Common use of FDA Matters Clause in Contracts

FDA Matters. Notify and consult with Parent immediately (A) after receipt of any material communication from the FDA and before giving any material submission to the FDA, and (B) prior to making any material change to a study protocol, the addition of new trials, or a material change to the development timeline for any its product candidates or programs.

FDA Matters. Notify and consult with Parent immediately promptly (A) after receipt of any material communication from between the Company and the FDA (or any similar foreign Governmental Entity) or inspections of any manufacturing facility or clinical trial site and before giving any material submission to the FDAFDA (or any similar foreign Governmental Entity), and (B) prior to making any material change to a study protocol, the addition of adding any new trials, making any material change to a manufacturing plan or process, or making a material change to the development timeline for any of its product candidates or programs.

FDA Matters. Notify and consult with Parent immediately promptly (A) after receipt of any material communication from the FDA and before giving any material submission to the FDA, and (B) prior to making any material change to a study protocol, the addition of new trials, or a material change to the development timeline for any of its product candidates or programs.

FDA Matters. Notify and consult with Parent immediately promptly (A) after receipt of any material communication from the FDA or inspections of any manufacturing or clinical trial site and before giving any material submission to the FDA, and (B) prior to making any material change to a study protocol, the addition of new trials, any material change to a manufacturing plan or process, or a material change to the development timeline for any of its product candidates or programs.

FDA Matters. Notify and consult with Parent immediately (A) after receipt of any material communication from the FDA and before giving any material submission to the FDA, and (B) prior to making any material change to a study protocol, the addition of new trials, or a material change to the development timeline for any of its product candidates or programs.

FDA Matters. Notify and consult with Parent immediately (A) after receipt of any material communication from the FDA and before giving any material submission to the FDA, FDA and (B) prior to making any material change to a study protocol, the addition of protocol commencing new trials, trials or making a material change to the development timeline for any of its product candidates or programs.