Examples of Marketed Products in a sentence
A copy of the Shire Investigational and Marketed Products Pregnancy Report Form (and any applicable follow-up reports) must also be sent to the CRO/Shire medical monitor using the details specified in the emergency contact information section of the protocol.
In addition to the above, if the investigator determines that the pregnancy meets serious criteria, it must be reported as an SAE using the Shire Clinical Study Serious Adverse Event andNon-serious AEs Required by the Protocol Form as well as the Shire Investigational and Marketed Products Pregnancy Report Form.
All pregnancies are to be reported from the time informed consent is signed until the defined follow-up period stated in Section 7.1.3. Any report of pregnancy for any female study participant must be reported within 24 hours to the Shire Global Pharmacovigilance and Risk Management Department using the Shire Investigational and Marketed Products Pregnancy Report Form.
To the extent that the FDA requests additional information or meetings regarding Buyer’s responsibilities as marketer and distributor of the Marketed Products in the applicable Territory, Buyer shall respond to the FDA at its own expense and through its own personnel.
Promptly after the Registrations have been transferred to Buyer and subject to applicable regulatory approvals, all Buyer advertising and promotional materials for the Marketed Products shall identify Buyer as the marketer of the Marketed Products in the applicable Territory, in such form as Buyer shall determine.
Promptly after the Registrations have been transferred to Buyer, Seller shall file with the FDA a notice that Buyer is the marketer and distributor of the Marketed Products in the applicable Territory.
Upon Closing, Seller shall sell, transfer, assign, convey and deliver or shall cause to be sold, transferred, assigned, conveyed and delivered to Buyer, all packaging material for the Marketed Products, including all package labels and product inserts used in connection with the Marketed Products owned or controlled by Seller or its Affiliates as of the Closing (the “Packaging Inventory”).
Marketed Products: comprises the sales, marketing, manufacture and distribution of drug developed from research and development activities.
Implementing processes shall be developed to be consistent with Electric Power Research Institute (EPRI) Guideline for the Utilization of Commercial Grade Items in Nuclear Safety Related Applications (NCIG-07), EPRI NP-5652 (6/88 as endorsed and modified by NRC Generic Letters 89-02, Actions to Improve the Detection of Counterfeit and Fraudulently Marketed Products (3/89) and 91-05, Licensee Commercial-Grade Procurement and Dedication Programs (4/91).
Promptly after the Registrations have been transferred to Buyer, Buyer shall make such changes in the package insert, Marketed Products labeling and packaging as may be required to reflect Buyer as the marketer of the Marketed Products in the applicable Territory, including making all required FDA and any other regulatory filings in connection therewith.