with respect to such Research Target. |
1.273 "Target Research Plan" means the written plan that sets forth in reasonable detail the specific Development activities to be conducted by each Party with respect to each Research Target Product up to the completion of IND Enabling Activities for such Research Target Product and the budget with respect to Calibr's... |
1.274 "Targets List" has the meaning set forth in Section 2.1.7(b). |
1.275 "Tax Amount" has the meaning set forth in Section 7.13.1. |
1.276 "TCR-Based Protein" means any protein incorporating any antigen-binding domain from a T-cell receptor or functional equivalent thereof and specifically binding to a Target. |
1.277 "TD-JRC" or "Target Discovery Joint Research Committee" has the meaning set forth in Section 6.1. |
1.278 "Technology Transfer Product" means (a) each Research Target Product (including the applicable sCAR-Ts and Switches), (b) if AbbVie exercises the CD19 License Option, the CD19 Products that are Developed by Calibr under the CD19 Plan (including the applicable sCAR-Ts and Switches) (each, a "CD19 Technology Transf... |
1.279 "Term" means the period beginning on the Original Effective Date ending upon the expiration or termination of this Agreement pursuant to Article 12. |
1.280 "Terminated Product" has the meaning set forth in Section 12.4.1. |
1.281 "Terminated Territory" has the meaning set forth in Section 12.4.1. |
1.282 "Termination Notice" has the meaning set forth in Section 12.2.1(a). |
1.283 "Territory" means worldwide, excluding any Terminated Territory. |
1.284 "Third Country" means a country outside of the European Economic Area (EEA) or a country not deemed to provide an adequate level of protection for Personal Data by the European Commission. |
1.285 "Third Party" means any Person other than Calibr, AbbVie and their respective Affiliates. |
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. |
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