Question
From: (redacted)
Sent: Tuesday, February21, 2006 12:26 PM
To: Ferkingstad, JamesH.
James:
Thank you for returning mycall this morning. I am writing to confirm our conversation regarding the HSRreportability of the acquisition of a limited exclusive license wheremanufacturing rights are retained by the grantor. Our client is entering intoan agreement whereby it will become the sole and exclusive distributor andpromoter in the US and two other countries of a product currently in the FDApipeline. The agreement contemplates our client engaging in developmentactivities related to obtaining FDA approval, thereafter distributing andpromoting the product in the defined territory for a specified field of use,and a supply arrangement whereby the grantor/counterparty manufactures andsupplies the product to our client. The agreement also contemplates the grantof an exclusive license for the right to use grantor's IP as required for thepurpose of performing obligations under the agreement, i.e., obtaining FDAapproval and distributing and marketing the product in a defined territory(that includes the US) and within a specified field of use. Grantor retains theright to manufacture the product, and will in fact take responsibility forsupplying our client the product. All IP will remain the sole property of theGrantor.
You confirmed to me that thegrant of an exclusive license supporting exclusive distribution and marketingrights where the grantor retains the right to manufacture the underlyingproduct is not viewed by the Premerger Notification Office as the transfer oracquisition of an asset that would require notification under HSR if relevantthresholds are met. In the situation described above the grantor of the licenseretains manufacturing rights and will undertake sole responsibility for themanufacture and supply of our client's needs for the product at issue.
Please let me know as soonas possible if I have not accurately summarized the advice you gave me. Manythanks in advance for your kind help on this. I can be reached at (redacted).