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SEC Company Response from Bausch Health Companies Inc. (BHC) (CIK 0000885590) (BHC) — Nov 25, 2005

Bausch Health Companies Inc. (BHC) (CIK 0000885590)
Date: Nov. 25, 2005 · CIK: 0000885590 · Accession: 0001047469-05-027399

AI Filing Summary & Sentiment

File numbers found in text: 000-22358

Date
November 25, 2005
Author
Not clearly detected
Form
CORRESP
Company
Bausch Health Companies Inc. (BHC) (CIK 0000885590)

Letter

Division of Corporation Finance United States Securities and Exchange Commission Form 20-F for Fiscal Year Ended December 31, 2004 Form 6-K filed August 12, 2005 File No. 000-22358

Re:Biovail Corporation

Dear Mr. Rosenberg:

Biovail Corporation (the "Company", "Biovail", "we", "us" or "our") acknowledges the receipt of the letter from the staff of the United States Securities and Exchange Commission (the "Commission") dated September 30, 2005. Please find below our detailed responses to the staff's comments on our Form 20-F for the fiscal year ended December 31, 2004 and Form 6-K filed August 12, 2005. For ease of reference, we have provided the text of each comment prior to our response.

Comment:

Where indicated, we think you should revise your Form 20-F for the year ended December 31, 2004. If you disagree, we will consider your explanation as to why our comment is inapplicable or a revision is unnecessary.

Response:

The proposed amended disclosures to our Form 20-F for the fiscal year ended December 31, 2004, in response to staff comments 1 and 3 are set forth in this letter. In response to staff comments 2, 4, 6, 10, 12 and 13 we have proposed to include additional disclosure in our future filings, beginning with our Form 20-F for the fiscal year ended December 31, 2005. In response to staff comments 5 and 7 we have noted that we do not believe that additional disclosure is necessary.

Comment:

Form 20-F for the Fiscal Year Ended December 31, 2004

Item 5. Operating and Financial Review and Prospects, page 56

MD&A in Accordance with U.S. GAAP, page 57

Critical Accounting Policies and Estimates, page 58

Revenue Recognition, page 59

1.We noted that revenue from product sales is recognized net of provisions for estimated discounts and allowances, returns, rebates and chargebacks. In addition, we noted that a significant change in the estimate of product returns could have a material impact on your results of operations. As we did not note the disclosures about these provisions contemplated by Section V of Financial Reporting Release 72, please revise your disclosures to provide the following information:

a.The nature and amount of each provision at each balance sheet date and the effect that could result from using other reasonably likely assumptions than what you used to arrive at each provision, such as, in the form of, a range of reasonably likely amounts or other type of sensitivity analysis.

b.The factors that you consider in estimating each provision, such as whether you use historical return of products, levels of inventory in the distribution channel, estimated shelf life, price changes from competitors, and introductions of generics and/or new products.

c.The extent to which you rely on information from external sources, such as, end-customer prescription demand or third-party market research data comparing wholesaler inventory levels to end-customer demand.

d.For returns, the total amount, in sales dollars, that could potentially be returned as of the balance sheet, in tabular format by product and by expiration period.

e.A roll forward of each provision, for each period presented, showing the following:

•beginning balance;

•current period provision related to sales made in current period;

•current period provision related to sales made in prior periods;

•actual payments or credits in current period related to sales made in current period;

•actual payments or credits in current period related to sales made in prior periods; and

•ending balance.

f.The amount and reason for period-to-period fluctuations in the amounts added to each provision, including the effect that changes in your estimates had on your revenues and results of operations.

Response:

We will amend our disclosure of critical accounting policies and estimates related to revenue recognition in our Form 20-F for the fiscal year ended December 31, 2004, as follows:

Revenue recognition

We recognize product sales revenue when title has transferred to the customer, provided that we have not retained any significant risks of ownership or future obligations with respect to the product sold. Revenue from product sales is recognized net of provisions for estimated cash discounts, allowances, returns, rebates and chargebacks. We establish these provisions concurrently with the recognition of product sales revenue. We continually monitor these provisions and evaluate the estimates used as additional information becomes available. We make adjustments to these provisions periodically to reflect actual and future estimated experience. In connection with these provisions related to sales of products manufactured by us for distribution by our third-party licensees, we rely on estimates made by these licensees.

Continuity of product sales provisions

The following table displays a continuity of each of our product sales provisions:

Cash Discounts

Allowances

Returns

Rebates and Chargebacks

Total

($ in 000s)

Balance at January 1, 2002

2,227

18,302

8,698

30,172

Current year provision

8,148

1,099

22,716

34,834

66,797

Prior year provision

—

—

1,800

(1,900 ) (100 )

Payments or credits

(8,924 ) (1,770 ) (15,404 ) (26,344 ) (52,442 )

Balance at December 31, 2002

1,451

27,414

15,288

44,427

Current year provision

8,551

1,604

33,426

35,565

79,146

Prior year provision

—

—

28,122

(6,308 ) 21,814

Payments or credits

(7,988 ) (1,428 ) (45,673 ) (23,394 ) (78,483 )

Balance at December 31, 2003

2,014

43,289

21,151

66,904

Current year provision

5,797

4,334

24,896

30,386

65,413

Prior year provision

—

—

14,062

(1,479 ) 12,583

Payments or credits

(4,751 ) (2,576 ) (51,826 ) (39,857 ) (99,010 )

Balance at December 31, 2004

3,060

2,208

30,421

10,201

45,890

Use of information from external sources

We use information from external sources to estimate our significant product sales provisions. We obtain prescription data for our products from IMS Health ("IMS"), an independent pharmaceutical market research firm. We use this data to identify sales trends based on end-customer demand and to estimate inventory requirements. Prior to 2004, we also relied on data obtained from IMS to estimate inventory levels in our distribution channels. Since 2004, IMS no longer provides this service. As a result, we are now obtaining this inventory pipeline data directly from our three major wholesalers (which are Cardinal Health, Inc., McKesson Corporation and AmerisourceBergen Corporation). The inventory data received from these wholesalers excludes inventory held by customers to whom they sell, such as retail pharmacies. In late 2004 and early 2005, we entered into fee-based distribution agreements with these wholesalers, which require these wholesalers to provide us with more extensive data with respect to the sales and inventory levels of our products, such as inventory levels on-hand and on order, aggregate sales out and product returns, as well as customer monitoring services to detect speculative buy activity by these wholesalers' customers.

The information from external sources is provided to us in aggregate only and not by specific lot number, which is the level of detail that would be required to determine the original sale date and remaining shelf life of inventory in our distribution channels. At December 31, 2004, our three major wholesalers maintained overall approximately two months worth of inventory of our products. These wholesalers accounted for approximately two-thirds of our direct product sales in 2004. Based on these inventory levels and projected sales demand for our products, the collection of lot information would have limited use in estimating our product sales provisions.

Cash discounts and allowances

We offer cash discounts for prompt payment and allowances for volume purchases to customers. Provisions for cash discounts are estimated at the time of sale and recorded as direct reduction to accounts receivable and revenue. At December 31, 2004 and 2003, reserves for cash discounts were $3.1 million and $2.0 million, respectively. Provisions for allowances are recorded in accrued liabilities. At December 31, 2004 and 2003, accrued allowances were $2.2 million and $0.5 million, respectively. We estimate provisions for cash discounts and allowances based on contractual sales terms with customers, an analysis of unpaid invoices and historical payment experience. Estimated cash discounts and allowances have historically been predictable and less subjective, due to the limited number of assumptions involved, the consistency of historical experience and the fact that we generally settle these amounts within one month of incurring the liability.

Returns

Consistent with industry practice, we generally allow customers to return product within a specified period before and after its expiration date. Provisions for these returns are estimated based on historical return and exchange levels, third-party data with respect to inventory levels in our distribution channels, and the estimated shelf life of our products (which range on average from approximately 18 to 48 months). Although the introduction of additional generic and/or new product competition does not give our customers the right to return product outside of our established policy, we do recognize that such competition could ultimately lead to increased returns. Our estimates of inventory in our distribution channels are subject to the inherent limitations of estimates that rely on information from external sources, as certain third-party data may itself rely on estimates, and reflect other limitations.

At December 31, 2004 and 2003, accrued product returns were $30.4 million and $43.3 million, respectively. In 2004, 2003 and 2002, provisions for product returns related to sales made in the current year were $24.9 million, $33.4 million and $22.7 million, respectively, or 3%, 5% and 3%, respectively, of gross product sales. If our product returns accrual rate as a percentage of gross product sales were to differ by 10% from our estimates, our provisions for product returns recorded in 2004, 2003 and 2002 would change by approximately $2.5 million, $3.3 million and $2.3 million, respectively. The higher product returns accrual rate as a percentage of revenue in 2003, relative to 2004 and 2002, was due primarily to higher inventory levels in our distribution channels that resulted from increased generic competition and investment buying by wholesalers. In 2004, our major wholesalers began to reduce these inventory levels in anticipation of the transition to the fee-based distribution agreements, which generally establish limits on inventory levels owned by these wholesalers, and are expected to moderate investment buying by these wholesalers that can result in sales fluctuations unrelated to end-customer demand. As a result, we were able to reduce our product returns accrual rate in 2004, to reflect a lower risk of product expiration and overstocking.

In situations where we become aware that product returns may be higher or lower than historical experience would indicate (for example, due to fluctuations in sales trends or changes in inventory levels in our distribution channels), we analyze the situation and if the analysis indicates that those factors may result in higher or lower product expiration, we adjust our product returns provision accordingly, taking into account the level of inventory in our distribution channels. We made adjustments to the product returns provision of $14.1 million, $28.1 million and $1.8 million in 2004, 2003 and 2002, respectively. These adjustments generally related to sales made in prior years, as the shelf life of our products range from 18 to 48 months, and customers are not permitted to return product with more than six months of shelf life remaining.

The adjustments made to the product returns provision in 2004 and 2003 were primarily related to sales of Teveten®, Vasotec® and Vaseretic® (which were acquired in 2002) and Cardizem® CD (which was acquired in 2000). In certain cases we were required to accept returns of these products related to sales made prior to our acquisition by the companies from whom we had acquired these products. As we had not recorded the original product sales, we had no basis to estimate the amount of these returns. As a result, a portion of the adjustments to the product returns provision in 2004 and 2003 were related to these returns based on actual experience.

During 2004, we received our first significant returns of Teveten®, Vasotec® and Vaseretic® related to sales that we had made of these products in 2003 and 2002. During 2003, we began to receive significant returns of Cardizem® CD related to sales that we had made of this product in 2002 and 2001. We initially based our provisions for returns related to these products on the historical experience rates of the companies from whom we acquired these products. As we developed our own historical experience, we adjusted those experience rates as appropriate. We noted that the returns levels for these products were higher overall than the historical experience of the companies from whom we acquired these products would have indicated. These relatively higher levels of returns reflected increasing generic competition for these products that resulted in lower prescription demand, as well as a higher than anticipated conversion of patients from Cardizem® CD to Cardizem® LA (which was launched in April 2003). These factors resulted in increased product expiration due to higher levels of inventory in our distribution channels.

Rebates and chargebacks

We are subject to rebates on sales made under governmental and managed care pricing programs. Provisions for these rebates are estimated based on historical experience, contractual sales terms with managed care organizations, and relevant statutes with respect to governmental pricing programs. The largest of these rebates are associated with sales covered by Medicaid. We participate in state government-managed Medicaid programs, as well as certain other qualifying federal and state government programs whereby discounts and rebates are provided to participating government entities. Medicaid rebates are typically billed up to six months after the product is shipped. As a result, a Medicaid rebate provision includes: an estimate of outstanding claims for end-customer sales that occurred but for which the related claim has not been billed; and an estimate for future claims that will be made when inventory in our distribution channels is sold through to end-customers. Our calculation also requires other estimates, such as estimates of sales mix, to determine which sales are subject to rebates and the amount of such rebates. Periodically, we adjust the Medicaid rebate provision based on actual claims paid. Due to the delay in billing, adjustments to actual may incorporate revisions of this rebate provision for several periods.

Chargebacks relate to our contractual agreements to sell products to group purchasing organizations and other indirect customers at contractual prices that are lower than the list prices we charge wholesalers. When these group purchasing organizations or other indirect customers purchase our products through wholesalers at these reduced prices, the wholesaler charges us for the difference between the prices they pay us and the prices they sold the products to the indirect customers.

At December 31, 2004 and 2003, accrued rebates and chargebacks were $10.2 million and $21.2 million, respectively. In 2004, 2003 and 2002, provisions for rebates and chargebacks related to

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CORRESP
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November 25, 2005

Mr. Jim
B. Rosenberg

Senior Assistant Chief Accountant

Division of Corporation Finance

United States Securities and Exchange Commission

Washington, D.C. 20549

Re:Biovail Corporation

Form 20-F for Fiscal Year Ended December 31, 2004

Form 6-K filed August 12, 2005

File No. 000-22358

Dear Mr. Rosenberg:

        Biovail
Corporation (the "Company", "Biovail", "we", "us" or "our") acknowledges the receipt of the letter from the staff of the United States Securities and Exchange
Commission (the "Commission") dated September 30, 2005. Please find below our detailed responses to the staff's comments on our Form 20-F for the fiscal year
ended December 31, 2004 and Form 6-K filed August 12, 2005. For ease of reference, we have provided the text of each comment prior to our response.

Comment:

        Where indicated, we think you should revise your Form 20-F for the year ended December 31, 2004. If you disagree, we will
consider your explanation as to why our comment is inapplicable or a revision is unnecessary.

Response:

        The proposed amended disclosures to our Form 20-F for the fiscal year ended December 31, 2004, in response to staff comments
1 and 3 are set forth in this letter. In response to staff comments 2, 4, 6, 10, 12 and 13 we have proposed to include additional disclosure in our future filings,
beginning with our Form 20-F for the fiscal year ended December 31, 2005. In response to staff comments 5 and 7 we have noted that we do not believe that
additional disclosure is necessary.

1

Comment:

Form 20-F
for the Fiscal Year Ended December 31, 2004

Item 5. Operating and Financial Review and Prospects, page 56

MD&A in Accordance with U.S. GAAP, page 57

Critical Accounting Policies and Estimates, page 58

Revenue Recognition, page 59

1.We
noted that revenue from product sales is recognized net of provisions for estimated discounts and allowances, returns, rebates and chargebacks. In addition, we noted that a
significant change in the estimate of product returns could have a material impact on your results of operations. As we did not note the disclosures about these provisions contemplated by
Section V of Financial Reporting Release 72, please revise your disclosures to provide the following information:

a.The
nature and amount of each provision at each balance sheet date and the effect that could result from using other reasonably likely assumptions than what you used to arrive at each
provision, such as, in the form of, a range of reasonably likely amounts or other type of sensitivity analysis.

b.The
factors that you consider in estimating each provision, such as whether you use historical return of products, levels of inventory in the distribution channel, estimated shelf
life, price changes from competitors, and introductions of generics and/or new products.

c.The
extent to which you rely on information from external sources, such as, end-customer prescription demand or third-party market research data comparing wholesaler
inventory levels to end-customer demand.

d.For
returns, the total amount, in sales dollars, that could potentially be returned as of the balance sheet, in tabular format by product and by expiration period.

e.A
roll forward of each provision, for each period presented, showing the following:

•beginning
balance;

•current
period provision related to sales made in current period;

•current
period provision related to sales made in prior periods;

•actual
payments or credits in current period related to sales made in current period;

•actual
payments or credits in current period related to sales made in prior periods; and

•ending
balance.

f.The
amount and reason for period-to-period fluctuations in the amounts added to each provision, including the effect that changes in your estimates had on your
revenues and results of operations.

2

Response:

        We will amend our disclosure of critical accounting policies and estimates related to revenue recognition in our Form 20-F for the
fiscal year ended December 31, 2004, as follows:

Revenue
recognition

We
recognize product sales revenue when title has transferred to the customer, provided that we have not retained any significant risks of ownership or future obligations with respect to the product
sold. Revenue from product sales is recognized net of provisions for estimated cash discounts, allowances, returns, rebates and chargebacks. We establish these provisions concurrently with the
recognition of product sales revenue. We continually monitor these provisions and evaluate the estimates used as additional information becomes available. We make adjustments to these provisions
periodically to reflect actual and future estimated experience. In connection with these provisions related to sales of products manufactured by us for distribution by our third-party licensees, we
rely on estimates made by these licensees.

 Continuity of product sales provisions

The
following table displays a continuity of each of our product sales provisions:

Cash Discounts

Allowances

Returns

Rebates and Chargebacks

Total

($ in 000s)

Balance at January 1, 2002

2,227

945

18,302

8,698

30,172

Current year provision

8,148

1,099

22,716

34,834

66,797

Prior year provision

—

—

1,800

(1,900
)
(100
)

Payments or credits

(8,924
)
(1,770
)
(15,404
)
(26,344
)
(52,442
)

Balance at December 31, 2002

1,451

274

27,414

15,288

44,427

Current year provision

8,551

1,604

33,426

35,565

79,146

Prior year provision

—

—

28,122

(6,308
)
21,814

Payments or credits

(7,988
)
(1,428
)
(45,673
)
(23,394
)
(78,483
)

Balance at December 31, 2003

2,014

450

43,289

21,151

66,904

Current year provision

5,797

4,334

24,896

30,386

65,413

Prior year provision

—

—

14,062

(1,479
)
12,583

Payments or credits

(4,751
)
(2,576
)
(51,826
)
(39,857
)
(99,010
)

Balance at December 31, 2004

3,060

2,208

30,421

10,201

45,890

 Use of information from external sources

We
use information from external sources to estimate our significant product sales provisions. We obtain prescription data for our products from IMS Health ("IMS"), an independent pharmaceutical
market research firm. We use this data to identify sales trends based on end-customer demand and to estimate inventory requirements. Prior to 2004, we also relied on data obtained from IMS
to estimate inventory levels in our distribution channels. Since 2004, IMS no longer provides this service. As a result, we are now obtaining this inventory pipeline data directly from our three major
wholesalers (which are Cardinal Health, Inc., McKesson Corporation and AmerisourceBergen Corporation). The inventory data received from these wholesalers excludes inventory held by customers to
whom they sell, such as retail pharmacies. In late 2004 and early 2005, we entered into fee-based distribution agreements with these wholesalers, which require these wholesalers to provide
us with more extensive data with respect to the sales and inventory levels of our products, such as inventory levels on-hand and on order, aggregate sales out and product returns, as well
as customer monitoring services to detect speculative buy activity by these wholesalers' customers.

3

The
information from external sources is provided to us in aggregate only and not by specific lot number, which is the level of detail that would be required to determine the original sale date and
remaining shelf life of inventory in our distribution channels. At December 31, 2004, our three major wholesalers maintained overall approximately two months worth of inventory of our products.
These wholesalers accounted for approximately two-thirds of our direct product sales in 2004. Based on these inventory levels and projected sales demand for our products, the collection of
lot information would have limited use in estimating our product sales provisions.

 Cash discounts and allowances

We
offer cash discounts for prompt payment and allowances for volume purchases to customers. Provisions for cash discounts are estimated at the time of sale and recorded as direct reduction to
accounts receivable and revenue. At December 31, 2004 and 2003, reserves for cash discounts were $3.1 million and $2.0 million, respectively. Provisions for allowances are
recorded in accrued liabilities. At December 31, 2004 and 2003, accrued allowances were $2.2 million and $0.5 million, respectively. We estimate provisions for cash discounts and
allowances based on contractual sales terms with customers, an analysis of unpaid invoices and historical payment experience. Estimated cash discounts and allowances have historically been predictable
and less subjective, due to the limited number of assumptions involved, the consistency of historical experience and the fact that we generally settle these amounts within one month of incurring the
liability.

 Returns

Consistent
with industry practice, we generally allow customers to return product within a specified period before and after its expiration date. Provisions for these returns are estimated based on
historical return and exchange levels, third-party data with respect to inventory levels in our distribution channels, and the estimated shelf life of our products (which range on average from
approximately 18 to 48 months). Although the introduction of additional generic and/or new product competition does not give our customers the right to return product outside of our
established policy, we do recognize that such competition could ultimately lead to increased returns. Our estimates of inventory in our distribution channels are subject to the inherent limitations of
estimates that rely on information from external sources, as certain third-party data may itself rely on estimates, and reflect other limitations.

4

At
December 31, 2004 and 2003, accrued product returns were $30.4 million and $43.3 million, respectively. In 2004, 2003 and 2002, provisions for product returns related to sales
made in the current year were $24.9 million, $33.4 million and $22.7 million, respectively, or 3%, 5% and 3%, respectively, of gross product sales. If our product returns accrual
rate as a percentage of gross product sales were to differ by 10% from our estimates, our provisions for product returns recorded in 2004, 2003 and 2002 would change by approximately
$2.5 million, $3.3 million and $2.3 million, respectively. The higher product returns accrual rate as a percentage of revenue in 2003, relative to 2004 and 2002, was due primarily
to higher inventory levels in our distribution channels that resulted from increased generic competition and investment buying by wholesalers. In 2004, our major wholesalers began to reduce these
inventory levels in anticipation of the transition to the fee-based distribution agreements, which generally establish limits on inventory levels owned by these wholesalers, and are
expected to moderate investment buying by these wholesalers that can result in sales fluctuations unrelated to end-customer demand. As a result, we were able to reduce our product returns
accrual rate in 2004, to reflect a lower risk of product expiration and overstocking.

In
situations where we become aware that product returns may be higher or lower than historical experience would indicate (for example, due to fluctuations in sales trends or changes in
inventory levels in our distribution channels), we analyze the situation and if the analysis indicates that those factors may result in higher or lower product expiration, we adjust our product
returns provision accordingly, taking into account the level of inventory in our distribution channels. We made adjustments to the product returns provision of $14.1 million,
$28.1 million and $1.8 million in 2004, 2003 and 2002, respectively. These adjustments generally related to sales made in prior years, as the shelf life of our products range from
18 to 48 months, and customers are not permitted to return product with more than six months of shelf life remaining.

The
adjustments made to the product returns provision in 2004 and 2003 were primarily related to sales of Teveten®, Vasotec® and Vaseretic® (which were acquired in
2002) and Cardizem® CD (which was acquired in 2000). In certain cases we were required to accept returns of these products related to sales made prior to our acquisition by the companies
from whom we had acquired these products. As we had not recorded the original product sales, we had no basis to estimate the amount of these returns. As a result, a portion of the adjustments to the
product returns provision in 2004 and 2003 were related to these returns based on actual experience.

5

During
2004, we received our first significant returns of Teveten®, Vasotec® and Vaseretic® related to sales that we had made of these products in 2003 and 2002.
During 2003, we began to receive significant returns of Cardizem® CD related to sales that we had made of this product in 2002 and 2001. We initially based our provisions for returns
related to these products on the historical experience rates of the companies from whom we acquired these products. As we developed our own historical experience, we adjusted those experience rates as
appropriate. We noted that the returns levels for these products were higher overall than the historical experience of the companies from whom we acquired these products would have indicated. These
relatively higher levels of returns reflected increasing generic competition for these products that resulted in lower prescription demand, as well as a higher than anticipated conversion of patients
from Cardizem® CD to Cardizem® LA (which was launched in April 2003). These factors resulted in increased product expiration due to higher levels of inventory in our
distribution channels.

 Rebates and chargebacks

We
are subject to rebates on sales made under governmental and managed care pricing programs. Provisions for these rebates are estimated based on historical experience, contractual sales terms with
managed care organizations, and relevant statutes with respect to governmental pricing programs. The largest of these rebates are associated with sales covered by Medicaid. We participate in state
government-managed Medicaid programs, as well as certain other qualifying federal and state government programs whereby discounts and rebates are provided to participating government entities.
Medicaid rebates are typically billed up to six months after the product is shipped. As a result, a Medicaid rebate provision includes: an estimate of outstanding claims for end-customer
sales that occurred but for which the related claim has not been billed; and an estimate for future claims that will be made when inventory in our distribution channels is sold through to
end-customers. Our calculation also requires other estimates, such as estimates of sales mix, to determine which sales are subject to rebates and the amount of such rebates. Periodically,
we adjust the Medicaid rebate provision based on actual claims paid. Due to the delay in billing, adjustments to actual may incorporate revisions of this rebate provision for several periods.

Chargebacks
relate to our contractual agreements to sell products to group purchasing organizations and other indirect customers at contractual prices that are lower than the list prices we charge
wholesalers. When these group purchasing organizations or other indirect customers purchase our products through wholesalers at these reduced prices, the wholesaler charges us for the difference
between the prices they pay us and the prices they sold the products to the indirect customers.

At
December 31, 2004 and 2003, accrued rebates and chargebacks were $10.2 million and $21.2 million, respectively. In 2004, 2003 and 2002, provisions for rebates and chargebacks
related to