This Testing Services Agreement (the “TSA”) is entered into by and between QualTex Laboratories, an Arizona non-profit corporation, headquartered at 6211 I-H 10 West, San Antonio, Texas 78201 (“QualTex”) and Client (as defined in the applicable Order). In consideration of the mutual promises contained herein, the parties, intending to be legally bound, agree as follows:
QualTex will:
(a) Test the Samples and interpret all Test results in accordance with Law, manufacturer’s package insert instructions (except where otherwise approved by the FDA), and any reasonable written requirements of Client (provided Client’s written requirements comply with Law), and use testing procedures at least as stringent as those recommended by the AATB, AABB, and/or PPTA (as applicable). QualTex may use outside providers in the performance of any of its obligations hereunder.
(b) Maintain records of the Testing and allow regulatory agencies and authorized representatives of Client to inspect or observe QualTex’s testing laboratory and Testing records upon reasonable advance written notice, but no more than once per twelve (12) month period, subject to the confidentiality obligations set forth in this Agreement.
(c) Use commercially reasonable efforts to provide Test results to Client within the time periods listed on Exhibit B attached hereto.
Client will:
(a) Procure, label, identify and ship to QualTex all Samples for Testing in sealed, validated containers acceptable to QualTex and in accordance with applicable Law for the transport of biological Samples and QualTex’s then applicable standard operating procedure.
(b) If required by QualTex, starting with the Effective Date of the Agreement and within thirty (30) days prior to December 31st of each calendar year, Client will provide QualTex with a good faith forecast (“Forecast”) of its anticipated volume of Samples to be submitted for Testing for the next calendar year. The Forecast will be categorized by calendar Quarter and will become an integral part of the Agreement and included (as applicable) as an additional exhibit. At any time during each calendar year, should events arise that will change the current Forecast (increases or decreases in the number of Sample submissions by more than five percent (5%)), such change(s) shall be immediately communicated to QualTex by Client. Forecasts and/or changes to forecasts that exceed five percent (5%) or more of the number of Samples in the prior or current Forecast, or sending a number of Samples that, when added to the volume of Samples previously sent to QualTex, exceeds five percent (5%) of the monthly or quarterly Sample volume in the current Forecast at the time of QualTex of Sample receipt, may result in delayed or extended Testing turnaround times exceeding the guidelines in Exhibit B. Any delay or extension of turnaround times for Testing of Samples shall not be a breach by QualTex under this Agreement.
(c) Prior to or contemporaneously with the Effective Date of this Agreement, Client and QualTex will develop a mutually agreed Sample Submission shipping schedule that will be followed throughout each calendar year of the Agreement. However, from time-to-time, it may be necessary for QualTex to temporarily alter a Client’s Sample shipping schedule to facilitate short term changes in Sample shipping and receipt timing, because of force majeure or various planned and unplanned events (e.g., holidays, inclement weather, courier issues and requests, minor laboratory operational issues, laboratory equipment and software upgrades and replacements). Client will comply with all requested Sample Submission shipping schedule changes, unless otherwise agreed by QualTex.
(a) If a Sample is determined to be non-conforming, defective, not viable due to delay in its arrival or substandard packaging and/or shipping or does not otherwise meet QualTex’s Standard Operating Procedures and testing guidelines, including those situations that fall outside of the assay manufacturer’s package insert, then Client has the option to request that QualTex test a Sample or assay on an Information Use Only (“IUO”) or Research Use Only (“RUO”) basis. Inherent in this request are risks that the tests will be incomplete or inaccurate. The results generated are therefore for investigational use and do not impact, replace, or modify any prior, current, or future Good Manufacturing Practice (“GMP”) testing, quality control procedures, or any other routine product testing.
(b) Client acknowledges and agrees that, subject to QualTex’s approval: (i) testing services for Samples on an unqualified assay will be rendered as IUO; and (ii) testing services for Samples on a qualified assay but where the Sample has not been qualified will be rendered as RUO.
(c) Client further acknowledges and agrees that testing rendered by QualTex as IUO or RUO cannot be used to determine donor acceptability, product acceptability, or to determine the safety, purity or potency of a therapeutic. QualTex cannot definitively answer any questions over the performance of the assay or attest to the validity of any results rendered as IUO or RUO.
(a) QualTex will invoice Client twice monthly for Testing in accordance with Exhibit A Client will be responsible for all costs associated with Sample collection and with Sample transportation to QualTex. Client shall pay amounts due to QualTex upon receipt of the invoice, unless Client has applied and been approved in writing for credit with QualTex, in which case amounts due are payable within thirty (30) days of the date of the invoice. Client agrees to pay interest on past due amounts at the lesser of eighteen percent (18%) per annum or the maximum non-usurious rate permitted by Law from the date the invoice becomes past due to the date of payment as well as costs of collection (including attorneys’ fees and court costs). All payments shall be made in immediately available funds by check, wire transfer or ACH deposit. Payment instructions are as follows:
QualTex Laboratories
Wire:
Account Number: 02-0165832
Routing Number: 114000093
SWIFT: FRSTUS44
Remittance email: accounts.receivable@biobridgeglobal.org
Checks:
P.O. Box 1507, San Antonio, Texas 78295
(b) QualTex may adjust its pricing fees under this Agreement, with thirty (30) days prior written notice to Client, if implementation of new processes, equipment, supplies or testing criteria is required for the Services (i) as mandated by the FDA, another applicable regulatory agency or by an applicable standard setting organization, (ii) as the new “standard of care” in the industry, or (iii) as specifically requested by Client (in which case the price increase shall be immediate).
(c) Furthermore, QualTex may adjust its fees under this Agreement annually (based on calendar year rather than the term of the Agreement) to reflect inflation as measured by the applicable MCPI. (For example: if in 2023 the MCPI for the month of October – or preceding next available month if unavailable in October – is 110.1, and in October – or preceding next available month if unavailable in October – of the previous year 2022 reflects a MCPI of 106.6, the difference would be 3.5. The 3.5 would be divided by 106.6 resulting in a MCPI increase of 3.8% in year 2024). Generally, such adjustment will be reflected on QualTex’s first invoice for the new year.
(a) Disclaimer. Client acknowledges that the results of Testing, when properly performed, using industry accepted equipment, supplies and procedures, cannot be guaranteed or warranted by QualTex because some false positives or false negatives will occur. Therefore, QualTex does not guarantee or warrant such test results and expressly disclaims any guarantee or warranty. In addition, Client acknowledges that false positive or false negative test results may result in a donor being excluded from being able to donate for a period of time and Client releases QualTex from any liability associated therewith. Additionally, Client acknowledges that QualTex does not and will not diagnose diseases or infections. QualTex does not represent that the results of IUO or RUO testing or validation will be acceptable to any regulatory or government agency to which they are presented. QualTex shall have no responsibility for the manner in which Client uses the results and Client’s acceptance, reliance on, or use of such results shall be at the sole risk of Client.
(b) Indemnity. Client shall defend, indemnify and hold harmless QualTex, and its directors, officers, members, employees, agents, successors, assigns, representatives and affiliates, from and against all claims, demands, damages, costs, expenses, liabilities, actions, suits, fines and penalties (including without limitation reasonable attorneys’ fees and expenses) of any kind or nature whatsoever (collectively “Claims”), incurred by any of such indemnified parties, based upon or arising out of: (i) Client’s products or services or Client’s customer’s products or services; (ii) IUO or RUO testing; (iii) false positive or false negative test results; or (iv) Claims by Client’s donors or Client’s customers’ donors, including without limitation, being excluded from being able to donate.
(c) Liability for Samples and Limitation of Liability.
(i) QualTex shall not be liable for any Samples received either by QualTex directly, or through a third party carrier, which are non-conforming, defective, not viable due to delay in its arrival or substandard packing and/or shipping, or for any Samples which QualTex never receives from Client or third party carrier. If Client requests the return of the Samples, QualTex shall return the Samples at Client’s expense.
(ii) For Samples that QualTex accepts as meeting Section 2(a) criteria above, if any results of Testing of such Samples are transmitted to Client later than the time guidelines outlined herein (or not transmitted or delivered) or not in compliance with standards of Section 1(a) of this Agreement, and as a result the Testing on such Sample (or lack thereof) renders the Sample or the plasma unit and/or plasma pool that relates to the Sample unusable by Client or other person, Client shall notify QualTex within seventy-two (72) hours after the earlier to occur of: (A) the time when Test results were due under the time guidelines of Exhibit B or (B) the time of delivery of Test results to Client. If Client notifies QualTex of any QualTex noncompliance with Section 1(a) within the foregoing 72-hour notice period, and the noncompliance arose from QualTex’s gross negligence, Client may provide to QualTex a replacement Sample, which will be tested at QualTex’s expense, as Client’s sole and exclusive remedy for QualTex’s delay or failure. If Client fails to provide notice to QualTex within the foregoing 72-hour requirement or if delay is not a result of QualTex gross negligence, QualTex has no liability to Client and Client has no claim against QualTex.
(d) EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT, QUALTEX MAKES NO OTHER WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO SERVICES, PRODUCTS, LABELING OR PACKAGING. ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE HEREBY EXPRESSLY DISCLAIMED. IN NO EVENT WILL QUALTEX, ITS SUBSIDIARIES, EMPLOYEES, OFFICERS OR DIRECTORS BE LIABLE FOR ANY LOSS OF PROFITS, LOSS OF OPPORTUNITIES, LOSS OF USE, BUSINESS INTERRUPTION, COST OF COVER, OR INDIRECT, SPECIAL, INCIDENTAL, PUNITIVE, OR CONSEQUENTIAL DAMAGES OF ANY KIND IN CONNECTION WITH OR ARISING OUT OF THE PERFORMANCE OF THIS AGREEMENT, WHETHER ALLEGED AS A BREACH OF CLIENT OR TORTIOUS CONDUCT, INCLUDING NEGLIGENCE, EVEN IF CLIENT HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. QUALTEX’S LIABILITY UNDER THIS AGREEMENT FOR DAMAGES OF ANY KIND WILL NOT, IN ANY EVENT, EXCEED THE FEES PAID BY CLIENT TO QUALTEX DURING THE TWELVE-MONTH PERIOD PRIOR TO THE ORIGINATION OF THE CLAIM FOR DAMAGES.
This Agreement shall commence on the Effective Date and will remain in effect for the Initial Term unless terminated sooner in accordance with this Agreement. Following the Initial Term, this Agreement shall be automatically extended for additional one year terms (each a “Renewal Term”), unless either party provides written notice of termination to the other party at least ninety (90) days before any such Renewal Term takes effect (the Initial Term and any applicable Renewal Term(s) collectively referred to as the “Term”).
A party may terminate this Agreement: (a) immediately, if the other party materially breaches the terms or conditions of this Agreement, and the breaching party does not cure such breach within thirty (30) days after receiving notice of such breach from the non-breaching party, or (b) upon thirty (30) days written notice to the other party (i) upon the other party becoming insolvent or making an assignment for the benefit of its creditors, (ii) upon appointment of a trustee or receiver for such party or all or substantially all of its property, or (iii) upon the filing of a voluntary or involuntary petition by or against such party under the United States Bankruptcy Code, or any similar law which is not dismissed within sixty (60) days. The foregoing notwithstanding, if Client fails to make any payment due under this Agreement within five (5) business days of the due date, QualTex may immediately terminate or suspend services under this Agreement upon written notice to Client. In the event of suspension, QualTex may require that Client pay a reasonable reactivation fee.
QualTex will perform its obligations hereunder as an independent contractor of Client. Neither party is an employee, agent of, partner or joint venturer with the other party. Due to the independent contractor relationship, neither party shall have any power to bind the other party.
During the term of this Agreement and for three (3) years thereafter, each party shall maintain a policy or policies of liability insurance in the amount of no less than two million dollars ($1,000,000) per occurrence and ($2,000,000) in the aggregate.
(a) During the term of this Agreement, each party may, directly or indirectly, disclose Confidential Information to the other party. Confidential Information includes all non-public, proprietary or confidential information furnished by or on behalf of one party to the other party (irrespective of the forms or means of communication), including, but not limited to: (i) all information concerning the business operations of a party and its affiliates, including financial statements and information, marketing strategies, pricing/fees, business plans and forecasts; (ii) any technology, trade secrets, design, scientific or technical information; (iii) any concepts and know-how; (iv) any information relating to a party’s employees, customers, suppliers and vendors; and (v) the fees charged by QualTex for Testing as set forth on Exhibit A. Notwithstanding the foregoing, Confidential Information shall not include information: (a) that is in the public domain or generally available to the public (through no fault of the receiving party); (b) that was in the possession of or disclosed to the receiving party prior to the date hereof, free of any obligation to keep the same confidential; and (c) that is lawfully acquired by the other from a third party under no obligation of confidence to the disclosing party.
(b) The parties agree not to disclose to any third party any Confidential Information. However, a party may disclose Confidential Information to its employees, agents and consultants who reasonably need to know such information in connection with their employment or consultant duties, provided that they personally agree, in writing, to be bound by the terms of this confidentiality covenant. This confidentiality covenant shall survive the termination of this Agreement for five (5) years. The foregoing confidentiality clauses of this Section 10 do not limit or prevent QualTex from disclosing Confidential Information to debt collectors or accounts receivable collection agencies in order for them or QualTex to collect from Client any unpaid amounts that are payable by Client under this Agreement.
This Agreement shall be governed by and construed in accordance with the laws of the State of Texas without application of any conflict of laws rules that may apply the laws of another jurisdiction. This Agreement shall be binding upon and shall inure to the benefit of the parties hereto and their respective successors and permitted assigns. Mandatory and exclusive venue for any action or proceeding shall be San Antonio, Texas.
ANY DISPUTE, CLAIM OR CONTROVERSY ARISING FROM OR RELATED IN ANY WAY TO THIS AGREEMENT OR THE INTERPRETATION, APPLICATION, BREACH, TERMINATION OR VALIDITY THEREOF, INCLUDING ANY CLAIM OF INDUCEMENT OF THIS AGREEMENT BY FRAUD OR OTHERWISE, WILL BE SUBMITTED FOR RESOLUTION TO ARBITRATION BEFORE A SINGLE ARBITRATOR IN SAN ANTONIO, TEXAS PURSUANT TO THE COMMERCIAL ARBITRATION RULES THEN PERTAINING OF THE AMERICAN ARBITRATION ASSOCIATION (AAA). The arbitration proceedings and award will be confidential. Any court of competent jurisdiction may enter judgment upon any award. Each party has the right before or during the arbitration to seek and obtain from the appropriate court provisional remedies such as attachment, preliminary injunction, replevin, etc. to avoid irreparable harm, maintain the status quo, or preserve the subject matter of the arbitration. Each party shall bear its own costs of arbitration, unless otherwise determined by the arbitrator.
Each party hereby waives, to the fullest extent permitted by Law, any right it may have to a trial by jury in any legal proceeding directly or indirectly arising out of or relating to this Agreement. Each party (a) certifies that no representative, agent or attorney of the other party has represented, expressly or otherwise, that the other party would not, in the event of litigation, seek to enforce the foregoing waiver and (b) acknowledges that it and the other parties hereto have been induced to enter into this Agreement by, among other things, the mutual waivers and certifications in this Section.
Neither this Agreement, nor the rights or obligations of any party hereto, may be assigned without the prior written consent of the other party. Notwithstanding the foregoing, QualTex may assign this Agreement without Client’s consent to an affiliate of QualTex or any entity to which QualTex transfers all or substantially all of its Testing services.
This Agreement may be executed in multiple counterparts, each of which shall be deemed an original for all purposes. Signatures transmitted by facsimile or PDF email scan will be binding to the same extent as an original.
Failure of either party to perform its obligations under this Agreement, except for any payment obligations, shall not subject such party to any liability to the other party if such failure is caused by acts or circumstances that are beyond the reasonable control of a party including acts of God, pandemic, fires, explosion, flood, drought, other weather-related events, war, riot, sabotage, supply chain disruption, strikes, court order or regulation of any government entity, whether or not foreseeable.
This Agreement constitutes the entire agreement between the parties and supersedes all other prior and contemporaneous agreements between the parties, whether written or oral, concerning the subject matter hereof. No person shall be deemed to be a third party beneficiary hereof. This Agreement may not be amended except pursuant to an instrument in writing signed by both parties hereto.
All notices permitted or required by this Agreement shall be in writing and delivered (i) by electronic mail effective upon receipt or (ii) by certified or registered mail, effective three (3) days after deposit in the U.S. mail, and addressed as follows for notices sent to QualTex and to the Client address specified on the Order, Fee Schedule or Statement of Work, or to such other address as may be designated by either party in writing delivered as provided herein:
If to QualTex Laboratories:
6211 IH-10 West
San Antonio, TX 78201
Attn: COO
With a copy to:
BioBridge Global
6211 IH-10 West
San Antonio, TX 78201
Attn: General Counsel
Legal.department@biobridgeglobal.org
(a) “AABB” shall mean the Association for Advancement of Blood & Biotherapies.
(b) “AATB” shall mean the American Association of Tissue Banks.
(c) “Agreement” shall mean, collectively, the TSA, and any terms incorporated by reference in the TSA, and any applicable Order or Fee Schedule, Statement of Work, Equipment Schedule, Quality Agreement, or other addenda which govern the provision of Services.
(d) “Client” shall mean the entity listed in the applicable Order.
(e) “FDA” shall mean the Food and Drug Administration.
(f) “IDT” shall mean individual donor testing.
(g) “Initial Term” shall mean the initial term of the applicable Order.
(h) “Law” shall mean all applicable laws, regulations, ordinances, judicial or administrative orders or any other requirements of any applicable government authority within the United States of America.
(i) “MCPI” shall mean The Medical Care Services Consumer Price Index published by the U.S. Department of Labor’s Bureau of Labor Statistics. If the MCPI is no longer reported, then the successor index reported by the same agency shall be used, and if there is no successor index reported, then QualTex in its reasonable discretion will select an inflationary index that most closely tracks the changes in prices for the stated categories.
(j) “Order” or “Fee Schedule” shall mean the document describing the Testing or Services that Client is purchasing from QualTex.
(k) “Person” shall mean an individual, a corporation, partnership, association, trust, or any other entity or organization, including a government or political subdivision or agency thereof.
(l) “PPTA” shall mean the Plasma Protein Therapeutics Association.
(m) “Sample” shall mean a Sample of the material collected from one individual or the pool when testing a production pool.
(n) “Services” shall mean the QualTex services identified in a specific Order or Statement of Work.
(o) “Testing” or similar words shall mean the laboratory tests listed on Exhibit A.