Terms and Conditions
The purchaser agrees as follows:
Service(s)" will be limited to Service(s) that have been purchased. Provision Consulting Group (from here on, "PCG") will be identified as the "registrant contact" for CLIENT's establishment(s). PCG herewith accepts such appointment and undertakes to exert its best efforts to conduct the Service(s) on behalf of CLIENT to comply with the guidelines and regulations set forth by the FDA.
CLIENT shall provide to PCG all documentation required to perform the Service(s).
CLIENT agrees and warrants that all information that CLIENT provides to PCG, including but not limited to any information necessary to register CLIENT's establishment and list CLIENT's device with the FDA, is true and accurate and shall be responsible for the authenticity and validity of the documentation provided to PCG.
CLIENT agrees that CLIENT will promptly inform any changes in a given information.
CLIENT shall be responsible for the shipping costs and import duties for the deliverance of the products or any related materials to PCG.
PCG is a regulatory consulting firm that provides regulatory consulting services. Any grammar and spelling-related matters shall be responsible by CLIENT. All documents must be in English.
For all of our work consumes our intellectual property and labor regardless of the service outcome, all fee is non-refundable in any circumstances.
During the course of Service(s), it is understood that PCG may be exposed to data and information that is confidential and proprietary to the CLIENT. All such data and information (hereinafter “Client Confidential Information”) written or verbal, tangible or intangible, made available, disclosed, or otherwise made known to PCG as a result of Service(s) shall be considered confidential and shall be considered the sole property of CLIENT. The Confidential Information shall be used by PCG only for purposes of performing its obligations hereunder. Each party agrees that it will not reveal, publish, or otherwise disclose the Confidential Information of the other party to any third party without the written consent of the disclosing party. Each party agrees it will not disclose the terms herein to any third party without the written consent of the other party, which shall not unreasonably be withheld. These obligations of confidentiality and non-disclosure shall remain in effect for a period of three (3) years after the completion of Service(s). The foregoing obligations shall not apply to Confidential Information to the extent that it: (a) is or becomes generally available to the public other than as a result of a disclosure by the receiving party; (b) becomes available to the receiving party on a non-confidential basis from a source which is not prohibited from disclosing such information; (c) was developed independently of any disclosure by the disclosing party or was known to the receiving party prior to its receipt from the disclosing party, as shown by contemporaneous written evidence; or (d) is required by law to be disclosed.
E. Ownership and Inventions.
All data and information delivered, generated, or derived by PCG as the result of Service(s) performed by PCG shall be and remain exclusive for CLIENT. Notwithstanding, the foregoing, CLIENT acknowledges that PCG possesses certain inventions, processes, know-how, trade secrets, improvements, other intellectual properties, and other assets, including, but not limited to, analytical methods, procedures and techniques, procedure manuals, personnel data, financial information, computer technical expertise, and computer software, which have been independently developed by PCG and which relate to its business or operations (collectively “PCG’s Property”). CLIENT and PCG agree that any PCG’s Property or improvements thereto that are used, improved, modified, or developed by PCG is the sole and exclusive property of PCG. At the completion of Service(s) by PCG, all materials and all other data owned by CLIENT, regardless of the method of storage or retrieval, shall be in possession of PCG. At CLIENT’s written request, such materials and data may be disposed of pursuant to the written directions of Client after two (2) years of period upon completion of Service(s). PCG, however, reserves the right to retain, at its own cost, one copy of all material provided to Client as the result of the Service(s), to be used to satisfy regulatory requirements or to resolve disputes regarding the Service(s).
F. Relationship with Affiliates.
Purchaser agrees that PCG may use the services of its corporate affiliates and/or hire subcontractors to fulfill PCG’s obligations and that they shall be subject to all of the Terms and Conditions applicable to PCG and entitled to all rights and protections afforded PCG. CLIENT shall not directly contact PCG’s affiliates and/or subcontractors without PCG’s mediation, intervention, and approval to discuss matters regarding the Service(s). This condition shall be effective for the following three (3) years of the completion of the Service(s). If a violation occurs, CLIENT shall immediately compensate PCG the doubled amount of the compensation that was provided to the affiliates, subcontractors, and/or employees whether it may be project-based or salary-based.
Nothing herein contained shall make either PCG or the purchaser the legal representative of the other party for any purpose whatsoever. The parties shall act solely as independent contractors, and nothing in Terms and Conditions shall be construed to give either party the power or authority to act for, bind or commit the other party.
H. FDA Inspection.
Purchaser understands and agrees that FDA has an obligation to inspect any establishments related to manufacturing/importing/distributing processes at any time after the completion of registration.
I. Conflict of Agreements.
The purchaser agrees that it will not enter into an agreement with a third party that would alter or affect any regulatory obligation delegated to PCG without the written consent of PCG, which consent will not be unreasonably withheld.
Service(s) results may not be published or referred to, in whole or in part, by PCG without the prior expressed written consent of the purchaser. Neither PCG nor the purchaser will use the other party’s name in connection with any publication or promotion without prior, written consent. However, expression of a business relationship in its simplest form (ex. publishing the other party’s company logo on its website) is permissible.
The purchaser shall indemnify, defend, and hold harmless PCG and its affiliates and its and their respective directors, officers, employees, subcontractors, and agents (each, “PCG Indemnified Party”) from and against any and all losses, damages, liabilities, reasonable attorney fees, court costs, and expenses (collectively “Losses”) resulting or arising from any third-party claims, actions, proceedings, investigations, or litigation relating to, arising from, or in connection with the Service(s) except to the extent such Losses are determined to have resulted solely from the negligence or intentional misconduct of PCG.
L. Catastrophic/uncontrollable Events.
Neither party shall be liable for delay and/or failure to perform with respect to any order or any other provision of the Service(s) to the extent performance in a customary manner shall be prevented, hindered, or delayed in whole or in part by riots, earthquakes, floods, or any event which shall not reasonably be within such party’s control and which such party is not able to overcome by the exercise of reasonable measures or which such party is able to overcome only at substantial expense. In such an event, no refund for any related fee will be granted. Nothing herein shall relieve the other party from the obligation to perform its obligations under the purchased Service(s).
M. Limits of Liability.
PCG disclaims any and all warranties, express or implied. Neither PCG, nor any of its officers, employees, subcontractors, or agents shall have any liability of any type (including, but not limited to, contract, negligence, and tort liability), for any special, incidental, indirect, or consequential damages, including, but not limited to, the loss of opportunity, loss of use, or loss of revenue or profit.
N. Modification of Terms and Conditions.
Terms and Conditions contain the entire understanding of the parties with respect to the subject matter herein and supersedes all previous agreements (oral and written) negotiations and discussions. Any modifications to the provisions herein must be in writing and signed by the parties.
Terms and Conditions may be terminated due to a breach by the other party if such breach remains uncured after fifteen (15) days written notice.
In the event that PCG determines in its sole discretion that its continued performances of the Service(s) would constitute a potential or actual violation of regulatory or scientific standards of integrity, PCG may terminate this Terms and Conditions by issuing a written notice stating the effective date, which date may be less than thirty (30) days from the notice date of such termination.
In the event this Terms and Conditionsis terminated, the purchaser agrees that all fees involving PCG’s works are non-refundable.
P. Governing Law, Venue.
Any controversy or claim arising out of or relating to Terms and Conditions or the breach thereof shall first seek to resolve the dispute with the help of a mutually agreed-upon mediator in the Los Angeles area. If it proves impossible to arrive at a mutually satisfactory solution through mediation, it shall be settled by arbitration, and judgment on the award rendered by the arbitrator shall be binding and may be entered in any court having jurisdiction thereof. Such arbitration shall be filed and be conducted in English in Los Angeles, California in accordance with the Arbitration Rules of the United States Commission on International Trade Law by one arbitrator mutually acceptable to both parties. All costs and fees involving any controversy, claim, and or dispute shall be borne by the side that incurred the costs.