Usa informed consent

Ethogen Biotech LLC 1712 Pioneer Ave. St. 143 Cheyenne, Wy. 82001 NPIS40 - VOLUNTARY PATIENTS INDEMNITY AGREEMENT This document governs the voluntary use, under medical supervision (by the “Treating Doctor”), of the undersigned patient (the “Patient”) of an experimental biological preparation (the “Preparation”) identified as:NPIS40 for the treatment of (complete as appropriate) ........................................................................ (the “Disease”) and its related syndrome.

PURPOSE The preparation is intended to reduce inflammation attending the Patient’s condition and assist in improving his/her quality of life with minimal or no side effects. In addition, it is intended to reduce or minimise other complications associated with the Disease, except for (a) such complications as are developed or contracted or caused or associated (whether directly or indirectly) with the Patient already having been treated under other drug protocols, or (b) the Patient having other primary disease conditions which have been diagnosed or remain undiagnosed in the Patient at this date.

PATIENT UNDERTAKING AND AGREED TREATMENT CONDITIONS I, the undersigned, confirm that the following has been fully explained to me and I agree that:1.

The Preparation is not at present licensed for human use, and that the suppliers of the Preparation are not medical entities and have no authorisation to practice medicine.

2.

I will assist my Treating Doctor in helping him or her to maintain the dosage and treatment protocols he or she prescribes.

3.

In the event that I am permitted to treat myself at home, I will at all times comply with the treatment and dosage protocol and store the Preparation in accordance with the instructions given to me.

4.

I will maintain a daily diary of my treatment results and deliver a copy of it on a monthly basis to my Treating Doctor, and I agree that a copy of this diary shall be made available by me for confidential evaluation of the treatment.

5.

I will immediately inform the Treating Doctor of any adverse side effects or unusual events, and will comply with any reasonable suggestions that my Treating Doctor might make to me.

6.

By my having chosen to be treated with the Preparation, I confirm my agreement that the supplier of the Preparation, its subsidiaries and associates, delegates, assigns, employees, contractors, associated

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Ethogen Biotech LLC 1712 Pioneer Ave. St. 143 Cheyenne, Wy. 82001 physicians, treating doctors, officers and directors assume no implied or other liability or responsibility for my current or future health.

7.

There is limited experience with the Preparation and that the consequences or any possible side effects of my being treated with it, either on a short or long term basis, may not be known.

8.

I have been told that the medication is a natural biological product derived from a caprine source, which will be given to me by subcutaneous injection (i.e. by injection under my skin) or applied topically.

9.

There could be risks involved in my treatment with the Preparation including (but not limited to) infection, shock, phlebitis, serum sickness, broncho-spasm, asthma, arrhythmia, heart attack, renal failure, headache, skin rash, immune complex disease, joint pain, anaphylactic reaction, death etc.

10. If I am a female, the consequences of a future pregnancy on either me or the embryo are entirely unknown and I affirm that I am not at present impregnated and will take all reasonable steps to avoid a future pregnancy.

11. For the avoidance of doubt, I confirm that I am willing to undertake a pregnancy test confirming that I am not currently impregnated, and I furthermore confirm that should I become pregnant I will personally assume all responsibility for the consequences.

INTERACTION WITH OTHER DRUGS 1.

I understand and agree that it is possible the Preparation may interact with other drugs that I might have taken, am currently taking, or may be required to take, and I agree that my own General Practice Doctor will monitor me for drug interactions or other symptoms.

2.

I agree that whilst taking the Preparation I will not take any other medication without the express written consent and knowledge of my Treating Doctor and in the event that any medicine is prescribed either by my General Practice Doctor or others I will at all times comply fully with the manufacturer’s protocol or dosage instructions even though the supplier, my General Practice Doctor or my Treating Doctor may not be able to advise on their combined or other side effects.

COST OF THE PREPARATION AND OTHER DRUGS I confirm and agree that unless otherwise agreed in writing the treatment cost of the Preparation will be in accordance with the written scale of charges determined by my Treating Doctor and that these and all other future medications of any type associated in any manner with my current USA Informed Consent Std Rev 01 AUG/15 -

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Ethogen Biotech LLC 1712 Pioneer Ave. St. 143 Cheyenne, Wy. 82001 or future medical condition howsoever caused will be my sole responsibility and that no further inducement has been either offered or implied.

TREATMENT PROTOCOL 1.

The treatment protocol will be determined in consultation with my Treating Doctor.

2.

If you are a new patient, The Treating Doctor may require you to receive an intradermal test dose, followed by a 30 minute wait, in order to ensure there is no allergic reaction.

3.

Thereafter, the Treating Doctor may agree to treat you on a regular basis (for example, each week) with a dosage agreed between you and the Treating Doctor, which may be varied in accordance with your medical response.

4.

(Notes, if any, of the Treating Doctor in relation to the Treatment Protocol) ....................................................................................................................... ....................................................................................................................... .......................................................................................................................

TREATMENT CONSENT I, the undersigned, hereby understand and agree that:1.

My treatment using the Preparation is completely voluntary and I fully accept any known or unknown risks to my person.

2.

I may entirely at my own risk choose to withdraw from treatment at any time without penalty or loss, save that, if I am a paying patient, I agree to pay for the Preparation already administered to me.

3.

I may entirely at my own discretion decline the recommendation of the Treating Doctor to vary the amount or frequency of the treatment or dosage. In the event that I decide to increase the dosage over and above that recommended by my Treating Doctor, I agree to sign another indemnity form.

4.

I have read the above, had it and the treatment fully explained to me (and/or my representative) in language that I understand, and have been given full opportunity to consult with a lawyer of my choice or other specialist or ask questions.

5.

I have been given a copy of this Agreement.

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Ethogen Biotech LLC 1712 Pioneer Ave. St. 143 Cheyenne, Wy. 82001

6. I will keep my treatment with the Preparation confidential and will not disclose any information to any third party, without the written consent of my Treating Doctor.

7. I unconditionally waive all claims of whatever nature (both personal or by any third party) associated with my being treated with the Preparation or in relation to any agency or other agreement whether existing or in the future against the manufacturer, supplier, Treating Doctor or their associates in the application of this experimental biological product for the treatment of my condition or any of its related syndromes or complications.

8. This Agreement shall be governed by the non-exclusive jurisdiction of the laws of the United States 9. I agree that if any provision of this Agreement is declared by any judicial or other competent authority to be void, voidable or illegal or otherwise unenforceable or indications of this are received by either party from any relevant competent authority the remaining provisions of this Agreement are to remain in full force and effect.

PATIENT Signed.................................................this day of..............................200........

Print Name............................................. Date of birth......................................

Address............................................................................................................... ............................................................................................................................

TREATING DOCTOR Signed................................................. Print Name...........................................

Clinic Name …………………………………………………………………………

Address..............................................................................................................

WITNESS Signed................................................. Print Name..........................................

Address.............................................................................................................

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