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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... |
(i) A "Debarred Individual" is an individual who has been debarred by the FDA pursuant to 21 U.S.C. § 335a (a) or (b) from providing services in any capacity to a Person that has an approved or pending drug or biological product application. |
(ii) A "Debarred Entity" is a corporation, partnership or association that has been debarred by the FDA pursuant to 21 U.S.C. § 335a (a) or (b) from submitting or assisting in the submission of any abbreviated drug application, or a subsidiary or affiliate of a Debarred Entity. |
(iii) An "Excluded Individual" or "Excluded Entity" is (A) an individual or entity, as applicable, who has been excluded, debarred, suspended or is otherwise ineligible to participate in federal health care programs such as Medicare or Medicaid by the Office of the Inspector General (OIG/HHS) of the U.S. Department of ... |
(iv) A "Convicted Individual" or "Convicted Entity" is an individual or entity, as applicable, who has been convicted of a criminal offense that falls within the ambit of 21 U.S.C. § 335a (a) or 42 U.S.C. § 1320a - 7(a), but has not yet been excluded, debarred, suspended or otherwise declared ineligible. |
10.2.23 The inventions claimed or covered by the Existing Patents (a) were not conceived, discovered, developed, or otherwise made in connection with any research activities funded, in whole or in part, by the federal government of the United States or any agency thereof, and (b) are not a "subject invention" as that t... |
10.2.24 During the period from the Execution Date until the Effective Date, Licensor and each of its Affiliates shall conduct its research and development with respect to the Licensed Antibody and the Licensed Products in the ordinary course. |
10.2.25 At the time of delivery of the PoC Trial Report, Licensor shall inform AbbVie in writing if Licensor or any of its Affiliates becomes aware that the representations and warranties made by Licensor herein (other than pursuant to Sections 10.2.9, 10.2.13, 10.2.14 and 10.2.17) as of the Execution Date are not true... |
10.2.26 To Licensor's Knowledge, the representations and warranties of Licensor in this Agreement, and the Information, documents and materials furnished to AbbVie in connection with its period of diligence prior to the Effective Date, do not, taken as a whole, (a) contain any untrue statement of a material fact, or (b... |
10.3 Additional Covenants of Licensor. Licensor further covenants to AbbVie as follows: |
10.3.1 During the Term, Licensor shall (a) not commit or omit any acts that would cause the breach or termination of any In-License Agreement, or (b) not amend or otherwise modify or permit to be amended or modified, any In-License Agreement, in each case in a manner that would encumber or diminish the rights granted t... |
10.3.2 Neither Licensor nor any of its Affiliates will enter into any assignment, transfer, license, conveyance or encumbrance of, or otherwise assign, transfer, license, convey or encumbered its right, title, or interest in or to the Existing Patents, Licensor Background Know-How, Regulatory Documentation or grant any... |
10.3.3 If Licensor secures a license to European Patent No. EP2625201B (including, if applicable, patents issuing thereon, foreign equivalents, or any patent claiming priority thereto), licensor shall ensure such license is sublicensable (through multiple tiers) to AbbVie under this Agreement at no cost to AbbVie and t... |
10.4 DISCLAIMER OF WARRANTIES. EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH HEREIN, NEITHER PARTY MAKES ANY REPRESENTATIONS OR GRANTS ANY WARRANTIES, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, AND EACH PARTY SPECIFICALLY DISCLAIMS ANY OTHER WARRANTIES, WHETHER WRITTEN OR ORAL, OR... |
ARTICLE 11. INDEMNITY |
11.1 Indemnification of Licensor. AbbVie shall indemnify Licensor, its Affiliates and its and their respective directors, officers, employees, and agents (the "Licensor Indemnitees") and defend and save each of them harmless, from and against any and all losses, damages, liabilities, penalties, costs, and expenses (inc... |
(a) the breach by AbbVie or its Affiliates of this Agreement; or |
(b) the negligence, reckless conduct or willful misconduct on the part of AbbVie or its Affiliates or their respective directors, officers, employees, and agents in performing its or their obligations under this Agreement. |
except in the case of clauses (a) and (b), for those Losses for which Licensor, in whole or in part, has an obligation to indemnify AbbVie pursuant to Section 11.2 hereof, as to which Losses each Party shall indemnify the other to the extent of their respective liability for such Losses. |
11.2 Indemnification of AbbVie. Licensor shall indemnify AbbVie, its Affiliates and its and their respective directors, officers, employees, and agents (the "AbbVie Indemnitees"), and defend and save each of them harmless, from and against any and all Losses in connection with any and all Third Party Claims incurred by... |
(a) the breach by Licensor or its Affiliates of this Agreement; |
(b) the negligence, reckless conduct or willful misconduct on the part of Licensor or its Affiliates or its or their respective directors, officers, employees, and agents in performing its obligations under this Agreement; |
(c) the use of Licensor's Corporate Name in connection with the Commercialization of the Licensed Antibodies or Licensed Products in the Territory as permitted under this Agreement; or |
(d) the Development, Commercialization, Manufacture, or other Exploitation of the Licensed Antibodies or the Licensed Products anywhere in the world prior to the Effective Date; |
(e) the Development, Commercialization, Manufacture, or other Exploitation of the Terminated Antibodies or Terminated Products anywhere in the world. |
except, in the case of clauses (a) through (c) above for those Losses for which AbbVie, in whole or in part, has an obligation to indemnify Licensor pursuant to Section 11.1 hereof, as to which Losses each Party shall indemnify the other to the extent of their respective liability for the Losses. |
11.3 Certain Losses. Any Losses, other than those Losses covered in ARTICLE 7, or which result from the unlawful conduct of a Party, or for which indemnification is otherwise provided in Section 11.1 or Section 11.2, in connection with any Third Party Claim brought against either Party resulting directly or indirectly ... |
11.4 Notice of Claim. All indemnification claims in respect of a Party, its Affiliates, or their respective directors, officers, employees and agents shall be made solely by such Party to this Agreement (the "Indemnified Party"). The Indemnified Party shall give the indemnifying Party prompt written notice (an "Indemni... |
11.5 Control of Defense. |
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