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This Intended Use Certification (this "Certification") is provided by the legal entity identified above ("Purchaser") to Chem-Impex International, Inc. ("Chem-Impex") in connection with Purchaser's purchase, receipt, use, resale, or transfer of any material, substance, compound, or product obtained from Chem-Impex, now or in the future (the "Material"), and governs all such transactions from the date of execution until superseded by a written re-execution signed by an authorized representative of Purchaser and acknowledged in writing by Chem-Impex.

Chem-Impex supplies the Material in reliance on the certifications, representations, warranties, and covenants set forth herein, which survive as to any Material previously received notwithstanding any later supersession of this Certification. This Certification does not modify any other agreement, terms, or conditions between the parties, except where expressly inconsistent, in which case the provision more protective of Chem-Impex controls.

SECTION 1 — INTENDED USE ELECTION

Please select all options that apply to your intended use of the Material. The option(s) you select define the full permitted scope of your use of the Material. Sign only if at least one option accurately describes your intended use; if you are unsure which option applies, contact Chem-Impex at support@chemimpex.com before signing.

The Material will be used exclusively for R&D Use as defined in Section 4, which includes in vitro studies, in vivo animal studies, process development, and analytical testing. R&D Use expressly excludes direct human administration and incorporation into any Consumable Product.

B. PRECURSOR, INTERMEDIATE, OR TRANSFORMATIVE SYNTHESIS USE

  1. :- The Material will be used solely as a Precursor or Intermediate, each as defined in Section 4, in an upstream manufacturing or synthesis process. Where the Material is used as an Intermediate, it will not be present in its original chemical form in any resulting substance or product.
  2. :- The Material will be used as a reactant or synthetic input in the manufacture of any other substance or product (including a food, dietary supplement, cosmetic, or industrial product), such that it is not present in its original chemical form in that product.
  3. :- The Material will be resold or otherwise transferred to third-party purchasers exclusively for uses that would be permitted under Option A, Option B, or Option D of this Certification, applying the requirements, conditions, and exclusions of the applicable Option (and the related definitions in Section 4) as though each such third-party purchaser were the Purchaser
  4. :- The Material will be used or incorporated solely for a Non-Consumable Commercial Use as defined in Section 4.

SECTION 2 — PURCHASER CERTIFICATIONS, REPRESENTATIONS, WARRANTIES AND COVENANTS

By signing below, the undersigned, on behalf of Purchaser, certifies, represents, warrants, and covenants to Chem-Impex as follows:

  1. Accuracy :- The intended use election(s) marked in Section 1 are accurate, complete, and not misleading as of the date of execution of this Certification.
  2. Use Restrictions :- Purchaser shall use, handle, store, distribute, and dispose of the Material solely and exclusively within the scope of the option(s) selected in Section 1 and in compliance with this Certification. Any use, incorporation, or transfer of the Material that is not expressly permitted by an option selected in Section 1 is prohibited, whether by Purchaser or by any affiliate, agent, subcontractor, or transferee.
  3. Change in Intended Use :- If Purchaser's intended use of the Material changes, Purchaser shall notify Chem-Impex at support@chemimpex.com within five (5) business days after becoming aware of the change and, in any event, before using or transferring any Material for the changed use. Chem-Impex may suspend, reject, or decline any order or further supply pending its review, and may terminate this Certification and refuse further orders upon written notice if it reasonably determines that Purchaser has breached this Certification.
  4. Regulatory Responsibility :- Purchaser is solely responsible for ensuring that its purchase, receipt, handling, storage, use, resale, transfer, and disposal of the Material comply with all applicable federal, state, local, and international laws and regulations, and for obtaining and maintaining all registrations, licenses, permits, notifications, and approvals and satisfying all recordkeeping, reporting, and security requirements applicable to its operations, including any under the Federal Food, Drug, and Cosmetic Act, the Controlled Substances Act, the Toxic Substances Control Act, and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), or, in the event of any breach permitting the Material to reach a dietary supplement or cosmetic, the Dietary Supplement Health and Education Act or the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), respectively. Chem-Impex shall have no liability in connection with any of the foregoing.
  5. Non-cGMP and Non-Food-Facility Acknowledgment :- Purchaser acknowledges that: (i) Chem-Impex is a research-grade distributor and is not a cGMP manufacturer, FDA-registered API supplier, or FDAregistered food facility (Section 415 of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 350d), and the Material is not manufactured, tested, stored, released, or supplied under cGMP or as food or a dietary ingredient; (ii) Chem-Impex's ISO 9001:2015 certification is a general quality management standard that does not constitute or satisfy any cGMP, pharmaceutical-grade, or dietary supplement GMP (21 C.F.R. Part 111) requirement; (iii) Purchaser is solely responsible for determining the Material's suitability for its intended use and for any qualification, requalification, or upgrading of the Material, which is undertaken at the sole risk of Purchaser or the applicable transferee and shall not implicate Chem-Impex; and (iv) no such qualification or upgrading can cause the Material to have originated from a cGMP or registered food facility, and the Material, in its original chemical form, is not authorized for ncorporation into any dietary supplement or other food.
  6. Flow-Down :- Prior to any transfer or delivery of the Material, Purchaser shall ensure that each affiliate, agent, subcontractor, and transferee receiving or using the Material is bound in writing by restrictions no less protective than those set forth in this Certification, with Chem-Impex expressly designated as an intended third-party beneficiary entitled to enforce such restrictions directly.
  7. Record-Keeping :- Purchaser shall maintain reasonable records relating to its receipt, use, disposition, resale, and transfer of the Material for two (2) years following the date of purchase. Upon reasonable prior written notice, Purchaser shall make such records available for inspection by Chem-Impex or its designee during normal business hours to verify compliance with this Certification; if any such inspection reveals a material breach, Purchaser shall reimburse Chem-Impex's reasonable out-of-pocket costs of the inspection.
  8. Reliance, No Duty to Verify :- Purchaser acknowledges and agrees that: (i) Purchaser is solely responsible for correctly identifying its intended use and selecting the applicable option(s) in Section 1, and for the accuracy of that election; (ii) Chem-Impex does not review, advise on, evaluate, or determine which option applies to Purchaser, and Purchaser shall not rely on Chem-Impex or its personnel for any such determination; and (iii) Chem-Impex is entitled to rely conclusively on Purchaser's election, certifications, representations, warranties, and covenants set forth herein in supplying the Material, and has no duty to independently investigate, verify, or confirm the accuracy of Purchaser's intended use. Nothing in this paragraph limits Chem-Impex's right, in its sole discretion, to decline, suspend, or condition any order, or to require re-certification, and this paragraph does not relieve Purchaser of any obligation under this Certification or under applicable law.

SECTION 3 — DISCLAIMER; INDEMNIFICATION; LIABILITY; AND DISPUTE RESOLUTION

  1. Disclaimer of Warranties :-  THE MATERIAL IS PROVIDED "AS IS," AND CHEM-IMPEX DISCLAIMS ALL WARRANTIES, EXPRESS, IMPLIED, OR STATUTORY, INCLUDING MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, AND FITNESS FOR ANY PHARMACEUTICAL, CLINICAL, OR COMMERCIAL APPLICATION. Supply of the Material does not constitute any endorsement or approval of any formulation, process, or regulatory pathway. Any Certificate of Analysis is issued solely for research-grade purposes and reflects Chem-Impex's ISO 9001:2015-based quality management system; it may not be relied upon, without independent requalification and confirmation testing by Purchaser, to satisfy any cGMP or other regulatory qualification requirement, and Purchaser assumes sole responsibility for such testing.
  2. Indemnification :- Purchaser shall defend, indemnify, and hold harmless Chem-Impex and its officers, directors, employees, agents, affiliates, successors, and assigns (each, an "Indemnitee") from all claims, liabilities, damages, penalties, costs, and expenses (including reasonable attorneys' fees) arising from (i) any breach of this Certification by Purchaser or its affiliates, agents, subcontractors, or transferees; (ii) any use of the Material outside the certified scope; or (iii) any negligence, recklessness, or willful misconduct of Purchaser or its affiliates, agents, subcontractors, or transferees, except to the extent the claim results from an Indemnitee's own sole negligence or willful misconduct. Chem-Impex shall promptly notify Purchaser of any claim for which indemnification is sought, and Purchaser shall control the defense with counsel reasonably acceptable to Chem-Impex; if Purchaser fails to promptly assume or diligently conduct the defense, Chem-Impex may defend the claim at Purchaser's expense. Purchaser shall not settle or compromise any such claim in a manner that imposes any obligation, restriction, or admission of liability on any Indemnitee without Chem-Impex's prior written consent (not to be unreasonably withheld, conditioned, or delayed).
  3. Limitation of Liability :- IN NO EVENT SHALL CHEM-IMPEX BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, OR PUNITIVE DAMAGES, INCLUDING LOSS OF PROFITS, REVENUE, OR DATA, ARISING OUT OF OR RELATING TO THIS CERTIFICATION OR THE MATERIAL, REGARDLESS OF THE THEORY OF LIABILITY. Chem-Impex's aggregate liability, if any, is limited to its own acts or omissions in connection with the lawful distribution of the Material to Purchaser and shall not exceed the amounts paid by Purchaser for the specific Material giving rise to such liability; Chem-Impex shall have no liability for any act, omission, or use occurring after delivery of the Material.
  4. Option B Downstream Responsibility :- Where Purchaser or any transferee uses the Material under Option B, all qualification, testing, cGMP or other regulatory compliance, and regulatory responsibility for any resulting downstream substance or product is borne exclusively by the applicable downstream manufacturer or other regulated party (including, in the case of pharmaceutical use, the applicable IND sponsor), and not by Chem-Impex; and Purchaser shall defend, indemnify, and hold harmless the Indemnitees from any claim relating to such downstream activities.
  5. Governing Law, Venue :- This Certification is governed by the laws of the State of Illinois, without regard to its conflict of laws principles. Each party irrevocably submits to the exclusive jurisdiction of the state and federal courts located in DuPage County, Illinois, for any dispute arising out of or relating to this Certification or the purchase, sale, or use of the Material. Purchaser acknowledges that any breach of the use restrictions may cause irreparable harm to Chem-Impex for which monetary damages would be inadequate, and Chem-Impex shall be entitled to seek injunctive or other equitable relief without the necessity of proving actual damages or posting any bond or other security.
  6. Severability :- If any provision of this Certification is held invalid, illegal, or unenforceable, it shall be modified to the minimum extent necessary to make it valid, legal, and enforceable, and the remaining provisions shall remain in full force and effect.

SECTION 4 — DEFINITIONS

For purposes of this Certification, the following terms shall have the meanings set forth below:

  1.  "API" means any substance intended to be used as an active ingredient in a finished drug product to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body, including any OTC or prescription drug substance.
  2. "API Starting Material" means a raw material or intermediate incorporated as a significant structural fragment into an API, consistent with ICH Q7.
  3. "Commercial Use" means any manufacture, processing, distribution, sale, or transfer of a product for commercial or industrial purposes. Commercial Use comprises Consumable Commercial Use and Non-Consumable Commercial Use, each as defined below. "Commercial Use" does not include R&D Use expressly permitted under Option A, or transformative synthesis use (as a Precursor, Intermediate, or reactant or synthetic input) expressly permitted under Option B, of this Certification.
  4. "Consumable Commercial Use" means any use in which the Material, in its original chemical form, is incorporated into or used as an ingredient of a Consumable Product, cosmetic (as defined in 21 U.S.C. 321(i)), drug, food, dietary supplement, or clinical trial material. Such use is not authorized under this Certification. Use of the Material under Option B — where it is not present in its original chemical form in the resulting product — is not a Consumable Commercial Use, even if the resulting product is a Consumable Product.
  5. "Consumable Product" means any product intended or reasonably likely to be ingested, inhaled, or otherwise internally administered to or by humans or animals, including dietary supplements, food additives, nutraceuticals, beverages, and foods. For the avoidance of doubt, a topically or externally applied product (such as a topical cosmetic) that is not intended or reasonably likely to be ingested or internally administered is not a Consumable Product; nonetheless, incorporation of the Material, in its original chemical form, into such a product constitutes a Consumable Commercial Use and is not authorized under this Certification, subject to the prohibition in Section 2(b).
  6. "Intermediate" means a material produced during the processing of an API that undergoes further molecular change or purification before it becomes an API, consistent with ICH Q7.
  7.  “Non-Consumable Commercial Use” means the incorporation or use of the Material, in its original chemical form, in a commercial or industrial product or process the resulting product of which (i) is not a Consumable Product, (ii) is not otherwise intended for human or animal use (including animal feed, animal food additives, and veterinary products), and (iii) is not itself intended or marketed for ingestion by, or internal administration to, any human or animal, including products such as fertilizers and other agricultural or horticultural products and industrial water-treatment products, in each case not administered or applied to, ingested by, or otherwise reasonably likely to be internally administered to, any human or animal; provided that the application of fertilizers or other agricultural or horticultural products to soil, plants, or crops in accordance with their intended industrial or agricultural use shall not, by itself, cause the resulting product to be treated as a Consumable Product or as intended for human or animal use for purposes of this definition. Non-Consumable Commercial Use is permitted only where Option D (or, for resale, Option C) is elected.
  8. "Precursor" means a material used in a step prior to the introduction of the API Starting Material (as determined under ICH Q7) into the manufacture of an API.
  9. "R&D Use" means any internal research, development, analytical, or investigational activity — including in vitro studies, in vivo animal studies, process development, synthesis research, analytical testing, and laboratory evaluation — conducted within Purchaser's own facilities or by a contracted research organization acting on Purchaser's behalf. R&D Use does not include: (i) direct administration of the Material to humans; or (ii) incorporation of the Material, in its original chemical form, into any product intended for human or animal consumption, clinical administration, commercial sale, or distribution.
  10. "cGMP" means current Good Manufacturing Practice requirements applicable to drugs (21 C.F.R. Parts 210 and 211) and dietary supplements (21 C.F.R. Part 111), and the corresponding active pharmaceutical ingredient good manufacturing practice guidance in ICH Q7.