FUNDACIÓN PARA LA INVESTIGACIÓN BIOMÉDICA HOSPITAL GREGORIO MARAÑÓN

Madrid, (DATE) 2017

ADDENDUM No. XXXXX to a Clinical Trial Agreement. Title of the study: XXXXXXXXXX, Protocol No.: XXXXXX; Principal Investigator: Dr. XXXXXXXXX

Clinical trial number: XXXXXXX

Agreement No.: XXXX

Foundation’s Ref.: XXXXX

This Addendum is executed for the following reason: XXXXXX

THE PARTIES

Fundación para la Investigación Biomédica del Hospital Gregorio Marañón (hereinafter referred to as FOUNDATION), represented by Ms. María Codesido López, Spanish identity number 33.236.014 W, acting in the capacity of Vice President of the FOUNDATION’s Trust.

Ms. María Codesido López, acting for and on behalf of Hospital General Universitario Gregorio Marañón (hereinafter referred to as HOSPITAL), in his capacity as the Manager of the HOSPITAL.

Dr. , holder of Spanish identity number XXXXX with his/her place of business for the purposes of this Agreement at Dr. Esquerdo, 46, 28007 Madrid, Hospital General Universitario Gregorio Marañón, acting in his/her capacity as the Principal Investigator (hereinafter referred to as PRINCIPAL INVESTIGATOR).

, holder of identity number XXXXXXXX, acting for and on behalf of , with registered address at XXXXXXXXXXX and tax identification number XXXXXXXX,(hereinafter referred to as SPONSOR).

The Parties recognize their mutual legal capacity to execute and be bound by this Agreement.

RECITALS

I.- Whereas, on XXXXXX, the HOSPITAL, the FOUNDATION, the INVESTIGATOR and signed an agreement for the conduct of a clinical trial entitled “XXXXXXXXX”, protocol number XXXXXXXX, reference number XXXX.

PABELLÓN DE GOBIERNO 1 Doctor Esquerdo, 46 28007 Madrid, Spain Tel: +34 914 008 155 Fax: +34 914 008 156 FUNDACIÓN PARA LA INVESTIGACIÓN BIOMÉDICA HOSPITAL GREGORIO MARAÑÓN

II.- Whereas, due to the study requirements it is needed to XXXXXXXXXX

III.- Whereas, […]

Now, therefore, the parties agree as follows.

TERMS AND CONDITIONS

1.- XXXXXXXXX

2.- XXXXXXXXX

3.- (As many as there may be…)

4.- ONE THOUSAND/FIVE HUNDRED EUROS (1.000 €/500 €)* will be paid to the Foundation, non-refundable, for the signature of this Addendum, in concept of management / processing. The Foundation will issue an invoice to the sponsor for this concept.

* It will only apply one of the two amounts. If the changes are coming from substantial changes will apply the 1,000 euros and are from minor changes will apply the 500 euros.

This addendum will enter into force on the date of signature of the same, although it will be applicable for all patients of the trial. However, as a consequence of this addendum, invoices already issued during the trial will not be rectified, canceled or modified. In addition, as a consequence of this addendum, under no circumstances will any refunds or discounts be paid corresponding to concepts included, approved and executed prior to this addendum.

The Parties ratify the full validity of all the terms and conditions in the Agreement signed on XXXXXX for the conduct of the clinical trial which have not been subject to change or annulment herein.

Should a copy of this Ad d end um become available in any other language or tongue, the Spanish version shall prevail.

In witness whereof, the Parties have signed this Addendum at the place and on the date indicated in the heading.

PABELLÓN DE GOBIERNO 2 Doctor Esquerdo, 46 28007 Madrid, Spain Tel: +34 914 008 155 Fax: +34 914 008 156 FUNDACIÓN PARA LA INVESTIGACIÓN BIOMÉDICA HOSPITAL GREGORIO MARAÑÓN

The SPONSOR

XXXXXXXX

The PRINCIPAL INVESTIGATOR

Dr. XXXXXXX

The FOUNDATION and the HOSPITAL

Dr. María Codesido López

PABELLÓN DE GOBIERNO 3 Doctor Esquerdo, 46 28007 Madrid, Spain Tel: +34 914 008 155 Fax: +34 914 008 156