On July 28, 2022, Radius Health, Inc. ("Radius") and Teijin Pharma Limited ("Teijin") reported that it entered into an Amendment to License and Development Agreement ("Amendment") to the License and Development Agreement ("LDA") entered into between Radius and Teijin on July 13, 2017 (Filing, 8-K, Radius, JUL 28, 2022, View Source [SID1234617277]).

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The LDA contemplates the commercialization of the active pharmaceutical ingredient abaloparatide for subcutaneous injection ("abaloparatide-SC") for the treatment of osteoporosis and included a joint commercialization opportunity between Teijin and Radius. Under the LDA, Radius grants Teijin a license to Radius intellectual property related to abaloparatide-SC in exchange for a royalty on net sales of abaloparatide-SC in Japan.

The LDA has been amended by the Amendment to remove references to the joint commercialization opportunity. The LDA has also been amended to waive the royalty on net sales of any abaloparatide-SC purchased by Teijin through a Commercial Supply Agreement ("CSA") entered into between Teijin and Radius concurrently with the Amendment. The Amendment does not have any impact on royalties owed on sales of abaloparatide-SC not purchased through the CSA, and accordingly, for any abaloparatide-SC sold by Teijin but not purchased through the CSA, royalty payments will be owed by Teijin to Radius under the LDA in consideration for the license granted by Radius to Teijin thereunder.

The Amendment also provides that the LDA may be terminated by either party due to a material breach of the CSA by the other party.

Under the CSA, Radius will supply to Teijin, and Teijin will purchase from Radius, a finished product comprising a cartridge filled with abaloparatide-SC ("Drug Product").

Specifically, Radius will purchase, for Teijin, the abaloparatide-SC from a material supplier and then have a commercial supplier fill the cartridges with abaloparatide-SC and supply final Drug Product for commercialization and distribution by Teijin in Japan. As consideration, Radius will receive an annual fee and a per-unit supply price for all Drug Product purchased by Teijin through Radius under the CSA. Any other costs borne by Radius for the purchase of abaloparatide-SC or manufacture of the Drug Product will be reimbursed by Teijin.

Radius has also agreed under the CSA, in the event of any breach of the supply agreement by the commercial supplier resulting in a Radius breach of the CSA, to pursue any potential claims against commercial supplier on behalf of Teijin to the extent required under the CSA.

The CSA will remain in effect, unless terminated earlier for breach, until the earlier of the expiration or termination of the LDA, the expiration or termination of Radius’s commercial supply agreement with the commercial supplier, or termination by either party in the event of the other party’s bankruptcy.