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NY L81490




January 4, 2005

CLA-2-98:RR:NC:2:238 L81490

CATEGORY: CLASSIFICATION

TARIFF NO.: 9817.85.01

Michael Jones, Ph.D.
Triangle Molecular, LLC
3710 Stoneycreek Rd.
Chapel Hill, NC 27514

RE: The tariff classification of the TM-101 Library from China

Dear Dr. Jones:

In your letter dated December 20, 2004, you requested a tariff classification ruling.

The subject product, designated as the TM-101 Library (“library”), will consist of approximately 1000 novel heterocyclic compounds that have never before been synthesized. The library was developed solely for use in the earliest stages of drug discovery research programs, and will be imported put up in 96-well plates or vials, with each well or vial containing only one of the heterocyclic compounds alluded to above. Subsequent to importation, potential licensees (e.g., pharmaceutical companies) of the library will test these compounds, hoping to generate interactions (“hits”), by means of high-throughput screening (HTS) or similar technology, between the compounds comprising the library and chosen “targets” (e.g., a specific group of enzymes). Further investigation of these “hit” compounds may then lead to development of related compounds that exhibit increased pharmacological activity and selectivity against the chosen target. These related compounds, referred to as “leads,” would then form the basis for additional research. Typically, at this point, the pharmaceutical company (licensee) will engage your firm to perform development work on hit or lead compounds. Your firm’s scientists would then collaborate with the pharmaceutical company to synthesize an array of compounds chemically similar to the hit compound(s), for additional testing. The goal of this collaboration would be, through an iterative process of design, synthesis, and testing, to optimize leads for further research and testing, with testing becoming progressively more stringent.

As noted above, the TM-101 Library will be used solely for testing and research. Any potential license agreement will stipulate that the compounds comprising the library cannot be used for any known purpose other than initial-stage drug discovery research and development. Furthermore, the compounds will be imported in very limited, noncommercial quantities, in accordance with industry practice. Specifically, the quantity of each compound will typically be between 10 and 50 milligrams, and never exceed 2 grams. In addition, the license will stipulate that these compounds cannot be resold or incorporated into other products, after testing

In actuality, the very nature of the high-throughput-screening process generally consumes the compounds, by virtue of their exposure to the media containing the targeted protein site, thus making it impossible for the compounds to be resold.. Finally, because the compounds comprising the library are novel heterocyclic compounds that have never before been synthesized, it appears highly unlikely that any such compound would be subject to any type of specific import restriction. Accordingly, it is our determination, based on the information submitted by you, that the subject product satisfies the relevant provisions of U.S. Note 6(a), (b) and (c) to subchapter XVII of Chapter 98, HTSUS.

The applicable subheading for the TM-101 Library will be 9817.85.01, Harmonized Tariff of the United States (HTS), which provides for “Prototypes to be used exclusively for development, testing, product evaluation, or quality control purposes.” The rate of duty will be free..

This merchandise may be subject to the requirements of the Toxic Substances Control Act (TSCA), which is administered by the U.S. Environmental Protection Agency. You may contact them at 401 M Street, S.W., Washington, D.C. 20460, telephone number (202) 554-1404, or EPA Region II at (212) 637-3526.

This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177).

A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, contact National Import Specialist Harvey Kuperstein at 646-733-3033.

Sincerely,

Robert B. Swierupski

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