Service Terms
Laboratory Services Terms and Conditions
This Agreement applies to all transactions for laboratory testing and consulting services between Customer and Canyon Labs, unless otherwise specified in a writing signed by an authorized representative of Canyon Labs. Customer accepts and agrees to the terms and conditions set forth herein in lieu of any Customer’s terms and conditions (even if terms and conditions are contained in the Customer’s purchase order or some other document) on all orders placed with Canyon Labs, unless otherwise agreed to in writing by both parties.
1. Definitions
1.1 Unless the context otherwise requires, the following terms as used in this Agreement shall have the following meanings:
“Agreement” means this Laboratory Services Terms and Conditions and any attachments, exhibits, or schedules attached hereto or referenced herein.
“Affiliate” means a person, company, or entity controlling, controlled by, under common control, or working in concert with, a party.
“Canyon Labs” means Canyon Laboratories, LLC, with a principal place of business at 16217 S. Bringhurst Blvd. Suite 600, Bluffdale, Utah 84065.
“Consulting Services” means the laboratory consulting services provided by Canyon Labs as described and set forth in an applicable Price Quote.
“Customer” means the customer identified in the price quote attached hereto as Exhibit A (the “Price Quote”).
“Disclosing Party” means the party disclosing Confidential Information (defined below) to the other party, including any Affiliate of such other party.
“Effective Date” means the date this Agreement is fully executed by the parties.
“Hazardous Materials” means those elements or compounds which are contained in the list of hazardous substances adopted by the United States Environmental Protection Agency (“EPA”) and the list of toxic pollutants designated by Congress or the EPA or defined by any other federal, state or local statute, law, ordinance, code, rule, regulation, order or decree regulating, relating to, or imposing liability or standards of conduct concerning any hazardous, toxic or dangerous waste, substance or material as now or at any time in effect.
“Laboratory Services” means the laboratory testing and analysis services conducted by Canyon Labs as described and set forth in an applicable Price Quote.
“Quality Agreement” means a separate laboratory quality agreement executed by the parties, if any.
“Receiving Party” means the party receiving Confidential Information (defined below) from the other party, including any Affiliate of such other party.
“Regulatory Authority” means any applicable competent authority, notified body, or other national, multinational, federal, state, provincial or local regulatory agency, department, or governmental entity that has regulatory authority relating to the Services performed hereunder.
“Reports” means a written report prepared by Canyon Labs detailing the data from the results of the Laboratory Services, as specified in an applicable Price Quote.
“Samples” means any item or material submitted by Customer to Canyon Labs for testing and/or analysis by Canyon Labs in accordance with this Agreement.
“Services” means, collectively, the Consulting Services and Laboratory Services conducted by Canyon Labs under this Agreement.
2. Laboratory and Consulting Services
2.1. Services. From time to time during the term of this Agreement, Canyon Labs shall perform the Services as set forth in an applicable Price Quote.
2.2. Changes to Scope of Work. Customer may request changes in the scope, protocol, and/or scheduling of the Services to be performed. Requests for such changes shall be made by Customer in writing (a “Change Order”). Upon Canyon Labs’ receipt of a Change Order, the parties shall negotiate in good faith an amendment to the Price Quote. If an amendment requires additional or different work on the part of Canyon Labs, Canyon Labs may agree to conduct such additional or other services at an additional cost, which amendment shall be reflected in an amended Price Quote. If the parties are unable to agree upon the terms and adjustments to be included, Canyon Labs shall have no obligation to perform the requested change and shall have no liability for its decision to not do so.
2.3. Procedural Changes. The parties acknowledge that during the course of performing the Services, additional costs may be incurred by Canyon Labs as a result of procedural changes which are deemed necessary by Canyon Labs to successfully perform the Services and which could not be reasonably foreseen at the time of the preparation of the Price Quote. If such procedural changes occur, Canyon Labs shall advise Customer prior to their implantation and solicit Customer’s agreement as to the necessity and additional cost thereof. Should Canyon Labs be unable to contact Customer in advance, Customer agrees that in order to maintain the integrity of the Services, Canyon Labs may proceed accordingly and be entitled to recover such additional costs from Customer upon presentation of an explanation of such procedural changes and the necessity thereof.
2.4. Customer Caused Delay. Canyon Labs shall not be responsible for any nonperformance or delay in the Services caused by Customer or Customer’s employees, agents, or contractors.
3. Price and Payment and Termination
3.1 Price. Subject to the terms and conditions of this Agreement, prices for the Services shall be set forth in an applicable Price Quote. Unless stated otherwise, Price Quotes for the Services are based on the assumption that the Samples to be tested and analyzed have properties within conventional parameters and do not require special handling, storage, or treatment, for which additional charges may apply.
3.2. Price Adjustments. The prices quoted by Canyon Labs are subject to change at the sole discretion of Canyon Labs. Unless otherwise stated in an applicable Price Quote, Canyon Labs shall be entitled to increase the price of Services to the Customer without prior notice.
3.3. Expedited Services. Customer may request, and Canyon Labs may agree, to perform expedited Services for Customer. In the event Canyon Labs agrees to perform such expedited Services, Canyon Labs shall be entitled to adjust the price of the Services to compensate Canyon Labs for, among other things, the interruption of generally scheduled tests, expedited material purchases, staff overtime/after-hours work, etc.
3.4. Payment Terms. Customer shall pay Canyon Labs in accordance with the payment terms set forth in the Price Quote. Canyon Labs may, as noted in the Price Quote, require full or partial prepayment. If prepayment is required, prepayment is due before Canyon Labs performs any Services. Unless otherwise agreed in writing, all fees are invoiced directly to Customer and payable only in U.S. currency. Settlement of an amount owed hereunder is effected only upon Canyon Labs’ receipt, in full, of the amount owed without deductions of any nature. Customer’s obligation to pay Canyon Labs is not in any way conditioned upon Customer receiving payment from any third party or on any specific result from Canyon Labs’ Services.
3.5. Late Payment/Default. If Customer fails to make any payment in accordance with this Agreement, in addition to any other remedies available at law, Canyon Labs has the full right to (i) cease all Services, withhold test data, results, Reports and other deliverables, and cause all invoices to be immediately due and payable, even if such ceasing would compromise Customer’s study and require Customer to prepare and submit new Samples; provided, however, that Customer is still obligated to pay for the Services up to the date the Services ceased by Canyon Labs; (ii) charge interest on all amounts not paid by the due date at the rate of 1.5% per month, compounded monthly, from the due date of payment; and/or (iii) terminate this Agreement and charge Customer for all losses (including loss of profits), costs (including the cost of all labor and materials and disposal of the Samples), damages, charges, and any other expenses incurred by Canyon Labs in connection with its performance of this Agreement or as a result of the termination thereof. Customer agrees to pay all costs and expenses incurred by Canyon Labs related to collection of amounts owed hereunder, including attorneys’ fees.
3.6. Cancellation. In the event Customer interrupts, suspends, or cancels the Services for any reason, the completed portion of the Services, including, but not limited to, supplies, materials, labor, and equipment utilization shall be billed to Customer. In such circumstances where Canyon Labs agrees to place Services on hold, Canyon Labs may bill Customer stand-by charges, as determined by Canyon Labs, including storage fees, until the Services resume or are terminated by Customer. If the Services are terminated by Customer, Customer shall pay for all Services performed by Canyon Labs up to the cancellation.
4. Sample Handling and Disposal
4.1. Submitting Samples. Subject to the provisions of Section 5 below, Customer shall, at its cost and expense, deliver all Samples with respect to which Canyon Labs is to perform Services to the designated Canyon Labs facility. Customer shall bear all liability, risk of loss or damage to, or contamination of, the Samples in transit. Customer shall package, label, and ship Samples to Canyon Labs strictly in accordance with the requirements of all applicable laws and any packaging, handling, and shipping instructions provided by Canyon Labs.
4.2. Sample Retains. Subject to the provisions of Section 5, Canyon Labs will, unless otherwise mutually agreed upon, store any portion of the Samples not consumed in the course of testing and analysis for a period of at least fourteen (14) days after completion of the testing and analysis with respect thereto and, if applicable, delivery to Customer of the applicable Reports (the “Retention Period”). At the expiration of the Retention Period, the Samples may be either (i) returned to Customer, at Customer’s expense and risk; or (ii) subject to Canyon Labs’ approval, stored by Canyon Labs beyond the Retention Period for a monthly fee fixed by Canyon Labs based on the size and nature of the Samples and the conditions under which such Samples must be stored in order to preserve its condition. In the event Customer does not request in writing either the return or storage of the Samples before expiration of the Retention Period, Canyon Labs may, in its sole and exclusive discretion, retain, dispose, or destroy the Samples at Customer’s cost.
5. Hazardous Material
5.1. Notification. Prior to shipping any controlled substance or Hazardous Material to Canyon Labs, Customer shall notify Canyon Labs of such materials including, without limitation, clearly identifying all hazardous characteristics by providing associated hazard documentation including a Material Data Safety Sheet for all substances known or suspected to contain Hazardous Material. Canyon Labs may, in its discretion, reject Samples if they are not accompanied by adequate and acceptable documentation.
5.2. Shipping of Hazardous Material. Customer shall be responsible for properly packaging, labeling, and shipping all controlled substances and suspected Hazardous Material to Canyon Labs. Customer shall ensure that all shipments to Canyon Labs shall comply with all applicable federal, state, and local regulations, including U.S. DOT. Canyon Labs reserves the right to refuse Samples which, in its sole judgment, may present a risk to health, safety, or the environment when handling, processing, or transporting, or if Canyon Labs is not authorized to accept them. Customer shall promptly remove from Canyon Labs’ facilities, at Customer’s expense, any and all Samples for which Canyon Labs revokes acceptance.
5.3. Return of Hazardous Material. Unless otherwise set forth in the applicable Price Quote, any Samples found or suspected to contain a controlled substance or Hazardous Material shall be returned to Customer at Customer’s expense upon completion of the Services. Customer shall be solely responsible for the proper disposal of the controlled substance or Hazardous Material. In the event the controlled substance or Hazardous Material cannot be returned or easily disposed of, Canyon Labs will dispose of such material and Customer shall incur an additional charge for such disposal, depending on the amount and type of the disposal required.
6. Reports
6.1. Reports. Canyon Labs shall prepare and deliver to Customer the applicable Report (or Reports) set forth in the Price Quote. Unless otherwise specified in the Price Quote or otherwise agreed upon by the parties, all Reports, including any accompanying data and/or analysis, shall be prepared in the standard format of Canyon Labs and provided to Customer in an electronic non-editable format. Canyon Labs shall have no obligation to prepare or deliver any Report with respect to an order for Services which is cancelled by Customer prior to the delivery of the Report or where Customer has failed to timely pay for the Services as set forth in this Agreement.
6.2. Specialized Reports. Canyon Labs may charge additional fees for customized reports not used in Canyon Labs’ routine report analysis. Prior to Canyon Labs performing the Services, Customer shall inform Canyon Labs of any customized report requests, including, without limitation, any Customer specific format and whether such Report (or Reports) will be used by Customer for submission to any regulatory agency.
6.3. Study Design Liability and Responsibility. Upon Customer’s request, and as set forth in an applicable Price Quote, Canyon Labs will assist Customer in the development of test plans for submission to a regulatory agency. Customer acknowledges and agrees that it is the sole responsibility of Customer to develop, seek, and obtain the regulatory agency’s pre-approval of the Customer’s study and design, including Canyon Lab’s test protocols to be used for the submission, prior to initiation of the testing. Customer assumes all liability for the design of all the testing necessary to meet the regulatory and other requirements for the Customer’s specific product. Canyon Labs’ only responsibility is to perform testing in accordance with the agreed upon Customer approved protocols. Failures resulting from study design are the sole responsibility of Customer. Pre-approval of the study design and test protocols is not a guarantee of regulatory or other approval and Canyon Labs bears no responsibility for the acceptance or rejection of any studies submitted to the U.S. Food and Drug Administration (“FDA”), or any other regulatory agency or third party.
6.4. Exclusive Use and Acceptance. All Reports issued by Canyon Labs are for the exclusive use of Customer. No other entity or person may rely upon or use such Report without the written consent of Canyon Labs. No Report may be reproduced, except in its entirety, without the prior written approval of Canyon Labs. Canyon Labs’ Reports apply only to the specific Samples tested under stated test conditions and protocols, and test results are not necessarily indicative of the qualities of apparent identical or similar testing or conditions. Canyon Labs shall have no liability for any deductions, inferences or generalizations drawn by Customer or others from Canyon Labs’ Reports. If Customer requests verification of any part of the Report, Customer shall notify Canyon Labs within no more than thirty (30) days of submission of the Report to Customer. Failure to notify Canyon Labs within this thirty (30) day period acknowledges acceptance of the Report by Customer. Should additional work be required for verification purposes, Canyon Labs shall be entitled to the reasonable value of the additional work performed by Canyon Labs. Payment for any Report or other Canyon Labs invoice shall not be conditioned upon acceptance and/or approval of a third party or the results of the test.
6.5. Retention of Reports. Canyon Labs will retain the Reports for a period of at least ten (10) years after the Reports have been provided to Customer, after which such Reports will be destroyed.
7. Term and Termination
7.1 Term. The term of this Agreement shall be as set forth in the applicable Price Quote.
7.2. Termination. The non-breaching party may immediately terminate this Agreement if the other party commits a material breach (“Breach”) under this Agreement, which Breach is not remedied within thirty (30) days after the receipt of a written notice of the Breach from the non-breaching party.
7.3. Survival. All obligations of both parties, including obligations of confidentiality, indemnity, and any accrued financial obligations hereunder which expressly or by their nature survive the expiration, termination, or assignment of this Agreement, shall continue in full force and effect subsequent to, and notwithstanding, such expiration, termination or assignment, until they are satisfied or, by their nature, expire.
8. Warranty, Limitation of Liability
8.1. Warranty. Canyon Labs warrants that the testing performed under this Agreement will be done in accordance with the referenced protocols, as applicable, and that reported test results will be accurate within generally accepted commercial ranges of accuracy, unless another measure of accuracy has been agreed to in writing between Canyon Labs and Customer. Canyon Labs’ testing laboratory is registered with the FDA and holds a number of accreditations and certifications as set forth on Canyon Labs’ website (www.canyonlabs.com). It is Customer’s responsibility to confirm that Canyon Labs has the accreditation Customer requires to meet its requirements. Further, Customer is responsible to confirm in writing and ensure that Canyon Labs is aware of any testing requiring accreditation or specific documentation for regulatory submission. Canyon Labs makes no claims or guarantees that reported test results or data will meet Customer’s requirements, whether regulatory, commercial, industrial, or otherwise. It is the complete and full responsibility of Customer to determine if Canyon Labs’ accreditation, certifications, and protocols will satisfy Customer’s requirements. Customer understands and agrees that Samples that are tested and reported are representative of the Sample received and may not be indicative of the entire manufactured batch and/or lot.
8.2. Warranty Disclaimer. Except as stated in Section 8.1, the Services provided by Canyon Labs under this Agreement are rendered “as is” and Canyon Labs disclaims to the fullest extent permitted by law all warranties, express or implied, including any warranties of merchantability or fitness for a particular purpose.
8.3. LIMITATION OF LIABILITY. THE ENTIRE LIABILITY OF CANYON LABS AND THE EXCLUSIVE REMEDY OF CUSTOMER FOR ANY AND ALL DAMAGES (DEFINED BELOW) ARISING FROM OR RELATING TO THIS AGREEMENT AND/OR THE SERVICES PROVIDED BY CANYON LABS TO CUSTOMER HEREUNDER SHALL BE LIMITED TO, AT CUSTOMER’S OPTION, EITHER (I) REPERFORMANCE BY CANYON LABS OF THE DEFICIENT SERVICES, AT NO ADDITIONAL CHARGE TO CUSTOMER; OR (II) RETURN OF THE FEES PAID BY CUSTOMER FOR THE DEFICIENT SERVICES. CANYON LABS SHALL HAVE NO OTHER LIABILITY. ANY ACTION BY CUSTOMER FOR SUCH DAMAGES MUST BE COMMENCED WITHIN ONE (1) YEAR AFTER THE CAUSE OF ACTION HAS ACCRUED. CANYON LABS SHALL NOT BE LIABLE TO CUSTOMER FOR ANY SPECIAL, INDIRECT, INCIDENTAL, OR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOSS OF PROFITS, REGARDLESS OF WHETHER CANYON LABS HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.
8.4. RELEASE AND WAIVER. TO THE FULLEST EXTENT PERMITTED BY LAW, CUSTOMER WAIVES AND RELEASES CANYON LABS AND ITS DIRECTORS, OFFICERS, EMPLOYEES, AFFILIATES, AGENTS AND SUBCONTRACTORS FROM ALL LIABILITY, CLAIMS, DEMANDS, ACTIONS, OR CAUSES OF ACTION FOR ANY ALLEGED LOSS, DAMAGE, OR INJURY, OTHER THAN CUSTOMER’S EXCLUSIVE REMEDY AS SET FORTH IN SECTION 8.3. THIS RELEASE AND WAIVER COVERS ALL CLAIMS ARISING IN TORT AS WELL AS THOSE ARISING UNDER ANY STATE OR FEDERAL STATUTE, THAT IN ANY WAY ARISE OUT OF, OR RELATE TO, THE SERVICES OR PERFORMANCE OR ALLEGED NON-PERFORMANCE UNDER ANY AGREEMENT BETWEEN THE PARTIES.
9. Confidentiality
9.1. Confidential Information. It is understood that during the term of this Agreement, each party may be exposed to data and information that is confidential and proprietary to the other party. All such data and information made available, disclosed, or otherwise made known to the Receiving Party as a result of the Services provided under this Agreement shall be considered confidential and is the sole property of the Disclosing Party (the “Confidential Information”). Confidential Information also includes all information regarding laboratory methods, laboratory pricing, laboratory services, laboratory management, and all other information regarding the Disclosing Party’s operations.
9.2. Confidentiality Obligations. The Confidential Information shall be used by the Receiving Party only for the purpose of performing the Receiving Party’s obligations hereunder. The Receiving Party agrees that it will not reveal, publish, or otherwise disclose the Confidential Information of the Disclosing Party to any third party without the prior written consent of the Disclosing Party. The obligations of confidentiality set forth herein shall remain in effect for a period of seven (7) years after the date of disclosure of such information.
9.3. Exceptions. The foregoing obligations, however, shall not apply to information or data that: (i) at the time of or after disclosure, is published, known publicly or becomes part of the public domain through no fault of the Receiving Party; (ii) is developed by or for the Receiving Party independent of any Confidential Information received from the Disclosing Party hereto; (iii) prior to disclosure, is known by the Receiving Party as evidenced by its written records maintained in the ordinary course of business; or (iv) information which has been or is disclosed to the Receiving Party without any obligation of confidentiality from a third party not having a contractual relationship with the Disclosing Party. Notwithstanding the foregoing, a party may disclose Confidential Information (i) to its attorneys, accountants, consultants, and Affiliates to the extent necessary to perform the Services; and (ii) as requested or required pursuant to an applicable federal, state, or local law or regulation, or in a bona fide legal process; provided that, unless others prohibited by law or a valid legal order or requirement, the Receiving Party will first have provided the Disclosing Party with prompt written notice of such required disclosure to allow the Disclosing Party to seek a protective order with respect to the confidentiality of the information required to be disclosed.
10. Indemnification
10.1. Indemnification. Customer shall indemnify, defend, and hold harmless Canyon Labs and its affiliates from and against any and all losses, liabilities, damages, costs, expenses and judgments of any kind (including attorneys’ fees) (“Damages”) that may be incurred by Canyon Labs in connection with a claim, action, or proceeding of any kind made or brought by a third party arising out of or relating to the Services provided by Canyon Labs hereunder, including, without limitation, testing results or testing data provided by Canyon Labs to Customer, the manufacture, marketing, or sale of Customer’s products, and any infringement of any third party’s intellectual property rights.
10.2. Indemnification Procedure. Canyon Labs agrees to notify Customer of a claim or suit to which Canyon Labs is entitled to indemnification under this Section 10. Canyon Labs shall provide reasonable cooperation and full authority to defend or settle the claim or suit. Canyon Labs may elect to participate in such defense at its sole option and expense. Customer may not enter into any non-monetary settlement without the prior written consent of Canyon Labs.
11. Intellectual Property
11.1. Intellectual Property. Customer acknowledges and agrees that all testing protocols or processes used to generate test results and Reports are the sole ownership of Canyon Labs. Unless otherwise agreed by Canyon Labs in writing, any and all inventions, techniques, analytical methods, procedures, protocols, scientific and technical data, and equipment developed by Canyon Labs for the performance of the Services shall be the exclusive property of Canyon Labs. Customer agrees that it shall not infringe upon any of the intellectual property rights of Canyon Labs.
11.2. Reservation of Ownership. Nothing in this Agreement shall be construed as a sale or transfer of Canyon Labs’ copyrights, trademarks or any other intellectual property owned or held by Canyon Labs. Until such time as Customer has paid Canyon Labs in full with respect to any Services provided by Canyon Labs, the license to use any Reports, test results or any data related thereto shall be prohibited and shall remain the property of Canyon Labs. Canyon Labs shall, in its sole discretion, without notice to Customer, be entitled to take possession of any such Reports which have not been paid for or for which payment is overdue. Customer shall not be entitled to a credit with respect to Services that may have been partially paid for.
12. Audits and Inspections
12.1. Audits and Inspections by Regulatory Authorities. Canyon Labs shall grant entry and access to applicable Regulatory Authorities where legitimate cause can be demonstrated by such Regulatory Authority and such Regulatory Authority products a formal written request, regardless of whether such request is through announced or unannounced visits to Canyon Labs’ facility. Canyon Labs shall grant reasonable access to information held by Canyon Labs in the course of the Services rendered hereunder for Customer, subject to prevailing obligations relating to disclosure of information governed by applicable confidentiality and non-disclosure agreements between Canyon Labs and Customer. Customer shall disclose to Canyon Labs the identity of any Regulatory Authority to whom extended access has been requested. Notwithstanding anything else herein to the contrary, Canyon Labs may deny entry and/or access to a Regulatory Authority where sufficient cause is determined to exist by Canyon Labs.
12.2. Compensation. Customer shall pay Canyon Labs at the rate of $250 per hour for work performed by Canyon Labs relating to preparation for and participation in the announced or unannounced audit/inspection. Following completion of the audit/inspection, Canyon Labs shall submit an invoice to Customer which invoice shall include the hours spent and the total amount owed by Customer. Customer shall pay Canyon Labs the amount identified on the invoice within thirty (30) days after the date of the invoice.
12.3. Indemnification. Customer shall indemnify, defend, and hold harmless Canyon Labs and its affiliates from and against any and all Damages incurred by Canyon Labs arising out of or relating to any pass-through omission or alleged deficiency identified by a Regulatory Authority during the course of Canyon Labs’ Services performed for Customer, unless caused by Canyon Labs’ negligence or failure to perform its obligations under this Agreement.
13. Miscellaneous
13.1. Force Majeure. No party shall be liable for delay or failure to perform its obligations hereunder (except for a failure to pay fees) due to any contingency directly impacting such party’s delay or failure to perform and beyond its reasonable control, after reasonable efforts to exercise such control, including, but not limited to war (declared or undeclared), riot, political insurrection, rebellion, revolution, acts or orders of or expropriation by any government (whether de facto or de jure), lack of availability or shortage of suppliers, of necessary materials, equipment or production facilities, quarantine restrictions, epidemic or pandemic, fuel shortage, fire, flood, explosion, earthquake, tornadoes or other natural events.
13.2. Governing Law. The parties agree that all questions of the validity, interpretation, or performance of the terms of this Agreement or of any rights or obligations of the parties related in any way to this Agreement shall be governed by Utah law and the federal laws of the United States of America without regard to principles of conflict of laws, and venue shall lie exclusively in the courts of the state of Utah, Salt Lake County. Each party expressly consents to the jurisdiction of the state or federal courts in the state of Utah and hereby further irrevocably waives any objection to jurisdiction or venue based on lack of personal jurisdiction, place of residence, improper venue, or forum non conveniens in any such action.
13.3. Subcontractors. At the sole discretion of Canyon Labs, Canyon Labs may retain the services of a sub-contractor which meets its qualifications to perform any of the Services contracted for on behalf of Customer.
13.4. Legal Fees and Collection Costs. Should Canyon Labs instruct its attorneys or collection agent to collect any overdue amounts, or to take any action against Customer in the implementation or protection of Canyon Labs’ rights, Canyon Labs shall be entitled to the recovery of all legal fees, costs, and collection costs arising therefrom.
13.5. Waiver. The waiver by any party hereto of a breach of any provision of this Agreement shall not operate or be construed as a waiver of any subsequent breach.
13.6. Entire Agreement. This Agreement and attachments, and any executed Quality Agreement (if applicable), contain the entire understanding among the parties and supersedes any and all prior agreements, understandings and arrangements whether written or oral among the parties with respect to the matters contained in this Agreement. No amendments, changes, modifications or alterations of the terms and conditions of this Agreement shall be binding upon any party, unless in writing and signed by an authorized representative of each party. Any terms and conditions, or any other provision in any purchase order or other communication used by Customer that may be different or inconsistent with this Agreement shall be entirely inapplicable unless otherwise mutually agreed upon in writing by the parties, and this Agreement shall take precedence over all such other documents or communications which may be used in the implementation or the administration of this Agreement. In the event of a conflict or inconsistency between any of the terms and conditions of this Agreement and the terms and conditions of an applicable Quality Agreement, the terms and conditions of the Quality Agreement shall prevail with respect to regulatory responsibilities only, and the terms and conditions of this Agreement shall prevail with respect to all other subjects.
13.7. Electronic Signature. This Agreement and any related agreement between the parties may be executed and delivered by facsimile, PDF, or by means of other electronic signature, and such electronic signature shall be deemed to be valid and original.
13.8. Severability. In the event that individual provisions of this Agreement become wholly or partially invalid as evidenced by a ruling of a court of competent jurisdiction, the effectiveness of the remaining provisions shall not be affected, to the extent severable. The parties undertake in good faith to replace an invalid provision by a valid one which most closely corresponds with the economic intention of the invalid ruling.