Medchem (P.R.), Inc. v. Commissioner , 116 T.C. No. 25 ( 2001 )


Menu:
  •                     116 T.C. No. 25
    UNITED STATES TAX COURT
    MEDCHEM (P.R.), INC., Petitioner v.
    COMMISSIONER OF INTERNAL REVENUE, Respondent
    MEDCHEM PRODUCTS, INC., Petitioner v.
    COMMISSIONER OF INTERNAL REVENUE, Respondent
    Docket Nos. 4065-98, 4066-98.             Filed May 18, 2001.
    P-USA is a corporation that is headquartered and
    has its manufacturing facility in the United States.
    Its wholly owned subsidiary is P-PR, which lists as its
    headquarters, officers, and directors the headquarters,
    officers, and directors of P-USA. A is a corporation
    unrelated to Ps that manufactures in Puerto Rico a drug
    named Avitene. On Dec. 18, 1987, A and certain related
    entities sold to Ps the equipment, technology, and
    other assets (except A’s manufacturing facility in
    Puerto Rico) connected to Avitene’s manufacturing. As
    part of the sale, A agreed to continue manufacturing
    Avitene primarily for P-PR using the facility and labor
    furnished by A and the raw materials and equipment
    furnished by P-PR. (A also used P-USA’s technology.)
    In return, P-PR generally agreed to pay A a fee equal
    to its manufacturing costs plus 10 percent. Throughout
    most of the relevant period, P-PR had no employees and
    - 2 -
    reported as its primary source of income receipts from
    the sale of Avitene. P-PR deducted from those receipts
    amounts that it paid to P-USA and A for labor that they
    expended on Avitene’s manufacturing process. P-PR
    claimed on its 1992 Federal income tax return that it
    was entitled to a $1,993,264 Puerto Rico and possession
    tax credit under sec. 936(a), I.R.C. Ps argue that P-
    PR met the “active conduct of a trade or business
    within a [U.S.] possession” requirement of sec.
    936(a)(2)(B), I.R.C., by virtue of: (1) A’s activities
    in Puerto Rico, (2) the fact that A manufactured
    Avitene using P-PR’s raw materials and equipment, (3)
    the fact that P-PR continued to own the raw materials
    from the time that it received them until the time that
    it sold them in their manufactured form as Avitene, and
    (4) the fact that P-PR paid P-USA and A for the cost of
    their labor connected to the Avitene manufacturing
    process.
    Held: P-PR did not actively conduct a trade or
    business in Puerto Rico as required by sec.
    936(a)(2)(B), I.R.C.; i.e., P-PR did not participate
    regularly, continually, extensively, and actively in
    the management and operation of a profit-motivated
    activity in that possession.
    David A. Hickerson, for petitioners.
    Theodore J. Kletnick, Alan S. Kline, George Curran, Jennifer
    Allan Kassabian, Marie E. Small, and Melanie A. Garger, for
    respondent.
    OPINION
    LARO, Judge:   These consolidated cases were submitted to the
    Court without trial.   See Rule 122.    Respondent determined an
    $815,196 deficiency in the Federal income tax of MedChem (P.R.),
    Inc. (MedChem P.R.), for its taxable year ended August 31, 1992.
    Respondent determined a $1,705,019 deficiency in the Federal
    income tax of MedChem Products, Inc., & Subsidiaries (MedChem
    - 3 -
    Group) for its taxable year ended August 31, 1992.    Following
    concessions, we must decide whether MedChem P.R. meets the
    “active conduct of a trade or business within a possession”
    requirement of section 936(a)(2)(B).    We hold it does not.1
    Unless otherwise indicated, section references are to the
    Internal Revenue Code applicable to the relevant years.    Rule
    references are to the Tax Court Rules of Practice and Procedure.
    We attach hereto as appendix A a summary of some of the critical
    events that occurred during:    (1) The 20½-month period from
    December 18, 1987, to August 31, 1989, that preceded the 3-year
    test period relating to our determination under section
    936(a)(2)(B), (2) the 3-year test period from September 1, 1989,
    to August 31, 1992, and (3) the 20-month period from August 31,
    1992, to April 1994 that followed the 3-year test period.2
    Background
    The parties have filed with the Court a stipulation of facts
    and certain related exhibits.   We incorporate herein by reference
    1
    Given that holding, we need not and do not decide the
    parties’ other dispute; to wit, whether MedChem P.R. manufactures
    or produces a product in the possession as required by sec.
    954(d)(1)(A).
    2
    We take into account petitioners’ actions in years
    subsequent to their 1992 taxable year to evaluate their prospects
    during their 1992 year. See Levin v. Commissioner, 
    832 F.2d 403
    ,
    406 n.3 (7th Cir. 1987) (Tax Court allowed to rely on subsequent
    events to determine whether those events were consistent with the
    Court’s judgment of the facts available in the year in issue),
    affg. 
    87 T.C. 698
     (1986).
    - 4 -
    the stipulated facts and exhibits.     We find the stipulated facts
    accordingly, and we set forth the relevant facts in this
    background section.
    MedChem Products, Inc. (MedChem U.S.A.), is a Massachusetts
    corporation whose principal place of business is in Woburn,
    Massachusetts (Woburn).   MedChem U.S.A. succeeded MedChem P.R.
    following the subject years through a merger of the latter into
    the former.   MedChem P.R. was incorporated in Delaware on
    December 8, 1987, as MedChem Puerto Rico, Inc., it changed its
    name on December 22, 1987, to BioChem Products, Inc., it changed
    its State of incorporation on March 1, 1992, to Massachusetts,
    and it changed its name on November 25, 1992, to MedChem P.R.
    MedChem P.R. and its predecessors (each hereinafter referred to
    as MedChem P.R.) were always wholly owned subsidiaries of MedChem
    U.S.A.
    The original books and records of MedChem P.R. and MedChem
    U.S.A. are maintained in Woburn on an accrual method of
    accounting and on the basis of a fiscal year ending on August 31.
    During each of MedChem P.R.’s taxable years ended on August 31,
    1990, 1991, and 1992, all of its reported income was “intangible
    property income”, sec. 936(h)(3), attributable to the sale of
    Avitene, a pharmaceutical manufactured in Puerto Rico by Alcon
    Puerto Rico Inc. (Alcon P.R.), an unrelated entity.    Avitene is a
    blood clotting drug that is manufactured from the interior
    - 5 -
    collagen-rich lining (corium) of cowhides.   It is used during
    surgery to control bleeding.   It was primarily manufactured by
    Alcon P.R. during the relevant years in the forms of 35x70 mm.
    nonwoven web and 1 gram finished flour.
    MedChem U.S.A. leases office, research, and manufacturing
    facilities in Woburn.   It leased 32,000 square feet in 1989, and
    its 63 full-time employees on August 31, 1991, worked in that
    space.   On August 31, 1992, MedChem U.S.A. leased approximately
    50,000 square feet at two facilities in Woburn.   MedChem U.S.A.’s
    144 full-time employees on August 31, 1992, worked at MedChem
    U.S.A.’s manufacturing facilities in Woburn and San Antonio,
    Texas.
    The individuals who were connected with the Avitene
    manufacturing and sales business (Avitene business) were employed
    by MedChem U.S.A., MedChem P.R., Alcon P.R., or Kelly Services,
    Inc. (Kelly), a supplier of temporary labor.    Each MedChem U.S.A.
    employee connected with Avitene was paid by MedChem U.S.A. and
    had his or her office at MedChem U.S.A.’s facility in Woburn.
    MedChem P.R. had no employees after June 30, 1990.   MedChem
    P.R.’s only employee before July 1, 1990, was Jose Perez, and
    MedChem P.R. terminated him on June 30, 1990.   Nor did any of
    MedChem P.R.’s officers or directors have an office in Puerto
    Rico after June 30, 1990.   All of MedChem P.R.’s officers and
    directors, except Mr. Perez, were officers and/or directors of
    - 6 -
    MedChem U.S.A., and, after June 30, 1990, none of MedChem P.R.’s
    officers or directors was paid by MedChem P.R.
    The individuals connected with the Avitene business are
    listed below by name, affiliate, office location, position, and
    period of affiliation in the listed capacity.
    Office                                    Period of
    Name               Affiliate         Location          Position                Affiliation
    1
    Acosta, Eugenia       MedChem U.S.A.       Woburn    Manager quality systems
    Alifonso, Ramon       Alcon P.R.           P.R.      Director of manufacturing       1985-93
    Brophy, Frank         MedChem U.S.A.       Woburn    Vice president-mkt.& sales   2/28/90-9/26/91
    Vice president–marketing     9/26/91-8/31/92
    Carrion, Jimmy        Alcon P.R.           P.R.      Avitene production manager      1992-95
    Castro, Raymond       Kelly, Alcon P.R.    P.R.      Planner/buyer                   1990-91
    Donaldson, Jonathan   MedChem U.S.A.       Woburn    Director                      9/1/89-8/31/92
    President/chief oper. off.    9/1/89-8/31/92
    Clerk                         9/1/89-8/31/92
    MedChem P.R.         Woburn    President                     9/1/89-8/31/92
    Secretary                     9/1/89-4/12/91
    Director                      9/8/89-8/31/92
    Falvey, Paul          MedChem U.S.A.       Woburn    Assistant treasurer          12/1/89-8/31/92
    Ferdman, Ariel        MedChem U.S.A.       Woburn    Dir. of core technology         1988-94
    Geffken, Daniel       MedChem U.S.A.       Woburn    Treasurer                    12/1/89-5/29/91
    Chief financial officer      2/28/90-5/29/91
    MedChem P.R.         Woburn    Treasurer                     9/1/89-5/29/91
    Assistant secretary           9/1/89-4/12/91
    Secretary                    4/12/91-2/17/92
    Hansen, Lee           Alcon P.R.           P.R.      General plant manager           1981-94
    1
    Micale, Domenic       MedChem U.S.A.       Woburn    Production supervisor
    Moran, Sean           MedChem U.S.A.       Woburn    Treasurer                    5/29/91-8/31/92
    MedChem P.R.         Woburn    Secretary/clerk              2/27/92-8/31/92
    Treasurer                    2/27/92-8/31/92
    1
    McDonough, John       MedChem U.S.A.       Woburn    Financial employee
    Perez, Jose           MedChem P.R.         P.R.      General manager              2/29/88-6/29/90
    Assistant treasurer           9/1/89-6/29/90
    Rivera, Luis          Kelly                P.R.      Planner/buyer                      1992
    Rodriguez, Maria      Alcon P.R.           P.R.      Avitene prod. supervisor        1990-92
    1
    Rudolph, Cathy        MedChem U.S.A.       Woburn    Quality assurance worker
    Santiago, Maria       Alcon P.R.           P.R.      Director quality assur.         1980-94
    1
    Severance, Scott      MedChem U.S.A.       Woburn    Vice president, operations
    Shepherd, Ronald      MedChem U.S.A.       Woburn    Dir. materials manager          1990-94
    Singer, Steven        MedChem U.S.A.       Woburn    Assistant clerk               9/1/89-8/31/92
    MedChem P.R.         Woburn    Assistant secretary/clerk     9/1/89-8/31/92
    1
    Stevens, James        MedChem U.S.A.       Woburn    Dir. qlty. control/assur.
    Sullivan, Bernard     MedChem U.S.A.       Woburn    Vice president–operations     9/1/89-9/26/91
    Sr. vice president-operat.   9/26/91-8/31/92
    MedChem P.R.         Woburn    Director                      9/1/89-2/28/92
    Swann, David          MedChem U.S.A.       Woburn    Director/chairman             9/1/89-8/31/92
    Chief executive officer       9/1/89-8/31/92
    MedChem P.R.         Woburn    Director/chairman             9/1/89-8/31/92
    1
    Tanny, Jay            MedChem U.S.A.       Woburn    Cost accountant
    Velez, Nelson         Alcon P.R.           P.R.      Planner/buyer                   1991-92
    1
    The individual’s affiliation occurred sometime between December 1987 and September 1992.
    MedChem U.S.A. initially sold only one product, Amvisc.
    Amvisc, which is unrelated to Avitene, is a hyaluronic-acid-based
    - 7 -
    product used to lubricate and separate tissues in ophthalmic
    surgical procedures.   MedChem U.S.A. decided in 1987 to diversify
    its operations by acquiring the Avitene business from Alcon P.R.,
    which at the time was Avitene’s manufacturer and seller.     MedChem
    U.S.A.’s decision was based in part on the fact that it was being
    sued for patent infringement as to Amvisc.   The plaintiffs in
    that lawsuit had commenced the lawsuit in 1984 and were seeking
    an injunction and treble damages.
    On December 18, 1987, petitioners entered into a series of
    agreements with Alcon P.R., Alcon Pharmaceuticals, Ltd. (Alcon
    Pharmaceuticals), and Alcon Laboratories, Inc. (Alcon Labs)
    (these three Alcon entities are collectively referred to as the
    Alcon Entities), to purchase the Avitene business for
    approximately $31 million.    The agreements included three asset
    purchase agreements, three noncompetition agreements, a guaranty,
    and a processing agreement.   All of the Alcon Entities were
    related, and none of the Alcon Entities was related to either
    petitioner.
    The assets sold under the asset purchase agreements
    generally included all Avitene inventories, all tangible assets
    used to manufacture Avitene, and all Avitene-related intangible
    assets such as receivables, contract rights, and intellectual
    property.   Under the first agreement, Alcon Labs sold to MedChem
    U.S.A. receivables valued at $1,085,000, a non-competition
    - 8 -
    agreement valued at $200,000, goodwill valued at $4,490,000,
    contract rights valued at $5,000, and records valued at $5,000;
    Alcon Labs sold to MedChem P.R. receivables valued at $1.3
    million and inventory valued at $2.5 million.    Under the second
    agreement, Alcon P.R. sold to MedChem U.S.A. patents and related
    know-how valued at $2.6 million, trademarks valued at $1.9
    million, various Food and Drug Administration (FDA) approvals
    (including the pre-market approval for Avitene) valued at
    $300,000, a non-competition agreement valued at $200,000,
    goodwill valued at $4,910,000, and contract rights valued at
    $5,000.    Under the third agreement, Alcon P.R. sold to MedChem
    P.R. inventory valued at $10.1 million and machinery and
    equipment valued at $800,000; the machinery and equipment had
    been used by Alcon P.R. to manufacture Avitene and was located in
    Alcon P.R.’s Avitene manufacturing facility in Humacao, Puerto
    Rico (Humacao).    That facility consisted of the Avicon (Avitene)
    plant, two unrelated plants, warehouse space, and administrative
    offices.
    Each of the asset purchase agreements required that the
    Alcon Entities manufacture and sell to petitioners 20,000 pounds
    of corium and provided that the Alcon Entities had to refund to
    petitioners the entire amount paid for the Avitene business, plus
    interest, if the corium could not be manufactured by December 31,
    1990.   At all times during the 3-year period ended August 31,
    - 9 -
    1992, Avitene was manufactured using the patents, know-how,
    product specifications (as reflected in the FDA pre-market
    approvals), and goodwill owned by MedChem U.S.A.    MedChem P.R.
    held the legal title to all of the Avitene manufacturing
    equipment, the raw materials used to manufacture Avitene, the
    Avitene work-in-process, and the finished Avitene inventory until
    sold.    When the finished Avitene was shipped from the Alcon P.R.
    facility, title passed to the purchaser, which in all cases but
    one was MedChem U.S.A.3   MedChem P.R. would invoice MedChem
    U.S.A. (or the other purchaser) for the Avitene sold to it at a
    price equal to MedChem P.R.’s manufacturing cost plus 10 percent.
    From September 1, 1989, through August 31, 1992, MedChem U.S.A.
    distributed, marketed, and sold Avitene from its offices in
    Woburn.    MedChem P.R. played no part in these sales or in the
    other sales of Avitene to end users.    The labels which MedChem
    P.R. used during its fiscal year ended August 31, 1992,
    3
    The sole exception concerned the sale of Avitene for
    distribution in Japan through June 6, 1991. In that case,
    MedChem P.R. sold Avitene to Alcon Pharmaceuticals, which owned
    the distribution rights to the Japanese market until June 6,
    1991; title to that Avitene passed to Alcon Pharmaceuticals when
    the finished Avitene was shipped from the Alcon P.R. facility.
    Alcon Pharmaceuticals sold the distribution rights to the
    Japanese market to MedChem U.S.A. on June 6, 1991, for $15
    million, and MedChem U.S.A. transferred those rights to MedChem
    P.R. on August 31, 1992. MedChem P.R.’s sales of Avitene for the
    Japanese market accounted for approximately 20 percent of its
    total net sales of Avitene.
    - 10 -
    designated Alcon P.R. as Avitene’s manufacturer.    The labels
    read:
    Manufactured by:      Alcon P.R.
    Humacao, Puerto Rico 00661
    For:                  MedChem P.R.
    Humacao, Puerto Rico 00661
    Distributed by:       MedChem U.S.A.
    Woburn, Massachusetts 01801
    Neither petitioner acquired under the asset purchase
    agreements Alcon P.R.’s Avitene-manufacturing facility in Humacao
    or the right to market, distribute, or sell Avitene in Japan.4
    That right to the Japanese market was initially retained by Alcon
    Pharmaceuticals, which, during the period of retention, purchased
    Avitene for the Japanese market from MedChem P.R.    Alcon P.R.
    manufactured the Avitene sold to Alcon Pharmaceuticals and
    treated it the same as all other Avitene for purposes of
    scheduling, planning and buying, manufacturing, and quality
    control.
    The respective parties to the non-competition agreements
    were:    (1) MedChem U.S.A. and Alcon Labs, (2) MedChem U.S.A. and
    Alcon Pharmaceuticals, and (3) MedChem U.S.A. and Alcon P.R.
    Under these agreements, the Alcon Entities generally promised not
    to manufacture, market, or sell any product having the same or
    4
    Neither petitioner has ever had an Avitene manufacturing
    facility in Puerto Rico.
    - 11 -
    substantially the same form, function, or application as Avitene
    during the 5-year period commencing on December 19, 1987.
    MedChem U.S.A. gave the guaranty to each of the Alcon
    Entities.    Under the guaranty, which was in effect throughout the
    fiscal year ended August 31, 1992, MedChem U.S.A. guaranteed to
    pay any debt and perform any obligation of MedChem P.R. arising
    from the asset purchase and related agreements.
    The processing agreement dealt primarily with a promise by
    Alcon P.R. to manufacture Avitene for MedChem P.R. using Alcon
    P.R.’s facility and labor and MedChem P.R.’s raw materials and
    equipment.   (Alcon P.R. also used MedChem U.S.A.’s technology but
    not pursuant to the processing agreement.)   See appendix B for
    the relevant provisions of the processing agreement.   The
    processing agreement expired initially on December 31, 1990, but
    was extended on four separate occasions to June 30, 1991,
    December 31, 1992, December 31, 1994, and the earlier of March 1,
    1995, or the date on which Alcon P.R. completed a set delivery
    schedule, respectively.   From September 1, 1989, through August
    31, 1992, Alcon P.R. manufactured Avitene for MedChem P.R.
    pursuant to the processing agreement, and Alcon P.R. sent its
    invoices for its manufacturing services directly to MedChem
    U.S.A. for payment from the account of MedChem P.R.    Alcon P.R.
    manufactured Avitene at its manufacturing facility in Humacao,
    using its own personnel to manufacture, test, and package Avitene
    - 12 -
    and to supervise each of these functions.   Alcon P.R. was solely
    responsible for resolving any problem that arose during the
    period from the time that it received the corium up until the
    time that the finished Avitene was delivered to a carrier for
    delivery to MedChem U.S.A. (manufacturing process).
    Alcon P.R. generally manufactured Avitene in accordance with
    a two-phase process and kept its inventory of finished Avitene in
    its warehouse attached to its manufacturing facility.   Avitene’s
    two-phase manufacturing process was as follows:
    Phase I
    (1) Frozen corium and component materials were
    ordered from the warehouse attached to the Avitene
    manufacturing facility and transferred to a preparation
    room in the facility, where the corium was thawed and
    machine washed.
    (2) The corium was machine cut into approximately
    4 square inch pieces, manually inspected for
    imperfections, and machine cut into smaller pieces of
    approximately one square inch in size.
    (3) The smaller pieces were acidified, washed with
    alcohol, and tested against product specifications.
    (4) The resulting product was refrigerated while
    the initial steps were repeated for a second lot of
    corium; the two lots were mixed together and dried in a
    rotary dryer.
    (5) The dried corium was machine milled into a
    loose, powdery, fibrous substance known as bulk flour.
    The bulk flour was placed in quarantined cages awaiting
    further processing into its final form as either
    finished flour or nonwoven web.
    - 13 -
    Phase II
    (6) As to the manufacturing of nonwoven web, bulk
    flour was transferred from the quarantined cage to the
    web forming room, where it was machine processed into
    rolls of nonwoven web.
    (7) The rolls of nonwoven web were transferred to
    the web cutting room where they were machine cut into
    the required size, visually inspected against product
    specifications, and placed in trays for drying and
    sterilization. Once sterilized, the nonwoven web was
    transferred to the pouch load and seal room where it
    was packaged in a sealed pouch. The packaged nonwoven
    web was sterilized, tested, and transferred to the
    loading and shipping area.
    (8) As to the manufacturing of finished flour,
    jars were machine washed, loaded into trays and carts,
    and dried in a walk-in oven.
    (9) The jars were moved to the filling process
    room where they were filled with bulk flour and placed
    back into an oven for further drying.
    (10) The dried jars (with bulk flour inside) were
    transferred by carts to the capping room where they
    were capped.
    (11) The capped jars (with bulk flour inside) were
    transferred by conveyor to the canning and sealing room
    where they were canned, banded, and sealed with tamper-
    proof material.
    (12) The resulting jars (with bulk flour inside)
    were moved to the sterilization room where they were
    oven sterilized and transferred to the loading and
    shipping area.
    Petitioners entered into the processing agreement to ensure
    a reliable supply of Avitene while they proceeded to establish
    MedChem P.R.’s own Avitene manufacturing facility in Puerto Rico.
    When the December 18, 1987, agreements were entered into,
    petitioners intended to have that facility ready to take over the
    - 14 -
    manufacturing of Avitene at the end of the processing agreement’s
    original 3-year term.
    In February 1988, Jonathan Donaldson traveled to Humacao and
    interviewed Mr. Perez for a position with MedChem P.R.5    At the
    time, Mr. Perez was involved in and familiar with all aspects of
    the Avitene manufacturing process; he was a longtime Alcon P.R.
    employee with various supervisory responsibilities as to
    Avitene’s manufacturing.   Shortly thereafter, while in Woburn,
    Mr. Donaldson decided to hire Mr. Perez and communicated that
    decision to Mr. Perez in Puerto Rico.   Mr. Perez accepted Mr.
    Donaldson’s offer and worked for MedChem P.R. until June 30,
    1990, reporting directly to Bernard Sullivan or to Mr. Sullivan’s
    superior, Mr. Donaldson.   Mr. Perez worked from May 1988 through
    June 30, 1990, primarily out of a one-room office (the only
    office) that MedChem P.R. maintained in Humacao during that
    period.   The office was equipped with three desks, a computer, a
    facsimile machine, a photocopier, and file cabinets.   The office
    contained product specifications, standard operating procedures,
    invoices, and copies of some of the financial statements and
    records which would be needed in the event of an audit.
    MedChem P.R. paid Mr. Perez an annual salary, plus benefits,
    to manage and coordinate its efforts in Puerto Rico as to the
    5
    This was one of the infrequent occasions on which Mr.
    Donaldson or any of either petitioner’s other officers or
    directors traveled to Puerto Rico on Avitene business.
    - 15 -
    manufacturing of Avitene.    From March 1988 through approximately
    June 1988, Mr. Perez spent approximately 75 percent of his time
    visiting Alcon P.R.’s Avitene manufacturing operation, making
    sure that the operation was running smoothly and aiding the
    anticipated transfer of that operation to MedChem P.R.     He spent
    the remainder of his time during that period on MedChem P.R.’s
    effort to establish its own Avitene manufacturing facility in
    Puerto Rico.   During the remainder of his employment by MedChem
    P.R., Mr. Perez spent approximately 70 percent of his time
    working on MedChem P.R.’s proposed facility and the rest of his
    time on Alcon P.R.’s Avitene manufacturing operation and the
    daily operation of MedChem P.R.’s Humacao office.
    Mr. Perez was the only employee that MedChem P.R. ever had
    during the relevant years.   MedChem P.R. did hire three
    independent contractors (Carlos Moya, Maria Pastrana, and Wanda
    Rodriguez) to assist Mr. Perez in the Humacao office.    Ms.
    Pastrana and Mr. Moya worked in the office during 1989, and Wanda
    Rodriguez worked in the office from October 1989 to June 1990.
    Mr. Moya was a materials coordinator, and Ms. Pastrana and her
    successor, Ms. Rodriguez, were administrative secretaries.
    MedChem P.R. directly paid these three individuals and issued to
    them Forms 1099-MISC, Miscellaneous Income, reporting these
    payments as nonemployee compensation.
    - 16 -
    On June 21, 1989, MedChem P.R. paid $842,500 to the Puerto
    Rico Industrial Development Co. for approximately 8.5 acres of
    land in Juncos, Puerto Rico (Juncos), to be used as the site of
    MedChem P.R.’s proposed manufacturing facility.   Conditions of
    the sale included that MedChem P.R. would submit plans for
    construction of an industrial building within 6 months, that
    construction of the building would begin within 6 months of the
    plans’ approval, that the completed building would be devoted to
    manufacturing operations for a minimum period of 10 years, that
    the building would include 30,000 square feet of ground floor
    space and 13,000 square feet of mezzanine space, and that MedChem
    P.R. would use its reasonable efforts to employ 50 people at the
    commencement of the facility’s manufacturing operations and 120
    people within 18 months thereafter.    Petitioners anticipated that
    the proposed facility would cost at least $9 million to build,
    and, through January 31, 1990, MedChem P.R. made $885,216.56 of
    capital expenditures relating to the facility’s proposed
    construction.   Most of these expenditures concerned the services
    of Unipro, an engineering and architectural firm retained by
    MedChem P.R. to work on the proposed facility.    Unipro prepared
    architectural drawings and designs for the facility.
    In early 1990, MedChem U.S.A. suffered a devastating
    financial blow from the Amvisc litigation.   On February 2, 1990,
    the District Court hearing the case issued a preliminary
    - 17 -
    injunction barring MedChem U.S.A. from using, manufacturing, and
    selling Amvisc in the United States.   Amvisc and Avitene were
    MedChem U.S.A.’s only products.   MedChem U.S.A. faced the
    possible payment of costly patent infringement damages, multiple
    damages, and an award of attorney’s fees.   The Amvisc injunction
    caused MedChem U.S.A. to default on $10 million in debt and to
    lay off a third of its workforce.   The Amvisc injunction caused
    petitioners to postpone indefinitely their plans to construct an
    Avitene manufacturing facility in Puerto Rico.
    Petitioners took several steps regarding Avitene in early
    1990, following the Amvisc injunction.   First, in connection with
    suspending their plans to construct the manufacturing facility in
    Puerto Rico, they notified Unipro to stop its work on that
    facility.   Second, in February 1990, MedChem P.R. wrote off for
    financial accounting and tax purposes all of the capitalized
    expenditures ($881,966) relating to the proposed facility.
    Third, MedChem P.R. closed its Humacao office and terminated the
    workers there (Mr. Perez and Wanda Rodriguez).   In connection
    therewith, Mr. Perez transferred to Alcon P.R. all of the records
    as to suppliers and vendors which had been kept in the Humacao
    office, and he transferred to MedChem U.S.A.’s Woburn facility
    all of the other records which had been kept in the office,
    including records relating to the design and construction of
    MedChem P.R.’s proposed facility in Puerto Rico.   Fourth,
    - 18 -
    petitioners decided to move during the fall of 1990 the Avitene
    manufacturing process (including the manufacturing equipment)
    from Alcon P.R.’s Puerto Rico facility to MedChem U.S.A.’s idled
    Amvisc facility in Woburn.6   Such a move would and did require
    MedChem U.S.A. to make additional leasehold improvements in order
    to conform the Amvisc facility to Avitene’s manufacturing
    requirements.   Fifth, MedChem P.R. attempted to sell the land in
    Juncos that it had purchased for the site of the proposed
    facility.   Sixth, as of July 1, 1990, MedChem U.S.A. employees
    wrote all of MedChem P.R.’s checks in Woburn and mailed those
    checks from Woburn to the payees.
    Petitioners moved the equipment used to process corium into
    bulk flour into MedChem U.S.A.’s Woburn facility in June 1990.7
    Within 7 months, they moved into that facility all or part of the
    frozen corium and the equipment used to process bulk flour into
    6
    MedChem U.S.A. eventually constructed a bulk Avitene
    manufacturing facility in Woburn in June 1992 and began producing
    bulk Avitene there 4 months later. In July 1993, MedChem U.S.A.
    began constructing an Avitene finished goods manufacturing
    facility in Woburn; at that time, Alcon P.R. performed that part
    of the Avitene manufacturing process at its facility in Puerto
    Rico pursuant to the processing agreement. MedChem U.S.A.
    substantially completed construction of the latter project in
    April 1994, at which time MedChem U.S.A. controlled Avitene’s
    entire manufacturing process.
    7
    At that time, the manufacturing of work-in-process was
    completed and the machinery and equipment used in that process
    disassembled and also readied for moving to Woburn.
    - 19 -
    nonwoven web.8   These two groups of equipment constituted all of
    the manufacturing equipment necessary to perform the work in
    phase 1 of the manufacturing process; as of the later date, all
    of the manufacturing equipment related to phase 1 was located in
    MedChem U.S.A.’s facility in Woburn.   By January 1, 1991,
    petitioners had also transferred certain raw material
    manufacturing functions into MedChem U.S.A.’s Woburn facility as
    well.
    The equipment used to perform the work in phase 2 of the
    manufacturing process, i.e., processing bulk flour into finished
    flour and finishing and packaging the nonwoven web, remained in
    Alcon P.R.’s manufacturing facility in Humacao until early 1995
    at which time it was shipped to the Woburn facility.    Alcon P.R.
    continued in Puerto Rico until early 1995 to manufacture finished
    Avitene from bulk flour and dry, sterilize, and package nonwoven
    web under the terms of the processing agreement.   Alcon P.R. did
    so using bulk flour and nonwoven web that had been manufactured
    in Humacao during a buildup in 1989 and 1990; it did not use any
    bulk flour or nonwoven web manufactured elsewhere.   When
    petitioners moved the bulk and nonwoven web equipment to MedChem
    U.S.A.’s facility in 1990, Alcon P.R. planned to use the part of
    8
    On separate occasions, MedChem U.S.A. reported to the
    Securities and Exchange Commission (SEC) that, as of Nov. 30,
    1990, and as of Feb. 28, 1991, respectively, MedChem U.S.A. was
    in the process of redesigning its Amvisc manufacturing facility
    in Woburn in order to start manufacturing Avitene there.
    - 20 -
    the plant where the equipment had been located for non-Avitene
    products.
    Alcon P.R. devoted 30 to 35 of its full-time production line
    employees to the manufacturing of Avitene before June 1990, and
    it devoted 12 to 15 of its full-time production line employees
    afterwards.   Alcon P.R. included the compensation paid to these
    employees in the calculation of the processing fee charged to
    MedChem P.R. under the processing agreement.    Of the 30 to 35
    production line employees who worked on Avitene before June 1990,
    approximately 15 to 20 worked in phase 1 of the manufacturing
    process, and the remainder worked in phase 2.    The number of
    Alcon P.R. employees producing Avitene decreased in June 1990
    after MedChem U.S.A. moved to Woburn the equipment used to
    convert corium into bulk flour.
    All of the production line employees were supervised by a
    manager employed by Alcon P.R.; namely, Maria Rodriguez from
    January 1990 to January 1, 1992, and Jimmy Carrion afterwards.
    These managers reported to Ramon Alifonso, Alcon P.R.’s director
    of manufacturing, who reported to Lee Hansen, Alcon P.R.’s
    general manager for its manufacturing facility.
    Alcon P.R. had a quality assurance department at its
    manufacturing facility and employed in that department a director
    and a staff of approximately 85 to 100.   The director, Maria
    Santiago, reported to Alcon Labs’ quality assurance director in
    - 21 -
    Fort Worth, Texas.   Alcon P.R. was responsible for the quality of
    Avitene, and its employees in its quality assurance department
    performed each of the required tests as set forth in the product
    specifications owned by MedChem U.S.A.    Alcon P.R. kept in its
    quality assurance department all master documentation for the
    manufacturing of Avitene and all related records such as
    inspection documents, charts, and forms.    After Alcon P.R.
    completed its quality assurance tests and document review, it
    used its regular carrier to ship the packaged Avitene to MedChem
    U.S.A. in Woburn, where MedChem U.S.A. stored the Avitene in a
    warehouse or quarantine cage awaiting distribution to its
    customers (i.e., the end users).    MedChem U.S.A. performed
    secondary quality tests on the finished Avitene product at its
    quality assurance department in Woburn.    MedChem P.R. did not
    have a quality assurance department, and it never tested Avitene
    for quality compliance.
    MedChem U.S.A. prepared and filed all applications, reports,
    and other documents required by the FDA to manufacture Avitene.
    Alcon P.R. provided MedChem U.S.A. with information relating to
    the manufacturing process, and MedChem U.S.A. incorporated that
    information into its FDA filings.    MedChem P.R. did not submit
    any applications, reports, or other documents to the FDA.
    MedChem U.S.A.’s filings with the FDA for the period August 26,
    1991, to October 27, 1993, identified Alcon P.R. as Avitene’s
    - 22 -
    manufacturer.     MedChem U.S.A. also reported to the SEC for most
    of 1989 and each of the relevant years thereafter that Alcon P.R.
    was Avitene’s manufacturer and that Alcon P.R. manufactured
    Avitene at its Puerto Rico facility for MedChem U.S.A.
    MedChem P.R. did not have a facility registered with the FDA
    to manufacture pharmaceuticals.    Alcon P.R.’s manufacturing
    facility was so registered, and the FDA performed a yearlong
    inspection of that facility beginning in August 1992.    During the
    inspection, the FDA dealt almost exclusively with employees of
    Alcon P.R.; contacts with non-Alcon P.R. personnel were minimal
    and insignificant.    The FDA’s report on the inspection listed
    Alcon P.R. as Avitene’s manufacturer.
    MedChem U.S.A. had a department in Woburn where its
    employees researched and developed Avitene.    During the subject
    years, for example, MedChem U.S.A. researched and developed a new
    form of Avitene named Endo-Avitene, which it began shipping in
    November 1992.    Ariel Ferdman generally directed MedChem U.S.A.’s
    research and development activities out of Woburn, and he was
    assisted in his work by MedChem U.S.A. employees and/or Alcon
    P.R. employees.    On a few occasions from 1990 through 1992, Dr.
    Ferdman (occasionally accompanied by other MedChem U.S.A.
    employees) traveled to Alcon P.R.’s manufacturing facility in
    Puerto Rico to research and develop Avitene.    Dr. Ferdman’s
    research and development work at Alcon P.R.’s manufacturing
    - 23 -
    facility related primarily to preparing validation studies to
    obtain approval of an application that MedChem U.S.A. had made to
    the FDA for Endo-Avitene.   Dr. Ferdman also worked at the Alcon
    P.R. facility from April through August 1990 studying and
    learning Avitene’s manufacturing process so that MedChem U.S.A.
    could later in that year move that process into, and implement
    that process in, MedChem U.S.A.’s Woburn facility.   MedChem P.R.
    did not have a research and development function, and it played
    no part in the development of new Avitene or the development of
    other products.
    Kelly provided temporary labor to Alcon P.R. at its
    facilities from June 1990 through August 31, 1992, pursuant to
    their written agreement stating in relevant part that the “Kelly
    assigned employees, are the employees of Kelly, and none of said
    persons assigned under this contract shall be regarded as
    employees of [the buyers of the services]”.   Neither petitioner
    was involved with that or any other agreement concerning
    temporary labor to be provided at the Alcon P.R. facility.   As
    relevant herein, Kelly charged Alcon P.R. $20.40 per hour for the
    use of a Kelly employee and included in this rate the cost of
    Kelly’s obligation to pay its employees’ workers’ compensation,
    unemployment insurance, and Social Security taxes.
    Kelly supplied Alcon P.R. with two of the three people who
    worked at the Alcon P.R. facility from July 1990 through August
    - 24 -
    31, 1992, as the Avitene planner/buyer.9    The planner/buyer
    generally established periodic schedules under which Alcon P.R.
    manufactured Avitene for MedChem P.R. in accordance with orders
    placed by MedChem U.S.A.    The planner/buyer also:   (1) Attended
    weekly manufacturing meetings held with Alcon P.R. managers at
    Alcon P.R.’s facility, (2) monitored the inventories of materials
    used in the manufacturing process, (3) purchased materials and
    components (exclusive of corium) through Alcon P.R.’s purchasing
    system, after receiving the authorization of an Alcon P.R.
    manager (and sometimes also a MedChem U.S.A. manager), (4) dealt
    with Alcon P.R. or MedChem U.S.A. personnel to cure problems
    arising mainly from the materials used in the Avitene
    manufacturing process, and (5) verified with Alcon P.R. personnel
    that the required quality assurance tests had been performed and
    confirmed that the product was ready for shipping.
    Raymond Castro was a Kelly employee who worked as
    planner/buyer from on or about June 30, 1990, through March 1991.
    Kelly hired him and paid him $12.02 per hour.    Neither petitioner
    was involved in his hiring or in his placement as planner/buyer.
    He reported to Ronald Shepherd and/or Luis Diaz, an Alcon P.R.
    manager, and Mr. Castro’s work required that he interact with
    Alcon P.R. employees and MedChem U.S.A. employees.    Alcon P.R.
    invoiced MedChem P.R. for the amount that it paid Kelly as to Mr.
    9
    Before this time, Mr. Perez was the planner/buyer.
    - 25 -
    Castro, and MedChem P.R. accounted for its payment of these
    invoices as an expense for outside services for office support.
    Mr. Castro’s status as a Kelly employee ceased in March 1991,
    when he was hired by Alcon P.R. as a full-time employee.    Mr.
    Castro continued to work on Avitene matters after he was hired by
    Alcon P.R., and he continued to interact with other Alcon P.R.
    employees and with MedChem U.S.A. employees.
    Nelson Velez succeeded Mr. Castro as planner/buyer from
    March 1991 through April 1992.   Mr. Velez was a longtime Alcon
    P.R. employee, and neither petitioner was involved in his
    selection or placement as planner/buyer.   Mr. Diaz, who was Mr.
    Velez’s superior, assigned Mr. Velez to serve concurrently as the
    planner/buyer of both Avitene and an unrelated Alcon P.R.
    product.   Mr. Velez divided his work equally between the two
    functions, and Alcon P.R. invoiced MedChem P.R. for 50 percent of
    his salary.   MedChem P.R. accounted for its payment of these
    invoices as an expense for outside services for office support.
    Mr. Castro’s Avitene-related work required that he interact with
    Alcon P.R. employees and MedChem U.S.A. employees.
    Luis Rivera was a Kelly employee who succeeded Mr. Velez as
    planner/buyer from April 1992 to August 31, 1992.    Kelly hired
    him and paid him $12 per hour.   Neither petitioner was involved
    in his hiring or with his placement as planner/buyer.   Mr. Rivera
    reported to Mr. Shepherd and/or various Alcon P.R. managers, and
    - 26 -
    Mr. Rivera’s work required that he interact with Alcon P.R.
    employees and with MedChem U.S.A. employees.    Alcon P.R. invoiced
    MedChem P.R. for the amount that it paid Kelly for Mr. Rivera’s
    services, and MedChem P.R. accounted for its payment of these
    invoices as an expense for outside services for office support.
    Mr. Rivera’s status as a Kelly employee ceased on November 1,
    1993, when he was retained by MedChem P.R. as an independent
    consultant.
    Mr. Sullivan supervised MedChem U.S.A.’s Amvisc operation
    through 1993.    He was listed as a MedChem P.R. director on its
    corporate records, but he never performed any duties as a MedChem
    P.R. director.   He performed as a MedChem U.S.A. officer the
    following ancillary activities relating to Avitene:   (1) He
    prepared and maintained schedules listing MedChem U.S.A.’s
    requirements for Avitene for specified periods during the year,
    (2) he forwarded those schedules to Mr. Shepherd to deliver (or
    sometimes he delivered them himself) to Alcon P.R. and to the
    planner/buyer, (3) he reviewed the results of the quality
    assurance tests which were prepared by and received from Alcon
    P.R., and (4) he monitored the sales of Avitene to customers.      He
    did not attend the weekly manufacturing meetings held with Alcon
    P.R. managers at Alcon P.R.’s facility.
    MedChem P.R. maintained a checking account in Puerto Rico
    through September 25, 1991.   MedChem P.R. used that account to
    - 27 -
    pay the routine operating expenses (e.g., office rent, supplies)
    of its Humacao office.   On September 5, 1991, MedChem P.R. opened
    a checking account in California (California account), listing as
    its address MedChem U.S.A.’s address in Woburn.   Alcon P.R. sent
    its invoices under the processing agreement to MedChem U.S.A.’s
    Woburn address, and MedChem U.S.A.’s personnel reviewed those
    invoices, authorized their payment, and paid them out of the
    California account.   Vendors also sent their invoices for raw
    materials and components, among other things, to MedChem U.S.A.’s
    Woburn address where, after September 4, 1991, MedChem U.S.A.
    personnel reviewed and paid those invoices out of the California
    account.   Sean Moran and/or John McDonough signed the checks
    payable to vendors drawn on the California account.   Mr. Moran,
    who reported to Mr. Donaldson, spent approximately 30 percent of
    his time on Avitene financial matters.10
    For its fiscal year ended on August 31, 1992, MedChem P.R.
    elected under section 936(h)(5) to allocate between itself and
    MedChem U.S.A. the Avitene-related costs, including the salary
    expense of MedChem U.S.A. employees.   MedChem P.R.’s audited
    financial statements for that year reported petitioners’
    calculation of 50 percent of the total Avitene product line cost
    of sales and selling, general, and administrative expenses.
    10
    Daniel Geffken also reported to Mr. Donaldson. Mr.
    Geffken spent less than 50 percent of his time on Avitene-related
    matters.
    - 28 -
    Those statements indicate that cost of goods sold of $1,730,804
    and selling, general, and administrative expenses (including the
    salary expense of MedChem U.S.A. employees working on Avitene
    matters) of $2,789,224 incurred by MedChem U.S.A. were charged to
    MedChem P.R.   On its Federal income tax return for that year,
    MedChem P.R. reported:    (1) Taxable income of $5,862,541 and (2)
    direct labor costs of $323,000.    MedChem P.R. claimed a
    $1,993,264 tax credit under section 936(a).
    Discussion
    The parties dispute whether MedChem P.R. may calculate its
    1992 Federal income tax liability by using the Puerto Rico and
    possession tax credit (possession tax credit) provided under
    section 936(a).    A domestic corporate taxpayer such as MedChem
    P.R. qualifies for this credit if it meets the following
    statutory requirements:
    SEC. 936. PUERTO RICO AND POSSESSION TAX CREDIT.
    (a) Allowance of Credit.--
    (1) In general.--Except as otherwise
    provided in this section, if a domestic
    corporation elects the application of this
    section and if the conditions of both
    subparagraph (A) and subparagraph (B) of
    paragraph (2) are satisfied, there shall be
    allowed as a credit against the tax imposed
    by this chapter an amount equal to the
    portion of the tax which is attributable to
    the sum of--
    (A) the taxable income, from
    sources without the United States,
    from–
    - 29 -
    (i) the active
    conduct of a trade or
    business within a
    possession of the United
    States, or
    (ii) the sale or
    exchange of substantially
    all of the assets used by
    the taxpayer in the
    active conduct of such
    trade or business, and
    (B) the qualified possession
    source investment income.
    (2) Conditions which must be satisfied.-
    -The conditions referred to in paragraph (1)
    are:
    (A) 3-year period.--If 80
    percent or more of the gross income
    of such domestic corporation for
    the 3-year period immediately
    preceding the close of the taxable
    year (or for such part of such
    period immediately preceding the
    close of such taxable year as may
    be applicable) was derived from
    sources within a possession of the
    United States (determined without
    regard to section 904(f)); and
    (B) Trade or business.--If 75
    percent or more of the gross income
    of such domestic corporation for
    such period or such part thereof
    was derived from the active conduct
    of a trade or business within a
    possession of the United States.
    Respondent determined and contends that none of MedChem
    P.R.’s taxable income for its fiscal year ended August 31, 1992,
    - 30 -
    qualifies for the possession tax credit.11    Respondent argues
    primarily that MedChem P.R. did not meet the active conduct of a
    trade or business requirement of section 936(a)(2)(B).
    Petitioners contend that all of MedChem P.R.’s taxable income
    qualifies for the possession tax credit.     Petitioners argue that
    MedChem P.R. met the active conduct of a trade or business
    requirement because, petitioners assert, all of MedChem P.R.’s
    income was derived from its sales in Puerto Rico of Avitene that
    it manufactured in Puerto Rico.   Petitioners assert that, in
    addition to that sales income, MedChem P.R. had significant
    business activities in Puerto Rico.     Petitioners assert that
    MedChem P.R.’s business activities in Puerto Rico included
    purchasing the raw materials necessary for Avitene, monitoring
    manufacturing and inventory levels of Avitene, and owning all of
    the manufacturing equipment, raw materials, work-in-process, and
    finished goods related to Avitene.     Petitioners assert that
    MedChem P.R. performed its business activities in Puerto Rico
    through its common law employees consisting of its officers, the
    Kelly employees, and employees who worked concurrently for
    MedChem P.R. and either MedChem U.S.A. or Alcon P.R.     Petitioners
    assert that MedChem P.R. also performed significant business
    11
    As an alternative to this determination, respondent
    determined that MedChem P.R.’s income was taxable to the MedChem
    Group under sec. 482(a). Because respondent does not pursue this
    argument on brief, we consider it conceded.
    - 31 -
    activities in Puerto Rico through Alcon P.R., a contract
    manufacturer.   Petitioners argue that activities performed
    through a contract manufacturer such as Alcon P.R. are imputed to
    the other party to the contract, in this case, MedChem P.R.
    We agree with respondent that MedChem P.R. does not qualify
    for the possession tax credit because it failed the active
    conduct of a trade or business requirement of section
    936(a)(2)(B).   As we read section 936(a), a domestic corporate
    taxpayer may elect to determine its Federal income tax liability
    by using the possession tax credit if it meets two requirements.
    The credit equals the amount of tax attributable to the sum of
    the taxpayer’s qualified possession-source investment income plus
    the taxpayer’s non-U.S.-source income that it earned from:    (1)
    Its active conduct of a trade or business in a U.S. possession or
    (2) its sale or exchange of substantially all of the assets used
    in the active conduct of that trade or business.   The two
    requirements are the 80-percent test of section 936(a)(2)(A) and
    the 75-percent test of section 936(a)(2)(B).   We concern
    ourselves only with the 75-percent test of section 936(a)(2)(B)
    because the parties agree that MedChem P.R. has met the 80-
    percent test.   Under the 75-percent test, MedChem P.R. qualified
    for the possession tax credit if at least 75 percent of its gross
    income for the 3-year period ended August 31, 1992, was derived
    - 32 -
    from its active conduct of a trade or business within Puerto
    Rico.
    We are unable to find that such was the case.    MedChem P.R.
    did not actively conduct a trade or business within Puerto Rico
    throughout the 3-year period.     Whether MedChem P.R. actively
    conducted such a trade or business is a highly fact intensive
    issue as to which petitioners bear the burden of proof.     Cf.
    Higgins v. Commissioner, 
    312 U.S. 212
    , 217 (1941); Deputy v. du
    Pont, 
    308 U.S. 488
    , 496 (1940); Welch v. Helvering, 
    290 U.S. 111
    ,
    115 (1933); Plymouth Sav. Bank v. United States, 
    187 F.3d 203
    ,
    210 (1st Cir. 1999).     Because Congress has not explicitly defined
    the phrase “active conduct of a trade or business” for purposes
    of section 936(a) (or, for that matter, for any other purpose of
    the Code), Congress has essentially left it to the Secretary to
    define that phrase by way of regulations or, in the absence of
    regulations, to the courts to construe the phrase by way of
    judicial interpretation.     As the Supreme Court observed in
    construing the phrase “trade or business” for purposes of section
    162(a):
    The phrase “trade or business” has been in §
    162(a) and in that section’s predecessors for many
    years. Indeed, the phrase is common in the Code, for
    it appears in over 50 sections and 800 subsections and
    in hundreds of places in proposed and final income tax
    regulations. The slightly longer phrases, “carrying on
    a trade or business” and “engaging in a trade or
    business,” themselves are used no less than 60 times in
    the Code. The concept thus has a well-known and almost
    constant presence on our tax-law terrain. Despite
    - 33 -
    this, the Code has never contained a definition of the
    words “trade or business” for general application, and
    no regulation has been issued expounding its meaning
    for all purposes. Neither has a broadly applicable
    authoritative judicial definition emerged. Our task in
    this case is to ascertain the meaning of the phrase as
    it appears in the sections of the Code with which we
    are here concerned. [Commissioner v. Groetzinger, 
    480 U.S. 23
    , 26 (1987); fn. refs. omitted.]
    Given the lack of a statutory or regulatory definition of
    the phrase “active conduct of a trade or business” as used in
    section 936(a), we believe it appropriate to construe that phrase
    by reference to the Secretary’s definitions of the phrase for
    other purposes of the Code, bearing in mind Congress’ intent in
    enacting section 936 as reflected in its legislative history.12
    Cf. Martin Ice Cream Co. v. Commissioner, 
    110 T.C. 189
    , 216
    (1998) (Court interpreted the subject phrase for purposes of
    section 355 by reference to the definition set forth in the
    regulations prescribed under section 355).   Our research reveals
    that the phrase “active conduct of a trade or business” appears
    22 times in the current version of the Internal Revenue Code13
    and that the Secretary has issued extensive regulations
    interpreting that phrase in three of those sections.   First, for
    12
    Of course, we also bear in mind the Supreme Court’s
    interpretation of the phrase “trade or business” as espoused in
    Commissioner v. Groetzinger, 
    480 U.S. 23
    , 35 (1987); to wit, an
    activity in which a taxpayer is involved with continuity,
    regularity, and a profit-motivated primary purpose.
    13
    See secs. 30A, 49, 168, 179, 351, 355, 367, 407, 543,
    731, 806, 861, 865, 936, 954, 957, 995, 1202, 1298, 1362, 2057,
    4001.
    - 34 -
    purposes of section 179, the Secretary prescribed in section
    1.179-2(c)(6), Income Tax Regs., the following relevant rules as
    to the meaning of the phrase:
    (6) Active conduct by the taxpayer of a trade
    or business--(i) Trade or business. For purposes of
    this section and § 1.179-4(a), the term “trade or
    business” has the same meaning as in section 162 and
    the regulations thereunder. * * *
    (ii) Active conduct. For purposes of
    this section, the determination of whether a trade or
    business is actively conducted by the taxpayer is to be
    made from all the facts and circumstances and is to be
    applied in light of the purpose of the active conduct
    requirement of section 179(b)(3)(A). In the context of
    section 179, the purpose of the active conduct
    requirement is to prevent a passive investor in a trade
    or business from deducting section 179 expenses against
    taxable income derived from that trade or business.
    Consistent with this purpose, a taxpayer generally is
    considered to actively conduct a trade or business if
    the taxpayer meaningfully participates in the
    management or operations of the trade or business. * *
    * A mere passive investor in a trade or business does
    not actively conduct the trade or business.
    Second, for purposes of section 355, the Secretary
    prescribed in section 1.355-3(b)(2), Income Tax Regs., the
    following relevant rules as to the phrase’s meaning:
    (2) Active conduct of a trade or business
    immediately after distribution--(i) In general. For
    purposes of section 355(b), a corporation shall be
    treated as engaged in the “active conduct of a trade or
    business” immediately after the distribution if the
    assets and activities of the corporation satisfy the
    requirements and limitations described in paragraph
    (b)(2)(ii), (iii), and (iv) of this section.
    (ii) Trade or business. A corporation
    shall be treated as engaged in a trade or business
    immediately after the distribution if a specific group
    of activities are being carried on by the corporation
    - 35 -
    for the purpose of earning income or profit, and the
    activities included in such group include every
    operation that forms a part of, or a step in, the
    process of earning income or profit. Such group of
    activities ordinarily must include the collection of
    income and the payment of expenses.
    (iii) Active conduct. For purposes of
    section 355(b), the determination whether a trade or
    business is actively conducted will be made from all of
    the facts and circumstances. Generally, the
    corporation is required itself to perform active and
    substantial management and operational functions.
    Generally, activities performed by the corporation
    itself do not include activities performed by persons
    outside the corporation, including independent
    contractors. A corporation may satisfy the
    requirements of this subdivision (iii) through the
    activities that it performs itself, even though some of
    its activities are performed by others. * * *
    (iv) Limitations. The active conduct of
    a trade or business does not include–
    (A) The holding for investment
    purposes of stock, securities, land, or other property,
    or
    (B) The ownership and operation
    (including leasing) of real or personal property used
    in a trade or business, unless the owner performs
    significant services with respect to the operation and
    management of the property.
    Third, for purposes of section 367, the Secretary prescribed
    in section 1.367(a)-2T(b), Temporary Income Tax Regs., 51 Fed.
    Reg. 17942 (May 16, 1986), the following relevant rules as to the
    phrase’s meaning:
    (b) Active conduct of a trade or business outside
    the United States--(1) In general. Property qualifies
    for the exception provided by this section if it is
    transferred to a foreign corporation for use in the
    active conduct of a trade or business outside of the
    United States. Therefore, to determine whether
    - 36 -
    property is subject to the exception provided by this
    section, four factual determinations must be made:
    (i) What is the trade or business of the
    transferee;
    (ii) Do the activities of the transferee
    constitute the active conduct of that trade or
    business;
    (iii) Is the trade or business conducted
    outside of the United States; and
    (iv) Is the transferred property used or
    held for use in the trade or business?
    Rules concerning these four determinations are provided
    in paragraph (b)(2), (3), (4), and (5) of this section.
    (2) Trade or business. Whether the
    activities of a foreign corporation constitute a trade
    or business must be determined under all the facts and
    circumstances. In general, a trade or business is a
    specific unified group of activities that constitute
    (or could constitute) an independent economic
    enterprise carried on for profit. For example, the
    activities of a foreign selling subsidiary could
    constitute a trade or business if they could be
    independently carried on for profit, even though the
    subsidiary acts exclusively on behalf of, and has
    operations fully integrated with, its parent
    corporation. To constitute a trade or business, a
    group of activities must ordinarily include every
    operation which forms a part of, or a step in, a
    process by which an enterprise may earn income or
    profit. In this regard, one or more of such activities
    may be carried on by independent contractors under the
    direct control of the foreign corporation. (However,
    see paragraph (b)(3) of this section.) The group of
    activities must ordinarily include the collection of
    income and the payment of expenses. If the activities
    of a foreign corporation do not constitute a trade or
    business, then the exception provided by this section
    does not apply, regardless of the level of activities
    carried on by the corporation. * * *
    *    *    *    *    *    *    *
    - 37 -
    (3) Active conduct. Whether a trade or
    business is actively conducted must be determined under
    all the facts and circumstances. In general, a
    corporation actively conducts a trade or business only
    if the officers and employees of the corporation carry
    out substantial managerial and operational activities.
    A corporation may be engaged in the active conduct of a
    trade or business even though incidental activities of
    the trade or business are carried out on behalf of the
    corporation by independent contractors. In determining
    whether the officers and employees of the corporation
    carry out substantial managerial and operational
    activities, however, the activities of independent
    contractors shall be disregarded. On the other hand,
    the officers and employees of the corporation are
    considered to include the officers and employees of
    related entities who are made available to and
    supervised on a day-to-day basis by, and whose salaries
    are paid by (or reimbursed to the lending related
    entity by), the transferee foreign corporation. * * *
    The rule of this paragraph (b)(3) is illustrated by the
    following example.
    Example. X, a domestic corporation, and Y, a
    foreign corporation not related to X, transfer property
    to Z, a newly formed foreign corporation organized for
    the purpose of combining the research activities of X
    and Y. Z contracts all of its operational and research
    activities to Y for an arm’s-length fee. Z’s
    activities do not constitute the active conduct of a
    trade or business.
    (4) Outside of the United States. Whether a
    foreign corporation conducts a trade or business
    outside of the United States must be determined under
    all the facts and circumstances. Generally, the
    primary managerial and operational activities of the
    trade or business must be conducted outside the United
    States and immediately after the transfer the
    transferred assets must be located outside the United
    States. Thus, the exception provided by this section
    would not apply to the transfer of the assets of a
    domestic business to a foreign corporation if the
    domestic business continued to operate in the United
    States after the transfer. In such a case, the primary
    operational activities of the business would continue
    to be conducted in the United States. Moreover, the
    transferred assets would be located in the United
    - 38 -
    States. However, it is not necessary that every item
    of property transferred be used outside of the United
    States. As long as the primary managerial and
    operational activities of the trade or business are
    conducted outside of the United States and
    substantially all of the transferred assets are located
    outside the United States, incidental items of
    transferred property located in the United States may
    be considered to have been transferred for use in the
    active conduct of a trade or business outside of the
    United States.
    (5) Use in the trade or business. Whether
    property is used or held for use in a trade or business
    must be determined under all the facts and
    circumstances. In general, property is used or held
    for use in a foreign corporation’s trade or business if
    it is--
    (i) Held for the principal purpose of
    promoting the present conduct of the trade or business;
    (ii) Acquired and held in the ordinary
    course of the trade or business; or
    (iii) Otherwise held in a direct
    relationship to the trade or business. * * *
    As to Congress’ intent for section 936, the roots of that
    section are found in section 262 of the Revenue Act of 1921, ch.
    136, 42 Stat. 271, which exempted a U.S. corporation from Federal
    taxes on foreign-source income if it derived at least 80 percent
    of its income from sources within a U.S. possession and satisfied
    certain other requirements.   The requirements for exemption from
    tax as a possession corporation were generally carried forward
    into section 931 of the Internal Revenue Code of 1954.   Congress
    promulgated section 931 and its predecessors to encourage
    American businesses to invest in U.S. possessions.   See G.D.
    - 39 -
    Searle & Co. v. Commissioner, 
    88 T.C. 252
    , 350-351 (1987); see
    also Coca-Cola Co. & Subs. v. Commissioner, 
    106 T.C. 1
    , 21
    (1996).   American companies operating in the possessions were
    originally subjected to double taxation in the form of the
    Federal corporate income tax and the taxes of the possessions.
    See Tariff Act of 1913, ch. 16, sec. II, 38 Stat. 166; Revenue
    Act of 1918, ch. 18, 40 Stat. 1057.    Congress perceived that this
    double tax burden placed American businesses at a competitive
    disadvantage when compared with their British and French
    counterparts which were not subject to taxation upon the profits
    they earned abroad unless paid back to the home company.
    Congress enacted section 931 to remove that competitive
    disadvantage.   See H. Rept. 350, 67th Cong., 1st Sess. 1 (1921),
    1939-1 C.B. (Part 2) 168, 174.   In its original form, section 931
    allowed a corporation to exclude its possession-source income if
    it met an “80-percent source” test and a “50-percent active trade
    or business" test.   Because of the exclusion, and because
    dividends received by a domestic corporation from its wholly
    owned possessions subsidiary were not eligible for the
    intercorporate dividends received deductions under section
    246(a)(2)(B), possessions corporations amassed large amounts of
    income not repatriated to the United States.
    In the Tax Reform Act of 1976, Pub. L. 94-455, sec. 1051, 90
    Stat. 1643, Congress revised the prior law in order to provide
    - 40 -
    for a more efficient system exempting possessions corporations so
    that the possessions would not lose a significant source of
    capital.   See Coca-Cola Co. & Subs. v. Commissioner, supra at 22.
    In place of the exemption mechanism contained in section 931,
    Congress enacted section 936 to permit a U.S. corporation to
    elect a tax credit to offset the U.S. tax on its possessions
    income.    Thus, the current version of the investment incentive
    takes the form of a tax credit rather than an exemption.
    It is clear from the legislative record that Congress was
    aware of the highly favorable tax benefits afforded U.S.
    corporations operating in Puerto Rico.    It is equally clear that
    Congress intended to retain and reaffirm such tax benefits by
    enacting section 936.    The Senate Finance Committee and the House
    Ways and Means Committee stated the following, in virtually
    identical reports:
    The special exemption provided (under sec. 931) in
    conjunction with investment incentive programs
    established by possessions of the United States,
    especially the Commonwealth of Puerto Rico, have been
    used as an inducement to U.S. corporate investment in
    active trades and businesses in Puerto Rico and the
    possessions. Under these investment programs little or
    no tax is paid to the possessions for a period as long
    as 10 to 15 years and no tax is paid to the United
    States as long as no dividends are paid to the parent
    corporation.
    Because no current U.S. tax is imposed on the
    earnings if they are not repatriated, the amount of
    income which accumulates over the years from these
    business activities can be substantial. The amounts
    which may be allowed to accumulate are often beyond
    what can be profitably invested within the possession
    - 41 -
    where the business is conducted. As a result,
    corporations generally invest this income in other
    possessions or in foreign countries either directly or
    through possessions banks or other financial
    institutions. In this way possessions corporations not
    only avoid U.S. tax on their earnings from businesses
    conducted in a possession, but also avoid U.S. tax on
    the income obtained from reinvesting their business
    earnings abroad.
    The committee after studying the problem concluded
    that it is inappropriate to disturb the existing
    relationship between the possessions investment
    incentives and the U.S. tax laws because of the
    important role it is believed they play in keeping
    investment in the possessions competitive with
    investment in neighboring countries. The U.S.
    Government imposes upon the possessions various
    requirements, such as minimum wage requirements and
    requirements to use U.S. flagships in transporting
    goods between the United States and various
    possessions, which substantially increase the labor,
    transportation and other costs of establishing business
    operations in Puerto Rico. Thus, without significant
    local tax incentives that are not nullified by U.S.
    taxes, the possessions would find it quite difficult to
    attract investments by U.S. corporations.
    However, investing the business earnings of these
    possession corporations outside of the possession where
    the business is being conducted does not contribute
    significantly to the economy of that possession either
    by creating new jobs or by providing capital to others
    to build new plants and equipment. Accordingly, while
    the committee believes it is appropriate to continue to
    exempt trade or business income derived in a possession
    and investment income earned in that possession, your
    committee does not believe it is appropriate to provide
    a tax exemption for income from investments outside of
    the possession.
    In addition, the committee recognizes that the
    provision of present law denying a dividends received
    deduction to the U.S. parent corporation forces a
    possessions corporation to invest its income abroad
    until the possessions corporation is liquidated
    (usually upon the termination of the local tax
    exemption) when it can be returned to the United States
    - 42 -
    tax free. These accumulated business profits are not
    available for investment within the United States, and
    the income produced is (under present law) not subject
    to U.S. tax. The committee believes that while it is
    appropriate to tax the foreign source investment income
    from possession business earnings, possessions
    corporations should at the same time be given the
    alternative of returning the business income to the
    United States prior to liquidation without paying U.S.
    tax. Permitting tax-free repatriation of the
    accumulated earnings only upon the liquidation of the
    possessions corporation, while taxing the foreign
    source investment derived from the accumulated
    earnings, would lessen to a significant extent the tax
    incentive of making the initial investment.
    To accomplish these two major changes, the
    committee’s amendment revises present law to provide
    for a more efficient system for exemption of
    possessions corporations. Under the amendment, these
    corporations are generally to be taxed on worldwide
    income in a manner similar to that applicable to any
    other U.S. corporation, but a full 48 percent foreign
    tax credit is to be given for the business and
    qualified investment income from possessions regardless
    of whether or not any tax is in fact paid to the
    government of the possession. The effect of this
    revised treatment will be to exempt from tax the income
    from business activities and qualified investments in
    the possessions, to allow a dividends received
    deduction for dividends from a possessions corporation
    to its U.S. parent corporation, and to tax currently
    all other foreign source income of possessions
    corporations (with allowance for the usual foreign tax
    credit). The committee believes that this revised
    treatment will assist the U.S. possessions in obtaining
    employment-producing investments by U.S. corporations,
    while at the same time encouraging those corporations
    to bring back to the United States the earnings from
    these investments to the extent they cannot be
    reinvested productively in the possession. [S. Rept.
    94-938, at 277-278 (1976), 1976-3 C.B. (Vol. 3) 57,
    315-316; fn. refs. omitted.]
    See also H. Rept. 94-658, at 254-255 (1975), 1976-3 C.B. (Vol. 2)
    945, 946-947.
    - 43 -
    On the basis of our understanding of the legislative record,
    we believe that Congress promulgated the “active conduct of a
    trade or business” requirement of section 936(a) intending to
    prevent a domestic corporate taxpayer from availing itself of the
    possessions tax credit unless it established and regularly
    operated an employment-producing, profit-motivated business
    activity in a U.S. possession.   We also believe that Congress
    expected the taxpayer to participate meaningfully in the
    management and operation of that activity and to invest
    significantly in that activity, the expected result of which
    would be to strengthen the economy of the possession where the
    activity was located.   In light of Congress’ intent for section
    936, the Secretary’s interpretations of the subject phrase for
    purposes of other sections of the Code, and the Supreme Court’s
    interpretation of the phrase “trade or business” in section
    162(a), we believe that, for purposes of section 936(a), a
    taxpayer actively conducts a trade or business in a U.S.
    possession only if it participates regularly, continually,
    extensively, and actively in the management and operation of its
    profit-motivated activity in that possession.   Cf. Commissioner
    v. Groetzinger, 480 U.S. at 26; Higgins v. Commissioner, 312 U.S.
    at 217; Stanton v. Commissioner, 
    399 F.2d 326
    , 329-330 (5th Cir.
    1968), affg. T.C. Memo. 1967-137.   We also believe that, for the
    purpose of this participation requirement, the services
    - 44 -
    underlying a manufacturing contract may be imputed to a taxpayer
    only to the extent that the performance of those services is
    adequately supervised by the taxpayer’s own employees.
    We ask ourselves in this case whether MedChem P.R.
    participated regularly, continually, extensively, and actively in
    the management and operation of Avitene’s manufacturing in Puerto
    Rico throughout the requisite 3-year period.   Under the facts at
    hand, we must answer that question in the negative.    Indeed, we
    are not even able to find that MedChem P.R. had any meaningful
    business activity in Puerto Rico during that period.   MedChem
    P.R.’s investment in the economy of Puerto Rico during that
    period was almost nonexistent in the sense that it placed in that
    possession only one employee and established in that possession
    only a one-room office.   Moreover, MedChem P.R. abandoned the
    office and terminated the employee on June 30, 1990.   Although
    MedChem P.R.’s decision to have Avitene manufactured in Puerto
    Rico did result in the use of some of that possession’s work
    force, and thus ostensibly harmonize with Congress’ intent for
    the possessions tax credit to produce employment in that
    possession, we are unable to find that more than a few if any of
    the individuals who worked in Puerto Rico on Avitene-related
    matters were hired as a result of the Avitene contract.    All the
    same, we do not believe that the creation of jobs in Puerto Rico
    - 45 -
    is the sole criterion that a taxpayer must meet in order to be
    entitled to the possession tax credit.
    Petitioners observe correctly that MedChem P.R. was involved
    with the Puerto Rico-based manufacturing business of Avitene by
    virtue of the fact that it supplied the raw materials and
    equipment necessary to manufacture the drug.     Such minimal
    association with a trade or business, however, does not
    constitute the active conduct of a trade or business in Puerto
    Rico for purposes of section 936(a).     The mere fact that a
    taxpayer owns property used in a trade or business is simply not
    enough to characterize the taxpayer as an active conductor of
    that trade or business.   The taxpayer in such a situation does
    not meet the requirement as to a regular, continual, extensive,
    and active participant in the management and operation of the
    profit-motivated activity.   Nor, in fact, does such a taxpayer
    subject itself to many of the economic risks and benefits of
    business in general.
    Here, MedChem P.R. lacked any operational or directional
    control over the Avitene business.     All of the business
    activities connected to Avitene were directed and controlled by
    Alcon P.R., out of its Puerto Rico-based operation, and by
    MedChem U.S.A., out of its Woburn-based facility.     In fact,
    petitioners’ involvement in Puerto Rico during the 3-year period
    failed even to qualify as a trade or business in Puerto Rico,
    - 46 -
    given that petitioners’ involvement in that possession focused
    mainly on the Woburn-based efforts of MedChem U.S.A.’s personnel
    to understand the Avitene manufacturing process and, after June
    30, 1990, to move that process from Alcon P.R.’s facility in
    Puerto Rico to MedChem U.S.A.’s facility in Woburn.    Whereas
    petitioners initially planned to establish a manufacturing
    facility in Puerto Rico during the relevant years and, to that
    end, hired Mr. Perez, opened an office in Humacao, and purchased
    land in Juncos, their plans changed in 1990.    In 1990,
    petitioners scuttled their efforts to establish a facility in
    Puerto Rico, wrote off the proposed facility’s capitalized costs,
    closed the Humacao office, terminated Mr. Perez, and began moving
    the Avitene manufacturing process into MedChem U.S.A.’s idled
    Amvisc facility in Woburn.   Petitioners also caused Alcon P.R. to
    move into that facility all of the equipment in Puerto Rico that
    had been and was required to be used to perform the work in phase
    1 of the Avitene manufacturing process.
    Petitioners assert that all of MedChem P.R.’s income was
    attributable to its sale in Puerto Rico of Avitene that was
    manufactured in that possession and that MedChem P.R. had a
    significant business presence in Puerto Rico.    We disagree.14
    14
    We distinguish Frank v. International Canadian Corp., 
    308 F.2d 520
     (9th Cir. 1962), a case cited by petitioners to support
    their assertion that MedChem P.R. actively conducted a trade or
    business by virtue of its sales activity. The relevant holding
    (continued...)
    - 47 -
    For purposes of section 936(a), MedChem P.R.’s “ business
    presence” in Puerto Rico was insignificant in that it did not
    contribute significantly to Puerto Rico’s economy either by
    creating new jobs or by providing capital to others to build new
    plants and equipment.    See S. Rept. 94-938, supra at 277-278,
    1976-3 C.B. (Vol. 3) at 315-316; see also H. Rept. 94-658, supra,
    1976-3 C.B. (Vol. 2) at 946-947.    All of MedChem P.R.’s business
    activities after June 30, 1990, were based in Woburn, and
    petitioners’ primary connection to Puerto Rico during that time
    was to further its efforts to move the manufacturing of Avitene
    to Woburn, where the nonmanufacturing, Avitene-related business
    and ancillary activities (e.g., financial oversight, sales, and
    product development) were performed by MedChem U.S.A. employees.
    Petitioners rely on the fact that title to the non-Japanese-
    market Avitene passed from MedChem P.R. to MedChem U.S.A. in
    Puerto Rico.    We do not believe that this fact, standing alone,
    leads to petitioners’ proffered conclusion that MedChem P.R.
    actively conducted a trade or business in Puerto Rico throughout
    the 3-year period.    Indeed, the facts of this case leads us to a
    contrary conclusion.15    Avitene was manufactured in Puerto Rico
    14
    (...continued)
    in Frank concerned whether the taxpayer actively conducted a
    trade or business and did not concern where that trade or
    business was located.
    15
    Petitioners rely in part on their assertion in brief that
    (continued...)
    - 48 -
    at the Alcon P.R. facility, and Alcon P.R.’s employees performed
    every task required in the manufacturing process, including the
    supervision thereof.    Alcon P.R.’s employees performed those jobs
    without the right or ability of either petitioner to manage,
    direct, or control any part of the manufacturing process.     Alcon
    P.R. employees also performed Avitene’s quality assurance
    function, including the retention of Avitene’s master
    documentation and manufacturing records.16   MedChem U.S.A.’s
    employees distributed, marketed, and sold Avitene from Woburn,
    and they did so without any interaction or involvement by MedChem
    P.R.    MedChem U.S.A.’s employees worked out of Woburn improving
    Avitene and developing new forms of Avitene.   MedChem U.S.A.’s
    Woburn-based personnel maintained for petitioners the books and
    records as to Avitene and received, reviewed, and processed
    payment on any Avitene-related invoice received by petitioners.
    MedChem U.S.A.’s personnel provided Alcon P.R. and the
    planner/buyers with manufacturing schedules prepared in Woburn;
    15
    (...continued)
    the parties have stipulated that “100 percent of MedChem P.R.’s
    income was derived from its sales in Puerto Rico of Avitene that
    was manufactured in Puerto Rico”. Actually, the stipulation
    reads that “100 percent of MedChem P.R.’s reported income came
    from the sale of Avitene that was manufactured in Puerto Rico.”
    The stipulation does not say that MedChem P.R. sold the Avitene
    in Puerto Rico.
    16
    Although MedChem U.S.A. occasionally performed limited
    quality assurance tests on finished Avitene, MedChem P.R.
    performed no quality testing at all.
    - 49 -
    the planner/buyers, who were employed at the Alcon P.R. facility
    by Kelly or Alcon P.R., made sure that Alcon P.R.’s personnel had
    the materials necessary to manufacture Avitene.   MedChem U.S.A.
    owned all of the intangible assets used to manufacture Avitene
    and, throughout the 3-year period, guaranteed to the Alcon
    Entities that it would pay all debts and perform all obligations
    of MedChem P.R. arising from the asset purchase and related
    agreements.
    Petitioners list in their brief 23 activities which, they
    assert, demonstrate that MedChem P.R. actively conducted a trade
    or business in Puerto Rico during the requisite 3-year period.
    We disagree with this assertion.   Some of the activities listed
    by petitioners preceded the 3-year period, and very few of the
    other listed activities occurred continually throughout that
    period.   The isolated activities which did occur during the
    period do not support petitioners’ conclusion that MedChem P.R.
    continued to conduct actively a trade or business in Puerto Rico.
    The mere fact that MedChem P.R. owned the necessary raw materials
    and manufacturing equipment and hired Alcon P.R. to use those
    materials and equipment to manufacture Avitene in Puerto Rico is
    not enough under the facts herein to conclude that MedChem P.R.
    actively conducted a trade or business in Puerto Rico throughout
    - 50 -
    the 3-year period.17   While it is true that petitioners continued
    to use the trade or business of Alcon P.R. to manufacture Avitene
    after June 30, 1990, while MedChem U.S.A. established an Avitene
    manufacturing facility in Woburn, the use of Alcon P.R.’s
    business was not MedChem P.R.’s trade or business.   In fact,
    petitioners have consistently reported in all but one instance
    that Alcon P.R. was Avitene’s manufacturer.   That one instance is
    here where, solely for the purpose of Federal income tax,
    petitioners invite the Court to hold that MedChem P.R. was in
    fact Avitene’s manufacturer.   We decline that invitation.
    Petitioners argue that MedChem P.R. had employees who
    performed Avitene-related services in Puerto Rico during the 3-
    year period.   Petitioners assert that MedChem P.R. paid for the
    Avitene-related services of these individuals and that the
    individuals represented the interests of MedChem P.R. while
    working on Avitene matters.    Petitioners assert that MedChem P.R.
    directed and controlled the Avitene-related work of these
    individuals and that no non-MedChem P.R. employee or entity had
    the ability to direct or control that work.   Petitioners
    generally identify these individuals as the MedChem P.R. officers
    17
    Contrary to petitioners’ request, we do not find that
    MedChem P.R. employees purchased those raw materials or monitored
    the production of Avitene or any of the inventory. As discussed
    herein, employees of either Alcon P.R. or MedChem U.S.A.
    generally performed all of the services connected to Avitene
    during the 3-year period.
    - 51 -
    and/or directors, the Kelly employees, certain MedChem U.S.A.
    employees, and a certain Alcon P.R. employee; petitioners assert
    that individuals in the latter two categories worked concurrently
    as employees of MedChem P.R. and either MedChem U.S.A. or Alcon
    P.R.    Petitioners specifically identify these individuals as:
    (1) Mr. Perez and his staff from September 1, 1989, through June
    30, 1990, (2) Messrs. Castro and Rivera from July 1990 through
    March 1991 and from April through August 1992, (3) Messrs. Castro
    and Velez from April 1991 through April 1992, (4) MedChem P.R.
    officers and/or directors Donaldson, Geffken, Moran, Sullivan,
    and Swann, (5) MedChem U.S.A. employees Acosta, Falvey, Ferdman,
    Micale, McDonough, Rudolph, Severance, Shepherd, Stevens, and
    Tanny, and (6) various unnamed engineers.
    We do not find that any of the listed individuals were
    MedChem P.R. employees.    The presence of an employer-employee
    relationship is a factual determination that rests on the
    principles of common law.    See, e.g., Nationwide Mut. Ins. Co. v.
    Darden, 
    503 U.S. 318
    , 322-324 (1992); Matthews v. Commissioner,
    
    92 T.C. 351
    , 360 (1989), affd. 
    907 F.2d 1173
     (D.C. Cir. 1990);
    Professional & Executive Leasing, Inc. v. Commissioner, 
    89 T.C. 225
    , 232 (1987), affd. 
    862 F.2d 751
     (9th Cir. 1988); Simpson v.
    Commissioner, 
    64 T.C. 974
    , 984-985 (1975); see also sec.
    3121(d)(2).    Factors commonly considered by courts in determining
    such a relationship are the:    (1) Right to control the details of
    - 52 -
    the work, (2) furnishing of the tools and the work place, (3)
    withholding of taxes, workers’ compensation, and unemployment
    insurance funds, (4) right to discharge, and (5) permanency of
    the relationship.   See Professional & Executive Leasing, Inc. v.
    Commissioner, 862 F.2d at 753 (citing United States v. Silk, 
    331 U.S. 704
    , 714-716 (1947); Simpson v. Commissioner, supra at
    984-985).   Although each factor is important, the test that is
    usually considered fundamental is set out in the regulations.
    Section 31.3401(c)-1(b), Employment Tax Regs., which generally
    sets forth rules as to an employer’s obligation to withhold
    Federal income taxes on the payment of wages, provides:
    Generally the relationship of employer and employee
    exists when the person for whom services are performed
    has the right to control and direct the individual who
    performs the services, not only as to the result to be
    accomplished by the work but also as to the details and
    means by which that result is accomplished. That is,
    an employee is subject to the will and control of the
    employer not only as to what shall be done but how it
    shall be done. In this connection, it is not necessary
    that the employer actually direct or control the manner
    in which the services are performed; it is sufficient
    if he has the right to do so. * * * In general, if an
    individual is subject to the control or direction of
    another merely as to the result to be accomplished by
    the work and not as to the means and methods for
    accomplishing the result, he is not an employee.
    See also secs. 31.3121(d)-1(c)(1) and 31.3306(i)-1(b), Employment
    Tax Regs., providing language virtually identical to sec.
    31.3401(c)-1(b), Employment Tax Regs., in the case of the Federal
    Insurance Contributions Act and the Federal Unemployment Tax Act,
    respectively.
    - 53 -
    Here, we find nothing in the record to persuade us that
    MedChem P.R. had the right to direct or control any of the
    purported MedChem P.R. employees in their performance of Avitene-
    related services.   Although petitioners invite us to find that
    MedChem P.R. directed and controlled the Avitene-related work of
    these individuals by virtue of the fact that they interacted with
    one or more individuals who served concurrently as an officer
    and/or director of MedChem P.R. and MedChem U.S.A., the record
    indicates to the contrary.   All of the individuals who worked on
    an Avitene matter were directed and controlled by either Alcon
    P.R. or MedChem U.S.A.   In fact, MedChem P.R. was expressly
    prohibited by the processing agreement from taking a managerial
    role in the manufacturing process.     Moreover, MedChem P.R. never
    even directed or controlled any of its officers, except possibly
    Mr. Perez up until July 1, 1990.   We also believe it most telling
    that MedChem P.R. did not hold any of these individuals out or
    report them as employees until the commencement of this
    litigation, that each of these individuals was hired and directly
    paid by MedChem U.S.A. or Alcon P.R., that MedChem P.R. never
    paid employment taxes as to these individuals, that MedChem P.R.
    never provided these individuals with workers’ compensation
    insurance or employee benefits, and that all of these individuals
    worked at the Alcon P.R. and MedChem U.S.A. facilities.
    - 54 -
    We conclude and hold that MedChem P.R. does not meet the
    “active conduct of a trade or business within a possession”
    requirement of section 936(a)(2)(B).   In so holding, we note that
    petitioners rely erroneously on Suzy’s Zoo v. Commissioner, 
    114 T.C. 1
     (2000), for a contrary holding.   There, the taxpayer was a
    corporation that sold greeting cards and other paper products
    bearing copies of one or more of the taxpayer’s cartoon
    characters.   The taxpayer’s employees developed the characters,
    and the taxpayer transferred the characters to printing companies
    to print the paper products in accordance with the taxpayer’s
    specifications.   The printers used their own ink and paperstock,
    and they held title to and bore the risk of loss of the supplies
    and printed goods until the goods were sent back to the taxpayer
    for its acceptance or rejection.   The printers could not sell any
    images of the characters, and they could not sell any of the
    taxpayer’s paper products.   The taxpayer argued that, for
    purposes of section 263A, the printers produced the finished
    goods, and it resold them.   We disagreed.   We held that the
    taxpayer was the producer of the finished goods.    We noted that
    the printing of the characters onto the paper products was
    ministerial and that the critical step in the manufacturing of
    the finished good was the drawing of the characters.    In contrast
    with the situation there, where the thrust of the work as to the
    finished product was performed by the taxpayer, the thrust of the
    - 55 -
    work here as to the manufacturing of Avitene was performed by
    Alcon P.R.   The Avitene manufacturing process was not ministerial
    but required specialized skill and expertise, unlike the
    reproduction process in Suzy’s Zoo.
    We have rejected all arguments not discussed herein as
    without merit or irrelevant.   To reflect the foregoing,
    Decisions will be entered
    under Rule 155.
    - 56 -
    APPENDIX A
    Pre-Sec. 936(a)(2)(B) Test Period (1987 to Aug. 31, 1989)
    Dec. 18, 1987       Petitioners buy the Avitene business from
    Alcon P.R., and Alcon P.R. agrees to (and
    ultimately does) manufacture Avitene for
    MedChem P.R. for the 3-year period ended Dec.
    31, 1990.
    Feb. 29, 1988       MedChem P.R. hires Mr. Perez and establishes
    a one-room office in Humacao.
    June 21, 1989       MedChem P.R. purchases land for the
    construction of an Avitene manufacturing
    facility in Puerto Rico.
    Sec. 936(a)(2)(B) Test Period (Sept. 1, 1989, to Aug. 31, 1992)
    Feb. 2, 1990        District Court issues preliminary injunction
    as to MedChem U.S.A.’s manufacture and sale
    of Amvisc. MedChem P.R. writes off
    capitalized expenses relating to its proposed
    facility in Puerto Rico. Unipro notified to
    stop work on that facility.
    Feb. 28, 1990       MedChem U.S.A. initiates plans to locate an
    Avitene manufacturing facility into its idled
    Amvisc facility in Woburn during the fall of
    1990.
    June 30, 1990       Petitioners move their bulk flour
    manufacturing equipment from Humacao to
    Woburn. Mr. Perez terminated, Humacao office
    closed, and records shipped to Woburn. Kelly
    hires Mr. Castro to replace Mr. Perez as
    Avitene planner/buyer.
    July 1, 1990        MedChem U.S.A. personnel in Woburn write all
    MedChem P.R. checks and mail those checks to
    the payees. MedChem U.S.A.’s personnel in
    Woburn approve and pay from MedChem P.R. bank
    account all invoices delivered to MedChem
    P.R.
    - 57 -
    December 1990       Petitioners move their bulk nonwoven web
    manufacturing equipment from Humacao to
    Woburn.
    March 1991          Mr. Castro becomes Alcon P.R. employee with
    non-Avitene duties, and Alcon P.R. assigns
    Mr. Velez to perform Mr. Castro’s former
    duties.
    April 1992          Kelly hires Mr. Rivera to replace Mr. Velez
    as Avitene planner/buyer.
    August 1992         FDA audits the Avitene manufacturing process
    and deals almost exclusively with Alcon P.R.
    personnel.
    Post-Sec. 936(a)(2)(B) Period (Aug. 31, 1992, to Apr. 1994)
    October 1992        MedChem U.S.A. starts manufacturing Avitene
    in Woburn.
    July 1993           MedChem U.S.A. begins constructing a new
    Avitene finished goods manufacturing facility
    in Woburn.
    April 1994          MedChem U.S.A. substantially completes the
    construction of that facility.
    - 58 -
    APPENDIX B
    PROCESSING AGREEMENT
    PROCESSING AGREEMENT dated as of December 18, 1987
    by and between MEDCHEM PUERTO RICO, INC. (“MedChem
    [P.R.]”), a Delaware corporation, and ALCON (PUERTO
    RICO) INC. (“Alcon [P.R.]”), a Delaware corporation.
    In consideration of the mutual covenants and
    agreements contained in this Agreement, MedChem [P.R.]
    and Alcon [P.R.] covenant and agree as follows:
    1. Definitions. As used in this Agreement, the
    following terms have the meanings set forth below:
    1.1 Acceptance Tests -- chemical, physical
    and performance tests conducted in accordance with the
    analytical procedures described in * * * [a referenced
    schedule], to be applied to Avitene in order to
    determine whether Avitene conforms to the Product
    Specifications.
    *    *    *     *    *      *   *
    1.4 Conversion Process -- the manufacturing
    process by which raw materials are converted into the
    finished Avitene product.
    *    *    *     *    *      *   *
    1.6 Delivery -- the delivery by Alcon [P.R.]
    of Avitene processed under this Agreement.
    1.7 Equipment –- the machinery and equipment
    owned by MedChem [P.R.] and required for the processing
    of Avitene.
    1.8 Humacao Plant – Alcon[ P.R.]’s Avitene
    processing facility in Humacao, Puerto Rico.
    *    *    *     *    *      *   *
    1.10 Order –- a writing from MedChem [P.R.]
    authorizing or directing Alcon [P.R.] to process and
    Deliver Avitene.
    - 59 -
    1.11 Product Specifications -– the
    specifications for Avitene set forth * * * [in a
    referenced schedule].
    1.12 Proprietary Information -- all patents,
    trademarks, trade secrets, copyrights, inventions,
    designs, logos, and any other proprietary rights owned
    by MedChem [P.R.] which relate to the production and
    processing of Avitene.
    1.13 Processing Fee and Option C Processing
    Fee –- the fees paid by MedChem [P.R.] to Alcon [P.R.]
    for each Order filled by Alcon [P.R.] pursuant to
    Section 9.
    *    *    *    *    *    *    *
    2.   Processing.
    2.1 In General. Subject to the provisions
    of Section 5, and in return for a Processing Fee as
    defined in Section 9, Alcon [P.R.] agrees to process
    from raw materials owned and supplied by MedChem [P.R.]
    all of MedChem[ P.R.]’s requirements of Avitene for
    sale by MedChem [P.R.] to third parties. The raw
    materials used in the Conversion Process as well as the
    finished Avitene Product will remain the sole property
    of MedChem [P.R.] throughout Alcon[ P.R.]’s physical
    possession thereof. Alcon [P.R.] agrees to commit its
    Humacao Plant for the processing of Avitene to satisfy
    MedChem[ P.R.]’s requirements, subject to the
    provisions of Section 5. In the event that MedChem[
    P.R.]’s requirements of Avitene ever exceed the
    capacity of the Humacao Plant as of the date hereof,
    MedChem [P.R.] shall, at its expense, obtain such
    additional Equipment as is necessary to increase
    production capacity at the Humacao Plant, or shall use
    reasonable efforts to obtain access elsewhere to
    additional production capacity in order to meet the
    requirements that the Humacao Plant is unable to
    satisfy.
    2.2 Specifications. Alcon [P.R.] agrees to
    process Avitene in accordance with the Product
    Specifications and Good Manufacturing Practices as
    defined by applicable laws and regulations * * *.
    - 60 -
    2.3 Processing Method. To assist Alcon
    [P.R.] in satisfying its obligations under this
    Agreement, MedChem [P.R.] shall grant to Alcon [P.R.]
    pursuant to the terms of Section 4 the right to use the
    Equipment, without charge therefor. Alcon [P.R.] shall
    furnish all labor, variable and fixed overhead and
    quality assurance required for the processing of
    Avitene hereunder. MedChem [P.R.] will employ a plant
    manager and other appropriate personnel who will
    inspect, advise and make corrections when appropriate
    with respect to the Conversion Process; however,
    MedChem [P.R.] employees will not participate in the
    Alcon [P.R.] management process. Alcon [P.R.] shall be
    responsible for all maintenance of the Equipment used
    in the Conversion Process and for the compliance of
    such Equipment with applicable regulations of
    governmental agencies, including but not limited to
    regulations promulgated by the U.S. Food and Drug
    Administration and the Environmental Protection Agency;
    the cost of such maintenance and compliance shall be
    borne initially by Alcon [P.R.] but shall be included
    in the Processing Cost (as such term is defined in
    Section 9). Alcon [P.R.] shall also be responsible for
    required validation studies on devices, formulae or
    processes used in the Conversion Process. In the event
    that Alcon [P.R.] is required by a regulatory authority
    to perform additional validation studies for purposes
    of validating new devices, new manufacturing procedures
    and/or new raw material and finished product assay
    procedures in order to continue lawfully to engage in
    the processing of Avitene for MedChem [P.R.] (and
    MedChem [P.R.], after notice from Alcon that such
    additional validation studies are required, directs
    Alcon [P.R.] to continue such processing), all expenses
    borne by Alcon [P.R.] in the conduct of any such
    validation studies shall be paid by Alcon [P.R.] and
    shall be included in the Processing Cost. To the
    extent that MedChem [P.R.] makes direct expenditures
    (not described in the preceding sentence) with regard
    to (a) the purchase of machinery or equipment, (b) the
    compliance of existing machinery or equipment with all
    applicable laws and regulations or (c) the performance
    of validation studies or any matter relating to the
    Conversion Process, such expenditures shall not be
    included in the Processing Cost.
    - 61 -
    3.   License.
    3.1 Grant. MedChem [P.R.] shall grant to
    Alcon [P.R.] a royalty-free nonexclusive,
    nontransferable license to use the Proprietary
    Information solely in connection with the processing of
    Avitene for MedChem [P.R.] pursuant to this Agreement.
    3.2 Ownership. Title to, and ownership of,
    the Proprietary Information shall at all times remain
    solely and exclusively with MedChem [P.R.], and Alcon
    [P.R.] shall not take any action inconsistent with such
    title and ownership.
    3.3 Protection. Alcon [P.R.] hereby
    covenants to hold such Proprietary Information in
    confidence. Alcon [P.R.] shall not, without the prior
    written consent of MedChem [P.R.], disclose or
    otherwise make available such Proprietary Information
    in any form to any person, except to Alcon[ P.R.]’s
    employees. * * *
    3.4 Equitable Relief; Indemnification.
    Since an unauthorized use or transfer of the
    Proprietary Information will substantially diminish the
    value to MedChem [P.R.] of its rights with respect
    thereto, if Alcon [P.R.] breaches any of its
    obligations under this Section 3, MedChem [P.R.] shall
    (without limiting its other rights or remedies) be
    entitled to equitable relief (including but not limited
    to injunctive relief) to protect its interests. Alcon
    [P.R.] shall indemnify and hold MedChem [P.R.] harmless
    for any losses or damages which MedChem [P.R.] may
    suffer as a result of any unauthorized use, transfer or
    disclosure of the Proprietary Information caused by the
    acts or omission of Alcon [P.R.].
    4. Machinery and Equipment. For the duration of
    this Agreement, MedChem [P.R.] shall grant to Alcon
    [P.R.] the right to use, free of charge, all Equipment
    owned by MedChem [P.R.] and required in the Conversion
    Process, provided that Alcon [P.R.] shall use such
    Equipment solely for the purpose of processing Avitene
    pursuant to this Agreement. Title to and ownership of
    the Equipment shall remain at all times solely and
    exclusively with MedChem [P.R.]. Alcon[ P.R.]’s rights
    with respect to the use of the Equipment shall be
    nontransferable. Alcon [P.R.] shall take reasonable
    - 62 -
    precautions to preserve the physical condition of the
    Equipment, and upon the termination of this Agreement
    pursuant to Section 12, shall return the Equipment to
    MedChem [P.R.] in good working order and in the same
    condition (taking into account normal wear and tear) as
    it was initially provided to Alcon [P.R.]. In the
    event of any damage to the Equipment covered by
    insurance maintained by MedChem [P.R.], MedChem [P.R.]
    shall be obligated to apply any proceeds received in
    respect of such insurance, and Alcon [P.R.] shall be
    relieved from liability to the extent of such proceeds.
    5.   Ordering Procedure.
    5.1 Initial Annual Forecast. MedChem [P.R.]
    shall be responsible for directing the quantity and
    types of Avitene processed by Alcon [P.R.]. In that
    regard, MedChem [P.R.] shall, within 60 days of the
    date of this Agreement, deliver to Alcon [P.R.] an
    annual forecast (the “Initial Forecast Amount”) of
    MedChem[ P.R.]’s projected requirements for each
    Avitene product for each calendar quarter or fraction
    thereof during the period commencing on the date of
    this Agreement and ending on December 31, 1988. * * *
    5.2 Subsequent Annual Forecast. No later
    than August 15, 1988 and 1989, MedChem [P.R.] shall
    submit to Alcon [P.R.] its preliminary annual forecast
    of its quarterly requirements of Avitene for the next
    calendar year (the “Current Annual Forecast Amount”).
    Such preliminary annual forecast shall be updated on
    November 30, 1988 and 1989.
    5.3 Annual Commitment. MedChem [P.R.] shall
    order at least 80% of the Initial Forecast Amount or
    the Current Annual Forecast Amount and Alcon [P.R.]
    shall be required to process up to 250% of the Initial
    Forecast Amount or the Current Annual Forecast Amount.
    In this regard, Alcon [P.R.] shall be given a
    reasonable amount of time to meet any increases over
    the Initial Forecast Amount. Alcon [P.R.] agrees, upon
    reasonable notice, to act in good faith to meet any
    such increases. In addition, in connection with
    MedChem[ P.R.]’s efforts to establish the MedChem
    [P.R.] Plant pursuant to Section 13, Alcon [P.R.]
    agrees, upon reasonable notice to use good faith
    efforts to process such reasonable amounts in excess of
    250% of the Current Annual Forecast Amount during the
    - 63 -
    ninety (90) day period prior to the effective
    termination of this Agreement so that MedChem [P.R.]
    may maintain sufficient inventory to continue normal
    sales activity while it commences operation at the
    MedChem [P.R.] Plant. * * *
    5.4 Orders and Quarterly Updates. Within a
    reasonable time after the date of this Agreement, and
    at least 15 days prior to January 1, April 1, July 1
    and October 1 of each year thereafter, MedChem [P.R.]
    shall furnish to Alcon [P.R.] (i) a binding order for
    Avitene to be processed and Delivered by Alcon [P.R.]
    on a date of Delivery specified by MedChem [P.R.],
    which will allow Alcon [P.R.] at least 30 days from the
    date of receipt of such Order before such Delivery is
    required, and (ii) a forecast of MedChem[ P.R.]’s
    projected requirements of Avitene for the three
    calendar months following the calendar quarter covered
    by the relevant Order * * *. Alcon [P.R.] shall
    Deliver the specified quantity and type of Avitene
    within not more than seven days after the Delivery date
    specified in the Order. It is understood and agreed
    that in the event Alcon [P.R.] is unable or unwilling
    through no fault of MedChem [P.R.] to process Avitene
    ordered by MedChem [P.R.] in the amount forecast and/or
    ordered, MedChem [P.R.] is free, without thereby
    restricting any rights or remedies it may have against
    Alcon [P.R.] as a result of such nonperformance
    hereunder, to seek the contract services of third
    parties to process the incremental quantities which
    Alcon [P.R.] is unable or unwilling to provide.
    5.5. Invoices. Alcon [P.R.] shall submit to
    MedChem [P.R.] an invoice as soon as practicable after
    delivery of Avitene to MedChem [P.R.]. Such invoice
    shall specify the amount and type of Avitene Delivered
    pursuant to the relevant Order, the date of shipment,
    and the Processing Cost, and a calculation of the
    Processing Fee allocable to the Order.
    *     *    *    *    *    *   *
    6.   Packaging and Labeling.
    6.1 Design of Package. MedChem [P.R.] shall
    be responsible for preparing and providing to Alcon
    [P.R.] labeling copy and/or artwork, as appropriate,
    for Avitene, and MedChem [P.R.] hereby warrants that
    - 64 -
    such labeling shall be, in content, in compliance with
    all applicable governmental regulations. In
    determining the labeling for Avitene, MedChem [P.R.]
    shall have the right to use its corporate and/or trade
    name(s) and its own trademark(s), and to determine the
    general design and appearance of such labeling.
    6.2 Packaging. Utilizing the labeling copy
    and/or artwork provided by MedChem [P.R.], Alcon [P.R.]
    shall be responsible initially for producing finished
    labeling and/or materials, and attaching or
    accompanying such labeling to or with Avitene. MedChem
    [P.R.] shall have the option of changing the labeling
    copy and/or artwork for Avitene packaging at any time,
    upon 90 days prior written notice to Alcon [P.R.].
    MedChem [P.R.] shall further have the option of
    assuming responsibility at any time for producing the
    finished labeling and packaging materials and
    delivering such materials to Alcon [P.R.] for
    association with Avitene, provided that Alcon [P.R.]
    has received 90 days prior written notice of such a
    change.
    7.   Delivery; Storage.
    7.1 Delivery. Alcon [P.R.] shall ship
    Avitene ordered by MedChem [P.R.] to such
    destination(s) as MedChem [P.R.] shall designate in its
    Order. All Deliveries of Avitene under this Agreement
    shall be F.O.B. common carrier designated by MedChem
    [P.R.]. Any potential liability for loss or damage
    that Alcon [P.R.] may maintain by reason of its
    physical possession throughout the Conversion Process
    of the raw materials and finished Avitene owned by
    MedChem [P.R.] shall cease upon Delivery of such
    Avitene to a common carrier. MedChem [P.R.] shall be
    responsible for (i) the payment of all transportation
    charges, taxes, and other charges incident to the
    storage and movement of Avitene in commerce subsequent
    to such transfer of the risk of loss to MedChem [P.R.],
    and (ii) the cost of all insurance relating to the
    Equipment, raw materials, inventory and the processing
    and storage of such Avitene, and such costs and charges
    shall not be included in the calculation of the
    Processing Costs.
    7.2   Storage; Related Documentation. At
    MedChem[ P.R.]’s request and for so long as this
    - 65 -
    Agreement is in effect, Alcon [P.R.] shall make
    available to MedChem [P.R.] adequate warehouse space at
    the Humacao Plant for the storage of Avitene processed
    pursuant to this Agreement or purchased by MedChem
    [P.R.] pursuant to the Asset Purchase Agreement.
    MedChem [P.R.] shall have the right to inspect such
    warehouse space upon reasonable prior notice and during
    normal business hours.
    8.   Acceptance and Rejection of Avitene by MedChem
    [P.R.].
    8.1 In General. Except as set forth below,
    MedChem [P.R.] shall have the right, within 30 working
    days following actual receipt by MedChem [P.R.] of any
    Delivery, to reject any Avitene so Delivered which does
    not conform in any material respect with the Product
    Specifications, provided that such nonconformity did
    not result from contamination or other physical damage
    cause by MedChem [P.R.] or third parties occurring
    after Delivery (other than contamination caused by
    subsequent Delivery by Alcon [P.R.] of contaminated
    Avitene.) [sic] * * *
    8.2 Changes in Conversion Process;
    Alternative Suppliers. Upon written consent by MedChem
    [P.R.], Alcon [P.R.] may alter the Conversion Process
    or obtain Avitene from alternative suppliers for
    Delivery to MedChem [P.R.]. * * *
    8.3 Testing by Alcon [P.R.]. Alcon [P.R.]
    shall submit to MedChem [P.R.], together with each
    shipment, batch or lot of Avitene Delivered to MedChem
    [P.R.] a written notice (i) certifying that such
    shipment, batch or lot of Avitene meets in every
    material respect the Product Specifications and (ii)
    specifying the results of Alcon[ P.R.]’s analysis of
    such shipment, batch or lot.
    8.4 Testing by MedChem [P.R.]. MedChem
    [P.R.], at its option, may perform the Acceptance Tests
    on random sample packages of Avitene in order to
    determine whether such Avitene conforms in every
    material respect with the Product Specifications.
    8.5 Notice; Return; Retesting; Replacement.
    MedChem [P.R.] shall not be obligated to remit the
    Processing Fee to Alcon [P.R.] for, and shall notify
    - 66 -
    Alcon [P.R.] in writing of, the failure of any sample,
    shipment or lot of Avitene to meet in any material
    respect the Product Specifications. MedChem [P.R.]
    shall return to Alcon [P.R.] any such rejected sample,
    shipment or lot of Avitene, at Alcon[ P.R.]’s expense.
    Alcon [P.R.], at its expense, shall replace any
    properly rejected sample, shipment or lot of Avitene.
    Alcon [P.R.] shall also reimburse MedChem [P.R.] for
    any inventory loss due to warehouse damage, damage
    resulting from the failure of the Conversion Process
    (except for damage resulting from changes in the
    Conversion Process requested by MedChem [P.R.] and
    instituted by Alcon [P.R.]) or the expiration of the
    expiration date of any Avitene products stored by
    MedChem [P.R.] in warehouse space provided by Alcon
    [P.R.], provided that such expiration of the expiration
    date is as a result of actions or omissions by Alcon
    [P.R.] with respect to the management of the inventory.
    Alcon [P.R.] will not be responsible for inventory
    losses due to product obsolescence.
    8.6 Product Recalls. If any Avitene product
    is subjected to a recall by a governmental agency, or
    in the event MedChem [P.R.], after notification to and
    consultation with Alcon [P.R.], elects to make such a
    recall based on MedChem[ P.R.]’s good faith belief that
    such Avitene is defective or not in conformity with
    Alcon[ P.R.]’s warranties, Alcon [P.R.] shall pay the
    actual out-of-pocket costs in connection with such
    recall, including without limitation the replacement of
    recalled Avitene. The payment of such costs by Alcon
    [P.R.] shall not be included in the computation of the
    Processing Fee pursuant to Section 9 hereof. However,
    if Alcon [P.R.] was not in breach of its warranties,
    MedChem [P.R.] shall hold Alcon [P.R.] harmless and
    shall bear all costs and expenses in connection with
    such recall.
    9.   Payment.
    9.1 Processing Cost. In return for the
    processing services performed by Alcon [P.R.] for
    MedChem [P.R.], MedChem [P.R.] shall pay to Alcon
    [P.R.] a Processing Fee in connection with each Order
    for Avitene Delivered pursuant to this Agreement. The
    Processing Fee shall be equal to Alcon[ P.R.]’s
    Processing Cost (as such term is defined below) plus
    ten percent (10%). However, the Processing Fee will be
    - 67 -
    adjusted at year end to account for manufacturing
    variances, which shall be calculated pursuant to the
    terms of this Section 9.
    The Processing Fee shall be determined in two
    steps. First, on or before December 31 of each year,
    Alcon [P.R.] shall determine the estimated Processing
    Cost for the coming year. Processing Costs shall be
    composed of Standard Cost less the cost of raw
    materials owned by MedChem [P.R.] and supplied to Alcon
    [P.R.] for processing and the depreciation on machinery
    and equipment owned by MedChem [P.R.] and used in the
    Conversion Process. Standard Cost shall consist of the
    sum of estimated direct labor, direct materials,
    variable overhead, fixed overhead, and quality
    assurance cost, and is defined in * * * [a referenced
    schedule]. Standard Cost shall not include costs
    associated with insurance provided by MedChem [P.R.],
    freight or shipping costs which shall be separately
    billed to MedChem [P.R.] by third parties. Standard
    Cost also shall not include any direct labor costs
    incurred by MedChem [P.R.] in connection with the
    provision of services by MedChem [P.R.] employees at
    the Humacao Plant. Such estimated Processing Cost plus
    10% will then be used as the estimated Processing Fee
    throughout the year for purposes of billing MedChem
    [P.R.] for the quantity of Avitene produced each month.
    Second, at the end of each year the parties shall
    determine any manufacturing and/or processing variances
    by comparing the Processing Cost for such year with the
    actual cost and volumes of Avitene during such year.
    If the variances indicate that the cost to Alcon [P.R.]
    to process the Avitene was greater than the Processing
    Cost, then MedChem [P.R.] shall pay to Alcon [P.R.] an
    amount of money equal to the total amount of such
    variance plus 10% within 30 days of MedChem[ P.R.]’s
    receipt of written notice setting forth the amount of
    such variance. If the variance indicates that the cost
    to Alcon [P.R.] was less than the Processing Cost, then
    MedChem [P.R.] shall receive from Alcon [P.R.] an
    amount of money equal to the total amount of such
    variance plus 10% within 30 days of the end of the
    year. * * * MedChem [P.R.] shall have the right to
    engage an independent auditor, upon reasonable written
    notice, to examine the relevant books and records of
    Alcon [P.R.] in order to confirm the accurate
    calculation of Processing Cost.
    - 68 -
    9.2 Option C Processing Fee. In addition to
    the Processing Fee payable pursuant to Section 9.1
    above, MedChem [P.R.] shall pay to Alcon [P.R.] an
    Option C Processing Fee in connection with the
    processing of Corium to Option C Flour pursuant to this
    Agreement. The Option C Processing Fee shall be
    determined in two steps. First, on or before December
    31 of each year, Alcon [P.R.] shall determine the
    Option C Processing Cost of the Option C Flour. The
    Option C Processing Cost shall be composed of the
    Option C Standard Cost less the cost of raw materials
    owned by MedChem [P.R.] and supplied to Alcon [P.R.]
    for processing and the depreciation on machinery and
    equipment owned by MedChem [P.R.] and used in the
    Conversion Process. Option C Standard Cost shall
    consist of direct labor, direct materials, variable
    overhead, fixed overhead and quality assurance cost,
    and is defined in * * * [a referenced schedule].
    Option C Standard Cost shall not include costs
    associated with insurance provided by MedChem [P.R.],
    freight or other costs which shall be separately billed
    to MedChem [P.R.] by third parties. Option C Standard
    Cost also shall not include any direct labor costs
    incurred by MedChem [P.R.] in connection with the
    provision of services by MedChem [P.R.] employees at
    the Humacao Plant. The Option C Processing Cost plus
    10% will then be used throughout the year for the
    purposes of billing MedChem [P.R.] for the quantity of
    Option C Flour produced each month.
    The second step in determining the Option C
    Processing Fee shall take place at the end of each
    year. At that time, Alcon [P.R.] shall determine any
    manufacturing and/or processing variances by comparing
    the Option C Processing Cost for such year with the
    actual cost and volumes of Option C Flour during such
    year. If the variances indicate that the cost to Alcon
    [P.R.] to process the Option C Flour was greater than
    the Option C Processing Cost, then MedChem [P.R.] shall
    pay to Alcon [P.R.] an amount of money equal to the
    total amount of such variance plus 10% within 30 days
    of MedChem[ P.R.]’s receipt of written notice setting
    forth the amount of such variance. If the variance
    indicates that the cost to Alcon [P.R.] was less than
    the Option C Processing Cost, then MedChem [P.R.] shall
    receive from Alcon [P.R.] an amount of money equal to
    the total amount of such variance plus 10% within 30
    days of the end of the year. MedChem [P.R.] shall have
    - 69 -
    the right to engage an independent auditor, upon
    reasonable written notice, to examine the relevant
    books and records of Alcon [P.R.] in order to confirm
    the accurate calculation of the Option C Processing
    Cost.
    10. Payment. MedChem [P.R.] shall pay Processing
    Fees pursuant to Alcon[ P.R.]’s invoice for Avitene
    Delivered under any Order within 30 days following
    receipt by MedChem [P.R.] of such invoice. Payment by
    MedChem [P.R.] of any invoice submitted by Alcon [P.R.]
    to MedChem [P.R.] shall not be required with respect to
    any shipment or lot of Avitene which has been properly
    rejected and returned by MedChem [P.R.] in accordance
    with Section 8.5. Payment of any disputed amount (but
    only to the extent of the disputed amount) shall be
    deferred until resolution of such dispute.
    11.   Warranty.
    11.1 General Warranty; Inspection. Alcon
    [P.R.] warrants that any Avitene Delivered under this
    Agreement shall meet the Product Specifications in
    every material respect, and that at the time of
    Delivery such Avitene shall be uncontaminated and free
    from defects in materials and workmanship. MedChem
    [P.R.] may make changes in the Product Specifications,
    but such changes must be made known to and agreed to by
    Alcon [P.R.], which agreement shall not be unreasonably
    withheld or delayed, and Alcon [P.R.] shall promptly
    incorporate said change(s) in such products, consistent
    with Good Manufacturing Practices and regulatory
    requirements. MedChem [P.R.] shall have the right to
    inspect the Humacao Plant during mutually agreed upon
    times when the processing of Avitene is in progress to
    insure that Alcon[ P.R.]’s processing of Avitene is in
    compliance with the Product Specifications. This right
    of inspection granted to MedChem [P.R.] shall not be
    deemed as granting to MedChem [P.R.] access to any
    trade secrets retained by Alcon [P.R.] subsequent to
    the closing of the transactions contemplated by the
    Asset Purchase Agreements.
    11.2 MedChem [P.R.] Indemnity. MedChem
    [P.R.] will indemnify and hold Alcon [P.R.] harmless
    from any and all claims, damages, costs and/or
    expenses, including, but not limited to attorneys fees,
    arising directly from (i) any change required by
    - 70 -
    MedChem [P.R.] in the Product Specifications or the
    Conversion Process from the manner in which such
    procedures were carried out by Alcon [P.R.] as of the
    date of this Agreement, if such change is the proximate
    cause of such claim, damages, costs or expenses, (ii)
    the promotion, distribution, sale and/or internal use
    by MedChem [P.R.] of Avitene processed by Alcon [P.R.]
    hereunder unless at the time of Delivery such Avitene
    did not meet the warranty set forth in Section 11.1
    hereof and (iii) any breach by MedChem [P.R.] of its
    warranties and obligations under this Agreement. Upon
    the filing of any such claim or suit, Alcon [P.R.]
    shall immediately notify MedChem [P.R.] thereof and
    shall permit MedChem [P.R.], at its cost, to handle and
    control such claim or suit provided, however, that
    Alcon [P.R.] may, at its own expense, retain such
    additional attorneys as it may deem necessary, which
    attorneys will be permitted to reasonably observe
    and/or participate in all aspects of (but not control)
    the defense of such claims or suits. MedChem [P.R.]
    shall have the right, after consultation with Alcon
    [P.R.], to resolve and settle any such claims or suits.
    This Indemnity shall not abrogate or in any way modify
    the obligations of Alcon [P.R.] pursuant to the
    representations and warranties contained in the Asset
    Purchase Agreement.
    11.3 Alcon [P.R.] Indemnity. Alcon [P.R.]
    will indemnify and hold MedChem [P.R.] harmless from
    and against any and all liability, damage, loss, cost,
    or expense resulting from any third party claims made
    or suits brought against MedChem [P.R.] which arise
    from Alcon[ P.R.]’s breach of any provision of this
    Agreement, including, but not limited to, claims of
    product defect relating to Avitene which is not in
    conformity with the warranty set forth in Section 11.1
    hereof. Upon the filing of any such claim or suit,
    MedChem [P.R.] shall immediately notify Alcon [P.R.]
    thereof and shall permit Alcon [P.R.], at its cost, to
    handle and control such claim or suit; provided,
    however, that MedChem [P.R.] may, at its own expense,
    retain such additional attorneys as it may deem
    necessary, which attorneys will be permitted to
    reasonably observe and/or participate in all aspects of
    (but not control) the defense of such claims or suits.
    Alcon [P.R.] shall have the right, after consultation
    with MedChem [P.R.], to resolve and settle any such
    claims or suits.
    - 71 -
    12.   Term and Termination.
    12.1 Term of Agreement. The term of this
    Agreement shall commence on the date hereof and shall
    end on December 31, 1990 (unless sooner terminated
    pursuant to this Section 12), and may be renewed on
    terms and conditions mutually satisfactory to the
    parties hereto.
    12.2   Insolvency. * * *
    12.3   Default.
    (a) In General. Except as otherwise
    provided in this Section 12, either party, at its
    option, may terminate this Agreement upon the
    occurrence of any breach by the other party, provided
    however (i) that the nonbreaching party shall have
    delivered to the breaching party a written notice
    specifying such breach in reasonable detail, (ii) that
    the breaching party shall not have cured such breach
    within 60 days after receipt of the notice and (iii)
    that the nonbreaching party must exercise its option to
    terminate this Agreement within 60 days after the
    expiration of the cure period.
    (b) Failure to Deliver by Alcon [P.R.].
    Subject to the provisions of Section 12.3(c) of this
    Agreement, MedChem [P.R.] may terminate this Agreement
    if Alcon [P.R.] fails to Deliver Avitene ordered by
    MedChem [P.R.] under this Agreement, provided, however,
    (i) that MedChem [P.R.] shall have delivered to Alcon
    [P.R.] a written notice of such failure to Deliver,
    (ii) that Alcon [P.R.] shall have failed to make
    Delivery within 60 days after receipt of such written
    notice and (iii) that MedChem [P.R.] must exercise its
    option to terminate this Agreement within 60 days after
    the expiration of the cure period. Alcon [P.R.]
    acknowledges and agrees that if Alcon [P.R.] fails to
    Deliver Avitene ordered by MedChem [P.R.] under this
    Agreement, MedChem [P.R.] may make alternative
    arrangements, at Alcon[ P.R.]’s expense, for the
    processing of Avitene for the then remaining term of
    this Agreement. However, Alcon [P.R.] shall not be
    liable for any incidental or consequential damages
    sustained by MedChem [P.R.] due to such failure to
    deliver.
    - 72 -
    (c)   Force Majeure. * * *
    12.4 Establishment of MedChem [P.R.] Plant.
    MedChem [P.R.] may terminate this Agreement pursuant to
    the provisions of Section 13.
    12.5 Remedies Not Exclusive. In the event
    of a breach of this Agreement, the rights of
    termination provided in this Section 12 shall not be
    exclusive of any remedies to which either party may be
    entitled at law or in equity (as limited by the express
    terms of this Agreement), provided, however, that such
    other remedies shall not be subject to the time
    limitations set forth in Sections 12.3(a) and (b).
    *    *     *    *    *    *       *
    13. MedChem [P.R.] Plant. The parties
    acknowledge and agree that, during the term of this
    Agreement, MedChem [P.R.] will take steps designed to
    establish alternative facilities (the “MedChem [P.R.]
    Plant”) that will enable MedChem [P.R.] to undertake
    the Conversion Process. In connection with the
    establishment of the MedChem [P.R.] Plant, MedChem
    [P.R.] shall bear the costs of removing the Equipment
    from the Humacao Plant, including, but not limited to,
    the costs of repairing any damage to the Humacao Plant
    caused by such removal. Alcon [P.R.] covenants that it
    will provide reasonable assistance to MedChem [P.R.] in
    establishing the MedChem [P.R.] Plant, including
    training of the Humacao Plant Manager and other
    appropriate MedChem [P.R.] personnel in all aspects of
    the Conversion Process. In this regard, appropriate
    MedChem [P.R.] employees shall have the right, during
    the term of this Agreement, to observe with regard to
    the Conversion Process carried out by Alcon [P.R.] at
    the Humacao Plant. However, such MedChem [P.R.]
    employees will not participate in Alcon[ P.R.]’s
    management process. In addition, upon the construction
    of the MedChem [P.R.] Plant, Alcon [P.R.] will assist
    with the validation of three initial Avitene production
    batches of each Avitene product produced at the MedChem
    [P.R.] Plant. When MedChem [P.R.] has successfully
    established the necessary machinery, equipment and
    quality control procedures, implemented the Conversion
    Process at the MedChem [P.R.] Plant and, in the sole
    opinion of MedChem [P.R.], conducted satisfactory
    validation tests and received all applicable
    - 73 -
    governmental approvals relating to the operation of the
    MedChem [P.R.] Plant, MedChem [P.R.] shall have the
    right to terminate this Agreement prior to December 31,
    1990 upon at least ninety (90) days prior written
    notice to Alcon [P.R.].
    *    *    *    *    *    *    *
    17. Applicable Law. The validity, performance
    and construction of this Agreement shall be governed by
    the laws of the Commonwealth of Massachusetts.
    *    *    *    *      *     *    *
    19. Notices. Notices and other communications by
    a party under this Agreement shall be in writing and
    hand-delivered, deposited with an overnight carrier for
    next day delivery, or deposited in the United States
    mail as certified mail, return receipt requested,
    postage prepaid, addressed to the parties as follows
    (or to such other addresses as either party may
    designate from time to time in writing):
    If to Alcon [P.R.]:
    Alcon Laboratories, Inc.
    6201 South Freeway
    Forth Worth, TX 76134
    Attention: Henry Meadows
    Vice President and Controller
    Surgical Specialty Division
    If to MedChem [P.R.]:
    MedChem Puerto Rico, Inc.
    43 Nagog Park
    Acton, MA 01720
    Attention: President
    and shall be deemed given when received.
    20. No Agency Relationship. Neither party shall
    be deemed to be the agent of the other party for any
    purpose. Alcon [P.R.] shall be deemed an independent
    contractor for the purposes of its performance of
    services for MedChem [P.R.]. * * *
    *    *    *    *      *     *    *
    - 74 -
    The parties hereto have executed this Agreement as
    a sealed instrument and this Agreement becomes duly
    effective, as of the date first written above.
    MEDCHEM PUERTO RICO, INC.
    By:     /s David A. Swann
    Title: CEO
    ALCON (PUERTO RICO) INC.
    By:     /s
    Title: Vice President