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(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; |
3.3 entering into this Amendment No. 2 is not in conflict with any other agreement to which such Party is a party; and |
3.4 this Amendment No. 2 has been duly executed and delivered on behalf of such Party and constitutes a legal, valid and binding obligation of such Party and is enforceable against it in accordance with its terms subject to the effects of bankruptcy, insolvency or other laws of general application affecting the enforce... |
judicial principles affecting the availability of specific performance and general principles of equity, whether enforceability is considered a proceeding at law or equity. |
4. Reference to Agreement. Upon and after the effectiveness of this Amendment No. 2, each reference in the License Agreement and this Amendment No. 2 to "this Agreement," "the License Agreement," "hereunder," "hereof" or words of the like import referring to the License Agreement shall mean and be a reference to the Li... |
5. California Law. This Amendment No. 2 shall be construed and enforced in accordance with the laws of the state of California without regard to its conflicts or choice of law principles thereof. |
6. No Other Waiver. Except as expressly set forth herein, the execution, delivery and effectiveness of this Amendment No. 2 shall not operate as a waiver of any right, power or remedy of either party under the License Agreement, nor constitute a waiver of any provision of the License Agreement. |
7. Counterparts. This Amendment No. 2 may be executed by original or facsimile signature in two or more in counterparts, all of which taken with the same effect as if both Parties had signed the same document, each of which shall be deemed an original, shall be construed together and shall constitute a single one and t... |
[Signature page follows.] |
10.3.3 – 4 [Signature Page to Amendment No. 2 to License Agreement] |
THIS AMENDMENT NO. 2 IS EXECUTED by authorized representatives of the Parties as of the date first written above. |
The Scripps Research Institute |
By: |
Name: |
Title: |
California Institute for Biomedical Research |
By: |
Name: |
Title: |
Schedule 13.5 Arbitration |
The arbitration of a Dispute shall be conducted as follows: |
1. The arbitration shall be administered by JAMS pursuant to its Comprehensive Rules and Procedures, except as modified under this Schedule 13.5. The Parties acknowledge that this Agreement evidences a transaction involving interstate commerce. Notwithstanding any provision with respect to the applicable substantive la... |
2. To begin an arbitration, a Party shall provide written notice to the other Party of the Dispute, including a brief statement of the factual basis for its claim(s) and the relief sought. Within fourteen (14) days after its receipt of such notice, the other Party (the "Respondent") may, by written notice to the Party ... |
3. Within twenty-one (21) days after the commencement of arbitration, the Parties shall select a mutually acceptable independent, impartial and conflicts-free neutral to preside in resolution of all issues in the arbitration. If the Parties are unable to agree on a mutually acceptable arbitrator within such period, wit... |
(a) A person shall be deemed to have a conflict, and shall not be appointed as an Arbitrator absent the consent of both parties, if such person (i) has presided over an evidentiary hearing relating to, or issued a ruling on, the merits of a dispute, involving either Party; (ii) has conducted a mediation involving eithe... |
Party within the last 10 years. The "merits of a dispute" are matters substantially related to the substance of the underlying claim, and do not include procedural or discovery-related matters; |
(b) A person shall be deemed to have a conflict, and shall not be appointed as an Arbitrator absent consent of both parties, if such person previously served as a party-appointed Arbitrator appointed by either Party, or by any party represented in a previous arbitration by one of the law firms representing either Party... |
(c) No earlier than forty-five (45) days or later than ninety (90) days after appointment, the Arbitrator shall hold a hearing to resolve each of the issues identified by the Parties. |
4. At least fourteen (14) days prior to the hearing, each Party shall submit the following to the other Party and the Arbitrator: |
(a) a copy of all exhibits on which such Party intends to rely in any oral or written presentation to the Arbitrator; |
(b) a list of any witnesses such Party intends to call at the hearing, and a short summary of the anticipated testimony of each witness; |
(c) a proposed ruling on each issue to be resolved, together with a request for a specific damage award or other remedy for each issue. The proposed ruling shall not contain any recitation of the facts or any legal arguments, and the proposed remedy shall not include any punitive damages. The proposed ruling and the pr... |
(d) a brief in support of such Party's proposed rulings and remedies; provided, that the brief shall not exceed twenty (20) pages unless the Arbitrator determines that the number and complexity of issues requires that the page-limit be expanded. |
5. Each Party shall be entitled to ten (10) document requests and two (2) depositions. The Arbitrator may permit additional discovery for good cause shown, subject to the limits specified below, where such discovery is reasonably calculated to lead to evidence regarding liability or damages, and with respect to a reque... |
6. The hearing shall be conducted on no more than five (5) consecutive days and shall be governed by the following rules: |
(a) Each Party shall be entitled to fifteen (15) hours of hearing time to present its case. The Arbitrator shall keep time and shall determine whether each Party has had the fifteen (15) hours to which it is entitled. |
(b) Each Party shall be entitled, but not required, to make an opening statement, to present regular and rebuttal testimony, documents, or other evidence, to cross-examine witnesses, and to make a closing argument. Cross-examination of witnesses shall occur immediately after their direct testimony, and cross-examinatio... |
(c) Except when testifying, witnesses shall be excluded from the hearing until closing arguments. |
(d) Settlement negotiations, including any statements made therein, shall not be admissible under any circumstances. As to all other matters, the Arbitrator shall have sole discretion regarding the admissibility of any evidence. |
7. Prior to the completion of the hearing, a Party may seek leave from the Arbitrator to modify its proposed rulings on one or more issues to be resolved. If the Arbitrator finds good cause for such modification, within seven (7) days following completion of the hearing, the Parties shall file a substitute proposed rul... |
8. Within seven (7) days following completion of the hearing, each Party may submit to the other Party and the Arbitrator a post-hearing brief in support of its proposed rulings and remedies; provided, that such brief shall not contain or discuss any new evidence and shall not exceed ten (10) pages. This page limitatio... |
9. Within fourteen (14) days following completion of the hearing, each Party may submit to the other Party and the Arbitrator a post-hearing brief in support of its proposed rulings and remedies; provided, that such brief shall not contain or discuss any new evidence and shall not exceed twenty (20) pages unless the Ar... |
10. The Arbitrator shall rule on each disputed issue within thirty (30) days either following completion of the hearing or the submission of post-hearing briefs, if any. Such ruling shall adopt in its entirety the proposed ruling and remedy of one (1) of the Parties on each disputed issue but may adopt one (1) Party's ... |
11. All Arbitrator and JAMS fees and expenses, along with the reasonable legal fees and expenses of the prevailing Party (including all expert witness fees and expenses), and any expenses for a hearing room, shall be paid as follows: |
(a) If the Arbitrator rules in favor of one (1) Party on all disputed issues in the arbitration, the losing Party shall pay one hundred percent (100%) of such fees and expenses. |
(b) If the Arbitrator rules in favor of one (1) Party on some issues and the other Party on other issues, the Arbitrator shall issue with the rulings a written determination as to how such fees and expenses shall be allocated between the Parties. The Arbitrator shall allocate fees and expenses in a way that bears a rea... |
12. Except as may be required by law or legal proceedings to confirm or enforce an award, the existence of the Dispute, any settlement negotiations, the arbitration, any submissions (including exhibits, testimony, proposed rulings, and briefs), and any rulings and the award shall be deemed to be Confidential Informatio... |
13. The language of the arbitration shall be English and the seat of arbitration shall be in San Diego, California, USA. |
14. Each Party shall have the right to be represented by counsel in all aspects of any arbitration proceeding. |
EXECUTION VERSION |
Collaboration and License Option Agreement |
Between |
Cugene, Inc. |
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