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Subject to the terms and conditions of this Agreement, the Modernization of Cosmetics Regulation Act of 2022 ("MoCRA") and any related implementing regulations thereto, the parties agree that Registrar shall advise and assist Company as its authorized agent in connection with certain services. The specific services that Registrar will perform for the Company are listed on the attached order form and may include one or more of the following: (i) filing facility registration(s) with the U.S. Food & Drug Administration ("FDA"), (ii) listing with the FDA only those of Company's cosmetic products that Company properly inputs into forms (e.g. on Company's MyFDA account) provided by Registrar, (iii) providing Company with Adverse Event Contact services, or (iv) serving as Registrant’s required U.S. Agent with the FDA.
1. Company will provide Registrar with all information, materials, and fees necessary or reasonably requested by Registrar to fulfill Registrar's responsibilities hereunder. Additionally, Company shall inform Registrar immediately of any information required to be reported to the FDA, including but not limited to, updates and/or changes to facility registration(s) and product listing(s) information. Company warrants that the information and materials provided by Company will be accurate, truthful, genuine, and current. If permitted by the implementing regulations of MoCRA, Company authorizes the employees of Registrar to submit information to the FDA, including facility registration(s) and product listing(s) information, any necessary or prudent updates thereof, and such other information as Registrar believes necessary or prudent for Company to submit. If applicable, Registrar may assist Company with flexible product listing(s). Registrar is not responsible for any rejections, resubmissions, or listing submission errors resulting from inaccurate or incorrect information provided by Company. Registrar has the right to refuse submission of any product listing. If the service described under (iv) above is listed on the attached order form, Registrar will forward all communications from the FDA to Company at the address, telephone number or email address stated above. In the event that Company provides e-mail or other written communication modifying or supplementing the Legal Company Name and/or the Company Address identified above, such information may be relied upon by Registrar and shall be incorporated by reference. Registrar shall act only as a conduit for submission and receipt of information and shall not be responsible for the substance thereof.
2. If the service described under (iii) above is listed on the attached order form, and consistent with Section 609(a) of MoCRA, Company may list the Adverse Event Contact (as defined herein) on its product package(s) and label(s), but only on those specific product package(s) or label(s) for which Company has properly provided the corresponding product listing(s) for each package or label to Company's MyFDA account ("Applicable Labels"). The "Adverse Event Contact" is the address or electronic contact information generated by Registrar Corp and provided to Company. Company must use the Adverse Event Contact as generated by Registrar without any modification. If Company applies the Adverse Event Contact to any package or label that is not an Applicable Label or if the Adverse Event Contact is modified on any of Company's packages or labels from the version generated by Registrar, Registrar may, in its sole and absolute discretion, terminate its Adverse Event Contact service for any such package or label. Company acknowledges that such termination may result in fines, penalties, and similar negative consequences (e.g. misbranding) for the product(s) still bearing the Adverse Event Contact. Company shall be identified as the responsible person on each product label bearing the Adverse Event Contact, and Company shall be responsible for any and all actions or inaction in connection with its product(s) or reports of adverse events.
3. This Agreement is not intended to benefit any third party or non-party, and nothing contained herein shall be construed as creating any right, claim, cause of action, or benefit to any person except Company and Registrar. To the extent Registrar is determined to be an agent of Company in connection with Company's product(s), adverse events, reports of adverse events, or any other matter hereunder, Company shall perform such steps as may be required to identify itself as a disclosed principal of Registrar.
4. The services performed by Registrar under this Agreement are limited strictly to those listed herein. Unless a separate agreement for such services is executed in writing by all parties, Registrar shall not assist nor be responsible for Company's compliance with any other requirements of the FDA or U.S. law or regulations, including but not limited to, services related to labeling, product classification (e.g. whether a product constitutes a cosmetic), suspensions, recalls, reporting to the FDA of serious adverse events, including fragrance and/or flavor ingredients that may be related to a serious adverse event, or corrections and removals related to any of the foregoing. Company represents and warrants it shall conduct such obligations and report any such events to the FDA without Registrar's assistance. For the avoidance of doubt, Registrar Corp has no responsibility hereunder related to the obligations set forth in Section 605 of MoCRA.
5. The fee shall be paid in accordance with Registrar's standard fee schedule and any modifications or revisions thereto. Registrar may perform additional services in its discretion at Company's request for additional fees. Registrar does not and will not practice law or render legal advice.
6. Company agrees to reimburse, indemnify and hold harmless Registrar from and against any and all expenses, costs and claims, including but not limited to claims by third parties and nonparties, including but not limited to any governmental agencies, and related costs and attorneys’ fees, whether such claims are alleged in tort, contract or under federal, state, or other law, related to or arising out of Company's products, adverse or serious adverse events, reports of adverse or serious adverse events, this Agreement, any termination of this Agreement or any termination of an Adverse Event Contact service, the transactions contemplated hereby, any claim connected to the business or operations of Company, or any breach of law by Company. Company waives any and all claims against Registrar arising out of or in connection with this Agreement except for willful misconduct or gross negligence and for those waives its claims to the extent the law permits. This waiver expressly includes, without limitation, any and all claims and fines related to or arising out of a finding by the FDA of misbranding or adulteration. Registrar makes no representations except those set forth herein and does not warrant or guarantee any specific result. As used in this Agreement, “Registrar” shall include Registrar Corp, its successors, assigns, affiliates, parents, subsidiaries, officers, directors, shareholders, agents and employees.
7. Neither party to this contract shall be held responsible for breach of contract caused by an act of God, insurrection, civil war, war, military operation, terrorism or local emergency, or by any act or failure to act by the FDA. Time shall not be of the essence for services to be rendered by Registrar. This Agreement, together with the documents attached hereto and incorporated herein by reference, contains the entire agreement between the parties, and may not be modified except by written agreement executed by both parties.
8. This Agreement shall be construed, and the legal relations between the parties determined, in accordance with the laws of the State of New York, without giving effect to its choice of law provisions. Any action or proceeding arising out of or in connection with this Agreement or the transactions contemplated hereby shall be brought in the courts of New York or the U.S. District Courts for the Southern or Eastern Districts of New York. The parties hereto consent to exercise of in personam and subject matter jurisdiction by the courts of the State of New York, and the U.S. District Courts for the Southern or Eastern Districts of New York.
9. Registrar may, in its sole and absolute discretion, terminate this Agreement at any time upon giving written notice to Company by U.S. Mail to the address stated above or provided by Company for its facility registration(s), or by e-mail to the e-mail address provided by Company for its facility registration(s). Company may terminate this Agreement at any time by FedEx, DHL, or UPS overnight delivery service to Registrar, with such information as will confirm that Company's facility registration(s) has been maintained or canceled consistent with the requirements of MoCRA. In the event of termination by either party, no part of the fees paid to Registrar hereunder shall be refunded. Unless terminated earlier pursuant to this paragraph, the Agreement will commence upon receipt of payment from Company and will continue in full force and effect until December 31, 2024, and thereafter, shall renew automatically for successive terms of one year beginning on each successive January 1st.
10. Company acknowledges that Registrar is a private registration agent not affiliated with the FDA. The person signing below represents and warrants that he/she is an owner, officer, or employee of the Company with authority to make binding commitments on behalf of the Company.
Agreement
AGREEMENT by and between Registrar Corp and Your Company ("Registrant")
The parties agree that Registrar Corp shall register or renew Registrant's food facilities with the U.S. Food and Drug Administration ("FDA") pursuant to section 415(a) of the U.S. Food, Drug and Cosmetic Act, 21 U.S.C. sec. 350(d)(a) (the "Act"), subject to the following terms and conditions:
1. Registrant authorizes Registrar Corp's individual employees to register its food facilities (identified above or on the accompanying Registrar Corp payment form) with FDA pursuant to section 415(a) of the Act and to update or renew such registration or information, during the term hereof, pursuant to 21 C.F.R. sec. 1.225 et seq. and to consent on Registrant's behalf to inspection of the facility by FDA and to such other conditions as are required by FDA for facility registration. Registrant authorizes Agent's individual employees to verify that a new registration's submission was authorized by the owner, operator, or agent in charge of the facility pursuant to 21 C.F.R. 1.231(4), by submitting the electronic "receipt code" in FDA's Food Facility Registration Module. Registrant represents and warrants that it is the owner, operator or agent in charge of the identified facility and is responsible for compliance pursuant to 21 C.F.R sec. 1.225 et seq Registrant will provide Registrar Corp with all information and materials necessary or reasonably requested by Registrar Corp to register or renew the food facilities pursuant to the Act. In the event that Registrant provides e-mail or other written communication modifying or supplementing the Legal Company Name and Company Address identified above, such information may be relied upon by Agent and shall be incorporated herein by reference. Registrant warrants that the information and materials provided by Registrant will be accurate, truthful, genuine and current. Registrar Corp will forward all communications from FDA to Registrant at the address, telephone number or email address stated above.
2. Registrant's Unique Facility Identifier ("UFI") is a prerequisite to obtain an FDA Food Facility Registration number. At this time, a DUNS number is the only UFI recognized by FDA. If Registrant does not have a DUNS, Agent will request one on Registrant's behalf using information provided by Registrant. Agent's services related to DUNS are limited to submission of the initial request; Registrant must communicate directly with the DUNS issuing authority to provide any supplemental information, verify company information, and attempt to secure the issuance of the DUNS. Since DUNS is issued by a third party, Agent cannot guarantee issuance of a DUNS nor any resulting food facility registration.
3. Registrant agrees to reimburse, indemnify and hold harmless Registrar Corp from and against any and all expenses, costs and claims, including claims by third parties and nonparties, including but not limited to any governmental agencies, and related costs and attorneys' fees, and including but not limited to any reinspection fees owed to FDA, whether such claims are alleged in tort, contract or under other law, arising out or in connection with this agreement, the transactions contemplated hereby, any claim connected to the business or operations of Registrant, or any breach of law by Registrant. Registrant waives any and all claims against Registrar Corp arising out of or in connection with this Agreement except for willful misconduct or gross negligence and for those waives its claims to the extent the law permits. As used in this agreement, "Registrar Corp" shall include its successors, assigns, affiliates, parents, subsidiaries, officers, directors, shareholders, agents and employees.
4. Neither party to this contract shall be held responsible for any delay, breach of contract, or failure to perform caused by an act of God, insurrection, civil war, war, military operation, terrorism or local emergency, inability to secure a DUNS number, or other similar causes beyond the party's control. Time shall not be of the essence for services to be rendered by Agent. This Agreement, together with the documents incorporated herein by reference, contains the entire agreement between the parties, and may not be modified except in writing signed by the party to be charged. The use of the plural herein includes the singular and vice versa. This Agreement shall be construed, and the legal relations between the parties determined, in accordance with the laws of the State of New York, without giving effect to its choice of law provisions. Any action or proceeding arising out of or in connection with this Agreement or the transactions contemplated hereby shall be brought in the courts of New York or the U.S. District Courts for the Southern or Eastern Districts of New York. The parties hereto consent to exercise of in personam and subject matter jurisdiction by the courts of the State of New York, and the U.S. District Courts for the Southern or Eastern Districts of New York.
5. Agent may terminate this Agreement at any time upon giving written notice to Registrant by U.S. Mail to the address stated above or provided by Registrant for its food facility registration, or by fax to the fax number provided by Registrant for its food facility registration, or by e-mail to the e-mail address provided by Registrant for its food facility registration. Registrant may terminate this Agreement at any time by FedEx, DHL, or UPS overnight delivery service, or by fax to the address and fax number stated above, with and must include such information as will confirm that Registrant's food facility registration has been maintained or canceled consistent with the requirements of the Act. In the event of termination by either party, no part of the fees paid to Agent hereunder shall be refunded, and the last sentence of paragraph 1 shall survive termination and remain in effect.
6. Unless terminated earlier pursuant to this paragraph, the Agreement will commence upon receipt of payment from Registrant and will continue in full force and effect until December 31, 2024, and thereafter, shall renew automatically for successive terms of one year beginning on each successive January 1st.
7. Registrant acknowledges that Registrar Corp is a private registration agent not affiliated with the FD