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With respect to any Licensed Compound or Licensed Product, AbbVie shall have the sole right to determine and make all filings and listings with Regulatory Authorities in the Territory with respect to any Plexium Product Patents and Joint Patents, including as required or allowed (a) in the United States, in the FDA's O... |
Plexium shall, at AbbVie's cost, (i) provide to AbbVie all Information under its control, including a correct and complete list of Plexium Product Patents, required to enable AbbVie to make such filings with Regulatory Authorities in the Territory with respect to such Patents, and (ii) cooperate with AbbVie's reasonabl... |
Each Party shall promptly notify the other Party in writing of any alleged or threatened infringement or misappropriation of the Licensed IP or Joint IP by a Third Party in the Territory of which such Party becomes aware based on the Exploitation of, or an application to register or market, a product containing any Com... |
During the Option Period, Plexium shall have the first right, but not the obligation, to prosecute and settle any Product Infringement to the extent relating to the Licensed IP in the Territory, and AbbVie shall have the first right, but not the obligation, to prosecute any Product Infringement to the extent relating t... |
In the event the prosecuting Party prosecutes any Selected Pre-Option Prosecuted Infringement, the non-prosecuting Party 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 the prosecuting Party shall not sett... |
Notwithstanding anything to the contrary in this Agreement, AbbVie shall have the sole right, but not the obligation, to prosecute, manage and settle any litigation with respect to Generic Products or any application seeking the approval, license, registration or authorization of any Regulatory Authority therefor, and ... |
If Plexium receives a notice or a copy of an application submitted to the FDA or its foreign counterpart for a Generic Product, or any application seeking the approval, license, registration, or authorization of any Regulatory Authority therefor (a "Generic Application") pursuant to 21 U.S.C. § 355(b)(2)(A)(iv) or 21 U... |
In the event that AbbVie exercises the License Option with respect to a particular Research Program, then, with respect to any intellectual property arising or relating to such Licensed Program, from and after the applicable License Option Effective Date, AbbVie shall have the sole right, but not the obligation, to pro... |
In the event AbbVie prosecutes any AbbVie Prosecuted Infringement, Plexium 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 control the prosecution of such claim, suit, or proceeding. |
Notwithstanding anything to the contrary in this Agreement, Plexium shall, at all times, have the sole and exclusive right, but not the obligation, to prosecute, manage and settle any litigation with respect to the following: (a) all Plexium Platform Patents, and (b) all Patents that relate exclusively to any Rejected ... |
The Parties agree to cooperate fully, at the enforcing Party's cost, in any infringement or misappropriation action pursuant to this Section 8.3 (including any proceedings or litigation with respect to Generic Products or any application seeking the approval, license, registration, or authorization of any Regulatory Au... |
Except as otherwise agreed by the Parties, any recovery realized as a result of such litigation described in Sections 8.3.3 or 8.3.4 (whether by way of settlement or otherwise) shall be first, allocated to reimburse the Parties for their costs and expenses in making such recovery (which amounts shall be allocated pro r... |
Following the applicable License Option Effective Date, if the Exploitation 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 AbbVie (or its Affiliates or Sublicensees), Abb... |
Without limitation of the foregoing, if AbbVie finds it necessary or desirable to join Plexium as a party to any such action, Plexium shall, at AbbVie's cost, execute all papers and perform such acts as shall be reasonably required. AbbVie shall keep Plexium reasonably informed of all material developments in connectio... |
Each Party shall promptly notify the other Party in writing of any alleged or threatened assertion of invalidity, unpatentability or unenforceability of any of the Plexium Product Patents or Joint Patents by a Third Party, in each case in the Territory and of which such Party becomes aware. |
During the Option Period, Plexium shall have the first right, but not the obligation, to defend, control and settle the defense of the validity, patentability and enforceability of the Plexium Product Patents at its own expense in the Territory. AbbVie may participate in any such claim, suit, or proceeding in the Terri... |
During the Option Period, AbbVie shall have the first right, but not the obligation to defend, control and settle the defense of the validity, patentability and enforceability of the Joint Patents, at its own expense in the Territory, and Plexium may participate in any such claim suit or proceeding at its own expense. ... |
In the event that AbbVie exercises the License Option with respect to a particular Research Program, then, with respect to any Plexium Product Patents and Joint Patents arising or relating to such Licensed Program, from and after the applicable License Option Effective Date, AbbVie shall have the first right, but not t... |
Notwithstanding any other provision of this Agreement, Plexium shall, at all times, have the sole and exclusive right, but not the obligation, to defend, control and settle the defense of the validity, patentability and enforceability, at its sole cost, of the following: (a) all Plexium Platform Patents, and (b) all Pa... |
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 8.5, including by being joined as a party in such action or proceeding when necessary, providing access to relevant documents and other evid... |
During the Option Period, if in the reasonable opinion of Plexium, the Exploitation of any Option Compound or Option Product by Plexium, any of its Affiliates, or any of its or their sublicensees infringes or misappropriates any Patent, trade secret, or other intellectual property right of a Third Party in any country ... |
Plexium shall be solely responsible for any payments thereunder, except to the extent approved in advance by AbbVie in writing. In the event Plexium obtains such Third Party license, Plexium shall also obtain the right to sublicense the intellectual property rights under any such Third Party license to AbbVie and its A... |
In the event that AbbVie exercises the License Option with respect to a particular Research Program, then, with respect to such Licensed Compound and Licensed Product, from and after the applicable License Option Effective Date, if in the reasonable opinion of AbbVie, the Exploitation of such Licensed Compound or Licen... |
If in the reasonable opinion of AbbVie, a Third Party's Patent may relate to the Exploitation of any Licensed Compound or Licensed Product by the Parties or their Affiliates or Sublicensees, AbbVie or its Affiliates shall have the sole right, but not the obligation, to challenge the patentability, validity or enforceab... |
Plexium shall not challenge the patentability, validity or enforceability of such Patent in any court or governmental body without AbbVie's prior written consent. If Plexium has challenged the patentability, validity or enforceability of such Patent before the License Option Effective Date, AbbVie shall have the right,... |
AbbVie or its Affiliates shall own all right, title, and interest to the Product Trademarks in the Territory, and shall have the sole right, but not the obligation, to conduct the registration, prosecution, and maintenance thereof. AbbVie shall have the sole right, but not the obligation, to conduct the selection, regi... |
8.7 Product Trademarks. |
8.7.1 Ownership and Prosecution of Product Trademarks. AbbVie or its Affiliates shall own all right, title, and interest to the Product Trademarks in the Territory, and shall have the sole right, but not the obligation, to conduct the registration, prosecution, and maintenance thereof. AbbVie shall have the sole right,... |
8.7.2 Enforcement of Product Trademarks. AbbVie or its Affiliates shall have the sole right, but not the obligation, to take such action as AbbVie, after consultation with Plexium, deems necessary against a Third Party based on any alleged, threatened, or actual infringement, dilution, misappropriation, or other violat... |
8.7.3 Third Party Claims. AbbVie or its Affiliates shall have the sole right, but not the obligation, to defend 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 Tradema... |
8.7.4 Notice and Cooperation. Plexium shall provide to AbbVie prompt written notice of any actual or threatened infringement of the Product Trademarks in the Territory of which Plexium becomes aware and of any actual or threatened claim that the use of the Product Trademarks in the Territory violates the rights of any ... |
8.8 Inventor's Remuneration. Each Party shall be solely responsible for any remuneration that may be due to such Party's inventors under any applicable inventor remuneration laws. |
8.9 Common Interest. All information exchanged between the Parties regarding the prosecution, maintenance, enforcement and defense of Patents under this ARTICLE 8 will be deemed to be Confidential Information of the disclosing Party. In addition, the Parties acknowledge and agree that, with regard to such prosecution, ... |
ARTICLE 9 CONFIDENTIALITY AND NON-DISCLOSURE |
9.1 Product Information. Plexium recognizes that by reason of, inter alia, AbbVie's status as an exclusive licensee pursuant to the grants under Section 6.2, AbbVie has an interest in Plexium maintaining the confidentiality of certain Confidential Information owned by Plexium. Accordingly, during the Term, Plexium shal... |
9.2 Confidentiality Obligations. At all times during the Term and for a period of seven (7) years following termination or expiration of this Agreement 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 ... |
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 or duty of confidentiality with respect to such information; |
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 and/or duty or obligation that such Third Party owes to such disclosing Party; or |
9.2.4 has been independently developed by or for the receiving Party without reference to, or use or disclosure of, or access to, 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 upon advice of the receiving Party's legal counsel, required to be disclosed pursuant to Applicable 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 reas... |
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 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 suc... |
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 Comp... |
9.3.7 made by Plexium or its Affiliates to its or their advisors, consultants, clinicians, vendors, service providers, contractors and the like to the extent necessary in assisting with Plexium's activities contemplated by this Agreement; provided, that such Persons shall be subject to obligations of confidentiality an... |
9.4 Use of Name. Except as expressly provided herein, neither Party shall mention or otherwise use the name, servicemark, logo, or Trademark of the other Party or any of its Affiliates (or any abbreviation or adaptation thereof) in any publication, advertising, press release, marketing and promotional material, or othe... |
9.5 Public Announcements. The Parties shall mutually agree upon the content of any joint press release in writing, the release of which the Parties shall coordinate in order to accomplish such release promptly upon a date and time agreed upon by the Parties in writing. Neither Party shall issue any other public announc... |
9.6 Publications. |
9.6.1 The Parties acknowledge that scientific publications must be strictly monitored to prevent any adverse effect from premature publication of results of the Research Plan Activities hereunder. Accordingly, neither Party shall publish, present, or otherwise disclose, and each Party shall cause its Affiliates and sha... |
9.6.2 AbbVie shall have the right to review and approve any paper proposed for publication by Plexium, including any oral presentation or abstract, in each case that includes any Mutually Applicable Product Information. Before any such paper is submitted for publication or an oral presentation is made, Plexium shall de... |
9.7 Return of Confidential Information. Upon the effective date of the termination of this Agreement for any reason, but excluding expiration of this Agreement, either Party may request in writing, and the other Party shall either, with respect to Confidential Information (in the event of termination of this Agreement ... |
9.8 Survival. All Confidential Information shall continue to be subject to the terms of this Agreement for the period set forth in Section 9.1. |
ARTICLE 10 REPRESENTATIONS AND WARRANTIES |
10.1 Mutual Representations, Warranties and Covenants. Plexium and AbbVie each represents, warrants, and covenants to the other, as of the Effective Date, as follows: |
10.1.1 Organization. It is a corporation duly organized, validly existing, and in good standing under the laws of the jurisdiction of its organization, and has all requisite power and authority, corporate or otherwise, to execute, deliver, and perform this Agreement. |
10.1.2 Authorization. The execution and delivery of this Agreement and the performance by it of the transactions contemplated hereby have been duly authorized by all necessary corporate action, and do not violate (a) such Party's charter documents, bylaws, or other organizational documents, (b) in any material respect,... |
10.1.3 Binding Agreement. This Agreement is a legal, valid, and binding obligation of such Party enforceable against it in accordance with its terms and conditions, subject to the effects of bankruptcy, insolvency, or other laws of general application affecting the enforcement of creditor rights, judicial principles af... |
10.1.4 No Conflicting Obligation. It is not under any obligation, contractual or otherwise, to any Person that conflicts in any material respect with the terms of this Agreement. |
10.1.5 Compliance with Applicable Law. Each Party shall perform the activities contemplated by this Agreement in accordance with Applicable Law. |
10.2 Additional Representations and Warranties of Plexium. Plexium further represents and warrants to AbbVie, as of the Effective Date, except as set forth in the corresponding section of Schedule 10.2 delivered by Plexium to AbbVie on the Effective Date, as follows: |
10.2.1 all Patents that comprise the Plexium Platform Patents are listed on Schedule 10.2.1 (the "Existing Patents"); |
10.2.2 all Existing Patents are subsisting and, to the Knowledge of Plexium, valid and enforceable; |
10.2.3 there are no judgments or settlements, or amounts with respect thereto, owed by Plexium or any of its Affiliates relating to the Existing Patents or the Plexium Background Technology; |
10.2.4 no claim or litigation has been brought or, to the Knowledge of Plexium, threatened by any Person alleging, and Plexium has no Knowledge of any claim, whether or not asserted, that (a) the Existing Patents or the Plexium Background Technology are invalid or unenforceable, or (b) the Existing Patents or the Plexi... |
10.2.5 to the Knowledge of Plexium, performance of the Research Plan Activities does not violate, infringe, misappropriate, or otherwise conflict or interfere with, any Patent or other intellectual property or proprietary right of any Person; |
10.2.6 to the Knowledge of Plexium, the use of the Existing Patents and the Plexium Background Technology as contemplated by this Agreement does not violate, infringe, misappropriate or otherwise conflict or interfere with, any Patent or other intellectual property or proprietary right of any Person; |
10.2.7 Plexium is the sole and exclusive owner of the entire right, title and interest in the Existing Patents listed on Schedule 10.2.1 and the Plexium Background Technology, each free of any encumbrance, lien, or claim of ownership by any Third Party. For the purpose of clarity, this Section 10.2.7 shall not be deeme... |
10.2.8 Plexium is entitled to grant the licenses specified in this Agreement; |
10.2.9 there are no agreements between Plexium or its Affiliates, on the one-hand, and any Third Party, on the other hand, under which AbbVie is granted a sublicense or other right under this Agreement, including with respect to the Existing Patents and the Plexium Background Technology; |
10.2.10 neither Plexium nor any of its Affiliates has previously entered into any agreement, whether written or oral, and neither Plexium nor any of its Affiliates will enter into any agreement, that is inconsistent with the rights and licenses granted by Plexium to AbbVie under this Agreement; |
10.2.11 to the Knowledge of Plexium, no Person is infringing or threatening to infringe or misappropriating or threatening to misappropriate the Existing Patents or the Plexium Background Technology or any Plexium trade secret; and |
10.2.12 the inventions claimed or covered by the Existing Patents (a) were not conceived, reduced to practice, 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, (b) are not a "subject inv... |
10.3 Additional Covenants of Plexium. Plexium agrees that, during the Term, Plexium and its Affiliates shall, and Plexium shall require each Third Party performing Research Plan Activities on its behalf to (and Plexium shall use Commercially Reasonable Efforts to enforce its rights under such agreement with respect the... |
10.3.1 not grant any license relating to the Licensed IP that would conflict with the rights or licenses granted or to be granted to AbbVie hereunder; |
10.3.2 not allow Tax or other government liens to attach to any of the Licensed IP, and shall not grant any liens on the Licensed IP that would conflict with the rights or licenses granted or to be granted to AbbVie hereunder; |
10.3.3 cause all Plexium Know-How transferred to AbbVie under this Agreement to be true, complete and correct in all material respects, subject to the provisions of Section 4.3.2(i); and |
10.3.4 with respect to supplies of Compound, comparators, co-administered agents or placebo Manufactured and supplied by or on behalf of Plexium pursuant to this Agreement, provide that (a) all such Compound, comparators, co-administered agents and placebo conform, in all material respects, with the applicable specific... |
10.4 Mutual Representations, Warranties, and Covenants. Each Party represents, warrants and covenants to the other Party, as of the Effective Date, as follows |
10.4.1 it and its Affiliates have an internal compliance program under which its (or its Affiliates') employees are required to comply with all Applicable Law, including applicable local and international anti-bribery and anti-corruption laws and regulations; |
10.4.2 its and its Affiliates' respective employees and agents are regularly trained, and will continue to be regularly trained, on the requirements of its compliance program and compliance with applicable anti-bribery and anti-corruption laws; |
10.4.3 it shall conduct, and cause their respective contractors and consultants to conduct, all Research Plan Activities allocated to such Party in accordance with GLP and GCP (to the extent applicable), Applicable Law, and the applicable Research Plan; |
10.4.4 it shall employ Persons with appropriate education, knowledge and experience to conduct and to oversee the conduct of Research Plan Activities allocated to such Party; and |
10.4.5 it shall continue to update and maintain during the Term an internal compliance program under which such Party's (or its Affiliates') employees are required to comply with all Applicable Law, including applicable local and international anti-bribery and anti-corruption laws and regulations. |
10.5 Debarment and Exclusion. Each Party represents, warrants and covenants to the other Party that neither it nor its Affiliates have ever been, are not currently, nor are they the subject of a proceeding that could lead to it or its Affiliates becoming a Debarred Entity, Excluded Entity or Convicted Entity, and it an... |
10.5.1 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. |
10.5.2 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. |
10.5.3 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... |
10.5.4 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. |
10.5.5 "FDA's Disqualified/Restricted List" is the list of clinical investigators restricted from receiving investigational drugs, biologics, or devices if the FDA has determined that the investigators have repeatedly or deliberately failed to comply with regulatory requirements for studies or have submitted false Info... |
10.6 Anti-Bribery and Anti-Corruption Compliance. Each Party and its Affiliates (a) have complied and shall comply with all Applicable Law governing bribery, money laundering, and other corrupt practices and behavior (including, as applicable, the U.S. Foreign Corrupt Practices Act and UK Bribery Act) and (b) shall not... |
10.7 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... |
10.8 Option Data Package Disclosure Schedules. In accordance with Section 3.6.2, Plexium shall deliver to AbbVie the Option Data Package, which shall include (a) disclosures required in connection with solely those certain representations and warranties set forth on Schedule 10.8, and (b) the Updated Existing Patents (... |
ARTICLE 11 INDEMNITY |
11.1 Indemnification of Plexium. AbbVie shall indemnify Plexium, its Affiliates and its and their respective directors, officers, employees, and agents (the "Plexium Indemnitees") and defend and save each of them harmless, from and against any and all losses, damages, liabilities, penalties, costs, and expenses (includ... |
11.1.1 the breach by AbbVie of this Agreement, including any of AbbVie's representations or warranties contained herein; |
11.1.2 the negligence, reckless conduct or willful misconduct on the part of AbbVie or its Affiliates or it or their respective directors, officers, employees, and agents in performing its or their obligations under this Agreement; |
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