Commercialization Restrictions Clause Samples
Commercialization Restrictions. (a) During the Term, for so long as there is a Licensed Product in the Field being Developed or Commercialized under this Agreement in a particular country in the Territory, neither Party shall Commercialize (itself or through a Third Party) any Long Acting Muscarinic Antagonist product in the Field that is not a Licensed Product (any such product, a “Competitive Product”) in such country. Further, during the Term neither Party shall Commercialize a generic Licensed Product in the Field outside of this Agreement. Notwithstanding the foregoing, MYLAN may Commercialize (itself or through an Affiliate or Third Party) a generic Competitive Product in any country in the Territory if a Third Party has launched such generic Competitive Product in such country prior to MYLAN’s launch of such generic Competitive Product in such country. MYLAN will pay to THERAVANCE, during the Term, a [***] calculated in a manner [***] and payable [***]. For clarity, the foregoing shall not prevent either Party from Commercializing LAMA products in the Non-Neb Field without any obligation to the other Party. For purposes of the foregoing, a “generic” product shall mean any product that is approved based on a Marketing Authorization Application submitted pursuant to ***CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
(a) Section 505(j) of the Federal Food Drug and Cosmetic Act or (b) an equivalent or counterpart of such section addressing approval of substitutable generics under applicable Laws in a jurisdiction outside of the U.S.
(b) Neither Party will be deemed to be in breach of the restrictions set forth in Section 5.06(a) if such Party or any of its Affiliates acquires a Competitive Product through an acquisition of or a merger with the whole or substantially the whole of the business or assets of another Person, so long as such Party (or its Affiliate) (i) enters into a definitive agreement with a Third Party to Divest such Competitive Product in the applicable Country(ies) in the Territory (other than as part of any Hold Separate Transaction) within twenty-four (24) months after the closing of such acquisition or merger, or, if such Divestiture is subject to the terms of a Hold Separate Transaction, within twelve (12) months after the closing of the acquisition or merger, or (ii) discontinues sales of the Competitive Product in the Territory no later than twelve (12)...
