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Adelle Infante |
1.847.938.8745 |
adelle.infante@abbvie.com |
Calibr and Scripps Research Media Contacts |
Chris Emery |
Scripps Research |
cemery@scripps.edu |
1.858.784.2207 |
Schedule 10.2.1: Initial Disclosure Schedules |
CALIBR DISCLOSURE SCHEDULE |
This initial disclosure schedule (this "Disclosure Schedule") is being furnished by The California Institute for Biomedical Research ("Calibr") to AbbVie Ireland Unlimited Company ("AbbVie") in connection with the execution and delivery of the License Agreement between Calibr and AbbVie dated as of June 21, 2018 (the "... |
This Disclosure Schedule has been arranged, for purposes of convenience only, as separate parts corresponding to the sections of Section 10 of the Agreement; provided, however, that any information disclosed herein under any section number shall be deemed to be disclosed and incorporated in any other section of the Agr... |
10.2.1 - 1 |
Section 10.2.1(a) |
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 10.2.1(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 10.2.1(e) |
Certain Information that relates to the sCAR-T Platform is not within the Calibr Know How because it is publicly available. |
Section 10.2.1(h)(ii) |
Reference is made to the Federally Funded Invention Schedule (Schedule 10.2.1(o)) with respect to international patent application number PCT/US2017/057460 (CIBR-011/01WO) with respect to the rights that the federal government has in the invention 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 10.2.1(n). |
Section 10.2.1(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 10.2.1(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. |
Section 10.2.1(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. |
10.2.1 - 5 |
Schedule 10.2.1(o): Federally Funded Inventions |
International patent application number PCT/US2017/057460 (CIBR-011/01WO) discloses that the invention was made with government support under grant number 1R01CA208398 awarded by the National Institute of Health. The government has certain rights in the invention pursuant to such grant. |
Schedule 10.2.2: A&R Disclosure Schedules |
CALIBR DISCLOSURE SCHEDULE |
This A&R disclosure schedule (this "A&R Disclosure Schedule") is being furnished by The Scripps Research Institute ("Calibr") to ABBVIE GLOBAL ENTERPRISES LTD. and its Affiliates ("AbbVie") in connection with the execution and delivery of the Amended and Restated License Agreement between Calibr and AbbVie dated as of ... |
This Disclosure Schedule has been arranged, for purposes of convenience only, as separate parts corresponding to the sections of Section 10 of the A&R Agreement; provided, however, that any information disclosed herein under any section number shall be deemed to be disclosed and incorporated in any other section of the... |
10.2.2 - 1 |
Section 10.2.2(a) |
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; |
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