Examples of FDA Transfer Letters in a sentence
Seller shall cause Mallinckrodt to file the Mallinckrodt FDA Transfer Letters, and Buyer shall file the Buyer FDA Transfer Letters, with the FDA on the date selected by Buyer by written notice to Seller, which date shall not be later than December 31, 2014.
Buyer shall have, and Buyer shall have caused its applicable Affiliates to have, duly executed and delivered to Seller, dated as of the Closing Date, counterparts to each of the: (i) Ancillary Agreements; (ii) Buyer Officer’s Certificate; (iii) Joint Written Instructions, duly executed by Buyer, directing the Escrow Agent to deliver to Seller the Escrowed Funds in accordance with Section 3.1(a); and (iv) the FDA Transfer Letters.
Horizon and AstraZeneca shall file the Horizon FDA Transfer Letters and the AstraZeneca FDA Transfer Letters, respectively, with the FDA pursuant to the Transition Agreement.
The Ancillary Agreements executed and delivered by Seller to Buyer at the Closing, together with the Mallinckrodt FDA Transfer Letters, effectively vest in Buyer (or, in the case of the Product NDA and the Product IND, upon the Transfer Date, will vest in Buyer Designee) good, valid and marketable title to, and ownership of, the Purchased Assets free and clear of all Encumbrances.
Minimum Front Yard23m(e)Minimum Interior Side Yard15m(f)Minimum Exterior Side Yard23m(g)Minimum Rear Yard15m(h)Maximum Building Height (By-law 4915/140/06)8 metres(i)Maximum Lot Coverage33 percent(j)Minimum Landscaped Area10 percent (k) AUTOMOBILE SERVICE STATION LOCATION: (By-law 1418/111/83) Notwithstanding any other provision hereof to the contrary, a detached automobile service station, excluding motor fuel retail outlets, shall not be located closer than 15.0m to any street line.
On or before [***] ([***])[***] after the Closing Date, Purchasers shall deliver the Purchaser FDA Transfer Letters to the FDA notifying the FDA of TJL Purchaser’s ownership of the Product Registrations and its acceptance of the regulatory responsibilities associated with the Product Registrations from Seller.
Seller shall have duly executed and delivered to Buyer, dated as of the Closing Date, counterparts to each of the: (i) Ancillary Agreements; (ii) Seller Officer’s Certificate; (iii) Joint Written Instructions, duly executed by Seller, directing the Escrow Agent to deliver to Buyer the Escrowed Funds in accordance with Section 3.1(a); and (iv) the FDA Transfer Letters.
Except for the Buyer FDA Intent Letters, the Buyer FDA Transfer Letters, the Mallinckrodt FDA Intent Letters and the Mallinckrodt FDA Transfer Letters, no notice to, filing with, permit of, authorization of, exemption by or consent of any Governmental Authority or other Person is required for Seller to consummate the Transactions.
Seller shall file the Seller FDA Transfer Letters with the FDA within [***] after the Closing.
The Parties shall execute and deliver to the FDA and other appropriate Governmental Authorities such documents and instruments of conveyance (including the Seller FDA Transfer Letters and the Purchaser FDA Transfer Letters) as necessary and sufficient to effectuate the transfer of each Transferred Governmental Authorization to Purchaser under applicable Law on the Closing Date or as soon as possible if the Transferred Governmental Authorizations are assigned after the Closing.