Legal
Research-Use Policy
Notice. This notice summarizes key restrictions. The numbered Sections of this Policy and the Terms control. Amino20 Labs offers, sells and supplies Materials solely for In Vitro Research by eligible research Organizations. Individuals, including sole proprietors, are not eligible to buy. No Material may be Administered to a human or an Animal by any route, or used for any Clinical Use, under any circumstances, and Amino20 Labs will not consent to any such use. No Material may be resold or otherwise Transferred to any other person, or exported, without Amino20 Labs’ prior written consent. Capitalized terms have the meanings given in Section 2. This Policy forms part of the Terms & Conditions of Sale and binds every Buyer.
1. Purpose, Scope and Relationship to the Terms
1.1 Purpose. This Research-Use Policy (this “Policy”) sets out: the conditions on which Amino20 Labs offers, sells and supplies Materials; the use for which Materials are supplied and the uses that are prohibited; the eligibility requirements for Buyers; Buyer’s obligations for the handling, storage, use, Transfer and disposal of Materials; and the measures Amino20 Labs may take, and in some cases will take, to prevent, detect and respond to any Prohibited Use.
1.2 Scope. This Policy applies to every account application, Account, Order and Material, and to every communication between Buyer and Amino20 Labs concerning Materials. Buyer shall ensure that its personnel, and every person who receives, accesses or uses any Material through Buyer, comply with the restrictions in this Policy, and Buyer is responsible for their acts and omissions as provided in Section 9.5.
1.3 Incorporation; the Agreement. This Policy is incorporated into and forms part of the Amino20 Labs Terms & Conditions of Sale, as provided in Terms §16. In this Policy, “Terms” means the Terms & Conditions of Sale, other than this Policy and the Refund Policy, and “Agreement” means the Terms, the Refund Policy and this Policy together. A breach of this Policy is a breach of the Agreement.
1.4 Order of precedence.
- (a)Reading together. This Policy supplements the Terms and the Refund Policy and is to be read together with them. A provision of this Policy is not inconsistent with a provision of the Terms or the Refund Policy merely because it is more detailed, imposes on Buyer a restriction or obligation in addition to those in the Terms, or confers on Amino20 Labs a right in addition to those in the Terms. Such a provision applies together with the Terms.
- (b)Provisions of this Policy that prevail. Each provision of this Policy listed in this Section 1.4(b) prevails, to the extent of any inconsistency, over the provisions of the Terms and the Refund Policy listed with it:
- (i)Section 3.7 and the definitions of “Buyer” and “Organization” in Section 2.1, over the introductory paragraph of the Terms and every other provision of the Terms and the Refund Policy, to the extent that provision would make an individual who acts for Buyer liable for an obligation of Buyer, or would prevent an individual described in the last sentence of Section 3.7 from being Buyer;
- (ii)the definitions of “Approved Shipping Address” and “Laboratory Facility” in Section 2.1, and Sections 7.3(b) and 8.1(a), over Terms §1, to the extent Terms §1 requires that the shipping address be the address of a laboratory;
- (iii)Sections 6.2 and 6.5, over every provision of the Terms and the Refund Policy;
- (iv)Sections 8.11 and 12.3(c), over Terms §§5 and 7 and Refund Policy §§1, 2, 3, 5 and 9;
- (v)the last sentence of Section 9.5 and Sections 15.1 and 15.3, over the last sentence of Terms §2 and over Terms §10;
- (vi)Sections 12.2, 12.3 and 12.4, over Terms §§6 and 8;
- (vii)Section 13.4, over Refund Policy §§1, 7 and 9;
- (viii)Section 15.4, over Terms §9;
- (ix)Section 17.1, over the survival provision of Terms §16;
- (x)Section 17.6, over Terms §§9, 10 and 15 (Section 17.6 also prevails over Sections 15 and 16 of this Policy);
- (xi)the definition of “Order” in Section 2.1 and Section 17.7, over Terms §§4 and 16, to the extent either provides for a purchase order as a means of placing an Order, or provides that the Terms supersede Buyer purchase-order terms;
- (xii)Section 18, over Terms §14, as provided in Section 18.4;
- (xiii)Section 15.5, over Terms §15, to the extent Terms §15 would require informal resolution before, or would prevent a court or an emergency arbitrator from granting, the relief described in Section 15.5; and
- (xiv)the last sentence of Section 19.1, over Refund Policy §§3 and 10.
- (c)Other inconsistencies. Except as provided in Section 1.4(b), if a provision of this Policy is inconsistent with a provision of the Terms or the Refund Policy, the provision of the Terms or the Refund Policy controls to the extent of the inconsistency.
- (d)Refunds and claims. Except as provided in Sections 8.11, 12.3(c) and 13.4 and the last sentence of Section 19.1, refunds, returns, order cancellations, and claims for damaged, incorrect, undelivered or non-conforming Materials are governed by the Refund Policy, as provided in Terms §7 and Refund Policy §9.
1.5 Provisions of the Terms that apply. Subject to Section 17.6, governing law and dispute resolution are governed by Terms §15, as provided in Sections 15.5 and 16. Amino20 Labs’ warranties and disclaimers, the limitation of its liability and Buyer’s indemnification obligations are governed by Terms §§7 through 10, as supplemented by Sections 3.3, 3.5, 4.8, 4.9, 11.5, 12 and 15 of this Policy. Those Sections add to the corresponding provisions of the Terms and, except to the extent stated in Section 1.4(b), do not replace or limit them.
2. Definitions and Interpretation
2.1 Definitions. Capitalized terms used but not defined in this Policy have the meanings given in the Terms. In this Policy:
- “Account” means a buyer account with Amino20 Labs, and “Approved Account” means an Account in approved status as described in Terms §1.
- “Administer” means to introduce a substance into, or apply it to, the body of a living human [at any stage of development, including an embryo or fetus] or Animal by any route or means, whether directly or by means of any article, preparation, device, cell, tissue or other material that contains, was prepared from or was exposed to the substance. “Administration” has a corresponding meaning. Accidental exposure of a person in the course of handling a Material for In Vitro Research is not Administration, but is reportable under Section 8.10(d).
- “Administration Information” means any information, instruction or recommendation concerning (a) the amount, frequency, timing, duration, route or method of any Administration of a Material; (b) the preparation of a Material for Administration; or (c) any effect, outcome, benefit or risk of a Material when Administered. Administration Information does not include (i) Safety Information; or (ii) a bibliographic citation to published scientific literature, or a statement identifying the scientific field in which a Material or a related compound has been studied, that Amino20 Labs provides under Section 10.3, if neither the citation (including the title of the cited work) nor any accompanying text states an amount, frequency, timing, duration, route or method of Administration or any effect, outcome, benefit or risk of Administration.
- “Agreement” has the meaning given in Section 1.3.
- “Amino20 Labs” means Glenhouse, a Texas LLC doing business as Amino20 Labs, and its successors and permitted assigns.
- “Animal” means any living non-human animal, vertebrate or invertebrate, at any stage of development.
- “Applicable Law” means all federal, state and local statutes, regulations, ordinances, orders and other requirements having the force of law that apply to the relevant person, activity or Material, including, where applicable: the FD&C Act; the Public Health Service Act, 42 U.S.C. 201 et seq.; the Controlled Substances Act, 21 U.S.C. 801 et seq.; state food, drug and cosmetic laws, state pharmacy, prescription-drug and drug-distribution licensing laws, and state controlled-substance laws; the Occupational Safety and Health Act of 1970, 29 U.S.C. 651 et seq., and its implementing regulations; the federal regulations on the protection of human subjects (45 C.F.R. Part 46 and 21 C.F.R. Parts 50 and 56) and on clinical laboratories (42 C.F.R. Part 493); federal, state and local environmental, hazardous-materials, hazardous-materials-transportation and waste-disposal laws; and the export-control and economic-sanctions laws of the United States.
- “Approved Shipping Address” means the non-residential address in the United States that is identified in Buyer’s Account as its shipping address and approved by Amino20 Labs, or any other such address that Amino20 Labs approves in writing after re-verification under Section 7.7. It may be the address of the Laboratory Facility or of a central receiving facility of Buyer or its institution from which Materials are delivered directly to the Laboratory Facility.
- “Attestation” means any confirmation, representation or certification concerning eligibility, age, intended use or compliance that Buyer gives to Amino20 Labs, whether by selecting a checkbox, submitting a form, signing a document or otherwise, including the confirmations requested at account application and at checkout. A confirmation given on entering the Site, as described in Section 3.4, is not an Attestation.
- “Authorized Signatory” means [an officer or manager] of Amino20 Labs, or another individual whom [an officer or manager] of Amino20 Labs has designated in writing to give consents under this Policy.
- “Buyer” means the Organization on whose behalf an account application is submitted, an Attestation is given or an Order is placed, and, where the last sentence of Section 3.7 applies, the individual described in it. Section 3.7 states the extent to which an individual who acts for Buyer is personally bound.
- “Change of Control” means any transaction or series of related transactions, whether by acquisition of equity, merger, acquisition of assets or otherwise, by which a person or group of persons acting together that did not control Buyer acquires control of Buyer, or of the business or Laboratory Facility in which Materials are used; and “control” means the power to direct the management and policies of a person, whether by ownership of voting securities, by contract or otherwise.
- “Clinical Use” means any use of a Material (a) to diagnose, cure, mitigate, treat or prevent any disease or other condition in a human or Animal; (b) in testing any specimen taken from a human or Animal where the test is performed for, or its outcome is reported or used for, the diagnosis, treatment or management of, or any other health-related decision about, an individual human or Animal; or (c) in any clinical investigation or other study in which the Material, or anything that contains, was prepared from or was exposed to it, is Administered to a human or Animal.
- “FD&C Act” means the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301 et seq.
- “FDA” means the U.S. Food and Drug Administration.
- “In Vitro Research” means scientific research, testing or analysis conducted in a laboratory using only (a) cells (including cell lines and cells derived from stem cells), tissues, organs, organoids, blood or other specimens derived from a human or Animal and maintained or tested outside the body, [cells or tissues of plants, algae or fungi maintained in culture,] or unicellular microorganisms; (b) cell-free, biochemical or molecular systems; or (c) chemical, physical or analytical methods, in which neither the Material nor anything that contains, was prepared from or was exposed to the Material is Administered to a human or Animal [or applied to any whole multicellular plant, alga or fungus]. In Vitro Research does not include any Clinical Use.
- “Institutional Requirements” means the policies, procedures and approval requirements of Buyer and of any institution that operates or controls the Laboratory Facility or the research, including those of any biosafety, chemical-safety or environmental health and safety committee or office.
- “Laboratory Facility” means a laboratory, located at a non-residential address in the United States, that (a) is operated by Buyer or is made available to Buyer under a written lease, membership or similar arrangement, such as a shared or incubator laboratory; and (b) either (i) is located at the Approved Shipping Address; (ii) where the Approved Shipping Address is a central receiving facility of Buyer or its institution, is a laboratory of Buyer to which that facility delivers in the ordinary course of the institution’s receiving operations; or (iii) is otherwise identified to Amino20 Labs and approved by it in writing.
- “Latent Non-conformity Claim” has the meaning given in Section 12.3(c).
- “Materials” (referred to in the Terms as “materials”) means the products, reagents, compounds, mixtures and other materials that Amino20 Labs offers, sells or supplies, in any form or quantity, together with any portion, aliquot, solution, dilution or mixture prepared from any of them, and “Material” means any of them. Where this Policy imposes an obligation or restriction on Buyer concerning Materials, it applies to Materials that Buyer, or any person through Buyer, has obtained directly or indirectly from Amino20 Labs, and not to any substance that Buyer obtains from another source.
- “OFAC” means the Office of Foreign Assets Control of the U.S. Department of the Treasury.
- “Order” means any offer by Buyer to purchase Materials, however it is submitted, including through the Site or through any storefront, cart link, hosted checkout or other sales channel operated by or for Amino20 Labs. Orders may be placed only through the Site Checkout. A purchase order issued by Buyer does not place an Order, and Amino20 Labs will not accept one as an Order (Section 17.7); if Materials are nonetheless supplied against a purchase order or any other offer not made through the Site Checkout, that offer is an Order for every purpose of the Agreement. As provided in Terms §4, Amino20 Labs accepts an Order only when it confirms shipment.
- “Organization” means (a) a corporation, limited liability company, partnership, limited partnership, cooperative, nonprofit corporation, trust or other legal entity, other than a sole proprietorship, that is organized under, or registered to do business under, the law of the United States or of a State; or (b) the United States, a State, a political subdivision of either, or an agency, instrumentality or public institution of any of them, including a public university. An individual is not an Organization, including an individual who does business as a sole proprietor or under an assumed business name, or who has obtained a federal employer identification number.
- “Permitted Use” has the meaning given in Section 5.1.
- “Personal Use” means any acquisition, possession or use of a Material by or for an individual, other than for In Vitro Research conducted by or for an Organization that is eligible under Section 7, and includes any Administration to that individual or to any other human or Animal.
- “Privacy Policy” means the Amino20 Labs Privacy Policy published on the Site, as amended from time to time.
- “Prohibited Use” means (a) any activity described in Section 6.1(a) through (k) or (n); and (b) any acquisition, possession or use of a Material for any purpose other than In Vitro Research, and any Transfer or export of a Material other than a Transfer permitted under Section 9 or an export permitted under Section 11.4. The receipt, storage, handling, recordkeeping and disposal of Materials acquired for In Vitro Research, their movement between Laboratory Facilities of Buyer (including by carrier or courier), the provision and handling of a Research Sample under Section 9.6, and their return to Amino20 Labs or to a person that Amino20 Labs designates in writing for the return, are not a purpose other than In Vitro Research. A failure to comply with Section 5.1, 5.2, 7.10, 8 or 9.3 in the course of In Vitro Research, with Section 9.2(c), (d) or (f) in connection with a Transfer permitted under Section 9, or with Section 9.6(a), (b) or (c) in connection with the provision of a Research Sample, is a breach of this Policy but is not, by itself, a Prohibited Use.
- “Qualified Personnel” means individuals who (a) are employees, students or contractors of Buyer or, if at least twenty-one (21) years of age, are authorized by Buyer to take part in its In Vitro Research under its supervision, such as visiting researchers, fellows and volunteers; (b) are authorized by Buyer to work with Materials; (c) have received the training described in Section 8.2 and any training required by Applicable Law and Institutional Requirements for the work they perform; and (d) either are Technically Qualified Individuals or work under the direct supervision of a Technically Qualified Individual who is also Qualified Personnel.
- “Refund Policy” means the Amino20 Labs Refund & Return Policy published on the Site, which Terms §7 incorporates into the Terms & Conditions of Sale.
- “Representative” means any officer, employee, contractor or agent of Amino20 Labs, and any automated assistant or other automated system that communicates through the Site or otherwise on behalf of Amino20 Labs.
- “Research Sample” means (a) any sample, specimen, extract, lysate, culture medium, reaction mixture or other preparation that contains, was prepared from or was exposed to a Material in the course of In Vitro Research and that is not intended, or reasonably suitable, for recovering the Material or for use in place of it; and (b) any portion of a Material, including a solution or dilution of it, no larger than is reasonably required for the analysis or testing, that is provided to a laboratory solely to be analyzed, or to be tested in In Vitro Research performed for Buyer, and then consumed, returned or disposed of.
- “Responsible Scientist” has the meaning given in Section 8.1(e).
- “Restricted Material” has the meaning given in Section 7.10.
- “Restricted Party” means any person that is (a) identified on any list of restricted or prohibited parties maintained by the U.S. government, including the Specially Designated Nationals and Blocked Persons List maintained by OFAC and the Entity List, Denied Persons List, Unverified List and Military End-User List maintained by the Bureau of Industry and Security of the U.S. Department of Commerce; (b) owned or controlled by, or acting for or on behalf of, any person described in clause (a); or (c) located in, organized under the laws of, or ordinarily resident in a country or territory that is the target of comprehensive U.S. sanctions.
- “Safety Information” means information concerning the hazards of a Material to persons who may be exposed to it occupationally or accidentally, including hazard classifications and statements, toxicological data, exposure controls, first aid, and precautions for safe handling, storage, spill response and disposal, that (a) is provided in a safety data sheet or on a label, is provided by Amino20 Labs under Section 12.4, or is contained in Buyer’s hazard assessment, training or chemical hygiene program under Sections 8.2 to 8.4; and (b) does not state or imply that any Material is intended or recommended for any use in or on a human or Animal or for any clinical or compounding use, and does not state any recommended, therapeutic or clinical dose, dosing schedule, route or method of Administration, or any therapeutic, beneficial or other intended effect of Administration.
- “Site” means the website at amino20labs.com, any successor or related website operated by Amino20 Labs, and all features and services offered through them, including any automated assistant.
- “Site Checkout” means the checkout process on the Site at amino20labs.com that requires an Approved Account and the checkout Attestation, together with the hosted payment page to which that process directs Buyer to complete payment. A storefront, cart link or checkout operated by or for Amino20 Labs that Buyer reaches other than through that process is not the Site Checkout.
- “State” means a State of the United States or the District of Columbia.
- “Technically Qualified Individual” means an individual who, by education, training or experience, is capable of understanding the hazards of the Materials and the health and environmental risks of the research in which they are used, and who is responsible for ensuring that Materials under that individual’s supervision are procured, stored, used and disposed of safely and in accordance with this Policy.
- “Terms” has the meaning given in Section 1.3.
- “Transfer” means to sell, resell, give, lend, consign, ship, deliver, distribute or otherwise make a Material available to any person, or to relinquish possession or control of a Material, whether or not for value, other than (a) making it available, for In Vitro Research conducted by Buyer, to Buyer’s employees, students or contractors or to other individuals described in clause (a) of the definition of “Qualified Personnel”; (b) the receipt of a shipping package containing Material by shipping and receiving staff of Buyer or its institution, and the delivery of it to Buyer’s personnel by those staff or by a courier engaged by Buyer or its institution; (c) discarding it as waste, or delivering it for disposal to environmental health and safety personnel of Buyer or its institution or to a waste contractor; (d) returning it to Amino20 Labs, or to a person that Amino20 Labs designates in writing for the return; (e) providing a Research Sample in accordance with the first sentence of Section 9.6, or handling a Research Sample in accordance with the second sentence of Section 9.6; or (f) delivering it to a carrier or courier, or to shipping staff of Buyer or its institution, solely for transport to another Laboratory Facility of Buyer or otherwise to Buyer’s personnel for a use described in clause (a), or for a delivery, disposal, return or provision described in clauses (b) to (e), and the custody of it by that carrier, courier or staff in transit. Moving Material between Laboratory Facilities of Buyer, whether by Buyer’s personnel or by a carrier or courier under clause (f), is not a Transfer, whether or not the movement complies with Section 8.5. Making Material available under clause (a) at premises that are not a Laboratory Facility is not, for that reason, a Transfer, but may breach Section 5.1(a), 8.1(b) or 8.5. A failure to comply with Section 8.1(a), 8.5 or 8.6, or with Amino20 Labs’ instructions for a return, in receiving, moving, disposing of or returning Material is a breach of this Policy but does not make the receipt, delivery, movement, disposal or return a Transfer. Passing title to Material to, or charging all or part of its cost to, a client or sponsor for which Buyer conducts In Vitro Research, other than a Restricted Party or a person described in Section 6.1(d), is not a Transfer if Buyer does not deliver the Material or make it available to that client or sponsor, except as described in clauses (a) to (f), and uses it only in In Vitro Research conducted by Buyer.
- “United States,” when used to describe a location, address or destination, means the fifty States of the United States and the District of Columbia.
- “Use Claim” means any statement or representation, express or implied and in any medium, that a Material, or any product that contains or was prepared or derived from a Material, (a) is fit, safe, effective or intended for any use in or on a human or Animal; (b) diagnoses, cures, mitigates, treats or prevents any disease or other condition; or (c) affects the structure or any function of the body of a human or Animal. Safety Information is not a Use Claim.
2.2 Interpretation. In this Policy: “including” and “such as” mean including without limitation; “shall” and “must” impose obligations; “may,” when used of Amino20 Labs, confers a right or discretion and not an obligation; “person” includes any individual, organization or governmental body; “business day” means a day other than a Saturday, a Sunday or a U.S. federal holiday, and “days” means calendar days; “written” and “in writing” include email; the singular includes the plural and vice versa; “or” is not exclusive; a reference to the Laboratory Facility is to each Laboratory Facility of Buyer; a reference to a statute or regulation includes any amendment, any successor provision and any implementing regulation; a reference to a “Section” is to a section of this Policy; a reference to “Terms §”, “Refund Policy §” or “Privacy Policy §” followed by a section designation, such as “Terms §14b” or “Refund Policy §§3 and 5”, is to that section of the Terms, the Refund Policy or the Privacy Policy, respectively; and headings are for convenience only. No provision of this Policy will be construed against Amino20 Labs on the ground that Amino20 Labs drafted it.
3. Acceptance, Attestations and Binding Effect
3.1 Acceptance. Buyer accepts this Policy by accepting the Terms, which incorporate it, and, where the account application or the Site Checkout asks Buyer to agree to this Policy, by doing so. Buyer reaffirms its acceptance of this Policy each time it submits an account application, gives an Attestation or places an Order.
3.2 Confirmation of agreement. Amino20 Labs may require Buyer to confirm its agreement to this Policy, or to a revised version of it, as a condition of opening or maintaining an Account or of placing any Order.
3.3 Effect of Attestations. Buyer represents and warrants that each Attestation is true, accurate and complete when given and, unless the Attestation by its terms relates only to a particular Order, on the date of each later Order. Each Attestation is also a covenant by Buyer to act in accordance with it. Each Attestation is given in addition to, and is to be read together with, the Agreement, and no Attestation limits any obligation of Buyer under the Agreement. A false or misleading Attestation is a material breach of the Agreement (Terms §3).
3.4 Site-entry confirmations. Confirmations and acknowledgments requested when a visitor enters the Site, including any acknowledgment of, or agreement to, this Policy or the Terms given there, give notice of this Policy, the Terms and the conditions on which Materials are offered. They are not Attestations, are not associated with any Account, do not create an Account, do not establish eligibility to purchase and do not make any visitor a party to the Agreement. They are in addition to, and not in place of, the acceptance and Attestations given at account application and at checkout.
3.5 Authority. The individual who submits an account application, gives an Attestation or places an Order on behalf of an Organization represents and warrants that the individual is authorized to bind that Organization (Terms §3). An Attestation concerning the individual’s own age, conduct or knowledge is given by that individual personally as well as on behalf of the Organization.
3.6 Electronic acceptance and records. Buyer agrees that its acceptance of this Policy and each Attestation may be given electronically; that, to the fullest extent permitted by the Electronic Signatures in Global and National Commerce Act, 15 U.S.C. 7001 et seq., and applicable state law, each has the same effect as a signed writing; and that Amino20 Labs’ electronic records of them may be used as evidence that, and of when, they were given, in any arbitration, court or governmental proceeding.
3.7 Organization and individual. The obligations of Buyer under the Agreement are obligations of the Organization that is Buyer. The individual who submits an account application, gives an Attestation or places an Order on behalf of that Organization is personally bound by, and personally liable for, only (a) the Attestations described in the second sentence of Section 3.5; (b) the representation of authority in Section 3.5; and (c) the individual’s own acts and omissions that would breach Section 6.1 if done by Buyer; and that individual shall not engage in, or knowingly assist any person in, any activity described in Section 6.1. As to those matters, the individual is also bound by Section 16 and Terms §15. If an account application is submitted, an Attestation is given or an Order is placed by an individual who does not in fact act on behalf of an Organization, that individual is Buyer and is bound by every provision of the Agreement, but this does not make that individual eligible under Section 7.
3.8 Account credentials. Buyer shall keep the credentials for its Account confidential, shall permit only individuals authorized to bind Buyer to place Orders or give Attestations through the Account, and shall notify Amino20 Labs promptly of any unauthorized access. Each Order placed and each Attestation given through Buyer’s Account is attributable to Buyer unless Buyer notified Amino20 Labs of the unauthorized access before that Order was placed or that Attestation was given.
4. Regulatory Status and Intended Use of Materials
4.1 Intended use. Amino20 Labs offers, sells and supplies Materials solely for In Vitro Research by Buyers that meet the eligibility requirements of Section 7.
4.2 Uses for which Materials are not supplied. Materials are not offered, intended or supplied for use as, or as a component of, any drug, biological product, dietary supplement, food, food additive, cosmetic, medical device (including any in vitro diagnostic product), new animal drug or animal food, or for any Clinical Use.
4.3 No FDA approval. No Material is approved, licensed, cleared or otherwise authorized by FDA under the FD&C Act or the Public Health Service Act for any use in or on humans or Animals. If a Material has the same or a similar chemical identity as an ingredient of a product that is, or has been, approved, licensed or marketed in the United States or elsewhere, that fact does not make the Material that product, does not make the Material suitable for any use for which that product is or was authorized, and does not permit any such use.
4.4 No representation of conformity with drug or device requirements. Amino20 Labs makes no representation that any Material is manufactured, processed, packed, tested or held in conformity with the current good manufacturing practice or quality system requirements that apply to drugs, biological products or medical devices, or that any Material meets any standard of the United States Pharmacopeia–National Formulary or any other compendium.
4.5 No Use Claims. Amino20 Labs makes no Use Claim for any Material, and no statement by Amino20 Labs or any Representative is intended as, or may be relied on as, a Use Claim.
4.6 Status of Amino20 Labs. As stated in Terms §14b, Amino20 Labs is a chemical supplier. It is not a pharmacy, a compounding pharmacy under section 503A of the FD&C Act or an outsourcing facility under section 503B of the FD&C Act. It does not compound, dispense or prescribe, and it provides no medical, veterinary or pharmacy services or advice.
4.7 Legal status depends on use; no representation of lawfulness. The regulatory status of a Material may depend on the use for which it is intended and on the circumstances in which it is sold, distributed and used, including the conduct of Buyer and of any person who receives it through Buyer. A Prohibited Use may violate Applicable Law as well as this Policy. Amino20 Labs makes no representation that any Material may lawfully be acquired, possessed or used in any particular jurisdiction or for any particular purpose (see also Terms §13).
4.8 Controlled substances; state classification. Amino20 Labs does not offer any substance listed in a schedule under the Controlled Substances Act (21 U.S.C. 812; 21 C.F.R. Part 1308). State law may classify or restrict substances that are not controlled under federal law. Buyer is solely responsible for determining, before ordering, whether any state or local classification, registration, licensing or other requirement applies to a Material and for complying with it, and Buyer shall not order any Material that it may not lawfully possess at the Laboratory Facility. With each Order, Buyer represents and warrants that it may lawfully receive, possess and use each ordered Material at the Approved Shipping Address and the Laboratory Facility under the law of each state and locality in which they are located, including any law that classifies the Material as a drug, prescription drug, controlled substance or other restricted substance.
4.9 Acknowledgment and non-reliance. Buyer acknowledges the matters stated in this Section 4 and represents that it has not relied on any statement by Amino20 Labs or any Representative that is inconsistent with them.
4.10 Changes in legal status. If, after an Order is placed, any Material becomes a controlled substance, a listed chemical, a select agent or toxin, or a biological product, or otherwise becomes subject to a registration, licensing, prescription or other restriction under Applicable Law, (a) Amino20 Labs may cancel any unshipped Order for that Material, and any amount collected will be refunded as provided in Refund Policy §7; and (b) from the effective date of the change, Buyer shall either comply with every requirement that applies to its continued possession and use of the Material or dispose of the Material under Section 8.6. Amino20 Labs may discontinue any Material at any time.
5. Permitted Use
5.1 Permitted Use. Buyer shall acquire, possess and use Materials only for In Vitro Research that meets all of the following conditions (such use, the “Permitted Use”). The In Vitro Research must be:
- (a)conducted at the Laboratory Facility;
- (b)performed only by Qualified Personnel;
- (c)not materially different from the description of Buyer’s research, if any, most recently given to Amino20 Labs, including under Section 7.3(c), 7.9 or 7.10; and
- (d)conducted in compliance with Applicable Law, Institutional Requirements and the Agreement.
5.2 Research quantities. Buyer shall order and hold only such quantities of Materials as are reasonably required for its current In Vitro Research.
5.3 Animal research excluded. Research in which any Material, or anything that contains, was prepared from or was exposed to a Material, is Administered to an Animal, including in vivo, preclinical and veterinary research, is not a Permitted Use, whether or not the research is otherwise lawful, approved by an institutional animal care and use committee, or conducted under an investigational new drug, investigational new animal drug or investigational device exemption.
5.4 No implied suitability. The Permitted Use describes the only use that this Policy allows. It is not a representation that any Material is suitable for any particular research purpose. Buyer is solely responsible for determining suitability and for any independent verification that its research requires (Terms §6 and §8).
6. Prohibited Uses and Conduct
6.1 Prohibited Uses. Buyer shall not, and shall not permit, assist or knowingly enable any person to:
- (a)Administer any Material to any human, including by self-administration, or to any Animal, by any route or means;
- (b)use any Material for any Clinical Use;
- (c)use any Material as an ingredient, component, starting material, intermediate or processing aid in the manufacture, preparation, compounding, formulation or processing of any drug, biological product, dietary supplement, food, food additive, cosmetic, medical device, new animal drug or animal food, or of any other product intended for use in or on humans or Animals;
- (d)Transfer any Material, for any purpose, to (i) any individual for Personal Use; (ii) any pharmacy, compounding pharmacy or outsourcing facility; (iii) any physician, veterinarian or other health-care practitioner, or any clinic, medical or veterinary practice or telehealth service, for use in or in connection with the practice of medicine, veterinary medicine or pharmacy; (iv) any medical spa or any wellness, aesthetic, anti-aging, fitness or athletic business; (v) any person whom Buyer knows or has reason to believe intends any Prohibited Use; or (vi) any individual under twenty-one (21) years of age;
- (e)(i) relabel or rebrand any Material, by applying to any container of Material, or to any packaging in which a Material is offered, sold or Transferred, any name, mark or labeling that presents the Material as a product of, or as supplied under the name or brand of, any person other than Amino20 Labs, or under a name or description other than the one under which Amino20 Labs supplied it; (ii) repackage any Material, apply any label to any Material or its container, or remove, alter, obscure or cover any labeling applied to any Material or its container by or for Amino20 Labs, in each case for the purpose of, or in connection with, any Transfer other than a Transfer permitted under Section 9, any Use Claim or any purpose other than In Vitro Research; or (iii) resell, distribute or otherwise Transfer any Material, or subdivide any Material for the purpose of any Transfer, other than a Transfer permitted under Section 9. No consent permits any activity described in clause (i), including in connection with a Transfer permitted under Section 9. The division of Material into secondary containers, and any labeling of a Material or its containers (including the labeling of secondary containers, the replacement of a damaged or illegible label and the addition of an inventory, barcode or tracking label), in the course of In Vitro Research by or for Buyer, whether or not the labeling complies with Section 9.3; the placing of a portion of Material into a container labeled as Section 9.3 requires for a Transfer that the consent expressly permits under Section 9.2(e); and the preparation, labeling and provision of a Research Sample under Section 9.6, are governed by Sections 9.2(e), 9.3 and 9.6 and are not activities described in this clause (e), except that labeling that presents a Material as a product of, or as supplied under the name or brand of, any person other than Amino20 Labs remains an activity described in clause (i);
- (f)list, advertise, offer or promote any Material, or any product represented as containing or derived from a Material, on any consumer marketplace, auction or classified-listing site, social-media platform or consumer messaging application, or through any other channel directed to the general public, to individuals acquiring for Personal Use, or to any person described in Section 6.1(d);
- (g)make, publish or disseminate any Use Claim, represent in any medium that any Material is fit or intended for human or veterinary use (Terms §2), or refer to any Material by, or associate any Material with, the proprietary name of any drug or biological product, in each case in connection with offering, promoting, labeling, selling or Transferring any Material, or for the purpose of, or in a manner that promotes or facilitates, any Administration;
- (h)publish, solicit or disseminate any testimonial, endorsement or other content that promotes, encourages or solicits the Administration of any Material, or the acquisition of any Material for Administration, or that identifies Amino20 Labs as a source of any material for Administration, or offer any incentive for any such content;
- (i)provide, publish or disseminate any Administration Information in connection with any Material, where the provision, publication or dissemination is for the purpose of, or promotes or facilitates, any Administration, or supply any solvent, diluent, device, calculator or instruction for preparing any Material for Administration;
- (j)export, re-export or transfer (in-country) any Material, Transfer any Material to a Restricted Party, or use or Transfer any Material for a prohibited end use, in each case in breach of Section 11;
- (k)acquire any Material on behalf of, or for Transfer to, any person other than Buyer that Buyer, or the individual acting for Buyer, knows or has reason to believe is not eligible under Section 7, has had an account application refused or has had its Account suspended or terminated (Buyer does not acquire Material on behalf of, or for Transfer to, a client or sponsor by reason only that the client or sponsor pays for, or takes title to, Material in the circumstances described in the last sentence of the definition of “Transfer”);
- (l)provide false or misleading information to Amino20 Labs, use another person’s Account or permit another person to use Buyer’s Account, or evade or attempt to evade any verification, screening, shipping or other control used by Amino20 Labs;
- (m)acquire, possess, use, Transfer or dispose of any Material in violation of Applicable Law or Institutional Requirements; or
- (n)use any Material in the synthesis, production or preparation of, or as a precursor to, any controlled substance, any controlled substance analogue within the meaning of 21 U.S.C. 802(32), any listed chemical under 21 C.F.R. Part 1310, or any select agent or toxin under 42 C.F.R. Part 73, 7 C.F.R. Part 331 or 9 C.F.R. Part 121.
6.2 Scientific publication. Neither Section 6.1 nor Section 8.12(c) restricts Buyer from publishing the findings of its In Vitro Research in scientific literature, theses or dissertations, or presenting them at scientific meetings, including citing and discussing published scientific literature in the ordinary course and identifying Amino20 Labs as the source of the Materials used, provided that Buyer does not use, and does not permit any person acting for Buyer to use, the publication or presentation to promote the sale or Administration of any Material, and that the publication or presentation does not identify Amino20 Labs as a source of any material for Administration.
6.3 Material condition of sale. Buyer acknowledges that the restrictions in this Policy, like those in Terms §2, are a material condition of sale, and that Amino20 Labs would not sell Materials to Buyer without them. Each Prohibited Use, and each breach of Section 6.1, is a material breach of the Agreement.
6.4 Consents; no authority to permit other uses.
- (a)A consent, waiver or modification by Amino20 Labs under this Policy is effective only if it is in writing, refers expressly to this Policy, is signed by an Authorized Signatory and, in the case of a consent to a Transfer or export, identifies the Material, the recipient or destination and the quantity to which it applies. An email sent from an Authorized Signatory’s Amino20 Labs email account that states the signatory’s name and title is a signed writing for this purpose.
- (b)Amino20 Labs will not consent to any activity described in Section 6.1, and no person, including any Authorized Signatory, has authority to consent to or permit any such activity or to make any Use Claim on behalf of Amino20 Labs. A Transfer permitted under Section 9, and an export that meets the conditions of Section 11.4, are not activities described in Section 6.1(e)(ii) or (iii), and an export, re-export or transfer (in-country) that meets those conditions is not an activity described in Section 6.1(j) unless it is made to or for the benefit of a Restricted Party or for an end use described in Section 11.6. A consent to a Transfer or export is not a consent to an activity described in Section 6.1 by reason only that the Transfer or export, as made, breaches Section 6.1(m). No consent permits any activity described in Section 6.1(d), 6.1(e)(i) or 6.1(j), whatever Buyer or any individual acting for Buyer knew or had reason to believe, and a Transfer or export that is such an activity is not permitted under Section 9 or Section 11.4.
- (c)No Representative other than an Authorized Signatory has authority to give any consent, waiver or modification under this Policy.
- (d)No other statement, no course of dealing and no failure by Amino20 Labs to object to any conduct is a consent, waiver or modification.
- (e)Approval of an account application, an Approved Shipping Address or a Laboratory Facility, a decision that information provided under Section 7.6 is satisfactory, and any other approval given in the ordinary course of account administration, is not a consent, waiver or modification for the purposes of this Section 6.4. Such an approval may be given by any person whom Amino20 Labs authorizes, including through the Site, but no such approval permits any activity described in Section 6.1.
6.5 Protected communications. Nothing in the Agreement prohibits or restricts any person from (a) reporting any possible violation of law, any adverse event or any safety concern to FDA or any other governmental authority, or cooperating in any governmental investigation, without giving notice to Amino20 Labs; (b) making any communication protected by the Consumer Review Fairness Act of 2016, 15 U.S.C. 45b; or (c) making any other disclosure that Applicable Law protects.
7. Eligibility and Account Verification
7.1 Laboratory research Organizations only. Amino20 Labs offers Materials for sale only to Organizations that are regularly and lawfully engaged in laboratory research that does not involve Clinical Use, for use solely in that research. Amino20 Labs does not offer Materials to consumers and does not operate any sales channel directed to consumers, and it will not knowingly sell any Material for Personal Use or to any person who is not eligible under this Section 7 (Terms §1).
7.2 Approved Account required before shipment. Amino20 Labs will not ship, or cause any supplier to ship, any Order unless Buyer holds an Approved Account at the time of shipment, and it may require Buyer to hold an Approved Account before Buyer can place an Order. Amino20 Labs may cancel, or decline to ship, any Order if Buyer does not hold an Approved Account at any time before shipment, and may cancel before shipment any Order that was not placed through the Site Checkout (Terms §1 and §4). Every Order, however placed, is subject to the Agreement.
7.3 Eligibility requirements. To be eligible for an Account, an applicant must:
- (a)act on behalf of an Organization of a type that Amino20 Labs accepts, which at the date of this Policy are academic institutions, government laboratories, healthcare research organizations, contract research organizations, commercial research organizations and independent laboratories;
- (b)submit accurate and complete organization details and contact information, and a non-residential shipping address in the United States that is either the Laboratory Facility or a central receiving facility of Buyer or its institution that delivers directly to the Laboratory Facility;
- (c)unless the Organization is described in clause (b) of the definition of “Organization” or is an institution of higher education accredited by an accrediting agency recognized by the U.S. Department of Education, submit the Organization’s legal name, legal form, State of organization and State business registration number, and a description of the In Vitro Research in which Materials will be used;
- (d)be at least twenty-one (21) years of age and confirm that fact by Attestation;
- (e)not be, or act for, a Restricted Party;
- (f)satisfy any additional requirement that Amino20 Labs communicates to the applicant; and
- (g)not be ineligible under Section 7.4, and disclose to Amino20 Labs in writing any matter described in Section 7.4(f) that is known to the applicant after reasonable inquiry.
7.4 Ineligible applicants. The following are not eligible for an Account:
- (a)individuals who do not act on behalf of an Organization, including individuals who operate as sole proprietors or under an assumed business name; individuals acquiring Materials for Personal Use; and any entity formed or used to acquire Materials for Personal Use, whatever its registration status;
- (b)any applicant whose intended use includes Administration, Clinical Use, any activity described in Section 6.1(c), or Transfer for any of those purposes;
- (c)pharmacies, compounding pharmacies and outsourcing facilities; hospitals, health systems and medical, veterinary and other health-care practices, clinics and telehealth services, except a research laboratory of a hospital, health system or academic medical center that acquires Materials solely for In Vitro Research and not for any patient-care, pharmacy or other clinical function; and medical spas and wellness, aesthetic, anti-aging, fitness and athletic businesses;
- (d)resellers and distributors, except with Amino20 Labs’ prior written consent given in accordance with Section 6.4;
- (e)Restricted Parties, any applicant whose Account has previously been terminated for breach of the Agreement, and any person acting for any of them; and
- (f)unless Amino20 Labs consents in writing in accordance with Section 6.4 after disclosure under Section 7.3(g), any applicant if any Covered Person is, or has been, the subject of an FDA warning letter, an injunction or consent decree, debarment under 21 U.S.C. 335a, or a criminal charge or conviction, in each case relating to the sale, distribution, compounding or Administration of any research chemical, or of any drug or biological product intended for use in humans or Animals that was not the subject of an approved application, a license or an investigational exemption under the FD&C Act or the Public Health Service Act. In this clause (f), “Covered Person” means (i) the Organization or, where the Organization is described in clause (b) of the definition of “Organization”, is an accredited institution of higher education, or is a hospital, health system or academic medical center whose application is made on behalf of a research laboratory within the exception in Section 7.4(c), the laboratory, department or other unit on whose behalf the application is made; (ii) the Responsible Scientist; and (iii) where the Organization is none of those and does not have equity securities listed on a national securities exchange, its officers and each person that owns, directly or indirectly, [twenty-five percent (25%)] or more of its equity interests or otherwise controls it. A matter that concerns a governmental body, an accredited institution of higher education, or a hospital, health system or academic medical center, as a whole is not within this clause (f) unless it involves that laboratory, department or unit or the Responsible Scientist. A matter within this clause (f) that Buyer did not know of after reasonable inquiry makes Buyer, or a recipient of a Transfer under Section 9 that the matter concerns, ineligible only from the time Buyer becomes aware of the matter, whether or not that recipient knew of it. Such a matter is not, by itself, a Prohibited Use, and it does not make a Transfer made before that time one that is not permitted under Section 9. When Buyer becomes aware of such a matter, Buyer shall notify Amino20 Labs under Section 7.9 or, for a matter concerning a recipient, promptly in writing under Section 19, and may then, as the case may be, place further Orders or make further Transfers to that recipient only with Amino20 Labs’ consent under this clause (f).
7.5 Verification. Amino20 Labs applies automated checks to some of the information submitted with an account application, such as the email domain, the format of any registration number, the shipping address and the organization type. Applications that are not approved automatically are held for review by a person, and Amino20 Labs may review any application or Account manually at any time. Before approving an application from an Organization that must submit a State business registration number under Section 7.3(c), Amino20 Labs confirms, through the business registry of the State named, that an entity with that name and number is registered there. Approval means only that Amino20 Labs decided to approve the application on the basis of the information then available to it. Amino20 Labs is not obliged to confirm independently any information submitted, and does not confirm every item of it independently. Approval is not a certification of Buyer’s qualifications, facilities, research or compliance with Applicable Law, and it does not relieve Buyer of any obligation under the Agreement. Meeting the eligibility requirements does not entitle any applicant to an Account (Terms §1).
7.6 Additional information and documentation. Amino20 Labs may at any time request information or documentation to establish or confirm eligibility or compliance, including: proof of business registration; evidence of the Laboratory Facility and of Buyer’s right to use it; confirmation from any institution with which Buyer is affiliated; the identity and qualifications of the Responsible Scientist; a description of the research for which particular Materials are ordered; and a signed statement of intended end use. Buyer shall provide the requested information within the period stated in the request or, if none is stated, within [ten (10)] business days after the request. Amino20 Labs may hold any Order, or suspend or close the Account, pending receipt of the information, or if the information is not provided or does not satisfy Amino20 Labs (Terms §1).
7.7 Re-verification. Amino20 Labs may require Buyer to complete verification again at any time, including after any change described in Section 7.9 and before shipping to any destination other than the Approved Shipping Address (Terms §5).
7.8 Discretion. Amino20 Labs may refuse any account application, may refuse, limit or cancel any Order, and may suspend or terminate any Account, at its sole discretion and without liability, including where ordering patterns, quantities, destinations or other information are inconsistent with laboratory research use (Terms §1).
7.9 Duty to keep information current. Buyer shall keep the information associated with its Account true, accurate and complete (Terms §3). Buyer shall notify Amino20 Labs in writing under Section 19, promptly and in any event before placing any further Order, of (a) any change in its legal name, legal form, ownership or control, any Laboratory Facility, the Approved Shipping Address, its primary contact or the Responsible Scientist; (b) any material change in the nature of the research described to Amino20 Labs; (c) any circumstance that makes Buyer ineligible under this Section 7; and (d) any Attestation ceasing to be true.
7.10 Restricted Materials. Amino20 Labs may designate any Material as a “Restricted Material” by marking it as such on the Site or by notice to Buyer, and may add or withdraw a designation at any time. A designation may name a compound, in which case every Material that is or contains that compound, including a blend, is a Restricted Material. Amino20 Labs may make its acceptance of an Order for a Restricted Material conditional on any of the following, in addition to the other requirements of this Policy: (a) a written statement, signed by the Responsible Scientist, that describes the specific In Vitro Research for which the Restricted Material is ordered and the quantity that research requires; (b) written confirmation of that research from an institution with which Buyer is affiliated; (c) a limit on the quantity that may be ordered in any Order or period; and (d) review of the Order by a person before shipment. Buyer shall use a Restricted Material only in the research described under clause (a).
7.11 Authorization to verify. Buyer authorizes Amino20 Labs and its service providers to verify any information submitted to Amino20 Labs, and to obtain information relevant to Buyer’s eligibility or compliance, from third parties, including any institution with which Buyer or its personnel are affiliated, the operator of the Laboratory Facility, governmental registries, address-validation and identity-verification services, carriers and payment providers, and to disclose to those third parties the information reasonably necessary for that purpose.
8. Buyer’s Handling, Safety and Recordkeeping Obligations
8.1 Responsible personnel and facilities. Buyer shall ensure that:
- (a)Materials are received only at the Approved Shipping Address and are delivered from there directly to the Laboratory Facility; shipping and receiving staff of Buyer or its institution may receive a shipping package containing Materials and deliver it, unopened, themselves or by a courier engaged by Buyer or its institution, to Qualified Personnel at the Laboratory Facility;
- (b)except for receipt and delivery under Section 8.1(a), movement between Laboratory Facilities under Section 8.5, a Transfer permitted by Section 9, a Research Sample provided under Section 9.6, disposal under Section 8.6 (including through a licensed waste contractor) and a return to Amino20 Labs in accordance with its written instructions, Materials are handled, stored, used and disposed of only by Qualified Personnel and only at the Laboratory Facility;
- (c)each Laboratory Facility is equipped and staffed for, and holds every permit required by Applicable Law for, the safe handling, storage and disposal of laboratory chemicals;
- (d)no individual under eighteen (18) years of age receives, handles or has access to any Material, except a student enrolled in an accredited educational program who is Qualified Personnel and works under the direct, in-person supervision of a Technically Qualified Individual who is also Qualified Personnel, at the Laboratory Facility and in accordance with Institutional Requirements; and
- (e)a Technically Qualified Individual who is Qualified Personnel and has authority over the research in which Materials are used is designated by Buyer as responsible for Buyer’s use of Materials and for its compliance with this Policy (the “Responsible Scientist”).
Buyer shall identify the Responsible Scientist and each Laboratory Facility to Amino20 Labs on request, and shall notify Amino20 Labs of any change in either under Section 7.9.
8.2 Training. Buyer shall ensure that every individual who handles Materials, other than shipping and receiving staff and couriers handling an unopened package under Section 8.1(a), and carriers and couriers handling a closed shipping package in transit, has been trained in (a) the hazards of the Materials and the procedures for their safe handling, storage, spill response and disposal; and (b) the restrictions in this Policy.
8.3 Hazard communication and chemical hygiene. Buyer shall comply with all Applicable Law concerning workplace chemical safety, including, as applicable, the OSHA Hazard Communication Standard (29 C.F.R. 1910.1200) and the OSHA standard for Occupational Exposure to Hazardous Chemicals in Laboratories (29 C.F.R. 1910.1450). This includes maintaining any required chemical hygiene plan, keeping safety data sheets and other hazard information readily accessible to personnel, and labeling containers as those requirements provide.
8.4 Hazard information. Buyer acknowledges that the chemical, physical and toxicological properties of many Materials have not been fully investigated, and that the hazard information supplied with or for a Material reflects the information available to the person who prepared it and may be incomplete. Buyer shall make its own hazard assessment of each Material before use and shall handle each Material with the precautions appropriate to a substance whose hazards have not been fully characterized.
8.5 Storage and security. Buyer shall store Materials (a) under the storage conditions stated in their labeling or documentation; (b) at the Laboratory Facility, in a secure location to which access is limited to Qualified Personnel, except while held unopened for delivery under Section 8.1(a) or while in transit after a removal permitted by this Section 8.5; and (c) in a manner that allows Buyer to account for all quantities received. Buyer shall not remove any Material from the Laboratory Facility except for a Transfer permitted by Section 9, to provide a Research Sample under Section 9.6, for disposal under Section 8.6, for a return to Amino20 Labs in accordance with its written instructions, or for movement to another Laboratory Facility of Buyer, by or under the direction of Qualified Personnel (including by carrier or courier), in compliance with Applicable Law (including, where applicable, the Hazardous Materials Regulations (49 C.F.R. Parts 171 to 180)) and Institutional Requirements.
8.6 Disposal. Buyer shall dispose of all Materials that are unused, expired, surplus, damaged or contaminated, and all waste containing Materials, (a) in accordance with Applicable Law, including, where applicable, the Resource Conservation and Recovery Act and its implementing regulations and state and local hazardous-waste requirements, and with Institutional Requirements; (b) through a licensed waste contractor where Applicable Law or Institutional Requirements so require; and (c) in a manner that prevents any person from obtaining the Material for any Prohibited Use. Buyer shall not return any Material to Amino20 Labs unless Amino20 Labs directs it to do so in writing (Refund Policy §1), and shall package, mark, label and document any return as Applicable Law requires, including, where applicable, the Hazardous Materials Regulations (49 C.F.R. Parts 171 to 180), and as the carrier requires.
8.7 Buyer’s records. Buyer shall make and keep records sufficient to show that each Material was received, stored, used, Transferred (where permitted) and disposed of only in accordance with this Policy, including, for each container: the date of receipt; the catalog and lot numbers; the quantity received; the storage location; the research in which it was used; and the date and method of its disposal. Buyer shall keep these records for at least [two (2)] years after the Material is used up or disposed of, or for any longer period required by Applicable Law or Institutional Requirements, and shall provide copies to Amino20 Labs on request under Section 13.6.
8.8 Institutional approvals. Buyer shall obtain and maintain every approval required by Institutional Requirements for the research in which Materials are used, and shall provide evidence of those approvals on request.
8.9 Licenses and local requirements. As provided in Terms §13, Buyer is responsible for compliance with all laws that apply to its acquisition, possession and use of Materials, including any licensing, registration, permit, fire-code or zoning requirement that applies to the Laboratory Facility.
8.10 Notice of loss, diversion, misuse or exposure. Buyer shall notify Amino20 Labs in writing under Section 19 within [five (5)] business days after Buyer, the Responsible Scientist or any Qualified Personnel becomes aware of (a) any loss or theft of any Material, or any quantity of Material that cannot be accounted for; (b) any actual or suspected Prohibited Use, or any Transfer in breach of this Policy, by any person; (c) any governmental inquiry, investigation, warning or proceeding concerning Buyer’s acquisition, possession, use or Transfer of Materials, to the extent Buyer may lawfully disclose it; or (d) any exposure of any person to a Material that results in injury or illness requiring medical attention, and any report that a Material has been Administered to any human or Animal, stating in each case the catalog and lot numbers of the Material involved. A notice under this Section does not relieve Buyer of any obligation or liability. This Section does not require Buyer to disclose that it has made any communication described in Section 6.5, or the content of any such communication.
8.11 Lot notices. If Amino20 Labs notifies Buyer of a documentation correction, quality concern or withdrawal affecting a lot of Material, Buyer shall promptly review the notice; take the actions it specifies, including quarantining affected Material and disposing of it under Section 8.6; confirm in writing that it has done so; and promptly forward the notice to every person to whom it has Transferred any Material from the affected lot and provide that person’s written confirmation to Amino20 Labs. If the notice states that a lot is withdrawn, or does not conform to its certificate of analysis or stated specifications, Amino20 Labs will, at its option, replace the affected Material that Buyer has not used or refund the price Buyer paid for it, upon Buyer’s written certification of its disposal under Section 8.6, notwithstanding the claim waiver in Terms §5 and the claim window and exclusions in Refund Policy §§3 and 5. Except as stated in this Section, Buyer’s sole and exclusive remedies for non-conforming Material are those stated in Section 12.3.
8.12 Human-derived materials. If Buyer’s In Vitro Research uses human cells, tissues, blood or other specimens, or information about identifiable individuals, Buyer shall (a) obtain every approval, exemption determination and informed consent required by Applicable Law, including, where applicable, 45 C.F.R. Part 46 and 21 C.F.R. Parts 50 and 56, and by Institutional Requirements; (b) comply with Applicable Law on biosafety, including, where applicable, the OSHA Bloodborne Pathogens Standard (29 C.F.R. 1910.1030); and (c) not return to any individual any result of that research that relates to that individual, and not report any result of that research to any health-care provider or other person for use in the diagnosis, treatment or management of, or any other health-related decision about, any individual human or Animal. Clause (c) does not restrict the communication of research results to collaborators, journal editors and reviewers, thesis committees, funders or the bodies responsible for Institutional Requirements, or their publication or presentation as described in Section 6.2.
8.13 Quality concerns. If Buyer has reason to believe that any Material is contaminated, misidentified, mislabeled or otherwise not as described in its lot documentation, Buyer shall stop using it, keep the container, labeling and remaining contents in quarantine for at least [sixty (60)] days or, if Buyer makes a claim under Section 12.3, until the claim is resolved, whichever is later, unless Amino20 Labs directs otherwise, and notify Amino20 Labs under Section 19, stating the catalog and lot numbers. Claims for replacement or refund remain subject to Section 12.3 (including the period for a Latent Non-conformity Claim in Section 12.3(c)), the Refund Policy and Section 8.11.
8.14 Cessation, change of control and departing personnel. Before Buyer (a) closes or vacates the Laboratory Facility, (b) ends the research for which Materials were acquired, (c) dissolves, liquidates or makes an assignment for the benefit of creditors, or (d) undergoes a Change of Control to which Amino20 Labs has not consented under Section 17.5, Buyer shall dispose of all Materials in its possession or control under Section 8.6, or Transfer them only with Amino20 Labs’ consent under Section 9, and shall certify in writing that it has done so. Buyer shall not include any Material in a sale of its assets except as permitted by Section 9, and shall ensure that no individual removes any Material from the Laboratory Facility on leaving Buyer’s employment or affiliation.
9. Transfers, Resale and Labeling Integrity
9.1 Transfers require consent. Buyer shall not Transfer any Material without Amino20 Labs’ prior written consent given in accordance with Section 6.4. Providing a Research Sample in accordance with the first sentence of Section 9.6, and handling a Research Sample in accordance with the second sentence of Section 9.6, are not Transfers and do not require consent. This Section supplements Terms §2.
9.2 Conditions of any permitted Transfer. Amino20 Labs may give or withhold consent at its sole discretion. A Transfer is permitted under this Section 9 only if it is made with that consent and clauses (a), (b) and (e) below, and every condition stated in the consent, are satisfied. Buyer shall also comply with clauses (c), (d) and (f) below for every Transfer:
- (a)the recipient meets the eligibility requirements of Section 7 (or, if it does not, neither Buyer nor any individual acting for Buyer in the Transfer knew or had reason to believe so at the time of the Transfer) and, if Amino20 Labs requires, holds its own Approved Account;
- (b)before the Transfer, the recipient agrees in writing, either directly with Amino20 Labs or in an agreement with Buyer that names Amino20 Labs as an intended third-party beneficiary entitled to enforce it directly, to restrictions on the Material that are no less protective than those in this Policy, including a prohibition on any further Transfer without Amino20 Labs’ prior written consent;
- (c)Buyer makes a record of the Transfer stating the recipient’s name and address, the date, the Material, the lot number and the quantity Transferred, and keeps it for the period stated in Section 8.7;
- (d)Buyer provides a copy of the recipient’s written agreement and of the Transfer record to Amino20 Labs on request;
- (e)the Material is Transferred only in its original, unopened container, with all labeling applied by or for Amino20 Labs intact, unless the consent expressly permits the Transfer of a portion of Material in a container labeled as Section 9.3 requires; and
- (f)every shipment of Material in connection with the Transfer is packaged, marked, labeled and documented in accordance with Applicable Law, including, where applicable, the Hazardous Materials Regulations (49 C.F.R. Parts 171 to 180), and the carrier’s requirements.
A failure to comply with Section 9.2(c), (d) or (f) is a breach of this Policy but does not make the Transfer one that is not permitted under this Section 9. The words in parentheses in clause (a) do not make permitted a Transfer that is an activity described in Section 6.1(d) or 6.1(j), such as a Transfer to a recipient that is in fact an individual, a pharmacy or a Restricted Party: no consent permits such a Transfer, whatever Buyer or any individual acting for Buyer knew or had reason to believe, and it is not permitted under this Section 9 (Section 6.4(b)). If Buyer becomes aware after a Transfer that the recipient did not meet, or has ceased to meet, the eligibility requirements of Section 7, Buyer shall promptly notify Amino20 Labs in writing under Section 19.
9.3 Labeling integrity. Buyer shall not remove, alter, obscure or cover any label, lot number or other marking on any container of Material, or any statement on it that restricts the Material to research use. Adding an inventory, barcode or institutional tracking label to a container is not a breach of this Section if the name of the Material, the lot number and the research-use statement on the container remain legible. Buyer shall ensure that each container in which Material is kept within the Laboratory Facility, other than a container intended only for the immediate use of the individual who transferred the Material into it and kept under that individual’s control, is labeled as Applicable Law and Institutional Requirements require, identifies the Material, and bears the statement: “For research use only. Not for use in humans or animals. Not for use in diagnostic procedures.” A container too small to carry that statement legibly may instead be kept in a rack, box or other outer container that carries it.
9.4 Inconsistent labeling or documentation. No label, marking, packaging, document or other statement that accompanies or refers to a Material and is inconsistent with this Policy authorizes any use other than the Permitted Use. If Buyer receives any Material whose labeling or documentation is inconsistent with this Policy, Buyer shall treat the Material as restricted to the Permitted Use and shall promptly notify Amino20 Labs.
9.5 Responsibility for personnel and recipients. Buyer is responsible for the acts and omissions of its personnel and of every person who receives, accesses or uses any Material through Buyer, whether or not the Transfer was permitted, as if they were Buyer’s own acts and omissions (Terms §2 and §10), including the acts of any of its personnel who take Material without Buyer’s authority. Buyer is not responsible under this Section, Section 15.1, Section 15.3 or Terms §10 for the acts of a person, other than Buyer’s personnel or any person acting for Buyer, who obtained Material by theft from Buyer, if Buyer complied with Sections 8.5 and 8.10.
9.6 Research Samples. Buyer may, without Amino20 Labs’ consent, provide a Research Sample to a laboratory in the United States that is operated by an Organization that is not a Restricted Party or a person described in Section 6.1(d), for analysis, or for In Vitro Research performed for Buyer, in collaboration with Buyer or, where Buyer conducts the research for another Organization, for that Organization, if Buyer has no reason to believe that the recipient will use it for any other purpose. A person to which a Research Sample has been provided in accordance with the first sentence of this Section 9.6 or with this sentence may, without Amino20 Labs’ consent, make it available to its personnel, return it to the person from which it received it or to Buyer, dispose of it, or provide it or any portion of it, for analysis or In Vitro Research (or, for a Research Sample described in clause (b) of the definition of “Research Sample”, only for analysis or for testing in In Vitro Research performed for Buyer), to a laboratory in the United States that is operated by an Organization that is not a Restricted Party or a person described in Section 6.1(d), if it has no reason to believe that the laboratory will use it for any other purpose. For each Research Sample that Buyer provides, Buyer shall:
- (a)inform the recipient in writing, which may be on the sample label, a sample-submission form or the shipping documents, that the Research Sample contains or was prepared from material supplied for In Vitro Research only; that it may not be Administered to any human or Animal, used for any Clinical Use or exported; that it may be provided to another person only for analysis or In Vitro Research (or, for a Research Sample described in clause (b) of the definition of “Research Sample”, only for analysis or for testing in In Vitro Research performed for Buyer), and only to a laboratory in the United States that is operated by an Organization that is not a Restricted Party or a person described in Section 6.1(d); and that this information must be given to any person to which it is provided;
- (b)record the recipient, the date, and the catalog and lot numbers of the Material from which the Research Sample was prepared, which it may do in its ordinary research or shipping records, and keep that record for the period stated in Section 8.7; and
- (c)package, mark, label and ship the Research Sample in accordance with Applicable Law and Institutional Requirements, including, where applicable, the Hazardous Materials Regulations (49 C.F.R. Parts 171 to 180).
A failure to comply with Section 9.6(a), (b) or (c) is a breach of this Policy but does not make the provision of the Research Sample a Transfer. A Research Sample remains a Material, and each person to which it is provided or made available under this Section 9.6 is a person who receives Material through Buyer for the purposes of Sections 9.5 and 13.8.
10. Communications and Information
10.1 No medical, veterinary or Administration Information. Amino20 Labs does not offer medical, veterinary or pharmacy advice or Administration Information, and does not offer any solvent, diluent, device or other article with, or for use with, any Material. No Representative is authorized to provide any such advice or information or to recommend any such article.
10.2 Requests indicating Prohibited Use. Buyer shall not request Administration Information from Amino20 Labs or any Representative. Amino20 Labs’ policy is to decline any request for Administration Information, and it may decline any request or Order that indicates that a Material is or may be intended for Administration, Clinical Use or any other Prohibited Use, and may end the communication. Any such request or communication may result in review of the Account and in any measure described in Section 13.3, including suspension or termination of the Account, and, where Section 13.8 applies, in the measures it requires.
10.3 Product and scientific information. Information that Amino20 Labs publishes about a Material, such as its chemical identity, specifications, storage conditions and lot documentation, is provided to identify and characterize the Material for In Vitro Research. Amino20 Labs may also provide a bibliographic citation to published scientific literature, or identify the scientific field in which a Material or a related compound has been studied, but only (a) in a form that is neither Administration Information nor a Use Claim; (b) without naming, in the identification of a field, in the title of a cited work or in any text that accompanies a citation, any disease or other condition, any outcome in an organ or tissue, or any physiological function, and, in the case of a scientific field, only in terms of a receptor, pathway, molecular target, chemical class or assay; and (c) [only on a page of the Site, or in another communication by or for Amino20 Labs, that displays no price for any Material and no means of ordering any Material]. The standard scientific name of a receptor, hormone, peptide or compound class is not the naming of a physiological function under clause (b) when it is used only to identify that receptor, hormone, peptide or class. None of this information is intended as, or may be relied on as, a Use Claim, a representation that any Material is safe or effective for any purpose, or a recommendation of any use other than the Permitted Use. A bibliographic citation to research published by others identifies that literature only. It is not a statement that any Material is intended or suitable for use in a living organism, and it does not describe, recommend or endorse any Administration. Research in which a Material is Administered to a human or Animal is not a Permitted Use (Section 5.3).
10.4 Automated assistant. Any automated assistant on the Site generates its responses by computer. It is not a physician, pharmacist, veterinarian or other licensed professional, and it does not provide professional advice. Its responses may be inaccurate or incomplete, do not modify the Agreement, and do not authorize any use of any Material. Messages sent through any automated assistant are transmitted to and processed by Amino20 Labs’ service providers, including the provider of the underlying artificial-intelligence model, and may be recorded and retained by Amino20 Labs or those service providers. Buyer consents to that transmission, processing, recording and retention, and shall ensure that its personnel who use the assistant are informed of it.
10.5 Unauthorized statements. Any statement by a Representative, including any response of an automated assistant, that is inconsistent with this Policy is unauthorized, does not bind Amino20 Labs and may not be relied on by Buyer or any other person. Any person may report such a statement to Amino20 Labs under Section 19.
10.6 Reports of Administration or exposure. If Buyer or any other person reports to Amino20 Labs’ personnel, through the contact in Section 19 or otherwise, that a Material has been Administered to a human or Animal, or that a person has been exposed to a Material, Amino20 Labs will not give medical, veterinary or dosing advice; will direct the person to seek medical or veterinary care or, in an emergency, to call 911 or Poison Control at 1-800-222-1222; and will record the report. Amino20 Labs configures any automated assistant on the Site to give the same response to such a report made through it, and refers each such report that it identifies to the contact in Section 19.1 and records it with the conversation in which it was made. Amino20 Labs may report the matter to FDA or another governmental authority and may take any measure described in Section 13.3, and Section 13.8 applies where its conditions are met.
11. Shipping, Destinations and Export
11.1 United States only. Amino20 Labs accepts Orders only for delivery to destinations within the United States, and will not knowingly ship, or cause any supplier to ship, any Material to a destination outside the United States (Terms §5).
11.2 Approved Shipping Address only. Buyer shall direct each Order only to the Approved Shipping Address. Amino20 Labs may hold, cancel or decline to ship any Order addressed to any other destination, including a residence, a post office box, a commercial mail-receiving agency, a mail-forwarding or freight-forwarding service, or any destination outside the United States. Buyer shall not authorize any carrier to release a shipment of Materials without a signature, and Amino20 Labs may require that a shipment be signed for by an adult at the Approved Shipping Address.
11.3 Changes of destination. Any change of shipping destination requires re-verification before shipment (Terms §5). Buyer shall not ask any carrier to redirect a shipment of Materials to another address. An Order shipped to an address later changed by Buyer, or by the carrier at Buyer’s request, is not eligible for a claim under the Refund Policy (Refund Policy §5).
11.4 Export and re-export. Buyer shall not export, re-export or transfer (in-country) any Material, or carry or send any Material outside the United States, except with Amino20 Labs’ prior written consent given in accordance with Section 6.4 and in full compliance with the Export Administration Regulations (15 C.F.R. Parts 730–774), the regulations administered by OFAC (31 C.F.R. Chapter V) and all other Applicable Law. This Section supplements Terms §2.
11.5 Restricted Parties. Buyer represents and warrants, when it submits its account application and again with each Order, that neither Buyer nor any person that owns or controls Buyer is a Restricted Party and that, to Buyer’s knowledge, no individual who will have access to Materials is a Restricted Party. Buyer shall not Transfer any Material to, or for the benefit of, any Restricted Party.
11.6 Prohibited end uses. Buyer shall not use or Transfer any Material for any end use prohibited by 15 C.F.R. Part 744, including any use in connection with the design, development, production, stockpiling or use of chemical or biological weapons.
11.7 Screening, refusal and excluded jurisdictions. Amino20 Labs may screen Buyer, its owners and any proposed recipient against restricted-party lists and other sources, and may refuse or cancel any Order, or decline to ship to any state, locality or address, at its sole discretion, including where it believes that shipment or possession may be restricted by Applicable Law. Amino20 Labs may designate any state or locality as a jurisdiction to which it does not ship some or all Materials, by notice on the Site, and will not accept an Order for any such Material for delivery to that jurisdiction.
12. Labeling and Product Documentation
12.1 Labeling does not expand the Permitted Use. Sections 9.3 and 9.4 apply to every label, package and document supplied with a Material.
12.2 Certificates of analysis. For each lot of Material that it ships, or causes any supplier to ship, Amino20 Labs will publish on the Site, no later than the time of shipment, a certificate of analysis for that lot that meets this Section 12.2, and will provide a copy to Buyer on request. The certificate is the document issued for that lot by the laboratory that tested the lot or by Amino20 Labs’ supplier, as Amino20 Labs obtained it from that laboratory or that supplier, and Amino20 Labs does not alter it. A certificate meets this Section 12.2 only if it identifies the laboratory that tested the lot, Amino20 Labs has the right to publish it, and it neither misidentifies the Material nor states or implies that the Material is intended for human, veterinary, clinical or compounding use (for example, by a physician-use, beyond-use-date or for-injection statement). Amino20 Labs will not ship, or cause any supplier to ship, any unit of a lot until a certificate for that lot that meets this Section 12.2 has been published on the Site; where a certificate does not meet this Section 12.2, the lot is held until the laboratory that tested the lot, or the supplier, issues a corrected certificate. Any summary of a certificate shown on the Site, such as a purity figure, testing laboratory or date, is provided for convenience only, and if the summary and the certificate differ, the certificate controls. A certificate of analysis describes the lot as tested on the date stated.
12.3 Specifications; exclusive remedy. Any purity, identity or other specification that Amino20 Labs states for a Material is to be read together with the certificate of analysis for the relevant lot. If Material does not conform on receipt by Buyer to that certificate or specification, Buyer’s sole and exclusive remedy, and Amino20 Labs’ sole obligation, is replacement of the non-conforming Material or refund of the price Buyer paid for it, at Amino20 Labs’ option, on a claim made:
- (a)on the terms and within the claim window stated in Terms §7 and the Refund Policy;
- (b)for a lot that is the subject of a notice under Section 8.11, as provided in that Section; or
- (c)by notice under Section 19 given within [thirty (30)] days after Buyer first opens the container and in any case within [six (6)] months after the Material is delivered to Buyer (a “Latent Non-conformity Claim”). A Latent Non-conformity Claim is not excluded because the container has been opened or part of its contents has been dissolved, aliquoted or used, provided that Buyer stored the Material under the conditions stated in its labeling or documentation, keeps the container, labeling and remaining contents in quarantine under Section 8.13, and provides with the claim the catalog and lot numbers and the test methods, data and results on which the claim relies. Amino20 Labs may require the return of the remaining contents in accordance with its written instructions, or their disposal under Section 8.6 with written certification, before it replaces or refunds.
Except for that obligation, no certificate of analysis or specification is a representation or warranty concerning the condition of any Material after receipt by Buyer or the suitability of any Material for any purpose, and none certifies that any Material is suitable or safe for any use in or on humans or Animals (Terms §6 and §8).
12.4 Safety data sheets and hazard information. For each Material for which 29 C.F.R. 1910.1200 requires a safety data sheet, Amino20 Labs will provide Buyer with the safety data sheet [prepared by the manufacturer or importer of that Material, or by Amino20 Labs as the responsible party,] with or before the first shipment of that Material to Buyer, and with or before the first shipment of that Material to Buyer after the safety data sheet is updated, either by including it in the shipment or by sending it, or a direct link to it, to the email address associated with Buyer’s Account no later than the time of shipment. Amino20 Labs will not ship, or cause any supplier to ship, any unit of such a Material until it holds a safety data sheet for that Material whose content meets clause (b) of the definition of “Safety Information”; where a safety data sheet does not meet that condition, the Material is held until the manufacturer or importer issues a corrected safety data sheet or Amino20 Labs prepares one as the responsible party in accordance with 29 C.F.R. 1910.1200. Amino20 Labs will provide a copy of any such safety data sheet again on request and will provide on request such other information as it holds about the hazards of any Material on occupational or accidental exposure, and about its safe handling, storage, spill response and disposal, to the extent that information meets clause (b) of the definition of “Safety Information”. Buyer is responsible for reviewing, maintaining and making available to its personnel the safety data sheet and other hazard information for each Material before use, and shall promptly request from Amino20 Labs any safety data sheet that it has not received.
12.5 No license; third-party rights. The sale of a Material grants no license under any patent, trademark or other intellectual-property right of Amino20 Labs or any third party, whether by implication, estoppel or otherwise. Buyer is solely responsible for determining whether its use of any Material requires a license and for obtaining any license required (Terms §8).
13. Compliance Review and Enforcement
13.1 Review. Amino20 Labs may review any account application, Account, Order or communication, and any other information, including publicly available information, to assess compliance with the Agreement. Amino20 Labs is not obliged to monitor Buyer and is not obliged to take any particular measure under Section 13.3, except as provided in Section 13.8. Neither a review nor the absence of a review relieves Buyer of any obligation.
13.2 Indications of Prohibited Use. Without limiting Section 7.8, Amino20 Labs may treat any of the following, among other circumstances, as indicating that a Material may be, or may have been, the subject of a Prohibited Use:
- (a)a request for Administration Information, or any reference to personal, patient, client, athletic or sport-related (including any use in connection with athletic competition), cosmetic or Animal use of a Material;
- (b)a shipping address that is or appears to be a residence, a post office box, a commercial mail-receiving agency or a mail-forwarding or freight-forwarding service, or that differs from the Approved Shipping Address;
- (c)organization, registration, contact or facility information that cannot be confirmed or that is inconsistent with laboratory research;
- (d)quantities, order frequency or combinations of Materials that are inconsistent with the research described to Amino20 Labs or with laboratory research generally;
- (e)a request to omit, alter or remove labeling, documentation or research-use statements, or for unusual packaging or shipping arrangements;
- (f)payment by a person, or with a payment method, not associated with Buyer;
- (g)use of an Account to order for another person, or multiple Accounts associated with the same person or address;
- (h)any listing, promotion or offer of a Material, or of any product said to contain one, through a channel described in Section 6.1(f);
- (i)an affiliation with any business described in Section 7.4(c), other than a research laboratory within the exception in Section 7.4(c);
- (j)failure or refusal to provide information requested under Section 7.6, 7.10 or 13.6;
- (k)a request for Material that is sterile, injectable-grade, pharmaceutical-grade, pre-filled or in solution, or for any solvent, diluent or device to be supplied with a Material;
- (l)any order, inquiry or communication that describes quantities of Material in terms of doses, dosing schedules, treatment periods or numbers of persons or Animals; and
- (m)information from a carrier, payment provider, governmental authority or other person indicating a Prohibited Use.
13.3 Measures. If Amino20 Labs believes that Buyer has breached or may breach this Policy, or that any Material may be the subject of a Prohibited Use, Amino20 Labs may, at its sole discretion and without liability, take any one or more of the following measures, in addition to its other rights under the Agreement and Applicable Law (Terms §1 and §3):
- (a)request information, documentation or a certification under Section 7.6, 7.10 or 13.6;
- (b)hold, limit or cancel any Order before shipment;
- (c)suspend or terminate the Account, and refuse future sales to Buyer and to any person acting for or affiliated with Buyer;
- (d)require Buyer to account in writing for all Materials in its possession or control and, where Amino20 Labs reasonably considers it appropriate, to quarantine those Materials, dispose of them under Section 8.6 and certify the disposal in writing;
- (e)retain records of the matter (Terms §3); and
- (f)take any action described in Section 13.5.
13.4 Refunds, compensation and held Orders. If Amino20 Labs cancels an Order before shipment under this Section 13, any amount collected for that Order will be refunded as provided in Refund Policy §7. Materials that have shipped remain governed by the Refund Policy. No suspension, termination or other measure under this Section 13 entitles Buyer to any refund, credit or compensation beyond what the Refund Policy provides. If Amino20 Labs holds an Order for any reason, including under Section 7.2, 7.6, 7.7, 7.10, 11.2, 11.7 or this Section 13, for more than [thirty (30)] days after payment is collected, Buyer may cancel the Order by notice under Section 19, whether or not the Order has been packed, and any amount collected for it will be refunded as provided in Refund Policy §7.
13.5 Reporting and cooperation with authorities. Amino20 Labs may report to FDA, to law-enforcement agencies or to other governmental authorities any information indicating a Prohibited Use or other violation of Applicable Law, and may disclose information about Buyer, its Account, Orders, Attestations and communications to those authorities, and to payment providers, carriers and Amino20 Labs’ suppliers, in each case to the extent required or permitted by Applicable Law, and Buyer consents to those disclosures. Personal information is otherwise handled as described in the Privacy Policy. Amino20 Labs will cooperate with lawful requests from governmental authorities.
13.6 Buyer cooperation and certification. Within [ten (10)] business days after Amino20 Labs’ written request, or within any longer period stated in the request, Buyer shall: (a) deliver a written certification, signed by an individual authorized to bind Buyer, that Buyer has complied with this Policy, or describing any non-compliance; (b) provide the records described in Sections 8.7, 9.2 and 9.6; and (c) answer Amino20 Labs’ reasonable questions concerning Buyer’s acquisition, storage, use, Transfer and disposal of Materials.
13.7 No waiver. Amino20 Labs’ decision to take, or not to take, any measure in a particular case does not waive any right and does not limit any measure it may take in any other case (Terms §16).
13.8 Required refusal. If Amino20 Labs knows, or determines after review, that Buyer, or any person acting for Buyer or receiving Materials through Buyer (other than a person described in the last sentence of Section 9.5), intends to engage or has engaged in any Prohibited Use, Amino20 Labs will cancel each of Buyer’s Orders that has not shipped, will not ship, or cause any supplier to ship, any further Material to Buyer, and will suspend Buyer’s Account. The Account may be reinstated only by a written decision of an Authorized Signatory, given in accordance with Section 6.4(a) after review of the matter. Amino20 Labs will not knowingly accept or ship any Order for Material that will be used for any Prohibited Use or Transferred to a person who is not eligible under Section 7. A breach of Section 6.1(l) or (m), or any other breach of this Policy that is not a Prohibited Use, does not of itself require these measures, and Amino20 Labs may take any measure described in Section 13.3 in response to it.
14. Attestations and Records Kept by Amino20 Labs
14.1 Attestations. Amino20 Labs requests research-use Attestations at account application and, for each Order, in the Site Checkout, and may request further Attestations at any time.
14.2 Records of Attestations. Amino20 Labs records each Attestation given at account application or in the Site Checkout together with the Account, the date and time, the IP address and browser user agent from which it was given, the Order or cart, if any, to which it relates, and the version of the Attestation text, of the Terms and of this Policy that was presented, and keeps these records in a system that logs any later change to them.
14.3 Other records. Amino20 Labs maintains, or has its service providers maintain, records of account applications, verification decisions and Orders. For each shipment, Amino20 Labs records the consignee, the ship-to address, the date of shipment, and the catalog number, lot number and quantity of each Material shipped. Amino20 Labs also keeps records of communications concerning Materials, including messages exchanged through any automated assistant on the Site and reports received under Sections 10.6 and 19.3.
14.4 Retention. Amino20 Labs retains the records described in this Section 14 for at least the periods stated in the Privacy Policy, and retains records for which the Privacy Policy states no period for as long as it considers necessary for the purposes described in Section 14.5, in each case including after an Account is closed.
14.5 Use and disclosure. Amino20 Labs may use and disclose these records to evaluate eligibility; to enforce the Agreement; to respond to payment disputes (Terms §7); to demonstrate compliance to regulators, auditors and payment providers (Terms §12); and otherwise as described in the Privacy Policy or as required or permitted by Applicable Law. Personal information in these records is handled as described in the Privacy Policy.
15. Assumption of Risk, Warranty, Indemnification and Liability
15.1 Assumption of risk. Subject to the Refund Policy and to Sections 8.11 and 12.3, and except to the extent caused by Amino20 Labs’ [negligence,] gross negligence or willful misconduct, Buyer assumes all risks arising from the receipt, handling, storage, use, Transfer and disposal of Materials after risk of loss passes to Buyer under Terms §5, and accepts sole responsibility for all use of Materials after risk of loss passes to Buyer and for the conduct of its personnel and, subject to the last sentence of Section 9.5, of every person who receives Materials through Buyer. As provided in Section 1.4(b), this Section qualifies the last sentence of Terms §2. Nothing in this Section limits or excludes any liability that cannot be limited or excluded under Applicable Law (Terms §9).
15.2 No warranty. Terms §8 applies to all Materials and to all information and documentation provided in connection with them. Except for the standard of conformity and the remedy stated in Section 12.3 and Terms §7, and the remedy stated in Section 8.11, no description in this Policy of Amino20 Labs’ practices, documentation or verification is a warranty.
15.3 Indemnification. Buyer’s obligations under Terms §10 extend to all claims, damages, losses, penalties and expenses, including reasonable attorneys’ fees, arising out of or relating to (a) any breach of this Policy or any inaccurate Attestation; (b) any Prohibited Use, or any Transfer not permitted under Section 9, by Buyer or by any person who receives Materials through Buyer, subject to the last sentence of Section 9.5; and (c) any governmental inquiry, investigation or proceeding, and any claim by a payment provider or carrier, to the extent arising out of any matter described in clause (a) or (b), including Amino20 Labs’ reasonable costs of responding to it. Buyer’s obligations under Terms §10 and this Section do not extend to any loss to the extent caused by Amino20 Labs’ [negligence,] gross negligence or willful misconduct, or to any loss to the extent caused by the non-conformity of Material that did not conform, when shipped, to its certificate of analysis or stated specifications, except, in the case of a non-conformity, to the extent the loss arises from a Prohibited Use, a Transfer not permitted under Section 9 or Buyer’s breach of this Policy. As provided in Section 1.4(b), Terms §10 does not apply to the acts of a person described in the last sentence of Section 9.5; it otherwise continues to apply to any Administration of Materials by any person receiving Materials through Buyer, including a recipient of a Transfer permitted under Section 9.
15.4 Limitation of liability. Terms §9 applies to every claim arising out of or relating to this Policy. For a claim that does not arise from a particular Material, “the amount paid for the Material giving rise to the claim” in Terms §9 means the amount Buyer paid for the Order to which the claim relates or, if there is none, [the total amount Buyer paid to Amino20 Labs in the twelve (12) months before the claim arose]. Nothing in this Policy otherwise increases Amino20 Labs’ liability under the Terms.
15.5 Irreparable harm. Buyer acknowledges that a Prohibited Use or a Transfer in breach of this Policy may cause Amino20 Labs harm for which damages would not be an adequate remedy, and that Amino20 Labs may seek injunctive or other interim relief to prevent or stop it, from a court of competent jurisdiction or from an arbitrator (including an emergency arbitrator) under Terms §15, in addition to any other remedy. The informal-resolution procedure in Terms §15 does not apply to a request for that relief.
16. Governing Law and Disputes
16.1 Terms §15 governs. Subject to Sections 15.5 and 17.6, the governing-law, informal-resolution, arbitration and class-action-waiver provisions of Terms §15 apply to every dispute arising out of or relating to this Policy, including any dispute concerning its formation, interpretation, performance or enforcement.
17. Survival, Severability and General Provisions
17.1 Survival. Sections 1 through 6, 7.6, 7.9(d), 7.10, 7.11 and 8 through 19, and every other provision of this Policy that by its nature should survive, survive the suspension, closure or termination of Buyer’s Account and any termination of the Terms, and the provisions of the Terms referred to in Sections 15 and 16 continue to apply to this Policy for that purpose. Buyer’s obligations concerning Materials continue for as long as Buyer, or any person who received Materials through Buyer, possesses any Material, and Buyer’s recordkeeping obligations continue for the periods stated in Sections 8.7, 9.2 and 9.6.
17.2 Severability. If any provision of this Policy is held invalid or unenforceable, it shall be enforced to the maximum extent permitted, and the remainder of this Policy continues in effect. This Section supplements the severability provision of Terms §16.
17.3 Statements of practice; commitments.
- (a)Statements in this Policy that describe Amino20 Labs’ practices, including Section 7.5, the second sentence of Section 10.2, the second sentence of Section 10.6 and Sections 14.1 through 14.4, describe how Amino20 Labs conducts its business. They create no obligation owed to Buyer or to any third party, and no departure from any such practice in a particular case relieves Buyer of any obligation under the Agreement.
- (b)Statements in this Policy that Amino20 Labs will, or will not, take an action, including those in Sections 7.2, 8.11, 10.6 (other than its second sentence), 11.1, 11.7, 12.2, 12.4, 13.4, 13.8, 18.1, 18.3 and 19.3, are obligations of Amino20 Labs under the Agreement and are not statements of practice under clause (a). Except as stated in Section 17.4, they create no right in favor of any person other than Buyer.
17.4 Third parties. The persons indemnified under Terms §10 may enforce Section 15.3 and Terms §10. A person who makes a report under Section 19.3 may enforce the third and fourth sentences of Section 19.3 as they apply to that report and, in doing so, is bound by Terms §15 as if a party to it. [Amino20 Labs’ suppliers of Materials may enforce Sections 5, 6 and 9 as to Materials they supplied.] No other person has any right to enforce this Policy.
17.5 Assignment. Buyer may not assign, delegate or otherwise transfer any right or obligation under this Policy, by operation of law, Change of Control or otherwise, without Amino20 Labs’ prior written consent given in accordance with Section 6.4, and any attempt to do so is void. Amino20 Labs may assign this Policy, together with the Terms, to any affiliate or to any successor to all or part of its business. This Policy binds and benefits the parties and their permitted successors and assigns.
17.6 Public-entity Buyers. If Buyer is the United States, a State, a political subdivision of either, or an agency, instrumentality or public institution of any of them, including a public university, then each provision of the Terms and this Policy on indemnification, governing law, arbitration, class-action waiver or limitation of liability applies to Buyer only to the extent permitted by the law that governs Buyer’s authority to contract, and any such provision that is unenforceable against Buyer for that reason is severed as to Buyer only. Every other provision of this Policy, including Sections 3 through 6, 8, 9, 11 and 13, applies to Buyer in full.
17.7 Buyer documents. No term of any purchase order, invoice or other document issued by Buyer adds to or modifies the Terms or this Policy unless an Authorized Signatory agrees to it in a writing that meets Section 6.4(a). A purchase order does not place an Order, and Amino20 Labs will not accept one as an Order. Where Buyer’s procedures require a purchase order, Amino20 Labs may accept it only as payment or accounting documentation for an Order placed through the Site Checkout, and its acceptance does not modify the Terms or this Policy (Terms §§4 and 16). If Materials are nonetheless supplied against a purchase order, the purchase order is an Order as provided in the definition of “Order” in Section 2.1, and the first sentence of this Section applies to its terms.
18. Changes to this Policy
18.1 Amendment. Amino20 Labs may amend this Policy by posting a revised version on the Site with a new version number and effective date, and will notify Buyer of each revised version by email under Section 19.2 at least [thirty (30)] days before its effective date. A revision required by Applicable Law, or needed to prevent a Prohibited Use, may take effect on the date the email notice is sent. Amino20 Labs may also require Buyer to accept a revised version before placing any further Order.
18.2 Application of revisions. The version of this Policy in effect when Buyer places an Order governs that Order, and a revised version does not apply to any Order placed before its effective date. Buyer accepts a revised version by confirming its agreement to it under Section 3.2, or by giving an Attestation or placing an Order on or after its effective date, provided that Amino20 Labs has notified Buyer of the revised version under Section 18.1. Buyer’s obligations concerning Materials delivered under an earlier Order continue under the version that governed that Order until Buyer accepts a later version, and from then on under the latest version that Buyer has accepted.
18.3 Prior versions. Amino20 Labs retains each prior version of this Policy and will provide a copy on request.
18.4 Priority. This Section 18 governs the amendment of this Policy and the version that applies to any Order, notwithstanding Terms §14 and Section 1.4(c).
19. Contact and Notices
19.1 Notices to Amino20 Labs. Buyer shall send each notice required by this Policy to Glenhouse, doing business as Amino20 Labs, by email to greg@weareglenhouse.com or by mail to [NOTICE ADDRESS]. Notice by email to that address satisfies any requirement in this Policy that Buyer give written notice. A notice from Buyer is effective when Amino20 Labs receives it. A notice sent to either the compliance contact in this Section or the support contact stated in Refund Policy §10 is effective both as a notice under this Policy and as a claim under the Refund Policy.
19.2 Notices to Buyer. Amino20 Labs may give notice to Buyer by email to the address associated with Buyer’s Account, and notice is given when the email is sent. Notices of general application may also be given by posting on the Site, but notice of a revised version of this Policy is given as provided in Section 18.1.
19.3 Questions and reports of misuse. Any person may use the contact in Section 19.1 for questions about this Policy or to report suspected misuse of Materials. A report of suspected misuse may be made without identifying the reporter, including by mail. Amino20 Labs will keep confidential the identity of a reporter who identifies themselves, except as Applicable Law requires or as needed to report the matter to a governmental authority. Amino20 Labs will not take any measure under Section 13 against any person on the ground that the person made a good-faith report under this Section or to a governmental authority, but a report does not prevent Amino20 Labs from taking measures based on the conduct reported.