EARNOUT AGREEMENT
Exhibit F to the Asset Purchase Agreement
Dated as of May 11, 2023
This EARNOUT AGREEMENT (this "Agreement") is made and entered into as of May 11, 2023, by and between Genome Dx Therapeutics Inc., a Delaware corporation ("Seller"), and Meridian Precision Diagnostics, Inc., a Delaware corporation ("Buyer," and together with Seller, the "Parties," and each, a "Party").
This Agreement is the exhibit contemplated by Section 2.7 of that certain Asset Purchase Agreement, dated as of May 11, 2023, by and between Seller and Buyer (the "APA"), governing the earnout payments to be made by Buyer to Seller in connection with the transactions consummated pursuant to the APA. Capitalized terms used but not otherwise defined herein shall have the meanings ascribed to them in the APA.
RECITALS
WHEREAS, the APA provides for the purchase by Buyer of all assets, intellectual property, contracts, inventory, equipment, regulatory filings, and goodwill exclusively related to Seller's OncuPath™ companion diagnostics assay line (collectively, the "OncuPath Business") for aggregate consideration of One Hundred Forty Million Dollars ($140,000,000) (the "Total Consideration");
WHEREAS, of the Total Consideration, One Hundred Twenty-Six Million Dollars ($126,000,000) is payable at the Closing (as defined in the APA, and scheduled to occur on August 8, 2023), and up to Fourteen Million Dollars ($14,000,000) is payable as contingent earnout consideration upon the achievement of certain clinical and regulatory milestones as described in this Agreement;
WHEREAS, the Parties desire to set forth the terms and conditions governing the determination, calculation, payment, and dispute resolution of such earnout payments, including the obligations of Buyer during the period following the Closing with respect to the continued development and commercialization of the OncuPath-HER3™ Assay; and
WHEREAS, as of the date hereof, a Premarket Approval ("PMA") supplement (PMA Supplement No. P230014) for the OncuPath-HER3™ assay was submitted to the U.S. Food and Drug Administration on January 30, 2023, and the Parties share a mutual interest in the successful development and commercialization of the OncuPath-HER3™ assay as a companion diagnostic for one or more FDA-approved therapeutic agents.
NOW, THEREFORE, in consideration of the mutual covenants and agreements herein contained, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:
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ARTICLE I — DEFINITIONS
For purposes of this Agreement, the following terms shall have the meanings set forth below:
"APA" means the Asset Purchase Agreement, dated as of May 11, 2023, by and between Seller and Buyer, as the same may be amended, supplemented, or otherwise modified from time to time in accordance with its terms.
"Buyer" means Meridian Precision Diagnostics, Inc., a Delaware corporation, with its principal offices located at 2400 Meridian Parkway, Suite 300, Durham, NC 27713, and its successors and permitted assigns.
"Change of Control" means any transaction or series of related transactions resulting in: (a) the acquisition by any person or "group" (within the meaning of Section 13(d)(3) of the Securities Exchange Act of 1934, as amended) of more than fifty percent (50%) of the outstanding voting securities of Buyer; (b) a merger, consolidation, or similar business combination involving Buyer in which Buyer is not the surviving entity or in which the stockholders of Buyer immediately prior to such transaction do not hold a majority of the voting securities of the surviving entity immediately following such transaction; or (c) a sale, transfer, or other disposition of all or substantially all of the assets of Buyer or of the OncuPath Business, in a single transaction or a series of related transactions.
"Closing Date" means August 8, 2023, or such other date on which the Closing occurs pursuant to Section 3.1 of the APA.
"CMS" means the Centers for Medicare & Medicaid Services, a component of the U.S. Department of Health and Human Services, or any successor agency thereto.
"Commercially Reasonable Efforts" means those efforts consistent with those that a similarly situated diagnostics company of comparable size, resources, and capabilities to Buyer would use with respect to a comparable companion diagnostics product at a similar stage of development, taking into account all relevant scientific, regulatory, and commercial factors, including without limitation: (i) the potential regulatory pathway and likelihood of obtaining FDA clearance or approval; (ii) the likely reimbursement profile, including the anticipated timeline for obtaining a unique HCPCS code and Medicare reimbursement; (iii) the competitive landscape for companion diagnostics in the applicable indication; and (iv) the overall product portfolio of the OncuPath Business. For purposes of this definition, Commercially Reasonable Efforts shall be determined on a product-by-product and milestone-by-milestone basis, without regard to any other product, technology, or program of Buyer or its affiliates outside of the OncuPath Business, except to the extent expressly provided in Section 4.2(e) of this Agreement.
"Earnout Payments" means the aggregate contingent payments of up to Fourteen Million Dollars ($14,000,000) payable by Buyer to Seller upon the achievement of the Milestones, as more fully described in Article II hereof.
"Earnout Period" means the thirty-six (36) month period commencing on the Closing Date and ending at 11:59 p.m. Eastern Time on August 8, 2026.
"FDA" means the U.S. Food and Drug Administration, a component of the U.S. Department of Health and Human Services, or any successor agency thereto.
"HCPCS Code" means a Healthcare Common Procedure Coding System code, as published and maintained by CMS or its designee for purposes of identification and billing of medical services, procedures, and equipment.
"Milestone 1" means the achievement of FDA clearance or approval of the OncuPath-HER3™ Assay (or a Successor Assay) as a companion diagnostic for any FDA-approved therapeutic agent, as more fully described in Section 2.1 hereof.
"Milestone 1 Deadline" means August 8, 2025, representing a period of twenty-four (24) months following the Closing Date.
"Milestone 1 Payment" means Eight Million Dollars ($8,000,000), payable by Buyer to Seller upon achievement of Milestone 1 on or before the Milestone 1 Deadline, subject to the terms and conditions of this Agreement.
"Milestone 2" means the satisfaction of both of the following conditions: (a) issuance by CMS of a unique HCPCS code for the OncuPath-HER3™ Assay (or a Successor Assay), and (b) receipt by Buyer (or its designee) of the first Medicare reimbursement payment for a test performed using the OncuPath-HER3™ Assay (or a Successor Assay) under such HCPCS code, as more fully described in Section 2.2 hereof.
"Milestone 2 Deadline" means August 8, 2026, representing a period of thirty-six (36) months following the Closing Date.
"Milestone 2 Payment" means Six Million Dollars ($6,000,000), payable by Buyer to Seller upon achievement of Milestone 2 on or before the Milestone 2 Deadline, subject to the terms and conditions of this Agreement.
"Milestones" means, collectively, Milestone 1 and Milestone 2, and each, individually, a "Milestone."
"OncuPath-HER3™ Assay" means the companion diagnostic assay designated OncuPath-HER3™, for which PMA Supplement No. P230014 is pending before the FDA as of the date hereof, together with all related regulatory submissions, clinical data, manufacturing processes, quality systems documentation, and know-how transferred to Buyer as part of the Purchased Assets under the APA.
"Seller" means Genome Dx Therapeutics Inc., a Delaware corporation, with its principal offices located at 10250 Science Center Drive, Suite 600, San Diego, CA 92121, and its successors and permitted assigns.
"Successor Assay" means any companion diagnostic assay that is derived from, based upon, or incorporates material technology from the OncuPath-HER3™ Assay, including without limitation any modification, improvement, enhancement, variant, or next-generation version thereof, regardless of the brand name or trade designation under which such assay may be marketed.
ARTICLE II — MILESTONES AND EARNOUT PAYMENTS
Section 2.1 — Milestone 1.
(a) Milestone 1 shall be deemed achieved upon the earlier of: (i) FDA clearance of the OncuPath-HER3™ Assay (or a Successor Assay) through the 510(k) premarket notification pathway or the de novo classification request pathway, as a companion diagnostic for any FDA-approved therapeutic agent; or (ii) FDA approval of the OncuPath-HER3™ Assay (or a Successor Assay) through the PMA pathway, including by means of a PMA supplement (such as the pending PMA Supplement No. P230014), as a companion diagnostic for any FDA-approved therapeutic agent. For purposes of this Section 2.1, "clearance" and "approval" shall have the meanings customarily ascribed to such terms in the context of the Federal Food, Drug, and Cosmetic Act, as amended, and applicable FDA regulations.
(b) The achievement of Milestone 1 must occur on or before August 8, 2025 (the "Milestone 1 Deadline"). For the avoidance of doubt, the relevant date for determining whether Milestone 1 has been achieved on or before the Milestone 1 Deadline shall be the date appearing on the FDA clearance letter, approval order, or PMA supplement approval letter, as applicable, and not the date on which Buyer receives physical or electronic delivery of such document.
(c) Upon achievement of Milestone 1 on or before the Milestone 1 Deadline, and subject to Buyer's delivery of a Milestone Achievement Notice in accordance with Section 3.1, Buyer shall pay to Seller the Milestone 1 Payment of Eight Million Dollars ($8,000,000) in accordance with Article III.
Section 2.2 — Milestone 2.
(a) Milestone 2 shall be deemed achieved upon the satisfaction of both of the following conditions:
(i) CMS shall have issued a unique HCPCS code specifically designated for the OncuPath-HER3™ Assay (or a Successor Assay), which code shall be effective and available for use by clinical laboratories and healthcare providers for billing and reimbursement purposes; and
(ii) Buyer (or its designee, including any reference laboratory operated by or on behalf of Buyer) shall have received the first Medicare reimbursement payment for a test actually performed using the OncuPath-HER3™ Assay (or a Successor Assay) and billed under the unique HCPCS code referenced in clause (i) above.
(b) Both conditions set forth in Section 2.2(a)(i) and Section 2.2(a)(ii) must be satisfied on or before August 8, 2026 (the "Milestone 2 Deadline"). For the avoidance of doubt, the date of satisfaction of the condition in clause (ii) shall be the date on which Buyer (or its designee) receives actual payment (not merely the date of submission of a claim or the date of adjudication of a claim by a Medicare Administrative Contractor).
(c) Upon achievement of Milestone 2 on or before the Milestone 2 Deadline, and subject to Buyer's delivery of a Milestone Achievement Notice in accordance with Section 3.1, Buyer shall pay to Seller the Milestone 2 Payment of Six Million Dollars ($6,000,000) in accordance with Article III.
(d) The Parties acknowledge and agree that achievement of Milestone 2 is not conditioned upon the prior achievement of Milestone 1. Each Milestone is independent, and the failure to achieve one Milestone shall not affect the obligation to pay the other Milestone Payment if and when the other Milestone is achieved.
Section 2.3 — Maximum Earnout.
The aggregate maximum Earnout Payments payable by Buyer to Seller under this Agreement shall not exceed Fourteen Million Dollars ($14,000,000), consisting of the Milestone 1 Payment of Eight Million Dollars ($8,000,000) and the Milestone 2 Payment of Six Million Dollars ($6,000,000). There shall be no duplication of payments; each Milestone may be achieved and the corresponding Milestone Payment may be earned and paid only once.
Section 2.4 — Expiration of Milestones.
(a) If Milestone 1 is not achieved on or before August 8, 2025 (the Milestone 1 Deadline), no Milestone 1 Payment shall be due or payable, and Buyer shall have no further obligation to Seller with respect to the Milestone 1 Payment, except as may otherwise be provided in Article VI (Acceleration Provisions) or Article VII (Anti-Embarrassment and Anti-Sandbagging Protections).
(b) If Milestone 2 is not achieved on or before August 8, 2026 (the Milestone 2 Deadline), no Milestone 2 Payment shall be due or payable, and Buyer shall have no further obligation to Seller with respect to the Milestone 2 Payment, except as may otherwise be provided in Article VI (Acceleration Provisions) or Article VII (Anti-Embarrassment and Anti-Sandbagging Protections).
(c) Upon the expiration of the Earnout Period on August 8, 2026, all obligations of Buyer with respect to unachieved Milestones shall terminate, subject in all cases to the survival of any obligations arising from acceleration events under Article VI, deemed achievement events under Article VII, and any disputes then pending under Article V.
ARTICLE III — PAYMENT MECHANICS
Section 3.1 — Notification of Milestone Achievement.
Within ten (10) business days following the achievement of either Milestone, Buyer shall deliver to Seller a written notice (a "Milestone Achievement Notice") setting forth in reasonable detail the basis for Buyer's determination that such Milestone has been achieved. Each Milestone Achievement Notice shall include, as applicable: (a) copies of all relevant FDA correspondence, including any clearance letter, approval order, PMA supplement approval letter, or 510(k) clearance letter; (b) copies of all relevant CMS correspondence, including any HCPCS code assignment letter or notification; (c) documentation of the first Medicare reimbursement payment received (including remittance advice or explanation of benefits from the applicable Medicare Administrative Contractor); and (d) such other supporting documentation as Seller may reasonably request. If Buyer becomes aware that a Milestone has been achieved but does not deliver a Milestone Achievement Notice within the timeframe specified in this Section 3.1, Seller may deliver written notice to Buyer asserting that such Milestone has been achieved, and the procedures set forth in Section 5.5 shall apply.
Section 3.2 — Payment Timing.
(a) Buyer shall pay the applicable Milestone Payment to Seller within thirty (30) calendar days following delivery of the Milestone Achievement Notice to Seller (or, in the event of a dispute, within ten (10) business days following the final resolution of such dispute in favor of Milestone achievement).
(b) All Milestone Payments shall be made by wire transfer of immediately available funds in United States dollars to the bank account designated by Seller in writing, which designation may be made by separate written notice delivered to Buyer or as set forth in the funds flow memorandum appended to the APA as Exhibit H. Seller may update its wire transfer instructions by providing not less than five (5) business days' prior written notice to Buyer, accompanied by such verification and authentication information as Buyer may reasonably request to confirm the validity of the updated instructions.
Section 3.3 — Tax Treatment of Earnout Payments.
(a) The Parties agree that, for United States federal and applicable state and local income tax purposes, the Earnout Payments shall be treated as additional purchase price for the Purchased Assets (as defined in the APA). Neither Party shall take any position on any tax return, report, or other filing that is inconsistent with such treatment, unless required to do so by a determination (within the meaning of Section 1313(a) of the Internal Revenue Code of 1986, as amended (the "Code")) of a taxing authority.
(b) The Earnout Payments shall be subject to the purchase price allocation methodology set forth in Section 2.9 of the APA, in accordance with Section 1060 of the Code and the Treasury Regulations promulgated thereunder. The Parties shall update the purchase price allocation to reflect any Earnout Payments actually made and shall cooperate in the preparation of the separate Purchase Price Allocation Agreement to be mutually agreed upon within one hundred twenty (120) days following the Closing Date (i.e., by December 6, 2023).
(c) Buyer shall be entitled to deduct and withhold from any Earnout Payment any amounts required to be deducted or withheld under applicable federal, state, local, or foreign tax law. To the extent that any amounts are so deducted and withheld by Buyer and timely remitted to the appropriate taxing authority, such amounts shall be treated for all purposes of this Agreement as having been paid to Seller. Seller shall cooperate with Buyer by providing such tax forms, certifications, and documentation (including, without limitation, IRS Form W-9) as may be reasonably necessary to minimize or eliminate any required withholding.
Section 3.4 — No Interest.
No interest shall accrue on any Earnout Payment amount during the period between the achievement of the applicable Milestone and the date on which such payment is due under Section 3.2. Notwithstanding the foregoing, if Buyer fails to make any Milestone Payment when due under this Agreement (including following the resolution of any dispute in favor of Milestone achievement), interest shall accrue on the unpaid amount at a rate per annum equal to the lesser of (a) the prime rate as published in The Wall Street Journal on the date such payment was due, plus three percent (3%) per annum, and (b) the maximum rate permitted by applicable law, from the date such payment was due until the date such payment is made in full. Such interest shall be calculated on the basis of a 365-day year and actual days elapsed.
Section 3.5 — No Set-Off.
Buyer shall not have the right to set off, deduct, counterclaim, or withhold any Earnout Payment (or any portion thereof) against or on account of any indemnification claims, losses, damages, liabilities, or other amounts that may be owed by Seller to Buyer under the APA, any ancillary agreement, or otherwise. The Earnout Payments are independent of and separate from the escrow and indemnification mechanics set forth in the APA. Notwithstanding the foregoing, this Section 3.5 shall not apply to the extent that a final, non-appealable arbitration award rendered pursuant to Article V of this Agreement, or a final, non-appealable order of a court of competent jurisdiction, expressly provides for the set-off or deduction of specific amounts from an Earnout Payment.
ARTICLE IV — COMMERCIALLY REASONABLE EFFORTS OBLIGATIONS
Section 4.1 — Buyer's Obligations.
During the Earnout Period, Buyer shall use Commercially Reasonable Efforts to achieve each Milestone on or before the applicable Milestone Deadline. Without limiting the generality of the foregoing, Commercially Reasonable Efforts shall include, at a minimum, the following:
(a) Regulatory Strategy. Continuing and diligently pursuing the regulatory strategy for the OncuPath-HER3™ PMA supplement (PMA Supplement No. P230014) pending before the FDA, including responding to any FDA requests for additional information, data, or clarification (including any Major Amendment, Interactive Review, Deficiency Letters, or requests for additional clinical data) in a timely manner consistent with the timelines customarily observed by similarly situated diagnostics companies.
(b) Staffing. Maintaining adequate staffing for OncuPath-HER3™ development, regulatory affairs, and commercial operations, including retaining or replacing (with individuals of comparable qualifications and experience) the following key personnel who are being transferred to Buyer as part of the OncuPath Business: Dr. Lara Okonkwo (Vice President, OncuPath Research & Development), Yuki Tanabe (Head of Regulatory Affairs, OncuPath), and Samuel Briggs (Director, OncuPath Commercial Operations).
(c) Resource Allocation. Allocating reasonable financial and operational resources to pursue the Milestones, consistent with the level of resources (including personnel, budget, and infrastructure) allocated by Seller to the OncuPath-HER3™ development program during the twelve (12) month period immediately preceding the Closing Date.
(d) HCPCS Code Application. Following FDA clearance or approval of the OncuPath-HER3™ Assay (or a Successor Assay), preparing and submitting applications to CMS for the issuance of a unique HCPCS code for the OncuPath-HER3™ Assay (or Successor Assay) and taking all steps reasonably necessary to support the processing and approval of such application, including providing CMS with requested technical documentation, clinical evidence, and coding justification.
(e) Laboratory Operations. Maintaining the CLIA certificate of accreditation (CLIA ID: 05D2178493) for the OncuPath reference laboratory located at 4820 Towne Centre Drive, Suite 200, San Diego, CA 92121, maintaining all necessary FDA establishment registrations and device listings for the OncuPath-HER3™ Assay, and ensuring compliance with all applicable quality system regulations (21 C.F.R. Part 820) and CLIA requirements (42 C.F.R. Part 493).
Section 4.2 — Limitations on Buyer's Obligations.
Notwithstanding anything to the contrary in Section 4.1, Commercially Reasonable Efforts shall not require Buyer to:
(a) Take any action that would be contrary to the reasonable business judgment of Buyer's management, as exercised in good faith and consistently with the fiduciary duties of Buyer's board of directors and officers;
(b) Incur costs or expenses materially in excess of those that a similarly situated diagnostics company of comparable size, resources, and capabilities would incur for a comparable companion diagnostics product at a similar stage of development;
(c) Accept terms or conditions imposed by the FDA or CMS (including post-market requirements, labeling restrictions, or risk evaluation and mitigation strategies) that are materially more burdensome than those customarily imposed on comparable companion diagnostic products;
(d) Initiate, conduct, or sponsor clinical trials, clinical studies, or analytical validation studies beyond those reasonably necessary to support the pending PMA supplement (P230014) or a HCPCS code application, including without limitation pivotal clinical trials or large-scale multi-center studies not contemplated by the existing regulatory strategy as of the date hereof; or
(e) Compromise or adversely affect the development, regulatory approval, or commercialization of any other product in Buyer's portfolio; provided, however, that Buyer may not prioritize a directly competing companion diagnostic assay over the OncuPath-HER3™ Assay to the detriment of Milestone achievement, as more fully set forth in Section 7.3 of this Agreement.
Section 4.3 — Reporting Obligations.
(a) During the Earnout Period, Buyer shall provide Seller with written quarterly reports summarizing the status of Buyer's efforts toward the achievement of each unachieved Milestone (each, a "Quarterly Report"). Each Quarterly Report shall include, at a minimum: (i) a summary of all material regulatory interactions with the FDA and CMS during the applicable quarter relating to the OncuPath-HER3™ Assay (or any Successor Assay); (ii) updates regarding the staffing of the OncuPath-HER3™ development team, including any departures or additions of key personnel; (iii) a summary of any material changes to the development timeline, regulatory strategy, or budget for the OncuPath-HER3™ program; and (iv) such other information as Seller may reasonably request that is relevant to the achievement of the Milestones.
(b) Each Quarterly Report shall be delivered to Seller (at the address specified in Section 12.2) within thirty (30) calendar days after the end of each calendar quarter (i.e., within thirty (30) days after March 31, June 30, September 30, and December 31 of each year during the Earnout Period). The first Quarterly Report shall cover the period from the Closing Date through the end of the calendar quarter in which the Closing Date falls.
(c) In addition to the Quarterly Reports, Seller and its advisors (including Brindoval Partners LLC, Seller's financial advisor) shall have the right to request one (1) in-person or videoconference meeting per calendar quarter with Buyer's OncuPath-HER3™ development team and management to discuss the progress of the OncuPath-HER3™ program and Buyer's efforts to achieve the Milestones. Buyer shall make appropriate personnel available for such meetings, including at least one senior member of the OncuPath regulatory affairs team and one member of Buyer's management. Such meetings shall be scheduled at mutually convenient times during normal business hours.
Section 4.4 — Books and Records Access.
(a) Buyer shall maintain complete, accurate, and detailed books and records relating to its efforts to achieve the Milestones, including without limitation records of regulatory submissions, FDA and CMS correspondence, internal development reports, staffing records, budget allocations, and laboratory operations data relevant to the OncuPath-HER3™ Assay.
(b) During the Earnout Period and for a period of twelve (12) months following the expiration of the Earnout Period (i.e., through August 8, 2027), Seller, through its duly authorized representatives (including Calderwood & Harkness LLP as counsel), shall have the right, upon not less than ten (10) business days' prior written notice to Buyer, to inspect and review such books and records at Buyer's principal offices or such other location where such records are maintained, during normal business hours, solely for the purpose of verifying Buyer's compliance with its obligations under this Agreement. Such inspections shall be conducted no more than two (2) times during any twelve (12) month period, unless Seller has a reasonable, good faith basis to believe that Buyer is not in compliance with its obligations hereunder, in which case Seller shall have the right to conduct additional inspections upon reasonable notice. Seller shall treat all information obtained through such inspections as confidential in accordance with the confidentiality provisions of the APA.
(c) Buyer shall provide Seller with copies of all material FDA correspondence (including, without limitation, any FDA Complete Response Letters, approval letters, clearance orders, Major Deficiency Letters, and minutes from any pre-submission meetings) and all material CMS correspondence (including, without limitation, HCPCS code application acknowledgments, determination letters, and reimbursement rate notices) relating to the OncuPath-HER3™ Assay (or any Successor Assay) within five (5) business days of Buyer's receipt of such correspondence. For the avoidance of doubt, Buyer shall have the right to redact from such correspondence any information that is not related to the OncuPath-HER3™ Assay or the Milestones, provided that Buyer shall not redact any information that is material to Seller's ability to assess Buyer's compliance with its obligations under this Agreement.
ARTICLE V — DISPUTE RESOLUTION
Section 5.1 — Good Faith Negotiations.
Any dispute, controversy, or claim arising out of or relating to this Agreement, or the breach, termination, or validity thereof (each, a "Dispute"), shall first be submitted to good faith negotiation between senior executives of the Parties. The Party asserting the Dispute shall deliver written notice thereof to the other Party (a "Dispute Notice"), describing in reasonable detail the nature of the Dispute and the relief sought. Within ten (10) business days following delivery of the Dispute Notice, the Parties shall cause their respective designated senior executives to meet (in person or by videoconference) and negotiate in good faith to resolve the Dispute. The designated senior executives for purposes of this Section 5.1 shall be: (a) for Seller, Martin Kowalski, Chief Financial Officer, or Rebecca Chiang, General Counsel; and (b) for Buyer, Angela Rossi, Chief Financial Officer, or David Pruitt, General Counsel. The good faith negotiation period shall extend for thirty (30) calendar days from the date of delivery of the Dispute Notice (the "Negotiation Period").
Section 5.2 — Mediation.
If the Dispute is not resolved within the Negotiation Period, either Party may, by written notice to the other Party, submit the Dispute to non-binding mediation administered by JAMS, Inc. ("JAMS") in San Diego, California. The mediation shall be conducted in accordance with the JAMS Mediation Rules in effect at the time of commencement of the mediation. The Parties shall cooperate in good faith in selecting a mutually acceptable mediator from the JAMS panel, and shall share equally in the fees and expenses of the mediator. Each Party shall bear its own attorneys' fees and costs incurred in connection with the mediation. The mediation shall be completed within forty-five (45) calendar days from the date of commencement (the "Mediation Period"), unless the Parties mutually agree in writing to extend such period. No statements, offers, or admissions made during the mediation shall be admissible in any subsequent arbitration or legal proceeding.
Section 5.3 — Binding Arbitration.
(a) If the Dispute is not resolved through mediation within the Mediation Period (or if either Party declines to participate in mediation after the expiration of the Negotiation Period), either Party may submit the Dispute to final and binding arbitration administered by JAMS in accordance with its Comprehensive Arbitration Rules and Procedures then in effect.
(b) The arbitration shall take place in San Diego, California. The arbitration shall be conducted before a panel of three (3) arbitrators, selected as follows: each Party shall select one (1) arbitrator within fifteen (15) business days following the commencement of the arbitration, and the two (2) party-appointed arbitrators shall jointly select the third arbitrator, who shall serve as the chair of the arbitral panel, within fifteen (15) business days thereafter. If the two party-appointed arbitrators are unable to agree on the third arbitrator within such period, the third arbitrator shall be appointed by JAMS in accordance with its rules.
(c) The arbitrators shall have demonstrated expertise in pharmaceutical, diagnostics, or life sciences industry matters, including regulatory and commercial considerations. The arbitrators shall apply the substantive law of the State of Delaware (without regard to conflict of laws principles) in resolving the Dispute.
(d) The arbitral panel shall have the authority to award any remedy or relief that would be available in a court of competent jurisdiction, including without limitation monetary damages, specific performance, and injunctive relief, subject to Section 5.4. The arbitral panel shall issue a written, reasoned decision within sixty (60) calendar days following the conclusion of the evidentiary hearing.
(e) The arbitration award shall be final and binding upon the Parties, and judgment thereon may be entered in any court of competent jurisdiction. The grounds for vacatur, modification, or correction of the award shall be limited to those set forth in the Federal Arbitration Act (9 U.S.C. §§ 1 et seq.).
(f) The prevailing Party in any arbitration under this Section 5.3 shall be entitled to recover its reasonable attorneys' fees, costs, and expenses (including the fees and expenses of the arbitrators and JAMS) from the non-prevailing Party, as determined by the arbitral panel.
Section 5.4 — Specific Performance.
The Parties acknowledge and agree that a breach by Buyer of its Commercially Reasonable Efforts obligations under Article IV, or a breach by Buyer of the anti-sandbagging or anti-embarrassment provisions of Article VII, may cause irreparable harm to Seller for which monetary damages alone would be inadequate. Accordingly, Seller shall be entitled to seek specific performance and injunctive relief (including temporary restraining orders, preliminary injunctions, and permanent injunctions) in any court of competent jurisdiction, or from the arbitral panel constituted pursuant to Section 5.3, to enforce Buyer's obligations under this Agreement, without the necessity of proving actual damages, posting a bond or other security, or establishing that monetary damages would be inadequate. Such remedies shall be in addition to, and not in lieu of, any other remedies available to Seller at law or in equity.
Section 5.5 — Disputes Regarding Milestone Achievement.
(a) Disputes regarding whether a particular Milestone has been achieved shall be determined based on objective criteria, as follows:
(i) Milestone 1: Milestone 1 shall be deemed achieved upon the issuance by the FDA of a clearance letter (in the case of a 510(k) or de novo pathway) or an approval letter or approval order (in the case of a PMA or PMA supplement pathway) that authorizes the marketing of the OncuPath-HER3™ Assay (or a Successor Assay) as a companion diagnostic for any FDA-approved therapeutic agent, with such letter or order bearing a date on or before the Milestone 1 Deadline.
(ii) Milestone 2: Milestone 2 shall be deemed achieved upon (A) CMS assignment of a unique HCPCS code for the OncuPath-HER3™ Assay (or a Successor Assay), as evidenced by the publication of such code in CMS's official HCPCS code set or by written notification from CMS to Buyer, and (B) Buyer's documented receipt of a first Medicare reimbursement payment for a test performed using the OncuPath-HER3™ Assay (or a Successor Assay) under such HCPCS code, as evidenced by a remittance advice or equivalent payment documentation from the applicable Medicare Administrative Contractor, with both conditions satisfied on or before the Milestone 2 Deadline.
(b) If Buyer disputes that a Milestone has been achieved notwithstanding Seller's assertion or claim to the contrary, Buyer shall deliver to Seller a written objection (a "Milestone Objection Notice") within twenty (20) business days of Buyer's receipt of Seller's written claim of Milestone achievement, setting forth in reasonable detail the factual and legal basis for Buyer's objection. If a timely Milestone Objection Notice is delivered, the matter shall be treated as a Dispute and shall proceed through the dispute resolution procedures set forth in Sections 5.1, 5.2, and 5.3 of this Agreement.
(c) If Buyer fails to deliver a Milestone Objection Notice within the twenty (20) business day period specified in Section 5.5(b), Buyer shall be deemed to have agreed that the applicable Milestone has been achieved as claimed by Seller, and Buyer shall pay the corresponding Milestone Payment in accordance with Section 3.2.
ARTICLE VI — ACCELERATION PROVISIONS
Section 6.1 — Acceleration on Buyer Change of Control.
If a Change of Control of Buyer occurs during the Earnout Period and prior to the achievement of either or both Milestones, then all unachieved Milestones shall be deemed achieved immediately prior to the consummation of such Change of Control, and Buyer (or its successor or acquirer, as the case may be) shall pay to Seller the full amount of any unpaid Milestone Payments within ten (10) business days following the closing of the Change of Control transaction. By way of illustration and not limitation: if a Change of Control occurs after Milestone 1 has been achieved and the Milestone 1 Payment has been made, but before Milestone 2 has been achieved, then Milestone 2 shall be deemed achieved immediately prior to the Change of Control and Buyer (or its successor) shall pay to Seller the Milestone 2 Payment of Six Million Dollars ($6,000,000) within ten (10) business days following the closing of the Change of Control. If neither Milestone has been achieved at the time of the Change of Control, then both Milestones shall be deemed achieved and the full Earnout Payment of Fourteen Million Dollars ($14,000,000) shall become due and payable.
Section 6.2 — Acceleration on Sale or Divestiture of OncuPath Business.
(a) If, during the Earnout Period, Buyer sells, assigns, licenses (on an exclusive basis), or otherwise divests or transfers all or substantially all of the OncuPath Business, or the OncuPath-HER3™ Assay specifically (including all related intellectual property, regulatory submissions, and know-how), to any third party (each, a "Divestiture"), then all unachieved Milestones shall be deemed achieved immediately prior to the consummation of such Divestiture, and the full amount of any unpaid Milestone Payments shall become due and payable to Seller within ten (10) business days following the consummation of such Divestiture.
(b) Notwithstanding Section 6.2(a), in lieu of acceleration, Buyer may cause the acquirer, assignee, or transferee (the "Assignee") to assume all of Buyer's obligations under this Agreement (including, without limitation, the Commercially Reasonable Efforts obligations under Article IV, the anti-sandbagging and anti-embarrassment obligations under Article VII, and the payment obligations with respect to all unachieved Milestones) by means of a written assumption agreement in form and substance reasonably acceptable to Seller. In such event, acceleration shall not apply, provided that (i) the Assignee has financial resources and operational capabilities reasonably sufficient to perform all of the assumed obligations, as demonstrated to Seller's reasonable satisfaction prior to the consummation of the Divestiture; (ii) the assumption agreement is executed and delivered to Seller prior to or concurrently with the consummation of the Divestiture; and (iii) Buyer remains jointly and severally liable with the Assignee for the performance of all obligations under this Agreement until such obligations have been fully discharged. If the Assignee fails to perform any assumed obligation, Seller's rights against Buyer shall not be diminished or otherwise affected.
Section 6.3 — No Acceleration for Internal Restructuring.
The acceleration provisions of Sections 6.1 and 6.2 shall not apply to any internal corporate restructuring, reorganization, or transfer of the OncuPath Business (or any portion thereof) among Buyer and its wholly-owned subsidiaries, provided that: (a) Buyer delivers prior written notice of any such restructuring or transfer to Seller; (b) Buyer remains fully liable for all of its obligations under this Agreement following any such restructuring or transfer; and (c) any wholly-owned subsidiary to which the OncuPath Business (or any portion thereof) is transferred executes a joinder or assumption agreement in form and substance reasonably acceptable to Seller, pursuant to which such subsidiary agrees to be bound by the terms and conditions of this Agreement.
ARTICLE VII — ANTI-EMBARRASSMENT AND ANTI-SANDBAGGING PROTECTIONS
Section 7.1 — Anti-Sandbagging.
Buyer shall not take any action, or fail to take any action, with the primary purpose or intent of preventing, impeding, or delaying the achievement of either Milestone in order to avoid the payment of the applicable Earnout Payment. Any deliberate frustration, obstruction, or delay of Milestone achievement by Buyer shall constitute a material breach of this Agreement, and the affected Milestone shall be deemed achieved as of the date on which such breach first occurred, entitling Seller to the applicable Milestone Payment as if such Milestone had been achieved on such date. The foregoing remedy shall be in addition to, and not in lieu of, any other remedies available to Seller under this Agreement, including specific performance and injunctive relief pursuant to Section 5.4.
Section 7.2 — Anti-Embarrassment — Discontinuation.
If, during the Earnout Period, Buyer discontinues, abandons, or materially curtails the development of the OncuPath-HER3™ Assay (or any Successor Assay) for any reason other than: (a) a bona fide safety concern substantiated by clinical data demonstrating an unacceptable risk-benefit profile for patients; (b) an FDA determination, communicated in writing, that the OncuPath-HER3™ Assay (or Successor Assay) cannot be approved or cleared for its intended use as a companion diagnostic; or (c) a material adverse change in the regulatory or reimbursement landscape (including the withdrawal or revocation of the approval of the therapeutic agent for which the OncuPath-HER3™ Assay is intended to serve as a companion diagnostic) that would render continued development commercially unreasonable as determined by an objective standard, then all unachieved Milestones shall be deemed achieved as of the date of such discontinuation, abandonment, or material curtailment, and the corresponding Earnout Payments shall become immediately due and payable to Seller. For purposes of this Section 7.2, "materially curtails" shall mean a reduction in development activities or resources that is so significant as to effectively preclude the timely achievement of any unachieved Milestone.
Section 7.3 — Anti-Embarrassment — Competing Products.
During the Earnout Period, Buyer shall not develop, commercialize, or launch (or cause any of its affiliates to develop, commercialize, or launch) a companion diagnostic assay that directly competes with the OncuPath-HER3™ Assay in the same clinical indication and therapeutic pairing in a manner that materially and adversely affects the prospects for achieving the Milestones, unless Buyer can demonstrate (with reasonable specificity and supporting documentation) that such development, commercialization, or launch does not diminish Buyer's Commercially Reasonable Efforts with respect to the OncuPath-HER3™ Assay. If Buyer develops, commercializes, or launches a directly competing product during the Earnout Period and Seller reasonably demonstrates (through objective evidence, including but not limited to market data, internal Buyer communications, or expert analysis) that such product launch has materially diminished the prospects for achievement of any unachieved Milestone, the affected Milestone shall be deemed achieved as of the date of such product launch, and the corresponding Milestone Payment shall become immediately due and payable to Seller.
Section 7.4 — Negative Covenants During Earnout Period.
Without limiting the generality of the foregoing provisions of this Article VII, during the Earnout Period, Buyer shall not, without Seller's prior written consent (which consent shall not be unreasonably withheld, conditioned, or delayed, except as otherwise specified below):
(a) Materially reduce the development budget for the OncuPath-HER3™ program below the level of expenditures maintained by Seller for the OncuPath-HER3™ program during the twelve (12) month period immediately prior to the Closing Date, as documented in the development budget delivered to Buyer pursuant to Section 4.8 of the APA, subject to adjustments for inflation and changes in scope that are mutually agreed by the Parties;
(b) Terminate or reassign any of the key OncuPath personnel identified in Section 4.1(b) (specifically, Dr. Lara Okonkwo, Yuki Tanabe, or Samuel Briggs) without reasonable business justification (which justification may include voluntary resignation, termination for cause, or performance-related issues) and without first providing Seller with not less than fifteen (15) business days' prior written notice and a reasonable opportunity to discuss the proposed action, including any proposed replacement candidates; or
(c) Withdraw, or cause to be withdrawn, the PMA supplement (PMA Supplement No. P230014) pending before the FDA, or materially amend the regulatory strategy, scope, or submissions relating to the OncuPath-HER3™ Assay in a manner that would reasonably be expected to delay or adversely affect the achievement of Milestone 1, without first providing Seller with not less than thirty (30) days' prior written notice and a reasonable opportunity to discuss the proposed action and its potential impact on Milestone achievement.
ARTICLE VIII — SELLER'S POST-CLOSING COOPERATION
Section 8.1 — Cooperation Obligations.
Seller shall cooperate reasonably and in good faith with Buyer in connection with Buyer's efforts to achieve the Milestones during the Earnout Period. Such cooperation shall include, without limitation:
(a) Personnel Access. Making available to Buyer (for reasonable periods during normal business hours and upon reasonable prior notice) Seller's retained employees who have knowledge of the OncuPath-HER3™ development program, including any scientists, engineers, or regulatory professionals who participated in the development or regulatory submission process for the OncuPath-HER3™ Assay prior to Closing, to the extent reasonably requested by Buyer and not unduly burdensome to Seller's retained operations, including the ongoing development and commercialization of Seller's GenoStrat™ liquid biopsy platform.
(b) Historical Records. Providing Buyer with reasonable access to historical regulatory files, clinical data, analytical validation data, manufacturing records, and correspondence with the FDA relating to the OncuPath-HER3™ Assay that are in Seller's possession or control but were not transferred to Buyer as Purchased Assets under the APA (if any such records exist), for the sole purpose of supporting Buyer's regulatory submissions and Milestone achievement efforts.
(c) Supplementary Instruments. Executing any supplementary instruments, assignments, consents, or other documents reasonably necessary to effectuate: (i) the intellectual Property Assignment Agreement (Exhibit C to the APA); (ii) the assignment of the Vantage Molecular Sciences license agreement (originally dated September 12, 2019, as amended; consent to assignment obtained July 14, 2023); or (iii) any other transfer, assignment, or license of intellectual property or regulatory rights in support of Milestone achievement.
Section 8.2 — Limitation on Seller's Cooperation.
(a) Seller's cooperation obligations under this Article VIII shall not require Seller to incur out-of-pocket costs or expenses in excess of Twenty-Five Thousand Dollars ($25,000) in the aggregate during the Earnout Period without Buyer's prior agreement to reimburse such costs. Out-of-pocket costs in excess of such amount shall be borne by Buyer upon presentation of reasonable documentation thereof.
(b) Seller's cooperation obligations under this Article VIII shall automatically terminate upon the earlier of: (i) the expiration of the Earnout Period on August 8, 2026; and (ii) the date on which both Milestones have been achieved and the corresponding Milestone Payments have been paid in full.
ARTICLE IX — REPRESENTATIONS AND WARRANTIES
Section 9.1 — Seller's Representations.
Seller hereby represents and warrants to Buyer as of the date hereof as follows:
(a) Corporate Power and Authority. Seller is a corporation duly organized, validly existing, and in good standing under the laws of the State of Delaware. Seller has the requisite corporate power and authority to execute, deliver, and perform its obligations under this Agreement.
(b) Authorization. The execution, delivery, and performance of this Agreement by Seller have been duly authorized by all necessary corporate action on the part of Seller, including approval by Seller's Board of Directors at a meeting duly convened and held on May 8, 2023. No additional corporate proceedings on the part of Seller are necessary to authorize the execution, delivery, or performance of this Agreement.
(c) Binding Obligation. This Agreement constitutes the legal, valid, and binding obligation of Seller, enforceable against Seller in accordance with its terms, except as enforcement may be limited by applicable bankruptcy, insolvency, reorganization, moratorium, or similar laws affecting creditors' rights generally, or by general equitable principles (whether considered in a proceeding at law or in equity).
(d) PMA Supplement. To Seller's knowledge, the PMA supplement (PMA Supplement No. P230014) filed with the FDA on January 30, 2023 was complete and accurate in all material respects as of the date of such filing and did not contain any untrue statement of material fact or omit to state a material fact necessary to make the statements contained therein not misleading, in each case as of the date of filing.
Section 9.2 — Buyer's Representations.
Buyer hereby represents and warrants to Seller as of the date hereof as follows:
(a) Corporate Power and Authority. Buyer is a corporation duly organized, validly existing, and in good standing under the laws of the State of Delaware. Buyer has the requisite corporate power and authority to execute, deliver, and perform its obligations under this Agreement.
(b) Authorization. The execution, delivery, and performance of this Agreement by Buyer have been duly authorized by all necessary corporate action on the part of Buyer, including approval by Buyer's Board of Directors at a meeting duly convened and held on May 10, 2023. No additional corporate proceedings on the part of Buyer are necessary to authorize the execution, delivery, or performance of this Agreement.
(c) Binding Obligation. This Agreement constitutes the legal, valid, and binding obligation of Buyer, enforceable against Buyer in accordance with its terms, except as enforcement may be limited by applicable bankruptcy, insolvency, reorganization, moratorium, or similar laws affecting creditors' rights generally, or by general equitable principles (whether considered in a proceeding at law or in equity).
(d) Financial Resources and Capabilities. Buyer has, and reasonably expects to continue to have throughout the Earnout Period, the financial resources and operational capabilities necessary to perform its obligations under this Agreement, including without limitation the Commercially Reasonable Efforts obligations set forth in Article IV and the obligation to make the Milestone Payments when and as they become due.
(e) Good Faith Intent. Buyer intends in good faith to pursue the achievement of the Milestones following the Closing in accordance with its obligations under this Agreement. As of the date hereof, Buyer is not aware of any facts, circumstances, or conditions that would prevent or materially impair Buyer's ability to use Commercially Reasonable Efforts to achieve the Milestones within the applicable Milestone Deadlines.
ARTICLE X — INDEMNIFICATION RELATIONSHIP
Section 10.1 — Relationship to APA Indemnification.
(a) This Earnout Agreement is an exhibit to and forms a part of the APA. The Parties acknowledge that the APA contains separate and independent indemnification provisions (set forth in Article IX of the APA) that govern the allocation of losses, damages, and liabilities arising from breaches of representations, warranties, and covenants under the APA.
(b) Except as expressly provided in Section 3.5 of this Agreement (No Set-Off), the earnout obligations of Buyer under this Agreement are separate from and independent of the indemnification obligations of the Parties under the APA. Without limiting the generality of the foregoing, the Parties acknowledge that the indemnification provisions of the APA include: (i) an aggregate indemnification cap of Twenty-Eight Million Dollars ($28,000,000), representing twenty percent (20%) of the Total Consideration; (ii) a survival period for representations and warranties of eighteen (18) months following the Closing Date (expiring February 8, 2025), except for Fundamental Representations, which survive for the applicable statute of limitations period; (iii) a tipping basket of One Million Four Hundred Thousand Dollars ($1,400,000), representing one percent (1%) of the Total Consideration, below which no indemnification obligations arise (with first-dollar coverage once the tipping basket threshold is exceeded); and (iv) a de minimis per claim threshold of Seventy-Five Thousand Dollars ($75,000), below which individual claims are excluded from the calculation of the tipping basket.
(c) The Parties further acknowledge that the Fourteen Million Dollar ($14,000,000) escrow deposited with Ashgrove Equity Partners Escrow Services, Inc. (Account No. 8841-7023-5500) pursuant to the Escrow Agreement (Exhibit D to the APA) secures Seller's indemnification obligations under the APA and does not secure, and shall not be used to satisfy, Buyer's earnout payment obligations under this Agreement. Buyer's obligation to make Milestone Payments is a direct, unconditional (subject to Milestone achievement) obligation of Buyer, and Seller shall not be required to look to the escrow for satisfaction of such payments.
Section 10.2 — R&W Insurance.
The Parties acknowledge that the buyer-side representations and warranties insurance policy issued by Apex Mutual Insurance Company (Policy No. RWI-2023-07182), with a coverage limit of Twenty-Eight Million Dollars ($28,000,000) and a retention of One Million Four Hundred Thousand Dollars ($1,400,000), was obtained by Buyer in connection with the transactions contemplated by the APA. Such policy does not cover, and shall not be deemed to cover, Buyer's obligations to make Earnout Payments under this Agreement. Nothing in this Agreement shall be construed to create any right of Seller to make claims under such insurance policy with respect to the Earnout Payments.
ARTICLE XI — TERM AND TERMINATION
Section 11.1 — Term.
This Agreement shall become effective as of the Closing Date (August 8, 2023) and shall remain in full force and effect until the earliest of:
(a) the date on which both Milestone Payments have been paid to Seller in full in accordance with Article III;
(b) the expiration of the Earnout Period on August 8, 2026, with respect to any unachieved Milestones (subject to the continuation of this Agreement with respect to any Disputes then pending under Article V and any acceleration or deemed-achievement events under Articles VI and VII that have been triggered prior to such expiration); and
(c) the date on which all Disputes arising under this Agreement have been finally resolved and all payment obligations of Buyer arising from such resolution have been satisfied in full.
Section 11.2 — Survival of Certain Provisions.
The following provisions of this Agreement shall survive the termination or expiration of this Agreement and shall continue in full force and effect in accordance with their respective terms: Article V (Dispute Resolution), Section 3.3 (Tax Treatment of Earnout Payments), Section 3.4 (No Interest; Interest on Late Payments), Section 4.4 (Books and Records Access, which shall survive for twelve (12) months following the expiration of the Earnout Period, i.e., through August 8, 2027), Article X (Indemnification Relationship), and Article XII (General Provisions). The survival of such provisions shall not be affected by the expiration of any unachieved Milestones or the termination of this Agreement.
ARTICLE XII — GENERAL PROVISIONS
Section 12.1 — Governing Law.
This Agreement and all Disputes arising out of or relating to this Agreement shall be governed by and construed in accordance with the internal laws of the State of Delaware, without giving effect to any choice of law or conflict of laws rules or provisions (whether of the State of Delaware or any other jurisdiction) that would cause the application of the laws of any jurisdiction other than the State of Delaware.
Section 12.2 — Notices.
All notices, requests, demands, consents, waivers, and other communications required or permitted under this Agreement shall be in writing and shall be delivered: (a) by hand delivery; (b) by nationally recognized overnight courier service (with tracking capability); (c) by registered or certified mail, return receipt requested, postage prepaid; or (d) by electronic mail (with confirmation of receipt), to the following addresses (or to such other address as a Party may designate by written notice to the other Party in accordance with this Section 12.2):
If to Seller:
Genome Dx Therapeutics Inc. 10250 Science Center Drive, Suite 600 San Diego, CA 92121
Attention: Rebecca Chiang, General Counsel
Email: rchiang@genomedx.com
with a copy (which shall not constitute notice) to:
Calderwood & Harkness LLP 555 South Hope Street, Suite 4400 Los Angeles, CA 90071
Attention: James Prentice
Email: jprentice@calderwoodharkness.com
If to Buyer:
Meridian Precision Diagnostics, Inc. 2400 Meridian Parkway, Suite 300 Durham, NC 27713
Attention: David Pruitt, General Counsel
Email: dpruitt@meridianprecision.com
with a copy (which shall not constitute notice) to:
Whitfield Sayer & Gregg LLP 200 South Tryon Street, Suite 2800 Charlotte, NC 28202
Attention: Jonathan Whitfield
Email: jwhitfield@wsglaw.com
Notices shall be deemed given: (i) when delivered by hand; (ii) one (1) business day after deposit with a nationally recognized overnight courier service; (iii) three (3) business days after deposit in the United States mail, registered or certified, return receipt requested, postage prepaid; or (iv) when sent by electronic mail during normal business hours of the recipient (or if sent outside of normal business hours, on the next business day), in each case with confirmation of receipt.
Section 12.3 — Assignment.
Neither Party may assign, transfer, or delegate its rights, interests, or obligations under this Agreement, in whole or in part, without the prior written consent of the other Party, and any purported assignment, transfer, or delegation without such consent shall be null and void; provided, however, that: (a) Buyer may assign its rights and obligations under this Agreement to a wholly-owned subsidiary of Buyer without Seller's consent, provided that Buyer shall not be released from any of its obligations under this Agreement by reason of any such assignment and Buyer shall remain primarily liable for the performance of all obligations hereunder; and (b) in connection with a Change of Control or Divestiture, the successor entity or Assignee shall assume all of Buyer's obligations under this Agreement in accordance with Section 6.2 of this Agreement. Subject to the foregoing, this Agreement shall be binding upon and shall inure to the benefit of the Parties and their respective successors and permitted assigns.
Section 12.4 — Entire Agreement; Amendment.
This Earnout Agreement, together with the APA and the other ancillary agreements, exhibits, schedules, and instruments referenced therein or delivered in connection therewith, constitutes the entire agreement among the Parties with respect to the subject matter hereof and supersedes all prior and contemporaneous agreements, understandings, negotiations, and discussions, whether oral or written, relating to the subject matter hereof. No amendment, modification, supplement, or waiver of any provision of this Agreement shall be effective unless set forth in a written instrument duly executed by both Parties.
Section 12.5 — Waiver.
No waiver of any provision of this Agreement shall be effective unless in writing and signed by the Party against whom enforcement of such waiver is sought. No single or partial exercise of any right, remedy, power, or privilege under this Agreement shall preclude any other or further exercise thereof, or the exercise of any other right, remedy, power, or privilege. The failure of either Party to enforce any provision of this Agreement shall not constitute a waiver of such provision or the right to enforce it at a later time.
Section 12.6 — Severability.
If a