Exhibit 10.3
AMENDMENT NO. 2 TO THE
CO-DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
     THIS AMENDMENT NO. 2 TO THE CO-DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
(this “Amendment”) is made and entered into as of the 5th day of October 2010
(the “Effective Date”) by and between GLAXO GROUP LIMITED, a company organized
under the laws of England and Wales with its principal place of business at
Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN, United
Kingdom (“GSK”) and HUMAN GENOME SCIENCES, INC., a Delaware corporation with its
principal place of business at 14200 Shady Grove Road, Rockville, Maryland 20850
(“HGS”). GSK and HGS are sometimes referred to herein individually as a “Party”
and collectively as the “Parties.”
RECITALS
     WHEREAS, GSK and HGS entered into a Co-Development and Commercialization
Agreement dated as of August 1, 2006, as amended on November 25, 2009
(collectively, the “Co-Development and Commercialization Agreement”);
     WHEREAS, the Parties recognize that Policy Disputes (as defined below)
between the Parties may from time to time arise under the Co-Development and
Commercialization Agreement; and
     WHEREAS, the Parties desire to establish separate procedures to facilitate
the resolution of such Policy Disputes in an expedient manner by mutual
cooperation as set forth in this Amendment.
     NOW, THEREFORE, in consideration of the foregoing premises and the mutual
promises, terms and conditions hereafter set forth, and other good and valuable
consideration, the receipt and sufficiency of which are hereby acknowledged, GSK
and HGS hereby agree to be legally bound as follows:
ARTICLE 1
DEFINITIONS
     1.1 New Defined Terms. The following terms shall be added to Article 1 of
the Co-Development and Commercialization Agreement in alphabetical order:
     1.1.1 “Designated Expert” shall mean a specialist healthcare/regulatory
attorney listed on Schedule A attached to Amendment No. 2 to the Co-Development
and Commercialization Agreement, or other individual(s) as may be mutually
agreed between the Parties in writing.
     1.1.2 “More Conservative Approach” shall mean, in the event of a dispute
between the Parties on how to address or resolve a certain issue arising under
the Co-Development and Commercialization Agreement (including without limitation
any Policy Disputes), the approach or position offered by a Party with

 

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respect to the resolution of such issue, which approach or position, in the
aggregate, is reasonably likely to expose the Parties or the Collaboration
Products to the smallest amount of legal, regulatory and/or compliance risk,
whether or not such opinion of a Party is set forth in such Party’s then-current
internal policies regarding the same, provided that such approach is not
Unreasonably Conservative.
     1.1.3 “Other Dispute” shall mean any dispute between the Parties relating
to the Agreement other than a Policy Dispute.
     1.1.4 “Policy Dispute” shall mean a difference of opinion between the
Parties regarding the permissibility of specific sales, marketing or medical
affairs activities in the Territory by GSK and/or HGS.
     1.1.5 “Unreasonably Conservative” shall mean, with respect to an approach
or position offered by a Party in order to address or resolve an issue, that
such approach or position is unreasonably conservative in light of the business
implications of the approach and overall consistency with industry best
practices as implemented by similarly-situated peer companies of such Party and
documented in applicable guidances (including, with respect to the United
States, the Department of Health and Human Services Office of Inspector General
Compliance Program Guidance, the Pharmaceutical Research and Manufacturers of
America Code on Interactions with Healthcare Professionals, the American Council
for Continuing Medical Education Guidelines, and similar guidances).
     1.2 Amended Defined Terms. The following term, as used in the
Co-Development and Commercialization Agreement, are hereby deleted in their
entirety and replaced with the following:
     1.2.1 “Laws” shall mean all laws, statutes, rules, regulations, ordinances,
guidances and other pronouncements, including without limitation, corporate
integrity agreements, having the effect of law of any government or Governmental
Authority.
     1.3 Other Defined Terms. All other capitalized terms included in this
Amendment that are not defined herein shall have the meaning ascribed to such
terms in the Co-Development and Commercialization Agreement.
ARTICLE 2
RESOLUTION OF POLICY DISPUTES
     2.1 Amendment to Article 3.
     2.1.1 Amendment to Section 3.1.3. Section 3.1.3 of the Co-Development and
Commercialization Agreement is hereby deleted in its entirety and replaced with
the following:

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     “Decision Making. All decisions of the JSC shall be made by unanimous vote,
with each Party having one vote. Reasonable efforts will be made to come to a
consensus decision. With respect to any issue, if the Joint Steering Committee
cannot reach consensus within ten (10) business days after the matter has been
brought to the Joint Steering Committee’s attention, either Party may elect to
have such issue resolved in accordance with Article 15 of this Agreement.”
     2.2 Amendments to Article 5.
     2.2.1 Amendment to Section 5.5.1. Section 5.5.1 of the Co-Development and
Commercialization Agreement is hereby amended by:
     2.2.1.1 deleting in its entirety the third sentence thereof and inserting
the following language in lieu thereof:
     “No Party shall be required to undertake, participate in, finance or
otherwise support any activity under this Agreement which it believes, in good
faith, may violate or conflict with that Party’s policies or any applicable
Law.”
     2.2.1.2 deleting in its entirety the last sentence thereof and inserting
the following language in lieu thereof:
     “In the event of a conflict between the policies of each Party with respect
to Promotional Materials or Co-Promotion and Detailing activities, the GJMC or
the relevant RJMC shall determine which policy will be followed; provided,
however, that for clarity, any disputes within the GJMC or RJMC regarding any of
the foregoing, including without limitation, any Policy Disputes, shall be
resolved in accordance with Article 3 and if required, finally in accordance
with Article 15.”
     2.2.2 Amendment to add Section 5.9. A new Section 5.9 is hereby added to
the Co-Development and Commercialization Agreement as follows:
     “5.9 Independent Third Party Reviews.
     5.9.1 Each Party shall have the right to engage a Third Party (the
“Reviewer”) to conduct periodic, independent reviews of the other Party’s
compliance program as applicable to the Collaboration Product, with a particular
focus on sales, marketing and medical affairs activities, or other activities
which are reasonably likely to expose the Parties requesting the review to
legal, regulatory and/or compliance risk (a “Review”). The purpose of the Review
is to determine, inter alia, whether the other Party’s current compliance
systems, policies, processes and procedures are functioning properly and are
consistent with applicable guidelines and

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industry best practices. The scope of any such Review must be mutually agreed by
the Parties prior to its initiation, which agreement by a Party shall not be
unreasonably withheld.
     5.9.2 Either Party may, at any time during the Term, initiate a Review of
the other Party by giving written notice to the other Party, provided that such
reviews of the same or similar scope may be requested no more frequently than
once per calendar year.
     5.9.3 The Parties shall mutually select the Reviewer, and the Review must
begin within a reasonable time thereafter, but in any event within ninety (90)
calendar days after the date of the written notice pursuant to which a Party
initiates the Review, as set forth in Section 5.9.2. The Parties may mutually
elect to limit a review to only one of the Parties.
     5.9.4 The Reviewer shall prepare a written report of his/her findings, a
copy of which report shall be provided to each Party. The Party that was subject
to the Review will be required to adequately address any findings or
deficiencies noted by the Reviewer within a reasonable period of time after
completion of the Review.
     5.9.5 The Parties will equally share the cost of the Reviewer.”
     2.2 Amendments to Article 15.
     2.2.1 Amendment to Section 15.1. Section 15.1 shall be deleted in its
entirety and replaced with the following:
     “15.1 Resolution of Other Disputes and Policy Disputes.
     15.1.1 Other Disputes. If the JSC cannot in good faith reach a consensus
within ten (10) business days (or such later date as may be mutually agreed in
writing by the Parties) after such Other Dispute has been referred to the JSC
for resolution as provided in Section 3.1.3 of this Agreement, then either Party
shall have a right to refer such Dispute to the following individuals (in each
case, the “Senior Officers”) for resolution as follows: (i) all Other Disputes
relating to Development of a Collaboration Product shall be elevated to GSK’s
Chairman of Research and Development and HGS’ Chief Executive Officer (“CEO”),
or their respective designees, for resolution, (ii) all Other Disputes relating
to Manufacturing of Collaboration Product shall be elevated to GSK’s President
of Global Manufacturing and Supply and HGS’ CEO, or their respective designees,
for resolution, and (iii) all Other Disputes relating to the Commercialization
of a Collaboration Product or any other items not covered in (i) or (ii) above
shall be elevated to GSK’s President of

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Pharmaceutical Operations and HGS’ CEO, or their respective designees, for
resolution. If the Senior Officers are unable to reach a resolution with respect
to an Other Dispute within ten (10) business days after a Party requests for
such Senior Officers to resolve an issue, the Other Dispute shall be resolved
pursuant to Section 15.2.
     15.1.2 Policy Disputes. If the JSC cannot in good faith reach a consensus
within ten (10) business days (or such later date as may be mutually agreed in
writing by the Parties) after such a Policy Dispute has been referred to the JSC
for resolution as provided in Section 3.1.3 of this Agreement, then the
compliance attorneys and senior legal and commercial officers (collectively, the
“Policy Officers”) of each Party shall in good faith attempt to resolve the
Policy Dispute. If the Policy Officers are unable reach a resolution with
respect to a Policy Dispute within ten (10) business days (or such later date as
may be mutually agreed in writing by the Parties) after such Policy Dispute has
been brought to the attention of the Policy Officers, then the Policy Dispute
shall be resolved pursuant to Section 15.3.”
     2.2.2 Amendment to Section 15.2. The heading of Section 15.2 shall be
deleted and replaced with the following “Arbitration for Other Disputes.”
Furthermore, all references in Section 15.2 to “dispute” shall be replaced with
“Other Dispute”.
     2.2.3 New Section 15.3. The following shall be inserted into the Agreement
as Section 15.3:
     “15.3 Resolution of Policy Disputes.
          15.3.1 If, despite good faith efforts, the Policy Officers are unable
to resolve a Policy Dispute within ten (10) business days (or such later date as
may be mutually agreed in writing by the Parties) after such matter has been
referred to them, then the More Conservative Approach shall be selected and
followed by the Parties. If the Policy Officers cannot agree on which approach
or position offered by the Parties is the More Conservative Approach with
respect to a particular issue or whether the More Conservative Approach is
Unreasonably Conservative, then either Party may, by written notice to the other
Party (a “Notice of Referral”), refer the Policy Dispute to a Designated Expert
for resolution in accordance with Section 15.3.2.
          15.3.2 Upon delivery of a Notice of Referral with respect to a Policy
Dispute, within three (3) business days following the date of the Notice of
Referral, the Parties shall agree on the selection of a Designated Expert, using
whatever selection criteria the Parties prefer. The Parties shall engage the
Designated Expert within three (3) business days following such Designated
Expert’s selection by the Parties. Each Party agrees to execute, if requested by
a

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Designated Expert, a reasonable engagement letter, including customary
indemnities in favor of the Designated Expert. The fees and other expenses of
the Designated Expert shall be shared equally between the Parties.
          15.3.3 At the time of engagement of the Designated Expert, the Parties
shall submit a joint request for opinion to the Designated Expert (a “Request
for Opinion”). The Request for Opinion shall contain the following:

  (a)   a very brief description of the disputed activity or inactivity;     (b)
  each Party’s proposed resolution of the Policy Dispute and the reasons
supporting such resolution, which shall be exchanged among the Parties; and    
(c)   instruction to the Designated Expert to provide to the Parties, within two
(2) business days of the Request for Opinion, a written opinion of not more than
two pages in length selecting the proposed resolution from one Party which
represents the More Conservative Approach.

Each Party agrees to cooperate with the Designated Expert and to provide any
materials and information reasonably requested by the Designated Expert.
          15.3.4 If a Party believes the More Conservative Approach is
Unreasonably Conservative, that Party shall immediately raise that issue to the
Designated Expert for a determination. If the Designated Expert determines that
the More Conservative Approach is Unreasonably Conservative, the Designated
Expert will then review an alternative proposal offered by the other Party (the
“Alternative Position”) to determine whether such Alternative Position is
“Sufficiently Conservative,” which means that the Alternative Position is not
reasonably likely to expose the Parties to a significant legal, regulatory
and/or compliance risk and is consistent with industry best practices as
documented in applicable guidances (including, with respect to the United
States, the Department of Health and Human Services Office of Inspector General
Compliance Program Guidance; the Pharmaceutical Research and Manufacturers of
America Code on Interactions with Healthcare Professionals; the American Council
for Continuing Medical Education Guidelines; and similar guidances and standards
including corporate integrity agreements issued within the industry). If the
Designated Expert determines that the Alternative Position is Sufficiently
Conservative, the Parties shall proceed with the Alternative Position, subject
to Section 15.3.5. If the Designated Expert determines that the Alternative
Position is not Sufficiently Conservative, then the Parties shall submit a
follow-on Request for Opinion to the Designated Expert in accordance with the
same procedures set forth in Section 15.3.3, which Request for Opinion shall
include modified proposed resolutions

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from each Party. This process shall continue until the Designated Expert selects
a proposed resolution that represents the More Conservative Approach.
          15.3.5 With respect to a Policy Dispute, the Parties agree to be bound
by and to proceed in accordance with the opinion of the Designated Expert which
decision shall have the same effect as a decision by an arbitrator under
Section 15.2 of the Co-Development and Commercialization Agreement; provided,
however, that, neither Party shall be required to undertake, participate in,
finance or otherwise support any activity under this Agreement which it
believes, in good faith, may violate or conflict with that Party’s policies, any
applicable Laws, or any Industry Guidelines. Nothing herein shall infringe any
Party’s right to disclose activities to Regulatory Authorities as may be
required by applicable Law.
          15.3.6 All offers, promises, conduct and statements, whether oral or
written, made in the course of the Designated Expert’s review by any of the
Parties, their respective agents, employees, experts and attorneys, and by the
Designated Expert, are confidential, privileged and inadmissible for any
purpose, including impeachment, in any litigation or other proceeding involving
the Parties, provided that evidence that is otherwise admissible or discoverable
shall not be rendered inadmissible or non-discoverable as a result of its use in
the Designated Expert’s review process; and further provided that either Party
may waive the privileges contemplated in this Section 15.3.6 upon receipt of
written consent of the other Party which shall not be unreasonably withheld.
     2.3 Addition of Schedule A to the Agreement. Schedule A to this Amendment
shall be added to the Agreement as a new Schedule.
ARTICLE 3
MISCELLANEOUS
     3.1 Scope of this Amendment. Except as explicitly amended above, all terms
and provisions of the Co-Development and Commercialization Agreement shall
remain in full force and effect, except that each reference to the “Agreement”
or words of like import in the Co-Development and Commercialization Agreement
will mean and be a reference to the Co-Development and Commercialization
Agreement as amended by this Amendment.
     3.2 Governing Law. This Amendment shall be governed by and construed in
accordance with the laws of Delaware, as if executed and fully performed within
Delaware, excluding any conflicts or choice of law rule or principle that might
otherwise refer construction or interpretation of this Amendment to the
substantive law of another jurisdiction. Any disputes under this Agreement shall
be subject to the exclusive jurisdiction and venue of the Delaware state courts
and the Federal courts located in Delaware, and the Parties hereby consent to
the personal and exclusive jurisdiction and venue of these courts.

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     3.3 Counterparts. This Amendment may be executed in one or more
counterparts, each of which shall be deemed to be an original but all of which
together shall constitute one and the same instrument.
[Remainder of Page Intentionally Left Blank]

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     IN WITNESS WHEREOF, each of the Parties has caused this Amendment No. 2 to
the Co-Development and Commercialization Agreement to be duly executed as of the
date first written above.

            GLAXO GROUP LIMITED
      By:   /s/ Paul Williamson         Name:   Paul Williamson        Title:  
Corporate Director        HUMAN GENOME SCIENCES, INC.
      By:   /s/ James H. Davis, Ph.D.         Name:   James H. Davis, Ph.D.     
  Title:   Executive Vice President and General Counsel     

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SCHEDULE A
List of Designated Experts
     [***]
 

[***]   INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.