Terms and Conditions

1. Parties and Service Lines

These Terms and Conditions (the "Agreement") govern services provided by CENIT Consulting LLC, a Texas entity with a U.S. presence at 2640 E. League City Parkway, Suite 104-987, League City, TX 77573, USA ("CENIT," "we," "us," or "our"), to the client identified in the applicable checkout, quote, statement of work, onboarding form, or written acceptance ("Client," "you," or "your").

These terms cover CENIT FDA Market Access Services, including the following separate service lines:

• Medical Device / IVD U.S. FDA Agent services.
• U.S. FDA Food Agent and Food Facility Registration support.
• MoCRA / Cosmetics U.S. Agent, facility registration, and administrative product listing support where separately scoped.

If a written quote, signed statement of work, or service-specific checkout term conflicts with these general terms, the more specific written term controls for that service.

2. Terms Applying to All Services

• Administrative and regulatory support. CENIT provides the service purchased or approved in writing. We do not provide legal advice and are not a law firm.
• Client responsibility. Client remains responsible for the accuracy of information provided to CENIT, product compliance, establishment compliance, recordkeeping, truthful claims, and timely responses to FDA or CENIT requests.
• No credentials by default. Do not send FDA portal passwords, PINs, bank details, tax IDs, or other sensitive credentials unless CENIT expressly requests them through an approved secure method for a separately scoped task.
• No outcome guarantee. Registration, listing, correspondence handling, or U.S. Agent support is not FDA approval, FDA certification, FDA clearance, product endorsement, or a guarantee of importation or regulatory outcome.
• Review before action. Payment, intake submission, or request submission does not mean FDA work has started. CENIT may review scope, risk flags, payment status, and required information before taking FDA portal or submission action.
• Business hours. Unless otherwise agreed, routine service is provided Monday-Friday, 9:00-17:00 U.S. Central Time, excluding U.S. federal holidays.

3. Medical Device / IVD FDA Agent

This section applies when Client purchases or accepts CENIT Medical Device / IVD U.S. FDA Agent services for a non-U.S. establishment involved with FDA-regulated medical devices or in vitro diagnostic devices intended for the United States.

Included when purchased

• Acting as U.S. FDA Agent point of contact for FDA communications related to the foreign establishment and listed products.
• Receiving and forwarding FDA notices and inquiries to Client's designated contacts.
• Assisting FDA in scheduling inspections of Client's foreign establishment.
• Official Correspondent, FURLS registration/listing administration, GUDID, eMDR, or related administrative support only when included in the purchased tier or written scope.

Not included unless expressly agreed

Legal advice, product classification, labeling review, 510(k), De Novo, PMA, Q-Sub, IDE, quality system consulting, audits, importer of record, customs brokerage, FSVP agent, emergency after-hours hotline, or substantive regulatory strategy unless separately scoped and agreed in writing.

4. Food FDA Agent and Facility Registration

This section applies when Client purchases or accepts CENIT U.S. FDA Food Agent and Food Facility Registration support for a foreign food facility.

Launch scope

• Food Facility Registration support through FDA systems, using Client-provided information.
• CENIT U.S. Agent designation and U.S. Agent consent/confirmation handling.
• FDA correspondence forwarding.
• Biennial renewal support for the covered facility when active and paid.
• Administrative updates to the registration record when separately scoped and billed.

Not included unless separately agreed

The base Food service does not include label review, FSVP, Prior Notice, customs brokerage, importer of record services, ingredient legality review, claims review, dietary supplement DSHEA/NDI work, food contact substance work, recall coordination, state licensing, or broad food compliance consulting.

Manual review and decline/pause conditions

CENIT may pause, decline, request more information, or require a separate quote if the request involves dietary supplements, juice, seafood, low-acid canned foods, infant formula, medical foods, alcohol, active enforcement, recall, import alert, Form 483, pending reinspection, unclear registration authority, missing emergency contact, missing authorization, or requests outside the base scope.

5. MoCRA / Cosmetics U.S. Agent

This section applies when Client purchases or accepts CENIT MoCRA / Cosmetics U.S. Agent, facility registration, or administrative product listing support.

Launch scope

• MoCRA facility registration support through FDA Cosmetics Direct or other applicable FDA system, using Client-provided information.
• CENIT U.S. Agent designation and consent/confirmation handling.
• FDA correspondence forwarding.
• Biennial facility renewal support when active and paid.
• Administrative product listing support only when separately scoped, using information provided and approved by Client or the Responsible Person.

Responsible Person boundary

CENIT does not act as the Responsible Person. Client must identify the Responsible Person and remains responsible for product safety, label accuracy, claims, ingredient legality, adverse event obligations, recall obligations, and MoCRA records.

Not included unless separately agreed

The base MoCRA / Cosmetics service does not include Responsible Person services, safety substantiation review, label review, claim substantiation, ingredient legality review, serious adverse event reporting, recall coordination, cosmetic GMP audits, drug/OTC/sunscreen support, formula review, or legal product classification advice.

Manual review and decline/pause conditions

CENIT may pause, decline, request more information, or require a separate quote if the request involves drug-like claims, SPF/sunscreen/UV claims, product classification uncertainty, active FDA enforcement, recall, serious adverse event issues, incomplete product listing data, contradictory information, high product listing volume, or any request for CENIT to act as Responsible Person.

6. Fees, Taxes, Billing, Renewal, and Refunds

• Fees. Fees are stated in the applicable quote, checkout, payment link, invoice, statement of work, or written acceptance. Unless stated otherwise, fees are in U.S. dollars.
• FDA fees. CENIT fees are service fees. If FDA or another authority charges a separate user fee or governmental fee, Client is responsible unless the written scope expressly says otherwise.
• Taxes. Fees exclude taxes, VAT, duties, withholding, and governmental charges. Client is responsible for applicable taxes except taxes on CENIT's income. If checkout does not calculate tax, Client remains responsible for any applicable tax reporting or payment obligations.
• Payment before action. CENIT may require payment or accepted quote before intake review, FDA portal work, registration support, correspondence handling beyond triage, or renewal support.
• Provisional payment review. For Food and MoCRA launch services, payment is provisional until CENIT reviews intake and scope. If the request is outside launch scope, CENIT may refund and decline before any FDA submission is made.
• Auto-renewal. Annual plans renew automatically unless canceled before renewal or unless a written agreement says otherwise. Client authorizes recurring charges to the payment method on file for active annual services.
• Refunds. Fees are generally non-refundable once the annual term or scoped service begins, except where required by law, where CENIT fails to commence the service after payment, or where CENIT declines a provisional Food/MoCRA launch request before FDA action. Subscription cancellation and refund of a prior payment are separate actions.
• Payment failures. CENIT may suspend or delay work for failed payment, chargeback, unresolved billing issue, or expired payment method.

7. Term, Cancellation, Suspension, and Withdrawal

• Term. Annual services begin on payment date, quote acceptance date, or another agreed start date.
• Cancellation. Client may cancel future renewals by using the available payment portal where provided or by emailing CENIT before the renewal date. Cancellation normally takes effect at the end of the current paid term.
• Suspension. CENIT may suspend work for non-payment, missing information, unsafe or unlawful activity, refusal to provide required attestations, repeated unresponsiveness, or a request outside the purchased scope.
• Withdrawal as agent. If service ends or CENIT reasonably determines it cannot continue as U.S. Agent, CENIT may notify FDA or take other appropriate administrative steps to end or decline the designation. Client remains responsible for appointing a successor and maintaining compliance.

8. Confidentiality, Privacy, and Data

• Confidentiality. Each party will protect the other's non-public information using reasonable care and use it only to perform this Agreement or comply with law.
• FDA and service providers. CENIT may share relevant information with FDA, payment processors, CRM/automation providers, document systems, and other service providers as needed to perform the service, collect payment, maintain records, or comply with law.
• Records. CENIT may maintain email, ticket, payment, registration, correspondence, and evidence records for operational, audit, billing, and risk-control purposes.
• Privacy. Website and personal data practices are described in the CENIT Privacy Policy. If a payment or checkout provider displays its own terms or privacy policy, those provider terms apply to that provider's processing in addition to CENIT's applicable terms.
• Electronic delivery. Client consents to electronic notices, agreements, checkout confirmations, receipts, and signatures.

9. No Guarantees, Liability, and Indemnity

• No regulatory outcome guarantee. CENIT does not guarantee FDA acceptance, clearance, approval, certification, successful importation, inspection outcome, absence of enforcement, or any other regulatory outcome.
• Client compliance. Client remains solely responsible for compliance of its establishment, products, labels, claims, ingredients, submissions, records, and commercial activities except for the specific administrative tasks CENIT expressly agrees to perform.
• Sanctions and lawful activity. Client represents that it and its activities are not prohibited by U.S. sanctions, export controls, or other applicable restrictions.
• Liability cap. To the maximum extent permitted by law, CENIT's total liability arising from or related to the service is limited to the fees paid by Client to CENIT for the affected service in the 12 months before the event giving rise to the claim.
• No consequential damages. Neither party is liable for lost profits, lost data, loss of business, indirect, special, incidental, punitive, or consequential damages, except where prohibited by law.
• Indemnity. Client will indemnify and hold CENIT harmless from third-party claims, fines, penalties, losses, or expenses arising from Client's products, data, claims, labeling, regulatory noncompliance, inaccurate information, failure to respond to FDA deadlines after CENIT forwarded notice within scope, or requests outside the agreed service.

10. General Terms

• Governing law and venue. Texas law governs this Agreement, without regard to conflict-of-law rules. Exclusive venue and jurisdiction lie in the state or federal courts located in Galveston County, Texas, unless a mandatory law requires otherwise.
• Notices. Legal notices to CENIT must be sent to CENIT Consulting LLC, 2640 E. League City Parkway, Suite 104-987, League City, TX 77573, USA, with a copy by email to contact@cenitconsulting.com. Notices to Client may be sent to the contacts provided in onboarding, checkout, quote, or CRM records.
• Changes. CENIT may update these terms. Material changes apply at the next renewal or new purchase unless required sooner by law or agreed in writing.
• Assignment. Client may not assign the service without CENIT's written consent. CENIT may assign or delegate administrative performance to affiliates, contractors, or service providers while remaining responsible for CENIT's express obligations.
• Severability. If a term is unenforceable, the remaining terms continue in effect.
• Entire agreement. These terms, together with the applicable quote, checkout, order, statement of work, onboarding, and written service-specific terms, form the agreement for the purchased service.

Questions about these terms may be sent to contact@cenitconsulting.com. Service-line inquiries may also be sent to agentfda@cenitconsulting.com.