OpGen, Inc. Laboratory Services Program Standard Terms & Conditions of Sale
1. Scope. Open, Inc. Standard Terms and Conditions will apply to laboratory services provided by OpGen, Inc. (“OpGen”). These Standard Terms and Conditions (the “Standard Terms and Conditions”) are incorporated into and made a part of each Clinical Laboratory Services Laboratory Account Information Request Form, Requisition Form, Purchase Order or Statement of Work entered into with a client (the “Client”) in connection with OpGen’s performance of the Services (as defined below) for the Client. OpGen and Client are each hereafter referred to individually as a “Party” and together as the “Parties.”
2.1. “Applicable Law” means all laws and related regulations, as they may be amended from time to time, governing the provision of clinical laboratory services, including, but not limited to, the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”), the federal Physician Self-Referral Law, 42 U.S.C. § 1395nn, and the regulations promulgated thereunder (together, the “Stark Law”), similar state physician self-referral laws and regulations (together with the Stark Law, the “Self-Referral Laws”), the federal Medicare/Medicaid Anti-kickback Law and regulations promulgated thereunder (the “Federal Anti-kickback Law”) and similar state Anti-kickback laws and regulations (together with the Federal Anti-kickback Law, the “Anti-kickback Laws”) and the data privacy and security requirements of Health Insurance Portability and Accountability Act of 1996 as codified at 42 U.S.C. § 1320d (“HIPAA”) and as amended by the Health Information Technology for Economic and Clinical Health Act as codified at 42 U.S.C. § 17901 (“HITECH”), enacted as part of the American Recovery and Reinvestment Act (“ARRA”) and regulations promulgated under HIPAA or HITECH.
2.2. “De-Identified Data” means any Protected Health Information de-identified in accordance with HIPAA.
2.3. “Protected Health Information” shall have the meaning as set forth under 45 CFR 160.103.
2.4. “Services” means the clinical laboratory services provided by OpGen to Client as set forth on any related Clinical Laboratory Services Laboratory Account Information Request Form, Requisition Form, Purchase Order or Statement of Work.
3. Requisitions Forms/Purchase Orders/Statements of Work. Requisition forms, purchase orders or statements of work for Services must be submitted in writing and executed by Client. All requisition forms, purchase orders, statements of work are subject to OpGen’s written acceptance. Any revision to or cancellation by Client of an accepted requisition form/purchase order/statement of work will be subject to OpGen’s written prior approval, and may be subject to a revision or cancellation fee.
4. Shipping, Delivery. Instructions related to the proper collection, processing and shipping of specimens to OpGen are provided in the OpGen Clinical Services Guide.
5. Payment Terms.
5.1. Payment terms may be granted upon a standard credit review and approval. The Client agrees to provide standard financial information as requested by OpGen to facilitate this review.
5.2. The total amount due will be invoiced upon delivery of the Services results unless otherwise agreed to by OpGen. Any non-refundable upfront fees will be invoiced upon receipt of the purchase order and credited against the total amount invoiced upon delivery of Services results.
5.3. All invoices will be due and payable in full, without counterclaim or deduction, within thirty (30) days after the date of the invoice unless otherwise agreed to by OpGen. Payment must be made by wire transfer, check or other method agreed by OpGen.
5.4. Past due amounts will bear a late payment charge of 1.5% per month (or the highest amount allowed by law, if lower) until paid in full. Client agrees to reimburse OpGen for all collection costs (including attorneys’ fees) incurred by OpGen in connection with late payments.
6. Taxes. Unless expressly provided otherwise, all amounts quoted are exclusive of federal, state, local and foreign taxes, duties, tariffs, levies and similar assessments on the sale, transport or use of any Product or Service. Client will be responsible for all surcharges.
7. Records and Reports. OpGen shall record and maintain all information pertaining to its performance of the Services. OpGen’s records of billings and receipts relating to Services performed hereunder shall be available to Client upon reasonable request.
8.1. The Parties agree to maintain and hold as confidential and to not disclose to any third party the terms of the arrangement between OpGen and Client or any confidential or proprietary information that either Party may provide to the other Party during the term of the arrangement, unless disclosure thereof is required by law or otherwise authorized by these Standard Terms and Conditions or consented to in writing by the other Party (“Confidential Information”). Confidential Information shall include, but is not limited to, pricing terms offered by OpGen to the Client, and all information or data results provided by OpGen to the Client, patient identification information, patient medical records, financial information, business forecasts, personnel information, customer lists, marketing information, Medicare, Medicaid and other payor information, reimbursement information, and other information relating to the business of either Party or any affiliate thereof or their respective patients, clients or customers. Confidential Information shall not include any De-Identified Data.
8.2. To the extent that OpGen receives Protected Health Information, OpGen agrees to use appropriate safeguards to protect the privacy and security of such Protected Health Information and shall not use or disclose such Protected Health Information except as permitted under these Standard Terms and Conditions and Applicable Law.
9. Proprietary Rights. OpGen retains all proprietary rights in and to all designs and other technology and information pertaining to its products and the delivery of Services. OpGen agrees that Client shall retain all proprietary rights to records and reports created in connection with the Services. Notwithstanding the foregoing, Client grants to OpGen a non-exclusive, unrestricted royalty-free license to distribute, modify, transmit, display, disclose, use and otherwise exploit any De-Identified Data, metadata or any other information that does not constitute Protected Health Information that is created, obtained or maintained by OpGen in connection with its performance of the Services (including, without limitation, any De-Identified Data related to Client’s patients) for the purpose of developing information or statistical compilations for use in conducting its operations in the ordinary course of business. In furtherance of the foregoing, OpGen shall be entitled to create De-Identified Data in connection with its performance of the Services (including any De-Identified Data related to Client’s patients).
10. Representations and Warranties; Covenants.
10.1. OpGen hereby represents and warrants that (a) it has the power and authority to enter into the contemplated arrangement with Client, and is duly licensed, authorized and qualified to perform the Services; (b) the performance of the Services will not, directly or indirectly, contravene, conflict with or result in a violation of any agreement, authorization or other obligation of OpGen; and (c) it will comply with all Applicable Laws in the course of the business dealings with Client.
10.2. Client hereby represents and warrants that (a) it has the power and authority to enter into the contemplated arrangement with OpGen and procure the Services; (b) the performance of its obligations hereunder will not, directly or indirectly, contravene, conflict with or result in a violation of any agreement, authorization or other obligation of Client; (c) it will comply with all Applicable Laws in the course of the business dealings with OpGen; and (d) it shall comply with all specimen collection, processing and shipping instructions provided by OpGen.
10.3. EXCEPT TO THE EXTENT OF THE LIMITED WARRANTIES SET FORTH IN SECTION 11 AND IN THIS SECTION 10, AND NOTWITHSTANDING ANY PROVISION TO THE CONTRARY CONTAINED HEREIN OR IN ANY REQUISITION FORM, PURCHASE ORDER OR STATEMENT OF WORK OR OTHER STATEMENT OR INSTRUMENT, OPGEN MAKES NO WARRANTY OR GUARANTEE, EXPRESS OR IMPLIED, WITH RESPECT TO THE SERVICES, INCLUDING, BUT NOT LIMITED TO, ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
10.4. If Client provides any De-Identified Data to OpGen in connection with OpGen’s performance of the Services (including, without limitation, any De-Identified Data related to Client’s patients), Client acknowledges and agrees that it will de-identify such data in accordance with the standards set forth under HIPAA.
11.1. OpGen agrees to indemnify, defend and hold Client harmless from and against all losses, costs or claims asserted by third parties against Client arising or asserted to arise from the gross negligence or willful misconduct of OpGen, its affiliates, agents or employees in the performance of, or failure to perform, its obligations under these Standard Terms and Conditions.
11.2. Client agrees to indemnify, defend and hold OpGen harmless from and against all losses, costs or claims arising or asserted to arise from Client’s or its affiliates’, agents’ or employees’ breach of or failure to perform their respective obligations under these Standard Terms and Conditions and either asserted by third parties against OpGen or arising directly as a result of Client’s breach of its obligations set forth herein.
12. Limitation of Liability. IN NO EVENT SHALL OPGEN BE LIABLE FOR ANY SPECIAL, COLLATERAL, INDIRECT, PUNITIVE, INCIDENTAL, CONSEQUENTIAL, OR EXEMPLARY DAMAGES ARISING OUT OF OR IN CONNECTION WITH THE DELIVERY OF SERVICES, REGARDLESS OF THE FORM OF ANY CLAIM OR ACTION (WHETHER IN CONTRACT, NEGLIGENCE. STRICT LIABILITY OR OTHERWISE), INCLUDING, BUT NOT LIMITED TO, LOSS OF BUSINESS REVENUES, PROFITS OR GOODWILL, EVEN IF ADVISED OF THEIR POSSIBILITY.
13. Relationship of the Parties. OpGen shall be an independent contractor of Client. Nothing contained in these Standard Terms and Conditions shall be construed as creating any agency, partnership, joint venture or other form of joint enterprise, employment or fiduciary relationship between the Parties. Neither Party, by virtue of the arrangement between OpGen and Client, will have any right, power or authority to act or create an obligation, express or implied, on behalf of the other Party.
14. No Implied Rights. Nothing in these Standard Terms and Conditions shall be deemed or construed as a license or grant of any intellectual property rights, whether express, implied, by estoppel or otherwise.
15.1. Entire Agreement. These Standard Terms and Conditions and any Clinical Laboratory Services Laboratory Account Information Request Form, Requisition Form, Purchase Order or Statement of Work entered into between the Parties contain the entire understanding of the Parties with respect to the subject matter hereof and supersedes all prior agreements, oral or written, and all other communications between the parties relating to such subject matter. These Standard Terms and Conditions control over any conflicting or inconsistent terms in any related Clinical Laboratory Services Laboratory Account Information Request Form, Requisition Form, Purchase Order or Statement of Work. Terms in Client’s purchase order, acknowledgment or other documentation that are in addition to or at variance with these Standard Terms and Conditions are specifically waived by Client and rejected.
15.2. Waiver. No change, consent or waiver will be effective unless in writing and signed by the Party against which enforcement is sought. The failure of either Party to enforce its rights under these Standard Terms and Conditions at any time for any period will not be construed as a waiver. Unless otherwise stated herein, each right and remedy in these Standard Terms and Conditions is in addition to any other right or remedy, at law or in equity, and the exercise of one right or remedy will not be deemed a waiver of any other right or remedy.
15.3. Severability. If any provision of the Agreement is determined to be illegal or unenforceable, that provision will be removed to the minimum extent necessary so that the Agreement otherwise remains in full force and enforceable.
15.4. Governing Law. Exclusive jurisdiction and venue for any action arising under the Agreement is in the federal and state courts located in Maryland, USA having jurisdiction over OpGen’s principal office, and both parties hereby consent to such jurisdiction and venue for this purpose. The Agreement will be governed by and construed in accordance with the laws of the State of Maryland, USA without regard to the conflicts of laws provisions thereof. In the event of any conflict between US and foreign laws, rules and regulations, US laws, rules and regulations will govern.
15.5. Equitable Relief. Any breach of the Agreement will cause irreparable harm to OpGen for which money damages are not an adequate remedy, and OpGen will be entitled to an order for specific performance, injunction or similar equitable relief against any such breach or threatened breach without posting any bond. In no event will OpGen have any liability to Client for any delay or nonperformance resulting in whole or in part, directly or indirectly, from any cause beyond OpGen’s reasonable control.
15.6. Survival. The provisions of Sections 8, 9, 10, 11, 12, 13, 14 and 15 shall survive the expiration or earlier termination these Standard Terms and Conditions.