Memorandum of Understanding
May 29, 2020
Vitro Diagnostics Inc. dba Vitro Biopharma(“Vitro”)and Global Institute of Stem Cell Therapy and Research,Inc.dba Giostar (“Giostar”) Memorandum of Understanding(“MOU”).
Whereas;Giostar and Vitrodesiretocollaborateon Giostar's application withtheUnited States FoodandDrug Administration (“FDA”) for anInvestigationalNew Drug (“IND”) application for a clinicaltrialof a COVID-19therapyutilizing umbilical cord (“UC”) mesenchymalstemcells(“MSC”).
Whereas;Giostar and Vitro desire toutilize inGiostarFDAapplication anditsclinical trial the UC MSC'smanufacturedby Vitro underitsbrandnameof AlloRx Stem Cells™ (“AlloRx”).
Whereas;Giostar and Vitro desire topursueother venues of collaboration with each other such as utilizing AlloRxinother US FDAINDclinical trials.
Whereas;Giostar and Vitro expressinterest inbuilding a collaborative relationship to explorethepossibilities of Vitro supplyingitsAlloRx product to Giostar's regenerative medical clinics.
It is therefore agreed by both partiesthat:
1.Vitro agrees to support Giostar's Covid-19INDapplication by providing Giostar the authorizationto utilizeVitro's Chemistry, Manufacturing, Controls(CMC)and Pharmacology, Toxicology (PT) sections of Vitro's current Covid-19 INDfiling.Vitroisto co-operate with Giostar and the FDA to support Giostar's effortsinobtaining a successful IND authorization for the Covid-19 therapyutilizingVitro's AlloRx Stem Cells™.
2.Giostar agrees to purchase and exclusively use Vitro's AlloRx Stem Cells™ and Vitro agrees to exclusively supply to Giostar for the Covid-19INDapplication and clinical trial resulting withtheutilization of Vitro's CMC as well as otherfilingswith the FDAinwhich Giostar relies on Vitro's proprietaryintellectualproperty.
3.Due to the highly confidential nature of theinformationcontained within Vitro's CMC and PTinformationand other information filed with the FDA or provided under theNon-DisclosureAgreement signed between Giostar and Vitro("NDA")attached herein, the use of thatinformationis restricted to supporting Giostar'sINDfiling withtheFDA for Covid-19 clinical trials and cannot be sharedinternallywithin Giostar's operations.Suchinformation isexclusively and confidentially onlytobe used for the express purpose of obtainingIND authorization for a Covid-19 clinical trial using exclusively AlloRx for that clinical trial.
4.Vitro agrees to supply its AlloRx and supportinginformationin the joint collaboration between
the parties; Vitro will provide Giostar with AlloRx for the Covid-19 IND at a price of $__ per 100M cells of AlloRx.
5.VitroandGiostar agrees that after successful completion of trials,the finalapproved product AlloRx will only and exclusively be used by Giostarto treatCovid-19 patients on commercial basis and Giostar will pay $_____ per 100M cells of AlloRxtoVitro. Vitro cannot and will not supply this approved AlloRx Covid-19 product to any other party accept Giostar.
6. Giostar and Vitro recognizes that Vitro manufactures and distributesitsAlloRx productintoother non Covid-19 markets worldwide for other medical indications, therapies and treatments for whichthere is noexclusivity to Giostar.
Proprietary Intellectual Property;shall mean allthe informationsupplied to the FDA in confidence that Vitro authorizes for use by Giostar for the Covid-19INDfiling. It shallincludeall of Vitro's patents and patents pending, trademarks, know-how and proprietary and confidentialinformationsubject to the NDA.
This MOUisbinding and serves as the understanding to support theimmediateneed necessitated with the current Covid-19 IND filing and can be amended by mutual consent of both parties.
This understanding and NDA shall be governed by and construed underthe lawsoftheState of California.Any action brought for the enforcement or any of the terms, conditions, or provisions of this Agreement shall be brought only in a court of competentjurisdiction inor for theSan Diego County in the State of California,and each Party hereby agrees to submittothe jurisdiction of such court and agrees that venue in such courtisproper.
/s/ Deven Patel/s/ James Musick
Chief Executive OfficerChief Executive Officer
Global Institute of Stem CellVitro Diagnostics, Inc.
Therapy and Research, Inc.4621 Technology Dr.
4660 la Jolla Village Drive, Ste. 100Golden, CO 80403
San Diego, CA 92122
