Terms and Conditions
SURE-BIOCHEM LABORATORIES STANDARD TERMS AND CONDITIONS
The following Standard Terms and Conditions shall govern the services provided by Sure-BioChem Laboratories, LLC to Customer. These Terms and Conditions together with an applicable proposal, protocol, study, work order, or part thereof shall constitute the Agreement.
SURE-BIOCHEM LABORATORIES WARRANTY
Sure-BioChem Laboratories agrees to perform its services in keeping with the standards set forth in Sure-BioChem Laboratories proposals, quotes, Customer-approved protocols, work orders and generally prevailing industry standards, as applicable to the project being performed. Sure-BioChem Laboratories shall use any materials or test articles provided by Customer solely for purposes of performing services in accordance with these Terms and Conditions and the applicable Sure-BioChem Laboratories proposal, quote, work order, or Customer-approved protocol under which such materials or test articles are provided.
Sure-BioChem Laboratories will endeavor to perform its services in a timely fashion, and will advise its Customer in a timely manner in the event of circumstances that may occasion any significant delay.
LIMITATION OF LIABILITY
Sure-BioChem Laboratories makes no warranty, express or implied, except as set forth herein. Sure-BioChem Laboratories shall not be liable for any claim or breach of warranty unless such claim is submitted in writing to the offices of Sure-BioChem Laboratories within one year following the date the services giving rise to the claim were performed. Except as provided herein, Sure-BioChem Laboratories shall not be liable to the Customer or any third party for any claim, whether based upon breach of warranty or any other theory. Without limiting the generality of the foregoing, Sure-BioChem Laboratories and Customer shall not be liable for any consequential, incidental or other damages, including, without limitation, loss of profits, business or damage to goodwill, regardless of the foreseeability of any of the foregoing. Sure-BioChem Laboratories' liability for breach of the Sure-BioChem Laboratories Warranty or any implied or statutory warranties or any claimed to arise by operation of law shall be limited to either 1) refund of the price paid by Customer to Sure-BioChem Laboratories for any service, adjudged or mutually agreed not to have been performed in accordance with the Sure-BioChem Laboratories Warranty or 2) reperformance of any service adjudged or mutually agreed not to have been performed in accordance with the Sure-BioChem Laboratories Warranty. THE WARRANTIES SET FORTH HEREIN ARE EXCLUSIVE AND IN LIEU OF ALL OTHER WARRANTIES, WHETHER ORAL OR WRITTEN, EXPRESS OR IMPLIED, INCLUDING THE WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, ALL OF WHICH ARE WAIVED BY CUSTOMER.
CHANGE IN SCOPE OF WORK
Customer shall have the right to request reasonable changes and/or modifications ("Changes") to the scope of a proposal, quote, Customer-approved protocol, or work order under which services are performed. Should the scope of the proposal, quote, Customer-approved protocol or work order increase or decrease, the prices will be revised accordingly. All such Change requests and associated pricing shall be in writing and shall be signed by authorized representatives of Sure-BioChem Laboratories and Customer to be considered effective. If such Changes affect the projected completion date and/or report date of the services, the completion and report due dates shall be adjusted commensurate with such effect.
RECORDS AND REPORTS
Sure-BioChem Laboratories shall deliver a report of findings for each service performed. Service records are available for Customer review at the Sure-BioChem Laboratories site. Unless the parties otherwise agree in writing, Sure-BioChem Laboratories will retain laboratory and other technical records of services for a ten (10) year period as set forth in the relevant Sure-BioChem Laboratories standard operating procedures (SOPs) or for at least the minimum period required by applicable law and consistent with regulatory bodies and guidance relating to testing of pharmaceutical products. To the extent that descriptions of any of Sure-BioChem Laboratories' protocols, test methods, or SOPs are not included in the Customer-approved protocol, work order, or report pertaining to any particular service and are required by a competent regulatory authority for submission in connection with articles of the type being tested, Sure-BioChem Laboratories will upon request provide a copy of the relevant portion of such protocols, test methods, or SOPs to be used solely for purposes of such regulatory submission.
During performance of services, each party will treat all information provided by each other in connection with the CWP Agreement as proprietary and confidential.
Sure-BioChem will assign invention rights to Customer upon full payment for Sure-BioChem's services. Ownership of property and inventions shall be governed by the CWP Agreement.
Upon at least 14-day advance notice, Customer representatives may visit Sure-BioChem Laboratories' facilities during normal working hours to observe services, discuss services with appropriate staff members of Sure-BioChem Laboratories, and to inspect Sure-BioChem Laboratories' facilities and records, as they relate to services. While on Sure-BioChem Laboratories' premises, Customer shall adhere to any and all safety, security, and confidentiality measures required by Sure-BioChem Laboratories.
TERMINATION OF STUDY
If any testing study, protocol or part thereof shall be terminated after commencement Customer shall be liable to Sure-BioChem Laboratories for the services actually performed and materials, reagents, and expenses consumed, employed, or specially obtained for such study, protocol or part thereof. If Customer cancels any testing study, protocol or part thereof before commencement, Customer shall reimburse Sure-BioChem Laboratories for expenses incurred or irrevocably committed to third parties in accordance with the Agreement up to receipt of notice of termination.
UNEXPECTED STUDY RESULT / INVALID RESULT/ OUT OF SPECIFICATION RESULT
If, within sixty (60) days of receiving a valid study result, Customer notifies Sure-BioChem Laboratories in writing that the result is unexpected, Sure-BioChem Laboratories will initiate a laboratory investigation of the result. The Customer and Sure-BioChem Laboratories will agree on an appropriate course of action pending the results of the laboratory investigation. If Sure-BioChem Laboratories observes an invalid result, it will notify Customer within two (2) business days of learning of such result. Customer and Sure-BioChem Laboratories will agree on the appropriate course of action to investigate the invalid result. In cases where Customer specifications have been provided to Sure-BioChem Laboratories, if Sure-BioChem Laboratories observes an Out Of Specification (OOS) result it will notify Customer within two (2) business days of learning of such result. Customer and Sure-BioChem Laboratories will agree on the appropriate course of action to investigate the OOS result. If Sure-BioChem Laboratories determines that an unexpected, invalid, or OOS result is due to the inherent condition of the test article or the act, omission, direction, or negligence of Customer, and not due to Sure-BioChem Laboratories error, Customer shall be liable to Sure-BioChem Laboratories for the services performed, including any retests, and materials, reagents, expenses, etc. consumed, employed, or specially obtained during the course of the laboratory investigation. If the unexpected, invalid, or OOS result was caused by a combination of test article condition or the act, omission, direction, or negligence of Customer, and Sure-BioChem Laboratories error, or a reasonable determination of cause cannot be ascertained, Customer shall be liable for 50% of the services performed, including any retests, and 100% of the cost of any materials or reagents specially obtained by Sure-BioChem Laboratories during the course of the laboratory investigation. Customer is not liable to Sure-BioChem Laboratories for unexpected, invalid, or OOS results due primarily to Sure-BioChem Laboratories error, and Sure-BioChem Laboratories shall perform a retest, or provide a refund of any payments made by Customer,
Customer shall indemnify and hold harmless Sure-BioChem Laboratories, its officers, directors, agents and employees from and against any and all losses, costs, damages and/or expenses (including, without limitation, reasonable costs of counsel), incurred by any such indemnity as a result of or in connection with any claim by any third party 1) for injury (physical, emotional, psychological or other) or death of any person or physical damage to any property arising out of the testing, development, manufacture, sale or other use or distribution of any material or product which is the direct or indirect subject of any study, protocol, or part thereof performed by Sure-BioChem Laboratories under the Agreement, provided such claim, injury, death or property damage is not the result of Sure-BioChem Laboratories' negligence or reckless or willful misconduct in carrying out its obligations under the Agreement, or 2) alleging Sure-BioChem Laboratories' use of Customer materials, Customer information or Customer patent rights that are supplied to Sure-BioChem Laboratories by Customer infringes any rights (including, without limitation, any intellectual or industrial property rights) vested in any third party (whether or not the Customer knows or ought to have known about the same). Sure-BioChem Laboratories will promptly notify Customer of any claim of which it becomes aware and will cooperate with Customer's reasonable requests in connection with defense of such claim, at Customer's expense.
Sure-BioChem Laboratories and Customer shall not be held responsible for failure or delay in performance of their obligations under or in connection with the Agreement due to, but not limited to, the following: acts of God, government actions, labor disputes, civil disturbances, power outages, fire, natural disasters, material shortages, or failure of suppliers or subcontractors because of any of the above conditions. If such delay persists for a period longer than sixty (60) days, Customer may terminate the services and shall pay Sure-BioChem Laboratories for services performed in compliance with the Agreement prior to receipt of the notice of termination.
Unless otherwise specified in a Sure-BioChem Laboratories' quotation, proposal, or work order submitted to Customer, consultation services will be invoiced 50% upon initiation and 50% upon completion of services, as applicable. All standard testing is invoiced 100% upon initiation. Terms are C.O.D, unless other arrangements are made between the parties. Invoices are billed and payable in U.S. dollars only.
Neither party may use the other party's name in any form of advertising, promotion or publicity, including press releases and technical reports, without the prior written consent of the other party. This term does not restrict a party's ability to use the other party's name in filings with the Securities and Exchange Commission, FDA, or other governmental agencies, when required to do so.
Nothing in these Terms and Condition, proposal, quote, or work order shall be construed as to create any relationship between Sure-BioChem Laboratories and Customer other than that of independent contracting parties. Neither party shall have any right, power, or authority to assume create or incur any expense, liability, or obligation, express or implied, on behalf of the other.
Either party's failure to enforce at any time any of the provisions of the Agreement, to exercise any election or option provided herein, or to require at any time performance of any of the provisions hereof, shall in no way be construed to be a waiver of such provisions, nor in any way to affect the validity of the Agreement or any part thereof, or the right of either party thereafter to enforce each and every such provision.
The illegality or invalidity of any provision (or any part thereof) of any applicable quote, proposal or work order, or these Standard Terms and Conditions shall not affect the legality, validity or enforceability of the remainder of its provisions or the other parts of such provision as the case may be.
Sure-BioChem Laboratories reserves the right to subcontract Customer’s work to an external laboratory that is appropriately accredited. When subcontracting analytical services, Sure-BioChem Laboratories assures work requiring accreditation is placed with an appropriately accredited laboratory or one that meets applicable statutory and regulatory requirements for performing the tests. Sure-BioChem Laboratories
In the event of any dispute arising under the Agreement, senior executives of Sure-BioChem Laboratories and Customer ("the parties") with decision-making authority will enter into good faith negotiations to resolve the dispute. The parties agree to submit any unresolved dispute to a sole mediator selected by the parties as soon as reasonably possible (but no later than sixty (60) days after notice). If not thus resolved, the matter shall be submitted to an arbitration proceeding in New Jersey and the parties shall share equally the filing fees, arbitration fess, or other costs of such proceedings, except that each party shall be responsible for its own attorney's fees and other out-of-pocket arbitration expenses unless the arbitrators decide otherwise. The proceeding shall be conducted under the then prevailing rules for commercial arbitration of the American Arbitration Association, by a panel of three (3) arbitrators reasonably acceptable to both of the parties, one of whom must have substantial experience in the field of contract testing services. The arbitrators shall have the authority to permit limited discovery to the extent required by a party in order to establish its case. The decision of the arbitrators shall be final and binding and may be entered and enforced in any court of competent jurisdiction. Any monetary award shall be payable in U.S. dollars, free of any tax, offset or other deduction. Any determination of the arbitration shall be confidential to the parties hereto and binding solely on the parties hereto.
This Agreement including the applicable price quotation embodies the entire understanding of Sure-BioChem Laboratories and Customer and there are no promises, terms, conditions or obligations, oral or written, expressed or implied, other than those contained in the Agreement. The terms of the Agreement shall supersede all previous agreements (if any) which may exist or have existed between Sure-BioChem Laboratories and Customer relating to the services. Notwithstanding the foregoing, any previously executed Confidentiality Agreement still in effect between the parties shall remain in full force and effect. These Terms and Conditions may only be modified by a written agreement signed by duty authorized representatives of the parties.