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.
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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.

Related to No ANDA

  • No xxxxxx Nothing in this document in any way restricts or otherwise affects the City’s unfettered discretion to exercise its statutory powers as a public authority.

  • No Abatement This Lease shall not terminate or be forfeited or be affected in any manner, and there shall be no reduction or abatement of Base Rent, Additional Costs or Impositions payable hereunder, by reason of damage to or total, substantial or partial destruction of any of the Project or any part thereof or by reason of the untenantability of the same or any part thereof, for or due to any reason or cause whatsoever, and Tenant, notwithstanding any law or statute present or future, waives any and all rights to quit or surrender the Premises or any part thereof. Tenant expressly agrees that its obligations hereunder, including, without limitation, the payment of all Additional Costs and Impositions required by this Lease shall continue as though the Project had not been damaged or destroyed and without abatement, suspension, diminution or reduction of any kind.

  • No U S. federal or state agency or any agency of any other jurisdiction has made any finding or determination as to the fairness of the terms of the Offering for investment nor any recommendation or endorsement of the Debentures.

  • No Authority This Agreement shall not create, nor shall it be deemed to create, the relationship of employer and employee, principal and agent, partnership, or joint venture, between City and Confidant. Confidant has no authority whatsoever to make any representation in respect of, enter any commitment on behalf of, or incur any liability for or on behalf of, City, or to bind or purport to bind City to any Third Party in any way whatsoever.

  • No Lockouts No lockouts, or refusal to allow employees to perform available work, shall be instituted by the Employer and/or its Appointing Authorities during the life of this Agreement.

  • No Avoidance Not to avoid or seek to avoid (whether by charter amendment or through reorganization, consolidation, merger, issuance of rights, dissolution or sale of assets, or by any other voluntary act) the observance or performance of any of the covenants, agreements or conditions to be observed or performed hereunder by Issuer and not to take any action which would cause any of its representations or warranties not to be true; and

  • No Knowledge The Company has no knowledge of any event which would be more likely than not to have the effect of causing such Registration Statement to be suspended or otherwise ineffective.

  • No Affiliation The Participant represents, covenants and warrants that, during the term of this Agreement, it will not be an affiliated person of a Fund, a promoter or a principal underwriter of a Fund or an affiliated person of such persons, except to the extent that the Participant may be deemed to be an affiliated person under 2(a)(3)(A) or 2(a)(3)(C) of the Investment Company Act of 1940, as amended (the “1940 Act”), due to ownership of Shares. The Participant shall give prompt notice to the Distributor, Transfer Agent and the Trust of any change to the foregoing status.

  • No Gifts Vendor shall not give a gift or make an expenditure to or for the personal benefit of a Citizens officer or employee.

  • No Advertisements It is not subscribing for the Units as a result of or subsequent to any advertisement, article, notice or other communication published in any newspaper, magazine, or similar media or broadcast over television or radio, or presented at any seminar or meeting.

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