Collegium enters authorized generic agreement with Hikma for Nucynta IR and ER

COLLEGIUM PHARMACEUTICAL, INC

Hikma gains exclusive US marketing rights for authorized generics of Nucynta IR and ER; launch 30 days before LOE.
Collegium receives profit share starting in mid-80% range, declining based on third-party generic equivalents entering.
Collegium will supply Nucynta AG products at fully burdened manufacturing cost; Hikma purchases exclusively from Collegium.
Hikma cannot market its own generic equivalents of Nucynta while marketing the authorized generics.
Initial term 5 years with auto-renewal; termination for material breach or bankruptcy; Hikma may terminate with 1-year notice after first anniversary of launch.

Key facts

Extracted from this filing and checked against the source text.

Material Agreements SEC 8-K Item 1.01/1.02 confidence 0.9

COLLEGIUM PHARMACEUTICAL, INC entered into Authorized Generic Agreement with Hikma Pharmaceuticals USA Inc. (effective 2024-04-26).

Action: entry
Agreement: license
Counterparty: Hikma Pharmaceuticals USA Inc.
Effective: 2024-04-26

Exact text from the filing

On April 26, 2024, Collegium Pharmaceutical, Inc. (the “Company”) entered into an Authorized Generic Agreement (the “AG Agreement”) with Hikma Pharmaceuticals USA Inc. (“Hikma”), pursuant to which the Company granted to Hikma certain rights relating to an authorized generic version of the Company’s Nucynta IR product (the “Nucynta IR Authorized Generic”) and the Company’s Nucynta ER product (the “Nucynta ER Authorized Generic” and, collectively, the “Nucynta AG Products”) in the United States.

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Source: SEC EDGAR

accession 0001104659-24-053506

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