General

Validity

Proposals are valid for 30 days.

Staff Assignment

Cedar and Stone will appoint qualified staff to support the engagement and the activities outlined in the Agreement. 

Service Delivery

Activities may take place remotely or on-site, as requested by Client. Tangible deliverables, such as SOPs or audit documentation, will be delivered to Client via secure email. When document approvals are necessary, signatures will be applied electronically using tools that meet 21 CFR Part 11 requirements. 

Independent Contractors

 Cedar and Stone and its staff are independent contractors and not employees, agents or partners of Client.  Accordingly, they shall have no authority to commit, bind or create any liability on the part of Client in any manner whatsoever.  Cedar and Stone shall be solely responsible for the timely payment of self-employment income taxes, and Client shall not deduct or withhold from any sums payable to Cedar and Stone hereunder any amount on account of any tax or employee benefit.

Liability Insurance

Cedar and Stone shall, at its own expense, maintain in full force and effect throughout the term of the Agreement professional liability (errors and omissions) insurance with limits of not less than $1 Million in the aggregate. Upon request, Cedar and Stone shall provide Client with a certificate of insurance evidencing such coverage. Failure to maintain required insurance shall constitute a material breach of the Agreement.

Non-competition and Non-solicitation

During the term of the Agreement and for a period of one (1) year following the termination of the Agreement, the Parties agree that neither shall offer, or assist any other person in offering employment to any then current employee of the other Party, or attempt, directly or indirectly, to persuade any such employee, or any consultant, vendor, or partner to terminate their employment or business relationship with the other Party. 

Budget and Change Orders

Project Cost

Budget may not be exceeded without prior written approval from Client. 

Change Orders

Changes to the terms in the Agreement shall not be effective unless and until agreed upon and approved in writing by the Parties. 

Additional Services 

 Client may request additional services during the time that Cedar and Stone is fulfilling the commitments outlined in the Agreement. The nature and scope of additional services must be discussed and agreed-upon by both Parties, prior to engaging staff in new activities. Upon agreement, the Parties will determine whether a new Statement of Work (SOW) will be prepared and approved to outline the scope of work, deliverables, and associated budget. Requests for audits will always require a new SOW. New SOWs will be incorporated into the Agreement as addenda.

Confidentiality 

All engagements involve the execution of a Non-Disclosure or Confidentiality Agreement by both Parties.

Cedar and Stone acknowledges that - while performing any work for Client - they may develop or learn information that is confidential and proprietary to Client, its vendors, customers, employees or partners (“Confidential Information”). Cedar and Stone agrees not to disclose any Confidential Information to any third party or to otherwise use any Confidential Information, directly or indirectly, without the prior express written consent from Client. 

Invoicing and Payments

Invoicing

Services. Consulting services will be billed monthly. Invoices will include a description of the work completed, hours worked, dates, and consultant name(s).

Audits. Audits will be billed upon submission to and Client acceptance of all final deliverables.

Expenses. Travel and other qualifying expenses may vary by project and will depend on the location of the personnel assigned to each project. Qualifying expenses include, but may not be limited to airfare, lodging, transportation (car rental, shared ride, train, etc.), fuel, mileage, tolls, parking, meals, travel time, and incidental expenses associated with the conduct of this type of consulting engagement. Expenses will adhere to the Cedar and Stone Travel and Expenses Policy. Travel expenses and accompanying receipts will be reported and submitted for reimbursement as they are incurred.

Time and Expenses Policy

Payments

Electronic payment is required within thirty (30) days of the invoice date.

Term and Termination 

The Agreement shall become effective on the Effective Date and it shall remain in effect for a period of three (3) months.  The Agreement will automatically renew unless notice of non-renewal is received in writing by either Party.

(a)       Client may terminate the Agreement at any time upon thirty (30) days prior written notice to the other Parties. Unless otherwise indicated in Client’s notice of termination, work under the Agreement and any SOW in progress at the time of the delivery of notice of termination shall continue as if the applicable SOW had not been terminated, and the terms hereof shall continue to apply to such work, until the termination date.

(b)       Client may terminate the Agreement for cause — due to Cedar and Stone’s failure to perform their obligations hereunder — upon three (3) days prior written notice to Cedar and Stone.

(c)       Client may terminate the Agreement immediately in the event of a proven violation or threatened violation of any of the provisions in the Agreement.

(d)       Upon termination of the Agreement, or any SOW hereunder, Client’s sole obligation to Cedar and Stone shall be to pay to Cedar and Stone

​ ​ ​​(i)          all undisputed amounts due and owing pursuant to the applicable Agreement and/or SOW up to the effective date of termination; and

​ ​ ​​(ii)        reimbursement of reasonable, documented, and approved expenses incurred in accordance with the terms of this Agreement.

(e)       Upon termination of this Agreement or any SOW hereunder, Cedar and Stone shall immediately turn over to Client all 

​ ​ ​​(i)          Work Product, whether completed or not;

​ ​ ​​(ii)        reports and other written documents of whatever type or nature related to the applicable SOW or to this Agreement; and

​ ​ ​ ​(iii)       property and materials furnished or paid for by Client in support of work performed.  In addition, Cedar and Stone shall cooperate fully with Client to effect a transfer of any arrangements or other interests with third parties related to the applicable work. 

Legal 

Indemnity

The Parties shall indemnify and hold harmless the other Party and their subsidiaries, parent companies, commonly held entities, and their respective directors, officers, employees and agents from any claim, loss, or expense incurred or arising from one Party’s gross negligence, willful misconduct, or breach of the Agreement.

Governing Law and Jurisdiction

The Agreement shall be governed by and construed in accordance with the laws of the State of Texas, without regard to its conflict-of-laws rules. Any legal proceeding arising out of or relating to the Agreement shall be instituted exclusively in the United States District Court for the Southern District of Texas, Houston Division. Client hereby irrevocably submits to the personal and exclusive jurisdiction of such court and waives any objection to the laying of venue in that court and any claim that such forum is inconvenient.