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7.1.3 Determination of Ownership. 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 Agreemen... |
7.1.4 Assignment Obligation. Each Party shall cause all Persons who perform Development activities, Manufacturing activities, or regulatory activities for such Party under this Agreement to be under an obligation to assign (or, if such Party is unable to cause such Person to agree to such assignment obligation despite ... |
7.1.5 Control of Intellectual Property. OSE shall not 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, invention, Patent, or other intellectual property right that w... |
7.2 Maintenance and Prosecution of Patents. |
7.2.1 Patent Prosecution and Maintenance of OSE Patents. |
(a) AbbVie shall have the first right, but not the obligation, to prepare, file, prosecute, and maintain the OSE Patents worldwide and to conduct any opposition, re-issuance, post-grant review, inter-partes review, reexamination request, nullity action, interference, or other similar post-grant proceedings and any appe... |
(b) AbbVie shall keep OSE fully informed of all material steps with regard to the preparation, filing, prosecution, and maintenance of, and any Defense Proceeding relating to, the applicable OSE Patents, including by providing OSE with a copy of material filings and communications to and from any patent authority in th... |
(c) In the event that AbbVie decides not to prepare, file, prosecute, or maintain an OSE Patent, or not to initiate or continue any Defense Proceeding relating to an OSE Patent, in a country or other jurisdiction in the Territory, AbbVie shall provide reasonable prior written notice to OSE of such intention (which noti... |
7.2.2 Patent Prosecution and Maintenance of Joint Patents. |
(a) AbbVie shall have the sole right to prepare, file, prosecute, and maintain the Joint Patents, and to conduct any Defense Proceeding relating thereto (except that in connection with any actions subject to Section 7.3, the Party with responsibility for such action pursuant to Section 7.3 shall have responsibility for... |
(b) AbbVie shall keep OSE fully informed of all material steps with regard to the preparation, filing, prosecution, and maintenance of, and any Defense Proceeding relating to Joint Patents, including by providing OSE with a copy of material filings and communications to and from any patent authority in the Territory re... |
7.2.3 Cooperation. The Parties agree to cooperate fully in the preparation, filing, prosecution, and maintenance of, and any Defense Proceeding relating to, the OSE Patents and Joint Patents in the Territory under this Agreement. The Parties shall direct their respective patent counsels to coordinate such activities. C... |
(a) executing all papers and instruments, or requiring its employees or contractors to execute such papers and instruments, so as to (i) effectuate the ownership of intellectual property set forth in Section 7.1.1 and Section 7.1.2; (ii) enable the other Party to apply for and to prosecute Patent applications in the Te... |
(b) consistent with this Agreement, assisting in any license registration processes with applicable governmental authorities that may be available in the Territory for the protection of a Party's interests in this Agreement; and |
(c) promptly informing the other Party of any matters coming to such Party's attention that may materially affect the preparation, filing, prosecution, or maintenance of, or any Defense Proceeding relating to, any such OSE Patents or Joint Patents in the Territory. |
7.2.4 Patent Term Extension and Supplementary Protection Certificate. AbbVie shall be solely responsible for making decisions regarding patent term extensions, including supplementary protection certificates and any other extensions that are now or become available in the future, wherever applicable, for OSE Patents an... |
7.2.5 CREATE Act. Notwithstanding anything to the contrary in this Article 7, neither Party shall have the right to make an election under the Cooperative Research and Technology Enhancement Act of 2004, 35 U.S.C. 103(c)(2)-(c)(3) (the "CREATE Act") when exercising its rights under this Article 7 without the prior writ... |
7.2.6 Patent Listings. AbbVie shall have the sole right to make all filings with Regulatory Authorities in the Territory with respect to OSE Patents and Joint Patents, including as required or allowed (a) in the United States, in the FDA's Orange Book, and (b) outside the United States, under the national implementatio... |
7.2.7 UPC Opt-Out and Opt-In. AbbVie shall have the sole right to make any decision regarding whether or not to elect Opt-Out or Opt-In with respect to any OSE Patent and Joint Patent; provided that AbbVie shall consider in good faith OSE's comments with respect thereto. |
7.3 Enforcement of Patents. |
7.3.1 Enforcement of OSE Patents. Each Party shall promptly notify the other Party in writing of any alleged or threatened infringement of the OSE Patents by a Third Party in the Territory of which such Party becomes aware (including alleged or threatened infringement of any OSE Patent based on the Development, Commerc... |
7.3.2 Enforcement of Joint Patents. Each Party shall promptly notify the other Party in writing of any alleged or threatened infringement of the Joint Patents by a Third Party in the Territory of which such Party becomes aware (including alleged or threatened infringement based on the development, commercialization, or... |
7.3.3 Patent Exclusivity Listings. If either Party receives a copy of an application submitted to the FDA under subsection (k) of Section 351 of the PHSA (a "Biosimilar Application") naming a Licensed Product as a reference product or otherwise becomes aware that such a Biosimilar Application has been filed (such as in... |
7.3.4 Conduct of Patent Litigation Under the Biologics Price Competition and Innovation Act. Notwithstanding anything to the contrary in this Section 7.3, AbbVie shall have the first right to bring an action for infringement of the OSE Patents or Joint Patents as required under Section 351(l)(6) of the PHSA following t... |
7.3.5 Cooperation. The Parties agree to cooperate fully in any infringement action pursuant to this Section 7.3. Where a Party brings such an action, the other Party shall, where necessary, furnish a power of attorney solely for such purpose or shall join in, or be named as a necessary party to, such action. Unless oth... |
7.3.6 Recovery. Except with respect to costs incurred by a Party that joins and participates in such litigation at its sole cost and expense as set forth in this Section 7.3, any recovery realized as a result of such litigation described in Section 7.3.1, Section 7.3.2, or Section 7.3.4 (whether by way of settlement or... |
7.4 Infringement Claims by Third Parties. |
7.4.1 If the manufacture, sale, or use of a Licensed Antibody or Licensed Product in the Territory pursuant to this Agreement results in, or may result in, any claim, suit, or proceeding by a Third Party alleging patent infringement by AbbVie (or its Affiliates or Sublicensees) (a "Third Party Infringement Claim"), inc... |
7.4.2 Notwithstanding Section 11.4, AbbVie shall have the sole right, but not the obligation, to defend and control the defense and settlement of any Third Party Infringement Claim at its own expense (but subject to deduction as provided below), using counsel of its own choice; provided that if the Third Party Infringe... |
7.4.3 AbbVie shall keep OSE reasonably informed of all material developments in connection with any Third Party Infringement Claim. AbbVie agrees to provide OSE with copies of all pleadings filed in the applicable action and to allow OSE reasonable opportunity to participate in the defense of the Third Party Infringeme... |
7.4.4 Except in respect of willful infringement and in respect of any Third Party Infringement Claim relating to an Other Active Ingredient in a Combination Product, AbbVie shall be entitled to deduct fifty percent (50%) of the reasonable Out-of-Pocket Costs borne by AbbVie in defending or settling such Third Party Inf... |
7.5 Invalidity or Unenforceability Defenses or Actions. |
7.5.1 Notice. Each Party shall promptly notify the other Party in writing of any alleged or threatened assertion of invalidity or unenforceability of any of the OSE Patents or Joint Patents by a Third Party, in each case in the Territory and of which such Party becomes aware. |
7.5.2 OSE Patents. AbbVie shall have the first right, but not the obligation, to defend and control any claim, suit, or proceeding regarding the validity and enforceability of the OSE Patents at its own expense in the Territory; provided that (a) if the assertion of invalidity or unenforceability of the OSE Patents is ... |
7.5.3 Joint Patents. AbbVie shall have the first right, but not the obligation, to defend and control any claim, suit, or proceeding regarding the validity and enforceability of the Joint Patents at its own expense; for clarity, this Section shall not apply to Defense Proceedings, which shall be governed by Section 7.2... |
7.5.4 Participation; Step-In. The non-controlling Party may participate in any claim, suit, or proceeding arising under this Section 7.5 in the Territory related to the OSE Patents or Joint Patents with counsel of its choice at its own expense; provided that the controlling Party shall retain control of the defense in ... |
7.5.5 Cooperation. Each Party shall assist and cooperate with the other Party as such other Party may reasonably request from time to time in connection with its activities set forth in this Section 7.5, including by being joined as a party plaintiff in the applicable claim, suit or proceeding described in Section 7.5.... |
7.5.6 Costs and Expenses. AbbVie shall be entitled to offset up to fifty percent (50%) of the reasonable Out-of-Pocket Costs of defending or settling any claim, suit, or proceeding under this Section 7.5 (including pursuant to any adverse judgment in connection therewith) in a given Calendar Quarter (solely to the exte... |
7.6 Third Party Licenses and Patents. If AbbVie determines that any Patent of a Third Party in any country or other jurisdiction in the Territory is necessary for the Manufacture or Commercialization of any Licensed Antibody or Licensed Product (but excluding Patents required for the Manufacture or Commercialization of... |
7.7 Product Trademarks. |
7.7.1 Ownership and Prosecution of Product Trademarks. AbbVie shall own all right, title, and interest to the Product Trademarks in the Territory, and shall be responsible for the registration, prosecution, and maintenance thereof. All costs and expenses of registering, prosecuting, and maintaining the Product Trademar... |
7.7.2 Enforcement of Product Trademarks. AbbVie shall have the sole right and responsibility for taking such action as AbbVie deems necessary against a Third Party based on any alleged, threatened, or actual infringement, dilution, misappropriation, or other violation of, or unfair trade practices or any other like off... |
7.7.3 Third Party Claims. AbbVie shall have the sole right and responsibility for defending against and settling 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 violates any Trademark or o... |
7.7.4 Notice and Cooperation. Each Party shall provide to the other Party 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 Territory violates the rights of any Third Party. Each P... |
7.8 Inventor's Remuneration. Each Party shall be solely responsible for any remuneration that may be due such Party's employees or agents that are inventors under any applicable inventor remuneration laws. |
ARTICLE 8 DATA PRIVACY |
8.1 Data Privacy and Security. |
8.1.1 For all Personal Data collected, Processed, hosted, or transmitted in performance by OSE of this Agreement, including in connection with the conduct of the Transition Development Activities, OSE shall: |
(a) comply at all times with the Data Security and Privacy Laws; |
(b) to the extent permitted by Applicable Law, notify AbbVie, as soon as practicable and in any event prior to making the relevant disclosure, if it is obliged to make a disclosure of the Personal Data under Applicable Law; |
(c) make timely notification to, and obtain any necessary authorizations from, any applicable Regulatory Authority where required under applicable Data Security and Privacy Laws of its collection and other Processing of Personal Data in order to comply with its obligations under this Agreement; |
(d) at all times, act in a manner such that it is not subject to any prohibition or restriction that (i) prevents or restricts it from disclosing or transferring the Personal Data to AbbVie, as required under this Agreement; or (ii) prevents or restricts either Party from Processing the Personal Data as envisaged under... |
(e) ensure that all fair Processing and required notices have been obtained and are maintained and are sufficient in scope, and that OSE has an appropriate legal basis under Data Security and Privacy Laws, to enable OSE to Process the Personal Data as required in order to comply with its obligation under this Agreement... |
(f) implement and maintain reasonable administrative, technical, and physical safeguards designed to (i) maintain the security and confidentiality of the Personal Data; (ii) protect against reasonably anticipated threats or hazards to the security or integrity of the Personal Data; and (iii) protect against unauthorize... |
(g) notify AbbVie promptly, and in any event within forty-eight (48) hours of receipt of, (i) any correspondence from a data protection regulator in relation to the Processing of Personal Data related to this Agreement, or (ii) a request or notice from a data subject exercising his rights under the Data Security and Pr... |
(h) refrain from taking actions related to the Processing of the Personal Data that would be reasonably likely to damage or impair AbbVie's reputation. |
8.1.2 Data Agreements; Data Export. At the reasonable request of AbbVie, the Parties shall cooperate to enter into any relevant data protection agreements which include but are not limited to any necessary joint controller agreements or controller-processor agreements with respect to such Personal Data as necessary to ... |
8.1.3 Security Breach Notification. OSE shall notify AbbVie immediately upon learning of any actual or suspected misappropriation or unauthorized access to, or disclosure or use of, the Personal Data collected, Processed, hosted, or transmitted in performance by OSE of this Agreement, including conducting the Transitio... |
ARTICLE 9 Confidentiality AND Non-Disclosure |
9.1 Product Information. OSE recognizes that by reason of, inter alia, AbbVie's status as an exclusive licensee pursuant to the grants under Section 5.1, AbbVie has an interest in OSE's maintaining the confidentiality of certain information of OSE. Accordingly, during the Term, OSE shall, and shall cause its Affiliates... |
9.2 Confidentiality Obligation. At all times during the Term and for a period of ten (10) years following termination or expiration hereof in its entirety, each Party shall, and shall cause its officers, directors, employees, and agents to, keep confidential and not publish or otherwise disclose to a Third Party and no... |
9.2.1 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 wrongful act, fault, or negligence on the part of the receiving Party; |
9.2.2 has 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 Product Information, Regulatory Documentation, or Joint Know-How; |
9.2.3 is subsequently received by the receiving Party from a Third Party without restriction and without breach of any agreement between such Third Party and the disclosing Party; |
9.2.4 that is generally made available to Third Parties by the disclosing Party without restriction on disclosure; or |
9.2.5 has been independently developed by or for the receiving Party without reference to, or use or disclosure of, the disclosing Party's Confidential Information; provided that the foregoing exception shall not apply with respect to Product Information, Regulatory Documentation, or Joint Know-How. |
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... |
9.3 Permitted Disclosures. Each Party may disclose Confidential Information to the extent that such disclosure is: |
9.3.1 in the reasonable opinion of the receiving Party's legal counsel, required to be disclosed pursuant to law, regulation or a valid order of a court of competent jurisdiction or other supra-national, federal, national, regional, state, provincial, or local governmental body of competent jurisdiction (including by r... |
9.3.2 made by or on behalf of the receiving Party to the Regulatory Authorities as required in connection with any filing, application, or request for any Regulatory Approval in accordance with the terms of this Agreement; provided that reasonable measures shall be taken to assure confidential treatment of such Confide... |
9.3.3 made by or on behalf of the receiving Party to a patent authority as may be reasonably necessary or useful for purposes of obtaining, defending, or enforcing a Patent in accordance with the terms of this Agreement; provided that reasonable measures shall be taken to assure confidential treatment of such Confident... |
9.3.4 made to its or its Affiliates' financial and legal advisors who have a need to know such disclosing Party's Confidential Information and are either under professional codes of conduct giving rise to expectations of confidentiality and non-use or under written agreements of confidentiality and non-use, in each cas... |
9.3.5 made by AbbVie or its Affiliates or Sublicensees to its or their advisors, consultants, clinicians, vendors, service providers, contractors, existing or prospective collaboration partners, licensees, sublicensees, or other Third Parties as may be necessary or useful in connection with the Exploitation of the Lice... |
9.3.6 made by OSE or its Affiliates, after receiving prior written approval from AbbVie, to its or their advisors, consultants, clinicians, vendors, service providers, contractors, and the like to the extent necessary in assisting with OSE to conduct the Transition Activities; provided that such Persons shall be subjec... |
9.4 Use of Name. 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 abbreviation or adaptation thereof) in any publication, press release, marketing and promotional material, or other form of publicity withou... |
9.5 Public Announcements. Each Party shall have the right to issue a press release announcing that they have entered into this Agreement, provided that the timing and content of such announcement must be reviewed and mutually agreed upon by the Parties. Notwithstanding the foregoing, neither Party shall issue any publi... |
9.6 Publications. The Parties acknowledge that scientific publications must be strictly monitored to prevent any adverse effect from premature publication of results of the Development activities hereunder. Accordingly, OSE shall not publish, present, or otherwise disclose, and shall cause its Affiliates and any Third ... |
9.7 Return of Confidential Information. Upon the effective date of the termination of this Agreement for any reason, either Party may request in writing, and the other Party shall either, with respect to Confidential Information of such first Party (in the event of termination of this Agreement with respect to one (1) ... |
9.8 Survival. All Confidential Information shall continue to be subject to the terms of this Agreement for the period set forth in Section 9.2. |
ARTICLE 10 REPRESENTATIONS, Warranties AND COVENANTS |
10.1 Mutual Representations and Warranties. OSE and AbbVie each represents and warrants to the other, as of the Effective Date, and covenants, as follows: |
10.1.1 Organization. It is a corporation duly organized, validly existing, and in good standing under the laws of the jurisdiction of its organization, and has all requisite power and authority, corporate or otherwise, to execute, deliver, and perform this Agreement. |
10.1.2 Authorization. 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,... |
10.1.3 Binding Agreement. 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 af... |
10.1.4 No Inconsistent Obligation. It is not under any obligation, contractual or otherwise, to any Person that conflicts with or is inconsistent in any material respect with the terms of this Agreement, or that would impede the diligent and complete fulfillment of its obligations hereunder. |
10.2 Additional Representations, Warranties and Covenants of OSE. OSE further represents and warrants to AbbVie, as of the Execution Date and as of the Effective Date as follows: |
10.2.1 All OSE Patents existing as of the Effective Date are listed on Schedule 10.2.1 (the "Existing Patents"). All granted Existing Patents are subsisting and are not invalid or unenforceable, in whole or in part. To OSE's and its Affiliates' Knowledge, the Existing Patents are being diligently prosecuted in the resp... |
10.2.2 The Existing Patents represent all Patents within OSE's or its Affiliates' ownership or Control relating to the Licensed Product, Licensed Antibodies, or the Exploitation thereof, as of the Effective Date. There is no Information owned or Controlled by OSE or any of its Affiliates as of the Effective Date that r... |
10.2.3 OSE is the sole and exclusive owner of the entire right, title, and interest in the Existing Patents listed on Schedule 10.2.1 and the OSE Know-How, free of any encumbrance, lien, or claim of ownership by any Third Party. OSE is entitled to grant the licenses thereto specified herein. OSE has no right, title, an... |
10.2.4 To OSE's Knowledge, the Development, Manufacture, or Commercialization of the Licensed Antibodies and the Licensed Products as contemplated herein will not be contrary to any other license or agreement to which OSE or any of its Affiliates is a party. |
10.2.5 There are no claims, judgments, or settlements against, or amounts with respect thereto owed by, OSE or any of its Affiliates relating to the Existing Patents or the OSE Know-How, other than the Ambiotis Contrat de Cession. No claim or litigation has been brought or threatened by any Person alleging, and OSE has... |
10.2.6 To OSE's Knowledge, the use of the OSE Patents and OSE Know-How for conduct of the Transition Activities and for AbbVie's Exploitation of the Licensed Products as contemplated herein will not violate, infringe, misappropriate or otherwise conflict or interfere with any Patent or other intellectual property or pr... |
10.2.7 To OSE's Knowledge, the conception, development, and reduction to practice of the Regulatory Documentation, the Existing Patents and OSE Know-How existing as of the Effective Date have not constituted or involved the misappropriation of trade secrets or other rights or property of any Person. |
10.2.8 To OSE's Knowledge, no Person (a) has infringed or is infringing or threatening to infringe any Existing Patent or (b) has misappropriated or is misappropriating or threatening to misappropriate the OSE Know-How. |
10.2.9 During the Term, neither OSE nor any of its Affiliates shall encumber or diminish the rights granted to AbbVie hereunder with respect to the OSE Patents. |
10.2.10 Schedule 10.2.10 (Third Party Agreements) sets forth a complete and correct list of all agreements, whether written or oral, entered into by OSE or any of its Affiliates that relate to the Exploitation of any Licensed Antibody, excluding confidentiality, material transfer, and non-disclosure agreements, entered... |
10.2.11 Neither OSE nor any of its Affiliates has previously entered into any agreement, whether written or oral, with respect to the assignment, transfer, license, conveyance, or encumbrance of, or otherwise assigned, transferred, licensed, conveyed, or encumbered its right, title, or interest in or to the Existing Pa... |
10.2.12 Each Person who has or has had any rights in or to any Existing Patents or any OSE Know-How, has assigned by way of operation of law and/or has executed an agreement assigning its entire right, title, and interest in and to such Existing Patents and OSE Know-How to OSE, and to the extent any of OSE's or its Aff... |
10.2.13 OSE has obtained the right (including under any Patents and other intellectual property rights) to use all OSE Know-How developed or delivered by any Third Party under any agreements between OSE and any such Third Party with respect to the Licensed Antibodies and Licensed Products, and OSE has the rights under ... |
10.2.14 Except for any OSE Know-How that has been included in the OSE Patents or in any of the OSE scientific publications set forth in Schedule 10.2.14, the OSE Know-How has been kept confidential or has been disclosed to Third Parties only under terms of confidentiality. To the Knowledge of OSE, no breach of such con... |
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