Systems without the expenditure of substantial time, resources and money on 

engineering and development. Accuray estimates that to train and qualify a third 

party, or to establish another subsidiary, in a country other than China to 

manufacture the linear accelerators to Accuray's precise specifications, tolerances 

and quality standards will take 1 to 2 years. 

In that context, we emphasize that qualification and confirmation that the 

manufacturer of the linear accelerators to Accuray's precise specifications, 

tolerances and quality standards is quite literally a matter of life and death. Any 

material deviation from those Accuray specifications, tolerances and/or quality 

standards in the manufacture of the linear accelerators that are then incorporated 

into the Accuray radiation surgery and radiation therapy equipment could result 

in: (i) a radiation beam that is insufficient to destroy patients' cancerous cells; or 

(ii) radiation leakage that could pose a threat to the health and safety of patients

and operators.

(ii) Harm to United States Interests: Accuray operates in a highly

competitive market in which Accuray is the smallest of the three major suppliers 

of equipment for radiation surgery and radiation therapy of cancer patients (with 

a market share of approximately 10 percent of the global market). The 

imposition of a 25 percent ad valorem duty on each linear accelerator that 

Accuray imports into the United States and incorporates into its medical devices 

will place Accuray at a very significant competitive disadvantage, as the linear

accelerators correspond to a significant percent of the overall material cost of

Accuray's medical devices. Accuray's cost of productjon of those medical 

devices will be concomitantly increased. 

The competitive harm to Accuray will be particularly acute, as one of Accuray's 

principal competitors (with a much larger market share than Accuray, both in the 

United States and globally) is a European company that manufactures its medical 

devices exclusively outside of the United States (i.e., in Europe). As such, that 

European competitor will not bear a comparable additional duty burden, either on 

medical devices sold and supplied in the global market, or on medical devices 

imported and supplied in the United States. Accuray fears that it may be unable 

to compete in the global market, which historically has accounted for 

approximately 70 percent of Accuray's sales ofits medical devices. Under the 

circumstances, Accuray believes that the competitive harm that it will suffer as a 

result of the imposition of the section 301 duties on its imported linear 

accelerators will be dramatically disproportionate to any impact on the Chinese

Government policies and practices that have been the subject of the United States 

Trade Representative's investigation under section 301. 

If the section 301 duties are imposed on the linear accelerators that Accuray 

imports from its wholly-owned Chinese subsidiaries, Accuray will be compelled 

to increase the prices of its medical devices, when sold to hospitals and oncology 

clinics, including hospitals and clinics in the United States. Those price increases 

will, then, have an impact on the cost of treating patients dealing with the

devastating physical and emotional effects of cancer. Actions, in the form of the 

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