500mg Product definition

500mg Product means the once-daily formulation of 500 mg of API that is the subject of the Product NDA.
500mg Product means the once-daily oral formulation of 500mg of the Active Ingredient in combination with the AcuForm Delivery Technology that is the subject of NDA No. 21-748 filed with the FDA on April 27, 2004 (as such NDA may be amended or supplemented subsequent to the Effective Date).
500mg Product means the once-daily formulation of 500 mg of metformin HCl that is the subject of NDA No. 21-748 filed with FDA on April 27, 2004 (as such NDA may be amended or supplemented subsequent to the filing date).

Examples of 500mg Product in a sentence

  • With respect to sales of 500mg Product made in the Territory prior to the Manufacture Transfer Date for the 500mg Product, the royalty payable by Depomed to BLS pursuant to Section 4.6 of the BLS Manufacturing Transfer Agreement shall be allocated between the parties according to the royalty percentage set forth in Section 8.1(a).

  • With respect to sales of 500mg Product made in the Territory on or after the Manufacture Transfer Date for the 500mg Product, the royalty payable by Depomed to BLS pursuant to Section 4.6 of the BLS Manufacturing Transfer Agreement shall be the sole responsibility of Depomed.

  • By way of illustration, Santarus shall not have the right to count both a P1 Detail for the 500mg Product and a P2 Detail for the 1000mg Product.

  • BLS shall have the right to use any Regulatory Data relating to the 500mg Product at any time after the Effective Date for the purpose of obtaining Regulatory Approval of the THE SYMBOL [***] IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

  • BLS shall endeavour to indicate in any promotional and marketing materials for the 500mg Product that the 500mg Products incorporates the AcuForm Delivery Technology, unless BLS determines in its sole discretion that the use of the trademark “AcuForm” may infringe a third party’s trademark in the Territory; provided, however, that BLS may deplete its existing stock of THE SYMBOL [***] IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

  • BLS may freely refer to the trademark “AcuForm” with respect to 500mg Product so long as it is used in a form that is approved by Depomed and protects the proprietary interests of Depomed in such trademark.

  • The Parties acknowledge that BLS has generated certain Technical Information related to the 500mg Product subsequent to the execution of the Prior Agreement.

  • If at any time during the Term of this Agreement BLS determines that the 500mg Product should not be Marketed in the Territory, BLS may Market, and authorize any Affiliate of BLS to Market, a Substitute Product.

  • Depomed shall have the right to use the Additional API solely for the purpose of having Manufactured 500mg Product for Santarus.

  • If requested by Depomed, BLS shall perform during the Supply Period, those services necessary to provide final, finished 500mg Product from bulk tablets manufactured for Depomed in Puerto Rico by a contract manufacturer other than BLS or an Affiliate of BLS.


More Definitions of 500mg Product

500mg Product and “1000mg Product” as defined as of the date of this Royalty Purchase and Sale Agreement in the Valeant Agreement; and (vii) in the case a New Arrangement entered into by a Selling Party in accordance with the terms hereof, the analogous term for “product,” “licensed product,” or comparable concept as defined in the New License Agreement.
500mg Product means the once-daily oral formulation of the Active Ingredient in combination with the AcuForm Delivery Technology that is the subject of NDS No. 091207, file number 9427-B1245-30 filed with the TPD on April 21, 2004 (as such NDS may be amended or supplemented subsequent to the Effective Date).