text stringlengths 1 5.46k |
|---|
7.17 Right to Offset. Each Party shall have the right to offset any (a) undisputed amount or (b) disputed amount once such dispute has been finally resolved pursuant to Section 13.5, in each case ((a) and (b)), owed by the other Party to such first Party under or in connection with this Agreement, including pursuant to... |
7.18 Diagnostic or Veterinary Products. The royalties in Section 7.6 or Section 7.7 shall apply to the Development and Commercialization of Licensed Products for diagnostic, veterinary or any other non-human use, or for uses solely for screening patients who have been diagnosed with a disease, state or condition for el... |
7.19 Financial Obligations under In-License Agreements. Unless otherwise agreed by the Parties, Calibr shall be responsible for all payments owed to Third Parties under the In-License Agreements or any other agreement (including funding agreements) to which it is a Party. |
ARTICLE 8 INTELLECTUAL PROPERTY |
8.1 Ownership of Intellectual Property. |
8.1.1 Ownership of IP. Subject to the license grants and other rights herein, including Calibr's assignment obligation under Section 8.1.3, as between the Parties, each Party shall own and retain all right, title and interest in and to any and all Information and inventions that are conceived, discovered, developed or ... |
8.1.2 Ownership of Joint IP. Subject to Section 8.1.3, as between the Parties, the Parties shall each own an equal, undivided interest in any and all: (a) Information and inventions that are conceived, discovered, developed or otherwise made under this Agreement jointly by or on behalf of Calibr or its Affiliates or it... |
8.1.3 Exceptions. Notwithstanding Section 8.1.1 and 8.1.2, as between the Parties, AbbVie shall own and retain all right, title and interest in and to any and all Information and inventions that are conceived, discovered, developed or otherwise made or acquired by or on behalf of either Party (or its Affiliates or its ... |
8.1.4 United States Law. The determination of whether Information and inventions are conceived, discovered, developed or otherwise made by a Party for the purpose of allocating proprietary rights (including Patent, copyright or other intellectual property rights) therein, shall, for purposes of this Agreement, be made ... |
8.1.5 Assignment Obligation. Each Party shall cause all Persons who perform Development activities, Manufacturing activities, Commercialization activities or regulatory activities for such Party under this Agreement or who conceive, discover, develop or otherwise make any Information or inventions by or on behalf of su... |
8.2 Control of Intellectual Property. Neither Party shall, and each Party shall cause its Affiliates not to, enter into or amend any agreement with a Third Party, or include in any such agreement or amendment any restrictive provisions, with an intent to limit its Control of, or to not Control, any Information, Patent ... |
8.3 Maintenance and Prosecution of Patents. |
8.3.1 Patent Prosecution and Maintenance of Joint Patents and Product Patents. As between the Parties, AbbVie shall have the first right, but not the obligation, using counsel of its own choice, to prepare, file, prosecute and maintain the Joint Patents and any Product Patent worldwide and to be responsible for any rel... |
8.3.2 Patent Prosecution and Maintenance of Calibr Patents Other Than Product Patents. Subject to the remainder of this Section 8.3.2, as between the Parties, Calibr shall have the sole right, but not the obligation, to prepare, file, prosecute and maintain the Calibr Patents (except those Calibr Patents that constitut... |
(a) With respect to Patents Controlled by Calibr or any of its Affiliates as of the Original Execution Date or at any time during the Term that are not Product Patents and are reasonably necessary or useful for the Exploitation of any products comprising sCAR-Ts, vectors encoding the chimeric proteins expressed by sCAR... |
(b) With respect to Patents Controlled by Calibr or any of its Affiliates as of the Original Execution Date or at any time during the Term that are not Product Patents and are reasonably necessary or useful for the Exploitation of any CD19 Products ("Calibr CD19 Patents"), (i) prior to AbbVie's exercise of the CD19 Lic... |
(c) While Calibr is the prosecuting Party for any Option Patents, Calibr shall periodically inform AbbVie of all material steps with regard to the preparation, filing, prosecution and maintenance of such Option Patents in the Territory, including by providing AbbVie with a copy of material communications to and from th... |
(d) Calibr shall use best efforts to ensure that any Calibr Patents being prepared, filed, prosecuted or maintained by Calibr are not Mixed Patents. Without limiting the foregoing, promptly after the Inclusion Date for a Target with respect to Licensed Products Directed to such Target or the Option Effective Date for t... |
(i) At AbbVie's request, Calibr shall instruct patent counsel for the Mixed Patents to, with respect to any substantive filings or responses with respect to any Mixed Patent, allow AbbVie or AbbVie's counsel to prepare the first draft of any portion thereof that is related to the Licensed Products or the Exploitation t... |
(ii) Calibr shall reasonably consider and not unreasonably reject the requests or suggestions of AbbVie with respect to (A) material communications to and from any patent authority regarding the Mixed Patents to the extent applicable to or potentially affecting claims relating to Licensed Products or the Exploitation t... |
(iii) If Calibr decides not to prepare, file, prosecute or maintain a Mixed Patent in a country, Calibr shall provide reasonable prior written notice to AbbVie of such intention (which notice shall, in any event, be given no later than thirty (30) days prior to the next deadline for any action that may be taken with re... |
8.3.3 Patent Prosecution and Maintenance of AbbVie Patents. As between the Parties, AbbVie shall have the sole right, but not the obligation, to prepare, file, prosecute and maintain all AbbVie Patents worldwide, and to be responsible for any related interference, re-issuance, re-examination, opposition and post-grant ... |
8.3.4 UPC Opt-Out and Opt-In under the UPC. As between the Parties, the Party with the right to prosecute any Patent under this Agreement (the "Prosecuting Party") shall have the sole right to make decisions regarding the Opt-Out or Opt-In under the UPC with respect to such Patent. If the Prosecuting Party wishes to Op... |
8.3.5 Cooperation. With respect to Joint Patents, Product Patents, Mixed Patents, Option Patents (until the CD19 License Option or Platform Option, as applicable, expires without exercise by AbbVie), the non-Prosecuting Party shall, and shall cause its Affiliates to, assist and cooperate with the Prosecuting Party, as ... |
8.3.6 Patent Term Extension and Supplementary Protection Certificate. As between the Parties, with respect to each Licensed Product, AbbVie shall have the sole right to make decisions regarding, and to apply for, patent term extensions worldwide, including the United States with respect to extensions pursuant to 35 U.S... |
8.3.7 Patent Listings. As between the Parties, with respect to each Licensed Product, AbbVie shall have the sole right to make all filings with Regulatory Authorities in the Territory, including as required or allowed (a) in the United States, in the FDA's Orange Book and (b) other international equivalents. With respe... |
8.4 Enforcement of Patents. |
8.4.1 Notice. Each Party shall promptly notify the other Party in writing of any alleged or threatened infringement of AbbVie Patents, Calibr Patents, or Joint Patents in any jurisdiction in the Territory of which such Party becomes aware in connection with the Exploitation of any Licensed Product or any product that c... |
8.4.2 Enforcement of Joint Patents, Product Patents, and Mixed Patents. |
(a) As between the Parties, AbbVie shall have the first right, but not the obligation, to prosecute any Infringement with respect to the Joint Patents and Product Patents, including as a defense or counterclaim in connection with any Third Party Infringement Claim, at AbbVie's sole cost and expense, using counsel of it... |
(b) With respect to any Infringement of a Mixed Patent by a Third Party, AbbVie shall have the first right, but not the obligation, to prosecute any Infringement with respect to any claim in such Mixed Patent that such Third Party infringes if AbbVie reasonably determines in good faith after consultation with Calibr an... |
(c) Subject to Section 8.4.3, if AbbVie prosecutes any such Infringement, Calibr shall have the right, but not the obligation, to join as a party to such claim, suit or proceeding in the Territory and participate with its own counsel at its sole cost and expense; provided, that AbbVie shall retain control of the prosec... |
8.4.3 Cooperation. The Parties agree to cooperate fully in any Infringement action pursuant to Section 8.4.2, including by making the inventors, applicable records and documents (including laboratory notebooks) of the relevant Patents available to the Party prosecuting such Infringement action upon such prosecuting Par... |
8.4.4 Recovery. Except as otherwise agreed by the Parties in connection with a cost sharing arrangement, any recovery realized as a result of any Infringement litigation pursuant to this Section 8.4 (whether by way of settlement or otherwise) shall be first allocated to reimburse the Parties for their costs and expense... |
8.4.5 Obligations for Option Patents. Until the CD19 License Option or Platform Option, as applicable, expires without exercise by AbbVie, Calibr shall use reasonable efforts to prosecute any Infringement of the Option Patents, including as a defense or counterclaim in connection with any Third Party Infringement Claim... |
8.5 Biosimilar Applicants. |
8.5.1 Notice. Notwithstanding the foregoing, if either Party receives notice or a copy of an application submitted to the FDA or another Regulatory Authority for a Biosimilar Product (a "Biosimilar Application") for which a Licensed Product is a reference product, whether or not such notice or copy is provided under an... |
8.5.2 Cooperation. If permitted pursuant to Applicable Law, upon AbbVie's request, Calibr shall assist AbbVie in identifying and listing any Patents as required pursuant to Section 351(l)(1)(3)(A) or Section 351(l)(7) of the PHSA, in negotiating with the filer of the Biosimilar Application pursuant to Section 351(l)(4)... |
8.5.3 Agreed Principles for Biosimilar Products. The Parties recognize that procedures other than those set forth above may apply with respect to applications for Biosimilar Products. If the Parties determine that certain provisions of Applicable Law in the United States or in any other country in the Territory apply t... |
8.5.4 Notwithstanding any other provisions contained herein, AbbVie shall be responsible for managing all aspects of any litigation with respect to Biosimilar Products, including any invalidity or unenforceability defense in courts or before patent offices in connection with such litigation. |
8.6 Enforcement of a Party's Patents. |
8.6.1 Calibr Patents. As between the Parties, Calibr shall have the sole right, but not the obligation, to prosecute Infringement with respect to the Calibr Patents, except those Calibr Patents that constitute (a) Product Patents, (b) Option Patents or (c) Mixed Patents subject to Section 8.4.2, including as a defense ... |
8.6.2 AbbVie Patents. As between the Parties, AbbVie shall have the sole right, but not the obligation, to prosecute Infringement with respect to AbbVie Patents, including as a defense or counterclaim in connection with any Third Party Infringement Claim, at AbbVie's sole cost and expense, using counsel of its own choi... |
8.7 Invalidity or Unenforceability Defenses or Actions. |
8.7.1 Responsibility for Defense. As between the Parties, (a) AbbVie shall have the first right, but not the obligation, to defend (including the right to settle) and control the defense of the validity and enforceability of the Joint Patents and the Product Patents, (b) AbbVie shall have the sole right, but not the ob... |
8.7.2 Cooperation. If a Party defends a Joint Patent, Product Patent, Mixed Patent, or Option Patent, the other Party shall, and shall cause its Affiliates to, assist and cooperate with the defending Party, as such defending Party may reasonably request from time to time in connection with its activities set forth in t... |
8.8 Infringement Claims by Third Parties. |
8.8.1 Notice. If the Exploitation of a Licensed Product, including any Calibr Component, in the Territory pursuant to this Agreement results in, or is reasonably expected to result in, any claim, suit or proceeding by a Third Party alleging infringement by AbbVie or any of its Affiliates or any of its or their Sublicen... |
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... |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.