Life Sciences Product Approval Representation and Warranty Clause

Summary

This Life Sciences Product Approval Representation and Warranty Clause from the seller discloses the status of relevant product approvals. This template includes practical guidance, drafting notes, and alternate clauses. In the United States, pharmaceuticals and biologics must, in most cases, be approved by the FDA before they can be marketed to the public. Novel pharmaceutical products are typically approved pursuant to a new drug application, or "NDA." Generic pharmaceuticals are typically approved through a more streamlined process pursuant to an abbreviated new drug application or "ANDA." Similarly, biologics are approved pursuant to a biologic license application or "BLA" and biosimilar products are approved pursuant to an abbreviated BLA process. Except in the case of Class I devices, such as simple bandages and tongue depressors, medical device manufacturers are required to submit either a premarket notification under Section 510(k) of the Federal Food Drug and Cosmetics Act or a premarket application (PMA) to the FDA. The seller represents that the product approvals are (i) registered in seller's name, (ii) in full force, (iii) all related application and fees have been paid, and (iv) not subject to any actions, pending or threatened, to withdraw such product approval. For detailed guidance on life sciences transactions, see Life Sciences M&A Transactions and Life Sciences Corporate Transactions Resource Kit. See also these annotated clauses: • Life Sciences FDA Matters Representation and Warranty Clause • Life Sciences Purchase Price Inventory Adjustment Clause • Life Sciences Inventory Count Clause • Life Sciences Inventory / Sufficiency of Assets Representation and Warranty Clause • Life Sciences Medical Device FDA Matters Representation and Warranty Clause • Life Sciences Milestone Based Earn-Out Clause (EU) • Life Sciences Net Sales Based Earn-Out Clause • Life Sciences Post-Closing Accounts Receivable Covenant Clause • Life Sciences Post-Closing Price Reporting Covenant Clause • Life Sciences Post-Closing Regulatory Covenant Clause • Life Sciences Post-Closing Transitional Brand License Clause • Life Sciences Post-Closing Transition Covenant Clause • Life Sciences Product Liability Representation and Warranty Clause • Life Sciences Sales / Net Revenue Based Earn-Out Clause • Life Sciences Survival Clause • Life Sciences Working Capital Adjustment Clause For information about the FDA approval process for pharmaceuticals, medical devices, and other life sciences products, see the FDA Approval Process topic in the Practical Guidance Life Sciences practice area.