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2.7.1 Grant of Acquisition Option. On an Option Program-by-Option Program basis, AbCellera hereby grants to AbbVie an exclusive first option, exercisable by AbbVie in its sole discretion during the applicable Acquisition Option Period, to cause AbCellera to sell, assign, convey, transfer, and deliver all right, title a... |
(a) AbbVie may conduct Acquisition Option Period Activities through one or more Third Party service providers or Affiliates, provided that AbbVie shall remain responsible for activities conducted by its Third Party service providers and Affiliates and shall at all times be fully responsible for the compliance of its Th... |
(b) For clarity, the Acquisition Option Period Activities shall exclude: (i) in vivo GLP-compliant toxicology testing of any Project Antibody or Derived Antibody; and (ii) clinical trials with respect to any Project Antibody or Derived Antibody (collectively, "Prohibited Activities"). |
(c) AbbVie hereby covenants on behalf of itself and its Affiliates that, unless and until AbbVie exercises the applicable Acquisition Option, neither AbbVie nor any of its Affiliates will (i) conduct, have conducted, or permit to be conducted, any Prohibited Activities, (ii) transfer or disclose, or cause to be transfe... |
2.7.2 Exercise of Acquisition Option. |
(a) On an Option Program-by-Option Program basis, AbbVie may exercise an Acquisition Option during the applicable Acquisition Option Period by, subject to Section 2.9 (HSR), providing written notice thereof to AbCellera (each such notice, a "Exercise Notice"). If AbbVie exercises an Acquisition Option, AbbVie will pay ... |
(b) Prior to AbbVie's exercise of an Acquisition Option during the applicable Acquisition Option Period, promptly upon AbbVie's request, AbCellera will provide to AbbVie an Updated Disclosure Schedule with respect to AbCellera's representations and warranties set forth in Section 11.2 (Representations, Warranties and C... |
2.8 Activities under Research Plan after Acquisition Option Effective Date. If AbbVie exercises an Acquisition Option prior to the completion of activities under the applicable Research Plan, then, unless otherwise requested by AbbVie in writing, AbCellera will remain responsible for completing all activities allocated... |
2.9 HSR. |
2.9.1 If AbbVie determines in its sole discretion prior to the delivery of the Exercise Notice for an Acquisition Option that the transactions to be consummated upon the exercise of the Acquisition Option require HSR Filings, AbbVie may provide the Exercise Notice for the Acquisition Option to AbCellera prior to the en... |
2.9.2 If HSR Filings are required, each Party shall use commercially reasonable efforts to prepare and file its respective HSR Filing as promptly as is practicable and advisable, with the goal of filing the HSR Filings within ten (10) Business Days after AbCellera receiving the Exercise Notice for the applicable Acquis... |
2.9.3 Tolling of Obligations. If the exercise by AbbVie of an Acquisition Option under Section 2.7.2 (Exercise of Acquisition Option) requires the making of filings under the HSR Act, then all rights and obligations related to the exercise of the Acquisition Option (including payment of any Acquisition Option Exercise ... |
2.10 No Exercise of Acquisition Option. If AbbVie does not exercise an Acquisition Option in accordance with Section 2.7.2 (Exercise of Acquisition Option), then, except as otherwise set forth in this Agreement, AbbVie shall have no rights under this Agreement with respect to those products that would be Earn-Out Antib... |
ARTICLE 3 MANAGEMENT OF THE RESEARCH |
3.1 Program Leader. Within ten (10) days of the Effective Date with respect to the Initial Option Program and the Collaboration Program, and within thirty (30) days of finalizing any other Research Plans, AbbVie and AbCellera will each assign one (1) employee to serve as primary point of scientific communication betwee... |
3.2 Joint Governance Committee. Within thirty (30) days after the Effective Date, the Parties shall establish a joint governance committee (the "JGC") to serve as the oversight and decision-making body for the activities to be conducted by the Parties pursuant to this Agreement, as more fully described in this Article ... |
3.3 Responsibilities. The JGC shall perform the following functions, subject to the final decision-making authority of the respective Parties as set forth in Section 3.6 (Decision-Making): |
(a) oversee the Parties' activities under each Research Plan; |
(b) review and decide whether to approve (and if so decided, approve in writing) each proposed Research Plan and any proposed amendment to a Research Plan; |
(c) establish a Working Group on an "as-needed" basis to review reports submitted by AbCellera under Section 2.5.3 (Information and Reports); |
(d) periodically review (i) reports submitted by AbCellera under Section 2.5.3 (Information and Reports), and (ii) progress of each Target Program, generally; |
(e) serve as an initial forum for discussion of any decisions, issues or disputes arising (i) from the conduct of the activities under each Research Plan, and (ii) in any Working Group; |
(f) make recommendations to AbbVie regarding targets to nominate in connection with Section 2.2.3 (Additional Option Programs) and Section 2.3 (Research Target Substitution); |
(g) review and resolve any reports, recommendations or disputes of any Working Group; |
(h) assign responsibilities that may fall within the purview of more than one Working Group to a particular Working Group; |
(i) determine whether a Research Target in a given Target Program no longer warrants further research, pursuant to Section 2.3 (Research Target Substitution); |
(j) determine whether a Target Program shall move forward to the applicable next stage of the Research Plan; |
(k) deem the Collaboration Program to be complete (notwithstanding that certain activities under the applicable Research Plan may be incomplete); and |
(l) perform such other responsibilities as may be assigned to the JGC pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time. |
For clarity, the JGC shall not have any authority beyond the specific matters set forth in this Section 3.3 (Responsibilities) and, further, the JGC's authority shall be subject to the limitations set forth in Section 3.6 (Decision-Making). |
3.4 Meetings and Minutes. The JGC shall meet quarterly or as otherwise agreed to by the Parties (including on an ad hoc basis), but in any event shall have at least two (2) in-person or video conference meetings per Calendar Year. To the extent the Parties agree to meeting in-person, the location of any such in-person ... |
3.5 Procedural Rules. The JGC 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 JGC shall exist whenever there is present at a meeting at least two (2) representatives appointed by each Party. Rep... |
3.6 Decision-Making. The JGC will endeavor to make decisions by consensus, with each of AbbVie and AbCellera having one (1) vote. If consensus is not reached by the Parties' representatives pursuant to such vote, then the matter may be escalated by either Party to the Executive Officers; provided, however, with respect... |
3.7 Alliance Managers. Promptly after the formation of the JGC, each Party shall appoint an employee (who may not be a then-current member of the JGC) to act as alliance manager for such Party (each, an "Alliance Manager"). Each Alliance Manager shall thereafter be permitted to attend meetings of the JGC as a nonvoting... |
3.8 Discontinuation of the JGC. |
3.8.1 Unless otherwise agreed by the Parties, on an Option Program-by-Option Program basis, upon AbbVie's exercise of an Acquisition Option with respect to an Option Program, the JGC will not have any decision-making role with respect to the applicable Option Program. |
3.8.2 Upon the end of the Research Term with respect to a Target Program, the role of the JGC and each Working Group with respect to the Target Program shall be automatically disbanded and the roles of the Program Leader and Alliance Manager with respect to such Target Program shall be automatically terminated. |
3.9 Interactions Between the JGC 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 3 (Management of the R... |
3.10 Working Groups. From time to time, the JGC may establish and delegate duties to other committees or directed teams (each, a "Working Group") on an "as-needed" basis to oversee particular projects or activities. Each such Working Group shall be constituted and shall operate as the JGC determines; provided that each... |
3.11 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 JGC or other Working Group. |
3.12 Authority. Each Party will retain the rights, powers and discretion granted to it under this Agreement and no such rights, powers or discretion will be delegated to or vested in the JGC or any Working Group unless such delegation or vesting of rights is expressly provided for in this Agreement or the Parties expre... |
ARTICLE 4 ASSIGNMENT OF ACQUIRED ASSETS |
4.1 Assignment and License Grants to AbbVie. |
4.1.1 Acquired Assets. |
(a) Upon completion of the Collaboration Program as set forth in the Research Plan for such Target Program, AbCellera hereby sells, transfers, conveys, assigns and delivers to AbbVie all of AbCellera's and its Affiliates' right, title and interest in and to the Collaboration Program Assets free and clear of all Encumbr... |
(b) On an Option Program-by-Option Program basis, upon AbbVie's exercise of an Acquisition Option with respect to an Option Program in accordance with Section 2.7.2 (Exercise of Acquisition Option), and subject to Section 2.9.3 (Tolling of Obligations), AbCellera hereby sells, transfers, conveys, assigns and delivers t... |
4.1.2 Excluded Liabilities. AbbVie shall not assume, nor shall it be liable for, or otherwise be obligated to pay, perform or discharge, any Liabilities of AbCellera or its Affiliates, including any Liabilities arising from or related to (a) the Option Program Assets (excluding the Functional Characterization Data) pri... |
4.1.3 Research License. AbCellera (on behalf of itself and its Affiliates), hereby grants to AbbVie and its Affiliates, a non-exclusive, royalty-free, transferable (in accordance with Section 14.3 (Assignment)), sublicensable (subject to Section 4.3 (Sublicensing Rights)) license (or sublicense, as applicable) under th... |
4.1.4 OrthoMab License. AbCellera (on behalf of itself and its Affiliates), hereby grants to AbbVie and its Affiliates, a non-exclusive, royalty-free, transferable (in accordance with Section 14.3 (Assignment)), sublicensable (subject to Section 4.3 (Sublicensing Rights)), perpetual, irrevocable sublicense under any Pa... |
4.1.5 Unblocking License. AbCellera (on behalf of itself and its Affiliates) hereby grants to AbbVie and its Affiliates (a) with respect to the Collaboration Program, on the Effective Date, and (b) with respect to each Option Program, on the applicable Acquisition Option Effective Date, in each case ((a) and (b)), a no... |
4.2 License Grants to AbCellera. |
4.2.1 On a Target Program-by-Target Program basis, subject to the terms and conditions of this Agreement, during the applicable Research Term, AbbVie hereby grants to AbCellera a non-exclusive, fully paid-up, royalty-free license under AbbVie Background Know-How that is necessary for AbCellera to perform the activities... |
4.2.2 In the event that AbbVie does not exercise an Acquisition Option with respect to an Option Program in accordance with Section 2.7.2 (Exercise of Acquisition Option), then, subject to Section 13.5 (Reverse Royalty) mutatis mutandis, AbbVie shall, and hereby does, effective as of the expiration of the applicable Ac... |
4.3 Sublicensing Rights. AbbVie shall have the right to grant and authorize sublicenses under the rights granted to it under the Research License, the OrthoMab License, and the Unblocking License to any of its Affiliates and Third Parties through multiple tiers (each such Affiliate or Third Party, a "Sublicensee"). Pri... |
4.4 No Other Rights. Except as otherwise expressly provided in this Agreement, under no circumstances shall a Party or Third Party, as a result of this Agreement, obtain any ownership interest, license right or other right in any Know-How, Patent Rights or other Intellectual Property Rights of the other Party or any of... |
ARTICLE 5 ABBVIE ACTIVITIES |
5.1 AbCellera Transition Obligation. On a Target Program-by-Target Program basis, upon AbbVie's request (a) with respect to the Collaboration Program, at any time, and (b) with respect to any Option Program, following the exercise of an Acquisition Option by AbbVie with respect to an Option Program, in each case ((a) a... |
5.1.1 Within thirty (30) days after such request or Acquisition Option Effective Date, as applicable, AbCellera shall transfer to AbbVie copies of all data, reports, records, materials and other information that comprise the applicable Acquired Assets; and |
5.1.2 AbCellera shall duly execute and deliver or cause to be duly executed and delivered, such instruments and shall do and cause to be done such acts and things, including the filing of such assignments, agreements, documents and instruments, as may be necessary under or as AbbVie may reasonably request in connection... |
5.2 AbbVie Development and Commercialization. On a Target Program-by-Target Program basis, following (a) with respect to the Collaboration Program, the Effective Date, and (b) the applicable Acquisition Option Effective Date, with respect to applicable Option Programs, in each case (a) and (b), other than any activitie... |
5.3 Alloy Selection Notice; Updated Alloy Selection Notice. On a Target Program-by-Target Program basis, within eighteen (18) months of (a) with respect to the Collaboration Program, AbCellera submitting to AbbVie a Data Package, and (b) with respect to any applicable Option Programs, the applicable Acquisition Option ... |
5.3.1 Record-Keeping; Audit. |
(a) For Target Programs that comprise an Alloy Mouse Product, AbbVie shall keep, and shall require that its Affiliates, Third Party subcontractors, Sublicensees, and Licensees keep, complete and accurate records of the Development of such Alloy Mouse Product ("Alloy Mouse Records"). Such Alloy Mouse Records shall be ke... |
(b) At the request of AbCellera, AbbVie shall, and shall cause its Affiliates to, and shall use reasonable efforts to require its Licensees and/or Sublicensees to, permit an attorney from a law firm with nationally recognized standing, familiar with pharmaceutical research and Development, at reasonable times during no... |
5.3.2 Development Report. For each Target Program, on an annual basis, until receipt of the first Regulatory Approval in the first country in the Territory, AbbVie shall provide to AbCellera a written summary of ongoing and planned material activities of each Target Program Asset (the "Development Report"). |
ARTICLE 6 GENERAL PROVISIONS RELATING TO ACTIVITIES |
6.1 Compliance. All Development activities to be conducted by a Party under this Agreement shall be conducted (a) in compliance with applicable Laws, including all applicable good laboratory practice requirements and good clinical practice requirements, (b) consistent with good scientific manner, and (c) consistent wit... |
6.2 Subcontracting. |
6.2.1 AbbVie shall have the right to engage Affiliates or Third Party subcontractors to perform any of its activities under this Agreement. |
6.2.2 AbCellera shall have the right to subcontract its Development activities under this Agreement to any Third Party subcontractor listed in Schedule 6.2.2 (Permitted Subcontractors) or otherwise with the prior written approval of AbbVie. |
6.2.3 Any Affiliate or Third Party subcontractor to be engaged by a Party to perform a Party's obligations set forth in this Agreement shall meet the qualifications typically required by such Party for the performance of work similar in scope and complexity to the subcontracted activity. Any Party engaging an Affiliate... |
6.3 Records and Audits. |
6.3.1 AbCellera shall, and shall require its Affiliates and permitted subcontractors to, maintain materially complete, current and accurate records of all work conducted pursuant to its Development activities under this Agreement, and all results, data, developments and Know-How made in conducting such activities. Such... |
6.3.2 AbbVie shall have the right to request copies of all records of AbCellera maintained pursuant to this Section 6.3 (Records and Audits), solely for the purpose of (a) exercising its rights or fulfilling its obligations under this Agreement, and (b) ensuring AbCellera's compliance with this Agreement. AbbVie shall ... |
6.3.3 Additionally, AbbVie shall have the right to arrange with AbCellera during normal business hours and upon reasonable notice, but not more frequently than twice per Calendar Year (except for "for-cause" audits, which are not limited in frequency), to visit the offices and laboratories of AbCellera to (a) discuss a... |
ARTICLE 7 UPFRONT FEE; MILESTONES AND EARN-OUTS; PAYMENTS |
7.1 Upfront Fee. No later than thirty (30) days following the Effective Date, AbbVie shall pay AbCellera a one-time, non-refundable, non-creditable upfront payment of Thirteen Million Dollars (US$13,000,000) as partial consideration for the rights and licenses granted to AbbVie hereunder. |
7.2 Additional Option Program Fee. On an Additional Option Program-by-Additional Option Program basis, AbbVie shall pay to AbCellera a one-time, non-refundable, non-creditable payment of Six Million Dollars (US$6,000,000) (the "Additional Option Program Fee") within the later of (a) thirty (30) days after the Addition ... |
7.3 Substitution Fee. On an Target Program-by-Target Program basis, AbbVie shall pay to AbCellera a one-time, non-refundable, non-creditable payment of (a) with respect to Substitute Target nominated before initiation of Antibody Discovery, Five Hundred Thousand Dollars (US$500,000), or (b) with respect to Substitute T... |
7.4 Acquisition Option Exercise Fee. On an Option Program-by-Option Program basis, if AbbVie exercises an Acquisition Option with respect to an Option Program in accordance with Section 2.7.2 (Exercise of Acquisition Option), AbbVie shall pay to AbCellera a one-time, non-refundable, non-creditable payment of Three Mill... |
7.5 Development and Regulatory Milestone Payments. |
7.5.1 In partial consideration for the rights and licenses granted to AbbVie hereunder, within sixty (60) days after the first achievement of each milestone event set forth in this Section 7.5 (Development and Regulatory Milestone Payments) with respect to an Earn-Out Product (each, a "Development Milestone Event") by ... |
Development and Regulatory Milestone Event |
(1) Dosing of third (3rd) patient in the first Phase 1 Clinical Trial of an Earn-Out Product |
(2) Dosing of first (1st) patient in the first Registrational Clinical Trial of an Earn-Out Product |
The Development Milestone Events (1) and (2) in the above table are intended to be successive for each Earn-Out Product. If any of the Development Milestone Events (1) and (2) in the above table is not achieved with respect to an Earn-Out Product prior to the achievement of the next successive Development Milestone Eve... |
7.5.2 Reporting. In consideration of each milestone event set forth in Section 7.5 (Development and Regulatory Milestone Payments) with respect to an Earn-Out Product (each, a "Development Milestone Event") by or on behalf of AbbVie, any of its Affiliates, Licensees, or any Sublicensee (other than any Dispute Settlemen... |
7.6 Commercial Milestone Payments. In partial consideration for the rights granted to AbbVie hereunder, and subject to Section 7.10 (Third-Party Licenses), within sixty (60) days after the first achievement of each milestone event set forth in this Section 7.6 (Commercial Milestone Payments) with respect to an Earn-Out... |
Commercial Milestone Event |
(1) First Commercial Sale in the United States |
(2) First Commercial Sale in at least two (2) of the Major European Markets |
For clarity, the maximum aggregate amount payable by AbbVie pursuant to this Section 7.6 (Commercial Milestone Payments) is (a) with respect to the Collaboration Program, Twelve Million Five Hundred Thousand Dollars (US$12,500,000), (b) with respect to the Initial Option Program, Fifty Million Dollars (US$50,000,000), ... |
7.7 Sales-Based Milestone Payments. In partial consideration for the rights and licenses granted to AbbVie hereunder, and subject to Section 7.10 (Third-Party Licenses), in the event that the aggregate Annual Net Sales of an Earn-Out Product by AbbVie or any of its Affiliates, Licensees or Sublicensees (other than Disp... |
Annual Net Sales Milestone Threshold |
Annual aggregate Net Sales of an Earn-Out Product greater than or equal to One Billion Dollars (US$1,000,000,000) |
Annual aggregate Net Sales of an Earn-Out Product greater than or equal to Two Billion Dollars (US$2,000,000,000) |
Annual aggregate Net Sales of an Earn-Out Product greater than or equal to Three Billion Dollars (US$3,000,000,000) |
For clarity, the maximum aggregate amount payable by AbbVie pursuant to this Section 7.7 (Sales-Based Milestone Payments) is (a) with respect to the Collaboration Program, Seventy Five Million Dollars (US$75,000,000), (b) with respect to the Initial Option Program, Two Hundred and Forty Million Dollars (US$240,000,000)... |
7.8 Earn-Out. |
7.8.1 Earn-Out Rates. Subject to the terms and conditions of this Agreement, including Section 7.9 (Earn-Out Term) and 7.10 (Third-Party Licenses), commencing upon the First Commercial Sale of an Earn-Out Product in a country or other jurisdiction in the Territory, on an Earn-Out Product-by-Earn-Out Product and country... |
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