1. Introduction

These terms and conditions (the "T&Cs") are intended to govern the operation of the Alpha-1 Antitrypsin Laurell's Training Award  (the "ALTA Award") organized by Grifols, S.A., a company duly incorporated under Spanish law, with Tax ID number A-58389123 and with registered offices at calle Jesús y María 6, 08022 Barcelona – Spain ("Grifols").

The objectives of the ALTA Award are to identify and engage investigators (both physicians and scientists) who are early in their careers in a longstanding commitment to investigating Alpha-1 Antitrypsin Deficiency (AATD) and to strengthen the network between scientists and clinicians working in the field of AATD.

• The period of Award & timelines:

The period of participation for the ALTA Award 2019 will commence on 24th September 2018 and will finish on 1st March 2019.

(a) Submission of the Application Form: from 24th September 2018 until 1st March 2019.

(b) Award ceremony will be at the ERS Congress, which date and place will be announced on the Website (as such term is defined below) during the second quarter of 2019 (the "Award Ceremony")

These T&Cs are available for consultation on www.alta-awards.com (the "Website").

2. Participants

Participation in the ALTA Award is voluntary and free of charge.

Applicants shall meet the following eligibility requirements:

- Early career clinicians, fellows-in-training, scientists and other Alpha-1 care professionals from hospitals, universities and independent research institutes and individuals, who are already working and/or are new in the field of AATD;

- Applicants seeking to conduct some or all their research during the fellowship at another national or international institution are specially encouraged to participate;

- Primary applicant must be under the age of 40 at the time of submitting the Letter of Intent (the "LoI");

- The applicant must be employed or supported by a hospital, university or independent institution (the "Institution"), and

- If the applicant becomes a selected Awardee (as such term is defined below), he/she shall sign a contract with the Institution and Grifols (the "Contract").

Hereinafter, individual participants shall be referred to as the "Participants".

None of Grifols' and/or its group companies' employees or any relative up to the second degree of kinship of the persons directly involved in the management of Grifols' scientific awards or in the appraisal process shall be eligible to participate in the ALTA Award.

Unless expressly stated in these T&Cs, in no case shall Grifols bear any costs and/or expenses in which the Participants may incur by reason of their participation in the ALTA Award.

Submissions from Awardees of previous editions of ALTA Award will not be accepted.

3. Awards details

Participants should complete the Application Form and submit the LoI together with the CV not later than 1st March 2019, following the requirements set forth in Section 3.1.

Once the period to submit the LoI ends, an independent jury formed by a panel of leading experts in clinical and academic medicine and one representative from Grifols (the Head of Medical Affairs EU and ROW) presented on the Website (the "ALTA Review Team") shall select a maximum of 4 best Research Projects (as such term is defined below) taking into consideration the appraisal criteria described in Section 3.2.

The Participants shortlisted by the ALTA Review Team will be invited to submit a full proposal of the Research Project, following the requirements set forth in Section 3.1, jointly with the following additional documents: (i) Applicants' and mentor's biographical Sketch, (ii) Letter of support from mentor and (iii) letter of support from director of the Institution, department or division head stressing Institution's commitment to the Participant assuring the reviewer that the Participant's time will be dedicated to purse the goals of the ALTA Awards as the Research Project should be their full-time activity for the year.

Based on the appraisal criteria described in Section 3.2, the ALTA Review Team will select 2 (two) Research Projects. The two (2) Participants whose Research Project are selected as awardees (the "Awardees") will be announced on the Website after the ceremony of ALTA Award, with his or her photograph, short biography and a brief description of the project. The Research Project, as well as the results derived, directly or indirectly, from such project will be presented in collaboration and agreement with Grifols.

The Awardees are required to attend the Award Ceremony to be awarded. Any costs and/or expenses associated to the attendance to the Award Ceremony will be borne by Grifols or, if it has already been paid by the Awardee or the Awardee's Institution, reimbursed by Grifols to the Awardee's Institution upon written evidence of such costs and/or expenses incurred, subject to any local laws and regulations applicable for these purposes.

The Awardees are encouraged to conduct all or some of their Research Project at another national and international centre. The renowned research laboratories headed by the members of the ALTA Review Team would be delighted to host and mentor the Awardee for certain aspects of its Research Project.

Participants shall provide all information and documents mentioned in this section in English using LoI and full proposal templates provided by Grifols.

3.1 Requirements of the Research Projects

Participants must present a project in basic or clinical research aimed at providing new insights into  the epidemiology, pathophysiology, clinical course, or treatment of lung disease related to AATD, or a proposal focusing on other AATD associated diseases such as liver disease, Wegener's granulomatosis, vasculitis, diabetes or panniculitis, which meets the following requirements (the "Research Project"):

(a) Research Project goals should be achieved within twelve (12) months from the date of the first payment according to the contract, in case Participants become selected as Awardees.

(b) Studies sponsored by industry are excluded;

(c) Basic research projects may include preclinical animal studies and in vitro studies;

(d) Clinical research projects may include any studies requiring patient informed consent, including treatment of patients and/or use of patient samples (e.g. for biomarker analysis, genotyping and diagnostics); 

(e) In no case, submitted Research Projects shall include any information or data which allows, directly or indirectly, the identification of patients and/or any other individuals who are not members of the applicant's team and/or institution;

(f) The Awardees agree to provide Grifols with an interim study report after half-time of the Research Project and a full report after completion of the study.

3.2 Appraisal criteria

The Research Projects will be assessed by the ALTA Review Team taking into account the following criteria:

(a) Scientific merit, which will take into account (i) the validity of the rationale and/or proposed methodology, (ii) the validity of the expected outcomes, (iii) the validity of the proposed timelines, and (iv) the feasibility of completing the proposed research within twelve (12) months;

(b) Innovation in design, methodology and objectives;

(c) Clinical/medical impact, which will take into account (i) the contribution of the Research Project results to clinical and scientific understanding, and (ii) the relevance of the Research Project to the Alpha-1-Antitrypsin disorders community, and

(d) Mentor and research environment, which will take into account (i) mentor's research focus, clinical/scientific expertise and experience, (ii) qualification of the Participant, and (iii) expertise in the academic research environment.

4. Prize

Two (2) selected Research Projects will be awarded with an amount of Euros 50,000 (the "Prize"). The payment of the Prize will only be transferred from Grifols to the Institution that employs or supports the Awardee with the following payment schedule:

• Twenty-five thousand Euros (€25,000) (Gross amount) within sixty (60) days of receipt of the corresponding invoice issued by the institution.
• Twenty-five thousand Euros (€25,000) (Gross amount) within sixty (60) days of receipt by Grifols of the interim Report, together with the corresponding invoice issued by the institution.

The Awardee acknowledges that Grifols will not transfer any payment of the Prize directly to him/her.

5. Guarantees and Intellectual and Industrial Property

The Participants guarantee that (a) they are the scientists or clinician responsible for the submitted Research Project, (b) any submitted documents and/or information provided are accurate and updated, (c) the Research Project is an original creation, (d) they have obtained all necessary approvals from the Institution to participate in the ALTA Award and their participation do not violate any duty owed to the Institution or any other third party, (e) if applicable, they will obtain the informed consent of the patients in accordance with applicable law, (f) the Research Project complies with all applicable health regulations, and (g) their participation in the ALTA Award and the exercise by Grifols of the rights licensed herein do not infringe any legal provisions, agreements, rights or assets owned by any third party.

The Institution will be the exclusive owner of the economic rights of intellectual and industrial property over the Research Project. By participating in the ALTA Award, Grifols is granted a worldwide, non-exclusive, non-transferable (except to Grifols' group companies) royalty free license to use any and all results derived, directly or indirectly, from the Research Project for Grifols' internal research and development purposes. The Awardee shall present any information, data and/or results derived from the Research Project only with the prior written consent of Grifols, which consent shall not be unreasonably withheld.

6. Data Protection

Any personal data provided by the Participants will be processed in accordance with the Privacy Policy. No commercial communications will be sent to Participants by email unless their prior express consent has been obtained.

Applicable Law and Jurisdiction

These T&Cs are governed by Spanish law.

In order to resolve any disputes that arise, a strictly literal interpretation of the rules contained in these T&Cs will be followed prevailing Grifols' criteria with regard to their interpretation and enforcement.

Notwithstanding the foregoing, Participants agree that any dispute that may arise regarding the interpretation or enforcement of these T&Cs shall be settled by the courts and tribunals of the city of Barcelona.

7. General

Participation in the ALTA Award implies full and complete acceptance of these T&Cs by the Participants. Any statement to the contrary such as not agreeing to the T&Cs, will result in the exclusion of the Participant and, as a result, Grifols will be released from fulfilling the obligation undertaken to the Participant.

It is hereby acknowledged that the Award granted is not conditioned upon any promotion, prescription and/or use of any products commercialized by Grifols nor it is intended to influence the Awardee and its Institution to do so.

Grifols reserves the right to cancel the ALTA Award at any time on grounds of force majeure, a lack of participation such as the delay of signing of collaboration agreement 6 months after the nomination date, or for any other valid reason.

Grifols reserves the right to disqualify any Participant who infringes any of the provisions regulated in these T&Cs and/or any applicable regulation.

Grifols reserves the right to modify these T&Cs in case any irregularity is detected that might influence the objectivity and transparency of the ALTA Award.

September 2018