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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.
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