Exhibit 10.3

 

[***] Indicates that information has been omitted and filed separately with the
Securities and Exchange Commission. Confidential treatment has been requested
with respect to the omitted portions.

Amendment No. 1
To the RESEARCH COLLABORATION AND LICENSE AGREEMENT Between
SAVARA INC. and PARI Pharma GmbH

 

This first amendment (“Amendment No. 1”) to the Research Collaboration and
License Agreement, effective as of 7th day of November 2014, between PARI Pharma
GmbH, Moosstrasse 3, D-82319 Starnberg, Germany (“PARI”) and Serendex
Pharmaceuticals A/S, Slotsmarken 17, 2.tv., DK-2970 Hørsholm, Denmark
(“Serendex”) (the “Agreement”), is made effective as of May 23rd, 2018
(“Amendment No. 1 Effective Date”) by and between PARI and Savara Inc. with a
principal place of business at 6836 Bee Cave Road, Building 3, Suite 200,
Austin, TX, 78746, United States of America (“Savara”).  PARI and Savara shall
be referred to each as a “Party” and collectively as the “Parties”.

WHEREAS, Serendex has been acquired by Savara and Savara has become the
successor in interest (including to all interest which relate to the Agreement)
to Serendex, and

WHEREAS, Savara intends to conduct development activities (including clinical
trials) with respect to the Product for the treatment of patients who suffer
from Non-Tuberculosis Mycobacteria infections (“NTM”) and potentially other
pulmonary infections and to commercialize the Product in such indications.

WHEREAS, the Agreement restricts the License to the indications of (i) Pulmonary
Alveolar Proteolysis (PAP), (ii) Cystic Fibrosis (CF), and/or (iii)
Bronchiectasis (BE) and the Parties therefore wish to extend the Indications in
light of the preceding paragraph.

NOW, THEREFORE, in consideration of the recitals set forth above, the mutual
covenants, terms and conditions set forth below, and other good and valuable
consideration, the receipt and sufficiency of which is hereby acknowledged, the
Parties agree as follows:

1.Indications.  Section 1.36 of the Agreement shall be deleted in its entirety
and replaced as follows:

“1.36“Indications” means (i) Pulmonary Alveolar Proteolysis (PAP), [***]
Non-Tuberculosis Mycobacteria infections (NTM);”

 

2.Successful Completion.  Section 1.71 of the Agreement shall be deleted in its
entirety and replaced as follows:

“1.71“Successful Completion” means, with respect to clinical study, (i) the date
on which the last patient exits the clinical study (last patient out), after the
clinical study has achieved at least 90% enrollment, and/or (ii) met its primary
endpoint.”  

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Exhibit 10.3

 

[***] Indicates that information has been omitted and filed separately with the
Securities and Exchange Commission. Confidential treatment has been requested
with respect to the omitted portions.

 

3.eFlow Inline-option. Section 2.6 of the Agreement shall include all
“Indications” as defined in Section 1.36 and potentially added by having
exercised the Pulmonary Infection Option set forth in Section 2.7 in addition to
VAP and ARDS currently agreed upon.

 

4.A new Section 2.7 is added which reads as follows:

“2.7Pulmonary Infection Option

Subject at all times to Savara’s compliance with the terms of this Agreement,
PARI hereby grants to Savara (but not to any Sublicensee), until four (4) years
after the point in time when the Drug Product first is granted Marketing
Approval in the Territory, an option to expand the definition of the term
“Indication” by one or more additional pulmonary infection(s)(the “Pulmonary
Infection Option”).  In the event that Savara wishes to exercise its Pulmonary
Infection Option pursuant to this Section 2.7, then Savara shall provide written
notice thereof to PARI, provide PARI the name of the specific pulmonary
infection it would like to add as well as a detailed and reasonable development
plan for the development of the Drug Product delivered via the Device for the
treatment of such specific pulmonary infection.  The Parties agree to execute an
amendment to this Agreement in order to amend the definition of the term
“Indication” which shall also include the development plan and in which
amendment Savara will confirm to exercise Commercially Reasonable Efforts to
pursue the development and commercialization of such pulmonary indication.“

 

5.Diligence Obligation. New sub-sections are added to Section 7.2 for each
specific indication for which Savara exercises the Pulmonary Infection Option in
accordance with Section 2.7.

 

(g)

Initiation of the first clinical trial in the specific pulmonary infection
within [***] after the exercise of the Pulmonary Infection Option for such
specific pulmonary infection;

 

(h)

Initiation of the first Phase III Clinical Trial in the specific pulmonary
infection within [***] after the exercise of the Pulmonary Infection Option for
such specific pulmonary infection;

 

(i)

First Commercial Sale of the Drug Product delivered via the Device in the USA
and one other Major Nation within [***] after the exercise of the Pulmonary
Infection Option for such specific pulmonary infection.

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Exhibit 10.3

 

[***] Indicates that information has been omitted and filed separately with the
Securities and Exchange Commission. Confidential treatment has been requested
with respect to the omitted portions.

 

 

6.Section 6.1. Table 2 in Section 6.1 shall be deleted and replaced as follows:

Table 2: Pulmonary Infection Development Milestone Payments

 

Development Milestone Event

Milestone Payment

Successful Completion of the first Phase II Clinical Trial in a pulmonary
infection, including CF, BE and NTM

[***]

Initiation of first Phase III Clinical Trial in a pulmonary infection including
CF, BE and NTM

 

[***]

First Marketing Approval in a pulmonary infection (including CF, BE and NTM)
obtained by Savara or its Affiliate or Sublicensee in either the USA, EU or
Japan

[***]

 

Table 4 in Section 6.1 shall be deleted and replaced as follows:

Table 4: eFlow Inline-Option Payments

 

Milestone Event

Milestone Payment

Exercise of the eFlow Inline-Option

[***]

Successful Completion of the first Phase II Clinical Trial with the eFlow Inline
in an Indication

[***]

Initiation of the first pivotal Phase III Clinical Trial with the eFlow Inline

[***]

First submission of NDA (or equivalent) for delivery via the eFlow Inline in
either the USA, EU or Japan

[***]

First Marketing Approval of the Drug Product for delivery via the eFlow Inline
obtained by Savara or its Affiliate or Sublicensee in either the USA, EU or
Japan

[***]

 

7.Section 7.3. Section 7.3 shall referrer to all subsection of Section 7.2 and
the words “(a) to (d)” in the first sentence of Section 7.3 shall be deleted.

 

8.Section 8.1. A new sentence is added to Section 8.1 which shall read as
follows:

“For the avoidance of doubt, this Agreement terminates in its entirety when,
after a First Commercial Sale has occurred, no Royalties are payable anymore.”

page  3/4

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Exhibit 10.3

 

[***] Indicates that information has been omitted and filed separately with the
Securities and Exchange Commission. Confidential treatment has been requested
with respect to the omitted portions.

 

 

9.Miscellaneous.  Capitalized terms used but not defined in this Amendment No. 1
shall have the meaning as ascribed to them in the Agreement. Upon execution,
this Amendment No. 1 shall be made part of the Agreement and shall be
incorporated therein by reference.  Except as provided herein, all other terms
and conditions of the Agreement shall remain in full force and effect.

IN WITNESS WHEREOF, the Parties have executed this Amendment No. 1 as of the
Amendment No. 1 Effective Date indicated above.

 

Savara Inc.

 

PARI Pharma GmbH

 

 

 

 

 

 

 

By:

 

/s/ Dave L. Lowrance

 

By:

 

/s/ Dr. Martin Knoch

 

 

 

 

 

 

 

Name:

 

Dave L. Lowrance

 

Name:

 

Dr. Martin Knoch

 

 

 

 

 

 

 

Title:

 

CFO

 

Title:

 

President

 

 

 

 

 

 

 

Date:

 

July 23, 2018

 

Date:

 

June 20, 2018

 

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