Terms of service
1. Parties, Acceptance, and Applicability
1.1 Contracting Party. WAYV LLC is the legal service provider and contracting party. Asla Partners is the name under which WAYV LLC offers the Services. References to "Asla," "we," or "us" mean WAYV LLC.
1.2 Users and Clients. A "User" is any person who accesses the Website. A "Client" is the business identified in an Order or signature block. The person accepting these Terms represents that the Services are obtained for business purposes and that the person has authority to bind the Client.
1.3 Acceptance. A User accepts the Website provisions by using the Website after being presented with these Terms. A Client accepts all provisions by: (a) checking an agreement box and submitting a Fillout or other online order; (b) electronically or manually signing; (c) approving an invoice or order by email; or (d) making full or partial payment after receiving or being linked to these Terms. Electronic records and signatures have the same effect as originals.
1.4 Two levels of application. Sections concerning Website use apply to all Users. Sections concerning fees, Services, Client duties, risk allocation, and Deliverables apply only when a Client purchases or authorizes a Service.
2. Website Use
2.1 Informational content only. Website content is general information and is not legal, medical, scientific, tax, customs, or accounting advice. No professional relationship is created merely by browsing, submitting an inquiry, or receiving an automated response.
2.2 Permitted use. Users may use the Website for lawful business evaluation and purchasing. Users may not interfere with the Website, introduce malicious code, scrape or reproduce substantial content, impersonate another person, submit false information, or use Asla's name, address, materials, or credentials without written authorization.
2.3 Availability and links. The Website and third-party links, forms, payment processors, and integrations are provided on an "as available" basis. Asla does not control third-party sites or guarantee uninterrupted, secure, or error-free operation. Asla may change, suspend, or discontinue Website features without liability.
3. Orders and Scope of Services
3.1 Order. An "Order" means the accepted Fillout submission, checkout record, invoice, quotation, statement of work, email approval, or signed document that identifies the selected Service, product(s), facility or facilities, quantity, price, and any stated service period. Only Services expressly identified in the Order are included.
3.2 Priority. These Terms control the Parties' general rights and allocation of risk. An Order controls only service selection, scope, quantity, price, stated deliverables, and timing. Any different risk, warranty, indemnity, liability, dispute, confidentiality, or intellectual-property term is ineffective unless a document signed by WAYV LLC expressly identifies the section being amended. Client purchase-order, portal, vendor, or payment terms do not apply.
3.3 Excluded work. Unless expressly included in the Order, Services exclude additional products, SKUs, facilities, jurisdictions, submissions, resubmissions, revisions, translations, testing, claim substantiation, safety assessments, state-law reviews, importer services, Responsible Person services, customs services, and ongoing monitoring or renewal.
3.4 Changes. A change in formula, ingredients, supplier, facility, ownership, label, claims, artwork, product name, packaging, quantity, assumptions, deadline, or requested deliverable may require a new or revised Order, additional fees, and a revised schedule.
4. Client Responsibilities and Reliance
4.1 Client Materials. Client shall timely provide complete, current, accurate, consistent, legible, and non-misleading information, formulas, ingredient data, labels, claims, artwork, registrations, records, credentials, instructions, approvals, and other materials ("Client Materials"). Client represents that it has the right to provide and authorize use of them.
4.2 Reliance and approval. Asla may rely on Client Materials and the Client's authorized contact without laboratory testing, audit, authentication, translation verification, or independent investigation unless expressly included. Client must review and approve all data, drafts, artwork, and submission content before filing or commercial use.
4.3 Regulated-business duties. Client remains responsible for product classification, legal eligibility, formulation, ingredients, safety substantiation, manufacturing, quality systems, testing, labeling, claims, advertising, adverse-event duties, records, importation, distribution, insurance, recalls, and commercial decisions, except for the precise administrative task expressly assigned to Asla.
4.4 Changes and deadlines. Client shall promptly report material changes and provide information early enough for the stated deadline. Asla has no duty to monitor unreported changes or remind Client of future filings unless a maintenance or renewal Service is active and paid. Courtesy reminders do not transfer Client's legal responsibility for deadlines.
5. Fees, Payment, Refunds, and Timing
5.1 Payment. Fees are due in U.S. dollars before work begins unless the Order states otherwise. Government, laboratory, testing, translation, notarization, courier, bank, card, tax, duty, and other third-party charges are excluded unless expressly included. Client is responsible for payment-processor and bank charges and for documented withholding required by law.
5.2 Start of work and refunds. Work may begin when Asla reviews Client Materials, allocates professional time, prepares a submission or deliverable, contacts a third party or agency, or otherwise performs the Order. Before work begins, Client may request cancellation and a refund less non-refundable processor and third-party charges. After work begins, fees are non-refundable except as expressly stated in Section 9.2 or required by law.
5.3 Nonpayment. Overdue amounts accrue interest at the lesser of 1.5% per month or the maximum lawful rate. Asla may suspend work, withhold unpaid Deliverables, decline a filing, or withdraw from a continuing role after reasonable notice. Client is responsible for reasonable collection costs and unauthorized chargeback costs to the extent permitted by law.
5.4 Timing. All completion and agency-processing dates are good-faith estimates. A schedule depends on timely Client Materials, payment, approvals, agency systems, and third parties. Time is not of the essence unless WAYV LLC expressly agrees in a signed writing.
5.5 Renewals. Annual, biennial, and U.S. Agent Services do not automatically renew unless the Order expressly states an auto-renewing term and the Client separately authorizes it. A prior registration, listing, or appointment does not include later maintenance, updates, or renewal unless separately selected and paid.
6. General Regulatory Boundaries
6.1 Administrative and regulatory support. Asla will perform selected Services with commercially reasonable care based on Client Materials and requirements reasonably available at the time. Asla is not a government agency and cannot bind FDA, U.S. Customs and Border Protection, any state regulator, marketplace, carrier, laboratory, or other third party.
6.2 No approval or outcome guarantee. A registration, listing, FEI, NDC, submission, acknowledgment, acceptance message, or label review is not FDA approval, certification, endorsement, a legal opinion, import clearance, or authorization to sell. Asla does not guarantee agency acceptance, timing, inspection outcome, import admissibility, marketplace acceptance, sales, or commercial success.
6.3 Limited authority. Submission authority extends only to the selected Service. Unless expressly accepted in the Order, Asla is not Client's manufacturer, facility owner or operator, Responsible Person, labeler, importer of record, customs broker, distributor, seller, insurer, guarantor, legal counsel, or product-safety decision maker.
6.4 Right to refuse. Asla may refuse or pause incomplete, misleading, unsafe, unlawful, sanctioned, or out-of-scope instructions without breach and may request supporting documents or corrected information.
7. Service-Specific Terms - Retain Only Selected Modules in a Custom Copy
Each module below applies only if that Service is identified in the applicable Order. Keeping all modules in the public Master TOS does not obligate Client to purchase, or Asla to provide, any unselected Service.
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7A Drug Product Listing Scope: preparation and/or submission of the initial or updated Structured Product Labeling (SPL) drug listing identified in the Order, using Client-approved establishment, labeler, NDC, product, ingredient, dosage-form, strength, packaging, label, and marketing data. Boundaries: Client remains responsible for product classification and eligibility, applicable OTC monograph or approval status, formulation, testing, cGMP, establishment registration, labeler code, claims, launch status, and all updates or certifications not separately selected. Listing does not mean FDA approval or verification. |
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7B OTC Annual Maintenance Scope: annual review, update, and/or no-change certification of the active OTC drug product listing(s) identified in the Order for the stated service year, subject to timely Client confirmation and FDA system availability. Boundaries: the Service does not include annual drug establishment registration, new products, changed formulations or labels, new NDCs, monograph analysis, or corrective submissions unless separately selected. Client must report material listing changes when they occur and remains responsible for every statutory deadline. |
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7C Drug Label Compliance Review Scope: review of the identified final label or artwork for federal U.S. drug-label elements within the review standard stated in the Order, with the number of revisions stated there. Boundaries: unless expressly included, review does not determine OTC monograph eligibility, formulation compliance, cGMP, testing, claim substantiation, patent or trademark clearance, state law, retailer rules, advertising beyond the supplied label, translation accuracy, or post-review changes. Client approves and owns the final labeling decision. |
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7D U.S. Agent Services for Drug Establishment Scope: for the foreign drug establishment and term identified in the Order, Asla serves only as the U.S. communications contact for FDA communications and inspection coordination within the legally permitted U.S. Agent role. Boundaries: Asla is not the owner, operator, manufacturer, labeler, importer, distributor, legal representative for all purposes, or guarantor. Client must keep facility and contact information current, respond promptly, maintain all registrations and listings not separately selected, and not use Asla's name, address, or contact details outside the authorized appointment. Suspension/withdrawal: Asla may resign or notify FDA of withdrawal for nonpayment, inaccurate information, non-response, unauthorized use, legal or safety risk, or termination. Client must promptly appoint a replacement and complete required updates. |
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7E Drug Establishment Registration & FEI Number Request Scope: administrative assistance with the FEI request and/or initial drug establishment registration for the establishment identified in the Order. FEI and registration activities are separate processes and are subject to FDA review, validation, and system requirements. Boundaries: Client and the establishment remain responsible for registration eligibility, legal identity, physical location, UFI/DUNS or other identifiers, operations and drug activities, contacts, supporting records, foreign-establishment requirements, and all later updates and annual renewals. Asla cannot guarantee FEI issuance, registration timing, or acceptance. |
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7F Annual Drug Establishment Registration Scope: preparation and/or submission of the annual registration renewal or no-change notification for the identified drug establishment for the stated registration year, generally during FDA's annual renewal period, subject to timely Client approval and agency availability. Boundaries: this Service does not include drug product listing certification or updates, new establishments, changed activities requiring separate work, cGMP review, inspection support, or U.S. Agent service unless separately selected. Client remains responsible for accurate current information and the deadline. |
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7G MoCRA Cosmetic Product Listing Scope: preparation and/or submission of the initial MoCRA cosmetic product listing(s) identified in the Order using Client-approved Responsible Person, facility, category, formulation, ingredient, brand, and label information. Boundaries: the Responsible Person remains responsible for determining whether listing or an exemption applies, the accuracy of all product and facility data, safety substantiation, records, serious adverse-event duties, and annual updates. Asla does not become the Responsible Person by preparing or submitting a listing, and the listing is not FDA approval or certification. |
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7H Annual Cosmetic Product Listing Update Scope: annual update, renewal, abbreviated renewal, or discontinuation update, as applicable, for the identified cosmetic product listing(s) and stated service year, based on Client's written confirmation of current data. Boundaries: new products, material changes requiring additional analysis, label review, facility registration or renewal, Responsible Person service, and correction of historical inaccuracies are excluded unless separately selected. Client remains responsible for reporting changes and ensuring timely annual updates. |
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7I Cosmetic Label Compliance Review Scope: review of the identified final cosmetic label or artwork for the federal U.S. cosmetic-label elements stated in the Order, with the number of revisions stated there. Boundaries: unless expressly included, review excludes drug/OTC requirements, MoCRA safety substantiation, testing, claim substantiation, state or local requirements (including California-specific requirements), environmental claims, patent or trademark clearance, retailer rules, websites and influencer content, translation accuracy, and post-review changes. |
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7J U.S. Agent Services for Cosmetic Facility Scope: for the foreign cosmetic facility and term identified in the Order, Asla serves only as the U.S. contact through whom FDA communications concerning the facility may be transmitted. Boundaries: Asla is not the facility owner or operator, Responsible Person, manufacturer, importer, distributor, seller, product owner, safety decision maker, or guarantor. Client must keep contacts current, respond promptly, maintain all filings not separately selected, and not use Asla's identity outside the authorized appointment. Suspension/withdrawal: Asla may resign or notify FDA of withdrawal for nonpayment, inaccurate information, non-response, unauthorized use, legal or safety risk, or termination. Client must promptly appoint a replacement and update FDA records. |
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7K MoCRA Facility Registration & FEI Number Request Scope: administrative assistance with an FEI request and/or initial MoCRA facility registration for the cosmetic facility identified in the Order, using Client-approved owner/operator, address, activity, brand, contact, and U.S. Agent information. Boundaries: the facility owner or operator remains responsible for determining whether registration or an exemption applies, accurate physical-address and FEI data, manufacturing activities, supporting records, changes, and later renewal. FEI assignment and facility registration are separate processes; Asla cannot guarantee issuance, timing, validation, or acceptance. |
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7L Biennial Cosmetic Facility Registration Renewal Scope: preparation and/or submission of the biennial renewal or abbreviated renewal for the identified cosmetic facility and renewal cycle, based on Client's written confirmation of current data. Boundaries: this Service does not include FEI corrections, new facilities, cosmetic product listings or annual updates, U.S. Agent service, inspection support, or material amendments outside the Order. Client remains responsible for reporting facility changes when required and for providing complete information before the renewal deadline. |
8. Excluded Events and Allocation of Responsibility
8.1 Direct causation required. Asla is responsible only for the portion of direct loss finally determined to have been proximately caused by Asla's material breach of these Terms or failure to use commercially reasonable care within the express scope of the selected Service. Asla is not responsible merely because a problem occurred while Asla was engaged or after a Deliverable was issued.
8.2 Excluded Events. To the maximum extent permitted by law, Asla is not responsible, to the extent caused or contributed to, by:
inaccurate, incomplete, inconsistent, misleading, untranslated, illegible, or late Client Materials, instructions, approvals, payments, or failure to disclose a change;
Client's or a third party's formulation, ingredients, quality, safety, testing, manufacturing, packaging, label, claims, advertising, importation, distribution, recall, or commercial decisions;
any change after review to a formula, supplier, facility, artwork, label, claim, product, website, advertisement, or distribution plan without a new written review;
the act, omission, delay, insolvency, data, or system of a manufacturer, laboratory, translator, attorney, broker, importer, retailer, marketplace, processor, carrier, technology provider, payment provider, or other third party outside Asla's reasonable control;
an agency's interpretation, discretion, request, rejection, inspection, enforcement, delay, outage, data issue, portal or filing-rule change, policy change, or change in law or guidance;
customs detention or refusal, tariff, sanctions, shipping or logistics, marketplace action, or use of a draft, expired, superseded, incomplete, or out-of-scope Deliverable;
Client's failure to implement a recommendation, correct an issue, respond, renew or update a filing, report an adverse event, maintain records, or obtain appropriate legal, scientific, safety, tax, insurance, or customs advice; or
unauthorized use or designation of Asla's name, address, identifier, U.S. Agent role, materials, or Deliverables; force majeure; or a cyberattack not caused by Asla's failure to use commercially reasonable safeguards.
8.3 Mitigation and correction opportunity. Client shall promptly notify Asla of a suspected issue and reasonably mitigate loss. Asla is not responsible for avoidable costs incurred before it receives a reasonable opportunity to investigate and, where possible, correct the issue.
9. Limited Warranty, Review, and Remedy
9.1 Limited warranty. Asla warrants only that it will perform the selected Service professionally and with commercially reasonable care. Client must give detailed written notice of an alleged service error within 10 Business Days after discovery and no later than 60 days after delivery of the affected Deliverable.
9.2 Exclusive correction remedy. Asla must receive a reasonable opportunity to investigate and correct or re-perform an in-scope, correctable error. Correction or re-performance is Client's first and exclusive remedy. If a material in-scope error cannot reasonably be corrected, Asla may refund the fee paid for the affected Deliverable, which is the exclusive monetary remedy subject to Section 11.
9.3 Disclaimer. EXCEPT FOR THE LIMITED WARRANTY ABOVE, THE WEBSITE, SERVICES, AND DELIVERABLES ARE PROVIDED "AS IS" AND "AS AVAILABLE." TO THE MAXIMUM EXTENT PERMITTED BY LAW, ASLA DISCLAIMS ALL OTHER EXPRESS, IMPLIED, STATUTORY, AND COLLATERAL WARRANTIES, INCLUDING MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, NON-INFRINGEMENT, ACCURACY, COMPLETENESS, ERROR-FREE OPERATION, AND RESULTS.
10. Client Indemnification
Client shall defend, indemnify, and hold harmless WAYV LLC, Asla Partners, and their members, managers, employees, contractors, and agents from third-party claims, government demands, losses, recalls, penalties to the extent legally indemnifiable, costs, and reasonable attorneys' fees arising from: (a) Client Materials; (b) Client's products, manufacturing, testing, safety, labeling, claims, advertising, importation, distribution, or sale; (c) Client's breach of these Terms or law; (d) an Excluded Event within Client's control; or (e) unauthorized use of Asla's name, address, role, identifiers, or Deliverables. Asla shall give reasonable notice and cooperation. Client may control the defense but may not admit Asla's fault, impose non-monetary duties, or settle without fully releasing Asla unless Asla consents.
11. Limitation of Liability
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PLEASE READ THIS SECTION CAREFULLY This Section allocates commercial risk between two businesses and is reflected in the fees. It applies regardless of legal theory, including contract, tort, negligence, statute, or otherwise. |
11.1 Excluded damages. TO THE MAXIMUM EXTENT PERMITTED BY LAW, ASLA AND ITS MEMBERS, MANAGERS, EMPLOYEES, CONTRACTORS, AND AGENTS WILL NOT BE LIABLE FOR INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, PUNITIVE, OR CONSEQUENTIAL DAMAGES; LOST PROFITS, SALES, REVENUE, BUSINESS, OPPORTUNITY, DATA, OR GOODWILL; OR COSTS OF RECALL, RELABELING, REFORMULATION, RE-MANUFACTURE, STORAGE, DEMURRAGE, DETENTION, SEIZURE, DISPOSAL, MARKETPLACE SUSPENSION, SUBSTITUTE SERVICES, OR BUSINESS INTERRUPTION, EVEN IF ADVISED SUCH LOSS WAS POSSIBLE.
11.2 Liability cap. TO THE MAXIMUM EXTENT PERMITTED BY LAW, ASLA'S TOTAL AGGREGATE LIABILITY ARISING FROM A SELECTED SERVICE WILL NOT EXCEED THE FEES ACTUALLY PAID TO ASLA FOR THE SPECIFIC SERVICE GIVING RISE TO THE CLAIM DURING THE 12 MONTHS BEFORE THE EVENT FIRST GIVING RISE TO LIABILITY. MULTIPLE CLAIMS OR EVENTS DO NOT INCREASE THIS CAP.
11.3 Carve-outs. The exclusions and cap do not apply to liability that cannot lawfully be limited or liability finally determined to result from Asla's fraud, willful misconduct, or gross negligence. They do not limit Client's payment, indemnity, confidentiality, intellectual-property, unauthorized-use, or legal-compliance duties.
12. Confidentiality, Data, and Intellectual Property
12.1 Confidentiality. Each Party shall use the other's non-public business, technical, and commercial information only for this relationship and protect it with reasonable care. Disclosure is permitted to personnel, contractors, advisers, agencies, and service providers with a need to know and suitable duties, or when legally required. This duty lasts three years after disclosure; trade secrets remain protected while legally qualifying.
12.2 Data handling and Privacy Policy. Client shall avoid sending payment-card data, passwords, government identification numbers, consumer health records, or other sensitive personal information unless Asla requests it through an approved method. Client authorizes reasonable cross-border processing and third-party systems needed for the Services. Asla will use commercially reasonable safeguards but cannot guarantee any system is immune from unauthorized access. Website and form data are also handled under the Privacy Policy available at [INSERT PRIVACY POLICY URL].
12.3 Ownership. Client owns Client Materials and licenses them to Asla as needed to perform Services. Asla retains its pre-existing and independently developed templates, checklists, methods, know-how, workflows, software, prompts, models, generic regulatory content, and improvements ("Asla Materials"). After full payment, Client may use final Deliverables for the products, facilities, markets, and purposes in the Order, but may not resell, publish as a template, or use them for another client or product. Neither Party may publicly use the other's name or marks without consent, except for an authorized agency submission or designated role.
13. Suspension, Termination, and Continuing Roles
13.1 Suspension or termination. Asla may refuse, suspend, or terminate an Order for nonpayment, incomplete or misleading information, lack of authority, unlawful or unsafe instructions, sanctions risk, agency or portal restrictions, or material breach. Asla may place a matter on hold after 30 days without required Client information or approval and close it after 60 days. Reopening is subject to availability, current requirements, and a reasonable reactivation fee.
13.2 Effect. Client shall pay accrued fees and non-cancellable costs and stop using drafts or unpaid Deliverables. After payment, Asla will reasonably provide Client-owned records. If Asla holds a continuing U.S. Agent or other expressly accepted role, Client must promptly appoint a replacement and update the agency; Asla may notify the agency of suspension, withdrawal, or termination.
13.3 Survival. Payment, regulatory boundaries, excluded events, correction remedies, warranty disclaimers, indemnification, limitation of liability, confidentiality, intellectual property, dispute resolution, and provisions intended by their nature to survive remain effective.
14. Governing Law and Dispute Resolution
14.1 Florida law. These Terms and each Order are governed by Florida law, without regard to conflict-of-law rules. The U.N. Convention on Contracts for the International Sale of Goods does not apply.
14.2 Good-faith discussion. Before arbitration, a Party shall give written notice describing the dispute and requested relief. Authorized representatives shall attempt in good faith to resolve it for at least 30 days unless urgent equitable relief is reasonably necessary.
14.3 Binding arbitration. Unresolved disputes shall be finally resolved by confidential binding arbitration administered by the American Arbitration Association through its International Centre for Dispute Resolution under the applicable Commercial Arbitration Rules or International Dispute Resolution Procedures before one arbitrator. The seat is [INSERT COUNTY], Florida, U.S.A.; the language is English; hearings may be remote; and judgment may be entered in any court with jurisdiction.
14.4 Individual proceedings and court relief. Proceedings are Party-to-Party only, not class, collective, consolidated, representative, or private-attorney-general proceedings, to the maximum extent permitted by law. Either Party may seek temporary or injunctive relief in state or federal courts in [INSERT COUNTY], Florida to protect confidential information, intellectual property, payment rights, or the status quo. For matters permitted in court, each Party submits to those courts and waives jury trial to the maximum lawful extent.
15. General Terms
15.1 Independent parties; assignment. The Parties are independent contractors. These Terms do not create a partnership, joint venture, fiduciary, employment, franchise, or general agency relationship. Client may not assign an Order or these Terms without Asla's consent, except to a qualified successor that assumes all obligations. Asla may assign to an affiliate or successor.
15.2 Compliance. Each Party shall comply with laws applicable to its own activities. Client shall not request false, misleading, unsafe, sanctioned, infringing, or unlawful conduct. Asla may conduct reasonable screening and request supporting documentation.
15.3 Notices. Legal notices must be written and sent by email with transmission confirmation, recognized courier, or registered/certified mail to the contacts below or an updated address given by notice. Operational communications may be sent to the Order contacts.
15.4 Entire agreement and construction. These Terms, the applicable Order, and any signed amendment are the entire agreement on the selected Service. No third party benefits except indemnified persons. Delay is not waiver. Invalid provisions will be enforced to the maximum lawful extent or reformed, and the remainder remains effective. Headings are for convenience; "including" is non-exclusive. English controls over any translation.
15.5 Updates to online Terms. Asla may update these Terms prospectively by posting a revised version and date. The version affirmatively accepted with an Order governs that Order unless the Parties agree otherwise. Material changes to an active continuing Service will not apply retroactively without notice and legally sufficient acceptance.
16. Recommended Fillout Acceptance Record
For online use, Asla should display a conspicuous link to these Terms immediately beside a required unchecked box and retain the accepted version, timestamp, order details, and submission record.