Test Purchase Agreement
Last Updated: October 6, 2022
Customer and GRAIL have entered into this Test Purchase Agreement (the “TPA”) as of the Effective Date (as defined in the Purchase Form). This Agreement starts on the Effective Date and continues until the end of the Term. Each Purchase Form that incorporates these TPA terms forms a separate contract. Customer and GRAIL may each be referred to herein as a “Party” or collectively as the “Parties.”
1.1 “Agreement” means, collectively, this TPA and the Purchase Form.
1.2 “Customer” means the legal entity defined as Customer in the Purchase Form.
1.3 “Effective Date” means the effective date of the Purchase Form.
1.4 “GRAIL” means the legal entity defined as GRAIL in the Purchase Form.
1.5 “Purchase Form” means the executed test purchase form or similar purchasing document that references this TPA and specifies the Test under this Agreement.
1.6 “Term” means the term of the Purchase Form, unless terminated earlier in accordance with this Agreement.
1.7 “Test” means the laboratory test defined as the Test in the Purchase Form.
2.1 GRAIL will provide the Test as specified in the SOW, in accordance with GRAIL procedures and applicable government regulations.
2.2 Customer will require and ensure that all the healthcare professionals under its direction and control (whether employees, consultants, or agents) who may order and/or deliver results of a Test (“Healthcare Professional”): (i) read any educational materials, labeling, and product information, which includes, among other information, a description of the Test and its instructions for use, warnings, risks, benefits and limitations, and attend any educational training made available or required by GRAIL (which may be performed remotely); (ii) utilize his/her own medical and clinical judgment in determining whether to order the Test and be in complete and exclusive control of all such medical judgments; and (iii) conduct all aspects of the Test ordering and results reporting in accordance with the highest standards of medical practice and all applicable laws.
3.0 Compensation and Payment
3.1 GRAIL will invoice Customer and any applicable third party for the Tests, as described in the Purchase Form. Invoicing will follow the delivery of the Test results report and not when any Collection Materials are provided to Customer by GRAIL. Customer will pay each invoice within thirty (30) days of the invoice date. In addition to any other rights and remedies available to GRAIL, interest will be payable on any payments that are not paid when due under this Agreement at a monthly rate of 1.5% or the maximum applicable legal rate, if less, calculated on the total number of days that payment is delinquent. In the event Customer fails to make payments due, GRAIL reserves the right to suspend providing additional Tests and/or to require, upon request by GRAIL, that Customer immediately cease use of all unused Collection Materials and return any such unused Collection Materials to GRAIL, as set forth below in Section 4.3, and Customer will comply.
3.2 All payments of amounts owing to GRAIL will be made at the account or address designated by GRAIL in writing.
4.0 Materials and Specimens
4.1 With respect to each Test, Customer or its designee will transfer to GRAIL blood specimens from patient(s) (“Specimens”). As between the Parties, GRAIL owns all rights, title and interest in and to the Specimens and will have sole right to use and analyze the Specimens and any related data consistent with the permissions granted by the relevant patient(s) and applicable laws. Customer will have no access to (i) Specimens after they are transferred to GRAIL and (ii) such related data other than the Test results provided in GRAIL’s standard Test results report form.
4.2 GRAIL or its designee will deliver to Customer the kits (the “Collection Materials”) necessary for collection of the Specimens for the Tests pursuant to the applicable Purchase Form. GRAIL will retain all right, title, and interest in and to any Collection Materials provided under this Agreement. Customer will ensure that such Collection Material in its possession or control is stored in accordance with the storage condition requirements provided by GRAIL. Customer may request additional Collection Materials from GRAIL, as needed, from time to time. To the extent any Collection Materials in Customer’s possession or control expire prior to use by Customer, Customer will notify GRAIL and promptly ship such expired Collection Material back to GRAIL, or, if instructed by GRAIL, promptly destroy such Collection Materials. Unless otherwise specified in the Purchase Form, GRAIL will be responsible for all expenses for shipping of Collection Materials to Customer and for Specimens and expired Collection Materials to GRAIL (other than any expedited shipping fees specifically requested by Customer which Customer will bear). For each Test for which Customer collects the Specimen, Customer will ensure a Specimen is drawn by a phlebotomist with the applicable qualifications, licenses and/or certifications, as required by applicable law, and packaged and shipped in accordance with GRAIL’s instructions. Customer will ensure that a completed Test requisition form is included with each Specimen. Customer expressly acknowledges and agrees that to the extent any Specimens are not collected, handled and/or shipped in accordance with the instructions provided and/or to the extent any information in the Test requisition form is incomplete, GRAIL may be unable to process the Test in a timely manner or at all.
4.3 In the event Customer fails to make payments due and/or GRAIL suspends providing additional Tests in accordance with the terms of this Agreement or if GRAIL determines, in its sole discretion, that Customer has otherwise materially breached the terms of this Agreement, GRAIL reserves the right, in addition to the other remedies available hereunder, to cease the provisioning of Collection Materials to Customer and Customer, upon request from GRAIL, will immediately cease the use of all unused Collection Materials and return all unused Collection Materials to GRAIL within three (3) business days of the request. Customer will be responsible for all costs, including shipping costs, and liabilities associated with the return of such Collection Materials.
4.4 GRAIL may not be able to process Specimens or to provide Test results reports to Healthcare Professionals in certain instances, including but not limited to: (i) Specimens lost or damaged prior to delivery at GRAIL laboratories; (ii) contaminated Specimens; (iii) incomplete or inaccurate information on the Test requisition form; (iv) the patient canceling the Test; (v) the ordering Healthcare Professional canceling the Test; and (vi) shipping delays. Specimens collected from patients who are twenty-one (21) years old or younger or who are pregnant will not be processed.
5.1 For purposes of this Agreement, the term “Confidential Information” means (i) all written information, including, but not limited to, data; know-how; technical and non-technical materials which one Party (the “Disclosing Party”) discloses to the other Party (the “Receiving Party”) pursuant to this Agreement that are marked as “Confidential” or “Proprietary,” (ii) all oral material which the Disclosing Party declares to be confidential at the time of disclosure and was confirmed in writing within thirty (30) days of disclosure; and (iii) information otherwise reasonably expected to be treated in a confidential manner under the circumstances of disclosure or by the nature of the information itself. The terms of this Agreement, including pricing specified in any Purchase Form, are Confidential Information of GRAIL.
5.2 During the term of this Agreement and until five (5) years after the expiration or termination of this Agreement, the Parties: (i) will not use Confidential Information other than to fulfill their obligations under this Agreement; (ii) will not disclose Confidential Information to unauthorized third parties; (iii) will protect the confidentiality of Confidential Information using at least the same level of efforts and measures used to protect its own confidential information, but no less than a reasonable standard of care; and (iv) will notify the Disclosing Party of any unauthorized use or disclosure of Confidential Information of which the Receiving Party becomes aware as promptly as practicable.
5.3 The Receiving Party’s obligations under this Section 5 will not apply to any Confidential Information that: (i) the Receiving Party knew prior to learning it under this Agreement, as demonstrated by written records; (ii) is now, or becomes in the future, publicly available other than by an act or omission of the Receiving Party; (iii) a third party discloses to the Receiving Party, without any restriction on disclosure or breach of confidentiality obligations to which such third party is subject to; or (iv) the Receiving Party independently develops without use of or reference to Confidential Information.
5.4 Except as required by law, Customer further agrees not to disclose the existence of this Agreement or any of its terms, including without limitation, the fact that GRAIL is a Party to this Agreement without prior written consent from GRAIL. All such information in this Section 5.4 is Confidential Information and subject to the terms and conditions of this Agreement.
5.5 Notwithstanding Section 5.2 above, the Receiving Party may disclose Confidential Information to the extent and to the persons or entities required under applicable governmental law, rule, regulation or order, provided that the Receiving Party (i) first gives prompt written notice of such disclosure requirement to the Disclosing Party so as to enable the Disclosing Party to seek any limitations on or exemptions from such disclosure requirement and (ii) reasonably cooperates in any such efforts by the Disclosing Party at the Disclosing Party’s request.
5.6 Upon the earlier of the completion of this Agreement or the Disclosing Party’s request for any reason, the Receiving Party will (i) immediately cease all use of all Confidential Information and (ii) promptly, at the Disclosing Party’s instruction, either return to the Disclosing Party or destroy all Confidential Information, including any copies, extracts, summaries, or derivative works containing Confidential Information, and, upon request, certify in writing to the Disclosing Party the completion of such return and/or destruction, provided, however, that the Receiving Party may retain one (1) copy solely for the purpose of monitoring the Receiving Party’s surviving obligations under this Agreement.
5.7 Each Party retains all right, title and interest in and to its Confidential Information, and this Agreement does not and will not be construed to give the Receiving Party any right or license, by implication or otherwise, to any Confidential Information or any intellectual property or other rights owned by or licensed to the Disclosing Party, except the right to use Confidential Information in accordance with the terms herein.
6.0 Term and Termination
6.1 This Agreement may be terminated, immediately, by either Party on written notice, if the other Party is in material breach of this Agreement and fails to cure that breach within thirty (30) days after receiving written notice from the non-breaching Party. This Agreement may be terminated by GRAIL, without cause, upon written notice to Customer.
6.2 Upon termination or expiration of this Agreement for any reason, Customer will make payment to GRAIL for any Test results reports provided to Customer, including those provided after the termination or expiration date for Tests ordered prior to such date (other than the Tests for which GRAIL has agreed in the Purchase Form to invoice any third party). In addition, Customer will return to GRAIL any Collection Materials it possesses as of the expiration or termination date.
6.3 Expiration or termination of this Agreement for any reason will not affect either Party’s rights or obligations which, at the time of such expiration or termination, have already accrued to such Party. In addition, the obligations of the Parties contained in Articles 3, 5, 6, 7, and 8 and Section 4.1 and 4.3 hereof will survive expiration or termination of the Agreement.
7.0 Indemnification and Limitation of Liability
7.1 Indemnification. Each Party hereby agrees to defend, hold harmless and indemnify the other Party and its officers, directors, employees, agents, representatives, and affiliates from and against any and all liabilities, expenses, damages and/or losses (including without limitation reasonable legal expenses and attorneys’ fees) resulting from any third-party claim to the extent arising out of (i) the material breach by the indemnifying Party or its officers, directors, employees, agents, or representatives of its obligations under this Agreement, (ii) the gross negligence or willful misconduct of the indemnifying Party or its officers, directors, employees, agents or representatives in the performance of its obligations under this Agreement, or (iii) any failure by the indemnifying Party to comply with any applicable federal, state, or local laws, regulations, or codes in the performance of its obligation under this Agreement.
7.2 Indemnification Procedure. To be eligible to be indemnified hereunder, the indemnified Party will provide the indemnifying Party with prompt written notice of the third-party claim giving rise to the indemnification obligation pursuant to this Article 7, but the indemnified Party’s failure to provide such notice does not relieve the indemnifying Party of its obligation, except to the extent that such failure materially prejudices the indemnifying Party. The indemnifying Party will have the right to control the defense (with the reasonable cooperation of the indemnified Party) and settlement of any such claim; provided, however, that the indemnifying Party will not enter into any settlement that admits fault or wrongdoing of the indemnified Party without the indemnified Party’s prior written consent. The indemnified Party will have the right to participate, at its own expense and with counsel of its choice, in the defense of any claim or suit that has been assumed by the indemnifying Party.
7.3 Limitation of Liability. THE LIABILITY AND OBLIGATIONS OF GRAIL, AND THE REMEDIES OF CUSTOMER, UNDER OR IN CONNECTION WITH THIS AGREEMENT WILL BE LIMITED TO REPEATING ANY TESTS FOR WHICH A RESULT CANNOT BE GENERATED OR, AT THE SOLE OPTION OF GRAIL, NOT BILLING CUSTOMER FOR SUCH TESTS. ANY CLAIMS BY CUSTOMER REGARDING THE TESTS MUST BE REPORTED IN WRITING TO GRAIL WITHIN THIRTY (30) DAYS AFTER THE DISCOVERY THEREOF, AND IN ANY EVENT WITHIN ONE YEAR FROM THE PERFORMANCE OF SUCH TESTS BY GRAIL, OR SUCH CLAIMS WILL BE DEEMED WAIVED. IN NO EVENT WILL GRAIL BE RESPONSIBLE FOR ANY PUNITIVE DAMAGES OR ANY CONSEQUENTIAL, INCIDENTAL, INDIRECT, OR SPECIAL DAMAGES (INCLUDING LOST PROFITS OR REVENUE) OF CUSTOMER, ITS AFFILIATES, OR OF ANY THIRD PARTY. GRAIL’S TOTAL AGGREGATE LIABILITY ARISING FROM OR RELATING TO THIS AGREEMENT WILL NOT EXCEED THE AMOUNTS PAID BY CUSTOMER TO GRAIL UNDER THIS AGREEMENT WITHIN THE TWELVE (12) MONTH PERIOD PRECEDING THE CLAIM.
8.1 Records. The Parties will maintain records and data related to its obligations under this Agreement in accordance with applicable laws and any specific record-keeping obligations included in the Purchase Form.
8.2 Feedback. To the extent Customer provides comments, suggestions or other feedback directly on and directly related to the Test (“Feedback”), Customer hereby grants to GRAIL and GRAIL accepts a worldwide, non-exclusive, royalty-free, fully paid, perpetual, irrevocable, transferrable, worldwide license, with the right to sublicense, under its intellectual rights to the Feedback, to incorporate or otherwise utilize Feedback as provided by Customer to GRAIL in the development and commercialization of GRAIL products and display, perform, copy, make, have made, use, sell, and otherwise dispose of and support GRAIL’s products and documentation embodying such Feedback.
8.3 Force Majeure. In the event either Party will be delayed or hindered in or prevented from the performance of any act required hereunder by reasons of strike, lockouts, labor troubles, pandemic, restrictive government or judicial orders or decrees, riots, insurrection, war, Acts of God, inclement weather or other similar reason or cause beyond such Party’s reasonable control, then performance of such act will be excused for the period of such delay, and the affected Party will receive time to perform the act equal to the period of delay. Notice of the start and stop of any such force majeure will be promptly provided to the other Party, and the affected Party will use commercially reasonable efforts to end the delay and resume performance under this Agreement as soon as reasonably practicable.
8.4 Notices. Every notice or other communication required or permitted under this Agreement or by applicable laws will be in writing and will be deemed to have been delivered and received (a) when personally delivered, (b) on the seventh (7th) business day after which sent by registered or certified mail, (c) by email with confirmation by the recipient confirming such email has been received and reviewed, or (d) on the third (3rd) business day after the business day on which deposited with a regulated public carrier (e.g., FedEx) for overnight delivery (receipt verified), addressed to the Party for whom intended at the mailing address set forth in the Purchase Form, or such other mailing address, notice of which is given in a manner permitted by this Section 8.4.
8.5 Publicity. Customer consents to GRAIL disclosing that GRAIL provides services to Customer, and a description of the nature of the services provided. Customer will not, without the prior consent of GRAIL, contact on behalf of GRAIL, or provide any information regarding GRAIL to, any financial media, the press, or any social media source, or otherwise for public distribution or accessibility. Customer will not create any content, media, or materials for public display or distribution or that are publicly accessible that utilize or incorporate GRAIL’s trademarks, logos, name or product name(s), or other intellectual property of GRAIL, without the prior written consent of GRAIL.
8.7 State Billing Laws. IN ORDER TO COMPLY WITH STATE BILLING LAWS FOR TEST ORDERS RECEIVED FROM HEALTHCARE PROFESSIONAL: (1) IN CA, MI AND OR, GRAIL MAY BILL CUSTOMER (AS REQUESTED BY THE CUSTOMER EITHER BY MARKING “OTHER” ON THE TRF, OR BY OTHER REQUEST IN WRITING) PROVIDED THAT THE TEST PRICING AS CHARGED BY GRAIL IS PASSED TO THE PATIENT OR PAYER WITHOUT ANY MARKUP, AND FURTHER, CUSTOMER AGREES TO DISCLOSE AT THE TIME OF PATIENT OR PAYER BILLING THAT: ‘GRAIL, LOCATED AT 1525 O’BRIEN DRIVE, MENLO PARK, CA 94025 IS THE LABORATORY THAT PERFORMED THE GALLERI TEST; GRAIL CHARGED $XXX FOR GALLERI; AND (2) IN CT, LA, NJ, OR AND PA, GRAIL MAY BILL CUSTOMER PROVIDED THAT CUSTOMER AGREES TO DISCLOSE AT THE TIME OF PATIENT OR PAYER BILLING THAT: ‘GRAIL, LOCATED AT 1525 O’BRIEN DRIVE, MENLO PARK, CA 94025 IS THE LABORATORY THAT PERFORMED THE GALLERI TEST; GRAIL CHARGED $XXX FOR GALLERI. CUSTOMER WARRANTS THAT IT WILL COMPLY WITH THE FORGOING PROVISIONS TO THE EXTENT APPLICABLE FOR SUCH ORDERS BILLED TO CUSTOMER.
8.8 Severability; Waiver. If any one or more provisions of the Agreement will be found to be illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining provisions will not in any way be affected or impaired thereby, provided that the surviving agreement materially comports with the Parties’ original intent. Waiver or forbearance by either Party or the failure by either Party to claim a breach of any provision of this Agreement or exercise any right or remedy provided by this Agreement or applicable law, will not be deemed to constitute a waiver with respect to any subsequent breach of any provision hereof.
8.9 Entire Agreement; Amendments. This Agreement, including all Exhibits attached hereto, represents the complete and entire understanding between the Parties regarding the subject matter hereof and supersedes all prior negotiations, representations or agreements, either written or oral, regarding this subject matter. No changes or modifications of this TPA or any Purchase Form will be deemed effective unless in writing and executed by the Parties hereto.
8.10 Order of Precedence. The terms in this TPA will take precedence over conflicting terms in the Purchase Form, unless the Purchase Form’s preamble or introductory terms expressly state that the Purchase Form’s terms may take precedence and all conflicting Purchase Form terms expressly refer to and state the Parties’ intent to supersede specific TPA terms.
8.11 Governing Law and Jurisdiction. ALL CLAIMS ARISING OUT OF OR RELATING TO THIS AGREEMENT WILL BE GOVERNED BY THE SUBSTANTIVE AND PROCEDURAL LAWS OF THE STATE OF CALIFORNIA, WITHOUT REGARD TO ITS CONFLICT OF LAW PRINCIPLES. ALL DISPUTES ARISING OUT OF OR RELATING TO THIS AGREEMENT WILL BE SUBJECT TO THE EXCLUSIVE JURISDICTION AND VENUE OF THE STATE COURTS LOCATED IN SAN MATEO COUNTY, CALIFORNIA AND THE FEDERAL COURTS LOCATED IN SAN FRANCISCO, CALIFORNIA, AND EACH PARTY HEREBY CONSENTS TO THE PERSONAL JURISDICTION THEREOF.