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Certain Information necessary for Calibr to fulfill its obligations under the Agreement and for which Calibr has the right to use is in the public domain (e.g., protocols, assays and biological methodologies) and may not be patentable subject matter. |
Section 10.2.2(b) |
US patent application number 15/644,657 (CIBR-002/05US, or "the '657 application") is a continuation of US patent application number 15/363,350 (CIBR-002/04US, or "the '350 application"). When the '657 application was filed, there was an outstanding notice to file missing parts in the '350 application requiring among o... |
Reference is made to Disclosure Schedule Section 10.2.1(h)(ii). |
Section 10.2.2(c) |
True, complete and correct copies of the file wrappers and other documents and materials relating to the prosecution, defense, maintenance, validity and enforceability of the Existing Patents, as amended as of such date, have been provided to AbbVie to the extent requested by AbbVie or otherwise shared in the ordinary ... |
Section 10.2.2(e) |
Certain Information that relates to the sCAR-T Platform is not within the Calibr Know How because it is publicly available. |
Section 10.2.2(h)(ii) |
Reference is made to the Federally Funded Invention Schedule (Schedule 10.2.1(o)) with respect to international patent application numbers PCT/US2017/057460 (CIBR-011/01WO) and PCT/US2022/023791 with respect to the rights that the federal government has in the inventions pursuant to Grant Number 1R01CA208398. |
Not-for-Profit Funding Agreement (Translation Fund) between California Institute for Biomedical Research and The Wellcome Trust Limited, dated June 30, 2017, ("Wellcome Agreement"), a copy of which has been made available to AbbVie in the due diligence data room in the "Contracts and Agreements" folder. Under this agre... |
Calibr is a party to the following grant and funding agreements (including subaward(s) thereunder), each of which have been made available to AbbVie in the due diligence data room in the "Contracts and Agreements" folder, and each of which reserve certain rights to the grantor in |
respect of inventions generated under the research projects supported by the relevant funding entity: |
• American Cancer Society; Grant Number RSG-16-200-01-LIB, for the period of 1 Jan. 2017 – 31 Dec. 2020, in support of the project entitled "Switch Mediated Activation and Retargeting of CAR-T cells." Under this agreement, ACS retains step-in prosecution rights for Funded Inventions (as defined in such American Cancer ... |
• USAMRMC and USAMRAA; Contract No. W81XWH-15-1-0424, dated 21 Sept. 2015, in support of the project entitled "Redirecting Engineered T Cells Using a Small Molecule Drug: A Novel Approach for the Treatment of Metastatic Prostate Cancer." |
• Department of Health and Human Services; National Institutes of Health; Grant Number 1R01CA208398-01 REVISED, dated 19 Dec. 2016, in support of the project entitled "CAR-T cell control through orthogonal antibody-based switches." |
Reference is made to Disclosure Schedule Section 10.2.2(n). |
Section 10.2.2(i)(ii) |
US patent 9,233,125 was disclosed to AbbVie prior to January 25, 2018, and was discussed on a conference call with AbbVie Patent Counsel Changxia (Walter) Sun on February 7, 2018. As a follow-up to the call, on February 20, 2018, Calibr sent Walter Sun a list of prior art references Calibr believes to be relevant to 9,... |
Section 10.2.2(j) |
Calibr is subject to certain payment obligations to Wellcome under the Wellcome Agreement. |
Calibr is subject to certain payment obligations to the American Cancer Society under the American Cancer Society Grant with respect to the commercialization of Funded Inventions (as defined in such American Cancer Society Grant). |
Certain payment obligations may arise with respect to service providers in connection with the Calibr's performance of its Development obligations with respect to Research Target Products and CD19 Products under the Agreement. |
Calibr has certain payment obligations to certain investors in Calibr based on amounts received by Calibr as a result of the Exploitation of certain Licensed Products, the recipients of such payment obligations have no other rights with respect to any Licensed Products or Calibr IP. |
Section 10.2.2(n) |
Calibr's representation with respect to any materials (including any formulations and manufacturing processes and procedures) developed or delivered by any Third Party under any agreements between Calibr and such Third Party is limited to Calibr's Knowledge of its agreements with such Third Parties, and Calibr makes no... |
Material Transfer Agreement by and between California Institute for Biomedical Research and Mayo Clinic, dated September 22, 2017 (the "Mayo Agreement"), a copy of which has been made available to AbbVie in the due diligence data room in the "Contracts and Agreements" folder, pursuant to which the Mayo Clinic (through ... |
Material Transfer Agreement by and between California Institute for Biomedical Research and Peter MacCallum Cancer Institute, dated October 4, 2017 (the "MacCallum Agreement"), a copy of which has been made available to AbbVie in the due diligence data room in the "Contracts and Agreements" folder, pursuant to which th... |
Material Transfer Agreement by and between California Institute for Biomedical Research and Queen Mary Institute of London, dated April 14, 2016 (the "Queen Mary Agreement"), a copy of which has been made available to AbbVie in the due diligence data room in the "Contracts and Agreements" folder, pursuant to which the ... |
Material Transfer Agreement by and between California Institute for Biomedical Research and the Reagents of the University of Minnesota, dated December 12, 2015 (the "Minnesota Agreement"), a copy of which has been made available to AbbVie in the due diligence data room in the "Contracts and Agreements" folder, pursuan... |
Work Order 001 between California Institute for Biomedical Research and WuXi Advanced Therapies (Business Unit of WuXi AppTec, Inc.) (the "WuXi Work Order 001") a copy of which has been made available to AbbVie in the due diligence data room in the "Contracts and Agreements" folder, pursuant to which WuXi Advanced Ther... |
AppTec Property" and "Service Instruments" (as defined in the WuXi Work Order 001). As of the Original Execution Date, no work has been performed pursuant to the WuXi Work Order 001. |
10.2.2 - 5 |
Schedule 10.2.2(o): Federally Funded Inventions |
International patent application numbers PCT/US2017/057460 (CIBR-011/01WO) and PCT/US2022/023791 disclose that the inventions were made with government support under grant number 1R01CA208398 awarded by the National Institute of Health. The government has certain rights in the inventions pursuant to such grant. |
Schedule 10.2.3: Representations and Warranties as of the applicable CD19 Option Bringdown Date |
Calibr additionally represents and warrants to AbbVie, as of the applicable CD19 Option Bringdown Date, that except as set forth in the Updated Disclosure Schedules provided as of such CD19 Option Bringdown Date: |
(a) Calibr has the right to use all Regulatory Documentation, Information and Patents necessary for Calibr to fulfill its obligations hereunder and that all such Information and Patents are and shall be Calibr Know-How or Calibr Patents, respectively; |
(b) All Existing Patents are listed on the Existing Patent Schedule, and all Existing Patents are (i) to Calibr's Knowledge, valid and enforceable, (ii) solely and exclusively owned or in-licensed pursuant to an In-License Agreement by Calibr or one of its Affiliates, free of any encumbrance, lien or claim of ownership... |
(c) True, complete and correct copies of (i) the file wrappers and other documents and materials relating to the prosecution, defense, maintenance, validity and enforceability of the Existing Patents and (ii) all In-License Agreements, as amended as of such date, in each case ((i) and (ii)) have been provided to AbbVie... |
(d) All In-License Agreements are listed on the In-License Schedule, and (i) the licenses to Calibr in the In-License Agreements are in full force and effect and by their terms are sublicensable to AbbVie as contemplated by this Agreement, (ii) neither Calibr nor any of its Affiliates is in breach under any of the In-L... |
(e) The Existing Patents represent all Patents that Calibr or its Affiliates own, in-license or otherwise have rights to relating to the sCAR-T Platform or CD19 Products or the Exploitation of either of the foregoing as contemplated as of such CD19 Option Bringdown Date. To Calibr's Knowledge, there is no Information o... |
(f) Neither Calibr nor any of its Affiliates has previously entered into any agreement, whether written or oral, with respect to or otherwise assigned, transferred, licensed, conveyed or otherwise encumbered its right, title or interest in or to any Patent or other intellectual property or proprietary right or Informat... |
(g) Merck has effectively waived any and all rights it had with respect to any Calibr IP and there is no basis for any claim that Merck has any rights to any Calibr IP or any Information or Patents that would be Calibr IP but for any such claim by Merck. Neither Merck nor any of its Affiliates performed any research, d... |
(h) Neither Calibr nor any of its Affiliates has entered into any written agreement that (i) grants any Third Party any rights of reference under or access to the Calibr Regulatory Documentation that are inconsistent with the rights granted to AbbVie hereunder, (ii) grants any Third Party any rights to or under the Exi... |
(i) (i) No written claim or litigation has been brought or asserted in writing (and Calibr has no Knowledge of any claim, whether or not brought or asserted) by any Person alleging that (A) any of the Existing Patents are invalid or unenforceable or (B) the conception, development, reduction to practice, disclosing, co... |
(j) Except as described in the In-License Agreements, there are no amounts that shall be required to be paid to a Third Party as a result of the Exploitation of any CD19 Product that arises out of any agreement to which Calibr or any of its Affiliates is a party as of such CD19 Option Bringdown Date; |
(k) To Calibr's Knowledge, no Person is infringing or threatening to infringe or misappropriating or threatening to misappropriate the Existing Patents, the Calibr Know-How, the sCAR-T Platform IP, or the Calibr Regulatory Documentation; |
(l) Each of the Existing Patents properly identifies each and every inventor of the claims thereof as determined in accordance with the laws of the jurisdiction in which such Existing Patent is issued or such application is pending; |
(m) There are no pending or, to Calibr's Knowledge, alleged or threatened, (i) inter partes reviews, post-grant reviews, interferences, re-examinations or oppositions involving the Existing Patents that are in or before any patent authority (or other Governmental Authority performing similar functions) or (ii) any inve... |
(n) Calibr or one of its Affiliates has obtained the right (including under any Patents and other intellectual property rights) to use all Information and all other materials (including any formulations and manufacturing processes and procedures) developed or delivered by any Third Party under any agreements between Ca... |
(o) Calibr or its licensor, as applicable, have complied with all of their obligations pursuant to the Bayh Dole Act with respect to the Federally Funded Inventions and the Existing Patents that claim or cover such Federally Funded Inventions, as well as any foreign equivalents to the Bayh Dole Act, or any other obliga... |
(p) Except for the Federally Funded Inventions, the inventions and discoveries claimed by the Existing Patents (i) were not conceived, discovered, developed or otherwise made in connection with any research activities funded, in whole or in part, by the federal government of the United States or any agency thereof, (ii... |
Governmental Authority, within or outside the United States, due to such Governmental Authority's funding of research and development or otherwise (other than the right to receive payments or any law of general application that applies to personal property generally, e.g., takings laws); |
(q) Calibr has made available to AbbVie all Calibr Regulatory Documentation, Calibr Know-How and other Information with respect to CD19 Products, including Information regarding the safety or efficacy of CD19 Products or any other pharmaceutical products developed using the sCAR-T Platform, in the possession or Control... |
(r) The Calibr Know-How has been kept confidential or has been disclosed to Third Parties only under terms of confidentiality. To the Knowledge of Calibr and its Affiliates no breach of such confidentiality has been committed by any Third Party; |
(s) Calibr and its Affiliates have generated, prepared, maintained and retained all Calibr Regulatory Documentation that is required to be generated, prepared, maintained or retained pursuant to and in accordance with good laboratory and clinical practice and Applicable Law and all such information is true, complete an... |
(t) Calibr and its Affiliates have conducted, and its and their respective contractors and consultants have conducted, all Development of the sCAR-T Platform and CD19 Products in accordance with good laboratory and clinical practice (as each are applicable to the relevant Development activities) and Applicable Law in a... |
(u) Neither Calibr nor any of its Affiliates, nor any of its or their respective officers, employees or agents has (i) committed an act, (ii) made a statement or (iii) failed to act or make a statement that, in any case ((i), (ii) or (iii)), that (A) would be or create an untrue statement of material fact or fraudulent... |
(v) Each report provided to AbbVie hereunder with respect to CD19 Products, including pursuant to Section 2.7, and the CD19 Data Package provided by Calibr to AbbVie hereunder is true, complete and, to Calibr's Knowledge correct in all material respects; and |
(w) Neither Calibr nor any of its Affiliates has been debarred or is subject to debarment and neither it nor any of its Affiliates shall use in any capacity, in connection with the activities to be performed under this Agreement, any Person who has been debarred pursuant to Section 306 of the FFDCA or who is the subjec... |
10.2.3 - 4 |
Schedule 10.2.4: Representations and Warranties as of the Existing Target ROFN Bringdown Date |
Calibr additionally represents and warrants to AbbVie, as of the Existing Target ROFN Bringdown Date for each Existing Target for which AbbVie provides an ROFN Notice, that except as set forth in the Updated Disclosure Schedules provided as of the Existing Target ROFN Bringdown Date for such Existing Target: |
(a) Calibr has the right to use all Regulatory Documentation, Information and Patents necessary for Calibr to fulfill its obligations hereunder and that all such Information and Patents are and shall be Calibr Know-How or Calibr Patents, respectively; |
(b) All Existing Patents are listed on the Existing Patent Schedule, and all Existing Patents are (i) to Calibr's Knowledge, valid and enforceable, (ii) solely and exclusively owned or in-licensed pursuant to an In-License Agreement by Calibr or one of its Affiliates, free of any encumbrance, lien or claim of ownership... |
(c) True, complete and correct copies of (i) the file wrappers and other documents and materials relating to the prosecution, defense, maintenance, validity and enforceability of the Existing Patents and (ii) all In-License Agreements, as amended as of such date, in each case ((i) and (ii)) have been provided to AbbVie... |
(d) All In-License Agreements are listed on the In-License Schedule, and (i) the licenses to Calibr in the In-License Agreements are in full force and effect and by their terms are sublicensable to AbbVie as contemplated by this Agreement, (ii) neither Calibr nor any of its Affiliates is in breach under any of the In-L... |
(e) The Existing Patents represent all Patents that Calibr or its Affiliates own, in-license or otherwise have rights to relating to the sCAR-T Platform or Licensed Products Directed to such Existing Target or the Exploitation of either of the foregoing as contemplated as of the Existing Target ROFN Bringdown Date for ... |
are not limited in any material respect by the In-License Agreements, including such that the rights granted to AbbVie hereunder to intellectual property licensed pursuant to an In-License Agreement are no more restricted than the analogous rights granted to AbbVie hereunder with respect to intellectual property rights... |
(f) Neither Calibr nor any of its Affiliates has previously entered into any agreement, whether written or oral, with respect to or otherwise assigned, transferred, licensed, conveyed or otherwise encumbered its right, title or interest in or to any Patent or other intellectual property or proprietary right or Informat... |
(g) Merck has effectively waived any and all rights it had with respect to any Calibr IP and there is no basis for any claim that Merck has any rights to any Calibr IP or any Information or Patents that would be Calibr IP but for any such claim by Merck. Neither Merck nor any of its Affiliates performed any research, d... |
(h) Neither Calibr nor any of its Affiliates has entered into any written agreement that (i) grants any Third Party any rights of reference under or access to the Calibr Regulatory Documentation that are inconsistent with the rights granted to AbbVie hereunder, (ii) grants any Third Party any rights to or under the Exi... |
(i) (i) No written claim or litigation has been brought or asserted in writing (and Calibr has no Knowledge of any claim, whether or not brought or asserted) by any Person alleging that (A) any of the Existing Patents are invalid or unenforceable or (B) the conception, development, reduction to practice, disclosing, co... |
(j) Except as described in the In-License Agreements, there are no amounts that shall be required to be paid to a Third Party as a result of the Exploitation of any Licensed Product Directed to such Existing Target that arises out of any agreement to which Calibr |
or any of its Affiliates is a party as of the Existing Target ROFN Bringdown Date for such Existing Target; |
(k) To Calibr's Knowledge, no Person is infringing or threatening to infringe or misappropriating or threatening to misappropriate the Existing Patents, the Calibr Know-How, the sCAR-T Platform IP, or the Calibr Regulatory Documentation; |
(l) Each of the Existing Patents properly identifies each and every inventor of the claims thereof as determined in accordance with the laws of the jurisdiction in which such Existing Patent is issued or such application is pending; |
(m) There are no pending or, to Calibr's Knowledge, alleged or threatened, (i) inter partes reviews, post-grant reviews, interferences, re-examinations or oppositions involving the Existing Patents that are in or before any patent authority (or other Governmental Authority performing similar functions) or (ii) any inve... |
(n) Calibr or one of its Affiliates has obtained the right (including under any Patents and other intellectual property rights) to use all Information and all other materials (including any formulations and manufacturing processes and procedures) developed or delivered by any Third Party under any agreements between Ca... |
(o) Calibr or its licensor, as applicable, have complied with all of their obligations pursuant to the Bayh Dole Act with respect to the Federally Funded Inventions and the Existing Patents that claim or cover such Federally Funded Inventions, as well as any foreign equivalents to the Bayh Dole Act, or any other obliga... |
(p) Except for the Federally Funded Inventions, the inventions and discoveries claimed by the Existing Patents (i) were not conceived, discovered, developed or otherwise made in connection with any research activities funded, in whole or in part, by the federal government of the United States or any agency thereof, (ii... |
200-212, as amended, as well as any regulations promulgated pursuant thereto, including in 37 C.F.R. part 401 and (iv) are not the subject of any licenses, options or other rights of any other Governmental Authority, within or outside the United States, due to such Governmental Authority's funding of research and devel... |
(q) Calibr has made available to AbbVie all Calibr Regulatory Documentation, Calibr Know-How and other Information, including Information regarding the safety or efficacy of Licensed Products Directed to such Existing Target or any other pharmaceutical products developed using the sCAR-T Platform, in the possession or ... |
(r) The Calibr Know-How has been kept confidential or has been disclosed to Third Parties only under terms of confidentiality. To the Knowledge of Calibr and its Affiliates no breach of such confidentiality has been committed by any Third Party; |
(s) Calibr and its Affiliates have generated, prepared, maintained and retained all Calibr Regulatory Documentation that is required to be generated, prepared, maintained or retained pursuant to and in accordance with good laboratory and clinical practice and Applicable Law and all such information is true, complete an... |
(t) Calibr and its Affiliates have conducted, and its and their respective contractors and consultants have conducted, all Development of the sCAR-T Platform and Licensed Products Directed to such Existing Target in accordance with good laboratory and clinical practice (as each are applicable to the relevant Developmen... |
(u) Neither Calibr nor any of its Affiliates, nor any of its or their respective officers, employees or agents has (i) committed an act, (ii) made a statement or (iii) failed to act or make a statement that, in any case ((i), (ii) and (iii)), that (A) would be or create an untrue statement of material fact or fraudulen... |
(v) Each report provided to AbbVie hereunder, including pursuant to Section 2.7 and Section 2.1.6, and each CD19 Data Package and Data Package provided by Calibr to AbbVie hereunder is true, complete and correct in all material respects; and |
(w) Neither Calibr nor any of its Affiliates has been debarred or is subject to debarment and neither it nor any of its Affiliates shall use in any capacity, in connection |
with the activities to be performed under this Agreement, any Person who has been debarred pursuant to Section 306 of the FFDCA or who is the subject of a conviction described in such section. |
10.2.4 - 5 |
Schedule 10.2.5: Representations and Warranties as of the Platform Option Bringdown Date |
Calibr additionally represents and warrants to AbbVie, as of the Platform Option Bringdown Date, that except as set forth in the Updated Disclosure Schedules provided as of the Platform Option Bringdown Date: |
(a) Calibr has the right to use all Regulatory Documentation, Information and Patents necessary for Calibr to fulfill its obligations hereunder and that all such Information and Patents are and shall be Calibr Know-How or Calibr Patents, respectively; |
(b) All Existing Patents are listed on the Existing Patent Schedule, and all Existing Patents are (i) to Calibr's Knowledge, valid and enforceable, (ii) solely and exclusively owned or in-licensed pursuant to an In-License Agreement by Calibr or one of its Affiliates, free of any encumbrance, lien or claim of ownership... |
(c) True, complete and correct copies of (i) the file wrappers and other documents and materials relating to the prosecution, defense, maintenance, validity and enforceability of the Existing Patents and (ii) all In-License Agreements, as amended as of such date, in each case ((i) and (ii)) have been provided to AbbVie... |
(d) All In-License Agreements are listed on the In-License Schedule, and (i) the licenses to Calibr in the In-License Agreements are in full force and effect and by their terms are sublicensable to AbbVie as contemplated by this Agreement, (ii) neither Calibr nor any of its Affiliates is in breach under any of the In-L... |
(e) The Existing Patents represent all Patents that Calibr or its Affiliates own, in-license or otherwise have rights to relating to the sCAR-T Platform or the Research Target Products or the Exploitation of either of the foregoing as contemplated as of the Platform Option Bringdown Date. To Calibr's Knowledge, there i... |
to AbbVie hereunder to intellectual property licensed pursuant to an In-License Agreement are no more restricted than the analogous rights granted to AbbVie hereunder with respect to intellectual property rights wholly owned by Calibr or its Affiliates; |
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