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(b) in the event that in any country or other jurisdiction in the Territory during the Royalty Term for a Licensed Product, but following the expiration, invalidation, revocation, cancellation, dedication to the public, disclaimer or abandonment date of the last Licensor Patent that includes a Valid Claim claiming the ... |
(c) except as set forth in Schedule 6.6.3(c) (Special Offset), in the event that 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 in a particular country or other jurisdiction pursuant to Sectio... |
(d) AbbVie shall have the right to deduct costs in accordance with Section 7.4 (Infringement Claims by Third Parties) and Section 7.5.4 (Costs and Expenses). |
6.6.4 Mechanics of Adjustments to Royalties. Except as set forth in Schedule 6.6.3(c) (Special Offset), any reductions set forth in Section 6.6.3 (Reductions) shall be applied in the order in which the event triggering such reduction occurs; provided that, subject to Schedule 6.6.3(c) (Special Offset), the adjustments ... |
6.7 Royalty Payments and Reports. AbbVie shall calculate all amounts payable to Licensor pursuant to Section 6.6 (Royalties) at the end of each Calendar Quarter, which amounts shall be converted to Dollars, in accordance with Section 6.8 (Mode of Payments; Offsets). AbbVie shall pay to Licensor the royalty amounts due ... |
6.8 Mode of Payment; Offsets. 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 purposes of calculating any sums due under, or otherwise reimburs... |
6.9 Withholding Taxes. |
6.9.1 Where any sum due to be paid to either Party hereunder is subject to any withholding or similar tax, the Parties shall use their commercially reasonable efforts to do all such acts and things and to sign all such documents as shall enable them to take advantage of any applicable double taxation agreement or treat... |
6.9.2 If AbbVie (or AbbVie's Affiliates or successors) is required to make a payment to Licensor subject to a deduction or withholding of tax, as described in Section 6.9.1 (Withholding Taxes), then if such deduction or withholding of tax obligation is increased solely as a result of the assignment or transfer of all o... |
6.10 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 at the applicable rate in respect of such payments followin... |
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 LIBOR, such interest to ... |
6.12 Audit. AbbVie shall, and shall cause its Affiliates to, keep complete books and records pertaining to Net Sales of Licensed Products in sufficient detail to calculate all amounts payable hereunder. Such books and records shall be retained by AbbVie and its Affiliates until the later of (a) three (3) years after th... |
6.13 Audit Dispute. In the event of a dispute with respect to any audit under Section 6.12 (Audit), Licensor and AbbVie shall work in good faith to resolve such dispute. If the Parties are unable to reach a mutually acceptable resolution of such dispute within thirty (30) days, such dispute shall be submitted for resol... |
6.14 Confidentiality. The receiving Party shall treat all information subject to review under this ARTICLE 6 (Payments and Records) in accordance with the confidentiality provisions of ARTICLE 9 (Confidentiality and Non-Disclosure) and the Parties shall cause the Audit Arbitrator to enter into a reasonably acceptable c... |
6.15 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 a Party to the other Party in connection with the transactions contemplated herein. Neither Party previously has pai... |
6.16 No Limitation. Nothing contained in this ARTICLE 6 (Payments and Records) 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 RIGHTS |
7.1 Ownership of Intellectual Property Rights. |
7.1.1 Ownership of Technology. Subject to Section 5.3.2 (Regulatory Matters) and Section 7.1.2 (Ownership of Joint Patents and Joint Know-How), as between the Parties, each Party (as used in ARTICLE 7 (Intellectual Property Rights), "Party," "Licensor," or "AbbVie" includes, respectively, its designated Affiliate(s)) s... |
7.1.2 Ownership of Joint Patents and Joint Know-How. Subject to Section 5.3.2 (Regulatory Matters), 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 jointly by or on behalf of Licenso... |
7.1.3 United States Law. The determination of inventorship and whether Information and inventions are conceived, reduced to practice, discovered, developed or otherwise made under this Agreement by a Party for the purpose of allocating proprietary rights (including Patent, copyright or other intellectual property right... |
7.1.4 Assignment Obligations. Licensor shall use commercially reasonable efforts to cause all Persons who perform Development activities, Manufacturing activities or regulatory activities for Licensor under this Agreement to be under an obligation to assign (or, if Licensor is unable to cause such Person to agree to su... |
7.2 Prosecution of Patents. |
7.2.1 Maintenance and Prosecution of Licensor Product Patents. |
(a) Prior to Option Effective Date. During the Term and prior to the Option Effective Date, in consultation with AbbVie, Licensor shall have the obligation to prepare, file, prosecute and maintain the Licensor Product Patents in the countries set forth on Schedule 7.2 (Licensor Prosecution Countries) (the "Licensor Pro... |
(b) Following Option Effective Date. Upon the Option Effective Date of a Licensed Compound, AbbVie shall have the first right, but not the obligation to prepare, file, prosecute and maintain the corresponding Licensor Product Patents worldwide, at AbbVie's sole cost and expense. AbbVie shall keep Licensor fully informe... |
7.2.2 Maintenance and Prosecution of Licensor Platform Patents. During the Term, Licensor shall have the sole right to prepare, file, prosecute and maintain the Licensor Platform Patents. Notwithstanding the foregoing, in the event that a Licensor Platform Patent discloses (but does not claim) any subject matter that w... |
7.2.3 Maintenance and Prosecution of Joint Patents. During the Term, AbbVie shall have the first right, but not the obligation, to prepare, file, prosecute and maintain the Joint Patents worldwide, at AbbVie's sole cost and expense. AbbVie shall keep Licensor fully informed of all steps with regard to the preparation, ... |
7.2.4 Cooperation. The Parties agree to cooperate fully in the preparation, filing, prosecution and maintenance of the Licensor Patents and Joint Patents in the Territory under this Agreement. Cooperation shall include: |
(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 (Ownership of Technology) and 7.1.2 (Ownership of Joint Patents and Joint Know-How); (ii) enable the other... |
(b) consistent with this Agreement, assisting in any license, transfer or assignment registration processes with applicable governmental authorities that may be available in the Territory for the protection of a Party's interests under this Agreement; and |
(c) promptly informing the other Party of any matters coming to a Party's attention that may materially affect the preparation, filing, prosecution or maintenance of any Licensor Patents or Joint Patents in the Territory. |
7.2.5 Patent Term Extension and Supplementary Protection Certificate. With respect to a Licensed Product, AbbVie shall be responsible for making decisions regarding patent term extensions, supplementary protection certificates, pediatric exclusivities and any other extensions that are now or become available in the fut... |
7.2.6 Patent Listings. As between the Parties, with respect to each Licensed Product, AbbVie shall have the sole right to determine and make all patent listings and filings with governmental authorities in the Territory with respect to the Licensor Patents and Joint Patents. AbbVie shall keep Licensor reasonably inform... |
7.2.7 UPC Opt-Out and Opt-In. AbbVie shall have the first right to make decisions regarding the Opt-Out or Opt-In under the Article 83(4) of the Agreement on a Unified Patent Court between the participating Member States of the European Union (2013/C 175/01), with respect to Licensor Product Patents and Joint Patents, ... |
7.3 Enforcement of Patents. |
7.3.1 Enforcement of Licensor Patents. Each Party shall promptly notify the other Party in writing of any alleged or threatened infringement of the Licensor Patents by a Third Party in the Territory of which such Party becomes aware (including alleged or threatened infringement based on the development, commercializati... |
(a) Prior to the Option Effective Date, during the Term, Licensor shall have the first right, but not the obligation, to prosecute any Product Infringement in the Territory at its sole expense and Licensor shall retain control of the prosecution of such claim, suit or proceeding. In the event Licensor prosecutes any Pr... |
(b) During the Term, following the Option Effective Date, AbbVie shall have the first right, but not the obligation, to prosecute any Product Infringement in the Territory (the "AbbVie Prosecuted Infringements") at its sole expense and AbbVie shall retain control of the prosecution of such claim, suit or proceeding. In... |
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 Biosimilar Applications. 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 an ... |
7.3.4 Cooperation. The Parties agree to cooperate fully in any infringement action pursuant to this Section 7.3 (Enforcement of Patents). 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... |
7.3.5 Recovery. Any recovery realized as a result of such litigation described in Section 7.3.1 (Enforcement of Licensor Patents), 7.3.2 (Enforcement of Joint Patents), 7.3.3 (Biosimilar Applications), or 7.3.4 (Cooperation) (whether by way of settlement or otherwise) shall be first allocated to reimburse the Parties f... |
7.4 Infringement Claims by Third Parties. If the manufacture, sale or use of a Licensed Compound 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 a Party (or its Affiliates), such Party shall prom... |
7.5 Invalidity, Unpatentability or Unenforceability Defenses or Actions. |
7.5.1 Licensor Patents. |
(a) During the Term, Licensor shall have the first right, but not the obligation, to defend and control the defense of the validity, patentability and enforceability of the Licensor Patents (excluding Licensor Product Patents upon the Option Effective Date) at its own expense in the Territory. AbbVie may participate in... |
(b) During the Term following and as of the Option Effective Date, AbbVie shall have the first right, but not the obligation, to defend and control the defense of the validity, patentability and enforceability of the Licensor Product Patents at its own expense in the Territory. Licensor may participate in any such clai... |
7.5.2 Joint Patents. AbbVie shall have the first right, but not the obligation, to defend and control the defense of the validity, patentability and enforceability of any Joint Patents at its own expense in the Territory. Licensor may participate in any such claim, suit or proceeding in the Territory related to the Joi... |
7.5.3 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 (Invalidity, Unpatentability or Unenforceability Defenses or Actions), including by being joined as a party plaintiff... |
7.5.4 Costs and Expenses. AbbVie shall be entitled to offset up to fifty percent (50%) of the reasonable out-of-pocket costs of defending a claim, suit or proceeding under this Section 7.5 (Invalidity, Unpatentability or Unenforceability Defenses or Actions) that are borne by AbbVie in a given Calendar Quarter (solely ... |
7.6 Third Party Licenses and Patents. If in the reasonable opinion of AbbVie, the Development, Manufacture, Commercialization or Exploitation of any Licensed Compound or Licensed Product by AbbVie or any of its Affiliates infringes or misappropriates any Patent, trade secret or other intellectual property right of a Th... |
7.7 Product Trademarks. |
7.7.1 Ownership and Prosecution of Product Trademarks. AbbVie shall own all rights, title and interests in and 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 Tr... |
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 offen... |
7.7.3 Third Party Claims. AbbVie shall have the sole right and responsibility for defending against 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 other right of s... |
7.8 International Nonproprietary Name. Prior to the Effective Date, Licensor has submitted to the World Health Organization a request/application for the International Nonproprietary Name (INN) for ALPN-101. Licensor shall keep AbbVie apprised of its communications with respect to such request/application for the INN f... |
7.9 Inventor's Remuneration. Each Party shall be solely responsible for any remuneration that may be due such Party's inventors under any applicable inventor remuneration laws. |
7.10 AbbVie Patents. For clarity, AbbVie shall have the sole right, but no obligation, to prosecute, maintain, enforce and defend any Patent controlled or owned by AbbVie or its Affiliates. |
7.11 Common Interest. All information exchanged between the Parties regarding the prosecution, maintenance, enforcement and defense of Patents under this ARTICLE 7 (Intellectual Property Rights) shall be deemed to be Confidential Information of the disclosing Party. In addition, the Parties acknowledge and agree that, ... |
ARTICLE 8 DATA PRIVACY AND SECURITY |
8.1 Data Privacy and Security. |
8.1.1 For all Personal Data collected, Processed, hosted or transmitted in performance by Licensor or its Affiliates of this Agreement, Licensor shall: |
8.1.2 comply at all times with the Data Security and Privacy Laws; |
8.1.3 to the extent permitted by Applicable Law, notify AbbVie, as soon as practicable and in any event prior to making the relevant disclosure, if Licensor is obliged to make a disclosure of Personal Data under Applicable Law; |
8.1.4 make timely notification to, and obtain any necessary authorizations from, any applicable Regulatory Authority where required under applicable Data Security and Privacy Laws of Licensor's collection and other Processing of Personal Data in order to comply with Licensor's obligations under this Agreement; |
8.1.5 at all times, act in a manner such that Licensor is not subject to any prohibition or restriction that (a) prevents or restricts Licensor from disclosing or transferring Personal Data to AbbVie, as required under this Agreement; or (b) prevents or restricts either Party from Processing Personal Data as envisaged ... |
8.1.6 ensure that all fair Processing and required notices have been obtained and are maintained and are sufficient in scope, and that Licensor has an appropriate legal basis under Data Security and Privacy Laws, to enable Licensor to Process Personal Data as required in order to comply with Licensor's obligations unde... |
8.1.7 implement and maintain reasonable administrative, technical and physical safeguards designed to (a) maintain the security and confidentiality of Personal Data; (b) protect against reasonably anticipated threats or hazards to the security or integrity of Personal Data; and (c) protect against unauthorized access t... |
8.1.8 notify AbbVie promptly, and in any event within forty-eight (48) hours of receipt of (a) any correspondence from a data protection regulator in relation to the Processing of Personal Data related to this Agreement, or (b) a request or notice from a data subject exercising his rights under the Data Security and Pr... |
8.1.9 refrain from taking actions related to the Processing of Personal Data that would be reasonably likely to damage or impair AbbVie's reputation. |
8.2 Data Agreements. At the reasonable request of AbbVie, the Parties shall cooperate to enter into any necessary joint controller agreements or controller-processor agreements with respect to such Personal Data as necessary to comply with Applicable Law. |
8.3 Security Breach Notification. Licensor shall notify AbbVie immediately upon learning of any actual or suspected misappropriation or unauthorized access to, or disclosure or use of Personal Data collected, Processed, hosted or transmitted in performance by Licensor of this Agreement, including the conduct of the Dev... |
ARTICLE 9 CONFIDENTIALITY AND NON-DISCLOSURE |
9.1 Product Information. Licensor recognizes that by reason of, inter alia, AbbVie's status as an exclusive optionee and licensee pursuant to the grants under Section 4.1 (AbbVie Option) and Section 4.4.1 (License Grants to AbbVie), AbbVie has an interest in Licensor's maintaining the confidentiality of certain informa... |
9.2 Confidentiality Obligations. 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 Regulatory Documentation; |
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 Regulatory Documentation. |
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 such Confidential Information is embraced by more general information in the public domain or in the possession of the receiving Party. Further, any combi... |
9.3 Permitted Disclosures. Subject to Section 9.1 (Product Information), a receiving Party may disclose the disclosing Party's 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 and local governmental body of competent jurisdiction, (including by ... |
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 necessary or reasonably useful for purposes of preparing, 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... |
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 the receiving Party or its Affiliates to potential or actual investors or acquirers that is necessary in connection with their evaluation of such potential or actual investment or acquisition; provided that such Persons shall be subject to obligations of confidentiality and non-use with respect to such Co... |
9.3.6 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 Licen... |
9.3.7 made by Licensor or its Affiliates, after receiving advance approval from AbbVie, to its or their advisors, consultants, clinicians, vendors, service providers, contractors and the like to the extent necessary in assisting with Licensor's activities contemplated by this Agreement; provided that such Persons shall... |
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. The Parties have agreed upon the content of a joint press release which shall be issued substantially in the form attached hereto as Schedule 9.5 (Press Release), the release of which the Parties shall coordinate in order to accomplish such release promptly upon execution of this Agreement. Ne... |
9.6 Publications. Each Party recognizes that the publication of papers regarding results of, and other information regarding, activities under this Agreement, including oral presentations and abstracts, may be beneficial to both Parties; provided such publications are subject to reasonable controls to protect Confident... |
9.7 Return of Confidential Information. Upon the effective date of the termination of this Agreement for any reason, a Party may request in writing, and the other Party shall either, with respect to Confidential Information (in the event of termination of this Agreement with respect to one (1) or more countries, other ... |
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 (Confidentiality Obligations). |
ARTICLE 10 REPRESENTATIONS AND WARRANTIES |
10.1 Mutual Representations and Warranties. Licensor 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 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 affe... |
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