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DFARS Deviation Removes “Technical Interchange” Requirement for IR&D Cost Allowability

Client Alert | 1 min read | 09.25.17

On September 14, 2017, the Department of Defense issued a Class Deviation waiving the requirement for “major contractors” to “engage in” and “document” a “technical interchange” with DoD as a prerequisite to making costs for IR&D projects allowable (previously discussed here and here). This deviation is “effective until it is incorporated in the DFARS” or otherwise rescinded. While it is certainly good news for contractors, it does not impact the portion of the rule requiring contractors to report at least annually IR&D projects to DTIC as a condition of allowability

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Client Alert | 5 min read | 04.13.26

EU Pharma Package: Global (Orphan) Marketing Authorization Compromise Proposal

In our fifth alert in this EU Pharma Package Series, we provided an analysis of the background and ongoing legal debates regarding the concept of the global marketing authorization (GMA). We discussed in particular the missed opportunities in the Pharma Package to further codify and clarify the GMA, in view of its central role in determining the regulatory data protection (RDP) rights of a medicinal product....