4.10. Required Notification. Seller shall promptly notify Buyer by electronic medium (fax or e-mail), with confirming notice via a nationally recognized overnight delivery service that guarantees overnight delivery and requires the signature of recipient, as soon as Seller becomes aware of any: (a) defect or condition which renders or may render any Product ineffective or dangerous; (b) Product that is not in compliance with the Specifications (including manufacturing processes, labeling or packaging) or any QA Standards; (c) any death or bodily injury caused by a Product (or suspected to be caused by a Product) or any malfunction of a Product; or (d) regulatory, FDA or ISO inspections and/or other communications with Regulatory Authorities related to Product or that would in any way impact the Product or Sellers performance of its responsibilities hereunder.
4.11. Quality Plan. Seller and Buyer shall establish a quality plan which shall define the quality practices, the resources and the activities relevant to Products that are designed or manufactured for Buyer. Notwithstanding the foregoing, at Buyers request, the parties shall negotiate in good faith and enter into a separate quality agreement setting forth the parties respective rights, responsibilities and obligations with respect to Product quality.
4.12. Compliance with Laws. Each party shall comply with all Laws and regulations applicable to the performance of its obligations under this Agreement, including Laws and regulations pertaining to the testing, manufacture, labeling, packaging import, export, distribution, sales or marketing of the Products.
4.13. Packaging and Labeling. All Products shall be labeled (including bar coding/UPN numbers) in accordance with the procedures specified from time to time by Buyer and Buyer shall have final approval over all packaging and labeling for Products. Buyer maintains the right to over label Products as it deems necessary but shall not utilize any trademarks of Seller without Sellers approval. Buyer is responsible for ensuring that all packaging and labeling materials, data, information, text, and graphics for use with the Products are in compliance with applicable Law and relevant regulatory approvals.
4.14. EEO Laws. Each party acknowledges that the other party is an equal employment opportunity/affirmative action employer subject to the EEO Laws. By acceptance of this Agreement, each party certifies that it complies and will continue to comply with all applicable EEO Laws, and it shall not, amongst other things, discriminate on the basis of race, age, color, religion, gender, sexual orientation, disability, veteran status, national origin or any other characteristic protected by federal, state or local Law.
5. Additional Representations and Warranties. Each party hereby represents and warrants to the other party that the execution and delivery of and performance under this Agreement by such party does not, and will not, conflict with or violate any other agreement or obligations with third parties or any restrictions of any kind or any Law to which it is bound or subject.
6. Confidential Information; Intellectual Property.
6.1. Confidential Information. Article 8 of the Transition Services Agreement shall apply to Confidential Information of each party disclosed or accessed under this Agreement, and is incorporated herein by reference.
6.2. Tangible Property. All tangible property of one party provided to the other party in connection with this Agreement, including reports, communications, and analyses (collectively, Tangible Property), shall be and remain the exclusive property of such party