Post by ashiwi on Aug 5, 2014 16:15:46 GMT -5
Item 1.01 Entry into a Material Definitive Agreement.
On July 31, 2014, MannKind Corporation (“MannKind”) and Amphastar France Pharmaceuticals S.A.S., a French corporation (“Amphastar”), entered into a Supply Agreement, pursuant to which Amphastar will manufacture for and supply to MannKind certain quantities of recombinant human insulin (“Insulin”) for use in MannKind’s product AFREZZA ® . Under the terms of the Supply Agreement, Amphastar will be responsible for manufacturing the Insulin in accordance with MannKind’s specifications and agreed-upon quality standards. MannKind has agreed to purchase annual minimum quantities of Insulin under the Supply Agreement of an aggregate of approximately €120.1 million in calendar years 2015 through 2019. MannKind may request to purchase additional quantities of Insulin over such annual minimum quantities.
Unless earlier terminated, the term of the Supply Agreement expires on December 31, 2019 and can be renewed for additional, successive two year terms upon 12 months written notice, given prior to the end of the initial term or any additional two year term. MannKind and Amphastar each have normal and customary termination rights, including termination for material breach that is not cured within a specific time frame or in the event of liquidation, bankruptcy or insolvency of the other party. In addition, MannKind may terminate the Supply Agreement upon two years’ prior written notice to Amphastar without cause or upon 30 days prior written notice to Amphastar if a controlling regulatory authority withdraws approval for AFREZZA, provided, however, in the event of a termination pursuant to either of the latter two scenarios, the provisions of the Supply Agreement require MannKind to pay the full amount of all unpaid purchase commitments due over the initial term within 60 calendar days of the effective date of such termination.
The foregoing description of the Supply Agreement is only a summary and is qualified in its entirety by reference to the Supply Agreement, a copy of which will be filed as an exhibit to MannKind’s quarterly report on Form 10-Q for the quarter ended September 30, 2014.
On July 31, 2014, MannKind Corporation (“MannKind”) and Amphastar France Pharmaceuticals S.A.S., a French corporation (“Amphastar”), entered into a Supply Agreement, pursuant to which Amphastar will manufacture for and supply to MannKind certain quantities of recombinant human insulin (“Insulin”) for use in MannKind’s product AFREZZA ® . Under the terms of the Supply Agreement, Amphastar will be responsible for manufacturing the Insulin in accordance with MannKind’s specifications and agreed-upon quality standards. MannKind has agreed to purchase annual minimum quantities of Insulin under the Supply Agreement of an aggregate of approximately €120.1 million in calendar years 2015 through 2019. MannKind may request to purchase additional quantities of Insulin over such annual minimum quantities.
Unless earlier terminated, the term of the Supply Agreement expires on December 31, 2019 and can be renewed for additional, successive two year terms upon 12 months written notice, given prior to the end of the initial term or any additional two year term. MannKind and Amphastar each have normal and customary termination rights, including termination for material breach that is not cured within a specific time frame or in the event of liquidation, bankruptcy or insolvency of the other party. In addition, MannKind may terminate the Supply Agreement upon two years’ prior written notice to Amphastar without cause or upon 30 days prior written notice to Amphastar if a controlling regulatory authority withdraws approval for AFREZZA, provided, however, in the event of a termination pursuant to either of the latter two scenarios, the provisions of the Supply Agreement require MannKind to pay the full amount of all unpaid purchase commitments due over the initial term within 60 calendar days of the effective date of such termination.
The foregoing description of the Supply Agreement is only a summary and is qualified in its entirety by reference to the Supply Agreement, a copy of which will be filed as an exhibit to MannKind’s quarterly report on Form 10-Q for the quarter ended September 30, 2014.