FDA Matters. Notify and consult with Parent promptly (A) after receipt of any material communication 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 FDA (or any similar foreign Governmental Entity), and (B) prior to making any material change to a study protocol, 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.
Appears in 2 contracts
Samples: Agreement and Plan of Merger (Genzyme Corp), Agreement and Plan of Merger (Bone Care International Inc)
FDA Matters. Notify and consult with Parent promptly (A) after receipt of any material communication between the Company and from 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 FDA (or any similar foreign Governmental Entity)FDA, and (B) prior to making any material change to a study protocol, adding any the addition of 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.
Appears in 2 contracts
Samples: Agreement and Plan of Merger (Ilex Oncology Inc), Agreement and Plan of Merger (Genzyme Corp)
FDA Matters. Notify and consult with Parent promptly (A) after receipt of any material communication between the Company and from 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 FDA (or any similar foreign Governmental Entity)FDA, and (B) prior to making any material change to a study protocol, adding any the addition of 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.
Appears in 2 contracts
Samples: Agreement and Plan of Merger (Geltex Pharmaceuticals Inc), Agreement and Plan of Merger (Genzyme Corp)
FDA Matters. Notify and consult with Parent promptly immediately (A) after receipt of any material communication between the Company and from 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 FDA (or any similar foreign Governmental Entity)FDA, and (B) prior to making any material change to a study protocol, adding any the addition of 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.
Appears in 2 contracts
Samples: Agreement and Plan of Merger (Antigenics Inc /De/), Agreement and Plan of Merger (Antigenics Inc /De/)
FDA Matters. Notify and consult with Parent promptly immediately (A) after receipt of any material communication between the Company and from 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 FDA (or any similar foreign Governmental Entity)FDA, and (B) prior to making any material change to a study protocol, adding any the addition of 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.
Appears in 1 contract
FDA Matters. Notify and consult with Parent promptly immediately (A) after receipt of any material communication between the Company and from 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 FDA (or any similar foreign Governmental Entity), and (B) prior to making any material change to a study protocol, adding any protocol commencing new trials, making any material change to a manufacturing plan or process, trials or making a material change to the development timeline for any of its product candidates or programs.
Appears in 1 contract
