Indemnity/Limitation of Liability/Insurance. DSM agrees to defend, reimburse, indemnify, and hold harmless Supplier from and against all assessments, claims, demands and judgments for liability, damages (including without limitation punitive damages), costs (including attorneys’ fees and litigation expenses through trial and appeal), and fines (collectively “Liability”) made or recovered against Supplier arising out of or relating to: a) any misrepresentations to DSM’s Customers to the extent caused by DSM or its Employees; b) any intentional misconduct or gross negligence by DSM or its employees; c) violation of any third party intellectual property rights caused by the Product Trade Name (defined below) (if provided by DSM); or d) violation of any law by DSM. Supplier agrees to defend, reimburse, indemnify and hold harmless DSM and all of its agents, employees, customers, and insurers and Suppliers from and against all Liability made or recovered against a DSM lndemnitee for any of the following caused by Supplier, Supplier’s employees, agents, representatives, principals, subcontractors or related entities (collectively “Staff’), or arising out of or relating to the manufacture, production, design, or shipment of any Product Supplier provides a:) bodily injury or death to any person or property damage; b) violation of any intellectual property rights; or c) violation of any law, misrepresentation or breach of the Agreement. An indemnitee shall promptly notify the indemnifying party in writing of any claim and cooperate in its defense. “Trade Name” means the Product name, trademark, and logo. Except for any obligations of indemnification or otherwise expressly provided herein, UNDER NO CIRCUMSTANCE WILL A PARTY BE LIABLE FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL OR PUNITIVE DAMAGES OR LOST PROFITS NO MATTER HOW ARISING OR WHETHER SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. Except for any obligations of indemnification or otherwise expressly provided herein, THE TOTAL LIABILITY, lF ANY, OF DSM WILL BE LIMITED TO THE COST OF THE PRODUCT(S) GIVING RISE TO THE CLAIM. You shall name Direct Supply Manufacturing, Inc. as an additional insured on all insurance policies required by this Blanket PO and its terms. This Section shall survive the termination or expiration of this Blanket PO for any reason.
Medical Device Information. Some or all of the Products are medical devices as that term is used by the U.S. Food and Drug Administration (“FDA”) under the Safe Medical Device Act and U.S. Food, Drug & Cosmetics Act (collectively the “Acts”). Except for Joerns-branded Products, FDA requirements for Products will be further described in the applicable Feature Guidelines for each Product. For Joerns branded Products, you are the Contract Manufacturer and agree to produce Products that meet the specifications provided by the Specification Developer (e.g., Joerns). For all non-Joerns branded products, DSM is solely a domestic distributor of the Products as is not the Specification Developer, Contract Manufacturer, Initial Importer, or Repackager/Relabeler (as those terms are defined in the Acts). Supplier, as the Product Manufacturer, agrees to (i) comply with all relevant laws and regulations relating to the specification, manufacture, importation and initial sale of the products, including but not limited to relevant FDA laws and regulations; (ii) maintain all applicable FDA registrations and listings throughout the term of the Blanket PO. All FDA Product listings shall be marked “Confidential” so they are not included on the FDA’s publicly available database; (iii) ensure the Products are not and will not become adultered or misbranded; (iv) implement, follow and provide certification of all Good Manufacturing Product’s (“GMP’s”) to the extent applicable to any Products; (v) maintain compliance with all post-sale requirements of the Act, including but not limited to Medical Device Reporting, Medical Device Reports of Corrections and Removals, and those record keeping requirements set forth in the Act, and (vi) obtain and maintain tests from recognized third-party laboratories which support all Product claims, in cluing but not limited to flammability, Underwriters Laboratory (UL) certifications, and ETL listings, if we agree to assist in procuring such tests, you agree to provide samples free of charge. FDA Establishment Registration 3004728444 (manufacturer). Upon our request, you agree to provide us documentation evidencing your compliance with these requirements and you agree to promptly notify us of any breach of these requirements.
Professionalism and Compliance. Each party represents and agrees that it and its Staff will comply with all applicable international, federal, provincial, state and local laws, rules and regulations applicable to this Blanket PO and the products provided hereunder including, without limitation, the U.S. Foreign Corrupt Practices Act, antitrust laws, local employee health and safety laws, and any applicable trade restrictions, export controls, and anti-boycott laws and regulations. Each party represents that it will not pay, offer, promise to pay, or authorize payment of any bribe or other unlawful benefit or remuneration to any government official, political party official, candidate for office, or representative of any public international organization to obtain or retain business or to secure any improper advantage. This includes without limitation any payment, offer, benefit, solicitation, or remuneration which is unlawful under the laws of the United States, a treaty to which the U .S. is a party, or the Supplier’s country of operation. Supplier certifies that it is not and has not been subject to any investigation (other than previously disclosed to DSM), prosecution, litigation, conviction, assessment or finding of liability by any governmental authority involving the design, manufacture, import or export of any products, materials or software; the unlawful treatment or employment of employees including without limitation any children; or any other law, regulation or treaty which is materially related to the Supplier’s obligations under this Blanket PO.
Export/lmport. Each party agrees that it and its subsidiaries, employees, agents, and Contractors, and, as to Supplier, additionally Supplier’s Staff, will comply with all export control laws and not export any product, equipment, software, data, device, information, or work product to any country in violation of such export laws. Supplier will be the importer and exporter of record and/or prepare all customs filings for any such importation or exportation. Supplier will be responsible for all duties, taxes, tariffs, and fees as well as proper filing of country of origin, U .S. and all other country’s customs documents and reports associated with the import and export of the Products in and from the U.S. and country of origin (or any other country). Supplier will be listed as the consignee on all documents, and only Supplier will be listed as “in care of” party for import in to the United States. DSM will cooperate with and assist Supplier with any information known or readily available to DSM necessary for Supplier to perform its obligations under this Blanket PO.
Miscellaneous. These Specialty Terms, our Standard T&Cs, the Blanket PO, and our individual POs are the full, final, and integrated Agreement (“Agreement”) between the parties and supersede all prior contracts or understandings which relate to the subject matter of the Agreement. This Agreement does not amend, supersede, or affect any “Approved Supplier Relationship Agreement (or similar contract) for the Supplier’s branded products nor does it amend, supersede, or affect ay contract DSM may have with any of your subsidiary or affiliated entities which remain in full force and effect. You may not assign or subcontract this Agreement or any right or obligation thereunder without our prior written consent.
Last updated 11.11.2020