No ANDA Sample Clauses
No ANDA. To the knowledge of Buyer, after due inquiry, no ANDA for a therapeutically equivalent product to the Product has been submitted to, or approved by, the FDA, or is planned to be submitted to the FDA. Neither Buyer (including any partnership or joint venture of which Buyer or any of its Affiliates is a party), nor any of its Affiliates (other than their employees outside of their capacity as such) or Representatives (in their capacity as such) is currently:
(a) working to file on their own behalf;
(b) advising or consulting with any Person in preparation for or in connection with filing;
(c) holding an investment in (other than the acquisition of less than five percent (5%) of the voting securities of a publicly traded entity) or providing debt financing to any Person that is preparing to file; or
(d) assisting or encouraging any Person in connection with the filing of, an ANDA using the Product as the reference listed drug with the FDA.
No ANDA. Prior to the earlier of (i) January 1, 2010 and (ii) the date on which the full amount of the Contingent Cash Purchase Price has been paid or is no longer payable, neither Buyer (including any successor (that at the time of becoming a successor is not already actively engaged in taking any of the actions set forth in this Section 6.16), partnership or joint venture of which Buyer or any of its Affiliates is a party), nor any of its Affiliates (other than their employees outside of their capacity as such) or Representatives (in their capacity as such) shall:
(a) file on their own behalf;
(b) advise or consult with any Person in preparation for or in connection with filing;
(c) invest in (other than the acquisition of less than five percent (5%) of the voting securities of a publicly traded entity) or provide financing to any Person that is preparing to file; or
(d) assist or encourage any Person in connection with the filing of, an ANDA using the Product as the reference listed drug with the FDA; provided, however, that Buyer may (i) agree with a Person for such Person to be the designated distributor and seller of a product for which the FDA has approved an ANDA using the Product as the reference listed drug to take effect only after another third party files an ANDA using the Product as the reference listed drug not in violation of the foregoing provisions of this Section 6.16 (“Competing ANDA”), and (ii) advise, consult and assist such Person so that they may be in a position to distribute and sell a product for which the FDA has approved an ANDA using the Product as the reference listed drug at any time after a third party has filed a Competing ANDA, provided, further, however, if Buyer or an Affiliate of Buyer invests in or provides financing to any Person which Buyer or such Affiliate does not control and continues not to control, and at the time of such investment the Person in which the investment is being made, to the knowledge of Buyer and its Affiliates after due inquiry, does not plan to and is not preparing to file an ANDA using the Product as the referenced listed drug with the FDA, such Person thereafter filing an ANDA using the Product as the referenced listed drug with the FDA shall not be a violation of this Section 6.16.