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(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 Regulatory Documentation owned by, or in the possession of or under the control of, Calibr or any of its Affiliates with respect to the sCAR-T Platform (the ... |
(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 Research Target Product that arises out of any agreement to which Calibr or any of its Affiliates is a party as of the Original Execution Date or the Origi... |
(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) Schedule 10.2.1(o) sets forth a list of all inventions or discoveries that were 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 or that are otherwise subject to the provisi... |
(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... |
(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 in accordance with good laboratory and clinical practice (as each are applicable to the relevant Development activities) and Applicable Law in all material respec... |
(u) None of the Third Parties to whom Calibr has provided any materials pursuant to a material transfer agreement has disclosed to Calibr any inventions made by such Third Party in connection with any activities performed by such Third Party with respect to such materials, in each case that is related to the sCAR-T Pla... |
(v) 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... |
10.2.2 Calibr additionally represents and warrants to AbbVie, as of the A&R Effective Date, that except as set forth in the disclosure schedules attached hereto as Schedule 10.2.2 (the "A&R Disclosure Schedules") or the Updated A&R Disclosure Schedules, as applicable: |
(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 as of the A&R Effective Date 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 encumbranc... |
(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 AbbVi... |
(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 Exploitation thereof as contemplated as of the A&R Effective Date. To Calibr's Knowledge, there is no Information owned by or otherwise in the possession or con... |
(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 Calibr Regulatory Documentation that are inconsistent with the rights granted to AbbVie hereunder, (ii) grants any Third Party any rights to or under the Existin... |
(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 Research Target Product that arises out of any agreement to which Calibr or any of its Affiliates is a party as of the A&R Effective Date, as applicable; |
(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) Schedule 10.2.2(o) sets forth a list of all sets forth a list of all Federally Funded Inventions. Calibr has complied with all of its obligations pursuant to the Bayh Dole Act with respect to the Federally Funded Inventions and the Existing Patents that claim any Federally Funded Inventions, as well as any foreign ... |
(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... |
(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 in accordance with good laboratory and clinical practice (as each are applicable to the relevant Development activities) and Applicable Law in all material respec... |
(u) None of the Third Parties to whom Calibr has provided any materials pursuant to a material transfer agreement has disclosed to Calibr any inventions made by such Third Party in connection with any activities performed by such Third Party with respect to such materials, in each case that is related to the sCAR-T Pla... |
(v) 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... |
10.2.3 Calibr makes the representations and warranties set forth on Schedule 10.2.3 to AbbVie as of the Acceptance Date for the CD19 Data Package and as of the Acceptance Date for the CD19 Autoimmune Data Package (each, a "CD19 Option Bringdown Date"), except as set forth in the Initial Disclosure Schedules or, subject... |
10.2.4 With respect to each Existing Target for which AbbVie provides an ROFN Notice, Calibr makes the representations and warranties set forth on Schedule 10.2.4 to AbbVie as of, if such Existing Target becomes an Included Existing Target, the Inclusion Date for such Included Existing Target or if such Existing Target... |
10.2.5 Calibr makes the representations and warranties set forth on Schedule 10.2.5 to AbbVie as of the earlier of (a) the date that Calibr actually delivers the Updated Platform Disclosure Schedules and (b) the last date by which Calibr is required to deliver the Updated Platform Disclosure Schedules pursuant to Secti... |
10.2.6 Subject to Section 10.2.7, Calibr shall provide AbbVie updated disclosure schedules as follows: |
(a) Calibr shall have the right to provide a further updated disclosure schedule within two (2) Business Days after the Original Effective Date (such updated disclosure schedules, the "Updated Effective Date Disclosure Schedules"); |
(b) Calibr shall have the right to provide a further updated disclosure schedule prior to the A&R Effective Date (such updated disclosure schedules, the "Updated A&R Disclosure Schedules"); |
(c) with the delivery of each of the CD19 Data Package and the CD19 Autoimmune Data Package or if AbbVie is considering exercising the CD19 License Option prior the receipt of the CD19 Data Package, within five (5) Business Days after AbbVie so notifies Calibr; provided, that if AbbVie does not exercise the CD19 Licens... |
(d) with the delivery of the Data Package with respect to each Existing Target for which AbbVie provides Calibr a ROFN Notice (each such updated disclosure schedules, the "Updated ROFN Disclosure Schedules"); and |
(e) on the last day of the New Platform Exclusivity Period or if AbbVie is considering exercising the Platform Option prior the end of the New Platform Exclusivity Period, within five (5) Business Days after AbbVie so notifies Calibr; provided, that if AbbVie does not exercise the Platform Option within forty-five (45)... |
10.2.7 Bring Down Limitations. The disclosures set forth in any Updated Disclosure Schedule shall be limited to (a) updating the Existing Patent Schedule, the Federally Funded Invention Schedule, and the In-License Schedule and (b) any matter (i) existing as of the Original Effective Date (or the relevant CD19 Option B... |
10.3 Additional Covenants of Calibr. |
10.3.1 Non-Infringement Covenant. From and after the Original Execution Date, Calibr shall not, and shall cause its Affiliates not to, (a) misappropriate, infringe or use without authorization any valid and enforceable intellectual property rights of a Third Party in connection with the performance of its activities un... |
10.3.2 Board of Director Conflicts of Interest. Calibr shall maintain and take steps to ensure compliance with one or more policies to identify, review and manage actual or potential conflicts of interest involving the members of its Board of Directors, officers and employees, including requiring members of the Board o... |
10.3.3 Scripps License Agreement. Within forty five (45) days after the Original Effective Date, The California Institute for Biomedical Research shall enter into an amendment in substantially the form attached hereto as Schedule 10.3.3 with The Scripps Research Institute. |
10.3.4 Merck. Calibr shall not, and shall cause its Affiliates not to, provide to Merck any Information regarding the sCAR-T Platform or any of the activities under this Agreement. |
10.3.5 Patent Management. At all times during the Term, except to the extent otherwise consented to by AbbVie in writing, such consent not to be unreasonably conditioned, withheld or delayed, Calibr shall (a) maintain patent protection on, and shall not decide not to pursue, discontinue its financial support for, aband... |
10.3.6 Wellcome Trust. Promptly after the Original Effective Date, Calibr shall use its best efforts to enter into an amendment with Wellcome, in a form reasonably acceptable to AbbVie, to amend the Wellcome Agreement to terminate Wellcome's rights under the Wellcome Agreement to (a) pursue, file, prosecute, protect, m... |
10.3.7 UCSD. Calibr shall not, and shall cause its Affiliates not to, use in connection with any activities under this Agreement any PCSD1 cells provided to Calibr or any of its Affiliates by the University of California, San Diego pursuant to that certain Material Transfer Agreement by and between Calibr and the Regen... |
10.3.8 Government Interest Matters. |
(a) Calibr shall, or shall use reasonable efforts to cause any applicable licensor to, take all actions necessary under the Bayh Dole Act to secure ownership of Patents that would constitute Calibr Patents that claim any Federally Funded Inventions for Calibr or its applicable licensor, including complying with all rep... |
(b) Calibr shall (i) not use or permit any funding or other resources of any Governmental Authority to be used in connection with the performance of any activities undertaken by or on behalf of Calibr under the Target Research Plan, the CD19 Plan, PRLR Switch Plan or SST Switch Plan, without the prior written consent o... |
(c) If any Licensed Product or any Calibr Component included in such Licensed Product becomes a "subject invention" as that term is described in 35 U.S.C. § 201(e) or is produced through the use of a "subject invention" including as a result of Calibr's failure to comply with the restrictions in Section 10.3.8(b), at A... |
10.3.9 Wellcome. Promptly after the Original Effective Date, Calibr shall negotiate with Wellcome and execute, as soon as practicable, a Revenue and Equity Sharing Agreement (as defined in the Wellcome Agreement) and, as soon as practicable thereafter, negotiate with Wellcome and execute an agreement setting forth the ... |
10.3.10 WuXi. Calibr shall make all payments necessary to obtain the assignment of intellectual property under any agreements relating to the sCAR-T technology between The California Institute for Biomedical Research and WuXi Advanced Therapies, including WO-001, dated May 31, 2018, subject to Calibr's withholding of a... |
10.4 Data Privacy and Security. For all Personal Data Processed by or on behalf of either Party or any of its Affiliates in performance of this Agreement, including, with respect to Calibr the conduct of the Phase I Clinical Trials under the PRLR Switch Plan, SST Switch Plan, CD19 Plan and in connection with the prepar... |
10.4.1 comply at all times with the applicable Data Protection Laws to which such Party is subject in accordance with Applicable Law; |
10.4.2 to the extent permitted by Applicable Law, notify the other Party, as soon as practicable and in any event prior to making the relevant disclosure, if it is obliged to make a disclosure of the Agreement Data under any statutory requirement; |
10.4.3 make timely notification to and obtain any necessary authorizations from any relevant data protection regulator where required under applicable Data Protection Laws of its collection and other Processing of Agreement Data in order to comply with its obligations under this Agreement; |
10.4.4 at all times, act in a manner such that it is not subject to any prohibition or restriction which shall (a) prevent or restrict it from disclosing or transferring the Agreement Data to the other Party as required under this Agreement or (b) prevent or restrict such other Party from Processing the Agreement Data ... |
10.4.5 ensure that all fair Processing notices or informed consents have been obtained and are maintained and are sufficient in scope to enable such Party to Process the Agreement Data as required in order to comply with its obligations under this Agreement to obtain the benefit of its rights and to fulfil its obligati... |
10.4.6 implement and maintain reasonable administrative, technical, organizational and physical safeguards designed to (a) maintain the security and confidentiality of all Agreement Data, (b) protect against reasonably anticipated threats or hazards to the security or integrity of Agreement Data and (c) protect against... |
10.4.7 notify the other Party promptly, and in any event within forty-eight (48) hours, of receipt of (a) any correspondence from a data protection regulator in relation to the Processing of Agreement Data related to this Agreement or (b) a request or notice from a data subject exercising his rights under applicable Da... |
10.4.8 refrain from taking actions related to the Processing of the Personal Data under this Agreement, which would be reasonably likely to damage or impair the other Party's reputation. |
10.5 Data Export. In the event that a Party needs to transfer Agreement Data originating from a Member State of the European Economic Area to an entity in a Third Country, such Party shall enter into then-applicable European Union standard contractual clauses or other required agreements under applicable Data Protectio... |
10.6 Debarment. Neither Party nor any of its Affiliates has been debarred or is subject to debarment and neither it nor any of its Affiliates will 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 ... |
10.7 DISCLAIMER OF WARRANTIES. EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH HEREIN, NEITHER PARTY MAKES ANY REPRESENTATIONS OR GRANTS ANY WARRANTIES, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, AND EACH PARTY SPECIFICALLY DISCLAIMS ANY OTHER WARRANTIES, WHETHER WRITTEN OR ORAL OR ... |
10.8 Anti-Bribery and Anti-Corruption Compliance. Each Party represents, warrants, and covenants to the other Party in connection with this Agreement that such Party and its Affiliates (a) have complied and shall comply with all applicable laws, rules, regulations and industry codes governing bribery, money laundering,... |
ARTICLE 11 INDEMNITY |
11.1 Indemnification of Calibr. AbbVie shall indemnify Calibr, its Affiliates and its and their respective directors, officers, employees and agents (collectively, "Calibr Indemnitees"), and defend and save each of them harmless, from and against any and all losses, damages, liabilities, costs and expenses (including r... |
11.2 Indemnification of AbbVie. Calibr shall indemnify AbbVie, its Affiliates and its and their respective directors, officers, employees and agents (collectively, "AbbVie Indemnitees"), and defend (except as provided in Section 8.8.2) and save each of them harmless, from and against any and all Losses in connection wi... |
11.3 Indemnification Procedures. |
11.3.1 Notice of Claim. All indemnification claims in respect of an AbbVie Indemnitee or a Calibr Indemnitee shall be made solely by Calibr or AbbVie, as applicable (each of Calibr or AbbVie in such capacity, the "Indemnified Party"). The Indemnified Party shall give the indemnifying Party (each of Calibr or AbbVie in ... |
11.3.2 Control of Defense. At its option, the Indemnifying Party may assume the defense of any Third Party Claim, except for any Third Party Infringement Claim, the procedures for which are set forth in Section 8.8.2, by notifying the Indemnified Party in writing within thirty (30) days after the Indemnifying Party's r... |
11.3.3 Right to Participate in Defense. Any Indemnified Party shall be entitled to participate in, but not control, the defense of a Third Party Claim and to employ counsel of its choice for such purpose; provided, that such employment shall be at the Indemnified Party's sole cost and expense unless (a) the employment ... |
11.3.4 Settlement. With respect to any Third Party Claim for which the Indemnifying Party has assumed the defense of such Third Party Claim in accordance with Section 11.3.2 that relates solely to the payment of money damages in connection with such Third Party Claim and that will not result in any AbbVie Indemnitee or... |
11.3.5 Cooperation. Regardless of whether the Indemnifying Party chooses to defend or prosecute any Third Party Claim, the Indemnified Party shall, and shall cause each AbbVie Indemnitee or Calibr Indemnitee, as applicable, to, reasonably cooperate in the defense or prosecution thereof and shall furnish such records, i... |
11.3.6 Expenses. Except as provided above, the costs and expenses, including fees and disbursements of counsel, incurred by the Indemnified Party in connection with any claim shall be reimbursed on a Calendar Quarter basis by the Indemnifying Party, without prejudice to the Indemnifying Party's right to contest any Abb... |
11.4 Special, Indirect and Other Losses. EXCEPT (A) IN THE EVENT OF THE WILLFUL MISCONDUCT OR FRAUD OF A PARTY OR OF A PARTY'S BREACH OF ITS OBLIGATIONS UNDER ARTICLE 9 OR SECTION 4.7, (B) AS PROVIDED UNDER SECTION 13.10, AND (C) TO THE EXTENT ANY SUCH DAMAGES ARE REQUIRED TO BE PAID TO A THIRD PARTY AS PART OF A CLAIM... |
11.5 Insurance. |
11.5.1 Calibr's Insurance Obligations. Calibr shall maintain, at its cost, type and amounts of insurance covering its activities hereunder as is reasonable under the circumstances, including insurance as is normal and customary in the research-based pharmaceutical industry generally for parties similarly situated, incl... |
11.5.2 AbbVie's Insurance Obligations. AbbVie shall have and maintain and AbbVie hereby represents, warrants and covenants to Calibr that it does have and shall maintain during the Term a self-insurance plan, adequate insurance against liability and other risks associated with its and its Affiliates' and any Sublicense... |
ARTICLE 12 TERM AND TERMINATION |
12.1 Term and Expiration. |
12.1.1 This Agreement shall take effect automatically without further action of either Party on the A&R Effective Date. This Agreement shall continue in force and effect until the date of expiration or earlier termination in accordance herewith. |
12.1.2 If AbbVie has not exercised the Platform Option, this Agreement shall, unless earlier terminated in accordance herewith, continue in force and effect until the date of expiration of the last Royalty Term for the last Licensed Product. If AbbVie has not exercised the Platform Option prior to the expiration of the... |
12.1.3 If AbbVie exercises the Platform Option, upon payment by AbbVie to Calibr of the Platform Option exercise fee in accordance with Section 3.2.2, this Agreement may only be terminated upon written agreement of the Parties. |
12.2 Termination. Prior to AbbVie's exercise of the Platform Option and payment by AbbVie to Calibr of the Platform Option exercise fee in accordance with Section 3.2.2, this Agreement may be terminated as follows. |
12.2.1 Material Breach. |
(a) In the event that either Party (the "Breaching Party") materially breaches any of its material obligations under this Agreement, in addition to any other right and remedy the other Party (the "Non-Breaching Party") may have, the Non-Breaching Party may terminate this Agreement by providing ninety (90) days' (or six... |
(b) Notwithstanding Section 12.2.1(a), if any uncured material breach by AbbVie of any of its material obligations under this Agreement is with respect to (i) only one (1) of the countries in the Territory, Calibr shall not have the right to terminate this Agreement in its entirety, but shall have the right to terminat... |
12.2.2 Additional Termination Rights. |
(a) AbbVie may terminate this Agreement at any time during the Term immediately upon written notice to Calibr (i) in its entirety if AbbVie in good faith determines that it is not advisable for AbbVie to continue to Develop or Commercialize the Licensed Products due to documented safety concerns or (ii) with respect to... |
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