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Date
Rule
801.2
Staff
Michael Verne
Response/Comments
Agree not reportable.

Question

From: (redacted)

Sent: Thursday, September 20, 2007 7:15 AM

To: Verne, B. Michael

Cc: (redacted)

Subject: HSR Question

Dear Michael,

I would like to confirm that thefollowing licensing arrangement does not constitute the transfer of beneficial ownership of an asset under applicable HSR rules andregulations.

For present purposes, pleaseassume that the requisite size-of-person and size-of-transaction tests would be satisfied.

We have a client that is in the process of negotiatinga license agreement for a new compound to treat certain medical conditions. Therelevant terms and conditions of the proposed license are set out in thenumbered paragraphs below:

1.Subject to certain rights retained by CompanyY as described in 3. below, Company X will receive from Company Y an exclusivelicense to develop, use, import, offer for sale, sell, market, and distributeand promote the compound in the United States, including patent rights andknow-how related to the compound;

2.Company X will receive a non-exclusivelicense to manufacture the compound or have the compound manufactured in oroutside of the United States.

3.Company Y will retain the right tomanufacture and to conduct certain development of the compound in or outside ofthe United States, as well as to use the compound for such purposes.Company Y will also retain the option to co-promote the compound with Company Xsubject to the terms of a co-promotion agreement to be agreed upon between theparties.

Based on informal staff opinions, we believe that theproposed agreement should not trigger HSR notification obligations because CompanyY retains manufacturing rights, along with certain co-promotion rights, for thecompound in the United States.

We would appreciate confirmationthat the situation outlined above would not constitute a reportable event for HSR purposes.

About Informal Interpretations

Informal interpretations provide guidance from previous staff interpretations on the applicability of the HSR rules to specific fact situations. You should not rely on them as a substitute for reading the Act and the Rules themselves. These materials do not, and are not intended to, constitute legal advice.

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