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1.167 "Research Program" means, on a Target-by-Target basis, the Research Plan Activities to be performed by the Parties. For clarity, (a) "Research Program" includes a Substitute Research Program (but not a Replaced Research Program or terminated Research Program), and (b) the Parties may establish more than one (1) R... |
1.168 "Royalty Term" means, on a Licensed Product-by-Licensed Product and country or other jurisdiction-by-country or other jurisdiction basis, the period beginning on the date of the First Commercial Sale of such Licensed Product in such country or other jurisdiction, and ending on the latest to occur of: (a) the expi... |
1.169 "Second Request" has the meaning set forth in Section 12.3.3(b). |
1.170 "Selected Pre-Option Prosecuted Infringement" has the meaning set forth in Section 8.3.2. |
1.171 "Senior Officer" means the respective executive officers designated by each Party. |
1.172 "Shared Cost Opt-Out" has the meaning set forth in Section 5.3.8. |
1.173 "Shared Cost Opt-Out Date" has the meaning set forth in Section 5.3.8. |
1.174 "Shared Cost Opt-Out Notice" has the meaning set forth in Section 5.3.8. |
1.175 "Shared Cost Report" has the meaning set forth in Section 5.3.4. |
1.176 "Shared Costs" has the meaning set forth in Section 5.3.3. |
1.177 "Sublicensee" means a Person, other than an Affiliate or a Distributor, that is granted a sublicense by AbbVie under the grants in Sections 6.1 and 6.2 as provided in Section 6.4, excluding any Third Party to which AbbVie or its Affiliates has granted such sublicense as a result of (a) a settlement involving a Pa... |
1.178 "Substitute Research Plan" has the meaning set forth in Section 3.4.1. |
1.179 "Substitute Research Program" has the meaning set forth in Section 3.4.1. |
1.180 "Substitute Research Program Fee" has the meaning set forth in Section 3.4.1. |
1.181 "Synthesis Process" has the meaning set forth in Section 3.10. |
1.182 "Target" means (i) a specific biological molecule that is identified by a GenBank accession number or similar information, or by its amino acid or nucleic acid sequence, (ii) a naturally occurring mutant or allelic variant of a molecule disclosed in clause (i), including transcriptional and posttranscriptional is... |
1.183 "Tax" means all taxes, duties, fees, premiums, assessments, imposts, levies, rates, withholdings, dues, government contributions and other charges of any kind whatsoever, whether direct or indirect, together with all interest, penalties, fines, additions to tax or other additional amounts, imposed by any governme... |
1.184 "Technology Transfer" has the meaning set forth in Section 3.10. |
1.185 "Technology Transfer Period" has the meaning set forth in Section 3.10. |
1.186 "Term" has the meaning set forth in Section 12.1.1. |
1.187 "Terminated Territory" means each country or other jurisdiction with respect to which this Agreement is terminated by Plexium pursuant to Section 12.2.2, each country or other jurisdiction with respect to which this Agreement is terminated by AbbVie pursuant to Section 12.3.2, or, if this Agreement is terminated ... |
1.188 "Territory" means worldwide. |
1.189 "Third Party" means any Person other than Plexium, AbbVie and their respective Affiliates. |
1.190 "Third Party Claims" has the meaning set forth in Section 11.1. |
1.191 "Trademark" means any word, name, symbol, color, designation or device or any combination thereof that functions as a source identifier, including any trademark, trade dress, brand mark, service mark, trade name, brand name, logo, business symbol or domain names, whether or not registered, including any registrat... |
1.192 "Unfinished Research Plan Activities" has the meaning set forth in Section 3.8. |
1.193 "United States" or "U.S." means the United States of America and its territories and possessions (including the District of Columbia and Puerto Rico). |
1.194 "Valid Claim" means a claim of any issued and unexpired Patent whose validity, enforceability, or patentability has not been affected by any of the following: (a) irretrievable lapse, abandonment, cancellation, revocation, dedication to the public, or disclaimer; or (b) a holding, finding, or decision of invalidi... |
1.195 "Voting Stock" has the meaning set forth in Section 1.31.1. |
1.196 "Withholding Amount" has the meaning set forth in Section 7.11. |
1.197 "Withholding Party" has the meaning set forth in Section 7.11. |
1.198 "Working Group" has the meaning set forth in Section 2.4.1. |
ARTICLE 2 GOVERNANCE |
2.1 Joint Research Committee. Within thirty (30) days after the Effective Date, the Parties shall establish a joint research committee (the "Joint Research Committee" or "JRC"), which shall consist of three (3) representatives from each of the Parties, each with the requisite experience and seniority to enable such per... |
2.1.1 establish secure access methods (such as secure databases) for each Party to access Confidential Information; |
2.1.2 serve as a forum for reviewing experimental results and datasets and discussing the Research Plans and any amendments, including Material Research Plan Amendments, thereto; |
2.1.3 determine which Research Plan Activities are Dependent Research Plan Activities and/or Cancelled Research Plan Activities in accordance with Section 3.2.1; |
2.1.4 direct and monitor the Parties' activities under the Research Plans; |
2.1.5 preview the strategy, timing, content, topics and questions for the preparation of documents or reports in connection with an Option Data Package or as necessary for the filing of any Patent; |
2.1.6 serve as a forum for discussing and approving publications by or on behalf of Plexium related to Mutually Applicable Product Information in accordance with Section 9.6.2; and |
2.1.7 perform such other functions as are set forth herein or as the Parties may mutually agree in writing, except where in conflict with any provision of this Agreement. |
2.2 General Provisions Applicable to the Joint Research Committee. |
2.2.1 Meetings and Minutes. The JRC shall meet quarterly, or as otherwise agreed to by the Parties, with the location of such meetings alternating between locations designated by AbbVie and locations designated by Plexium. The chairperson of the JRC shall be responsible for calling meetings (including upon request of e... |
2.2.2 Procedural Rules. The JRC shall have the right to adopt such standing rules as shall be necessary for its work, to the extent that such rules are not inconsistent with this Agreement. A quorum of the JRC shall exist whenever there is present at a meeting at least one (1) representative appointed by each Party. Re... |
2.2.3 Decision Making. The JRC shall take action in good faith by consensus of the representatives present at a meeting at which a quorum exists, with each Party having a single vote irrespective of the number of representatives of such Party in attendance, or by a written resolution signed by at least one (1) represen... |
2.2.4 Limitations on Authority. Each Party shall retain the rights, powers, and discretion granted to it under this Agreement and no such rights, powers, or discretion shall be delegated to or vested in the JRC unless such delegation or vesting of rights is expressly provided for in this Agreement or the Parties expres... |
2.2.5 Disbandment. If AbbVie does not exercise a License Option, then, the JRC shall disband upon the expiration of the last-to-expire Option Period. Subject to the remainder of this Section 2.2.5, if AbbVie exercises a License Option following delivery of an Option Data Package, then AbbVie may choose to discontinue a... |
2.2.6 Alliance Manager. Within thirty (30) days after the Effective Date, each Party shall appoint a person(s) who shall oversee contact between the Parties for all matters between meetings of the JRC and shall have such other responsibilities as the Parties may agree in writing after the Effective Date (each, an "Alli... |
2.3 Interactions Between the Joint Research Committee and Internal Teams. The Parties recognize that each Party possesses an internal structure (including various committees, teams and review boards) that will be involved in administering such Party's activities under this Agreement. Nothing contained in this ARTICLE 2... |
2.4 Working Groups. |
2.4.1 From time to time, the JRC may establish and delegate duties to sub-committees or directed teams (each, a "Working Group") on an "as-needed" basis to oversee particular projects or activities (for example, joint project team, joint finance group, and/or joint intellectual property group). Each such Working Group ... |
2.4.2 Within thirty (30) days after the Effective Date, the JRC shall establish a Working Group to (a) oversee the Parties' performance of the Research Plan Activities, and (b) review experimental datasets and results. Such Working Group shall meet no less frequently than monthly. |
2.5 Expenses. Each Party shall be responsible for all travel and related costs and expenses for its members and other representatives to attend meetings of, and otherwise participate on, the JRC or any Working Group. |
ARTICLE 3 RESEARCH |
3.1 Research Plans. Each Research Plan shall be attached to this Agreement (a) on the Effective Date, or (b) with respect to a Substitute Research Plan, on the date that the Parties finalize such Substitute Research Plan in accordance with Section 3.4.1. Either Party, directly or through its representatives on the JRC ... |
3.2 Performance of the Research Plans. |
3.2.1 Subject to the terms and conditions of this Agreement, following the Effective Date, Plexium shall perform the Research Plan Activities allocated to Plexium in accordance with each Research Plan, including using Commercially Reasonable Efforts to perform such Research Plan Activities in accordance with the timeli... |
certain Research Plan Activities (the "Dependent Research Plan Activities") are dependent upon the outcome(s) of preceding Research Plan Activity(ies), and, consequently, the JRC may determine in accordance with Section 2.2.3 that Plexium shall not be obligated to perform such Dependent Research Plan Activity, and it s... |
the JRC may determine in accordance with Section 2.2.3, from time to time, not to (i) screen certain compounds, or (ii) perform certain Research Plan Activities under a particular Research Plan ("Cancelled Research Plan Activities"), and, consequently, it shall not be deemed a breach of this Agreement for Plexium not t... |
3.2.2 After Plexium has completed an assessment of all of the applicable compounds against the Preliminary Hit Criteria with respect to a Program, if Plexium is in material breach of its obligation to perform any Research Plan Activities allocated to Plexium thereafter with respect to such Program and Plexium fails to ... |
3.2.3 Plexium shall have the right to subcontract any Research Plan Activities allocated to Plexium (including Manufacturing activities in support of Plexium's obligations under Section 3.9) to a Third Party (a) to the extent expressly provided for in a Research Plan or to those Third Parties listed in Schedule 3.2.3, ... |
3.2.4 Plexium shall, and shall cause its Affiliates, and, subject to Plexium's obligation to use Commercially Reasonable Efforts to enforce subcontracts pursuant to Section 3.2.3, shall require its subcontractors to, maintain, in good scientific manner, complete and accurate books and records pertaining to all Research... |
3.2.5 AbbVie shall have the right to subcontract any Research Plan Activities allocated to AbbVie to a Third Party, without Plexium's prior written consent in its sole discretion; provided that any agreement pursuant to which AbbVie engages a subcontractor shall contain terms obligating such subcontractor to comply wit... |
3.3 Amendments to Research Plans. In the event that either Party proposes an amendment to a Research Plan, all amendments, including any Material Research Plan Amendments shall be considered by the JRC. Any such amendment may be approved in writing by mutual consent of a representative of the JRC for each Party; provid... |
3.4 Substitute Research Program. |
3.4.1 AbbVie has the right, solely with respect to each of the Programs for α-Syn, Tau and OTUB1, in its sole and absolute discretion and at no additional cost (except as expressly contemplated herein), at any time following the Effective Date through the date on which Plexium completes assessment of all of the applica... |
3.4.2 Subject to Section 3.4.1, promptly upon the Parties' mutual agreement on the Substitute Research Plan, Plexium shall perform all Research Plan Activities allocated to Plexium in the Substitute Research Plan in accordance with Sections 3.2. |
3.5 Interim Development Reports. Within thirty (30) days following the end of each Calendar Quarter, Plexium shall provide to the JRC and AbbVie (a) a reasonably detailed written report, in a format to be agreed upon by the Parties, summarizing the performance of all Research Plan Activities allocated to Plexium on a P... |
3.6 Option Data Packages. |
3.6.1 Within forty-five (45) days of the completion of the Research Plan Activities allocated to Plexium under an applicable Research Program, Plexium shall deliver to AbbVie electronic access to the Option Data Package for the applicable Program. |
3.6.2 AbbVie shall have forty-five (45) days after the date Plexium provides the Option Data Package in which to review such Option Data Package to determine completeness of such Option Data Package, and, if AbbVie believes in good faith that any of the Information required by the Research Plan to be included in such O... |
3.6.3 In addition to the Option Data Package, during the Option Period, upon AbbVie's reasonable request, Plexium shall use Commercially Reasonable Efforts to provide to AbbVie any additional Information related to the applicable Option Compounds, Option Products, or Research Plan Activities completed by Plexium, in ea... |
3.7 Expenses. Plexium shall be solely responsible for and shall bear (a) all costs and expenses (i) incurred by or on behalf of Plexium and its Affiliates in connection with the performance of any Research Plan Activities allocated to Plexium or (ii) reasonably incurred by or on behalf of AbbVie and its Affiliates in c... |
3.8 Completion of Research Plans After Exercise of License Option. If AbbVie exercises an applicable License Option prior to completion of the applicable Research Plan Activities, Plexium shall be responsible, at its sole cost and expense (internal and external), for completing any Research Plan Activities that are bot... |
3.9 Manufacturing in Support of Research Plan. Plexium shall Manufacture (or cause to be Manufactured), at Plexium's reasonable cost and expense, a reasonable quantity of pre-clinical supply of the Option Compounds, Option Products (including the Cost-Sharing Product), comparators, co-administered agents and placebo fo... |
3.10 Technology Transfer. During the six (6) month period following the License Option Effective Date for a particular Licensed Program (the "Technology Transfer Period"), upon AbbVie's written request with respect to the applicable Licensed Compound and Licensed Product, Plexium shall use Commercially Reasonable Effor... |
3.10.1 With respect to each Technology Transfer, during the applicable Technology Transfer Period, each Party shall provide, and shall cause its Affiliates and Third Party contract manufacturers to provide, all reasonable assistance requested by the other Party to facilitate the Technology Transfer. If requested by Abb... |
(i) Plexium shall make reasonably available, and shall cause its Affiliates and, subject to Plexium's obligation to use Commercially Reasonable Efforts to enforce subcontracts pursuant to Section 3.2.3, shall require its Third Party contract manufacturers to make reasonably available, to AbbVie (or its Affiliate or des... |
(ii) Upon AbbVie's reasonable request, Plexium shall cause certain employees and representatives of Plexium and its Affiliates, and shall use Commercially Reasonable Efforts to require employees and representatives of its Third Party contract manufacturers, to meet with employees or representatives of AbbVie (or its Af... |
(iii) Upon AbbVie's reasonable request, Plexium shall use Commercially Reasonable Efforts to support AbbVie (or its Affiliate or designated Third Party contract manufacturer, as applicable) in connection with AbbVie obtaining any necessary licenses, permits or approvals from Regulatory Authorities with respect to the M... |
3.10.2 On a Program-by-Program basis, after Plexium FTEs have collectively spent eighty (80) hours in furtherance of the Technology Transfer, the Parties shall bear the costs associated with any Technology Transfer equally. |
3.11 Regulatory Matters. In no event shall Plexium (a) own, obtain or maintain any IND or other Regulatory Approval with respect to any Compound or Product, or (b) communicate with any Regulatory Authority regarding any Compound or Product (i) in writing, without AbbVie's prior written approval of the form and content ... |
3.12 Data Security and Privacy. The Parties acknowledge and agree that Plexium will not Process any Personal Data in connection with its performance of the Research Plan Activities allocated to Plexium. |
ARTICLE 4 LICENSE OPTION |
4.1 License Option Grant to AbbVie. On a Research Program-by-Research Program basis, Plexium hereby grants to AbbVie an exclusive (including with regard to Plexium and its Affiliates) option to obtain an Exclusive License to such Research Program (each a "License Option"), exercisable by AbbVie in its sole discretion d... |
4.2 Exercise of the License Option. At any time during the Option Period, on a Research Program-by-Research Program basis, AbbVie shall have the right to exercise such Research Program's License Option by delivering to Plexium a License Option Exercise Notice for such Research Program. |
4.3 Consequences of Exercise. |
4.3.1 If AbbVie exercises a License Option, from and after the License Option Effective Date, AbbVie (itself or through its Affiliates or Sublicensees or its or their designees) shall have an Exclusive License for the applicable Research Program (as set forth in Section 6.2.1) and such Research Program shall become a L... |
4.3.2 In the case of any agreement with any Third Party that relates to the conduct of a Research Plan for a Licensed Program, Plexium shall promptly identify such agreement and provide a copy thereof to AbbVie. Upon the License Option Effective Date for an applicable Licensed Program, (i) Plexium shall use Commerciall... |
4.4 HSR. |
4.4.1 If AbbVie reasonably determines in good faith prior to the delivery of a single or multiple License Option Exercise Notice(s) that the transactions to be consummated upon the exercise of the applicable License Option(s) require one or more HSR Filings, AbbVie shall provide such License Option Exercise Notice(s) t... |
4.4.2 In connection with the Parties' activities under this Section 4.4, AbbVie and Plexium shall each use commercially reasonable efforts to resolve as promptly as practicable any objections that may be asserted by the FTC or the DOJ with respect to the transactions notified in the HSR Filings. Nothing in this Section... |
4.4.3 AbbVie shall be responsible for all filing fees in connection with the filing of submissions to the FTC and DOJ under the HSR Act, and each Party shall be responsible for its costs and expenses, including attorneys' fees, incurred by it in preparing submissions or responses or responding to any Second Request or ... |
4.4.4 If the exercise by AbbVie of a single or multiple License Option(s) under Section 4.2 requires the making of filings under the HSR Act, then all rights and obligations related to the exercise of such License Option(s) and the granting of the applicable Exclusive License(s) shall be tolled until the HSR Clearance ... |
4.5 Termination of License Option. If (a) upon the expiration of an Option Period AbbVie has not delivered a License Option Exercise Notice for the applicable Research Program pursuant to Sections 4.2 or 4.4.1, or (b) prior to the expiration of an Option Period AbbVie has delivered a License Option Exercise Notice purs... |
ARTICLE 5 DEVELOPMENT AND COMMERCIALIZATION AFTER LICENSE OPTION EXERCISE |
5.1 In General. From and after the License Option Effective Date for each Licensed Program, AbbVie (itself or through its Affiliates or Sublicensees) shall, subject to Plexium's rights pursuant to Section 5.3, and as between the Parties, have the sole right to Exploit the Licensed Compounds and Licensed Products (inclu... |
5.2 Diligence. From and after the License Option Effective Date for each Licensed Program, AbbVie shall use Commercially Reasonable Efforts to (a) obtain and maintain Regulatory Approval for at least one (1) Licensed Product (which may be the Cost-Sharing Product) arising from such Licensed Program, in the Field in the... |
5.3 Cost-Sharing Option. |
5.3.1 Approximately ninety (90) days prior to the anticipated commencement of a Phase II Clinical Study for a Licensed Product, or otherwise upon Plexium's written request (which Plexium may only request once per Licensed Product), AbbVie shall deliver to Plexium a Cost-Sharing Option Package. |
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