Bergmann GmbH Adolf-Dambach-Str. 2-4 76571 Gaggenau the introduction and application of a management system according to ISO 50001:2018 Scope: DEVELOPMENT AND PRODUCTION OF TECHNICAL POLYMERS The proof has been furnished by an audit.

主要特性 生产符合高于CAS编号级别的变更控制原则 （与MEVOPUR母粒类似），降低变更风险 不含动物源性物质和邻苯二甲酸盐 适用于吹膜、注塑、吹塑和挤出 • • • 注册药品主文件（III型） 食品接触符合FDA/EU*要求 法规支持 原材料根据以下法规测试：- ISO 10993-1 - USP第、章，包括VI级别，符合眼 科和鼻腔用药物要求 - 欧洲药典3.1.3/3.1.5（聚烯烃） - 美国药典（聚乙烯） - ICH Q3D 杂质元素 - USP和USP，透光率 • • • 载体材料 耐光性 热稳定性 产品代码颜料含量/类型 HDPE 50% TiO2 8 300°C PH00075525 LLDPE 60% TiO2 8 300°C PL00075542 LLDPE 70% TiO2 8 300°C PL00075545 PP 50% TiO2 8 300°C PP00075717 适用医疗保健使用限制—见下文。埃万特的产品不为以下目的或用途而设计，也不会宣传或预期用于以下目的或用途：(a) 被美国食品药品监督管理局（FDA）或国际标准化组织（ISO）归类为“植入”类器械的医疗器械；或美国药典（USP）或ISO标准定义的“永久”使用器械；或 (b) 经修订的欧盟指令90/385/EEC中定义的有源植入式医疗器械；或者 (c) 经修订的欧盟指令93/42/EEC中定义的“长期”使用的医疗器械。

All Rights Reserved 2024 33 Drug delivery devices CATALYZE THE CORE M ARKET DRIVERS & NEEDS • Regulatory compliance • Reliable material quality and uninterrupted supply • Supply chain risk mitigation • Global reach $6B ADDRESSABLE MARKET A V I E N T E N D M A R K E T S , A P P L I C A T I O N S AVIENT VALUE PROPOSITION • ISO 13485 accredited sites • Globally approved raw material portfolio • Strict change management • Global supply Auto injectors Syringes Inhalers OTHER APPLICATONS • In-vitro diagnostics • Remote monitoring • Pharma packaging • Catheters • Medical equipment Copyright © .

KEY CHARACTERISTICS • Manufactured under change control principles beyond CAS number (similar level as MEVOPUR concentrates), reducing risk of change • Free from animal-derived substances and phthalates • Suitable for blown film, injection molding, blow molding and extrusion REGULATORY SUPPORT • Raw materials tested to: - ISO 10993-1 - USP chapters , including Class VI, a requirement for ophthalmic and nasal drugs - European Pharmacopeia 3.1.3/3.1.5 (polyolefin) - USP (polyethylene) - ICH Q3D elemental impurities - USP and USP light transmission • Registered Drug Master File (Type III) • Food contact compliance established with FDA/EU* APPLICATION BULLETIN CARRIER MATERIAL PIGMENT CONTENT/TYPE LIGHT FASTNESS THERMAL STABILITY PRODUCT CODE HDPE 50% TiO2 8 300°C PH00075525 LLDPE 60% TiO2 8 300°C PL00075542 LLDPE 70% TiO2 8 300°C PL00075545 PP 50% TiO2 8 300°C PP00075717 Healthcare use limitations apply—see below. Avient products have not been designed for nor are they promoted or intended for use in: (a) medical devices categorized by either the United States Food and Drug Administration (FDA) or the International Standards Organization (ISO) as an “implant” device; or “Permanent” as defined under US Pharmacopoeia (USP) or ISO standards; or (b) active implantable medical devices as defined in EU Directive 90/385/EEC as amended; or (c) medical devices for “Long Term” use as defined in EU Directive 93/42/EEC as amended.

Normative base ISO 22000:2018 Food Safety Management Systems - Requirements for any organization in the food chain Reg. no. 46389 Page 1 of 1 Validity 25. 02. 2024  – 24. 02. 2027 Issue 20. 12. 2023  A.Grisard, President SQS F.

Avient Colorants Germany GmbH Kornkamp 50 22926 Ahrensburg Germany Scope Production of Color- and Additives Concentrates, Compounds and Foaming Agents Normative base ISO 50001:2018 Energy Management System Reg. no. 46090 Validity 20. 01. 2021 – 19. 01. 2024 Issue 12. 04. 2021 Swiss Made Swiss Association for Quality and Management Systems (SQS) Bernstrasse 103, 3052 Zollikofen, Switzerland sqs.ch F.

Bergmann GmbH Adolf-Dambach-Str. 2-4 76571 Gaggenau the introduction and application of a management system according to ISO 50001:2018 scope: Delelopment and production of technical Polymers; at the sites according to appendix.

Versaflex HC - Syringe Plunger - English SYRINGE MANUFACTURER D I S P O S A B L E S Y R I N G E P L U N G E R • USP VI and ISO 10993-4,5 compliant • Sterilize by gamma & EtO • Long-term sealing performance • Low coefficient of friction (COF) • Consistent performance across barrel sizes • Provided a formulated solution that met rigorous medical application requirements • Improved global supply continuity • Increased process efficiency by replacing previous thermoset material with TPE Versaflex™ HC 2110-57B KEY REQUIREMENTS WHY AVIENT?

SYRINGE MANUFACTURING D I S P O S A B L E S Y R I N G E T I P C A P • Excellent sealing and resealing performance • No DEHP or natural rubber latex added during processing • Can be sterilized by EtO • Compliance with ISO 10993-4&5, USP Class VI Dynaflex™ Thermoplastic Elastomer KEY REQUIREMENTS WHY AVIENT?

FAMOUS UNDERWEAR BRAND U N D E R W I R E • Formulated a 40% bio-derived material to help meet customer’s sustainable goals with good rigidity and supporting strength • Improved comfort and softness compared to a normal steel underwire design • Passed ISO 105-X18 textile test with good chemical resistance, durability, and wash fastness Customized reSound™ BIO TPE WHY AVIENT?