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(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; |
(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 the Licensed Products that arises out of any agreement to which Calibr or any of its Affiliates is a party as of the Platform 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 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) are not a "sub... |
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 development or otherwise (other than the right to receive payments or any law of general application that applies to personal pr... |
(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 pharmaceutical products developed using the sCAR-T Platform, in the possession or Control of Calibr or any of its Affiliates and all such Regulato... |
(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 Research Target Products in accordance with good laboratory and clinical practice (as each are applicable to the relevant Development activities) and Applicab... |
(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, including pursuant to Section 2.8, and each CD19 Data Package and 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... |
10.2.5 - 4 |
Schedule 10.3.3 Scripps License Agreement Amendment |
[See attached.] |
10.3.3 – 1 |
AMENDMENT NO. 2 TO LICENSE AGREEMENT |
This AMENDMENT NO. 2 TO LICENSE AGREEMENT (this "Amendment No. 2") is made and entered into effective as of [___], 2018 by and between The Scripps Research Institute, a California nonprofit public benefit corporation ("TSRI") and California Institute for Biomedical Research, a California nonprofit public benefit corpor... |
RECITALS |
WHEREAS, TSRI and Calibr entered into that certain License Agreement, effective May 1, 2015 (the "License Agreement"), pursuant to which TSRI exclusively licensed to Calibr technology related to switchable chimeric antigen receptor T cell therapy for development and exploitation; |
WHEREAS, TSRI and Calibr entered into that certain Amendment No. 1 to License Agreement, effective February 27, 2018; and |
WHEREAS, the Parties desire to modify certain provisions set forth in the License Agreement as set forth herein. |
NOW, THEREFORE, in consideration of the premises and the mutual promises and conditions set forth herein and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, do hereby agree as follows: |
1. Definitions. Capitalized terms used in this Amendment No. 2 that are not defined herein shall have the meanings ascribed to them in the License Agreement. |
2. Amendments. |
2.1 Amendment to Article 1. Article 1 of the License Agreement is hereby amended by inserting the following definition: |
"AbbVie License Agreement" means that certain License Agreement between Licensee and AbbVie Ireland Unlimited Company ("AbbVie") dated June 21, 2018." |
2.2 Amendment to Section 1.19(a). Section 1.19(a) of the License Agreement is hereby amended by replacing "Joint Invention" with "TSRI Sole Invention". |
2.3 Amendment to Section 8.1. Section 8.1 of the License Agreement is hereby amended by inserting the following at the end of Section 8.1: |
"; provided, that, during the term of the AbbVie License Agreement, AbbVie may disclose such Confidential Information to the extent such disclosure is a permitted disclosure of Calibr's Confidential Information |
(as defined in the AbbVie License Agreement) under the AbbVie License Agreement." |
2.4 Amendment to Section 8.2. Section 8.2 of the License Agreement is hereby amended by inserting the following sentence at the end of Section 8.2: |
"Notwithstanding the foregoing, during the term of the AbbVie License Agreement (and any applicable survival period), the provisions of Section 9.6.1 of the AbbVie License Agreement shall apply with respect to any publication by TSRI that meets the criteria set forth in such section." |
2.5 Amendment to Section 8.3. Section 8.3 of the License Agreement is hereby amended by inserting the following at the end of the first sentence thereof: |
"; provided, that TSRI's consent shall not be required with respect to any such publication, news release or other public announcement that is made in accordance with Section 9.5 of the AbbVie License Agreement." |
2.6 Amendment to Section 9.6(b). Section 9.6(b) of the License Agreement is hereby amended by inserting the following at the end of the first sentence thereof: |
"; provided, that, during the term of the AbbVie License Agreement, this Section 9.6(b) shall not apply for so long as TSRI is an Affiliate (as defined the AbbVie License Agreement) of Calibr." |
2.7 Amendment to Section 9.6(d)(i). Section 9.6(d)(i) of the License Agreement is hereby amended by deleting the following language therefrom " and its economic obligations to TSRI shall be the same in amount and type as those paid to Licensee". |
3. Representations and Warranties. Each Party represents and warrants to the other Party, as of the effective date of this Amendment No. 2, that: |
3.1 such Party has the power and authority and the legal right to enter into this Amendment No. 2 and perform its obligations under the License Agreement as amended hereunder; |
3.2 such Party has taken all necessary action on its part required to authorize the execution and delivery of this Amendment No. 2 and the performance of its obligations under the License Agreement as amended hereunder; |
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