VAL RR:IT:VA 545998 LR

Robert L. Eisen, Esq.
Karen Bysiewicz, Esq.
Coudert Brothers
114 Avenue of the Americas
New York, N.Y. 10036-7703

RE: Price Actually Paid or Payable; Royalties; Pharmaceuticals

Dear Mr. Eisen and Ms. Bysiewicz:

This is in response to your letter dated May 9, 1995, on behalf of your client, Pfizer Inc. ("the importer/buyer"), requesting a ruling on the dutiability of payments to UCB Pharmaceuticals, Inc., now Pharma, Inc. ("the licensor") for royalties, research studies, and co-promotion fees relating to the imported product, cetirizine ("the imported product"). The arguments presented in the meeting on April 15, 1996, and summarized in your supplemental submission dated May 28, 1996 were also taken into account in rendering this decision. This ruling does not contain any of the information which you claim is confidential as set forth in your letters dated May 17, 1995 and May 28, 1996, and clarified in your November 11, 1996 fax. We regret the delay in responding.

FACTS:

The imported product is a pharmaceutical active ingredient. The importer/buyer purchases it in bulk form from UCB, S.A. ("the seller), an unrelated company located in Belgium. Upon importation, the importer/buyer combines the imported product with other ingredients of U.S. origin in the manufacture of Zyrtec ("the finished product"), an antihistamine available to consumers by doctor's prescription only. After receiving FDA approval in 1995, the finished product was launched commercially in the U.S. market in February, 1996. A portion of the imported product was also used to conduct research and to prepare samples of the finished product. There is one licensor-owned, U.S. patent for the imported product which will expire in 2002. This patent concerns the chemical composition of the imported product.

You indicate that the imported product and the finished product have different forms, functions and physical characteristics. The former is a powdered, chemical bulk material which is not suitable for use as a pharmaceutical end-product because of its unpleasant taste and lack of reliable dosage form. In contrast, the finished product contains precise amount of the imported product in combination with other ingredients presented in the form of a film-coated tablet. You state that in this form, the finished product can be relied upon to achieve the desired antihistamine benefits for which it has been tested and approved by the FDA. You point out that FDA approval was required for both products.

The importer/buyer has entered into five agreements with respect to the imported product: the "License Agreement," "Supply Agreement", "Combination Agreement", "Trademark Agreement" and a "Co-Promotion Agreement". Copies of these agreements were submitted. These agreements are summarized below. The various payments provided for in three of these agreements are the subject of this ruling. The Supply Agreement is between the importer/buyer and the seller. The other agreements are between the importer/buyer and the licensor, a party related to the seller.

The License Agreement

On August 15, 1983, the importer/buyer and the licensor, a U.S. subsidiary of the seller, entered into a license agreement ("the License Agreement"). Under its terms, the licensor granted the importer/buyer (1) the exclusive right under the imported product patent to sub-license, make, use and sell within the United States Licensed Products in the United States and (2) an exclusive license to use the licensor's Technical Information in connection with the manufacture, use and sale of the Licensed Products in the United States. These rights are subject to the licensor's own rights to make, use and Licensed Products in the U.S.

The term "Licensed Products" is defined as "any of the Products the manufacture, use or sale of which would, in the absence of a license, infringe the Licensed Patents or which utilize the licensor's Technical Information. The term "Licensed Patents" is defined as all U.S. patents owned or acquired by the licensor or its affiliates related to the Products, or methods of use or intermediates or processes for the manufacture thereof. As noted above, you indicate that there is one licensor-owned, U.S. patent for the imported product which is currently in force pertaining to the composition of ceterizine. Thus, "Licensed Products" means the imported product, together with all pharmaceutical compositions and dosage units containing ceterizine as the sole therapeutically active ingredient.

Under the License Agreement, the importer/buyer shall, at its own expense, take all steps and make all efforts necessary or desirable to obtain FDA approval to market Licensed Product for all appropriate indications as determined by the importer/buyer after consultation with the licensor and shall use its best efforts to promote and market the Licensed Products in the United States. The License Agreement further provides that the first commercial sale of Licensed Products will occur within six months from the date of FDA approval.

In consideration of the licenses described above, the importer/buyer has agreed to pay the licensor advance royalties and continuing royalties based on the net sales of the Licensed Products in the U.S. (The advance royalties are to be credited against any continuing royalties). The License Agreement provides for the payment of minimum royalties. The continuing royalties begin to accrue on the date of the first commercial sale of the Licensed Products to third parties.

Also, under the License Agreement the importer/buyer agreed to pay the licensor a fixed sum within sixty days of receiving the results of two preclinical studies conducted by the licensor. The two studies concerned the long-term toxicity of the imported product and were conducted in the early 1980's outside the United States. In addition, the licensor conducted two chronic (two-year) carcinogenicity studies and ten toxicology studies of the imported product which it conducted outside the United States. The importer/buyer reimbursed the licensor for the results of these studies. All fourteen studies concern the general safety of the imported product and were necessary in order to obtain FDA approval for the finished product.

The Combination License Agreement

On November 10, 1987, the importer/buyer and the licensor entered into a Combination License Agreement ("Combination Agreement,") in which the licensor granted to the importer/buyer the exclusive license under the Licensed Patents to make, use and sell combinations in the United States and an exclusive license to use the licensor's Technical Information in connection with the manufacture, use and sale of combinations in the United States. This agreement differs from the License Agreement in that the earlier agreement applies only to products containing the imported product as the sole active ingredient, whereas the Combination Agreement applies to products containing the imported product and at least one other active ingredient (the latter products will be referred to as "Combinations").

In exchange for the right to combine the imported product with other pharmaceutical active ingredients, the importer/buyer is obligated to pay a royalty to the licensor, a percentage of the importer/buyer's net sales of the Combinations in the U.S., which would infringe the licensor's licensed patent (for the imported product or the licensor-developed Combinations) and a percentage of net sales of Combinations whose manufacture, use or sale in the U.S. involves the licensor technical information. You indicate that to date, the importer/buyer has conducted research in the U.S. to develop Combinations, but presently has not obtained FDA approval for any such products.

The Supply Agreement

On the date the Combination Agreement was executed, the importer/buyer also entered into a supply agreement ("Supply Agreement") with the seller, the licensor's foreign parent. Under the Supply Agreement, the importer/buyer agreed to purchase its requirements of the imported product from the seller for five years from the date of the first commercial sale of a Licensed Product. Thereafter, the importer/buyer agreed to purchase all its requirements except for any bulk of the imported product produced by the importer/buyer itself. The price of the imported product is established in the Supply Agreement and is based on the seller's costs of production plus a specified percentage. The Supply Agreement provides that "all terms used herein that are defined in the License Agreement or in the Combination Agreement will have, unless otherwise specified herein, the meanings set forth in the License Agreement or the Combination Agreement."

With regard to patents, the Supply Agreement provides that the seller represents and warrants that neither the manufacture, use or sale of the imported product to the importer/buyer nor the manufacture, use or sale by the importer/buyer of products incorporating the imported product will infringe any valid and subsisting United States patent other than any such patent licensed to the importer/buyer under the License Agreement or the Combination Agreement or owned by or licensed to the importer/buyer. The Supply Agreement provides that if the License Agreement and Combination Agreement are both terminated, the Supply Agreement will terminate.

Co-Promotion Agreement

The importer/buyer and the licensor entered into an agreement on June 20, 1995 (the "Co-Promotion Agreement") which permits the licensor to assist the importer/buyer in marketing the "Product" in the United States. The Co-Promotion Agreement defines the term "Product" as "cetirizine". Under the agreement, the licensor has the opportunity to make sales presentations to licensed prescribers of medications. In exchange for its marketing and promotion efforts in the U.S., the licensor will earn a fee ("Co-Promotion Fee") in accordance with a formula provided in the agreement.

Trademark Agreement

The importer/buyer and the licensor entered into a Trademark License Agreement ("Trademark Agreement") on June 20, 1996. Under the terms of the Agreement, the licensor grants the importer/buyer the use of its U.S. trademarks, "Zyrtec" and "Zirtek". You indicate that the grant of the exclusive right to use, and to license the use of, these trademarks is royalty-free and poses no customs valuation issues. ISSUES:

Whether the following fees are part of the transaction value of the imported product:

1) initial and continuing royalties which the importer/buyer must pay the licensor under the license and combination agreements; 2) payments the importer/buyer must pay the licensor under the license agreement relating to the various clinical studies performed by licensor; 3) [payments the importer/buyer must pay the licensor under the Co-Promotion Agreement].

LAW AND ANALYSIS:

For the purpose of this ruling, we assume that transaction value is the proper basis of appraisement. Transaction value, the preferred method of appraisement, is defined by 402(b)(1) of the Tariff Act of 1930, as amended by the Trade Agreements Act of 1979 (TAA, 19 U.S.C. 1401a(b)) as "the price actually paid or payable for the merchandise when sold for exportation to the United States...." plus certain additions specified in 402(b)(1)(A) through (E).

1. Royalties

Section 402(b)(1)(D) of the TAA provides for an addition to the price actually paid or payable for:

(D) any royalty or license fee related to the imported merchandise that the buyer is required to pay, directly or indirectly, as a condition of the sale of the imported merchandise for exportation to the United States.

In a General Notice on the Dutiability of "Royalty" Payments (Vol. 27 Cust. Bull. No. 6, dated February 10, 1993) (hereinafter referred to as the "General Notice") Customs set forth a three-part analysis designed to provide importers and Customs with a uniform approach to determine whether certain payments constitute dutiable royalties. This analysis identifies the following three questions, the answers to which assist in determining whether a royalty payment is related to the imported merchandise and is a condition of sale:

1) Was the imported merchandise manufactured under patent? 2) Was the royalty involved in the production or sale of the imported merchandise? 3) Could the importer buy the product without paying the fee?

General Notice at pages 9-11.

Negative responses to the first two questions and a positive response to the third points to nondutiability.

Question 1

In this case, there is one licensor-owned U.S. patent covering the imported product. It concerns the composition of ceterizine. Nonetheless, your contention is that based on the language in the Statement of Administration Action (SAA) adopted by Congress upon passage of the TAA, and as interpreted by Customs, the answer to question one is "no". You base this conclusion on the fact that the patent does not cover processes to manufacture the imported product. In this regard, you note that the SAA provides that royalties paid for patents covering processes to manufacture the imported merchandise will generally be dutiable (emphasis added). Statement of Administrative Action, H.R. Doc. No. 153, Reprinted in Customs Valuation Under the Trade Agreements Act of 1979, at pp.46-69 (1981). You also cite HRL 545379, July 7, 1995, which held that license fees paid for rights to use an ornamental design in connection with U.S. sales of hair bands were not dutiable as royalties or proceeds of subsequent resale. The decision notes that the design patent was linked more to the appearance of the article, and thus was not for rights associated with its manufacture. You indicate that the patent at issue merely protects the chemical structure of the compound much in the same way as the design patent protects the appearance of the hair bands in HRL 545379.

We do not consider the patent covering the imported product to be comparable to the patent covering the hair bands in HRL 545379. The hair bands were covered by a design patent pertaining to "the ornamental design for a hair or foot band as shown and described". 35 U.S.C. 171, entitled Patents for Designs, provides for the patentability of "any new, original and ornamental design for an article of manufacture"(emphasis added). To be patentable, a design must be new, inventive, and ornamental; it must be the product of aesthetic skill and artistic conception. See Bliss v. Gotham Industries, Inc., 316 F.2d 848 ( 9th Cir., 1963). HRL 545379 concluded that the design patent at issue was akin to royalties and license fees paid for the right to use copyrights and trademarks.

In contrast to the design patent covering the hair bands, the licensor-owned patent concerns the chemical composition of a pharmaceutical active ingredient. This is obviously not a design patent covering a product's ornamental design. Nor is the patent comparable to royalties and license fees paid for the right to use copyrights and trademarks. We find that the patent at issue is the type of patent that was intended to come within the purview of question one. Thus, even if this patent does not technically cover the process by which the imported product is manufactured, we find that in the circumstances presented, the imported product was "manufactured under patent" and that the answer to question one is "yes".

Question 2

You indicate that the response to the second question, whether the royalty is involved in the production or sale of the imported merchandise, is "no." You base this conclusion on the fact that a portion of the royalties is paid for unpatented Technical Information necessary to manufacture the finished product in the United States. Thus, you argue the royalties are paid not for ownership rights to the imported product, but for the right to use the imported product in conjunction with other ingredients to make a finished end-product. You also indicate that the importer/buyer's internal accounting procedure requires that the royalties be booked as cost of U.S. sales, as opposed to costs of the imported product. Finally, you contend that the subject royalty payments are not inextricably intertwined with the imported product as demonstrated by the fact that the License Agreement was negotiated and signed nearly four years before the Supply Agreement for the imported product. You contend that the four-year time span indicates the lack of relationship between the royalty payments and the imported product.

While the royalties are paid in part for the right to use the imported product in conjunction with other ingredients to make a finished end-product, they are also involved in both the production and sale of the imported merchandise. The royalties are involved in the production of the imported merchandise because as discussed above such product is "manufactured under patent" and the license for which royalties are paid specifically covers those patent rights. Under the License and Combination Agreements, the licensor granted the importer/buyer the exclusive right under the imported product patent to sub-license, make, use and sell within the U.S. Licensed Products in the U.S.

The royalties are also involved in the sale of the imported product. We reach this conclusion on the basis of the various agreements discussed above. First, we note that the imported product is one of the Licensed Products as that term is defined in the License and Combination Agreements for which royalties are paid. As discussed above, the term "Licensed Product" includes any of the Products the manufacture, use or sale of which would, in the absence of a license, infringe the Licensed Patents. Also, the Supply Agreement covering the imported product requires the importer/buyer to purchase its requirements of the imported product from the licensor's parent, except for any of the product produced by the importer/buyer itself. In addition, the Supply Agreement specifically provides that "if the License Agreement and Combination Agreement are both terminated, this Agreement will terminate." These facts demonstrate that the royalties are involved in the sale of the imported merchandise. See HRL 545331, January 19, 1996 (Royalties are involved in the sale of the imported merchandise because the supply agreement provides that it is only in effect as long as the license agreement is in effect, and there would be no sale for exportation to the importer without the license agreement). The fact that the Supply Agreement was executed four years after the License Agreement does not negate the fact that the agreements are inter-related. We also note that the Supply Agreement and the Combination Agreements were executed on the same date.

Question 3

You indicate that the response to the third question, whether the buyer could purchase the product without paying the fee, is "yes." According to the General Notice, this question goes to the heart of whether a payment is considered a condition of sale. You take the position that the answer to this question is "yes" because the importer/buyer's royalty payments to the licensor only accrue on the commercial sale of the finished products. You indicate further that the imported product differs in material ways, and possesses different properties than the finished products. Unlike the imported product, the finished product is in a stable, durable form which is capable of being swallowed by consumers. In addition, it may be consumed with the assurance that the dosage is precise and exact.

You also note that the royalty on the imported product is not due on each and every ounce of imported merchandise sold to the importer/buyer. Rather, there are numerous occasion where no royalty accrues. You note that when the importer/buyer fails to produce the royalty product with the imported product, no royalty payment will be owing to the licensor. You also note that if no sale of the finished products occurs, no royalty is owing. Also, you state that sales between the importer/buyer and its affiliates do not trigger the royalty obligation. Finally, the amounts of imported product used in the importer/buyer's research and development of Combinations that do not yield Royalty Products would not trigger the royalty obligation. You also point out that the royalty payments may be incurred even if the importer/buyer does not import any cetirizine, e.g., when it produces its own cetirizine.

Based on the facts presented, we find that the payment of the royalty is a condition of sale of the imported product. First, Customs has concluded that the method of calculating the royalty-e.g. on the resale price of the goods - is not relevant to determining the dutiability of the royalty payment. See General Notice; HRL 545331, January 19, 1996 Second, as indicated above, the Supply Agreement requires the importer to purchase all its requirements for the imported product from the licensor's parent company and terminates upon termination of the License Agreement and Combination Agreement. In HRL 545331, this fact supported the conclusion that the payment of the royalties is a condition of sale of the imported product. The decision notes that without the license agreements which call for the payment of royalties, there would be no sale for exportation of the imported product. The payment of the royalties is closely tied to the sale of the imported product. These facts support the conclusion that the importer/buyer may not buy the imported product without paying the fee. See HRL 544978, April 27, 1995; HRL 544991, September 13, 1995. The fact that the importer/buyer must pay royalties even if it does not import cetirizine but produces it itself does not warrant a different conclusion. The importer/buyer would obviously not pay any duties (including royalties) on any product which it manufactures completely in the United States.

Although royalties are not incurred when the importer/buyer sells the imported product to its affiliates, royalties are incurred upon resale to independent third parties. The importer/buyer remains responsible for royalties on sales of the imported product through its affiliates. Thus, royalties will ultimately be due on all imported products which are sold in the United States.

You contend that the facts presented are similar in material respects to HRL's 545114, September 30, 1993 (C.S.D. 93-26) , 544656, June 19, 1991, and 545770, June 21, 1995, all of which found that the payments in question were not dutiable. These cases involved the payment of royalty/license fees to the foreign supplier in exchange for the rights to use technical information and know-how in the manufacture of a finished product incorporating the imported product. Customs found that such royalty/license fees were not dutiable based in part on the fact that the royalty was for technical information and know-how related to using the imported products in the process of manufacturing the royalty product in the United States. Thus, Customs concluded that the royalties did not relate to the imported merchandise. However, none of these cases involved an imported product which was covered by a patent. We consider this to be an important difference. In addition, none of those rulings addressed the question of whether the payment of royalties was linked to the sale of the imported product. In HRL 544991, September 13, 1995, royalty payments were paid in consideration of licensed technology and technical assistance provided by the seller/licensor to the importer/buyer. The imported merchandise (parts) was used to manufacture a finished product (machine) and the royalties were based on the selling price of the finished product. An agreement between the seller/licensor and the importer/buyer effectively linked the payment of the royalties to the purchase of the imported parts. For example, the license and sublicense agreement specifically referred to the purchase of parts. In addition, a separate agreement between the parties makes reference to both the license agreement and the sale of parts. Consequently, it was determined that since the importer could not buy the imported merchandise without paying the fee, the royalties were a condition of sale. Therefore, Customs ruled that the royalties were dutiable under 402(b)(1)(D) of the TAA.

Thus, the fact that the imported product undergoes further processing after importation is not determinative of whether the payment of royalties is a condition of the sale of the imported merchandise. Other relevant considerations are whether the imported product is manufactured under patent, whether the royalties are related to the sale of the imported merchandise and whether the payment of the royalty is a condition of the sale of the imported product.

Here, not only is the imported product manufactured under patent and the royalties are paid in part for such patent rights, the Supply Agreement is conditioned upon the continued existence of the license agreement. In these circumstances, we find that the royalties are related to the imported merchandise and that the buyer is required to pay them as a condition of the sale of the imported merchandise for exportation to the United States. As such, the royalties are to be added to the price actually paid or payable of the imported ceterizine under 402(b)(1)(D) of the TAA. Based on this finding, there is no need to address the question of whether these payments they could alternatively be considered dutiable as proceeds under 402(b)(1)(E) of the TAA.

2. Payments for Pre-Clinical Studies

The next issue to be addressed is whether the payments from the importer/buyer to the licensor for pre-clinical studies pertaining to the safety of the imported product are part of the price actually paid or payable of the imported the imported product.

The "price actually paid or payable" is defined in section 402(b)(4)(A) of the TAA as the "total payment (whether direct or indirect, and exclusive of any costs, charges, or expenses incurred for transportation, insurance, and related services incident to the international shipment of the merchandise...) made, or to be made, for the imported merchandise by the buyer to, or for the benefit of, the seller."

Two recent court cases have addressed the meaning of the term "price actually paid or payable." In Generra Sportswear Co. v. United States, 8 CAFC 132, 905 F.2d 377 (1990), the court considered whether quota charges paid to the seller on behalf of the buyer were part of the price actually paid or payable for the imported goods. In reversing the decision of the lower court, the appellate court held that the term "total payment" is all-inclusive and that "as long as the quota payment was made to the seller in exchange for merchandise sold for export to the United States, the payment properly may be included in transaction value, even if the payment represents something other than the per se value of the goods." The court also explained that it did not intend that Customs engage in extensive fact-finding to determine whether separate charges, all resulting in payments to the seller in connection with the purchase of imported merchandise, were for the merchandise or something else.

In Chrysler Corporation v. United States, 664 F. Supp. 527 (CIT, 1993), the Court of International Trade applied the Generra standard and determined that although tooling expenses incurred for the production of the merchandise were part of the price actually paid or payable for the imported merchandise, certain shortfall and special application fees which the buyer paid to the seller were not a component of the price actually paid or payable. With regard to the latter fees, the court found that the evidence established that the fees were independent and unrelated costs assessed because the buyer failed to purchase other products from the seller and not a component of the price of the imported engines.

It has been our position that based on Generra, there is a presumption that all payments made by a buyer to a seller are part of the price actually paid or payable for the imported merchandise. However, this presumption may be rebutted by evidence which clearly establishes that the payments, like those in Chrysler, are completely unrelated to the imported merchandise. It is also Customs position that the Generra standard applies whether payments are made directly to the seller or to a party related to the seller. Thus, in HRL 545663, July 14, 1995, Customs determined that foreign warehousing costs paid to the warehouse proprietor, a party related to the seller, are part of the price actually paid or payable for the imported merchandise. In this regard, the ruling states that:

this position is consistent with the definition of the price actually paid or payable' as the total payment made directly or indirectly by the buyer to, or for the benefit of, the seller. In our opinion, payments to a party related to the seller represent indirect payments made to, or, at the very least, for the benefit of, the seller. We note that the same rebuttable presumption discussed above, that is, that such payments are part of the price actually paid or payable, would equally apply in such instances. For these reasons, numerous Customs decisions have recognized that payments made from the buyer to a party other than the seller, particularly to a party related to the seller, also may be included as part of the price actually paid or payable.....

Thus, Customs has ruled that the price actually paid or payable for the imported merchandise includes payments for tooling, research and development, testing as well as payments for samples and prototypes. See HRL's 545320; February 28, 1995 (and the rulings cited therein); 544381, November 25, 1991. The rationale for these decisions is that these costs are necessary for the production of the imported product and part of the total payment.

In this case, the payments at issue were made to the licensor (the seller's subsidiary) pursuant to a provision in the License Agreement. The agreement provides that in consideration of the granting of the licenses and the disclosure of technical information, in addition to royalties discussed above, the importer/buyer agrees to pay the licensor a sum of money for the results of two pre-clinical studies conducted by the licensor and to pay the licensor all costs incurred for certain long term toxicity and/or carcinogenicity studies to be performed by the licensor. You indicate that fourteen such studies were performed all of which concerned the general safety of the imported product.

Your position is that these payments are not part of the price actually paid or payable for the imported merchandise because the studies are not necessary for the manufacture of the imported product. Rather, you indicate that the studies were conducted for the purpose of obtaining FDA approval of the finished product which is manufactured in the U.S. from the imported product. You believe that the payments are akin to U.S. marketing expenses. You also indicate that the payments were not linked to any transaction for the sale or importation of the imported product. We find that the payments are related to the imported merchandise and are part of their total payment. Pre-clinical studies to test the safety of an imported pharmaceutical product are crucial steps in the production and sale of a pharmaceutical product. They are essentially research and development costs relating to that product and are an important element of the cost of the pharmaceutical. While these studies may have been necessary in order to obtain FDA approval of the final product, this does not mean that they do not also relate to the production and sale of the imported product. Without studies confirming the safety of the imported pharmaceutical product, it would have been of little value to the importer. Language in the License Agreement that the importer/buyer may terminate the agreement if the results of the studies are unsatisfactory, shows the importance of these studies to the importer/buyer's subsequent agreement to purchase its requirements for the imported product from the seller. The studies facilitated the subsequent production and sale for exportation of the imported product

The cost of testing and other research and development costs incurred by the seller (or in this case by the seller's subsidiary) can be recouped in various ways, e.g., by including them directly in the purchase price, by charging royalties or by a separate payments covering these costs. When the seller or its related company passes along these costs to the buyer, they become part of the price actually paid or payable for the imported merchandise, or in the case of royalties, an addition thereto. In this case, the parties agreed in the License Agreement that the importer/buyer would make separate payments covering these costs. As noted above, the License Agreement specifically provides that these payments along with royalties were in consideration of the granting to the importer/buyer of the licenses and the disclosure to the importer/buyer of the licensor's technical information. Had the license agreement not provided for payment by the importer/buyer to obtain the results of the clinical studies, these costs would have been recouped either as part of the purchase price of the imported merchandise or as royalties. In either case, these costs would be dutiable.

In the pre-Generra ruling you cited, HRL 542831 (TAA 52), September 21, 1982, there was a service agreement between the importer and the seller which provided that the importer would pay the seller for services rendered for ensuring the delivery and inspection of fabric used in the assembly of the imported wearing apparel. The payments were to be made periodically and were not tied to the sale for exportation of any specific merchandise. Customs found that payments for services related to inspection and delivery were not part of the price actually paid or payable for the imported merchandise. We do not consider payments for incidental inspection services to be comparable to payments for the result of the safety studies relating to the imported product. Nor do we consider the payments at issue to be U.S. marketing expenses. The studies were conducted abroad prior to the importation and sale of the imported merchandise and relate to the safety of such product.

Based on the above considerations, we find that the evidence presented is insufficient to rebut the presumption that the payments to the seller's subsidiary for the results of pre-clinical studies are part of the price actually paid or payable.

3. Co-Promotion Fees

Under the Co-Promotion Agreement the importer/buyer and the licensor agreed to co-promote the "product(s)" on an exclusive basis in the United States. Under the agreement, the term "product(s)" is defined as cetirizine. In exchange for its marketing and promotion efforts in the United States, the licensor will earn a fee from the importer/buyer in accordance with a complex formula set forth in the Co-Promotion Agreement. You contend that the Co-Promotion fees paid by the importer/buyer are not part of the transaction value of the imported merchandise either as part of price actually paid or payable, or as an addition thereto.

You claim that the Co-Promotion Fees are not included in the price actually paid or payable of the imported product because they are not paid "for the imported merchandise". Rather, you contend that they result directly from the licensor's marketing and promotion efforts with respect to Zyrtec, not cetirizine. You note that these Co-Promotion fees are booked by the importer/buyer as cost of goods sold in the United States, and not for the imported cetirizine. You contend that the Co-Promotion fees are similar to certain brand marketing expenses discussed in HRL 544638, July 1, 1991. In that case, the agreement between the manufacturer and the importer required the importer to develop and execute a brand marketing plan for the imported vodka. Brand marketing included advertising, merchandising, promotion, market research, etc. The arrangement required the importer to make the expenditures and for the manufacturer to reimburse a specified portion the following year. Customs held that payments for brand marketing to be made by the importer and the manufacturer were not part of the price actually paid or payable for the merchandise. Specifically, Customs ruled that pursuant to 19 CFR 152.103(a)(2) there is no legal authority to treat these expenses as part of the price actually paid or payable for the imported merchandise.

While we agree that the types of brand marketing expenses involved in HRL 544638 appear to be similar to those involved here, in that case, the finding that these expenses were not part of the price actually paid or payable for the imported merchandise was based on the application of 19 CFR 152.103(a)(2) which provides in pertinent part that:

activities such as advertising, undertaken by the buyer on his own account, other than those for which an adjustment is provided in section 152.103(b), will not be considered an indirect payment to the seller though they may benefit the seller. The costs of those activities will not be added to the price actually paid or payable in determining the customs value of the imported merchandise (emphasis added).

In the present case, the importer/buyer is to pay Co-Promotion fees to the licensor for marketing activities to be undertaken by the licensor. Since these activities are not "undertaken by the buyer on his own account" neither 19 CFR 152.103(a)(2) nor HRL 544638 is controlling. Nonetheless, we agree that the Co-Promotion fees are not properly included in the transaction value of the imported merchandise because such fees are not "for the imported merchandise." Although there is a presumption that payments from the buyer to the seller or a party related to the seller are part of the price actually paid or payable for the imported merchandise, this presumption may be rebutted by evidence that the payments are for something else.

In this case, the evidence indicates that these fees are not payments associated with the sale for exportation of the imported merchandise. The evidence indicates that the Co-Promotion fees result from the specific undertakings of the licensor in promoting the sale of the product in the United States and that the amount the licensor receives under the agreement directly relates to its specific undertakings. This is set forth in detail in the Co-Promotion Agreement. This conclusion is supported by the manner in which these costs are treated by the importer/buyer in its accounting records. According to counsel, the Co-Promotion fees are booked by the importer/buyer as cost of goods sold in the United States, and not for the imported cetirizine. Moreover, there is nothing in the Supply Agreement or in the other agreements provided which suggests that the Co-Promotion fees are part of the total payment for the imported merchandise. To the contrary, it appears that the price actually paid or payable by the importer/buyer to the seller is entirely separate from any amounts the importer/buyer pays to the licensor as a result of the latter's participation in marketing events. Therefore, even though the Co-Promotion fees are made to a party related to the seller, based on the evidence presented, we conclude that they do not constitute payments for the imported merchandise and thus are not part of the price actually paid or payable for the imported merchandise.

You also contend that the Co-Promotion Fees are not one of the enumerated statutory additions to the transaction value of the imported merchandise. Your position is that they are neither selling commissions incurred by the buyer with respect to the imported merchandise under section 402(b)(1)(B) nor proceeds of a subsequent resale of the imported merchandise under 402(b)(1)(E) because they are incurred not with respect to the imported product, but with respect to and upon resale of the finished product.

We agree that the Co-Promotion fees do not constitute "selling commission(s) incurred by the buyer with respect to the imported merchandise" within the meaning of section 402(b)(1)(B). Selling commissions are fees paid to a selling agent for the services it performs on behalf of the seller in the sale of the imported goods. In this case, the services performed by the licensor are for marketing functions performed in the United States subsequent to the sale of the imported merchandise. The fees incurred directly relate to the specific activities performed by the licensor in the United States rather than to activities performed abroad in the sale of the imported merchandise. They are not the type of fees which are contemplated under section 402(b)(1)(B).

We also agree that the Co-Promotion fees do not constitute "proceeds of any subsequent resale, disposal, or use of the imported merchandise that accrue, directly or indirectly, to the seller" within the meaning of 402(b)(1)(E) of the TAA. As stated in the General Notice, generally proceeds are defined as "issues; income; yield; receipts; produce; money or article or other thing of value arising or obtained by the sale of property; the sum, amount or value of property sold or converted into money or into other property. Black's Law Dictionary, 6th ed., 1990 at p. 1204. Another definition of proceeds is "what is produced by or derived from something (as a sale, investment, levy, business) by way or total revenue; the total amount brought in ***" Webster's Third New International Dictionary 1986. In this case, the Co-Promotion fees to be paid by the importer/buyer, while paid upon the resale of the finished product, are based upon the specific undertakings of the licensor in the United States to promote such product and are not issues, income yield, receipts, etc. arising or obtained by the sale of property. We do not consider these fees to be "proceeds of any subsequent resale" within the meaning of section 402(b)(1)(E) of the TAA. HOLDING:

Based on the information provided, the royalty payments at issue constitute additions to the price actually paid or payable for the imported product under 402(b)(1)(D) of the TAA. Having reached this conclusion, it is not necessary to address the issue of whether the payments could alternatively be considered proceeds under 402(b)(1)(E) of the TAA. The payments relating to the pre-clinical studies are included in the transaction value of the imported product as part of the price actually paid or payable. The Co-Promotion fees to be paid under the Co-Promotion Agreement are not included in the transaction value of the imported product.

Sincerely,

Acting Director
International Trade
Compliance Division