Biostax (BTAX) 8-K Entry into a Material Definitive Agreement

Exhibit 10.1

CONTRACT FOR THE COMPOUNDING OF PHARMACEUTICAL PRODUCTS

ThisCONTRACT FOR THE COMPOUNDING OF PHARMACEUTICAL PRODUCTS (this “Agreement”) is hereby entered into this 8th day of December, 2014, by and between Immune Therapeutics, Inc., a company organized and currently existing in good standing under the laws of the State of Florida and formerly known as TNI BioTech, Inc. (“TNI”); and KRS Global Bio Technology, Inc., a company organized and currently existing in good standing under the laws of the State of Florida (“KRS”). TNI and KRS are sometimes hereinafter referred to individually as a “party” and/or collectively as the “parties”.

WHEREAS, TNIhasdevelopedapharmaceuticalproductdesignedtoenhancetheimmunesystemand treat various diseases, including lymphoma,HIVvirus/AIDS,KaposiSarcoma,Lymphoma,OvarianCancer, Epithelial, GermCellTumor, Low Malignant Potential Tumor, Crohn’sDisease, Prostate Cancer, Irritable Bowel Syndrome, Pancreatic Cancer, Pancreatic NeuroendoctrineTumors, Parkinson’sdisease,multiplesclerosis, and herpes.This product is composedof the active drug naltrexone hydrocholoride and can be commercialized in the form ofa tablet, capsule, or as a cream. The productis calledLDN. TNI has all of the proprietary and legal rights to LDN. The form of this drugcan be modifiedas agreed to in writing by the parties; and

WHEREAS, KRS is a pharmacy that specializes in the compounding of a variety of pharmaceutical products, and has the necessary licenses and permits to compound, import and sell pharmaceutical products. At such time as TNI obtains the necessary approvals to commercialize LDN, TNI will notify KRS in a timely manner to obtain the necessary permits to produce and commercialize LDN and will provide the information and documentation for KRS to obtain these permits; and

WHEREAS, the purpose of this Agreement is to set out the terms and conditions under which KRS will carry out the services of compounding, packaging and distributing the LDN tablets, capsules and/or creams (the“LDN-CDS”); and

WHEREAS,the tablets, capsules and creams will be compounded for shipment to patients in the United States or any other areas authorized by KRS. In the compounding and packaging process, KRS must also comply with the United States of America’s Food and Drug Administration’s (“FDA”) good manufacturing practices (“CGMP”) and those of any regulatory bodies.

NOW, THEREFORE, FOR AND IN CONSIDERATION OF THE RECITALS/WHEREAS CLAUSES SET FORTH ABOVE, WHICH SHALL BE DEEMED AN INTEGRAL PART OF THIS AGREEMENT AND NOT MERELY RECITALS THERETO, AND FOR $10.00 AND OTHER GOOD AND VALUABLE CONSIDERATION, THE RECEIPT AND SUFFICIENCY OF WHICH IS HEREBY ACKNOWLEDGED AS RECEIVED BY EACH PARTY FROM THE OTHER, THE PARTIES AGREE AS FOLLOWS:

1. KRS REPRESENTATIONS ANDOBLIGATIONS:KRS hereby represents and agrees as follows:

A)	To have all permits and licenses necessary to carry out the LDN-CDS;
B)	Toshiptheamountsofcompounded LDNorderedbyphysicians fortheirpatientswithin thirty (30)daysfromthedaytheorderisreceived;

C) To useonlythe Active Pharmaceutical Ingredients (the “API”)andrawmaterialsthathavebeen previously approvedbyTNIandonlyintheamountsthat havebeenpreviouslyindicated inwriting;

D) To obtainandpayforaninsurancepolicythatprotectstheraw materialsthatareprovidedby TNIandthefinishedLDN tablets, capsules and/or creams (the “LDN-P”) against any natural disaster,ordestruction ofany reasonably insurable type (the “Insurance”). The Insurancemust atall times protect the goods at themarket value of the inventory, finished andunfinished goods andrawmaterials provided byTNI fromtimeto time, and must name TNI as an additional loss payee;

E) To allow, upon prior reasonable notice,periodic inspectionofthecompounding andpackagingprocesstobecarriedout eitherbyTNIdirectlyorbyan agreed to thirdpartyon behalf of TNI;

F) To order in advance and have shipped directly to KRS all API for the LDN-CDS and packaging materials for the LDN-P;

G)	To ensure strict compliance with the CGMP;
I)	To providesufficientstoragespacefortherawmaterials, ingredients,andpackaged products andtoprotectthemfromtheft,flooding orvermin andspoilage andprovide the aforementioned Insurance.

2. TNI'SREPRESENTATIONS ANDOBLIGATIONS: TNI hereby represents and agrees as follows:

A) To providesalesandmarketingassistance necessary to allow KRS to fulfill its obligations;

B) KRS and TNI agree that under the authorization of TNI and TNI’s patents, KRS shall order and have shipped directly to KRS the API necessary for the production of the LDN-CDS and KRS shall submit a purchase order for such API to TNI. TNI shall pay such purchase order directly to the supplier of the API by sending funds by wire transfer to such supplier within three (3) business days of receipt of such purchase order. Notwithstanding the foregoing, upon KRS receiving a minimum of 10,000 orders (prescriptions) per month (a “10K Month”), KRS will pay for the API for each such 10K Month;

C) The rights provided to KRS herein to provide the LDN-CDS and produce the LDN-P, are exclusive only to KRS and will not be provided to any other party or entity during the term of this Agreement;

C) ToprovideKRSwith specificationsfor rawmaterials and theLDN-P;

D) To provide KRSwiththenecessarytechnicalspecificationsforthecompoundingand packagingprocessesof the LDN-P, as available;

E) In the event this Agreement is terminated by TNI for any reason, to reimburse KRS for all unused packaging materials for the LDN-P, which unused packaging materials KRS will provide to TNI;

F) To payKRS,allagreeduponamounts,inatimelymanner (within 10 days of receipt of an invoice from KRS);

G) In the event that KRS does not receive and ship at least 1,000 orders (prescriptions), to reimburse KRS for 100% of the “ramp up costs” of providing the LDN-CDS and producing the LDN-P, even in the case where TNI cancels/terminates this Agreement, which provision shall survive the cancellation/termination of this Agreement (for purposes of this Agreement, “ramp up costs” are defined as all costs and expenses of labor and materials related to the testing, and required FDA and other governmental documentation/approvals of test data);

H) To assigna person from TNI, agreeable to both parties,tobe inchargeofcommunicationbetween TNIandKRS;

I) To providethedesignofthesecondarypackingandtheinstructionsinanylanguageTNI needs; and

J) To submit all marketing materials to KRS for review and approval and such marketing materials must be reviewed and approved by KRS in writing.

3. KRSagrees that:

A) The rawmaterialsprovidedfor the LDN-CDSaretobeusedstrictlyforthecompoundingand packaging processofLDNandmay under no circumstance besold, transferred, or create a lienover, unless TNI hasgiven prior written consentfor such sale, transfer or lien;

B) Under nocircumstances will KRSsellapharmaceuticalproductcontainingthesame formulaandtechnicalspecificationsasthoseusedto manufacture and produceLDN; and/or

C)KRSwillnotshare,license,orotherwisetransfertheformulaortechnicalspecifications forthemanufacturing ofLDN.

4. QUALITY CONTROL:TNIwillhavetheright, upon reasonable prior notice and at TNI’s own cost and expense,to carryoutqualityauditsortoconsent throughan agreed tothirdpartytoinspectthecompoundingand packagingprocesses. TNI maysolicitany quality certificate from KRS that may be required by the regulatory bodies of the UnitedStates, as it relates to the LDN-P.

5. TERM. This Agreementwillhave aninitial termofthree (3)yearsstartingonthedateof execution by all parties.Thepartiesmayagreeto extend the term of this Agreementforone (1)year under the sameterms and conditions, which agreement shall be madein writing, and executedat least sixty (60) daysbefore the expirationof this Agreement.

6. EARLY TERMINATION:ThepartiescanterminatethisAgreementunder any ofthefollowingcircumstances:

A) Mutual agreement, in writing,

B) Either partymayterminatethisAgreementiftheother partyfailstomateriallycomplywithanyof the materialobligationsthataretobefulfilled hereunder.In suchanevent, thenonbreachingpartyshallgive written noticeof suchbreach and the otherpartyshall have thirty (30) days to cure same beforethe termination is final.Incase of early termination by TNI, KRS will returnany and allraw materials, finished products, patents, documents containing technical information, and any other property that belongs to TNI andcompleteallexistingLDNpurchase orders beforetermination, so long as TNI simultaneously reimburses KRS for all costs, expenses and profit related to same.

7. PAYMENT: KRSwillpayTNIforeverytabletorcapsuleitmanufactures, packages and thereafter sells, calculated in accordance with the attached Exhibit “A” Payment Terms and Conditions, which Exhibit A is incorporated into this Agreement by this reference. Reconciliation and payment for each week (ending Friday)willbe madeby the following Wednesday.

To enable TNI to reconcile amounts paid weekly in accordance with this section 7, KRS will provide TNI with the following information on a per batch basis:

(a) A list of all invoices evidencing shipments that occurred for the subject batch, showing the number of the tablets, capsules and/or creams that were compounded and shipped to patients, and the prices paid by patients; and

(b) A list of all shipping costs incurred by KRS to make the shipments in (a) above, together with copies of invoices or statements provided by the shipping vendor; provided, however, that if KRS receives a 10K Month, KRS will not be required to provide the information in 7 (a) and (b) above for that 10-K Month.

TNI shall have the right, upon reasonable prior notice and at TNI’s own cost and expense, to carry out periodic audits to verify that all amounts owed to TNI have been paid.

IfduringthetermofthisAgreement,thecostsformanufacturingandpackagingshould increase,KRS shallinformTNIin writingwithin no more thansixty (60) days of such increase (the “Increase Notice”), at which time both partiesshall, within 10 days of the date of such Increase Notice, reachanewagreement on pricingin the formof an addendum or KRS may immediately terminate this Agreement without any further notice or cure period.

8. ASSIGNMENT:Neither partymay, underanycircumstances,assignthisAgreement, either totallyor partially, northerightscontainedhereinwithout thepriorwritten consent of the other party and the assignee’s assumption of all of theobligations of the assignor asset forthherein.

9. LABOR RELATIONSHIP:This Agreementdoesnotcreateany typeoflabor relationshipbetweenTNIandtheemployeesofKRS.Therefore,KRS and TNIwillbe solely responsible for payingany andall wages,indemnifications, insurance policies, or any other payment dueto itsemployees in accordance with all labor laws, any internalregulation and any tradeunion agreement, if one were to exist.

10. NONDISCLOSURE: “ConfidentialInformation”shallbedefinedasanynonpublic informationdisclosedbyonepartytotheotherpartyandshallbedeemed to includethe following information of therespective parties, without limitation: (a)e-mail addresses, customer lists,the names of customercontacts,the names ofinvestorcontacts, investor lists, professionalcontacts, businessplans, technicaldata, productideas, personnel,contracts and financial information; (b) patents,trade secrets, techniques, processes, business methodologies, schematics, employee suggestions,developmenttools andprocesses,computer printouts,computer programs,design and drawings and manuals, and improvements;(c) information about costs, profits, markets and sales; (d) plans forfuturedevelopment and new product concepts; (e)all documents, books, papers, drawings, models,sketches, graphic design, photographs, type fonts, topographical treatments and text, illustrations,visual designs, animation,sound, visual elements, prints and other data of any kind anddescription, includingelectronic data recordedor retrieved by any means, that have been or will be disclosed, as well as written or oral instructions or comments.

Notwithstanding theforegoing,ConfidentialInformationofapartyshallnotincludeinformation that (i)has becomepublicknowledgethroughlegal meanswithout fault by the receiving party,(ii) is already public knowledge priorto the disclosure oftheConfidential Information by theparty disclosing ConfidentialInformation(“DisclosingParty”) totheparty receiving Confidential Information (“Receiving Party”), (iii) is known to the Receiving Party priortoDisclosingParty’s disclosure of the same pursuant to thisAgreement, or (iv) is independentlydevelopedby the Receiving Party withoutreference to or use of theConfidential Information.

In theperformanceofthisAgreementorincontemplationthereof,eachpartyanditsemployeesand agentsmayhaveaccessto Confidential Information ownedor controlled by the other party. All Confidential Information supplied byoneparty to the othershall remain theexclusiveproperty of theparty supplying same. The ReceivingParty shall use a reasonable degree ofcare,whichin any event shallnot be less than the same degreeof care whichthe ReceivingParty usestoprotect its own proprietary andconfidential information, tokeep, and have its employeesandagents keep, confidential any andall Confidential Information.Inkeepingtherewith,therecipient shallnotcopy or publish or disclose the ConfidentialInformation toothers, orauthorize itsemployees, or agents or anyone else to copy, publishor disclose itto others, without the Disclosing Party’s written approval,nor shall the Receiving Party make use ofthe Confidential Information except for the purposes of executing its obligationsunder this Agreement, and shall return the Confidential Informationto theDisclosing Party at its request.

Without limitingtheprecedingparagraph,eachpartyrecognizesandacknowledgesthat:

(i)            theConfidentialInformationisavaluable,specialanduniqueassetof the DisclosingPartyandthatdisclosureofanyconfidentialinformationwould cause considerable harm to the Disclosing Party's business reputation;

(ii)          itisvitaltotheDisclosingParty’slegitimatebusiness intereststhat(1)the confidentialityoftheConfidentialinformationbe preserved and(2) the Confidential information only be usedfor the purposeof this Agreement;

(iii)         disclosureoftheConfidentialInformationtoanyotherpersonorentityoruseof theConfidentialInformationbyoronbehalfofanyotherpersonorentitycouldresultin irreparable harm to the Disclosing Party;

(iv)         disclosureorusebeyondthepermittedscopeofConfidentialInformationentrusted totheDisclosingPartybyitsclientsand contractors could expose Disclosing Party to substantialdamages; and

(v)           ReceivingPartyshallnotuse orinanywayimplementtheConfidentialInformation to competewiththeDisclosingParty.

The furnishingofConfidentialInformationhereundershallnot constitute orbeconstrued asagrant ofanyexpressorimpliedlicenseorotherright,or a covenant not to sue or forbearance from anyother right of action (exceptas it relatesto the purpose of this Agreement), by Disclosing Party under any of its patents or other intellectual property rights.

11. INTELLECTUAL PROPERTYRIGHTSANDUSEOFINFORMATION:All

trademarks, USandforeignpatentsandextensionsthereof,tradesecrets,formulas,ideas,designs, computer software,discoveriesandproceduresusedordisclosed by TNIinrelationto theservicesagreed uponinthis Agreementareowned exclusively byTNI and may be used onlyin relationto the manufacturing and packaging processes described herein. Unless otherwise in the public domain, theymaybegivennoother useunless there is prior writtenconsent byTNI.

12. FORCE MAJEURE:ForpurposesofthisAgreement,ForceMajeureshallmeana causeoreventthatisnotreasonablyforeseeableor preventedorotherwise causedby or under the control of the party, suchas floods, warsand riots. Ifacase of force majeurewere to arise which materially affect the duties or obligations of a party,the partyaffectedbyit must informtheother party in writing ofits occurrence within three (3) businessdays. In that case,both partiesmay then agreeonone of thefollowing:

A) To continuetocarryoutthisAgreementunderthesameterms andconditions, making provision for compliance subject to the issues affected by the Force Majeure;

B) To continuetocarryoutthisAgreementundernewconditions;

C) Toterminatethis Agreementwithoutanyfurtherobligations;

D)If noagreementisreached,thisAgreementmaybeterminated by the party to whom the duties or obligations are due, after proper notice and time to cure regarding a default (as set forth in this Agreement).

13. CONFLICT RESOLUTION: ThisAgreementshallbegovernedby,construedandenforcedinaccordancewiththelawsofthe jurisdictioninthe State of Florida.Any dispute that the parties cannot resolvethrough mediationmust submit toarbitration.Such arbitration shall be arbitratedin Palm Beach County, Florida, whether commenced by TNI or KRS,in accordance with the applicable rulesof the American ArbitrationAssociation,Commercial Dispute ResolutionProcedures, and judgment on the award rendered by the arbitrator(s)shall be binding on the partiesand may be entered in any court having jurisdiction.

14. REVISION ANDMODIFICATIONSTOTHIS AGREEMENT:The partiesagreetorevisethis Agreement,onanannualbasis.Anymodificationthatmaybe agreed upon must be donein writing signed by the parties and in theform of anaddendumandwill beconsidered partof this Agreement.

15. MISCELLANEOUS:

A) Subject to applicable law, this Agreement may be amended, modified, or supplemented only by a written agreement signed by parties.

B) Any failure of any party to comply with any obligation, covenant, agreement, or condition herein may be waived by the party entitled to the performance of such obligation, covenant, or agreement or who has the benefit of such condition, but such waiver or failure to insist upon strict compliance with such obligation, covenant, agreement, or condition will not operate as a waiver of, or estoppel with respect to, any subsequent or other failure. Whenever this Agreement requires or permits consent by or on behalf of any party hereto, such consent will be given in a manner consistent with the requirements for a waiver of compliance as set forth above.

C) All notices, requests, demands, and other communications required or permitted hereunder will be in writing and will be deemed to have been duly given when delivered by hand, or one day when sent overnight by a nationally recognized overnight delivery service (such as FEDEX), or two days after being mailed by certified or registered mail, return receipt requested, with postage prepaid:

If to TNI:	Immune Therapeutics, Inc.
	37 North Orange Ave., Suite 607

	Orlando, Florida 32801
	Attention: General Counsel
If to the KRS:	KRS Global Bio Technologies, Inc.
	791 Park of Commerce Blvd. Suite 600
	Boca Raton, Florida 33487
Copy to:	Bruce Jay Toland, Esq.,
	Bruce Jay Toland, P.A.
	Brickell City Tower
	80 SW 8thStreet, #2805
	Miami, FL 33130

or to such other address as the parties may furnish to each other in writing.

D) All section titles or captions contained in this Agreement are for convenience only and shall not be deemed part of the context nor effect the interpretation of this Agreement.

E) This Agreement contains the entire understanding between and among the parties and supersedes any prior understandings and agreements among them respecting the subject matter of this Agreement.

F) This Agreement shall be binding upon the heirs, executors, administrators, successors and assigns of the parties hereto.

G) In the event an arbitration is brought by any party under this Agreement to enforce any of its terms, or in any appeal therefrom, it is agreed that the prevailing party shall be entitled to reasonable attorneys’ fees to be fixed by the arbitrator and/or appellate court.

H) In computing any period of time pursuant to this Agreement, the day of the act, event or default from which the designated period of time begins to run shall be included, unless it is a Saturday, Sunday, or a legal holiday, in which event the period shall begin to run on the next day which is not a Saturday, Sunday, or legal holiday, in which event the period shall run until the end of the next day thereafter which is not a Saturday, Sunday, or legal holiday.

I) All pronouns and any variations thereof shall be deemed to refer to the masculine, feminine, neuter, singular, or plural as the identity of the person or persons may require.

J) This Agreement or any section thereof shall not be construed against any party due to the fact that said Agreement or any section thereof was drafted by said party.

K) The parties hereto shall execute and deliver all documents, provide all information and take or forbear from all such action as may be necessary or appropriate to achieve the purposes of the Agreement.

L) Nothing herein shall be construed to be to the benefit of any third party, nor is it intended that any provision shall be for the benefit of any third party.

M) If any provision of this Agreement, or the application of such provision to any person or circumstance, shall be held invalid, the remainder of this Agreement, or the application of such provision to persons or circumstances other than those as to which it is held invalid, shall not be affected thereby.

IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the date set forth above.

Immune Therapeutics, Inc.	KRS Global Bio Technology, Inc.
By:/s/ Chris Pearce	By:/s/ Ricardo Roscetti
Christopher Pearce, COO	Ricardo Roscetti, CEO
By:/s/ Noreen Griffin
Noreen Griffin, CEO

Exhibit “A” Payment Terms and Conditions
Net Distributable Revenue Calculation (30 day supply) Without blister pack:
Gross Revenue (excluding actual shipping costs)	(A)
Less API Cost .06 Per Tablet (Advanced by TNI)	(B)
Less Packaging, Excipient & CC Charges (Advanced by KRS)	(C)
Box for Medication
Shipping Box
Bottle & Label
Excipients
Less Credit Card Charge @ 2.5% (calculated with shipping charge)
Total Per Order
Net Distributable Revenue	(D)
Net Distributable Revenue Calculation (30 day supply) With blister pack:
Gross Revenue (excluding actual shipping costs)	(A)
Less API Cost .06 Per Tablet (Advanced by TNI)	(B)
Less Packaging, Excipient & CC Charges (Advanced by KRS)	(C)
Blister pack
Box for Medication
Shipping Box
Excipients
Less Credit Card Charge @ 2.5% (calculated with shipping charge)
Total Per Order
Net Distributable Revenue	(D)
*Shipping charge of a flat $10.00 for ground will be collected and retained by KRS.
Additional charge for overnight shipping will be determined based on patient zip code.
TNI Reimbursement Calculation:
API Reimbursement	(B)
50% of Net Distributable Revenue (D)	(D)
Due to TNI	Total of B&D