Exhibit 10.1

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

 

 

First Amendment to the Collaboration and License Agreement

 

This First Amendment to the Collaboration and License Agreement (this
“Amendment”) entered into between AcelRx Pharmaceuticals, Inc., a company
organized under the laws of the State of Delaware, United States (“AcelRx”), and
having a principal place of business at 351 Galveston Drive, Redwood City, CA
94063, United States, and Grünenthal GmbH, a company organized under the laws of
Germany (“Grünenthal”), having its registered office at Zieglerstrasse 6, 52078
Aachen, Germany effective as of 17th July 2015 (the “Amendment Effective Date”).

 

WHEREAS, AcelRx and Grünenthal (the “Parties”) entered into that certain
Collaboration and License Agreement dated as of December 16, 2013 (the
“Agreement”), and the Parties desire to amend certain aspects of the Agreement,
as set forth herein.

 

NOW, THEREFORE, in consideration of the foregoing premises and the mutual
covenants herein contained, and for other good and valuable consideration, the
receipt and sufficiency of which are hereby acknowledged, AcelRx and Grünenthal
hereby agree as follows:

 

 

1.

The Parties have agreed to amend the Agreement as of the Amendment Effective
Date as follows:

 

 

a.

Section 1.1 of the Agreement shall be amended and replaced in its entirety to
read as follows:

 

“1.1     “Accessories” shall mean the [*].”

 

 

b.

Section 1.15 of the Agreement shall be amended and replaced in its entirety to
read as follows:

 

“1.15     “Assigned Trademarks” shall mean (a) the AcelRx Trademarks that are
approved by the EMA and by any other Regulatory Authority in the Territory for
use with the Licensed Product upon the grant of the respective Marketing
Approval in the Territory, if and when assigned to Grünenthal pursuant to the
terms of this Agreement; and (b) for purposes of Sections 14.2, 14.3, 14.4 and
14.5, the Grünenthal Trademarks and Grünenthal Supplemental Trademarks
registered or used in connection with the Licensed Products.”

 

 

c.

Section 1.42 of the Agreement shall be amended and replaced in its entirety to
read as follows:

 

“1.42 (a) “Dispenser Kit” shall mean a complete kit consisting of 1 Dispenser, 1
Dispenser Cap, 1 Thumb Tag and 1 patient reference sheet (a PRS) for use with or
as part of the Device.

 

1.42(b) “Disposable Components” shall mean the Dispenser Caps and Thumb Tags.”

 

 
1

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d.

Section 1.65 shall be amended and replaced in its entirety to read as follows::

 

“1.65 (a)      “Grünenthal Trademark” shall have the meaning set forth in
Section 10.7.

 

1.65 (b)     “Grünenthal Supplemental Trademarks” shall mean the trademarks,
trade names, trade dresses, domain names, logos and brandings, including domain
names and design marks, that have been and/or will be obtained by Grünenthal
and/or its Affiliates in connection with the Licensed Product, including those
that are listed in Exhibit 1.65 (b) .”

 

 

e.

Section 1.78 of the Agreement shall be amended and replaced in its entirety to
read as follows:

 

“1.78      “Licensed Product” shall mean (a) AcelRx´s ARX-01 (any and all
components thereof, and the system, which as existing as of the Effective Date
is described in Exhibit 1.78), and (b) any and all improvements and/or
modifications thereof. For clarity, for purposes of this Section 1.78, Licensed
Product shall include the Drug, Device, Dispenser, Kit, Disposable Components,
Reusable Components, and Accessories, whether sold together or separately.”

 

 

f.

Section 1.83 shall be amended and replaced in its entirety to read as follows:

 

“1.83      “Material Agreements” shall have the meaning set forth in Section
11.2 (j). The Material Agreements identified on the Effective Date and any
further Material Agreements further identified by the Parties are listed in
Exhibit 1.83.

 

 

g.

The last sentence of the second full paragraph of Section 1.89 shall be amended
and replaced in its entirety to read as follows:

 

“For clarity, for purposes of this Section 1.89, the “Licensed Product” shall
include the Drug, Device, Reusable Components, Dispenser Kit, Disposable
Components and Accessories, whether sold together or separately.”

 

 

h.

Section 1.102 of the Agreement shall be amended and replaced in its entirety to
read as follows:

 

“1.102     “Reusables Kit” shall be replaced in its entirety in all uses in this
Agreement by the term “Reusable Components” and shall mean the [*].”

 

 

i.

Section 2.1(a) shall be amended and replaced in its entirety to read as follows:

 

“(a)     Technology and AcelRx Trademark Licenses to Grünenthal. Subject to the
terms and conditions of this Agreement, including the payment of milestones and
royalties hereunder, AcelRx hereby grants and causes its Affiliates to grant to
Grünenthal under the AcelRx Technology, the Assigned Patent(s) and the AcelRx
Trademarks (i) an exclusive (even as to AcelRx, its Affiliates and Third
Parties) license to research (subject to Sections 2.1(c) and 2.3 hereunder),
develop (subject to Sections 2.1(c) and 2.3 hereunder), import (subject to
Sections 2.1(c) and 2.3 hereunder), use, commercialize, sell, offer for sale the
Licensed Product in the Field, in each case in the Territory, and (ii) a
co-exclusive (with AcelRx or its Affiliates only) license to Manufacture and
have Manufactured, use and import the Licensed Product anywhere in the world
solely for use, commercialization, importation, sale or offer for sale in the
Field in the Territory by Grünenthal, its Affiliates, Sublicensees and
Distributors; provided, that the foregoing licenses to Grünenthal under the
AcelRx Trademarks shall end upon assignment of the Assigned Trademark as
provided under Section 10.1(c) and the foregoing licenses to Grünenthal under
the Assigned Patents shall end upon assignment of the Assigned Patent as
provided under Section 10.1(b) (subject to reinstatement in the case of Section
10.2(c)). For the avoidance of doubt, “Licensed Product” as used in this Section
2.1(a), and as applicable in other provisions of this Agreement, refers to and
includes all the components of the Licensed Product (e.g. Device, Drug,
Dispenser Kit, Disposable Components, Reusable Components and/or Accessories) as
well as the system as a whole.”

 

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

 

 
2

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j.

Section 2.1(c) of the Agreement shall be amended and replaced in its entirety to
read as follows:

 

“(c) License to AcelRx. Subject to the terms and conditions of this Agreement,
Grünenthal hereby grants and causes its Affiliates to grant to AcelRx:

 

(i) a royalty-free, fully-paid, exclusive license, with the right to grant
sublicenses, under the Grünenthal Technology for AcelRx and its Affiliates:

 

(A) to commercialize, sell, and offer for sale the Licensed Product for any
purpose outside the Field or outside the Territory; and

 

(B) to Manufacture, have Manufactured, use and import the Licensed Product for
any purpose outside the Field; and

 

(ii) a royalty-free, fully-paid, non-exclusive license, with the right to grant
sublicenses, under the Grünenthal Technology for AcelRx and its Affiliates:

 

(A) to conduct research and development activities with respect to the Licensed
Product worldwide but, during the Term, subject to the terms of Article 4 with
respect to the Territory, including the limitations imposed by Section 4.3(d);
and

 

(B) to perform AcelRx’s obligations under this Agreement and the Supply
Agreement (in the Field in the Territory) but, during the Term, subject to the
terms of Article 4 with respect to the Territory, including the limitations
imposed by Section 4.3(d); and

 

(iii) a royalty-free, fully-paid, co-exclusive (with Grünenthal or its
Affiliates only) license, with the right to grant sublicenses, under the
Grünenthal Technology, the Assigned Patent(s) and the Assigned Trademark(s) for
AcelRx and its Affiliates to Manufacture and have Manufactured, use and import
the Licensed Product anywhere in the world solely for use, commercialization,
importation, sale or offer for sale in the Field in the Territory by Grünenthal,
its Affiliates, Sublicensees and Distributors; and

 

(iv) a royalty-free, fully-paid, non-exclusive license, with the right to grant
sublicenses, under the exclusive license granted to Grünenthal pursuant to
Section 2.1(a) for AcelRx and its Affiliates to conduct research and development
activities with respect to the Licensed Product worldwide but, during the Term,
subject to the terms of Article 4 with respect to the Territory, including the
limitations imposed by Section 4.3(d).”

 

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

 

 
3

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k.

Section 2.2(a) of the Agreement shall be amended and replaced in its entirety to
read as follows:

 

“(a)     Right to Sublicense and Sub-Contract. Grünenthal shall have the right
to sublicense any of its rights granted to it under this Agreement to its
Affiliates as and when elected by Grünenthal. Grünenthal shall also have the
right to sublicense its rights granted under this Agreement to any Third Parties
(who may further sublicense to a Distributor), [*], it being understood that
[*]. AcelRx’s review and approval shall [*]. AcelRx shall have thirty (30) days
to review and notify Grünenthal [*]. If AcelRx timely notifies Grünenthal in
writing [*] within such thirty (30) day period, then Grünenthal shall not enter
into such proposed sublicense [*]. [*], provided that [*], as applicable, and
shall provide that [*]. Grünenthal shall remain responsible for the performance
of its Affiliates, Sublicensees and sub-contractors hereunder. For clarity,
Affiliates of Grünenthal to which Grünenthal has sublicensed its rights
hereunder may further sublicense consistent with this Section 2.2(a) the same as
Grünenthal itself may grant sublicenses consistent with this Section 2.2(a).”

 

 

l.

Section 2.8 of the Agreement shall be amended and replaced in its entirety to
read as follows:

 

“2.8 Australia Sub-licensing and Right of Removal. Either Party shall have the
right to remove the country of Australia from the Territory immediately upon
prior written notice to the other Party if [*]. For clarity, effective upon such
written notice from either Party as permitted and contemplated by the foregoing,
Australia shall no longer be included in the Territory, neither of this
Agreement nor the Supply Agreement, and such notice shall relieve both Parties
of obligations with respect to one another relating to Australia.

 

 

m.

In Section 5.1(b) of the Agreement, the parenthetical “(e.g. Device, Drug,
Dispenser Kit, Reusable Components and Accessories)” shall be amended to add
“Disposable Components” to the list within the parenthetical.

 

 

n.

In Section 5.1(b) of the Agreement, the second sentence shall be amended and
replaced in its entirety to read as follows:

 

“Grünenthal shall use Commercially Reasonable Efforts to conduct the
commercialization activities in accordance with such Commercialization Plan;
provided, that for purposes of this Section 5.1(b), Commercially Reasonable
Efforts means that Grünenthal shall have [*]”.

 

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

 

 
4

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o.

Section 6.2 of the Agreement shall be amended and replaced in its entirety to
read as follows:

 

“6.2     Demo Device. AcelRx shall Manufacture and have Manufactured the Device
or other samples of components of the Licensed Product (“Demo Device”) for use
in training in accordance with applicable Regulatory Requirements in the
Territory, as then in effect for use by Grünenthal (and its Affiliates,
distributors or licensees) for sampling or demonstration purposes [*]. In any
event, the Parties will discuss and agree upon the nature and quality of the
Demo Device, planned quantities and supply of Demo Devices to be delivered to
Grünenthal in advance of any Manufacture of Demo Device. Rights to the Demo
Devices Manufactured in accordance with Grünenthal’s specifications shall remain
with Grünenthal, other than to the extent of AcelRx Technology, provided that
AcelRx shall have the right, upon written notice to Grünenthal, to use,
Manufacture, commercialize and/or sell all or any portion of such Demo Device
outside of the Territory [*] a full-paid, royalty free worldwide license for the
non-exclusive right to use, sell, have sold, Manufacture, have manufactured or
imported any such Demo Device outside of the Territory.”

 

 

p.

In Section 7.2(a), R&D Milestone 7 shall be amended and replaced in its entirety
to read as follows (without affecting the terms set forth in the “R&D
Milestones” table for the payment of such R&D Milestone 7):

 

“[*]

 

[*]”

 

 

 

q.

In Section 7.2(b), the Commercial Milestones 2 and 3 shall be reduced and
replaced in its entirety as follows:

 

  “[*]

 

[*]

  [*]

 

[*]”

 

(A)

 

 

 

r.

A new Section 7.2 (c) of the Agreement shall be added which shall read as
follows:

 

“7.2(c)          Grünenthal shall pay to AcelRx [*] within thirty (30) days
after the [*].”

 

 

s.

In Section 7.5 of the Agreement the term “three Business Days” shall be replaced
by “fifteen (15) days”, referring to the payment of Royalties accrued following
the delivery of the Royalty Report

 

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

 

 
5

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t.

Section 10.7 shall be amended and replaced in its entirety to read as follows:

 

“10.7     Trademarks; General. The Licensed Product shall be sold in each
country of the Territory under the AcelRx Trademark “Zalviso” and if applicable,
the related Grünenthal Supplemental Trademarks, unless such AcelRx Trademark is
determined to be unacceptable to the respective competent Regulatory Authority
for the country/countries of the Territory concerned, in which event AcelRx and
Grünenthal will agree on another AcelRx Trademark (the “Alternative AcelRx
Trademark”) and upon written agreement by both Parties, Grünenthal may obtain
additional Grünenthal Supplemental Trademarks related to such Alternative AcelRx
Trademark. If all AcelRx Trademarks are determined to be unacceptable to the
respective competent Regulatory Authority in the Territory, then Grünenthal
shall have the right to select a trademark owned by Grünenthal (the "Grünenthal
Trademark") for use with the Licensed Product in the Territory. Upon request of
AcelRx, the Parties shall discuss whether Grünenthal may grant license rights
under the Grünenthal Trademark and/or any Grünenthal Supplemental Trademarks to
commercialize, sell, offer for sale the Licensed Product outside the Territory
and under what terms. Grünenthal shall own the Assigned Trademark(s) in the
relevant countries in the Territory, subject to prosecution and maintenance of
such AcelRx Trademark with AcelRx's consent, which consent shall not be
unreasonably withheld, and subject to Sections 14.2, 14.3, 14.4 and 14.5, as
applicable. AcelRx shall provide all reasonable assistance required by
Grünenthal in connection therewith. AcelRx will have the right to use the AcelRx
Trademarks, Grünenthal Trademarks or Grünenthal Supplemental Trademarks used
with the Licensed Product in connection with the supply of Licensed Product to
Grünenthal. Grünenthal shall not use the Assigned Trademarks, the Grünenthal
Trademarks or the Grünenthal Supplemental Trademarks in connection with (i) the
using, promotion, marketing, importing, distributing, selling or offering for
sale of any product other than the Licensed Product nor (ii) in connection with
using, promoting, marketing, importing, distributing, selling or offering for
sale of any product outside the Territory. The Assigned Trademarks shall be used
in accordance with the quality guidelines of AcelRx to ensure that the use of
such Assigned Trademarks in the Territory is maintained in a manner consistent
with the quality standards of AcelRx applicable outside of the Territory.”

 

 

u.

The first sentence of Section 10.8 shall be amended and replaced in its entirety
to read as follows:

 

“The Party that owns (the “Trademark Owner”) the applicable Trademark (whether
AcelRx Trademarks, Assigned Trademarks, Grünenthal Trademarks or Grünenthal
Supplemental Trademarks), shall have the right to take appropriate steps to
protect its Trademark from all harmful or wrongful activities of Third Parties
in the Territory.”

 

 

v.

In Section 16.9 of the Agreement, the AcelRx address for notices shall be
amended and replaced in its entirety to read as follows (without affecting the
Cooley LLP address for copies):

 

“To AcelRx:

 

AcelRx Pharmaceuticals, Inc.

351 Galveston Drive

Redwood City, CA 94063

Attention: Chief Executive Officer

Facsimile: + 1-650-216-6500”

 

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

 

 
6

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w.

The following text and table shall be added to the end of Exhibit 1.38 of the
Agreement:

 

“[*]”

 

x.     Exhibit 1.1 of the Agreement shall be amended and replaced in its
entirety to read as the Exhibit 1.1 attached to this Amendment as of the
Amendment Effective Date.

 

y.     A new Exhibit 1.65(b) shall be added, reading as Exhibit 1.65 (b)
attached to this Amendment.

 

z.     Exhibit 1.83 shall be amended and replaced in its entirety to read as the
Exhibit 1.83 attached to this Amendment.

 

aa.     Exhibit 3.3 of the Agreement shall be amended and replaced in its
entirety to read as the Exhibit 3.3 attached to this Amendment.

 

bb.     All capitalized terms and definitions used in this Amendment shall have
the same meaning as defined in the Agreement.

 

 

2.

The Agreement continues in full force and effect in accordance with its terms,
as amended by this Amendment. Except as expressly set forth in and as
contemplated by this Amendment, the Agreement shall not be amended hereby.

 

 

3.

This Amendment comes into force as of the date both AcelRx and Grünenthal have
executed this Amendment, which shall be as of the date first set forth above.

 

[Signature Page Follows]

 

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

 

 
7

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IN WITNESS WHEREOF, each Party hereto has executed or caused this Amendment to
be executed on its behalf as of the Amendment Effective Date.

 

 

AcelRx PHARMACEUTICALS, INC.

 

 

 

 

 

 

 

 

 

 

By:

/s/ Timothy E. Morris     

 

         

Name: 

Timothy E. Morris

            Title: Chief Financial Officer                       

 

  GRÜNENTHAL GmbH             By: /s/ Alberto Grua                  Name: DoH.
Alberto Grua                  Title: Member of Corporate Executive
Board                CCO EU, AUS, NA & GPS                    

 

  By:  /s/ Eric Paul Paques                  Name: Prof. Dr. Eric Paul
Paques                  Title: CEO       

      

  

 [*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

 

 
8

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Exhibit 1.1

 

Accessories:

 

[*]

 

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended. 

 

 
9

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Exhibit 1.65(b)

 

 

 

Grünenthal Supplemental Trademarks (in any color):

 

Design marks:

 

 

 

[ex10-1img001.jpg](1*)

 

(1*) This Grünenthal Supplemental Trademark shall not be an Assigned Trademark
nor subject to assignment to AcelRx notwithstanding anything in the Agreement.

 

[ex10-1img002.jpg]

 

[ex10-1img003.gif]

 

[ex10-1img004.jpg]

 

and any other design trademark(s) relating to the Licensed Product registered by
or on behalf of AcelRx or Grünenthal for the Territory.

 

Domain names:

 

 

1.       zalviso.es

2.       zalviso.co.uk

3.       zalviso.it

4.       zalviso.fi

5.       zalviso.se

6.       zalviso.no

7.       zalviso.dk

8.       zalviso.be

9.       zalviso.nl

 

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

 

 
10

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10.   zalviso.fr

11.   zalviso.lu

12.   zalviso.ie

13.   zalviso.pt

14.   zalviso.ch

15.   zalviso.at

16.   zalviso.eu

 

and any other domain names relating to the Licensed Product registered by or on
behalf of AcelRx or Grünenthal for the Territory.

 

 

 [*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

 

 
11

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Exhibit 1.83

 

Material Agreements

 

[*]

 

 

 [*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

 

 
12

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Exhibit 3.3

 

“For Grünenthal:

 

Corporate Alliance Management and/or Project Management (each of whom shall be
separately identified and designated)

 

 

For AcelRx:

 

Alliance Management & Corporate Development (to be separately identified and
designated)

 

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

 

 

12