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LPCN > SEC Filings for LPCN > Form 8-K on 3-Sep-2013All Recent SEC Filings

Show all filings for LIPOCINE INC.

Form 8-K for LIPOCINE INC.


Entry into a Material Definitive Agreement


On August 27, 2013, Lipocine Inc. entered into an Agreement for the Manufacture of Testosterone Undecanoate Liquid Fill Capsules and the Conduct of an ICH Stability Study in Support of Product Registration with Encap Drug Delivery, or Encap, a United Kingdom based contract manufacturer, pursuant to which Encap will manufacture and supply to Lipocine a total of six lots of LPCN 1021 capsules under current good manufacturing practices, using active pharmaceutical ingredients supplied by Lipocine. Encap will manufacture two strengths of the product, three lots of each strength. These lots will be used in Lipocine's planned Phase III study for LPCN 1021. Under the agreement, Encap will also conduct an International Conference on Harmonisation stability program on all six capsule lots in support of Lipocine's planned new drug application filing for LPCN 1021.

Lipocine may terminate the agreement prior to the commencement of any project work stage (as defined in the agreement) without penalty. Lipocine may also terminate the agreement after authorizing commencement of a stage or after confirmation of a purchase order, subject to payment of cancellation fees. Lipocine and Encap may each terminate the agreement upon a material breach of the agreement by the other party, so long as the other party has not cured such breach within a defined period after written notice of the breach by the non-breaching party. Lipocine also has the right to terminate the agreement for other good cause, including technical, scientific or business reasons, upon a minimum period of written notice to Encap. If Encap achieves certain milestones by the applicable due dates, Lipocine will be obligated to purchase a percent of its commercial supply of LPCN 1021 from Encap for a limited time period, subject to Lipocine's right to buy out such commitment on terms to be negotiated.

The foregoing does not purport to be a complete description of the agreement, and is qualified by reference to the full text of such document, which Lipocine will file in a subsequent filing with the Securities and Exchange Commission.

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