...We Welcome You To The Resverlogix HUB withIn The AGORACOM COMMUNITY!

Free
Message: Hepalink

Bear/KOO – Below is some of the actual Framework Agreement regarding what we discussed about the HL license. A lot of context was lost when they attempted to shorten it in the news release back then. This is much clearer. The agreement is for RVX-208 for all indications. It appears that the cost plus 10% price to HL was for the period from regulatory approval in the Territories until HL received their manufacturing license from the CFDA. RVX would choose a US manufacturer to provide RVX-208 to HL for distribution and HL would pay RVX cost plus 10% of what RVX paid that supplier. Once HL has their manufacturing license, they would have the right to produce RVX-208 themselves for the Territories. It doesn’t state exclusive right but maybe so. RVX would then grant HL the right to produce and supply RVX-208 or combo with products to the rest of the world if up to industry standard. The supply price would be cost plus 10% which seems to say that HL would have to supply it to RVX for them to distribute or pass on to someone to distribute outside the Territories. This would require a separate agreement. Item 21 seems to say that RVX has the right to use other suppliers at any time outside the Territories so it would seem that HL wouldn’t necessarily be the exclusive supplier. Of course, any buyout by a Pharma could change all of this. It could make this go away or make all but the Territories portion go away.

 

 

15. Option of Manufacturing for the supply of RVX 208 in the Rest of the World

After the registration of the Licensed Product is approved in the Territory, Party A will select a US based CMO to supply the Licensed Product to Party B for commercialization in the Territory. The supply price shall be the procurement price Party A has paid to such CMO plus 10% profit margin. Subject to the obtaining of the manufacturing license at the CFDA, Party B has the right to manufacture and supply the Licensed Product in the Territory. Party A will grant Party B an option to manufacture and supply products comprising RVX 208 in the Rest of the World provided that Party B demonstrates its compliance with Applicable Law and the required industry standard, i.e. EU GMP or US GMP. The supply price of Party B will be manufacturing cost plus 10% profit margin. Parties agree to enter into a separate supply agreement in time regarding the supply from Party B to Party A RVX208 products for the development and commercialization of the RVX208 in the Rest of the World. Detailed terms on back-up supplies and inventory stocks will be discussed and set forth in the supply agreement. In the event Party B fails to meet the industry standard required, Party A reserves the right to select a qualified third party to be the supplier of RVX208 products for the Rest of the World.

21. Exclusivity

Party A shall at any time be free to enter into research, development, manufacture and commercialization activities with any third party with respect to the Licensed Product outside of the Territory. Prior to the execution of the final binding Definitive Agreement which shall take place within three months after the execution date of this Framework Agreement (“Exclusivity Period”), Party A shall not enter into negotiations with third parties with regards to the grant of license of RVX 208 in the Field in the Territory.

Share
New Message
Please login to post a reply