Each of such adjustments has not yet occurred, are out of the Company's control and/or cannot be reasonably predicted. For the same reasons, the Company is unable to address the probable significance of the unavailable information. They are based on management's expectations that involve a number of business risks and uncertainties, any of which could cause actual results to differ materially from those expressed in or implied by the forward-looking statements.

Seller makes no representation or warranty of any kind with respect to the Product, express or implied, respecting merchantability or fitness for any particular purpose, whether used alone or in combination with any other material or in any process, and neither party has relied on any statement outside of these terms. Buyer assumes all risk of infringement of third-party intellectual property rights by reason of any use Buyer makes of the Product in combination with other substances or in the operation of any process, and all infringement arising out of Seller’s compliance with Buyer’s designs, specifications or instructions, and Buyer shall defend, indemnify and hold Seller harmless from and against the same. Seller may, during any period of shortage due to any cause, prorate, and allocate its supply of such materials among itself for its own consumption, its subsidiaries, affiliated companies, its accepted orders, contract customers, and its regular customers not then under contract in such a manner as may be deemed fair and reasonable by Seller.

Seller makes no representation or warranty of any kind with respect to the Product, express or implied, respecting merchantability or fitness for any particular purpose, whether used alone or in combination with any other material or in any process, and neither party has relied on any statement outside of these terms. Buyer assumes all risk of infringement of third-party intellectual property rights by reason of any use Buyer makes of the Product in combination with other substances or in the operation of any process, and all infringement arising out of Seller’s compliance with Buyer’s designs, specifications or instructions, and Buyer shall defend, indemnify and hold Seller harmless from and against the same. Seller may, during any period of shortage due to any cause, prorate, and allocate its supply of such materials among itself for its own consumption, its subsidiaries, affiliated companies, its accepted orders, contract customers, and its regular customers not then under contract in such a manner as may be deemed fair and reasonable by Seller.

Seller makes no representation or warranty of any kind with respect to the Product, express or implied, respecting merchantability or fitness for any particular purpose, whether used alone or in combination with any other material or in any process, and neither party has relied on any statement outside of these terms. Buyer assumes all risk of infringement of third-party intellectual property rights by reason of any use Buyer makes of the Product in combination with other substances or in the operation of any process, and all infringement arising out of Seller’s compliance with Buyer’s designs, specifications or instructions, and Buyer shall defend, indemnify and hold Seller harmless from and against the same. Seller may, during any period of shortage due to any cause, prorate, and allocate its supply of such materials among itself for its own consumption, its subsidiaries, affiliated companies, its accepted orders, contract customers, and its regular customers not then under contract in such a manner as may be deemed fair and reasonable by Seller.

Seller makes no representation or warranty of any kind with respect to the Product, express or implied, respecting merchantability or fitness for any par- ticular purpose, whether used alone or in combination with any other material or in any process, and neither party has relied on any statement outside of these terms. Buyer assumes all risk of infringement of third-party intellectual property rights by reason of any use Buyer makes of the Product in combination with other sub- stances or in the operation of any process, and all infringement arising out of Seller’s compliance with Buyer’s designs, speci- fications or instructions, and Buyer shall defend, indemnify and hold Seller harmless from and against the same. Seller may, during any period of shortage due to any cause, prorate, and allocate its supply of such materials among itself for its own consumption, its subsidiaries, affiliated com- panies, its accepted orders, contract customers, and its regular customers not then under contract in such a manner as may be deemed fair and reasonable by Seller.

Each of such adjustments has not yet occurred, are out of the Company's control and/or cannot be reasonably predicted. For the same reasons, the Company is unable to address the probable significance of the unavailable information. You are advised to consult any further disclosures we make on related subjects in our reports on Form 10-Q, 8-K and 10-K that we provide to the

Certificate of Product Liability Insurance Provided upon request, contact your sales representative. Core processes that may be additional at the ISO 13485 sites include the following as they relate to the Mevopur medical line of products: Change control All changes concerning any Mevopur products are evaluated to determine whether there will be any impact on the product specification or the quality of the product. These standards are designed to mitigate potential health risks related to food products and or nutraceutical products from their packaging and/or any other material that may come into direct contact with it.

You are advised to consult any further disclosures we make on related subjects in our reports on Form 10-Q, 8-K and 10-K that we provide to the Securities and Exchange Commission. Each of such adjustments has not yet occurred, are out of the Company's control and/or cannot be reasonably predicted. For the same reasons, the Company is unable to address the probable significance of the unavailable information.

They are based on management's expectations that involve a number of business risks and uncertainties, any of which could cause actual results to differ materially from those expressed in or implied by the forward-looking statements. You are advised to consult any further disclosures we make on related subjects in our reports on Form 10-Q, 8-K and 10-K that we provide to the Securities and Exchange Commission. Each of such adjustments has not yet occurred, are out of the Company's control and/or cannot be reasonably predicted.

Brands using silicone or TPU materials have been seeking an alternative for a number of reasons, including long sourcing lead times and manufacturing challenges for silicone and the inability of TPU to endure blue jeans contact without staining.