The company does not own or operate manufacturing facilities and relies on third-party Contract Development and Manufacturing Organizations (CDMOs) and Contract Manufacturing Organizations (CMOs) for the clinical supply of the API used in PALI-2108, the PALI-2108 drug product, and to supply the Newsoara Licensed Products to Newsoara. These third parties are selected based on technological capabilities, regulatory compliance, quality assurance, and production capacity. Their responsibilities include API production, formulation development, manufacturing of clinical trial materials under cGMP regulations, and packaging and labeling. LBS serves as the supplier for all of Newsoara’s requirements for Newsoara Licensed Products within the designated territory and is obligated to approve Newsoara's manufacturing rights without undue refusal or delay. The company held license agreements with the Regents of the University of California related to LB1148; as of December 31, 2025, only the 2015 UC License remains active to maintain the Newsoara Co-Development Agreement.
Palisade Bio Inc's Comment on Supply Chain
The company does not own or operate manufacturing facilities and relies on third-party Contract Development and Manufacturing Organizations (CDMOs) and Contract Manufacturing Organizations (CMOs) for the clinical supply of the API used in PALI-2108, the PALI-2108 drug product, and to supply the Newsoara Licensed Products to Newsoara. These third parties are selected based on technological capabilities, regulatory compliance, quality assurance, and production capacity. Their responsibilities include API production, formulation development, manufacturing of clinical trial materials under cGMP regulations, and packaging and labeling. LBS serves as the supplier for all of Newsoara’s requirements for Newsoara Licensed Products within the designated territory and is obligated to approve Newsoara's manufacturing rights without undue refusal or delay. The company held license agreements with the Regents of the University of California related to LB1148; as of December 31, 2025, only the 2015 UC License remains active to maintain the Newsoara Co-Development Agreement.
Sources:
Palisade Bio Inc 's official press releases and regulatory filings; CSIMarket.com's supply-chain research; and the financial filings and press releases of other companies cited in this report.
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