October 1, Dear Valued Customer:
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- Ilene Bell
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1 October 1, 2010 Dear Valued Customer: We are pleased to inform you that, with the sale of our company to an affiliate of New Mountain Capital, LLC, we have a new name. Effective today, Mallinckrodt Baker is now Avantor Performance Materials. It s a new name for us and a new day for us all. Avantor (pronounced ah-vahn-tor) comes from: Avant, which means leading or innovating (as in avant-garde); and Tor, which means mountain. Avant captures our new energy, innovation, passion and bold, cutting-edge ideas. Tor signifies our aspiration to achieve new heights of performance and quality. The name Avantor captures the heart and soul of innovation; pushing known boundaries and overcoming obstacles. It tells you we ll be a high-tech company that is bold and energetic, passionate about helping you soar to new heights, take on new challenges and achieve new breakthroughs. It promises you a market-leading partner in advancing cutting-edge performance. The support of our new owners gives us the opportunity to realize our full potential by enhancing our product lines and global supply chain to better serve you anywhere in the world. We know that you depend on our product quality and consistency in existing and new technologies where reliable, reproducible results are critical. Looking ahead, we will continue to enhance our offerings to provide you with advanced chemistries and materials that enable performance, increase speed to market and enhance your processes. Over the years, our strong customer relationships have enabled us to achieve success in the worldwide chemical industry. We remain committed to providing you with the high level of quality and service you have come to expect from Mallinckrodt Baker. We do not anticipate any supply interruptions or process changes as a result of the acquisition which closed last month. And while we will continue to use the J.T.Baker brand, the Mallinckrodt name will be retained by Covidien. Over time, any products sold under our Mallinckrodt product line brand name will be transitioned to a new name. We expect to make further announcements regarding the branding of the Mallinckrodt product line in the near future. Thank you for your continued support and partnership. We will update you regarding significant developments during this exciting time as they occur. If you have any questions about our company or any of the matters discussed in this letter, please do not hesitate to contact your Avantor sales representative. Sincerely, Ron J. Harding President Mallinckrodt is a trademark of Mallinckrodt Inc. Other trademarks are owned by Avantor Performance Materials, Inc. or its affiliates unless otherwise noted Avantor Performance Materials, Inc.
2 October 1, 2010 Dear Valued Customer: Our records indicate that you have requested notification of change by registering in the Mallinckrodt Baker change notification database or you have purchased Mallinckrodt Baker product(s) within the last three years. Change Type Tracking Notification Type Product(s) Company Name Change MOC-QUAL-4896 Final All Mallinckrodt Baker products Description of Change From: Mallinckrodt Baker, Inc. to Avantor TM Performance Materials, Inc. Change affects all company documentation including but not limited to product labels, Certificate of Analysis, MSDS, Shipping documents, and all other company documentation. This may result in the relocation of company name or address on our labels or other documents. Changes will begin occurring October 1, Reason for Change New Company name due to acquisition. Please contact your Mallinckrodt Baker representative if you have any questions regarding this change. We appreciate your continued confidence and interest in Mallinckrodt Baker products. Sincerely Nicole Mlezvia Documentation Supervisor NM/dj If you wish to update your contact information or are currently receiving this notification via mail and would prefer to receive these notifications electronically, please provide us with your address by contacting us at All Trademarks owned by Mallinckrodt Baker, Inc. unless otherwise noted. Mallinckrodt is a registered Trademark of Mallinckrodt Inc. Mallinckrodt Baker, Inc. Mallinckrodt Baker B.V. Mallinckrodt Baker Sdn Bhd Mallinckrodt Baker S.A. de C.V. 222 Red School Lane Teugseweg 20 A , 12th Floor, Kelana Brem Tower 1 Plomo 2, Fracc. Industrial Esfuerzo Nacional Phillipsburg NJ USA 7418 AM, Deventer Jalan SS7/15,(Jalan Stadium),Kelana Jaya Xalostoc CP Ecatepec Technical Service Department The Netherlands Petaling Jaya Estado de Mexico MEXICO Tel: Tel: Selangor Malaysia Tel: Toll Free: jtbaker.nl@covidien.com Tel: mbi@covidien.com sales.mbm@covidien.com
3 Avantor Performance Materials, Inc. 222 Red School Lane Phillipsburg, NJ U.S.A. Tel: To our valued customers, Fax: October 4, 2010 Mallinckrodt Baker, Inc. was acquired from Covidien by an affiliate of New Mountain Capital on August 27, As part of the contract, Covidien retained the exclusive use of the Mallinckrodt name, resulting in the need to rename Mallinckrodt Baker. On October 1, 2010, Mallinckrodt Baker announced the new company name as Avantor TM Performance Materials, Inc. This change is simply a renaming of the company. It is not an establishment of a new company and does not entail any changes to any operating or administrative processes of the company. The initial notice that the company name would change occurred in June More recently, you received a management of change notification (MOC-QUAL-4896) and we would like to proactively provide further information that would be helpful.. With this name change, we want to clearly state there are no changes to our legal entity, existing processes or systems. More specifically, there are no changes to our EIN number, quality systems, product codes, product lot numbering system, facilities, analytical methods, supply chain, supplier quality program, validations, customer service, management of change or standard operating procedures. As required by our management of change process, you would receive appropriate notification of such changes in the future with these systems; though no change is expected at this time. The label system was updated to replace Mallinckrodt Baker, Inc. with the new company name, Avantor Performance Materials, on October 1, However, existing product inventory will not be relabeled to reflect this change, so there will be a transition period during which you may continue to receive product labels with a Mallinckrodt Baker company name until all that inventory pipeline is cleared. The certificates of analysis are being updated during the week of October 4, 2010 with the new company name and will reference formerly known as Mallinckrodt Baker Inc. for a transition period of at least six months. Attached are examples of a product label before and after the change, as well as certificates of analysis before and after the change for your reference. ISO and FDA registrations are being updated with the new company name during the week of October 4, These changes will not affect the FDA, NDC or registration numbers. Avantor will continue to offer the J.T. Baker brand.. Covidien is retaining exclusive use if the Mallinckrodt brand for its pharmaceutical line of products, so Avantor must rename our line of Mallinckrodt brand products. Therefore, we will be announcing a new brand name to replace the Mallinckrodt brand before the end of the calendar year. No manufacturing, process, or raw material changes will be made as a result of this re-branding. Thank you for your business and if you have any further questions or concerns, please contact Juanita Garofalo, Regulatory Affairs Manager at Sincerely, Marcy Matlosz Global Director of Quality Assurance and Regulatory Affairs
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5 Previous Methanol 'BAKER ANALYZED' HPLC Solvent For Use in Liquid Chromatography and Spectrophotometry (methyl alcohol) Product No Lot No. J33E42 Release Date 08/17/2010 Assay (CH 3 OH) (by GC, corrected for water) 99.8 % min % Ultraviolet Absorbance (1.00-cm cell vs. water): nm 0.01 max nm 0.15 max UV Cut-off, nm 205 max. 205 Gradient Elution Test (a.u.): 254 nm max Fluorescence Trace Impurities, in ppb, measured as Quinine Base: at 450 nm Emission 0.3 max at Emission Maximum for Impurities 1.0 max. 0.1 Acetone % max. < % Residue after Evaporation 1 ppm max. 0.2 ppm Titrable Acid (ueq/g) 0.3 max. 0.2 Titrable Base (ueq/g) 0.1 max Water (by KF, coulometric) 0.05 % max. < 0.01 % For Laboratory, Research or Manufacturing Use Country of Origin: USA For questions on this Certificate of Analysis please contact Technical Services at or Mallinckrodt Baker, Inc. 222 Red School Lane Phillipsburg, NJ Phone: Fax:
6 Current Methanol 'BAKER ANALYZED' HPLC Solvent For Use in Liquid Chromatography and Spectrophotometry (methyl alcohol) Product No Lot No. J33E42 Release Date 08/17/2010 Assay (CH 3 OH) (by GC, corrected for water) 99.8 % min % Ultraviolet Absorbance (1.00-cm cell vs. water): nm 0.01 max nm 0.15 max UV Cut-off, nm 205 max. 205 Gradient Elution Test (a.u.): 254 nm max Fluorescence Trace Impurities, in ppb, measured as Quinine Base: at 450 nm Emission 0.3 max at Emission Maximum for Impurities 1.0 max. 0.1 Acetone % max. < % Residue after Evaporation 1 ppm max. 0.2 ppm Titrable Acid (ueq/g) 0.3 max. 0.2 Titrable Base (ueq/g) 0.1 max Water (by KF, coulometric) 0.05 % max. < 0.01 % For Laboratory, Research or Manufacturing Use Country of Origin: USA For questions on this Certificate of Analysis please contact Technical Services at or Avantor Performance Materials, Inc. (formerly Mallinckrodt Baker, Inc.) 222 Red School Lane Phillipsburg, NJ Phone: Fax:
7 Previous Acetic Acid, Glacial U.S.P., F.C.C., A.C.S. Product No Lot No. J35006 Release Date 08/24/2010 GMP Manufactured Product Meets U.S.P., F.C.C. & A.C.S. Requirements Assay (CH 3 COOH) % % Assay (CH 3 COOH) (by GC) 99.7 % min % Acetic Anhydride ((CH 3 CO) 2 O) 0.01 % max. < 0.01 % Arsenic (As) 3 ppm max. < 3 ppm Appearance Passes Test Passes Test Chloride (Cl) 1 ppm max. < 1 ppm Chloride (Cl) (USP) Passes Test Passes Test Color (APHA) 10 max. 5 Congealing Temperature 15.6 C. min C. Copper (Cu) % max. < % Dilution Test Passes Test Passes Test Freezing Point 16.0 C. min C. Heavy Metals (as Pb) (ACS) 0.5 ppm max. < 0.5 ppm Heavy Metals (as Pb) (USP) 5 ppm max. < 5 ppm Identification Passes Test Passes Test Iron (Fe) 0.2 ppm max. < 0.2 ppm Lead (Pb) 0.5 mg/kg max < 0.5 mg/kg Nickel (Ni) % max. < % Nonvolatile Residue % max. < % Readily Oxidizable Substances Passes Test Passes Test Residue after Evaporation % max. < % Solidification Point 15.6 C. min C. Substances Reducing Dichromate (ml) 0.40 max. < 0.40 Substances Reducing Permanganate Passes Test Passes Test Sulfate (SO 4 ) 1 ppm max. < 1 ppm Sulfate (USP)(SO 4 ) Passes Test Passes Test Titrable Base (meq/g) max. < Only Class 3 Solvents are likely to be present. Residual concentration of all Class 3 Solvents is <0.5% Bulk Food Chemical Bulk Pharmaceutical Chemical IMPORTANT: Material will freeze if stored below 17 C (63 F). Country of Origin: Manufacturer: USA P For questions on this Certificate of Analysis please contact Technical Services at or Mallinckrodt Baker, Inc. 222 Red School Lane Phillipsburg, NJ Phone: Fax:
8 Current Acetic Acid, Glacial U.S.P., F.C.C., A.C.S. Product No Lot No. J35006 Release Date 08/24/2010 GMP Manufactured Product Meets U.S.P., F.C.C. & A.C.S. Requirements Assay (CH 3 COOH) % % Assay (CH 3 COOH) (by GC) 99.7 % min % Acetic Anhydride ((CH 3 CO) 2 O) 0.01 % max. < 0.01 % Arsenic (As) 3 ppm max. < 3 ppm Appearance Passes Test Passes Test Chloride (Cl) 1 ppm max. < 1 ppm Chloride (Cl) (USP) Passes Test Passes Test Color (APHA) 10 max. 5 Congealing Temperature 15.6 C. min C. Copper (Cu) % max. < % Dilution Test Passes Test Passes Test Freezing Point 16.0 C. min C. Heavy Metals (as Pb) (ACS) 0.5 ppm max. < 0.5 ppm Heavy Metals (as Pb) (USP) 5 ppm max. < 5 ppm Identification Passes Test Passes Test Iron (Fe) 0.2 ppm max. < 0.2 ppm Lead (Pb) 0.5 mg/kg max < 0.5 mg/kg Nickel (Ni) % max. < % Nonvolatile Residue % max. < % Readily Oxidizable Substances Passes Test Passes Test Residue after Evaporation % max. < % Solidification Point 15.6 C. min C. Substances Reducing Dichromate (ml) 0.40 max. < 0.40 Substances Reducing Permanganate Passes Test Passes Test Sulfate (SO 4 ) 1 ppm max. < 1 ppm Sulfate (USP)(SO 4 ) Passes Test Passes Test Titrable Base (meq/g) max. < Only Class 3 Solvents are likely to be present. Residual concentration of all Class 3 Solvents is <0.5% Bulk Food Chemical Bulk Pharmaceutical Chemical IMPORTANT: Material will freeze if stored below 17 C (63 F). Country of Origin: Manufacturer: USA P For questions on this Certificate of Analysis please contact Technical Services at or Avantor Performance Materials, Inc. (formerly Mallinckrodt Baker, Inc.) 222 Red School Lane Phillipsburg, NJ Phone: Fax:
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