21 CFR Consulting was started in 2003 with over 20 years of combined IT and Regulatory Compliance experience with one thing in mind - to provide quality software compliance services to the small and midsize life science companies and their software vendors. To date we continue to succeed in achieving that goal; by providing Consultants knowledgeable in the software compliance requirements of 21 CFR Part 11, 210, 211, 820, GCP for Computerized Systems, HIPAA, and SOX who will meet all your software compliance service needs.
With a minimum of 5 years life science industry and/or IT experience, our software compliance Consultants are assigned to your project, based on your specific needs, according to their respective experience. Subsequently, whatever the size and scope of your software compliance efforts, with our professional, results-oriented Consultants as part of your project team, the outcome will be a regulatory compliant environment that provides real business value.
Upon approval of the provided project estimate, the following terms and conditions will apply in full to 21 CFR Consulting and to the approving Company (Client) for the project defined in the estimate.
CONTRACT TYPE
All costing is exclusive to the estimate and will be considered confidential.
Fix Price Projects – Client will be billed, at the proposed fixed rate, for all work within the scope of the estimate. Any work requested outside of the scope of the estimate will be billed at $150 per hour, in quarter hour increments. Travel time will be billed at $75 US/hour. Travel time will be billed in full hour increments. Automobile mileage costs will be billed at current IRS rate. All lodging, airfare, car rental, meals, and incidentals specific to the project will be charged to the Client.
Time and Expense Projects – Due to the dynamic nature of projects, it is difficult to estimate an “average day” therefore all resources rates have been quoted on an hourly basis. Client will be billed, at the proposed bill rate, for actual time spent on the outlined tasks whether the hours spent are less than or more than the project estimates. Time will be billed in quarter hour increments. Travel time will be billed at $75 US/hour. Travel time will be billed in full hour increments. Automobile mileage costs will be billed at current IRS rate. All lodging, airfare, car rental, meals, and incidentals specific to the project will be charged to the Client.
PROJECT COMMENCEMENT
Agreements to commence the project prior to receipt of a PO, payment and/or deposit shall be made on a case-by-case basis and shall not be considered a waiver of this part, or the Clients agreement to comply with the terms and conditions.
Fix Price Projects – Client shall issue a Purchase Order (PO) or equivalent to 21 CFR Consulting, within 5 days of approval of the estimate. Upon receipt of the PO, 21 CFR Consulting shall invoice Client for the total approved task cost. Payment must occur before scheduling and commencement of the project.
Time and Expense Projects – Client shall issue a Purchase Order (PO) or equivalent to 21 CFR Consulting, within 5 days of approval of this estimate. Upon receipt of the PO, 21 CFR Consulting shall invoice Client for 15% of the approved task cost as a deposit, which will be credited against the final invoice. Payment of this deposit must occur before scheduling and commencement of the project.
INVOICING AND PAYMENT
Invoices shall be submitted to Client by 21 CFR Consulting on a weekly basis. All payments shall be made per NET 15; amounts not paid within 15 days of the invoice date will be subject to a finance charge at the rate of 1-1/2% per month (18% per annum) and will be calculated on the outstanding balance.
CANCELLATION AND RESCHEDULING FEE
21 CFR Consulting requires two weeks notice (10 business days) of any changes to scheduled onsite time where air travel is required. If two weeks notice is not given, Client will be charged an amount equal to five (5) person-days and any nonrefundable travel costs.
RIGHT TO HIRE
Client agrees not to directly or indirectly employ, offer to hire, hire, or engage as an independent contractor any resource assigned under the estimate/contract during any such assignment until 12 months from the date assigned work is completed or 12 months from the date final payment is received, whichever comes last.
Client also agrees not to permit or cause any such resource to provide services to Client while on the payroll of any other firm for a like period without the express prior written consent of 21 CFR Consulting. If Client violates this term, Client promises to pay to 21 CFR Consulting, as liquidated damages and not as a penalty, 30% of each such resource’s annualized compensation.
CONFIDENTIALITY
During the performance of this Agreement, it may be necessary for 21 CFR Consulting and Client to disclose information that each regards as proprietary and/or confidential. 21 CFR Consulting and Client agree to maintain such information in confidence and to employ adequate and appropriate procedures to prevent its unauthorized publication and/or disclosure, in occurrence with effective confidentially agreements.
TERMINATION
This Agreement may be terminated by either party upon thirty (30) days written notice. In the event that a termination occurs, Client will not be relieved of its responsibility to pay 21 CFR Consulting for any services performed prior to such termination. The obligations of secrecy and confidentiality set forth herein will survive termination of this Agreement.
DISPUTES
Any disputes that arise between 21 CFR Consulting and Client with respect to the performance of this Agreement will be submitted to binding arbitration by the American Arbitration Association, and be determined and resolved by the Association under its rules and procedures in effect at the time of submission. 21 CFR Consulting and Client agree to equally share in the costs of any arbitration. The final arbitration decision will be enforceable through the courts of the state of California. In the event that any court of competent jurisdiction holds this arbitration provision unenforceable, then this Agreement will be as binding and enforceable as if this term was not a part of the Agreement.
LIABILITY
21 CFR Consulting warrants to Client that the material, analysis, and services to be delivered or rendered as a part of this Agreement will be of the kind and quality designated and will be performed by qualified personnel. Special requirements for format or standards to be followed will be attached as an additional exhibit and signed by both Client and 21 CFR Consulting. 21 CFR Consulting makes no other warranties, whether written, oral or implied, including without limitation, warranty of fitness for a particular purpose or merchantability. In no event will 21 CFR Consulting be liable for special or consequential damages, including, but not limited to, loss of profits, revenue, data, or use by Client or any third party, regardless of whether a claim or action is asserted in contract or tort, whether or not the possibility of such damages has been disclosed to 21 CFR Consulting in advance or could have been reasonably foreseen by 21 CFR Consulting. In the event this limitation of damages is held unenforceable then the parties agree that by reason of the difficulty in foreseeing possible damages all liability to client will be limited to one hundred dollars ($100.00) as liquidated damages and not as a penalty.
COPYRIGHT
Except as specifically set forth in writing and signed by both Client and 21 CFR Consulting, 21 CFR Consulting shall have all copyright and patent rights with respect to all materials developed under the approved estimate, and Client is hereby granted a non-exclusive license to use and employ such materials within the Client’s business.
Standard 21 CFR Consulting document templates shall remain copyrighted to 21 CFR Consulting, LLC.
LIKENESS
Client agrees to allow 21 CFR Consulting the right to list Client as a client/partner on the 21 CFR Consulting website, and provide Client as project reference.
COMPLETE AGREEMENT
This agreement contains the entire Agreement between 21 CFR Consulting and Client with respect to the matters covered within this Agreement. No other agreements, representations, warranties or other matters, oral or written, purportedly agreed to or represented by or on behalf of 21 CFR Consulting by any of its resources or agents, or contained in any sales materials or brochures, will be deemed to bind 21 CFR Consulting and Client with respect to the subject matter of this Agreement. Client acknowledges that it is entering into this Agreement solely on the basis of the representations contained within the Agreement. In the event of a conflict in the provisions of any attachments and the provisions set forth in this Agreement, the provisions of such attachments will govern.
APPROVAL
Approval of the estimate constitutes a legal agreement between the approving company and 21 CFR Consulting, LLC to these terms and conditions.
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