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8.8.2 Defense. As between the Parties, AbbVie shall have the first right, but not the obligation, to defend and control the defense of any such claim, suit or proceeding at its sole cost and expense (but subject to offset as provided below if applicable), using counsel of its own choice. Calibr may participate in any s... |
8.8.3 Cooperation. If a Party controls such an action, the other Party shall, and shall cause its Affiliates to, assist and cooperate with the controlling Party, as such controlling Party may reasonably request from time to time, in connection with its activities set forth in this Section 8.8, including where necessary... |
8.8.4 Offset. AbbVie shall be entitled to offset eighty percent (80%) of the reasonable Out-of-Pocket Costs of defending, settling, compromising or paying any damages (other than treble damages that are assessed with respect to infringement of Third Party Rights for which the applicable Third Party offered AbbVie the o... |
8.8.5 Recoveries. Any recoveries awarded to a Party in connection with any Third Party Infringement Claim defended under this Section 8.8 shall be applied first to reimburse such Party for its reasonable Out-of-Pocket Costs of defending such claim, suit or proceedings and then to reimburse the other Party for amounts o... |
8.9 Third Party Rights. If, in the reasonable opinion of AbbVie, any Patent, trade secret or other intellectual property right of a Third Party in any country in the Territory exists that may be necessary or reasonably useful in connection with the Exploitation of a Licensed Product hereunder (such right, a "Third Part... |
8.10 Product Trademarks. |
8.10.1 Ownership of Product Trademarks. As between the Parties, AbbVie shall have the sole right to determine and shall own all right, title and interest in and to the Trademarks that are used in connection with any Licensed Product (the "Product Trademarks") on a worldwide basis. Calibr shall not, and shall cause its ... |
8.10.2 Registration of Product Trademarks. As between the Parties, AbbVie shall have the sole right to register, prosecute and maintain the Product Trademarks. All costs and expenses of registering, prosecuting, and maintaining the Product Trademarks shall be borne solely by AbbVie. Calibr shall provide all reasonable ... |
8.10.3 Enforcement of Product Trademarks. As between the Parties, AbbVie shall have the sole right to take such action as AbbVie, after consultation with Calibr, deems necessary against a Third Party based on any alleged, threatened, or actual infringement, dilution, misappropriation, or other violation of, or unfair t... |
8.10.4 Third Party Claims. As between the Parties, AbbVie shall have the sole right to defend against (including the right to settle) any alleged, threatened, or actual claim by a Third Party that the use or registration of the Product Trademarks in the Territory infringes, dilutes, misappropriates, or otherwise violat... |
8.10.5 Notice and Cooperation. Calibr shall, and shall cause its Affiliates and its and their (sub)licensees to, (a) provide prompt written notice of any actual or threatened infringement of the Product Trademarks in the Territory and of any actual or threatened claim that the use of the Product Trademarks in the Terri... |
ARTICLE 9 CONFIDENTIALITY AND NON-DISCLOSURE |
9.1 Confidentiality Obligations. |
9.1.1 Generally; Non-Use and Non-Disclosure Obligations. At all times during the Term and for a period of ten (10) years following termination or expiration of this Agreement in its entirety (and thereafter with respect to any Confidential Information that either Party specifically identifies to the other Party in writ... |
9.1.2 AbbVie Target Information. Without limiting Calibr's obligations under Section 9.1.1, Calibr shall, and shall cause its Affiliates to, (a) maintain the confidentiality of any AbbVie Target Information, including by limiting the disclosure thereof to (i) employees of Calibr who (A) have a need to know the AbbVie T... |
9.1.3 Exceptions. Notwithstanding Section 9.1.1 and Section 9.1.2, the confidentiality and non-use obligations under this Section 9.1 with respect to any Confidential Information shall not apply to any information that: |
(a) has been published by a Third Party or otherwise is or hereafter becomes part of the public domain by public use, publication, general knowledge or the like through no breach of this Agreement by the Receiving Party; |
(b) can be demonstrated by documentation or other competent proof to have been in the Receiving Party's possession prior to disclosure by the Disclosing Party without any obligation of confidentiality with respect to such information; provided, that the foregoing exception shall not apply with respect to (i) Program Pr... |
(c) is subsequently received by the Receiving Party from a Third Party who is not bound by any obligation of confidentiality to the Disclosing Party with respect to such information; |
(d) can be demonstrated by documentation or other competent evidence to have been independently developed by or for the Receiving Party without reference or access to the Disclosing Party's Confidential Information; provided, that the foregoing exception shall not apply with respect to (i) Program Product Inventions, (... |
Specific aspects or details of Confidential Information shall not be deemed to be within the public domain or in the possession of the Receiving Party merely because the Confidential Information is embraced by more general information in the public domain or in the possession of the Receiving Party. Further, any combin... |
9.2 Permitted Disclosures. |
9.2.1 The Receiving Party may use and disclose Confidential Information of the Disclosing Party to the extent that such disclosure is: |
(a) made in response to a valid order of a court of competent jurisdiction or other supra-national, federal, national, regional, state, provincial and local governmental or regulatory body of competent jurisdiction or, if in the reasonable opinion of the Receiving Party's legal counsel, such disclosure is otherwise req... |
(b) made by or on behalf of the Receiving Party to a patent authority as may be reasonably necessary or useful for purposes of obtaining or enforcing a Patent as permitted under this Agreement; provided, however, that reasonable measures shall be taken to assure confidential treatment of such information, to the extent... |
9.2.2 The terms of this Agreement may be disclosed by a Party or its Affiliates to potential or actual investors or acquirers as may be necessary in connection with their evaluation of such potential or actual investment or acquisition under obligations of confidentiality and non-use at least as protective as the oblig... |
9.3 Additional Permitted Disclosures. Each Party and its Affiliates and its and their sublicensees may disclose and use Confidential Information of the other Party as may be necessary or useful in connection with the Exploitation of the Licensed Products (to the extent such Party is permitted to do so Exploit in accord... |
9.4 Use of Names. Except as expressly provided herein, neither Party shall mention or otherwise use the name, logo or Trademark of the other Party or any of its Affiliates or any of its or their (sub)licensees (or any abbreviation or adaptation thereof) in any publication, press release, marketing and promotional mater... |
9.5 Public Announcements. The Parties have agreed upon the content of one (1) joint press release issued substantially in the form attached hereto as Schedule 9.5 following the Original Effective Date. Neither Party shall issue any other public announcement, press release or other public disclosure regarding this Agree... |
9.6 Publications. |
9.6.1 Publications by Calibr. It is understood that Calibr and its Affiliates, as non-profit research institutions, shall have the right to, and may make publications or public disclosures related to or arising in connection with this Agreement, subject to the following limitations: |
(a) regarding the sCAR-T Platform generally and not in connection with any specific Selected Target, Option Target or Substitute Target, or regarding any Existing Target, prior to (i) the end of the Platform Option Period, if AbbVie does not exercise its Platform Option or (ii) the end of the Term, if AbbVie exercises ... |
(b) regarding any Selected Target, Option Target or Substitute Target, during the period beginning on the Inclusion Date with respect thereto and ending on the last day of the Term, subject to Section 4.7.1(c) with respect to any Selected Target that becomes a Failed Target; or |
(c) regarding CD19 or any CD19 Products, prior to (i) the end of the CD19 License Option Period, if AbbVie does not exercise its CD19 License Option or (ii) the end of the Term, if AbbVie exercises its CD19 License Option, in either case ((i) or (ii)), subject to Section 4.7.4, |
in each case of (a) through (c) (and during the time periods set forth therein), provided, that no later than ninety (90) days prior to the date that Calibr (or any Affiliate as applicable) intends to make any such publication or public disclosure, (x) Calibr shall provide AbbVie with drafts of such proposed abstracts,... |
9.6.2 Academic Collaboration Publications. Calibr shall have the right to permit each Academic Collaborator to publicly disclose the results of and information regarding such Academic Collaborator's activities in connection with the applicable Academic Collaboration, subject to the prior review and comment by AbbVie of... |
9.6.3 Publication by AbbVie. AbbVie shall be free to publicly disclose the results of and information regarding activities under this Agreement, subject to prior review by Calibr of any disclosure of Confidential Information of Calibr for issues of patentability and protection of such Confidential Information, in a man... |
9.7 Return of Confidential Information. Upon the effective date of the termination of this Agreement for any reason, upon the written request of a Party, the non-requesting Party shall either, at the requesting Party's election: (a) promptly destroy all copies of the requesting Party's Confidential Information in the p... |
ARTICLE 10 REPRESENTATIONS AND WARRANTIES |
10.1 Mutual Representations and Warranties. Calibr and AbbVie each represents and warrants to the other, as of the Original Effective Date and the A&R Effective Date: |
10.1.1 it is duly organized, validly existing and in good standing under the Applicable Laws of the jurisdiction of its incorporation and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof; |
10.1.2 the execution and delivery of this Agreement and the performance by it of the transactions contemplated hereby have been duly authorized by all necessary corporate action and do not violate: (a) such Party's charter documents, bylaws or other organizational documents; (b) in any material respect, any agreement, ... |
10.1.3 this Agreement is a legal, valid and binding obligation of such Party enforceable against it in accordance with its terms and conditions, subject to the effects of bankruptcy, insolvency or other laws of general application affecting the enforcement of creditor rights, judicial principles affecting the availabil... |
10.2 Additional Representations and Warranties of Calibr. |
10.2.1 Calibr additionally represents and warrants to AbbVie, as of the Original Execution Date and the Original Effective Date, that except as set forth in the disclosure schedules attached hereto as Schedule 10.2.1 (the "Initial Disclosure Schedules") or the Updated Effective Date 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 Original Execution Date or the Original Effective Date, as applicable, 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 Cal... |
(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 Original Execution Date or the Original Effective Date, as applicable. To Calibr's Knowledge, there is no Informa... |
(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 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... |
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