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SEC Company Response from SINOVAC BIOTECH LTD (SVA) (CIK 0001084201) (SVA) — Nov 28, 2005

SINOVAC BIOTECH LTD (SVA) (CIK 0001084201)
Date: Nov. 28, 2005 · CIK: 0001084201 · Accession: 0001127855-05-000757

AI Filing Summary & Sentiment

Date
October 3, 2005
Author
Not clearly detected
Form
CORRESP
Company
SINOVAC BIOTECH LTD (SVA) (CIK 0001084201)

Letter

Via EDGAR SECURITIES AND EXCHANGE COMMISSION 450 Fifth Street, N.W. Washington, D.C. U.S.A., 20549-0405 Attention: Mr. Mark Brunhofer, Staff Accountant, Division of Corporation Finance

Dear Mr. Brunhofer:

Re:

Sinovac Biotech Ltd. (the “Company”)

File No. 1-32371

E-MAIL CORRESPONDENCE BETWEEN THE COMPANY AND THE SEC

We are counsel for the above-referenced Company and are writing on its behalf. With respect to our telephone conversation on September 29, 2005, we have compiled the additional information set forth below relating to the SEC's further concerns and requests for information on the accounting treatment of the Licenses and Permits for Sinovac Biotech Ltd.'s recently filed Form 20-F/A-2.

Association of Law Corporations

Securities and Exchange Commission

October 3, 2005

Page 2

When we acquired our vaccine licenses, we capitalized the excess of the purchase price over the fair value of the net tangible assets acquired (“purchased R&D costs”). The SEC has questioned whether or not the purchased R&D costs relating to the vaccines should have been capitalized, suggesting instead that expensing the costs would have been more appropriate.

The SEC has further questioned when amortization of any capitalized costs should begin. Our policy is to commence amortization when production begins, but an alternative would be to commence amortization on the purchase of the vaccines. This discussion does not address the issue of amortization period.

In principle, FASB Statement No. 2 requires that research and development expenses be expensed, unless alternative future use tests can be met. FASB Interpretation No. 4 provides further guidance in this regard with regard to purchased R&D costs. For purchased R&D costs to be recorded as an asset, there must be a “probable future economic benefit” (FASB Concepts Statement No. 6). In practical terms, we understand that normal US practice is to expense purchased R&D costs unless the drug in question has received FDA approval. In Sinovac’s case, we have to relate this test to the Chinese approval process which has four main elements: Clinical trial approval New drug certificate Production license

GMP certification

Sinovac Experience

In general, under the Chinese system, we believe that there is a probable future economic benefit associated with a vaccine once the new drug certificate has been awarded. Obtaining a production license is straightforward when the new drug certificate requirements have been met, and is more related to production than the merits of the drug as such. The GMP certification relates more to the production facility than the vaccine itself. Once the new drug certificate has been received, the vaccine could be sold or licensed to a third party, which could in turn manufacture it.

Of the three vaccines, we only had the new drug certificate at the purchase date for the hepatitis A vaccine:

Securities and Exchange Commission

October 3, 2005

Page 3

Milestone

Hepatitis A

Hepatitis A&B

Influenza

Purchase / contribution date

April 2001

April 2002

March 2003

Clinical trial approval

April 1998

March 2002

February 2003

New drug certificate

December 1999

January 2005

February 2005

Production license

May 2002

January 2005

July 2005

GMP certificate

March 2002

May 2003

TBA

Date amortization began

July 2002

April 2005

TBA

There are, however, other circumstances that affect Sinovac’s decision to capitalize the hepatitis A&B and influenza vaccine purchase costs.

The hepatitis A&B vaccine is based on a combination of the company’s proprietary hepatitis A vaccine, which received its new drug certificate in 1999, and a third party’s hepatitis B vaccine which was already being marketed. Since the hepatitis A&B vaccine was a combination of two approved products, it believed that the test necessary to record an asset had been met.

The influenza vaccine had been developed using a recognized production technique and accordingly, the Company believed there was a probable future benefit to be derived from this vaccine.

Conclusion

We hope that this information more fully explains the Chinese regulatory process and risk associated with the commercialization of Sinovac’s vaccines. We would like the opportunity to talk with you regarding your interpretation of this additional material.

Yours very truly,

DEVLIN JENSEN

Per:

/s/ Mike Shannon

MICHAEL T. SHANNON

Show Raw Text
CORRESP
1
filename1.htm

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		Untitled Page

			Vancouver Office:

			D     E     V     L    I     N

			P.O. Box 12077

			J     E    N     S     E     N

			Suite 2550

			Barristers & Solicitors

			555 West Hastings St.

			Vancouver, B.C.

						Canada V6B 4N5

						Tel: (604) 684-2550

						Fax: (604) 684-0916

						E-mail: mshannon@devlinjensen.com

			File Reference:            4020\045a

		Via EDGAR

		October 3, 2005

			SECURITIES AND EXCHANGE COMMISSION

				450 Fifth Street, N.W.

			Washington, D.C.

			U.S.A., 20549-0405

			Attention:        Mr. Mark Brunhofer, Staff Accountant, Division of Corporation Finance

				Dear Mr. Brunhofer:

			Re:

		Sinovac Biotech Ltd. (the “Company”)

			File No. 1-32371

				E-MAIL CORRESPONDENCE BETWEEN THE COMPANY AND THE SEC

		            We are counsel for the above-referenced Company and are writing on its behalf.  With respect to our telephone conversation on September 29, 2005, we have compiled the additional information set forth below relating to the SEC's further concerns and requests for information on the accounting treatment of the Licenses and Permits for Sinovac Biotech Ltd.'s recently filed Form 20-F/A-2.

		Association of Law Corporations

		Securities and Exchange Commission

			October 3, 2005

		Page 2

		When we acquired our vaccine licenses, we capitalized the excess of the purchase price over the fair value of the net tangible assets acquired (“purchased R&D costs”). The SEC has questioned whether or not the purchased R&D costs relating to the vaccines should have been capitalized, suggesting instead that expensing the costs would have been more appropriate.

		The SEC has further questioned when amortization of any capitalized costs should begin. Our policy is to commence amortization when production begins, but an alternative would be to commence amortization on the purchase of the vaccines. This discussion does not address the issue of amortization period.

		In principle, FASB Statement No. 2 requires that research and development expenses be expensed, unless alternative future use tests can be met. FASB Interpretation No. 4 provides further guidance in this regard with regard to purchased R&D costs. For purchased R&D costs to be recorded as an asset, there must be a “probable future economic benefit” (FASB Concepts Statement No. 6). In practical terms, we understand that normal US practice is to expense purchased R&D costs unless the drug in question has received FDA approval. In Sinovac’s case, we have to relate this test to the Chinese approval process which has four main elements:
			Clinical trial approval
			New drug certificate
			Production license

			GMP certification

		Sinovac Experience

		In general, under the Chinese system, we believe that there is a probable future economic benefit associated with a vaccine once the new drug certificate has been awarded. Obtaining a production license is straightforward when the new drug certificate requirements have been met, and is more related to production than the merits of the drug as such. The GMP certification relates more to the production facility than the vaccine itself. Once the new drug certificate has been received, the vaccine could be sold or licensed to a third party, which could in turn manufacture it.

		Of the three vaccines, we only had the new drug certificate at the purchase date for the hepatitis A vaccine:

		Securities and Exchange Commission

			October 3, 2005

		Page 3

					Milestone

					Hepatitis A

					Hepatitis A&B

					Influenza

					Purchase / contribution date

					April 2001

					April 2002

					March 2003

					Clinical trial approval

					April 1998

					March 2002

					February 2003

					New drug certificate

					December 1999

					January 2005

					February 2005

					Production license

					May 2002

					January 2005

					July 2005

					GMP certificate

					March 2002

					May 2003

					TBA

					Date amortization began

					July 2002

					April 2005

					TBA

		There are, however, other circumstances that affect Sinovac’s decision to capitalize the hepatitis A&B and influenza vaccine purchase costs.

		The hepatitis A&B vaccine is based on a combination of the company’s proprietary hepatitis A vaccine, which received its new drug certificate in 1999, and a third party’s hepatitis B vaccine which was already being marketed. Since the hepatitis A&B vaccine was a combination of two approved products, it believed that the test necessary to record an asset had been met.

		The influenza vaccine had been developed using a recognized production technique and accordingly, the Company believed there was a probable future benefit to be derived from this vaccine.

		Conclusion

		We hope that this information more fully explains the Chinese regulatory process and risk associated with the commercialization of Sinovac’s vaccines. We would like the opportunity to talk with you regarding your interpretation of this additional material.

		                                                                                                   Yours very truly,

			                                                                                                   DEVLIN JENSEN

				                                                                                                    Per:

		                                                                                                                /s/ Mike Shannon

		                                                                                                                MICHAEL T. SHANNON