For the plastics used in these medical applications, this can mean compliance with the relevant chapters of the International Organization for Standardization (ISO), the United States Pharmacopeia Class VI (USP VI) the European Pharmacopeia (EP 3.1), and the International Conference on Harmonization (ICH Q3D) standards and guidelines. All four sites are ISO 13485 certified and use a harmonized raw material range as the base for globally available Mevopur standard portfolios and for custom formulations. The raw materials are pre-tested to the relevant chapters of ISO 10991, USP 661, USP Class VI, EP 3.1 and to the ICH Q3D guidelines to help manufacturers increase the certainty of regulatory compliance for their devices and packaging.

Avon Lake, OH for technical competence in the field of Chemical Testing This laboratory is accredited in accordance with the recognized International Standard ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories. This accreditation demonstrates technical competence for a defined scope and the operation of a laboratory quality management system (refer to joint ISO-ILAC-IAF Communiqué dated April 2017). Presented this 28th day of February 2020. _______________________ Vice President, Accreditation Services For the Accreditation Council Certificate Number 0514.02 Valid to December 31, 2021 Revised September 21, 2021 0514-02s SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017 Test Method or Standard: Test Description: 0514-02c

Avon Lake, OH for technical competence in the field of Chemical Testing This laboratory is accredited in accordance with the recognized International Standard ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories. This accreditation demonstrates technical competence for a defined scope and the operation of a laboratory quality management system (refer to joint ISO-ILAC-IAF Communiqué dated April 2017). Presented this 30th day of March 2018. _______________________ Vice President, Accreditation Services For the Accreditation Council Certificate Number 0514.02 Valid to December 31, 2019 Revised October 08, 2019 0514-02.pdf SCOPE OF ACCREDITATION TO ISO/IEC 17025:2005 Test Method or Standard: Test Description: 0514-02c.pdf

The timetable for testing, certification and enforcement as outlined on the CPSC web site (see link in adjacent column), generally requires compliance in advance of testing and certification. PDI is accredited under ISO 17025 by A2LA (the American Association for Laboratory Accreditation) to perform testing as an independent laboratory body. Global ISO Certificate Library

AS9100 Certication DEKRA CERTIFICATE Certificate Number: 131789.01 The Aerospace Quality Management System and implementation of: Fiber-Line, LLC With Central Functions At: 3050 Campus Drive Hatfield, PA 19440 United States The certification has been performed in accordance with the requirements of AS9104/1:2012, including its implementation, and meets the requirements of the standard: AS9100D (Based on and including ISO 9001:2015) Scope: The value added design and development of synthetic fiber products for use in public and private sectors. Certification Structure: Single Certificate Expiry Date: April 26, 2024 Certificate Issue Date: April 27, 2021 Certified Since: April 27, 2018 Dr. Onus Managing Director DEKRA Certification, Inc. 1120 Welsh Road, Suite 210 North Wales, PA 19454 USA (215) 997-4519 www.dekra.us/en/audits DEKRA Certification Inc. is an accredited Aerospace Registration Management Program Certification Body, under the ICOP scheme.

Manufactured across a global network of ISO 13485 facilities, they meet or exceed requirements for regulations such as USP Class VI, ISO 10993, USP 661, and ICH Q3D. Like other Mevopur formulations, they are manufactured in dedicated ISO 13485 facilities and supported by testing to ISO 10993-1, USP, European Pharmacopeia, and ICH Q3D guidelines. They are offered in pre-colored or concentrate form in a range of vivid opaque and transparent colors that are fully bio-compatible per ISO 10993 standards to provide ultra-high-heat resistance and performance without compromising safety.

Global ISO Certificate Library

Global ISO Certificate Library

Industrial Valle del Cinca s/n Apartado 18 22300 Barbastro, Huesca Spain has been assessed by ABS Quality Evaluations, Inc. and found to be in conformance with the requirements set forth by: ISO 9001:2015 The Quality Management System is applicable to: DEVELOPMENT, PRODUCTION & DISTRIBUTION OF TECHNICAL THERMOPLASTICS. This certificate may be found on the ABS QE Website (www.abs-qe.com). Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.

Industrial Valle del Cinca s/n Apartado 18 22300 Barbastro, Huesca Spain has been assessed by ABS Quality Evaluations, Inc. and found to be in conformance with the requirements set forth by: ISO 14001:2015 The Environment Management System is applicable to: DEVELOPMENT, PRODUCTION & DISTRIBUTION OF TECHNICAL THERMOPLASTICS. This certificate may be found on the ABS QE Website (www.abs-qe.com). Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.