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7.2.5 Patent Term Extension and Supplementary Protection Certificate. Beginning after the Option Exercise Date for a given Collaboration Program, AbbVie shall be responsible for making decisions regarding patent term extensions, including supplementary protection certificates and any other extensions that are now or be... |
7.2.6 Patent Listings. Beginning or after the Option Exercise Date for a given Collaboration Program, AbbVie shall have the sole right to make all patent listings of such Patents with Regulatory Authorities in the Territory. Licensor shall cooperate with the AbbVie's reasonable requests in connection therewith, includi... |
7.2.7 European Patents. AbbVie shall have the sole right to decide whether a European Patent within Licensor Background Patents, Licensor Program Patents and Joint Program Patents should be validated or maintained as a Unitary Patent, whether and when such European Patent should be opted out of or opted in to the juris... |
7.3 Enforcement of Patents. |
7.3.1 Enforcement of Licensor Background Patents, Licensor Program Patents, and Joint Program Patents. Each Party shall promptly notify the other Party in writing of any alleged, threatened or actual infringement of the Licensor Background Patents, Licensor Program Patents, or Joint Program Patents by a Third Party in ... |
In the event AbbVie prosecutes any Product Infringement, Licensor shall have the right to join as a party to such claim, suit, or proceeding in the Territory and participate with its own counsel at its own expense; provided that AbbVie shall retain control of the prosecution of such claim, suit, or proceeding. During a... |
If AbbVie does not take commercially reasonable steps to prosecute a Product Infringement (i) within ninety (90) days following the first notice provided above with respect to the Product Infringement, or (ii) provided such date occurs after the first such notice of the Product Infringement is provided, ten (10) Busine... |
7.3.2 Enforcement of AbbVie Background Patents and AbbVie Program Patents. AbbVie shall have the sole right, but not the obligation, to prosecute any infringement of AbbVie Background Patents or AbbVie Program Patents at its sole expense (provided such costs with respect to AbbVie Program Patents shall be deemed an All... |
7.3.3 Conduct of Patent Litigation Under the Biologics Price Competition and Innovation Act. If either Party receives a copy of an application submitted to the FDA under subsection (k) of Section 351 of the PHSA or equivalent in any other jurisdiction in the Territory (a "Biosimilar Application") naming a Licensed Prod... |
If either Party receives any equivalent or similar certification or notice in any other jurisdiction in the Territory, either Party shall, within three (3) Business Days, notify and provide the other Party with copies of such communication. Regardless of the Party that is the "reference product sponsor" for purposes of... |
7.3.4 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... |
Each Party shall use Commercially Reasonable Efforts to avoid making any admissions or asserting any position in such infringement action with specific intent to materially diminish the other Party's rights or interest under this Agreement. The Party commencing the litigation shall provide the other Party with copies o... |
7.3.5 Recovery. Except as otherwise agreed by the Parties in connection with a cost sharing arrangement, any recovery realized as a result of litigation described in Section 7.3.1 or 7.3.3 (whether by way of settlement or otherwise) shall be first, allocated to reimburse the Parties for their costs and expenses in maki... |
AbbVie shall retain all recoveries realized as a result of such litigation described in Section 7.3.2. Notwithstanding anything to the contrary, (i) if Licensor has exercised a Licensor Opt Out, Licensor is solely responsible for any recovery sharing obligations under the Adimab Agreement and (ii) if Licensor has not e... |
7.4 Infringement Claims by Third Parties. 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), AbbV... |
Licensor may participate in any such claim, suit, or proceeding with counsel of its choice at its own expense. Without limitation of the foregoing, if AbbVie finds it necessary or desirable to join Licensor as a party to any such action, Licensor shall execute all papers and perform such acts as shall be reasonably req... |
Each Party agrees to provide the other Party with copies of all pleadings filed in such action and to allow the other Party reasonable opportunity to participate in the defense of the claims. If Licensor has exercised a Licensor Opt Out for a Collaboration Program and such costs are not included as an Allowable Expense... |
Any recoveries by AbbVie of any sanctions awarded to AbbVie and against a party asserting a claim being defended under this Section 7.4 shall be applied as follows: such recovery shall be applied first to reimburse each Party (in proportion to amounts expended) for its reasonable Out-of-Pocket Costs of defending such c... |
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 Licensor Background Patents, Licensor Program Patents, AbbVie Program Patents, AbbVie Background Patents and Joint Program Patents by a Third Party, in each ca... |
7.5.2 Licensor Background Patents, Licensor Program Patents, and Joint Program Patents. AbbVie shall have the first right, but not the obligation, to defend and control the defense of the validity and enforceability of the Licensor Background Patents, Licensor Program Patents, and Joint Program Patents at its own expen... |
7.5.3 AbbVie Background Patents and AbbVie Program Patents. AbbVie shall have the sole right, but not the obligation, to defend and control the defense of the validity and enforceability of the AbbVie Background Patents and AbbVie Program Patents at its own expense (except to the extent such expense constitutes an Allo... |
7.5.4 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 such action or proceeding, providing access to relevant documents ... |
7.5.5 Costs and Expenses. AbbVie shall be entitled to offset the reasonable Out-of-Pocket Costs of defending such claim, suit, or proceeding under this Section 7.5 that are borne by AbbVie and not included as an Allowable Expense against Net Sales for purposes of calculating royalties due under Section 6.5.1. |
7.6 Product Trademarks. |
7.6.1 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... |
7.6.2 Enforcement of Product Trademarks. AbbVie shall have the sole right and responsibility for taking such action as AbbVie, after consultation with Licensor, deems necessary against a Third Party based on any alleged, threatened, or actual infringement, dilution, misappropriation, or other violation of, or unfair tr... |
7.6.3 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... |
7.6.4 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... |
7.6.5 Existing In-License Agreements. The rights and obligations of Licensor under this Agreement shall be subject to, and limited by, the terms of the Existing In-License Agreements specifically identified on Schedule 7.6.5. |
7.7 Licensor's Costs. Any Out-of-Pocket Costs and FTE Costs reasonably incurred by Licensor, after the Option Exercise Date of the applicable Collaboration Program, in providing assistance, cooperation or other activities as required by AbbVie in accordance with this ARTICLE 7 shall be included in Development Costs or ... |
7.8 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. |
ARTICLE 8. PHARMACOVIGILANCE AND SAFETY |
8.1 Pharmacovigilance. Within ninety (90) days after the Option Exercise Date for the first Collaboration Program, the Parties shall enter into an agreement to initiate a process for the exchange of safety data (including post-marketing spontaneous reports received by each Party and its Affiliates) in a mutually agreed... |
8.2 Global Safety Database. |
8.2.1 Licensor shall initially set up, hold, and maintain (at Licensor's sole cost and expense) the global safety database for Licensed Antibodies and Licensed Products with respect to safety data obtained in connection with the Pre-Exercise Development Activities. |
8.2.2 Within thirty (30) days after the Option Exercise Date for each Collaboration Program, Licensor shall transfer to AbbVie, in a mutually agreed electronic format, the complete contents of the safety database maintained by Licensor pursuant to Section 8.2.1 for the Licensed Antibodies and Licensed Products correspo... |
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 pursuant to the grants under Section 5.1, AbbVie has an interest in Licensor's maintaining the confidentiality of certain information of Licensor. Accordingly, during the Term, Licensor shall use Commerc... |
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... |
Notwithstanding the foregoing, the Parties acknowledge the practical difficulty of policing the use of information in the unaided memory of the receiving Party or its Affiliates and its and their officers, directors, employees, and agents, and as such each Party agrees that the receiving Party shall not be liable for t... |
Notwithstanding the foregoing, to the extent the receiving Party can demonstrate by documentation or other competent proof, the confidentiality and non-use obligations under this Section 9.2 with respect to any Confidential Information shall not include any information that: |
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 have been in the receiving Party's possession prior to disclosure by the disclosing Party, to the extent the receiving Party has the right to use or disclose such information without violating obligations of confidentiality to Third Parties; |
9.2.3 is subsequently received by the receiving Party from a Third Party, to the extent the receiving Party has the right to use or disclose such information without breach of any agreement with such Third Party; |
9.2.4 that is published or otherwise generally made available to Third Parties by the Disclosing Party without restriction on disclosure; or |
9.2.5 have been independently developed by or for the receiving Party without reference to, or use or disclosure of, the disclosing Party's Confidential Information. |
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 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 Regulatory Approval in accordance with the terms of this Agreement; provided that reasonable measures shall be taken to assure confidential treatment of such Confidential... |
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 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 as may be 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 ... |
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 Lice... |
9.3.7 made by Licensor or its Affiliates (or Third Parties acting under their authority) to its or their advisors, consultants, clinicians, vendors, service providers, contractors, or other Third Parties to the extent necessary or useful in in connection with the performance of Licensor's obligations or exercise of rig... |
9.3.8 a disclosure of the terms of this Agreement made on a need to know basis to advisors, consultants, prospective or actual acquirers, investors, or lenders, or with AbbVie's prior written consent (not to be unreasonably withheld) other Persons, in each case on a need to know basis and who are subject to obligations... |
This Section 9.3 shall apply mutatis mutandis to Licensor with respect to Confidential Information of AbbVie solely to the extent applicable to a Licensed Product being developed and commercialized by Licensor pursuant to the licenses set forth in Section 12.8.1, if and as applicable. |
For clarity, in any case where the foregoing disclosure must be subject to obligations of confidentiality and non-use substantially similar to those under this ARTICLE 9, it is understood that the duration of such confidentiality and non-use obligations shall be no less than five (5) years from the date of disclosure. |
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, website, or other form of publici... |
9.5 Public Announcements. Promptly after the Effective Date, the Parties shall agree upon the content of a joint press release to announce the collaboration and shall coordinate the release promptly thereafter. Neither Party shall issue any other public announcement, press release, or other public disclosure regarding ... |
In the event a Party is, in the opinion of its counsel, required by Applicable Law or the rules of a stock exchange on which its securities are listed to make such a public disclosure, such Party shall submit the proposed disclosure in writing to the other Party as far in advance as reasonably practicable (and in no ev... |
9.6 Publications. |
9.6.1 Subject to Section 9.6.4, Licensor may publish or present the results of any non-clinical Development activities conducted solely by Licensor (alone or through Third Party contractors working on Licensor's behalf) with respect to a Licensed Product (but may not, without AbbVie's prior written consent, make any su... |
9.6.2 Licensor shall not publish, publicly present, or otherwise publicly disclose any materials that contain Clinical Data or pertain to results of Clinical Studies with respect to one or more Licensed Products, except in accordance with Section 9.6.4 below, without the prior written consent of AbbVie, not to be unrea... |
9.6.3 Following AbbVie's exercise of its Option with respect to a given Collaboration Program, AbbVie, its Sublicensees and its and their respective Affiliates shall have the right to publish, present or otherwise disclose research, development and commercial information (including with respect to regulatory matters) r... |
9.6.4 Each party shall have the right to review any paper or other public disclosure proposed for publication by the other Party, including any oral presentation or abstract, that contains Clinical Data or pertains to results of Clinical Studies with respect to the Licensed Antibodies or Licensed Products or that inclu... |
9.6.5 Notwithstanding the foregoing it is understood that the requirements of this Section 9.6.5 are subject to and limited by the provisions of Sections 9.3.1 and 9.5 above (i.e., with respect to disclosures required by Applicable Law), and to the publication rights of academic Third Party clinical investigators and c... |
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 (in the event of termination or expiration of this Agreement with respect to a Terminated P... |
9.8 Prior Confidentiality. Any Information disclosed by a Party or its Affiliate to the other Party or its Affiliate prior to the Effective Date under that certain Bilateral Confidential Disclosure Agreement between the Parties or their respective Affiliates dated October 6, 2015 (as amended October 6, 2016), shall be ... |
9.9 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. Licensor and AbbVie each represents and warrants to the other, as of the Execution Date, and covenants, as follows: |
10.1.1 Organization. It is 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 its obligations under this Agreement. |
10.1.2 Authorization. The execution and delivery of this Agreement and the performance by it of its obligations hereunder 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 agreem... |
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. |
10.2 Additional Representations and Warranties of Licensor. Except as otherwise disclosed on Schedule 10.2, Licensor further represents and warrants to AbbVie, as of the Execution Date, and covenants, as follows: |
10.2.1 All Licensor Background Patents existing as of the Execution Date are listed on Schedule 10.2.1 (the "Existing Patents"). All Existing Patents are subsisting and, to Licensor's Knowledge, are not invalid or unenforceable, in whole or in part. |
10.2.2 There are no claims, judgments, or settlements that have been brought or obtained against Licensor or any of its Affiliates relating to the Existing Regulatory Documentation, the Existing Patents, or the Licensor Background Know-How. No claim or litigation has been brought or to Licensor's Knowledge threatened i... |
10.2.3 Licensor is either (a) the sole and exclusive owner of the entire right, title and interest in or (b) the sole and exclusive licensee, with respect to the Licensed Antibodies, of the Existing Patents listed on Schedule 10.2.1, in each case ((a) and (b)) free of any encumbrance (other than Non-Material Licenses),... |
10.2.4 To Licensor's Knowledge, Licensor has the right to use all Information, and Patents necessary to conduct the Pre Exercise Development Activities, and the Development or Commercialization of the Licensed Antibody or the Licensed Products as contemplated herein will not be subject to any other license or agreement... |
10.2.5 To Licensor's Knowledge none of Licensor, its Affiliates or any counter party is in breach of any In-License Agreement. Licensor has not threatened to terminate, nor alleged any material breach under, any such In-License Agreement. Licensor has not received any written notice from any counter party to any In-Lic... |
10.2.6 The Existing Patents are being diligently prosecuted in the respective patent offices in the Territory in accordance with Applicable Law. To Licensor's Knowledge, the Existing Patents have been filed and maintained properly and correctly. All applicable fees have been paid on or before the due date for payment f... |
10.2.7 Except for Non-Material Licenses entered into in the standard course, neither Licensor 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, conve... |
10.2.8 To Licensor's Knowledge, no Person is infringing or threatening to infringe or misappropriating or threatening to misappropriate the Existing Patents, the Licensor Background Know-How, or the Regulatory Documentation. |
10.2.9 True, complete, and correct copies of: (a) the file wrapper and other documents and materials relating to the prosecution, defense, maintenance, validity, and enforceability of the Existing Patents; (b) all Existing In-License Agreements; (c) all Existing Regulatory Documentation; and (d) all material adverse in... |
10.2.10 All Regulatory Documentation generated, prepared, maintained, and retained by Licensor and its Affiliates that is required to be maintained or retained pursuant to and in accordance with good laboratory and clinical practice and Applicable Law, has been so generated, prepared, maintained, and retained, and to L... |
10.2.11 No written claim of infringement has been filed, or to Licensor's Knowledge, threatened in writing against Licensor or any of its Affiliates by any Third Party with respect to the Development, Manufacture or Commercialization of any Licensed Antibody or Licensed Product. To Licensor's Knowledge, the conduct of ... |
10.2.12 No written claim has been filed, or to Licensor's Knowledge, threatened in writing, against Licensor or any of its Affiliates by any Third Party alleging that the conception, development, or reduction to practice of the Regulatory Documentation, the Existing Patents, or Licensor Background Know-How constitute o... |
10.2.13 The Existing Patents represent all Patents within Licensor's or its Affiliates' ownership or Control as of the Execution Date that are reasonably necessary or useful for the Development, Manufacture, or Commercialization of the Licensed Antibodies or the Licensed Products. There is no non-public Information own... |
10.2.14 Licensor does not Control any Antibody specifically binding to and modulating CD33 that has been actually reduced to practice other than the Antibodies described on Schedule 1.127. Licensor does not Control any Antibody specifically binding to and modulating Trem2 that has been actually reduced to practice othe... |
10.2.15 To Licensor's Knowledge, each Person who has or has had any rights in or to any Existing Patents or any Licensor Background Know-How, has assigned and has executed an agreement obligating such Person to assign its entire right, title, and interest in and to such Existing Patents to Licensor or to the licensor u... |
10.2.16 Licensor has used the same degree of diligence to protect the confidentiality of the Licensor Background Know-How as Licensor uses to protect its other proprietary information of similar importance but in all cases at lease a reasonable degree of care. |
10.2.17 Licensor has made (and will make) available to AbbVie all Regulatory Documentation, Licensor Background Know-How and other Information in its possession or Control regarding or related to the Licensed Antibodies or the Licensed Products and all such Regulatory Documentation, Licensor Background Know-How and oth... |
10.2.18 Neither Licensor nor any of its Affiliates, nor to Licensor's Knowledge, any of its or their respective officers, employees, or agents has (a) (i) knowingly made an untrue statement of material fact or (ii) made a fraudulent statement, in either case to the FDA or any other Regulatory Authority with respect to ... |
10.2.19 Licensor and its Affiliates have conducted, and their respective contractors and consultants have conducted, all Development of the Licensed Antibodies or the Licensed Products that they have conducted prior to the Execution Date in accordance with Applicable Law and (to the extent applicable) good laboratory p... |
10.2.20 Except as set forth in the Existing In-License Agreements, there are no amounts that will be required to be paid to a Third Party as a result of the Development, Manufacture or Commercialization of the Licensed Antibodies or Licensed Products that arise out of any agreement to which Licensor or any of its Affil... |
10.2.21 Neither Licensor nor any of its Affiliates has intentionally failed to disclose to AbbVie any scientific or technical facts or circumstances that it believes would reasonably be expected to materially adversely affect the scientific, therapeutic, or commercial potential of the Licensed Antibodies or Licensed Pr... |
10.2.22 Neither Licensor nor any of its employees nor to its Knowledge, any of the agents performing hereunder, has ever been, is currently, or is the subject of a proceeding that could lead to it or such employees or agents becoming, as applicable, a Debarred Entity or Debarred Individual, an Excluded Entity or Exclud... |
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