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6.5.2 Sublicensee Income. Sublicensee Income shall be included in the calculation of Net Sales for the relevant period for the relevant Product. |
6.5.3 Royalty Obligations. AbbVie shall have no obligation to pay any royalty with respect to Net Sales of any Licensed Product in any country or other jurisdiction after the Royalty Term for such Licensed Product in such country or other jurisdiction has expired. With respect to each Licensed Product in each country o... |
6.6 Reductions. |
6.6.1 Notwithstanding Section 6.3, Section 6.4 and Section 6.5: |
(a) in the event that in any country or other jurisdiction in the Territory during the Royalty Term for a Licensed Product sales of all Biosimilar Products in such country or other jurisdiction in a Calendar Quarter exceed fifty percent (50%) of the sales of such Licensed Product and all Biosimilar Products in such cou... |
(b) in the event that, and in such case from and after the date on which, a Licensed Product is Exploited in a country or other jurisdiction and is not covered by a Valid Claim of a OSE Patent that claims the Licensed Antibody as a composition of matter contained in such Licensed Product in such country, then (x) the m... |
(c) in the event that a court or a governmental agency of competent jurisdiction requires AbbVie or any of its Affiliates or Sublicensees to grant a compulsory license to a Third Party permitting such Third Party to make and sell a Licensed Product in a country or other jurisdiction in the Territory, then, for the purp... |
(d) in the event that during the Royalty Term for a Licensed Product, such Licensed Product is designated as a Selected Drug by the Secretary of the U.S. Department of Health and Human Services, and AbbVie is required to negotiate, and is ultimately subject to, a Maximum Fair Price that will apply to sales of such Lice... |
6.6.2 Mechanics of Adjustments. Any reductions set forth in Section 6.6 shall be applied to the milestone payments set forth in Section 6.3 and Section 6.4 and royalty rate payable to OSE under Section 6.5.1, as applicable, in the order in which the event triggering such reduction occurs. Any adjustments pursuant to Se... |
6.7 Third Party Payments; Patent Costs. |
6.7.1 In the event that (a) AbbVie enters into an agreement with a Third Party in order to obtain a license or right under a Patent or intellectual property right owned or Controlled by such Third Party pursuant to Section 7.6 or (b) AbbVie incurs any reasonable Out-of-Pocket Costs in defending or settling any Third Pa... |
6.7.2 AbbVie shall have the right to deduct costs in accordance with Section 7.4.4 and Section 7.5.6. |
6.8 Minimum Payment. Notwithstanding the application of any reductions contemplated in Section 6.6, Section 6.7, Section 7.4.4, or Section 7.5.6, in no event shall any single payment payable to OSE with respect to the sale of any Licensed Product in any country during the applicable Royalty Term or a milestone be reduc... |
6.9 Royalty Payments and Reports. AbbVie shall calculate all amounts payable to OSE pursuant to Section 6.5 at the end of each Calendar Quarter, which amounts shall be converted to Dollars, in accordance with Section 6.10. AbbVie shall pay to OSE the royalty amounts due with respect to a given Calendar Quarter within n... |
6.10 Mode of Payment. All payments to either Party under this Agreement shall be made by deposit of Dollars in the requisite amount to such bank account as the receiving Party may from time to time designate by notice to the paying Party. For the purpose of calculating any sums due under, or otherwise reimbursable purs... |
6.11 Interest on Late Payments. If any payment due to either Party under this Agreement is not paid when due, then such paying Party shall pay interest thereon (before and after any judgment) at an annual rate (but with interest accruing on a daily basis) of one hundred (100) basis points above the U.S. effective feder... |
6.12 Withholding Taxes. Where any sum due to be paid to either Party hereunder is or would otherwise be subject to any withholding or similar tax, the Parties shall cooperate with each other and use their commercially reasonable efforts to do all such acts and things and to sign all such documents as will enable them t... |
6.13 Indirect Taxes. All payments are exclusive of value added taxes, sales taxes, consumption taxes, and other similar taxes (the "Indirect Taxes"). If any Indirect Taxes are chargeable in respect of any payments, the paying Party shall pay such Indirect Taxes in addition to the amounts due hereunder at the applicable... |
6.14 Financial Records. AbbVie shall, and shall cause its Affiliates and Sublicensees to, keep complete and accurate books and records pertaining to Net Sales of Licensed Products, as applicable, including books and records of actual expenditures in sufficient detail to calculate all amounts payable hereunder and to ve... |
6.15 Audit. At the request of OSE, AbbVie shall, and shall cause its Affiliates to, permit an independent public accounting firm of nationally recognized standing designated by OSE and reasonably acceptable to AbbVie, at reasonable times during normal business hours and upon reasonable notice, to audit the books and re... |
6.16 Audit Dispute. In the event of a dispute with respect to any audit under Section 6.15, OSE and AbbVie shall work in good faith to resolve the disagreement. If the Parties are unable to reach a mutually acceptable resolution of any such dispute within thirty (30) days, the dispute shall be submitted for resolution ... |
6.17 Confidentiality. The receiving Party shall treat all information subject to review under this Article 6 in accordance with the confidentiality provisions of Article 9, and the Parties shall cause the Audit Arbitrator to enter into a reasonably acceptable confidentiality agreement with the audited Party obligating ... |
6.18 No Other Compensation. Each Party hereby agrees that the terms of this Agreement fully define all consideration, compensation, and benefits, monetary or otherwise, to be paid, granted, or delivered by one (1) Party to the other Party in connection with the transactions contemplated herein. Neither Party previously... |
6.19 No Limitation. Nothing contained in this Article 6 shall in any way limit either Party's right to indemnification under this Agreement or to otherwise recover damages for breach of this Agreement. |
ARTICLE 7 INTELLECTUAL PROPERTY |
7.1 Ownership of Intellectual Property. |
7.1.1 Ownership of Technology. Subject to Section 3.6.1(b), Section 5.1, and Section 7.1.2, each Party shall own and retain all right, title, and interest in and to any and all: (a) Information and inventions that are conceived, discovered, developed, or otherwise made by or on behalf of such Party (or its Affiliates o... |
7.1.2 Ownership of Joint Patents and Joint Know-How. Subject to Section 3.6.1(b), 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 by or on behalf of either Party or its Affiliates o... |
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... |
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