NDC Number. Xxxxxx shall submit drug listing information to the FDA with respect to the Generic Product. Xxxxxx shall distribute and sell only Generic Product bearing an NDC Number that reflects Xxxxxx as the distributor and seller thereof. Within fourteen (14) days after the Effective Date, Xxxxxx shall obtain an NDC Number for each packaging configuration of the Generic Product set forth on Exhibit D.
NDC Number. American Regent shall submit drug listing information to the FDA with respect to American Regent being the distributor of the Product. American Regent shall only distribute and sell Product bearing an NDC Number that reflects American Regent as the distributor and seller thereof. Within fourteen (14) days after the Effective Date, or such other time period mutually agreed by the Parties in writing, American Regent shall obtain an NDC Number for each packaging configuration of the Product. American Regent shall have thirty (30) days after the Effective Date to conduct additional diligence on the use of its NDC Number on the Product packaging and it may terminate this Agreement with fifteen (15) days written notice in the event it determines that there is an unacceptable risk to American Regent in using its NDC Number.
NDC Number. As set forth in the Transition Plan, Impax shall use its Commercially Reasonable Efforts to obtain and provide to AstraZeneca the ten (10) digit NDC number for each mode of administration and dosage strength for each Existing Product (each an “Impax NDC”) no later than two (2) weeks after the Effective Date in order to facilitate the conversion of the packaging and trade dress in a timely and effective manner. Except as otherwise provided in this Agreement, AstraZeneca shall include the Impax NDC on the packaging of the Supplied Product supplied to Impax pursuant to Article 8.
NDC Number. Gxxxx will utilize an NDC number in the form of XXXX-YYYY- ZZ that contains Galen’s or its Affiliate’s own labeler code (i.e., the XXXX portion of the NDC) as assigned by FDA, for Galen’s or its Affiliate’s sales and distribution of Licensed Product. Gxxxx may change the product code (the YYYY portion of the NDC) or the package size code (the ZZ of the NDC) of its NDC number with the consent of Bxxx, which consent shall not be unreasonably withheld, subject in each case to applicable provisions of the Supply Agreement.
NDC Number. Lilly and ViroPharma acknowledge and agree that the current Vancocin Pulvules® capsule is stamped with a four digit string of numbers [***] which is the product portion of Lilly’s NDC Code for the Marketed Product. It is the intention of Lilly and ViroPharma that this four digit string of numbers be incorporated as the product portion of ViroPharma’s NDC Code for the Marketed Product. The parties agree to cooperate in order for this four digit string of numbers to be incorporated as the product portion of ViroPharma’s NDC Code for the Marketed Product.
NDC Number. The Parties acknowledge and agree that (a) the Licensed Product may be distributed initially for up to 90 days under the National Drug Code number for the Licensed Product assigned to NOVAVAX and (b) ESPRIT shall be responsible, at its expense, for complying with on NOVAVAX’s behalf, or assisting NOVAVAX in its compliance, with all FDA and other obligations or requirements (including without limitation adverse reaction reports, adverse events, and recall activities) applicable to NOVAVAX as a result of any and all distribution of the Licensed Product under the National Drug Code number for the Licensed Product assigned to NOVAVAX.
NDC Number. As soon as practicable following the Closing Date and within such period as provided in the Marketing Authorization Transfer Plan, Buyer shall obtain its own NDC number relating to the Product (the “Buyer NDC Number”). For Product
NDC Number. The Parties acknowledge and agree that (a) the Licensed Product may be distributed initially for a limited period under the National Drug Code number for the Licensed Product assigned to Depomed and (b) Esprit shall be responsible, at its expense, for complying with on Depomed’s behalf, or assisting Depomed in its compliance, with all FDA and other obligations and requirements (including without limitation adverse reaction reports, adverse events, and recall activities) applicable to Depomed as a result of any and all distribution of the Licensed Product under the National Drug Code number for the Licensed Product assigned to Depomed.
NDC Number. Buyer shall use commercially reasonable efforts to obtain a new NDC Number for the Product as soon as reasonably possible but not later than twelve (12) months after the Closing Date. For clarity, until such time as Buyer obtains a new NDC Number for the Product in the Territory, Buyer shall be entitled to use Seller’s NDC Number for the sales of the Product in the Territory.
NDC Number. Buyer shall use its Best Efforts to establish its own NDC number for Nascobal and market Nascobal thereunder as soon as practicable. In no event shall Buyer, and Buyer shall cause its Affiliates not to, directly or indirectly distribute, market or sell Nascobal units pursuant to Sellers NDC number. For purposes of determining whether the Nascobal units were sold by Buyer or Seller pursuant to this Agreement, including, without limitation, Sections 5.3 and 5.4, Buyer and Seller shall refer to the NDC number under which the relevant Nascobal units were sold.
