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FDA Issues a Final Rule on Biologics License Applications, Investigational New Drug Applications and Master Files

JD Supra Law

On February 12, the FDA issued a final rule regarding the use of Drug Master Files (“DMF”) in Biologics License Applications. DMFs are submissions to the FDA “used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products.”.

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Strategic Intellectual Property Licensing In India

Intepat

Licensing is a legal tool that permits the utilization or reuse of already protected intellectual property. This raises discussions on various factors influencing the decision of licensors and licensees regarding the licensing process. Considerations for sub-licensing, including any specific limitations or financial terms.

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Arbitrator Awards Company $155M for Competitor’s Use of Its Confidential Information

JD Supra Law

Though the arbitrator did not find Pennymac liable for trade secret misappropriation, they found that the use of BK’s product accelerated the development of Pennymac’s product and caused BK to lose licensing profits. By: Proskauer - Minding Your Business

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FDA Issues a Final Rule on Biologics License Applications, Investigational New Drug Applications and Master Files

LexBlog IP

On February 12, the FDA issued a final rule regarding the use of Drug Master Files (“DMF”) in Biologics License Applications. The post FDA Issues a Final Rule on Biologics License Applications, Investigational New Drug Applications and Master Files appeared first on Big Molecule Watch.

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Daniel Alexander KC says "no" on indemnity costs, blanket confidentiality orders and permission to appeal in Oxford University Innovation dispute

The IPKat

In the consequentials hearing judgment [2023] EWHC 138 , the Judge dealt with (1) royalty payments; (2) costs; (3) confidentiality; and (4) permission to appeal. Of the most interesting to this Kat was the treatment of costs (well, some of them), confidentiality and permission to appeal.

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IP Licensing for Business Companies & Organizations – How to Do it Right?

Kashishipr

Any form of Intellectual Property (IP) , be it a trademark, patent, or copyright, can be licensed to third parties. Through IP licensing, IP rights holders grant third parties the exclusive right to use their IP while retaining their ownership. Understanding the IP License. Creating the IP Licensing Agreement.

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NPE Showcase – Sockeye Licensing

LexBlog IP

This installment will focus on a company named Sockeye Licensing TX, LLC. Settlement agreements are typically confidential so the exact arrangement is unclear. But what we do know is Sockeye cannot sue a defendant for activity that is already licensed. NPEs are also known to limit their license when suing software companies.