Document:

exv10w1

Exhibit 10.1

CONFIDENTIAL

License and Devlopment Agreement

between

Genentech, Inc., 

F. Hoffmann-La Roche, Ltd.

and

SurModics, Inc.

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

 

 

CONFIDENTIAL

License and Development Agreement

     This License and Development Agreement (“Agreement”) is made and entered into as of
the 5th day of October, 2009 (the “Effective Date”) by and between SurModics,
Inc., a Minnesota corporation with a principal place of business at 9924 West 74th
Street, Eden Prairie MN 55344 (together with its Affiliates, “SurModics”), Genentech, Inc.,
a Delaware corporation, with offices located at 1 DNA Way, South San Francisco, CA 94080
(“GNE”) and F. Hoffmann-La Roche, Ltd., Grenzacherstrasse 124, CH 4070 Basel, Switzerland
(“Roche”) (GNE and Roche together referred to as “Genentech”). SurModics and
Genentech are each referred to herein individually as a “Party” and collectively as the
“Parties.”

Recitals

     WHEREAS SurModics possesses certain expertise and proprietary technologies relating to
controlled-release drug delivery;

     WHEREAS Genentech is a health care company with expertise and capability in researching,
developing, manufacturing and marketing human therapeutics and diagnostics;

     WHEREAS Genentech, Inc., and SurModics’ Affiliate, SurModics Pharmaceuticals, Inc., have
entered into that certain Feasibility Study Agreement [*] (the “Existing Feasibility
Study”); and

     WHEREAS concurrently with this Agreement, Genentech and SurModics are entering into a separate
Master Services Agreement (as defined below) pursuant to which SurModics will supply materials and
provide certain services, each in connection with the Development (as defined below) of Licensed
Products (as defined below) in the Field (as defined below);

     WHEREAS SurModics and Genentech wish to collaborate in the development of Microparticles (as
defined below) for the controlled-release delivery of Genentech’s products in the Field under this
Agreement and the MSA.

     NOW, THEREFORE, in consideration of the mutual covenants contained herein, and for other good
and valuable consideration, the amount and sufficiency of which are hereby acknowledged, the
Parties hereby agree as follows:

Article 1. Definitions

     Capitalized terms used in this Agreement, whether used in the singular or plural, shall have
the meanings set forth below, unless otherwise specifically indicated herein:

          1.1 “Accounting Standard” means (a) with respect to SurModics, United States generally
accepted accounting principles (“GAAP”); and (b) with respect to Genentech, International Financial
Reporting Standards (“IFRS”) or the applicable international accounting standard in use.

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

 

 

CONFIDENTIAL

          1.2 “Affiliate” means any entity that, directly or indirectly (through one or more
intermediaries) controls, is controlled by, or is under common control with a Party. For purposes
of this Section 1.2, “control” means (a) the direct or indirect ownership of fifty
percent (50%) or more of the voting stock or other voting interests or interest in the profits of
the Party, or (b) the ability to otherwise control or direct the decisions of the board of
directors or equivalent governing body thereof. Notwithstanding the foregoing, unless expressly
specified otherwise, for the purposes of this Agreement, [*] and all entities controlled by [*],
shall not be considered an Affiliate of Genentech unless and until Genentech provides written
notice to SurModics specifying Chugai Pharmaceutical Co., Ltd as an Affiliate of Genentech.

          1.3 “Combination Know-How” is defined in Section 10.3(a).

          1.4 “Combination Patents” mean Patents which during the Term are Controlled by Genentech in
accordance with Section 10.3(a) of this Agreement, which claim or cover the Combination Know-How.

          1.5 “Commercially Reasonable Efforts” means, with respect to particular obligations or tasks
of a Party [*]. The efforts and resources of a Party’s Affiliates and sublicensees will be
considered as a Party’s activities under this Agreement for purposes of determining whether a Party
is exercising, or has exercised, “Commercially Reasonable Efforts.”

          1.6 “Commercial Sale” means, with respect to a particular Licensed Product in a given country,
a bona fide arms length commercial sale to a Third Party of such Licensed Product following final
Regulatory Approval in such country by or under authority of Genentech, its Affiliates or Genentech
sublicensees or their Affiliates. Commercial Sale shall not include the provision of any Licensed
Product for use in clinical trials or for compassionate use prior to the receipt of necessary
marketing approvals.

          1.7 “Commercialization” means manufacturing for commercial sale; marketing; promotion; sale;
and/or distribution of Licensed Product. “Commercialize” has a correlative meaning.

          1.8 “Compound” means [*].

          1.9 “Confidential Information” is defined in Section 9.1.

          1.10 “Control(s)” or “Controlled” means the possession, as of the Effective Date or during the
Term, of (a) with respect to materials, data or information, physical possession or the right to
such physical possession of those items, with the right to provide them to Third Parties; and (b)
with respect to intellectual property rights, rights sufficient to grant the applicable license or
sublicense under this Agreement; in each case without violating the terms of any agreement with any
Third Party.

          1.11 “Development” means all activities that relate to (a) obtaining, maintaining or expanding
Regulatory Approval of a Licensed Product, (b) studies conducted to expand the scientific or
medical understanding of a Licensed Product, whether for publication in a peer-reviewed journal or
not, but not necessarily for the intent of obtaining, maintaining or expanding

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

2

 

CONFIDENTIAL

Regulatory Approval of a Licensed Product (e.g., investigator-sponsored trials) or (c)
developing the ability to manufacture clinical and commercial quantities of Licensed Product. Such
activities include: (i) research, preclinical testing, toxicology, and clinical studies of a
Licensed Product; (ii) preparation, submission, review, and development of data or information for
the purpose of obtaining, maintaining and/or expanding Regulatory Approval of a Licensed Product;
(iii) manufacturing, process development and scale-up, bulk production and fill/finish work
associated with the supply of Licensed Product for preclinical and clinical studies, and related
quality assurance and quality control activities; and (iv) post-Regulatory Approval product support
for a Licensed Product (including manufacturing and quality assurance support, and laboratory and
clinical efforts directed toward the further understanding of the safety and efficacy of a Licensed
Product). “Develop” has a correlative meaning.

          1.12 [*].

          1.13 [*].

          1.14 “FDA” means the U.S. Food and Drug Administration or corresponding governmental authority
in another country, or any successor thereto.

          1.15 “Feasibility Study” is defined in Section 2.3(c)(ii)(C), and include the Existing
Feasibility Study.

          1.16 “Field” means [*]

          1.17 “Genentech IP Rights” means the Genentech Know-How and the Genentech Patents.

          1.18 “Genentech Know-How” means [*].

          1.19 “Genentech Microparticle Formulation” means [*].

          1.20 “Genentech Patents” means [*].

          1.21 “GXP” means (a) the current Good Manufacturing Practices pursuant to the U.S. Food, Drug
and Cosmetic Act and any U.S. regulations found in Title 21 of the U.S. Code of Federal Regulations
(including Parts 11, 210 and 211) and other regulations, policies, or guidelines, as applicable to
the manufacture, labeling, packaging, handling, storage, supply and transport of Licensed Products.
“GXP” also includes comparable laws, rules and regulations of any jurisdiction where Licensed
Products are or may be marketed, but that are not governed by United States law; (b) the
then-current FDA regulations and guidelines for “Good Laboratory Practice,” as promulgated by the
FDA under Title 21 of the U.S. Code of Federal Regulations Part 58, as amended from time to time,
or any foreign equivalents thereto in the country in which research is conducted; and (c) the then
current FDA regulations and guidelines for “Good Clinical Practice,” as promulgated by the FDA
under 21 CFR Parts 50, 54, 56 and 312, as amended from time to time, or any foreign equivalents
thereto (e.g., ICH Guideline for Good Clinical Practice) in the country in which such studies or
clinical trials are conducted.

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

3

 

CONFIDENTIAL

          1.22 “IND” means an Investigational New Drug Application filed with the FDA pursuant to 21 CFR
Part 312 before the commencement of clinical trials for a Licensed Product.

          1.23 “IND-Enabling Study” means a study conducted by or on behalf of Genentech, a Genentech
Affiliate or sublicensee, in a non-rodent animal, of the toxicological effects (and, in some cases,
pharmacokinetic properties) of a compound or other substance that the entity directing the study
believes may be useful as a drug, where (i) such study is conducted to Good Laboratory Practices
standards, and (ii) the data is intended to be used to file an IND with the FDA.

          1.24 “Initial [*]” means [*].

          1.25 “Injection Vehicle” means [*].

          1.26 “Joint Project IP Rights” is defined in Section 10.4(b)(i).

          1.27 “Know-How” means information, materials, results, compositions of matter and uses
thereof, techniques, data and other know-how and technical information, including inventions,
improvements, developments, practices, methods, processes, concepts, trade secrets, documents,
computer data, computer code, apparatus, clinical and regulatory strategies, test data, analytical
and quality control data, formulation, manufacturing, patent data or descriptions, development
information, drawings, specifications, designs, plans, proposals and technical data and manuals and
all other proprietary information.

          1.28 “Licensed Product” means any preparation of a Compound formulated as Microparticles,
including, without limitation the Ranibizumab Product, that [*].

          1.29 “Master Services Agreement” or “MSA” means the Master Services Agreement between the
Parties dated as of the Effective Date and attached hereto as Exhibit A (as modified, amended, or
restated from time to time).

          1.30 “Major EU Market” is any one of the following countries: [*].

          1.31 “Microparticles” means injectable, biodegradable microparticles composed of any polymer,
including without limitation, the SurModics Polymers.

          1.32 “Milestone Event” means a milestone event set forth in the table in Section 7.3.

          1.33 “Net Sales.”

               (a) Definition. “Net Sales” means, subject to the provisions of this Section
1.33(a), the gross amounts invoiced for sales of Licensed Products (in final form for end use) by
Genentech and its Affiliates, and their respective sublicensees and their Affiliates, less the
following reasonable and customary deductions from such invoiced amounts that are actually
incurred:

[*]

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

4

 

CONFIDENTIAL

               (b) All of the foregoing elements of Net Sales calculations shall be determined in accordance
with Accounting Standards.

               (c) Sales Among Affiliates and Sublicensees. Sales between or among a Party and its
Affiliates, and their respective sublicensees and their Affiliates, shall be excluded from the
computation of Net Sales, but Net Sales shall include the first sales to Third Parties by any such
Affiliates or sublicensees and their Affiliates.

               (d) [*].

               (e) Licensed Products Sold in Combinations.

                    (i) In the event a Licensed Product is sold in combination with one or more other active
ingredients that are not the subject of this Agreement (for purposes of this Section 1.33(d), a
“Combination”), the gross amount invoiced for such Licensed Product shall be calculated
[*].

                    (ii) In the event that such other active ingredient(s) are not sold separately (but such
Licensed Product is), the gross amount invoiced for such Licensed Product shall be calculated [*].

          1.34 “Net Sales Report” is defined in Section 8.1.

          1.35 “Option Term” means [*].

          1.36 “Patent” means a patent or a patent application, including any additions, divisions,
continuations, continuations-in-part, invention certificates, substitutions, reissues,
reexaminations, extensions, registrations, patent term extensions, supplementary protection
certificates and renewals of any of the above.

          1.37 “Phase I Clinical Trial” means, as to a specific Licensed Product, a controlled and
lawful study in humans designed with the principal purpose of preliminarily determining the safety
of a pharmaceutical product in healthy individuals or patients, and for which there are no primary
endpoints related to efficacy, as further defined in 21 C.F.R. § 312.21(a); or similar clinical
study in a country other than the United States.

          1.38 “Phase II Clinical Trial” means, as to a specific Licensed Product, a controlled and
lawful study in humans designed with the principal purpose of determining initial efficacy and
dosing of such Product in patients for the indication(s) being studied, as further defined in 21
C.F.R. § 312.21(b); or similar clinical study in a country other than the United States.

          1.39 “Phase III Clinical Trial” means, as to a specific Licensed Product, a controlled and
lawful study in humans of the efficacy and safety of such Product, which is prospectively designed
to demonstrate statistically whether such Product is effective and safe for use in a particular
indication in a manner sufficient to file an application to obtain Regulatory Approval to market
and sell that Licensed Product in the United States or another country for the indication being
investigated by the study, as further defined in 21 C.F.R. § 312.21; or similar clinical study in a
country other than the United States.

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

5

 

CONFIDENTIAL

          1.40 “Program Budget” means the budget associated with a Feasibility Study, Project Plan, or
(if applicable) an SOW to the MSA, which [*].

          1.41 “Project Know-How” means any and all Know-How (whether or not patentable) first
conceived, first reduced to practice, or otherwise first made, discovered, or created as a direct
result of (a) the use of any Confidential Information disclosed by one Party to the other Party
hereunder, (b) the exercise by either Party of the rights licensed under this Agreement, or (c) a
Party’s activities under this Agreement, the Existing Feasibility Study, or the MSA, in each case;
whether solely by one Party or its Affiliates and/or their respective employees, contractors or
consultants, or jointly by the Parties and/or their employees, contractors or consultants, or
solely or jointly by a Third Party engaged to perform work thereunder. For clarity, “Project
Know-How” shall not cover any information made, discovered, or created by a Party independently of
activities under this Agreement, the Existing Feasibility Study, or the MSA

          1.42 “Project Plan” is defined in Section 4.2.

          1.43 “Prosecution and Maintenance” or “Prosecute and Maintain,” with regard to a particular
Patent, means the preparation, filing, prosecution and maintenance of (including a decision to
abandon) such Patent, as well as re-examinations, reissues, applications for patent term extensions
and the like with respect to that Patent, together with the conduct of interferences, the defense
of oppositions and other similar proceedings with respect to that Patent.

          1.44 “Ranibizumab Product” means [*].

          1.45 “Regulatory Approval” means all approvals, licenses, registrations or authorizations of
any federal, state or local regulatory agency, department, bureau or other governmental entity,
necessary for the manufacturing, use, storage, import, transport, marketing and/or sale of a
particular Licensed Product in a country or regulatory jurisdiction.

          1.46 “SurModics FTE Rates” [*]

          1.47 “SurModics IP Rights” means [*].

          1.48 “SurModics Know-How” means [*].

          1.49 “SurModics Patents” means [*].

          1.50 “SurModics Polymers” means [*].

          1.51 “SurModics Project Deliverables” means [*].

          1.52 “SurModics Raw Materials” mean [*].

          1.53 “SurModics Technology” means [*].

          1.54 [*]

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

6

 

CONFIDENTIAL

          1.55 “Term” is the term of this Agreement, in accordance with Section 12.1.

          1.56 “Territory” means [*].

          1.57 “Third Party” means any party other than SurModics or Genentech or their Affiliates.

          1.58 [*].

          1.59 “Valid Claim” means a claim of an issued and unexpired patent that has not been: (a)
disclaimed, cancelled, withdrawn or abandoned, (b) dedicated to the public; (c) declared invalid,
unenforceable, unpatentable or revoked by a decision of a court, government agency or other
authority of competent jurisdiction from which no appeal can be or has been taken; or (d) admitted
to be invalid or unenforceable through reexamination, reissue or otherwise.

Article 2. License Grant

          2.1 License Grant to Genentech.

               (a) SurModics hereby grants to Genentech and its Affiliates, under the [*], the following
licenses:

                    (i) an exclusive [*] license to make, use, offer to sell, sell, and import Licensed Products
in the Field in the Territory;

                    (ii) an exclusive [*] license to make, use, offer to sell, sell, and import the Injection
Vehicle exclusively for use with the Development and Commercialization of Licensed Products in the
Field in the Territory; and

                    (iii) [*]

               (b) The licenses granted to Genentech in this Section 2.1, are subject to a retained right by
SurModics under [*] as necessary for SurModics to perform any of the obligations assigned to it
under this Agreement, the Existing Feasibility Study, or the MSA.

          2.2 [*]

          2.3 Option to Acquire Rights to [*].

               (a) Genentech [*] Option. Subject to Third Party rights granted by SurModics
as of the Effective Date, or otherwise granted by SurModics after the Effective Date (in each case,
so long as such Third Party rights remain in effect), and on the terms and conditions of this
Section 2.3, SurModics hereby grants to Genentech the option to obtain [*] additional exclusive,
worldwide, sublicensable licenses for Licensed Products [*].

               (b) [*]

               (c) Procedure for Obtaining Rights [*].

                    (i) Option Notice. At any time during the Option Election Term, Genentech may, in
good faith, notify SurModics of its interest in evaluating the feasibility of

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

7

 

CONFIDENTIAL

Microparticles as a sustained delivery [*] by submitting a written selection notice to
SurModics (each, an “Option Notice”). [*].

                    (ii) Determination
Regarding an [*]. Within thirty (30) days after receiving an
Option Notice, SurModics will determine whether the [*] identified in such Option Notice is
available for licensing to Genentech. [*]

                         (A) [*]

                         (B) Excluded [*]. In the event that SurModics determines that a particular [*] is not
available for licensing to Genentech [*], then such [*] will be considered an “Excluded
[*].” [*]

                         (C) Feasibility Study. As soon as reasonably practical following delivery of a Notice
of Availability with respect to a particular [*], SurModics shall prepare and deliver to Genentech
a good faith proposal for a feasibility study aimed at evaluating the in vitro and in vivo
feasibility of Microparticles [*] incorporating a molecule selected by Genentech that is Directed
to such [*] (each, a “Feasibility Study”). The Feasibility Study shall [*]. Within [*] of
the date of Genentech’s receipt of the Feasibility Study proposal with respect to a particular [*],
the Parties shall in good faith finalize the details of such proposal to allow Genentech, in its
sole discretion, to Initiate a Feasibility Study (as defined below) with respect to such [*].

                    (iii) Exercise of a Genentech [*] Option. [*] Upon Genentech’s exercise of a
Genentech [*] Option in accordance with this Section 2.3(c)(iii) for a particular [*], Genentech
shall have the following rights:

                         (A) If such [*] is an Available [*], then, at Genentech’s sole discretion, Genentech may
request that such [*] be automatically be included [*] and shall be subject to the terms and
conditions of this Agreement, including, without limitation the automatic grant to Genentech of the
exclusive and non-exclusive licenses under and in accordance with Section 2.1; and

                         (B) [*]

                    (iv) Failure to Exercise. [*]

          2.4 License Grant to SurModics. Genentech hereby grants SurModics a non-exclusive,
non-sublicensable (except to the extent SurModics is permitted to use a Third Party in performing
its obligations under this Agreement in accordance with Section 4.3(b)), royalty-free right and
license under the Genentech IP Rights solely to the extent necessary for SurModics to perform the
activities assigned to it under this Agreement, a Feasibility Study, Project Plan or the MSA.

          2.5 No Other Licenses. Neither Party grants to the other Party any rights or licenses in or
to any intellectual property, whether by implication, estoppel, or otherwise, other than the rights
and licenses that are expressly granted under this Agreement.

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

8

 

CONFIDENTIAL

          2.6 Reservation of Rights. Genentech acknowledges that the licenses granted under this
Article 2 are limited to the scope expressly granted and all other rights under the SurModics IP
Rights are expressly reserved to SurModics. Without limiting the foregoing, as between the
Parties, SurModics retains all of its rights under the SurModics Technology and the SurModics IP
Rights for all purposes not expressly licensed under this Agreement. Genentech acknowledges that
SurModics’ business involves the application of the SurModics Technology and/or the SurModics IP
Rights to molecules, compounds and products and that SurModics retains the right (expressly subject
to SurModics’ obligations under, and the terms and conditions of, this Agreement or any other
agreement between the Parties) to apply such SurModics Technology and/or the SurModics IP Rights to
compounds, molecules or products, other than Licensed Products, or compounds or molecules Directed
to a [*] in the Field. For clarity, the foregoing reservation of rights is not meant to limit in
any manner Genentech’s rights in and to any Project IP Rights.

Article 3. Governance

          3.1 Joint Steering Committee. Within thirty (30) days after the Effective Date, SurModics and
Genentech shall form a joint steering committee (the “JSC”) responsible for monitoring the
activities under each Feasibility Study, Project Plan, and, as appropriate, the MSA. The JSC shall
be composed of [*] representatives designated by SurModics and [*] representatives designated by
Genentech, or such other number of representatives as the Parties may agree to in writing. Such
representatives will be appropriate, in terms of their seniority, availability, function in their
respective organizations, training and experience, for the JSC tasks then being undertaken and the
stage and scope of the activities being performed. Each Party shall designate one of its
representatives as its primary JSC contact. Each Party may replace its JSC representatives at any
time upon prior written notice to the other Party. From time to time, the JSC may establish
subcommittees to oversee particular projects or activities, and such subcommittees will be
constituted and will operate as determined by the JSC. The JSC shall continue to exist until [*]
after the later of: (a) expiration of the Option Term [*], or (b) completion of the last Project
Plan, Feasibility Study or SOW (as defined in Section 2.1.1 of the MSA) (the “JSC Term”).
Notwithstanding the foregoing, either Party may, at its sole discretion, terminate its
participation on the JSC at any time after the [*] anniversary of the Effective Date by providing
thirty (30) days written notice to the other Party. Should either Party elect to terminate its JSC
participation, the Parties will amend the respective decision making and disclosure rights and
obligations enumerated in this Agreement to preserve the Parties’ respective decision making and
disclosure rights and obligations in the absence of participation through the JSC.

          3.2 Meetings of the JSC. Unless otherwise agreed by the Parties, the JSC shall meet at least
twice each calendar year during the JSC Term. In addition, the JSC or a JSC designated
subcommittee shall meet prior to the commencement, and within thirty (30) days after the
completion, of each Project Plan and/or Feasibility Study. Such meetings shall be held on such
dates and at such times and places as reasonably agreed to by the Parties. Meetings may be held in
person, by teleconference or videoconference. Each Party shall bear the expense of its respective
representatives’ participation in JSC meetings. If a Party’s representative is unable to attend a
given meeting, such Party may designate an alternate to attend such meeting and perform the
functions of such representative. Each Party may invite a reasonable number of

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

9

 

CONFIDENTIAL

additional participants to attend JSC meetings where deemed appropriate by the Parties’
primary JSC contact, provided that each are bound by appropriate confidentiality obligations.

          3.3 Minutes; Other Documentation. The JSC shall keep minutes of its meetings that record in
writing all decisions made, action items assigned or completed and other appropriate matters. The
responsibility for keeping meeting minutes shall alternate between the Parties, beginning with
Genentech. Meeting minutes shall be sent to all members of the JSC promptly after a meeting for
review and comment.

          3.4 Responsibilities of the JSC. The JSC shall have the responsibility and authority to:

            [*]

          3.5 Updates. The regularly scheduled meetings of the JSC will include as an agenda item an
update of (a) Genentech’s progress and plans for Development and Commercialization of Licensed
Products, and (b) any serious adverse events which Genentech determines to be reasonably
attributable to the SurModics Technology as incorporated into any Licensed Product. All updates,
and all information contained in any such update, are Genentech’s Confidential Information, except
to the extent such updates or information incorporate SurModics’ Confidential Information.

          3.6 Areas Outside the JSC’s Authority. [*]

          3.7 JSC Decisions.

               (a) Consensus; Good Faith; Action Without Meeting. With respect to the responsibilities of
the JSC each Party shall [*] in all decisions, and the Parties shall attempt in good faith to make
decisions by consensus. The members of the JSC shall act in good faith and cooperate with one
another in discussing and seeking to reach agreement on all matters before the JSC. A decision
that may be made at a JSC meeting may also be made without a meeting, if such decision is agreed to
in writing (including by email) by each Party’s primary JSC contact (or its designee), provided
that each Party’s writing clearly indicates that such decision is a formal decision by such Party’s
primary JSC contact.

               (b) [*]

          3.8 No Deliverables. The Parties acknowledge and agree that the JSC under this Agreement is
strictly for the purposes of decision making and governance of the activities conducted under a
Feasibility Study, Project Plan, or an SOW to the MSA, and does not in any way include any
significant deliverable of either Party.

Article 4 Project Plans

          4.1 Overview. For each [*], Genentech may request that SurModics perform certain activities
related to Compounds Directed to such [*] and the Genentech Microparticle Formulations generated
pursuant to a Feasibility Study. In particular, Genentech may request that SurModics, using the
SurModics Technology, work on certain projects designed to develop and optimize the Genentech
Microparticle Formulations and/or Injection Vehicles, and generate

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

10

 

CONFIDENTIAL

such other SurModics Project Deliverables as the Parties may agree. In all cases the Parties
intend the details of such activities to be set forth in a Project Plan; notwithstanding the
foregoing, the Parties acknowledge that certain activities may be agreed between the Parties
outside of a formalized Project Plan, and, provided there is a clear intent and agreement between
the Parties, such activities will be deemed to be part of a Project Plan hereunder.

          4.2 Project Plans. The Parties shall mutually agree upon project plans (each a “Project
Plan”) detailing the specific activities to be performed by SurModics in connection with a
Genentech Microparticles Formulation, [*]. Genentech will compensate SurModics for the activities
conducted and expenses incurred under a Project Plan as set forth in Section 7.2. For each new
Project Plan the specific activities to be performed by SurModics will be established as follows:
Genentech shall notify SurModics in writing as to the general scope of the work Genentech would
like SurModics to perform. Promptly thereafter, Genentech and SurModics shall, in good faith
develop and mutually agree on a detailed written Project Plan and Program Budget. Each Project Plan
and Program Budget shall be agreed by the Parties in writing prior to its commencement.

          4.3 Conduct of Project Plans.

               (a) In General. SurModics and Genentech shall each conduct their respective responsibilities
under each Project Plan in good scientific manner, and in compliance in all material respects with
all requirements of applicable laws, rules and regulations (including, as applicable, GXPs) and
shall attempt to achieve their objectives efficiently and expeditiously. Each Party’s tasks under
each Project Plan shall include cooperating with and providing reasonable support to the other
Party in such other Party’s performance of its responsibilities under the Project Plan. SurModics
and Genentech shall each use their respective Commercially Reasonable Efforts in the performance of
their obligations under each Project Plan by allocating sufficient time, effort, equipment and
facilities to the Project Plan and using personnel with sufficient skills and experience as are
required to accomplish the Project Plan in accordance with its terms and the terms of this
Agreement.

               (b) Third Party Contractors. [*] SurModics may use the services of Third Parties to perform
its Project Plan [*] or as otherwise explicitly set forth in a Project Plan. [*]

               (c) Updates and Disclosure of SurModics’ Technology. From time to time, and on Genentech’s
request, during the term of a Project Plan, SurModics shall disclose to Genentech the SurModics IP
Rights necessary or useful for Genentech to conduct its activities under such Project Plan and to
exercise the rights granted to Genentech under this Agreement.

               (d) Project Reports. SurModics shall maintain complete and accurate records of its activities
conducted under each Project Plan. From time to time during the conduct of each Project Plan, at
Genentech’s request, SurModics and Genentech shall discuss SurModics progress (including, without
limitation, anticipated and incurred costs) under any Project Plan. In addition, SurModics shall
provide Genentech with a written update [*] summarizing in reasonable detail all Project Plan
activities assigned to SurModics and its Affiliates, sublicensees, and Third Party contractors
during such month. Within [*] of the conclusion of its activities

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

11

 

CONFIDENTIAL

under each Project Plan, SurModics shall provide Genentech with a complete and detailed report
summarizing its observations and results from such Project Plan (the “Report”) for
Genentech’s review and approval. In addition, as reasonably requested by Genentech, within [*] of
its receipt of the Report, SurModics will provide Genentech with any additional documentation and
data (including raw data) in SurModics’ Control generated under the Project Plan related to any
SurModics’ Project Deliverables or any Project Know-How. [*].

          4.4 [*].

Article 5. Development and Commercialization

          5.1 In General. As between the Parties, Genentech shall be solely responsible for, have
complete control of, and bear all costs for the Development and Commercialization of Licensed
Products, including without limitation all regulatory activities. Except as provided in Article 6
below, as between the Parties, Genentech shall be responsible for, have complete control of, and
bear all costs for, the manufacturing (or otherwise obtaining supply) of Licensed Products in bulk
and finished form for use by Genentech, its Affiliates, and its sublicensees in conducting
Development and Commercialization in the Field in the Territory.

          5.2 General Diligence.

               (a) Commercially Reasonable Efforts by Genentech. Subject to SurModics’ fulfillment of its
obligations under each respective Feasibility Study, Project Plan, and SOW to the MSA, and under
Sections 4.3(c), 5.3, or 6.3 of this Agreement, and Sections 13.3.7 and 13.3.8 of the MSA (if
applicable), Genentech shall use Commercially Reasonable Efforts to Develop and Commercialize at
least one Licensed Product [*] in the Territory.

               (b) Commercially Reasonable Efforts by SurModics. Subject to Genentech’s fulfillment of its
obligations under this Agreement, SurModics shall use Commercially Reasonable Efforts to execute
and perform all Development activities (including the manufacturing and/or scale up and transfer of
manufacturing capabilities performed under an SOW to the MSA) reserved for or assigned to SurModics
under this Agreement or the MSA.

          5.3 SurModics’ Cooperation. At Genentech’s request, SurModics will, and will cause its
Affiliates, employees, contractors and agents to, cooperate with and provide all necessary and
reasonable support, Know-How, expertise and assistance to Genentech in its conduct of any
activities in the Development and Commercialization of Licensed Products, including, without
limitation, assistance related to Genentech’s preparation of materials for regulatory authorities.
Genentech shall reimburse SurModics for pre-approved time expended and pre-approved expenses by
SurModics in providing such assistance in accordance with Section 7.2.

Article 6 Manufacturing

          6.1 In General. As between the Parties Genentech will be solely responsible for, have
complete control over, and bear all costs for the manufacturing (or otherwise obtaining supply) of
Licensed Products (including without limitation, related SurModics Polymers, Injection Vehicles or
any component thereof) for use by Genentech, its Affiliates and

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

12

 

CONFIDENTIAL

sublicensees in conducting all research, Development and Commercialization of Licensed
Products in the Field and in the Territory.

          6.2 Manufacture and Supply by SurModics

[*]

Article 7 Payments

          7.1 Up Front Payment. Genentech shall pay SurModics a one-time, non-refundable, upfront
payment of three million five hundred thousand dollars (US$3,500,000) within thirty (30) days of
the Effective Date.

          7.2 Program Funding.

               (a) Program Budgets. In consideration of SurModics’ performance of its activities under each
Feasibility Study, Project Plan and (to the extent applicable) SOW, Genentech shall reimburse
SurModics for all undisputed amounts incurred by SurModics in accordance with the associated
Program Budget. SurModics will provide Genentech with an invoice for SurModics’ activities, [*].
Genentech shall pay SurModics [*] in accordance with Program Budgets, [*] after Genentech’s receipt
of an invoice. Each invoice will include [*]

               (b) Costs. [*] SurModics will notify Genentech through the JSC (or JMT under the MSA as
applicable) promptly during the course of a Feasibility Study Project Plan, or SOW if it believes
its costs and expenses will exceed those estimated in the applicable Program Budget [*].

               (c) Cooperation.
Genentech shall pay SurModics [*] for any other
SurModics’ activities related to providing additional cooperation to Genentech under and in
accordance with Sections 4.3(c), 5.3 or 6.3 of this Agreement, and as provided under Section 13.3.6
of the MSA, [*].

          7.3 Development Milestone Payments. With respect to each [*], Genentech shall pay to
SurModics the following milestone payments [*] after the first achievement by Genentech, its
Affiliates or sublicensees or their Affiliates of each of the corresponding Milestone Events by the
first Licensed Product Directed to such [*]:

[*]

          7.4 Valid Claim Royalty Payment. Subject to the provisions of this Article 7, on a
country-by-country and Licensed Product-by-Licensed Product basis, for the applicable Royalty Term,
Genentech shall pay SurModics a royalty (the “Valid Claim Royalty”) on Net Sales by
Genentech, its Affiliates and sublicensees of Licensed Products, [*]:

[*]

          7.5 [*].

          7.6 [*]

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

13

 

CONFIDENTIAL

          7.7 Single Royalty. In no event shall more than one royalty payment be due to SurModics
hereunder with respect to the sale of a particular Licensed Product even, without limitation, if
the sale of such Licensed Product is covered by more than one Valid Claim in the SurModics IP
Rights or Combination Patent Rights.

          7.8 Royalty Term. On a Licensed Product-by-Licensed Product and country-by-country basis,
Genentech’s obligation to pay SurModics royalty payments based on Net Sales of a particular
Licensed Product in a specific country in accordance with Sections 7.4, 7.5, or 7.6 shall commence
on the first Commercial Sale of such Licensed Product in such country [*]. Upon expiration of the
Royalty Term for a particular Licensed Product in a given country, the licenses granted to
Genentech under this Agreement with respect to such Licensed Product in such country shall become
fully paid-up and irrevocable.

          7.9 [*].

Article 8 Reports, Audits and Financial Terms

          8.1 Net Sales Reports and Royalty Payment. Genentech’s obligation to pay royalties under
Article 7 accrues on the sale of each Licensed Product during its Royalty Term. For Net Sales
occurring within the United States, within [*] days after [*] in which a royalty payment under
Article 7 has accrued, Genentech shall pay SurModics the total royalty payment owed based on the
royalty obligations that accrued [*], which payment will be accompanied by a report of Net Sales of
Licensed Product for which a royalty is due (each, a “Net Sales Report”). [*] Genentech
shall pay SurModics the total royalty payment owed based on the royalty obligations that accrued in
[*], which payment will be accompanied by a Net Sales Report. Each Net Sales Report will set forth
for [*] the following information: [*].

          8.2 Additional Financial Terms.

               (a) Currency. All payments to be made under this Agreement shall be made in United States
dollars, unless expressly agreed otherwise by the Parties in writing. Amounts invoiced in a
currency other than dollars must be expressed in the United States dollar equivalent as well as any
local currency. Net Sales outside of the United States shall be first determined in the currency
in which they are earned and shall then be converted into an amount in United States dollars. In
each calendar quarter, whenever conversion of payments from any foreign currency shall be required,
such conversion shall be made using Genentech’s (or Genentech Affiliate’s or sublicensee’s)
then-current policy used for external financial reporting.

               (b) Payment Type. Amounts paid by one Party to the other Party under this Agreement shall be
paid in immediately available funds, by means of wire transfer to an account identified by the
payee.

               (c) Withholding of Taxes. Genentech may withhold from the royalty payments due to SurModics
the amount of any withholding taxes that are required by law to be paid to any taxing authority
with respect to such payments. Genentech shall provide to SurModics (a) all relevant documents and
correspondence, and (b) any other cooperation or assistance on a reasonable basis, in each case as
may be necessary to enable SurModics to claim

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

14

 

CONFIDENTIAL

exemption from such withholding taxes and to receive a full refund of such withholding tax or
claim a foreign tax credit. Genentech, upon SurModics’ request, shall provide SurModics with
proper documentation to prove such taxes have been paid within the time period required by
applicable laws. The Parties shall cooperate with each other in seeking deductions under any
double taxation or other similar treaty or agreement from time to time in force.

               (d) Late Payments. Any amounts not paid within thirty (30) calendar days after the date due
under this Agreement are subject to interest from the date due through and including the date upon
which payment is received. Interest is calculated, over the period between the date due and the
date paid, at a rate equal to [*], calculated on the number of days such payment is past due,
compounded monthly.

               (e) Blocked Currency. If, at any time, legal restrictions prevent the prompt remittance of
part or all royalties based on Net Sales in any country where a Licensed Product is sold, payment
shall be made through such lawful means or methods as the Party paying may determine. When, in any
country, laws or regulations prohibit both the transmittal and deposit of royalties or other
payments; the Party paying shall continue to report all such amounts, but may suspend payment for
as long as such prohibition is in effect. As soon as such prohibition ceases to be in effect, all
amounts that would have been obligated to be transmitted or deposited, but for the prohibition,
shall forthwith be deposited or transmitted promptly.

          8.3 Accounts and Audit.

               (a) Records. To the extent applicable, Genentech shall keep full, true and accurate books of
account containing the particulars of Net Sales and the calculation of royalties, and SurModics
shall keep full, true and accurate books of account containing the particulars of all time,
materials and expenses invoiced to Genentech hereunder. Such books of account and the supporting
data will be maintained available for examination for [*], and otherwise as required to comply with
the Accounting Standard relevant for each Party.

               (b) Appointment of Auditor. A Party may appoint an independent certified public accounting or
consulting firm reasonably acceptable to the other Party to inspect the relevant books of account
of such other Party to verify any reports or statements provided, or amounts paid or invoiced (as
appropriate), by the audited Party. The accounting or consulting firm (and any individuals, if
applicable) appointed to perform the examination under this Agreement must execute a confidential
disclosure agreement with the audited Party or otherwise be subject to terms governing non-use and
non-disclosure of information that the audited Party has agreed in writing are acceptable.

               (c) Procedures for Audit. A Party may exercise its right to have relevant records [*]. The
audited Party is required to make its records available for inspection only during regular business
hours, only at such place or places where such records are customarily kept, and only upon receipt
of at least thirty (30) calendar days written advance notice from the auditing Party.

               (d) Audit Report. The independent accountant or consultant will be instructed to provide an
audit report containing its conclusions regarding the audit, and specifying whether the amounts
paid were correct, and, if incorrect, the amount of any underpayment or overpayment. The
independent accountant or consultant further will be

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

15

 

CONFIDENTIAL

instructed to provide that audit report first to the audited Party, and to redact any proprietary
information of the audited Party not relevant to the calculation of royalties or other
applicable payment information prior to providing that audit report to auditing Party. That audit
report shall be deemed to be Confidential Information of the audited Party, and used only for
purposes germane to this Section 8.3.

               (e) Underpayment and Overpayment. After review of the auditor’s report: (i) if the auditor
determines there has been an underpayment by the audited Party for the period in question, then the
audited Party shall pay to the auditing Party the full amount of that underpayment, and (ii) if the
auditor determines there has an overpayment by the audited Party for the period in question, then
the audited Party shall have a credit against future payments due to the auditing Party (such
credit equal to the full amount of that overpayment), or, if the audited Party is not obligated to
make any future payments, then the auditing Party shall pay to the audited Party the full amount of
that overpayment. [*]

Article 9 Confidentiality

          9.1 Confidential Information. As used in this Agreement, “Confidential Information” means
nonpublic information, including, without limitation Know-How, disclosed by one Party to the other
Party in connection with this Agreement. Whether or not marked as confidential, Genentech’s
Confidential Information shall include, without limitation, the Option Notice provided under
Section 2.3, updates provided by Genentech in accordance with Section 3.5, the work plan for each
Feasibility Study, each Project Plan, any Reports provided under Section 4.3(d), all information
(and not materials) in the SurModics Project Deliverables, and Net Sales Reports provided to
SurModics in accordance with Section 8.1; and SurModics’ Confidential Information will include
non-public patent applications provided by SurModics to Genentech under this Agreement, if any.

          9.2 Limitations on Use. Except to the extent expressly authorized by this Agreement, during
the Term and for [*] years following its expiration or termination each Party agrees (a) to use
such Confidential Information only for the purposes contemplated under this Agreement, (b) to
protect such Confidential Information as it would its own proprietary information which in all
events shall be with a reasonable standard of care, and (c) to prevent the unauthorized disclosure
of such Confidential Information to a Third Party.

          9.3 Limitations of Confidentiality. The obligations of confidentiality, non-disclosure, and
non-use set forth in this Article 9 shall not apply to Confidential Information of a particular
Party to the extent that the other Party (the “Recipient”) can demonstrate through written
records that such Confidential Information: (a) is in the public domain, other than as a result of
actions of the Recipient, its Affiliates, employees, licensees, agents or subcontractors, in breach
of this Agreement; (b) is received by the Recipient or its Affiliates on an unrestricted basis from
a Third Party rightfully in possession of such information and not under a duty of confidentiality;
(c) is independently developed by the Recipient or its Affiliates without any access to or use of
any Confidential Information of the disclosing Party (as applicable); or (d) is information
generated from a clinical trial sponsored or undertaken by Genentech or its sublicensee (which will
be Genentech’s Confidential Information, and not the Confidential Information of SurModics).
Further, the obligations of confidentiality, non-disclosure, and non-

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

16

 

CONFIDENTIAL

use set forth in this Article 9 shall not apply to specific Confidential Information of a disclosing
Party to the extent that the Recipient can demonstrate through written records that such
Confidential Information was rightfully known by the Recipient or its Affiliates prior to the date
of disclosure to the Recipient by the disclosing Party.

          9.4 Exceptions. Notwithstanding the foregoing, a Party may use and disclose Confidential
Information of the other Party (a) if required by applicable law, rule, regulation (including
securities laws and regulations), government requirement and/or court order, including as may be
required in connection with any filings made with, or by the disclosure policies of a major stock
exchange, provided, that, the Party proposing such disclosure promptly notifies the other Party of
its notice of any such requirement and provides the other Party a reasonable opportunity to seek a
protective order or other appropriate remedy and/or to waive compliance with the provisions of this
Agreement; (b) to the extent such use and disclosure is necessary for undertaking clinical trials
or the filing or publication of any patent application or patent on inventions in accordance with
the provisions of Section 10; (c) as reasonably necessary for securing any Regulatory Approvals,
including pricing approvals, for any Licensed Products, provided, that, the disclosing Party shall
take all reasonable steps to limit disclosure of the Confidential Information outside such
regulatory agency and to otherwise maintain the confidentiality of the Confidential Information;
and (d) to the extent necessary or reasonably useful, to its Affiliates, directors, officers,
employees, consultants, sublicensees (and potential sublicensees), and other Third Parties under
written agreements of confidentiality at least as restrictive on those set forth in this Agreement,
who have a need to know such information in the normal conduct of a Party’s internal business
operations or in connection with a Party performing its obligations or exercising its rights under
this Agreement, including, without limitation to Third Parties involved in the clinical development
of a Licensed Product.

          9.5 Return of Confidential Information. On expiration or termination of the entirety of this
Agreement, at the request of the disclosing Party, the receiving party shall use reasonable efforts
to return or destroy all Confidential Information of the disclosing party that remains in the
receiving party’s possession and that is not reasonably necessary to exercise rights that survive
such expiration or termination, except one copy of which may be retained for archival purposes to
ensure compliance with the terms of this Agreement.

          9.6 Publicity and Public Announcements. Without limiting the exclusions to Confidential
Information under Section 9.3, neither Party shall issue any public announcement, press release or
other publicity materials, or make any public presentation with respect to the existence of, or any
of the terms or conditions of, this Agreement or the programs or efforts being conducted hereunder,
in each case without the prior written consent of the other Party; provided that no consent shall
be required for any press release, publicity material or public presentation (a) that has already
been made or authorized by the Parties, to the extent a Party merely uses or refers to such
materials, presentation or announcement, or (b) made by Genentech or a Genentech sublicensee and
related to any clinical data generated in the course of Development of a Licensed Product or
related to the Development status, plans and strategy for the Licensed Product. When practicable,
Genentech shall provide SurModics with an advance copy of any such announcement at least [*]
Business Days prior to its scheduled release. SurModics shall expeditiously review and recommend
changes (if any) to any such announcement and, except as otherwise required by applicable laws,
Genentech shall remove any

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

17

 

CONFIDENTIAL

Confidential Information of SurModics. Either Party may refer to the other Party as a
“collaborator” on its website, provided such reference has received prior written approval
from such Party. The Parties hereby consent to the disclosure of the press release attached hereto
as Exhibit F.

          9.7 Disclosure of Agreement. Subject to Sections 9.3, 9.4, and 9.6, during the Term and for
[*] years following its expiration or termination, neither Party may disclose the existence of this
Agreement or any of the terms (including, but not limited to, the financial terms) of this
Agreement to a Third Party without the prior written consent of the other Party.

Article 10 Intellectual Property Matters.

          10.1 Disclosure. SurModics shall disclose to Genentech any Project Know-How promptly after
SurModics learns of such Project Know-How having been conceived, reduced to practice, or otherwise
made, discovered, or created. Genentech shall use reasonable efforts to disclose to SurModics any
Joint Project Know-How or SurModics Project Know-How promptly after Genentech learns of such
Project Know-How having been made by Genentech.

          10.2 Pre-Existing and Independently Developed Intellectual Property Rights. All intellectual
property rights of SurModics existing as of the Effective Date, or developed, made or acquired
separately from activities under the Existing Feasibility Study, any other Feasibility Study,
Project Plan, or the MSA, shall remain owned and vested at all times exclusively in SurModics, and
Genentech shall have no interest whatsoever in any such intellectual property rights other than the
rights expressly granted under the Existing Feasibility Study, this Agreement or the MSA. All
intellectual property rights of Genentech existing as of the Effective Date, or developed, made or
acquired separately from activities under this Agreement, shall remain owned and vested at all
times exclusively in Genentech, and SurModics shall have no interest whatsoever in any such
intellectual property rights other than the rights expressly granted under this Agreement.

          10.3 Ownership of Project Know-How.

               (a) Genentech Project Know How. [*]

               (b) SurModics Project Know How. [*]

               (c) Joint Project Know How. [*]

          10.4 Patent Filings.

               (a) Solely Owned. Genentech may, at its sole discretion and expense, prosecute, maintain and
enforce Patents covering the Genentech Project Know How (the “Genentech Project Patents”)
(Genentech Project Patents and Genentech Project Know-How collectively “Genentech Project IP
Rights”). SurModics may, at its sole discretion and expense, prosecute, maintain and enforce
Patents covering the SurModics Project Know-How (the “SurModics Project Patents”)
(SurModics Project Patents and SurModics Project Know-How collectively “SurModics Project IP
Rights”). Notwithstanding the foregoing, SurModics agrees

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

18

 

CONFIDENTIAL

to Prosecute and Maintain in the Territory, as appropriate and upon appropriate consultation with
Genentech, SurModics Patents that cover Licensed Products or their use. With respect to any
such SurModics’ Patents, SurModics shall keep Genentech advised of the status of any actual and
prospective patent filings and, upon Genentech’s request, shall provide advance copies of any
papers related to the filing, prosecution and maintenance of such patent filings. SurModics shall
promptly give notice to Genentech of the grant, lapse, revocation, surrender, invalidation or
abandonment of any SurModics Patents licensed to Genentech for which SurModics is responsible for
the Prosecution and Maintenance. For clarity, SurModics shall have the sole right, at its sole
expense, to Prosecute and Maintain the SurModics Patents to the extent such Patents do not cover
the Licensed Products or the Injection Vehicles (or uses thereof).

               (b) Jointly Owned.

                    (i) Filing of Applications. The Parties shall select a mutually agreed upon outside
patent counsel (“Outside Patent Counsel”) to prepare and/or file any patent application
claiming Joint Project Know-How (a “Joint Project Patent”) (Joint Project Patents and Joint
Project Know-How collectively “Joint Project IP Rights”). Should a Party wish to file a
patent application for a Joint Project Patent, it shall so inform the other. With respect thereto,
SurModics shall engage Outside Patent Counsel and each Party shall receive a copy of any such
patent application for review and comment as set forth in (ii) below. If SurModics declines to
Prosecute and Maintain a Joint Project Patent, then Genentech may elect to do so as provided under
this Section 10.4(b). The Party that is Prosecuting and Maintaining a particular Joint Project
Patent shall be referred to as the “Prosecuting Party.”

                    (ii) Review and Comment. With respect to Joint Project Patents, the Prosecuting
Party shall, or shall instruct the Outside Patent Counsel to: (1) keep both Parties informed as to
the Prosecution and Maintenance (including as pertains to which countries in which to initiate or
continue prosecution (including validation) and questions of the scope, issuance, or rejection of
an interference involving or an opposition to any such Patents), such that each Party has
sufficient time to review and comment on any documents intended for submission to any patent
office; (2) promptly furnish to each Party a copy of any patent application and copies of documents
relevant to such Prosecution and Maintenance, including copies of correspondence with any patent
office, foreign associates, and outside counsel; and (3) reasonably consider and incorporate
comments of both Parties on documents filed with any patent office.

                    (iii) Abandonment of Prosecution and Maintenance. If SurModics elects (1) not to
Prosecute and Maintain a Joint Project Patent (whether worldwide or with respect to any particular
country), (2) not to file a patent application with respect thereto, or (3) to allow any such
Patent to lapse or become abandoned or unenforceable, then SurModics shall promptly notify
Genentech in writing (which such notice shall be at least [*] days prior to the lapse or
abandonment of any such Patent). Thereafter, Genentech may, but is not required to, undertake, at
its sole expense and in its sole discretion, the Prosecution and Maintenance of such Joint Project
Patent. In the event that Genentech undertakes such Prosecution, SurModics shall cooperate as set
forth in this Section 10.4.

                    (iv) Costs. [*]

                    (v) Cooperation. The Parties agree to cooperate reasonably in the Prosecution and
Maintenance of all Patents under this Section 10.4 including obtaining and

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

19

 

CONFIDENTIAL

executing necessary powers of attorney and assignments by the named inventors, providing
relevant technical reports to the filing Party concerning the invention disclosed in each such
Patent, obtaining execution of such other documents which may be needed in the Prosecution and
Maintenance of each such Patent, and, as requested, updating each other regarding the status of
each such Patent, and shall cooperate with the other Party so far as reasonably necessary with
respect to furnishing all information and data in its possession and Control reasonably necessary
to Prosecute and Maintain such Patents.

Article 11 Enforcement of Project Patent Rights and Defense of Third Party Claims

          11.1 Notice. Each Party shall promptly notify, in writing, the other Party upon learning of
any actual or suspected infringement of the SurModics IP Rights or a Joint Project IP Rights by a
Third Party Microparticle Product, or of any claim of invalidity, unenforceability, or
non-infringement of a SurModics Patent or a Joint Project Patent and shall, along with such notice,
supply the other Party with all evidence in its possession pertaining thereto.

          11.2 Infringement Actions.

               (a) Genentech Project Know How. As between the Parties, Genentech shall have the right, but
not the obligation, to seek to abate any actual or suspected infringement of the Genentech IP
Rights or the Genentech Project IP Rights by a Third Party, or to file suit against any such Third
Party.

               (b) SurModics IP Rights. Except as otherwise provided in this Section 11.2(b), SurModics
shall have the sole right, but not the obligation, to seek to abate any actual or suspected
infringement of the SurModics IP Rights or the SurModics Project IP Rights by a Third Party, or to
file suit against any such Third Party. Notwithstanding the foregoing, if the actual or suspected
infringement by a Third Party of the SurModics IP Rights or the SurModics Project IP Rights affects
a Licensed Product or [*] which is (at such time) exclusively licensed to Genentech under this
Agreement (a “Field Infringement”), SurModics shall have the first right, but not the obligation,
to seek to abate such actual or suspected Field Infringement of the SurModics IP Rights or the
SurModics Project IP Rights by a Third Party, or to file suit against any such Third Party. If
SurModics does not, within [*] of receipt of a notice under Section 11.1, take steps to abate the
actual or suspected Field Infringement, or file and thereafter prosecute a suit to enforce the
SurModics IP Rights or the SurModics Project IP Rights against such Third Party with respect to
such Field Infringement, Genentech shall have the right (but not the obligation) to take action to
enforce the SurModics Project IP Rights or the SurModics Project IP Rights related to the Field
Infringement against such Third Party, provided that Genentech first obtains SurModics’ consent to
take such action, such consent not to be unreasonably withheld or delayed. The non-controlling
Party shall cooperate with the Party controlling any such action (as may be reasonably requested by
the controlling Party and at its expense), including, if necessary, by being joined as a party, and
the Party controlling any such action shall keep the other Party updated with respect to any such
action, including providing copies of all documents received or filed in connection with any such
action.

               (c) Joint Project IP Rights. SurModics shall have the first right, but not the obligation, to
seek to abate any actual or suspected infringement of the Joint Project IP Rights by a Third Party,
or to file suit against any such Third Party. If SurModics does not,

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

20

 

CONFIDENTIAL

within [*] of receipt of a notice under Section 11.1, take steps to abate the actual or suspected
infringement, or file and thereafter prosecute a suit to enforce thee Joint Project IP Rights
against such Third Party, Genentech shall have the right (but not the obligation) to take action to
enforce the Joint Project IP Rights against such Third Party. The non-controlling Party shall
cooperate with the Party controlling any such action (at the controlling Party’s expense and as may
be reasonably requested by the controlling Party), including, if necessary, by being joined as a
party, and the Party controlling any such action shall keep the other Party updated with respect to
any such action, including providing copies of all documents received or filed in connection with
any such action.

          11.3 Settlement. The Party controlling any action described in Section 11.2 may not settle
the action, or consent to a judgment in the action, that adversely affects the scope, validity or
enforcement of the other Party’s Patents or Joint Project IP Rights (as applicable), without the
express written consent of the non-controlling Party (such consent not to be unreasonably withheld
or delayed).

          11.4 Damages. Unless otherwise mutually agreed by the Parties, and subject to the respective
indemnity obligations of the Parties set forth in Article 14, all monies recovered upon the final
judgment or settlement of any action described in this Article 11, shall be used: [*]

          11.5 Third Party Suits.

               (a) Against Genentech. If a Third Party makes a claim or brings a suit or other proceeding
against Genentech, or any of its Affiliates, sublicensees or customers, alleging that the research,
development making, using selling, offering for sale, import or export of Licensed Product
infringes or otherwise violates the intellectual property rights of such Third Party, Genentech
shall have the sole right to defend and control the defense of such claim, suit or other proceeding
as well as to initiate and control any counterclaim or other similar action. SurModics shall fully
cooperate with Genentech in defense of such claim, suit or other proceeding, at Genentech’s expense
(including any reasonable costs or expenses incurred by SurModics in connection with such claim,
suit or other proceeding, such as, costs incurred in responding to subpoenas), including by being
joined as a party. Unless otherwise mutually agreed by the Parties, and subject to the respective
indemnity obligations of the Parties set forth in Article 14, the provisions of Sections 11.3 and
11.4 shall apply to any proceeding covered by this Section 11.5(a), except that any license from
the Third Party shall be subject to Section 7.9. Notwithstanding the foregoing, Genentech may, in
its sole discretion, settle any claim or suit under this Section 11.5(a) consistent with the terms
of Section 11.3

               (b) Against SurModics. If a Third Party makes a claim or brings a suit or other proceeding
against SurModics or any of its Affiliates, sublicensees or Third Party contractors, alleging that
their activities under this Agreement or the MSA infringes or otherwise violates the intellectual
property rights of such Third Party, SurModics shall have the right to defend and control the
defense of such claim, suit or other proceeding. Any counterclaim or other similar action, to the
extent they involve any Genentech IP Rights, SurModics IP Rights or Project IP Rights, will be
treated as enforcement actions subject to Section 11.2 (as applicable). Promptly upon receipt of
notice of any such claim, suit or other proceeding against SurModics, SurModics shall provide
written notice thereof to Genentech. On Genentech’s written request, SurModics will discuss
cooperation regarding any such claims and/or will keep Genentech

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

21

 

CONFIDENTIAL

informed as to the status of the claim suit or proceeding and defense. Also on Genentech’s
written request, SurModics will permit Genentech to participate in the defense and settlement
of any such claim, suit or proceeding, at its own expense and represented by counsel of its own
choice, provided that SurModics will in all events control such defense of any claim against it.
Unless otherwise mutually agreed by the Parties, and subject to the respective indemnity
obligations of the Parties set forth in Article 14, the provisions of Sections 11.3 and 11.4 shall
apply to any proceeding covered by this Section 11.5(b).

Article 12 Term and Termination

          12.1 Term. This Agreement shall be effective as of the Effective Date and shall remain in
effect on a country-by-country and Licensed Product-by-Licensed Product basis until expiration of
all royalty obligations hereunder, unless sooner terminated as provided in this Article 12. Upon
expiration of this Agreement, Genentech’s licenses pursuant to Section 2.1 shall become fully
paid-up, perpetual licenses. For the purposes of this Agreement, “Term” shall mean the period
commencing with the Effective Date through to the date of such expiration or earlier termination
referenced in the first sentence of this Section, and in the event this Agreement is terminated or
expires only with respect to a particular Licensed Product [*], “Term” of this Agreement as it
applies to such Licensed Product [*] shall terminate as of the effective termination or expiration
date for such Licensed Product [*] as specified in this Article 12.

          12.2 Termination for Convenience. Genentech shall have the right to terminate any Feasibility
Study, Project Plan, or SOW, or the MSA or this Agreement (each in its entirety [*]), at any time
in its sole discretion by giving [*] prior written notice to SurModics.

          12.3 Termination for Material Breach. SurModics may terminate this Agreement [*] for breach
by Genentech of its material obligations hereunder. Genentech may terminate this Agreement in its
entirety [*] for breach by SurModics of its material obligations hereunder. Provided, however that
the terminating Party gives the breaching Party written notice of such breach indicating its intent
to terminate and the breach remains uncured after the expiration of [*] after such written notice
was given. Notwithstanding the foregoing, if the allegedly breaching Party disputes in good faith
such material breach or its failure to cure such breach by written notice to the other Party within
such [*] period, then such dispute shall be submitted to the dispute resolution procedures set
forth in Article 15. In that event, the notifying Party does not have the right to terminate until
it has been determined, pursuant to the procedures set forth in Article 15, that the allegedly
breaching Party is in material breach of this Agreement, and such breaching Party further fails to
cure such breach within [*] after the conclusion of any proceedings under Article 15.

          12.4 Termination on Challenge. [*]

          12.5 Termination for Bankruptcy.

               (a) Bankruptcy. Genentech may terminate this Agreement immediately upon (i) the bankruptcy,
insolvency, liquidation, dissolution or cessation of operations of SurModics; (ii) the filing of
any voluntary petition for bankruptcy, dissolution, liquidation or

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

22

 

CONFIDENTIAL

winding-up of the affairs of SurModics; (iii) any assignment by SurModics for the benefit of
creditors; (iv) the filing of any involuntary petition for bankruptcy, dissolution,
liquidation or winding-up of the affairs of SurModics that is not dismissed within [*] of the date
on which it is filed or commenced; or (v) upon any final judicial or administrative determination
that this Agreement violates, or if continued would violate, in a substantial manner, any provision
of the Federal Internal Revenue Code.

               (b) Survival of the License. The licenses granted to Genentech under this Agreement are, and
shall otherwise be deemed to be, for purposes of Section 365(n) of the “Bankruptcy Code” (i.e.,
Title 11, U.S. Code), licenses of rights to “intellectual property” as defined under Section
101(56) of the Bankruptcy Code. The Parties agree that Genentech shall retain and may fully
exercise all of its rights and elections under the Bankruptcy Code in the event of a bankruptcy by
SurModics.

          12.6 Effects of Termination or Expiration.

               (a) In General. Termination or expiration of this Agreement shall not affect the rights and
obligations of the Parties that accrued prior to the effective date of such termination or
expiration. In particular, no termination or expiration of this Agreement shall relieve Genentech
of its obligation to pay any milestone payments or royalty payments that accrued prior to such
termination or expiration. In addition, no termination of this Agreement shall relieve Genentech
of its obligation to pay SurModics for any amounts accrued by SurModics, and any non-cancelable
fees and expenses committed by SurModics, in each case prior to the effective date of such
termination in the performance of its activities under this Agreement and otherwise in accordance
with a Program Budget. Within [*] after the date of any termination, SurModics shall provide
Genentech with an accounting for any such accrued and/or any non-cancelable amounts which may
include reasonable non-cancelable obligations properly incurred for the applicable Feasibility
Study, Project Plan, or SOW and reasonable wind-down activities by SurModics prior to the effective
date of termination to extent such obligations cannot reasonably be mitigated. Within [*] after
SurModics provides Genentech with such accounting, Genentech shall pay SurModics the amounts due
for such activities properly performed.

               (b) Termination for Convenience; Termination for Genentech’s Material Breach; Termination on
Challenge. Upon any voluntary termination of this Agreement by Genentech pursuant to Section 12.2,
by SurModics for a material breach by Genentech pursuant to Section 12.3, or by SurModics for a
Challenge pursuant to Section 12.4 with respect to each [*] for which such right of termination is
exercised (each a “Terminated [*]”): (i) to the extent not already completed, the
activities under this Agreement or the MSA for such Terminated [*] shall immediately terminate;
(ii) the rights and licenses granted to Genentech under Section 2.1 with respect to Licensed
Products Directed to such Terminated [*], and not otherwise applicable to other [*] or Licensed
Products, shall immediately terminate; (iii) all rights and licenses granted to SurModics under
Section 2.4 with respect to such Terminated [*], and not otherwise applicable to other [*], shall
immediately terminate; (iv) the limitations regarding Third Party Microparticles Products under
Section 4.4 with respect only to a Terminated [*] shall terminate; (v) Genentech’s rights under
Section 2.3 (except with respect to Section 2.3(v) as may be applicable to such Terminated [*])
shall survive any termination other then a termination of this Agreement in its entirety; (vi) each
Party shall return or destroy,

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

23

 

CONFIDENTIAL

subject to the terms of Section 9.6, any Confidential Information of the other Party related to
such Terminated [*] and not otherwise applicable to other [*]; and (vii) Sections 10.2, 10.3,
11.2, 11.3, and 11.4 shall survive with respect to Licensed Products Directed to a Terminated [*].
Except as set forth in this Section 12.5(b), all rights and obligations of each Party under this
Agreement with respect to such Terminated [*] and Licensed Products Directed to such Terminated [*]
shall immediately terminate, and any provisions and rights applicable to other [*] or Licensed
Products shall survive. [*]

               (c) [*].

          12.7 [*].

          12.8 Survival. The rights and obligations set forth in this Agreement shall extend beyond the
Term or termination of this Agreement only to the extent expressly provided in this Agreement. In
addition to as set forth in this Article 12, and without limiting the foregoing, Article 1, Section
2.5, Articles 9, 10, and 11 (except 11.1) Sections 12.5(c), 12.6, 12.7 and 12.8, Articles 14 and
15, and Sections 16.1, 16.4, 16.5, 16.6, and 16.7, 16.8, 16.9, and 16.10 shall survive expiration
or termination of this Agreement for any reason, but in all cases shall be interpreted to exclude
the subject matter of non-surviving terms.

Article 13 Representations, Warranties and Disclaimers

          13.1 Mutual Representations and Warranties. Each Party hereby represents and warrants to the
other Party as follows:

               (a) it is duly organized and validly existing under the laws of the state of its organization
and has full corporate power and authority to enter into this Agreement and carry out the
provisions hereof;

               (b) the execution, delivery and performance of this Agreement by it does not violate any law
or regulation of any court, governmental body or administrative or other agency having jurisdiction
over it; and

               (c) it has not, prior to the Effective Date, entered into and shall not, following the
Effective Date, enter into any agreement, instrument or understanding, oral or written, that
materially conflicts in any way with this Agreement or its obligations hereunder.

               (d) it has the right to grant the rights and licenses described in this Agreement.

          13.2 SurModics Representations and Warranties. SurModics represents and warrants to Genentech
that,

               (a) SurModics has the full right, power and authority, and has obtained all approvals, permits
or consents necessary, to enter into this Agreement and the [*] (as defined in Section
1.13), to perform all of its obligations, and to grant the licenses provided hereunder.

               (b) SurModics has not, prior to the Effective Date, entered into and shall not, following the
Effective Date, enter into any agreement and has not granted any now existing,

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

24

 

CONFIDENTIAL

or agreed to grant any future, license, right or privilege which agreement, license, right or
privilege conflicts in any way with this Agreement, the licenses granted, or SurModics’
obligations hereunder.

               (c) SurModics owns or Controls the SurModics IP Rights licensed to Genentech hereunder.

               (d) as of the Effective Date, to its knowledge, the SurModics Patents set forth on Exhibit C
are free and clear of any liens or encumbrances, and following the Effective Date SurModics will
not knowingly encumber the SurModics Patents with any liens or encumbrances.

[*]
CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

25

 

CONFIDENTIAL

          13.3 DISCLAIMER. THE WARRANTIES SET FORTH IN THIS ARTICLE 13 ARE IN LIEU OF ALL OTHER
WARRANTIES, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO, WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE; WARRANTIES OF INTELLECTUAL PROPERTY VALIDITY OR NON-INFRINGEMENT
OF THIRD PARTY INTELLECTUAL PROPERTY; WARRANTIES OF SUCCESSFUL DEVELOPMENT OR COMMERCIALIZATION;
AND ALL SUCH OTHER WARRANTIES ARE HEREBY EXPRESSLY DISCLAIMED.

Article 14 Indemnification, Insurance, Limitations on Liability

          14.1 Indemnification by SurModics. Unless otherwise provided herein, SurModics shall
indemnify, hold harmless and defend Genentech, its Affiliates and their
directors, officers, employees and agents (the “Genentech Indemnitees”) from and
against any and all damages, judgments, liabilities, expenses and/or losses [*]

          14.2 Indemnification by Genentech. Unless otherwise provided herein, Genentech shall
indemnify, hold harmless and defend SurModics and its directors, officers, employees and agents
(the “SurModics Indemnitees”) from and against any and all Losses to the extent that such
Losses arise out of [*]

          14.3 Procedure. The indemnities set forth in this Article 14 are subject to the condition
that the Party seeking the indemnity shall promptly notify the indemnifying Party on being notified
or otherwise made aware of Claim and the indemnifying Party being permitted to defend and control
any proceedings with the other Party being permitted to participate at its own expense (unless
there is a conflict of interest which would prevent representation by joint counsel, in which event
the indemnifying Party shall pay for the indemnified Party’s counsel). Provided, however, that (a)
the Party seeking indemnity reasonably cooperates in any such defense (at the indemnifying Party’s
expense), and (b) the indemnifying Party may not settle the liability, claim, suit, action or
expense, or otherwise consent to any judgment, without the written consent of the other Party (such
consent not to be unreasonably withheld).

          14.4 Insurance.

               (a) General. Each Party shall maintain insurance coverage as set forth in this Section 14.4
at its own cost; provided, however, Genentech has the right, in its sole discretion, to
self-insure, in part or in whole, for any such coverage. Insurance coverage shall be primary
insurance with respect to each Party’s own participation under this Agreement and shall be
maintained with an insurance company or companies having an A.M. Best’s rating (or its equivalent)
of A-VII or better. On request, each Party shall provide to the other Party certificates of
insurance evidencing the insurance coverage required under this Section 14.4. Each Party shall
provide to the other Party at least [*] prior written notice of any cancellation, nonrenewal or
material change in any of the required insurance coverages.

               (b) Commercial General Liability. For as long as a Party is performing obligations under the
Agreement, and thereafter as required under this Section 14.4, each Party shall maintain commercial
general liability (“CGL”) insurance, including contractual liability, at a combined single limit
for bodily injury and property damage liability [*].

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

26

 

CONFIDENTIAL

               (c) Form of CGL. The CGL insurance policies shall be under an occurrence form, but if only a
claims-made form is available to a Party, such Party shall maintain the insurance [*]. Each Party
shall name the other Party as an additional insured under its CGL insurance policy.

               (d) Workers’ Compensation and Employers’ Liability Insurance. Each Party shall maintain (i)
workers’ compensation insurance according to applicable law and (ii) employers’ liability
insurance, in the minimum amount of [*].

[*]

          14.5 Limitation of Liability. IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY FOR
ANY CONSEQUENTIAL, INDIRECT,
INCIDENTAL OR PUNITIVE DAMAGES, HOWEVER CAUSED, ARISING OUT OF THIS AGREEMENT OR THE EXERCISE
OF ITS RIGHTS HEREUNDER, INCLUDING, WITHOUT LIMITATION LOST PROFITS, REGARDLESS OF WHETHER ARISING
FROM BREACH OF CONTRACT, WARRANTY, TORT, STRICT LIABILITY, OR OTHERWISE, EVEN IF THE PARTY IS
ADVISED OF THE POSSIBILITY OF SUCH LOSS OR DAMAGE OR IF SUCH LOSS OR DAMAGE COULD HAVE BEEN
REASONABLY FORESEEN. NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS SECTION IS INTENDED TO LIMIT OR
RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF EITHER PARTY.

Article 15 Dispute Resolution

          15.1 Disputes. “Dispute” means any controversy, claim or legal proceeding arising out
of or relating to this Agreement, or the breach, termination, or invalidity thereof.
Notwithstanding the foregoing, Disputes shall not include any disagreements solely about decisions
for which one Party has final decision making authority under this Agreement.

          15.2 Internal Resolution. Except as otherwise expressly provided in this Agreement (including
under Section 3.6), any Disputes shall be first referred to the Parties’ Senior Executives
for resolution, prior to proceeding under the other provisions of this Article 15. A Dispute shall
be referred to such executives upon one Party providing the other Party with written notice that
such Dispute exists, and such executives, or their designees, shall attempt to resolve such Dispute
through good faith discussions. In the event that such Dispute is not resolved within [*] of such
other Party’s receipt of such written notice, either Party may initiate the Dispute resolution
procedures set forth in Section 15.3. The Parties agree that any discussions between such
executives, or their designees, regarding such Dispute do not constitute settlement discussions,
unless the Parties agree otherwise in writing.

          15.3 Arbitration.

               (a) Rules. Except as otherwise expressly provided in this Agreement (including, without
limitation, under Section 3.6 and this Article 15), the Parties agree that any Dispute not resolved
internally by the Parties in accordance with Section 15.2 shall be resolved through binding
arbitration conducted by the American Arbitration Association in accordance with the then
prevailing Commercial Arbitration Rules of the American Arbitration Association

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

27

 

CONFIDENTIAL

(for purposes of
this Article 15, the “Rules”), except as modified in this Agreement, applying the
substantive law specified in Section 16.

               (b) Arbitrators; Location. Each Party shall select one (1) arbitrator, and the two (2)
arbitrators so selected shall choose a third arbitrator. All three (3) arbitrators shall serve as
neutrals and have at least ten (10) years of (a) dispute resolution experience (which may include
judicial experience) or (b) legal or business experience in the biotech or pharmaceutical industry.
In any event, at least one (1) arbitrator shall satisfy the foregoing experience requirement under
clause (b). If a Party fails to nominate its arbitrator, or if the Parties’ arbitrators cannot
agree on the third arbitrator, the necessary appointments shall be made in accordance with the
Rules. Once appointed by a Party, such Party shall have no ex parte communication with its
appointed arbitrator. The arbitration proceedings shall be conducted in
San Francisco, California if SurModics initiates the arbitration or in Minneapolis, Minnesota
if Genentech initiates the arbitration.

               (c) Procedures; Awards. Each Party agrees to use reasonable efforts to make all of its
current employees available, if reasonably needed, and agrees that the arbitrators may deem any
party as “necessary.” The arbitrators shall be instructed and required to render a written,
binding, non-appealable resolution and award on each issue that clearly states the basis upon which
such resolution and award is made. The written resolution and award shall be delivered to the
Parties as expeditiously as possible, but in no event more [*] after conclusion of the hearing,
unless otherwise agreed by the Parties. Judgment upon such award may be entered in any competent
court or application may be made to any competent court for judicial acceptance of such an award
and order for enforcement. Each Party agrees that, notwithstanding any provision of applicable
laws or of this Agreement, it will not request, and the arbitrators shall have no authority to
award, punitive or exemplary damages against any Party.

               (d) Costs. The “prevailing” Party, as determined by the arbitrators, shall be entitled to (i)
its share of fees and expenses of the arbitrators and (ii) its attorneys’ fees and associated costs
and expenses. In determining which Party “prevailed,” the arbitrators shall consider (1) the
significance, including the financial impact, of the claims prevailed upon and (2) the scope of
claims prevailed upon, in comparison to the total scope of the claims at issue. If the arbitrators
determine that, given the scope of the arbitration, neither Party “prevailed,” the arbitrators
shall order that the Parties (A) share equally the fees and expenses of the arbitrators and (B)
bear their own attorneys’ fees and associated costs and expenses.

               (e) Interim Equitable Relief. Notwithstanding anything to the contrary in this Section 15.3,
in the event that a Party reasonably requires relief on a more expedited basis than would be
possible pursuant to the procedure set forth in Section 15.3, such Party may seek a temporary
injunction or other interim equitable relief in a court of competent jurisdiction pending the
opportunity of the arbitrators to review the decision under Section 15.3. Such court shall have no
jurisdiction or ability to resolve Disputes beyond the specific issue of temporary injunction or
other interim equitable relief.

               (f) Protective Orders; Arbitrability. At the request of either Party, the arbitrators shall
enter an appropriate protective order to maintain the confidentiality of information produced or
exchanged in the course of the arbitration proceedings. The arbitrators shall have the power to
decide all questions of arbitrability.

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

28

 

CONFIDENTIAL

               (g) Expedited Review. With respect to any dispute brought by either Party, no later than [*]
after selection of the third arbitrator in accordance with Section 15.3(b), the Parties and their
representatives shall hold a preliminary meeting with the arbitrators, to mutually agree upon and
thereafter follow procedures seeking expedite in a timely manner the arbitration. Failing any such
mutual agreement, the arbitrators will design and the Parties shall follow procedures to such
effect.

          15.4 Subject Matter Exclusions. Notwithstanding the provisions of Section 15.3, any Dispute
not resolved internally by the Parties pursuant to Section 15.2 that involves the validity,
infringement or enforceability or claim construction of a Patent, or defenses to any of the
foregoing (a) that is issued in the United States shall be subject to actions before the United
States Patent and Trademark Office and/or submitted to a federal court of appropriate
jurisdiction; and (b) that is issued in any other country (or region) shall be brought before
an appropriate regulatory or administrative body or court in that country (or region), and the
Parties hereby consent to the jurisdiction and venue of such courts and bodies.

Article 16 MISCELLANEOUS

          16.1 Governing Law. This Agreement shall be governed by and construed under the laws of the
State of New York (other than Section 5-1401 of the New York General Obligations Law), without
regard to conflict of laws principles. The Parties hereby exclude from this Agreement the
application of the United Nations Convention on Contracts for the International Sale of Goods.

          16.2 Assignment. Except as otherwise expressly provided in this Agreement, neither Party may
assign this Agreement, in whole or in part, without the prior written consent of the other Party,
such consent not to be unreasonably withheld. Either Party may assign this Agreement, in its
entirety, to (a) an Affiliate or (b) an acquirer of all its capital stock (by reverse triangular
merger or otherwise), a successor by merger or consolidation or an acquirer of all or substantially
all its assets relating to the subject matter of this Agreement, provided, in each case, that the
party to which this Agreement is assigned expressly agrees in writing to assume and be bound by the
obligations of the assigning Party under this Agreement. A copy of such writing shall be provided
to the non-assigning Party within [*] of the assignment. Subject to the foregoing, this Agreement
will inure to the benefit of and bind the Parties’ successors and assigns. Any assignment in
contravention of the foregoing shall be null and void.

          16.3 Force Majeure. Neither Party shall be deemed to have breached this Agreement for failure
to perform its obligations under this Agreement to the extent such failure results from causes
beyond the reasonable control of the affected Party, including acts of God, earthquakes, fires,
floods, embargoes, wars, acts of terrorism, insurrections, riots, civil commotions and similar
events. If a force majeure event occurs, the Party unable to perform shall promptly notify the
other Party of the occurrence of such event, and the Parties shall meet (in person or
telephonically) promptly thereafter to discuss the circumstances relating thereto. The Party
unable to perform shall (a) provide reasonable status updates to the other Party from

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

29

 

CONFIDENTIAL

time to time,
(b) use commercially reasonable efforts to mitigate any adverse consequences arising out of its
failure to perform and (c) resume performance as promptly as possible.

          16.4 Relationship of the Parties. The Parties to this Agreement are independent contractors,
and nothing contained in this Agreement shall be deemed or construed to create a partnership, joint
venture, employment, franchise, agency or fiduciary relationship between the Parties.

          16.5 Notices. All notices, requests, demands, and other communications relating to this
Agreement shall be in writing and shall be delivered in person or by mail, courier or facsimile
transmission (with a confirmation copy forwarded by courier or mail). Notices sent by mail shall
be sent by first class mail or the equivalent, registered or certified, postage prepaid, and shall
be deemed to have been given on the date actually received. Notices sent by courier
shall be sent using a service which provides traceability of packages. Notices shall be sent
as follows:

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

30

 

CONFIDENTIAL

	 	 	 
	Notices to SurModics:

	 	with a required copy (which alone shall not
	 

	 	constitute notice) to each of:
	SurModics, Inc.
	 	 
	9924 W. 74th Street

	 	SurModics, Inc.
	Eden Prairie, MN 55344

	 	2855 Michelle Drive, Suite 190
	Attn: Chief Executive Officer

	 	Irvine, CA 92606
	[*]

	 	Attn: President, Ophthalmology Division
	 

	 	[*]
	 
	 	 
	 

	 	SurModics Pharmaceuticals Inc.
	 

	 	750 Lakeshore Parkway
	 

	 	Birmingham, Alabama 35211
	 

	 	Attn: President
	 

	 	[*]
	 
	 	 
	Notices to Genentech:

	 	with a required copy (which alone shall not
	 

	 	constitute notice) to each of:
	Genentech Inc.
	 	 
	1 DNA Way

	 	Genentech Inc.
	South San Francisco, CA 94080

	 	1 DNA Way
	Attention: Corporate Secretary

	 	South San Francisco, CA 94080
	[*]

	 	Attention: Vice President, Alliance Management
	 

	 	[*]
	 
	 	 
	 

	 	and
	 
	 	 
	 

	 	F. Hoffmann-La Roche Ltd
	 

	 	Grenzacherstrasse 124
	 

	 	CH-4070 Basel
	 

	 	Switzerland
	 

	 	[*]

          16.6 Amendment; Waiver. Except as otherwise expressly provided in this Agreement, no
amendment to this Agreement shall be effective unless made in writing and executed by an authorized
representative of each Party. A Party’s failure to exercise, or delay in exercising, any right,
power, privilege or remedy under this Agreement shall not (a) operate as a waiver thereof or (b)
operate as a waiver of any other right, power, privilege or remedy. A waiver will be effective
only upon the written consent of the Party granting such waiver.

          16.7 Construction; Captions. Each Party acknowledges that it participated in the negotiation
and preparation of this Agreement and that it had the opportunity to consult with an attorney of
its choice in connection therewith. Ambiguities, if any, in this Agreement shall not
be construed against either Party, irrespective of which Party may be deemed to have drafted
the Agreement or authorized the ambiguous provision. Capitalized terms defined in the singular

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

31

 

CONFIDENTIAL

shall include the plural and vice versa. The terms “includes” and “including” mean “includes,
without limitation,” and “including, without limitation,” respectively. Titles, headings and other
captions are for convenience only and shall not affect the meaning or interpretation of this
Agreement.

          16.8 Severability. If any of the provisions of this Agreement are held to be illegal, invalid
or unenforceable, such illegal, invalid or unenforceable provisions shall be replaced by legal,
valid and enforceable provisions that will achieve to the maximum extent possible the intent of the
Parties, and the other provisions of this Agreement shall remain in full force and effect.

          16.9 Entire Agreement. This Agreement, the Master Services Agreement and the Existing
Feasibility Study contain the entire understanding between the Parties with respect to the subject
matter hereof and supersedes and terminates all prior agreements, understandings and arrangements
between the Parties with respect to such subject matter, whether written or oral.

          16.10 Genentech Entities. GNE and Roche shall be jointly and severally liable for all acts
and omissions of Genentech, and their respective Affiliates, relating to or in connection with this
Agreement, and any act or omission of, or notice to, either of them shall constitute the act or
omission of, or notice to, each of them. Genentech shall cause each Affiliate who is licensed
hereunder to be bound by the terms and conditions of this Agreement as if each were an original
signatory to this Agreement, and shall be liable for all acts and omissions of any such Affiliate
in connection therewith.

          16.11 Counterparts; Facsimiles. This Agreement may be executed in two (2) or more
counterparts, each of which will be deemed an original, but all of which together will constitute
one and the same instrument. A facsimile or electronic pdf copy of this Agreement, including the
signature pages hereto, will be deemed to be an original.

* * * * *

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

32

 

CONFIDENTIAL

     IN WITNESS WHEREOF, the Parties hereto have caused the Agreement to be executed by their
duly authorized representative.

	 	 	 	 	 	 	 	 	 
	SurModics, Inc.	 	Genentech, Inc.	 	 
	 
	 	 	 	 	 	 	 	 
	By: 

Name:

	 	/s/ Bruce J Barclay
 

Bruce J Barclay
	 	By:

Name:
	 	[*]
 

[*]
	 	 
	Title:

	 	President and Chief Executive Officer
	 	Title:
	 	[*]	 	 
	 
	 	 	 	 	 	 	 	 
	 	 	 	 	F. Hoffmann-La Roche Ltd	 	 
	 
	 	 	 	 	 	 	 	 
	 

	 	 	 	By:

Name:
	 	[*]
 

[*]
	 	 
	 

	 	 	 	Title:
	 	[*]	 	 
	 
	 	 	 	 	 	 	 	 
	 

	 	 	 	By:

Name:
	 	[*]
 

[*]
	 	 
	 

	 	 	 	Title:
	 	[*]	 	 

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

 

 

CONFIDENTIAL

EXHIBIT A

MASTER SERVICES AGREEMENT

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

 

 

EXHIBIT
A

MASTER SERVICE AGREEMENT

by and between

Genentech, Inc.,

F. Hoffmann-La Roche, Ltd.

and

SurModics, Inc.

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED
WITH RESPECT TO THE OMITTED PORTIONS.

 

 

MASTER SERVICE AGREEMENT

by and between

Genentech, Inc. and SurModics.

THIS MASTER SERVICE AGREEMENT (the “MSA”) is entered into as of the 5th day of October
2009 (“Effective Date”) by and between Genentech, Inc., a Delaware corporation, with offices
located at 1 DNA Way, South San Francisco, CA 94080 (“GNE”) and F. Hoffmann-La Roche, Ltd.,
Grenzacherstrasse 124, CH 4070 Basel, Switzerland (“Roche”) (GNE and Roche together
referred to as “Genentech”) and SurModics, Inc. a Minnesota corporation with a principal place of
business at 9924 West 74th Street, Eden Prairie, MN 55344 (SurModics, Inc. together with
its Affiliates hereinafter referred to as “SurModics”) (each individually a “Party” and
collectively, the “Parties”).

RECITALS

WHEREAS, the Parties have entered into a License and Development Agreement effective as of the date
hereof (the “License Agreement”); and

WHEREAS, as part of the License Agreement, Genentech desires to purchase from SurModics, and
SurModics desires to supply to Genentech, Product and Raw Materials (as hereinafter defined) in the
Territory (as hereinafter defined) pursuant to the terms set forth herein.

NOW, THEREFORE, in consideration of the premises and the undertakings of the Parties hereinafter
set forth, the Parties agree as follows:

ARTICLE 1

DEFINITIONS

     Capitalized terms used but not defined herein shall have the meanings set forth in the License
Agreement. As used in this MSA, the following terms, whether used in the singular or the plural,
shall have the meanings set forth in this Article:

1.1 “Acceptance Criteria” shall be defined in the applicable SOW.

1.2 “Acquisition Cost” is defined in Section 13.3.4(b).

1.3 “Approved Suppliers” is defined in Section 5.5.2.

1.4 “BLA” means a Biologics License Application and amendments thereto filed pursuant to the
requirements of the FDA, as defined in 21 C.F.R. § 600 et seq., for FDA approval of a therapeutic
biological product.

1.5 “Decommissioning” is defined in Section 13.3.4.

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED
WITH RESPECT TO THE OMITTED PORTIONS.

 

 

1.6 “EMEA” means the European Union European Medicines Evaluation Agency, or any successor agency.

1.7 “European Union” means the countries of Austria, Belgium, Cyprus, Czech Republic, Denmark,
Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg,
Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Switzerland, Sweden,
United Kingdom and any additional countries that may subsequently become members of the European
Union.

1.8 “Facility” means the SurModics’ manufacturing facility at the location specified under the
applicable SOW, or such other manufacturing facility of SurModics as Genentech may approve in
writing.

1.9 “FDA” means the United States Food and Drug Administration, or any successor agency thereto.

1.10 “GNE Materials” means any physical embodiments, supplies or materials provided to SurModics by
or on behalf of GNE in connection with the Services, including the Compounds.

1.11 “Good Manufacturing Practices”, “GMP” or “cGMP” means current Good Manufacturing Practices
pursuant to the U.S. Food, Drug and Cosmetic Act and any U.S. regulations found in Title 21 of the
U.S. Code of Federal Regulations (including Parts 11, 210 and 211) and other regulations, policies,
or guidelines, as applicable to the Manufacture of Products hereunder.

1.12 “Joint Management Team” or “JMT” is defined in Section 3.2.

1.13 “Manufacture,” “Manufactured” or “Manufacturing” means, except as otherwise provided in a SOW,
the manufacture, inspection, storage and/or packaging of Product.

1.14 “Manufacturing Documentation” means all data, documents and records describing or otherwise
related to the Manufacturing Process (or any part thereof) provided to SurModics by or on behalf of
GNE or provided to GNE by or on behalf of SurModics as required by, and in connection with, this
MSA or the Quality Agreement [*].

1.15 “Manufacturing Process” means the process for the Manufacture of Product pursuant to this MSA,
the Quality Agreement and the Manufacturing Documentation, as such process may be changed from time
to time in accordance with this MSA.

1.16 “Manufacturing Joint Steering Committee” or “Manufacturing JSC” is defined in Section 3.3.

1.17 “Non-Conforming” means, (a) with respect to a Product, a Product Manufactured by SurModics
pursuant to this MSA that (i) fails to conform to the Specifications or Acceptance Criteria; or
(ii) was not Manufactured in compliance with the Specifications,

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED
WITH RESPECT TO THE OMITTED PORTIONS.

2

 

cGMPs, the Manufacturing Documentation, the Quality Agreement, the Standard Operating Procedures
and all applicable laws and (b) with respect to any other deliverable, a deliverable that fails to
conform to the requirements of this MSA or the Quality Agreement.

1.18 “PFSB” means the Japan Pharmaceutical and Food Safety Bureau of the Ministry of Health,
Labour, and Welfare and its review agency, the Pharmaceutical and Medical Devices Agency, or any
successor agency thereto.

1.19 “Product” means the Licensed Product or the SurModics Raw Material specified in the applicable
SOW.

1.20 “Quality Agreement” means that certain quality agreement entered into by the Parties, as the
same may be amended from time to time by the Parties.

1.21 “Raw Materials” means the materials used in the Manufacturing Process, including, but not
limited to, chemicals, reagents, chromatography resins, and filters; and any materials used for
testing, validation, qualification or other activities required to implement and support the
Manufacturing Process at the Facility. Raw Materials include the SurModics Raw Materials.

1.22 “Regulatory Authority” means any national (e.g., the FDA), supra-national (e.g., the EMEA),
regional, state or local regulatory agency, department, bureau, commission, council or other
governmental entity, in any jurisdiction of the world, involved in the granting of Regulatory
Approval.

1.23 “Services” means the activities in support of GXP compliant Development and/or Manufacturing
of a Product, including: manufacturing, process development and scale-up, bulk production and
fill/finish work associated with the supply of such Product for research, preclinical and clinical
studies and related quality assurance and quality control activities, packaging, storage,
stability, release testing, and/or quality control services and other related services provided by
SurModics to GNE with respect to such Product under this MSA, as further defined in the applicable
SOW.

1.24 “Specifications” are defined in the applicable SOW and/or Quality Agreement.

1.25 “Standard Operating Procedures” or “SOPs” means the standard operating procedures established
by SurModics generally.

1.26 “Term” is defined in Section 13.1.

1.27 “United States” means the United States of America, its territories and possessions, Guam and
the Commonwealth of Puerto Rico.

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED
WITH RESPECT TO THE OMITTED PORTIONS.

3

 

ARTICLE 2

RELATED AGREEMENTS AND EXHIBITS

2.1 Statements of Work.

     2.1.1 In General. A description of the Services to be performed and the Product to be
Developed and/or Manufactured and supplied by SurModics for each project agreed upon by the Parties
(each, a “Project”) shall be contained in individual appendices to this MSA (each, a “SOW”, a form
of which is attached hereto as Exhibit A), executed by a duly authorized officer of each Party.
Each SOW shall include all applicable process requirements, a list of any deliverables, regulatory
compliance requirements, the anticipated period of performance, a Program Budget for Services [*],
delivery schedules, [*], and quantity requirements. The Parties agree to negotiate, in good faith,
payment criteria for each task in a SOW under a Program Budget [*]. Each SOW shall be subject to
and deemed a part of this MSA. No SOW, or any modification thereto, shall be attached to or made a
part of this MSA without first being executed by the Parties hereto in a writing which specifically
references this MSA. To the extent any terms set forth in a SOW conflict with the terms set forth
in this MSA, the terms of this MSA shall control unless otherwise expressly agreed by the Parties
in such SOW.

     2.1.2 Changes to a SOW. Except as otherwise provided in Section 5.8 below for changes related
to regulatory requirements, if GNE reasonably determines that modifications to a SOW are required,
GNE shall communicate those proposed modifications to SurModics and the reasons therefore in
writing, and the Parties shall negotiate in good faith to implement mutually acceptable
modifications in an amended SOW, including any change in the timelines, budget and fees.

     2.1.3 Change Order Process.

          (a) Any change in the scope of work, timeline, the corresponding Program Budget, and/or the
Project specific compensation terms or payment schedule for an individual Project will require a
written amendment to the applicable SOW (“Change Order”). For clarity, Change Orders amend only
the applicable SOW and not the terms and conditions of this MSA. Each Change Order will detail the
requested changes to the applicable scope of work, timeline, corresponding Program Budget, Project
specific compensation terms, or payment schedule. Both Parties agree to act in good faith and
promptly when considering a Change Order requested by the other Party.

          (b) If the scope of a Project does not change but SurModics must perform additional work in
order to perform the Services for the Project in accordance with the applicable SOW (i.e. in
compliance with the Manufacturing Process), and such additional work is due to circumstances
primarily within SurModics’ control, SurModics will perform the additional work at no charge to
GNE. For clarity, and except as set forth in Section 6.2.2 below, Genentech will be responsible
for the cost of any additional GNE Material required in the performance of such additional work,.
The Parties agree that termination of either a Project or some of the Services to be performed in
furtherance of the completion of a Project, in each case before the completion of

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED
WITH RESPECT TO THE OMITTED PORTIONS.

4

 

the Project, are changes in Project scope, and the affected Project budget and payment
schedule shall be modified accordingly.

2.2 Quality Agreement. The Parties have entered into a Quality Agreement effective as of the date
hereof (attached hereto as Exhibit B) that governs the responsibilities related to quality systems
and defines quality requirements for the Product, including quality control, testing and release of
the Product.

ARTICLE 3

MANAGEMENT OF PROJECT

3.1 In General. Each Party will be responsible for its internal decision making process and for
reasonably informing the other Party of decisions made affecting the Services in a regular and
timely manner. Without limiting the foregoing, the Parties shall establish the joint team set
forth herein to advise the Parties and execute on certain matters relating to the Services under
this MSA.

3.2 Joint Management Team (JMT)

     3.2.1 Formation. Within thirty (30) days of the Effective Date, the Parties will establish a
joint management team (the “Joint Management Team” or “JMT”) to oversee and manage the Services
under each SOW. If there are multiple SOWs hereunder the Parties may specify separate JMT’s in the
applicable SOW’s, and each reference herein to “the JMT” or “the Joint Management Team” shall be a
reference to the JMT applicable to each SOW. The Joint Management Team shall consist of such
number of representatives of each Party as are reasonably necessary to accomplish the goals of the
SOW. Each Party shall promptly notify the other Party of its initial appointees to each JMT.
Subject to Section 3.2.2 (a), each Party shall be free to change its JMT representatives effective
upon written notice to the other Party.

     3.2.2 Management Team Leader.

          (a) Appointment. Within thirty (30) days of the Effective Date, each Party shall appoint an
employee to act as a primary contact for such Party in connection with this MSA, including without
limitation, all SOWs and any Services and other activities conducted under any Project (each, a
“Management Team Leader”). The GNE Management Team Leader will be responsible for overall
leadership of the Joint Management Team. A Party may replace its Management Team Leader at any
time by providing written notice of the change to the other Party: provided, SurModics shall have
good faith consultation with GNE prior to the change and provided further, any such new
representative shall be no less qualified than the representative being replaced and shall be
mutually agreed to by the Parties. GNE shall not unreasonably withhold its agreement to any such
new representative proposed by SurModics.

          (b) Responsibilities. The Joint Management Team, led by the Management Team Leaders, will be
responsible for [*]. The Management Team Leaders will dialog regularly
about the progress of the Services and use good faith efforts to resolve any difficult issues

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED
WITH RESPECT TO THE OMITTED PORTIONS.

5

 

regarding the Services addressed by the Joint Management Team as well as facilitate expeditious
resolution of any issues escalated to the Manufacturing JSC.

3.3 Manufacturing Joint Steering Committee (Manufacturing JSC).

     3.3.1 Formation. Within thirty (30) days of the Effective Date, the Parties will establish a
Manufacturing Joint Steering Committee (the “Manufacturing Joint Steering Committee” or
“Manufacturing JSC”) to give direction and advice to the Joint Management Team (or Teams if more
than one Project is being worked on by SurModics) relating to the Services. The Manufacturing
Joint Steering Committee will be made up of at least two senior level members from each Party,
representing functions within each Party directly involved in the Services; provided, however, that
no Party’s representative will serve on both the Manufacturing JSC and either a JMT or JSC
established under the License Agreement. Either Party may replace any or all of its
representatives at any time by providing written notice to the other Party.

     3.3.2 Responsibilities. The Manufacturing Joint Steering Committee will be responsible for
[*].

3.4 Meetings.

     3.4.1 JMT Meetings. The JMT shall meet at least monthly during the course of any SOW. These
meetings may be called on a more frequent basis as reasonably determined by the GNE Management Team
Leader. These meetings may be held via teleconference or videoconference but should be held face
to face at least two times per year, alternating between the Parties facilities or at such other
location as the Parties may otherwise agree. Each Party shall be responsible for all of its own
expenses of traveling to and participating in any of the JMT meetings. SurModics will assume the
project management responsibility for each Project; documenting meetings, maintaining a project
timeline, enabling risk management planning and resource forecasting, and otherwise tracking the
progress of the Services under each Project for the Joint Management Team.

     3.4.2 Manufacturing JSC Meetings. The Manufacturing JSC shall meet at least two (2) times per
year during the term of this MSA. These meetings shall be held face to face, alternating between
the Parties facilities or at such other location as the Parties may otherwise agree. By mutual
agreement of the Parties, meetings may also be held via teleconference or videoconference. Each
Party shall be responsible for all of its own expenses associated with travel to and participating
in any of Manufacturing JSC meetings.

3.5 Decisions.

     3.5.1 In General. The Management Team Leaders will be responsible for making all decisions on
day to day activities that do not materially impact critical milestones, Program Budgets, or supply
of materials. These decisions may be made in the context of discussion at the Joint Management Team; [*].
Notwithstanding the foregoing, either Management Team Leader may
escalate material issues and disputes to the Manufacturing JSC.

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED
WITH RESPECT TO THE OMITTED PORTIONS.

6

 

     3.5.2 GNE Decisions. Notwithstanding anything to the contrary in the License Agreement, this
MSA and/or the Quality Agreement, with respect to issues relating to: (i) interpretation of quality
or cGMPs, (ii) acceptability of validation results, (iii) acceptability of Product testing
(including in-process testing), results or procedures, (iv) disposition of any Product (including
Non-Conforming Product) and/or (v) changes to a Manufacturing Process and/or Specifications, in
each case, [*]. SurModics shall use Commercially Reasonable Efforts to effect any such
implementation in accordance with a timeline approved by GNE. [*]

3.6 Disputes. If the Manufacturing JSC is unable to resolve a material issue or dispute presented
to it, then either Party’s Manufacturing JSC representative may escalate such Dispute to the JSC
established under the License Agreement, and such dispute shall be resolved in accordance with
ARTICLE 3 of the License Agreement.

3.7 Committee Term Limits. Either Party may, at its sole discretion, terminate its participation
on the JMT or the Manufacturing JSC at any time [*] of the Effective Date by providing [*] written
notice to the other Party. Should either Party elect to terminate its JMT or Manufacturing JSC
participation, the Parties will amend the respective decision making and disclosure rights and
obligations enumerated in this Agreement to preserve the Parties’ respective decision making and
disclosure rights and obligations in the absence of participation through the JMT or Manufacturing
JSC.

3.8 No Deliverables. The Parties acknowledge and agree that the Manufacturing JSC under this
Agreement is strictly for the purposes of decision making and governance of the activities
conducted under a SOW to this MSA, and does not in any way include any significant deliverable of
either Party.

ARTICLE 4

SERVICES

4.1 General Obligations. Subject to the terms and conditions set forth in this MSA and the License
Agreement, during the Term, GNE hereby retains SurModics to perform the Services specified in the
SOW(s).

4.2 Compliance with Law; Facility Permits and Licenses. SurModics shall, and shall ensure that its
Project Personnel, perform the Services in accordance with all applicable laws and regulations,
including, without limitation applicable GXPs. SurModics shall be responsible for obtaining and
maintaining all applicable licenses and permits required for it to perform the Services hereunder.

4.3 Manufacturing Facility. Unless otherwise expressly agreed by the Parties in writing (including
in a SOW), all Services shall be performed by SurModics at the Facility or by other SurModics’
personnel at SurModics’ locations. [*]

4.4 Project Personnel. It is understood that GNE is entering into this MSA, each SOW and the
Quality Agreement in reliance on the commitment by SurModics to staff the Facility

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED
WITH RESPECT TO THE OMITTED PORTIONS.

7

 

with managers,
supervisors, engineers, technicians, inspectors, and other personnel including, but not limited to,
temporary employees, consultants and sub-contractors (in accordance with Section 4.5 below), as
SurModics deems necessary, in each case having sufficient technical expertise to perform its
obligations under this MSA and the Quality Agreement (collectively, “Project Personnel”). Without
limiting any other provision of this MSA, so long as such Project Personnel remain employed by
SurModics, SurModics will ensure that such individuals (not specific individuals but individuals
with similar functional expertise) are available to perform the obligations, as appropriate, to be
provided by SurModics hereunder. In addition, SurModics shall ensure that the Management Team
Leader and Project Personnel have read, understood and agreed to be bound by obligations of
confidentiality and non-use at least as restrictive as those applicable to this MSA.

4.5 Subcontracting. SurModics shall not subcontract all or any portion of its obligations under
this MSA without GNE’s prior written approval and in accordance with the Quality Agreement. In the
event of such approval, the applicable subcontract shall be consistent with the terms and
conditions of this MSA. [*]For the avoidance of doubt, SurModics may [*] to the extent such [*]
are under the general supervision of SurModics’ Project Personnel, and have sufficient technical
expertise, and SurModics is responsible to Genentech for their performance.

4.6 [*]

ARTICLE 5

FACILITY MODIFICATIONS, EQUIPMENT, MATERIALS, DOCUMENTATION AND

IMPLEMENTATION

5.1 In General. Modification of the Facility and/or transfer of equipment, materials and/or
processes to be carried out in order to perform the Services at the Facility, are summarized below
and may be further described in detail in a SOW, if applicable.

5.2 [*]

5.3 [*]

5.4 GNE Materials. GNE shall transfer to SurModics the GNE Materials and any Manufacturing
Documentation in Genentech’s Control necessary to perform the Services as specified in the
applicable SOW. Such transfer will be in accordance with the applicable SOW. GNE and SurModics
will make their personnel available at the Facility and/or other facilities to enable the transfer
and implementation of each of the foregoing. Prior to delivery of GNE
Materials to SurModics, GNE shall provide documentation similar to that described in the Quality
Agreement and a Certificate of Analysis or other documentation (i.e. certificate of testing, etc)
as appropriate for the development stage of the GNE Material for SurModics’ review and approval.
SurModics shall approve or reject such documents not more than [*] after receipt thereof, and may
reject such documents only as specifically set forth in the applicable Quality Agreement. Upon
SurModics’ approval of such documents, SurModics shall release GNE Material for delivery to
SurModics and GNE shall deliver the GNE Material to SurModics

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED
WITH RESPECT TO THE OMITTED PORTIONS.

8

 

in accordance with the terms and
conditions of this MSA. The provisions set forth in the Quality Agreement regarding release shall
control the procedures and standards for release. For purposes hereof, “Certificate of Analysis”
means, as further specified in the Quality Agreement, for each shipment of GNE Material, a document
prepared by GNE: (a) listing the Manufacturing date(s) of such GNE Material, and (b) certifying
that all GNE Material in the shipment conform to the specifications and were Manufactured in
compliance with specifications, cGMPs, the Quality Agreement, standard operating procedures and all
applicable laws. The Parties shall from time to time agree upon a format or formats for the
Certificate of Analysis to be used under this MSA.

5.5 Raw Materials & Change Parts.

     5.5.1 Raw Materials. [*] Specifications for the Raw Materials shall be set forth in the
SOW(s).

     5.5.2 [*]

     5.5.3 Testing and Evaluation of Raw Materials. SurModics shall perform all testing and
evaluation of the Raw Materials as required by the applicable SOW, Specifications, Manufacturing
Documentation, cGMPs, the Quality Agreement and Standard Operating Procedures.

     5.5.4 [*]

5.6 Product Documentation. SurModics will maintain and retain true and accurate books, records,
test and laboratory data, validation data, reports and copies of all other information related to
the Services, including all information required to be maintained and retained under the License
Agreement, this MSA, the Quality Agreement or applicable law (including cGMPs) (the “Records”).
SurModics will maintain all Records in separate forms and notebooks to the extent reasonably
possible (i.e., not commingled with other information) and will maintain Records for at least that
period specified in the License Agreement and the Quality Agreement (or longer if required by law).
GNE shall have the right to review the Records at the Facility during the time such Records are
required to be maintained, as part of any audit conducted pursuant to Section 7.2.

5.7 Changes to the Manufacturing Process. Except as otherwise expressly set forth in the Quality
Agreement, in the event that GNE is required by a Regulatory Authority to change the Manufacturing
Process, SurModics shall use Commercially Reasonable Efforts to accommodate such required change,
provided, that if any such change to the Manufacturing
Process renders obsolete or unusable any Raw Materials used to manufacture the Product, and to the
extent such Raw Materials can not be utilized by SurModics for its other manufacturing operations,
GNE shall reimburse SurModics for the documented costs of such materials and disposal costs, if
any.

5.8 Regulatory Requirements for the Manufacturing Process and the Product. In accordance with the
terms of this MSA and the License Agreement, GNE shall be responsible

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED
WITH RESPECT TO THE OMITTED PORTIONS.

9

 

for obtaining and maintaining
all Regulatory Approvals required to Develop and Manufacture Product at the Facility; provided that
SurModics shall use Commercially Reasonable Efforts to timely prepare, assist and enable GNE with
obtaining and maintaining such Regulatory Approvals, including, without limitation, by preparing,
filing and maintaining IND amendments to any existing FDA licenses held by SurModics.

ARTICLE 6

SUPPLY

6.1 In General. During the Term, and subject to the terms and conditions of this MSA and the
License Agreement (including, without limitation, for supply of Licensed Product [*], SurModics
agrees to supply to GNE, and GNE agrees to purchase from SurModics, such amounts of Product and
other deliverables as set forth in the applicable SOW.

6.2 Acceptance of Product and Other Deliverables.

     6.2.1 Acceptance.

          (a) Product. Prior to delivery of Product to GNE, SurModics shall provide Genentech with [*].
Upon GNE’s approval of such documents, GNE shall release the Product for delivery in accordance
with the Quality Agreement, and SurModics shall deliver the Product in accordance with the terms
and conditions of this MSA. The provisions set forth in the Quality Agreement regarding release
shall control the procedures and standards for release. For purposes hereof, “Certificate of
Analysis” means, as further specified in the Quality Agreement, for each shipment of Product, a
document prepared by SurModics: [*]. The Parties shall from time to time agree upon a format or
formats for the Certificate of Analysis to be used under this MSA.

          (b) Other Deliverables. Upon receipt of any deliverable specified in an SOW other than
Products, GNE (or its designee) shall, as appropriate, perform any testing and review required for
such deliverable per any Acceptance Criteria in the SOW, and for the requirements of the Quality
Agreement. Such testing and review will be completed within [*] of its receipt or such other
period of time specified in a SOW.

     6.2.2 Non-Conforming Product. In accordance with Section 7.1 of the Quality Agreement, GNE
will notify SurModics of any claim that Product is Non-Conforming upon GNE discovering such Product
is Non-Conforming, but no later than [*] after receipt of such Product and its associated
Manufacturing Documentation by GNE from SurModics. [*]

     6.2.3 Replacement Product. [*]

6.3 Delivery of Product.

     6.3.1 Shipping; Title.

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED
WITH RESPECT TO THE OMITTED PORTIONS.

10

 

          (a) SurModics shall ship the Product (and any other deliverables) to such destinations chosen
by GNE to the extent that such shipments are permitted by law for SurModics given the regulatory
requirements of the exporting and the importing countries. Unless otherwise requested by GNE,
SurModics shall arrange for the delivery of Product (or such other deliverables) from the Facility
to such permitted destinations by carriers acceptable to, and in accordance with, GNE’s shipping
instructions on [*].

          (b) SurModics will provide customary export documentation, as specified by GNE or by separate
delivery and shipment documentation instructions, together with each shipment of Product (or such
other deliverables). At SurModics’ request, GNE shall assist SurModics with export consultant
expertise regarding shipment of Product. SurModics shall also provide GNE with all relevant
shipping information (e.g., carrier, shipment details, scheduled arrival date, quantity) prior to
or coincident with shipping any Product (or such other deliverables) to GNE. SurModics shall also
provide GNE with all relevant storage and handling instructions for such Product with each shipment
and GNE agrees to comply with such instructions.

          (c) GNE shall be the importer of record of each shipment of Product (or such other
deliverables) shipped to GNE. In conjunction therewith, prior to shipping any Product (or such
other deliverables), GNE shall obtain all appropriate approvals and consents of any governmental
authority necessary for the import, transportation or shipment of such Product (or such other
deliverables).

          (d) Any customs, freight, insurance and other shipping expenses, as well as any special
packaging expense incurred by SurModics prior to delivery to GNE shall be paid by GNE upon delivery
to GNE (or its designee) at the Facility. GNE shall also bear all applicable taxes, duties and
similar charges that may be assessed against the Product (or such other deliverables) after
delivery to GNE (or its designee) at the Facility.

     6.3.2 Storing, Packaging and Shipping Containers. SurModics shall provide sufficient and
suitable cGMP storage facilities that meet the Specifications for storage of Product for a period
of up [*] after release thereof. SurModics shall store, package, label and ship the Product
according to the Specifications, the Quality Agreement, and according to procedures and using
storage containers mutually agreed upon by GNE and SurModics in writing. [*]

ARTICLE 7

QUALITY COMPLIANCE

7.1 Quality Agreement. Both Parties are obligated to adhere to the provisions of the Quality
Agreement and agree that all elements of quality assurance, quality control and the like shall be
governed by the terms and conditions of the Quality Agreement. In the event of a conflict between
this MSA and the Quality Agreement, this MSA shall prevail over those of the Quality Agreement,
with the exception of quality-related matters and provisions that are in violation of cGMPs.

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED
WITH RESPECT TO THE OMITTED PORTIONS.

11

 

7.2 Compliance Audits. Genentech will have the right to perform compliance audits as set forth in
Section 8.1 of the Quality Agreement.

7.3 Responsibility for Recalled Products. GNE shall notify SurModics promptly if any Product
manufactured by SurModics is the subject of a threatened or actual recall, market withdrawal or
correction attributable to any activities conducted by of SurModics. The responsibility for any
such recall shall be as set forth in the Quality Agreement.

ARTICLE 8

CONSIDERATION

8.1 Pricing. [*]

8.2 Invoices. SurModics shall invoice GNE for Services performed under this MSA in accordance with
Section 7.2 of the License Agreement or the applicable SOW. [*]

8.3 Payment Terms. The provisions contained in Section 7.2 and Article 8 of the License Agreement
are hereby incorporated by reference as if set forth herein in full

ARTICLE 9

OWNERSHIP OF INTELLECTUAL PROPERTY, MATERIALS AND EQUIPMENT

9.1 Equipment and Materials. [*]

9.2 Intellectual Property. The provisions contained in Articles 10 and 11 of the License Agreement
are hereby incorporated by reference as if set forth herein in full.

ARTICLE 10

CONFIDENTIALITY

The provisions contained in Article 9 of the License Agreement are hereby incorporated by reference
as if set forth herein in full.

ARTICLE 11

REPRESENTATIONS AND WARRANTIES

11.1 General Representations and Warranties. The provisions contained in Article 13 of the License
Agreement are hereby incorporated by reference as if set forth herein in full. In addition:

     11.1.1 SurModics Representations and Warranties. SurModics represents and warrants that all
Product, at the time of delivery to GNE’s designated carrier, shall: [*].

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED
WITH RESPECT TO THE OMITTED PORTIONS.

12

 

     11.1.2 GNE Manufacturing Representations and Warranties. GNE represents and warrants to
SurModics that: [*].

     11.1.3 Services Warranties SurModics represents and warrants that: (a) the Services shall be
performed and completed in a good and workmanlike manner; and (b) SurModics, and SurModics’
employees and/or subcontractors assigned to perform the Services, are qualified and equipped
therefor, have the requisite expertise and have all rights, licenses, permits and consents
necessary to perform the Services hereunder.

     11.1.4 Compliance with Anti-Corruption Practices. SurModics represents and warrants that
SurModics and its directors, officers, employees and permitted subcontractors will not, directly or
indirectly, pay, promise to pay, or authorize the payment of any money, or give, promise to give,
or authorize the giving of anything of value to any official or employee of any government, or of
any agency or instrumentality of any government (including any official or employee of any
government-controlled hospital or other healthcare organization) in connection with any Services
except in exchange for legitimate services provided by such official, employee, agency, or
instrumentality to achieve the purposes of this MSA. In the event that SurModics learns of any
activities in violation of this Section 11.1.4, it shall immediately notify GNE and provide
detailed information about the nature and extent of such activities.

ARTICLE 12

INDEMNIFICATION, INSURANCE, LIMITATION OF LIABILITY

The provisions contained in Article 14 of the License Agreement are hereby incorporated by
reference as if set forth herein in full.

ARTICLE 13

TERM AND TERMINATION

13.1 Term. This MSA shall commence on the Effective Date and, unless earlier terminated in
accordance with the provisions of this Article 13, shall continue in full force and effect until
terminated by mutual agreement of the Parties (the
“Term”).

13.2 Termination. This MSA may be terminated in accordance with Article 12 of the License Agreement
(in its entirety or as to any SOW). In addition, either Party may terminate any SOW for any
material breach of the MSA or such SOW by the other Party, provided, however, that the nonbreaching
Party shall give the breaching Party written notice detailing such
breach and indicating its intent to terminate, and, if the breaching Party fails to cure or dispute
in good faith, that breach within (a) [*] after receipt of written notice of breach of an
obligation to make a payment under this MSA and (b) [*] after receipt of written notice of any
other breach, or a longer period of time not to exceed [*] if the breaching Party is working
diligently to cure such breach.

13.3 Effect of Expiration or Termination.

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED
WITH RESPECT TO THE OMITTED PORTIONS.

13

 

     13.3.1 In General. In the event of any termination of this MSA, or any SOW to the MSA, the
terms of Sections 12.6, 12.7, and 12.8 of the License Agreement shall apply (as applicable). In
addition:

     13.3.2 Effect of Termination. Following any termination of this MSA, Product or other
deliverables that has been, or is in the process of being, Manufactured as of the date of notice of
such termination (or which result from Manufacturing initiated prior to delivery of such notice),
shall remain subject to the terms and conditions of this MSA, and such terms and conditions shall
continue to survive with respect to such Product.

     13.3.3 Return of Materials. In the event of termination of this MSA or any SOW to this MSA
for any reason, SurModics agrees promptly to surrender and deliver to GNE (a) all applicable GNE
Materials, Product and deliverables, and (b) records, materials, equipment, drawings, documents,
data and any work product of any nature in each case directly pertaining to applicable GNE
Confidential Information, Product, deliverables and/or Genentech Project IP Rights, or Joint
Project IP Rights, excluding original notebooks, and all other materials belonging to GNE, in
SurModics’ possession. Notwithstanding the foregoing, (i) SurModics may retain and continue to use
copies of such records, as required to comply with all applicable laws, and (ii) SurModics’ legal
department may retain one (1) copy of the foregoing, in each case, subject to its continuing
obligation of confidentiality related to this MSA.

     13.3.4 Decommissioning. Upon termination of the License Agreement, this MSA or any SOW for
any reason, unless otherwise provided in this Section 13.3.4, SurModics shall promptly perform the
Decommissioning, taking into account that such actions may be delayed to the extent necessary for
SurModics to fulfill any obligations continuing as of the date of such termination. As used
herein, “Decommissioning” means the process of verifying that all GNE contractual commitments
applicable to such termination have been met, including the requirements related to the return of
information and material set forth in Section 13.3.3. In addition, Decommissioning shall include
the following actions by SurModics:

          (a) Cease and refrain from all Services for GNE applicable to the termination;

          (b) [*]

          (c) Any GNE equipment in SurModics’ possession shall, at GNE’s election and cost, either be
(i) removed and returned to GNE, (ii) removed and destroyed, or (iii) rendered inoperable. In the
event GNE does not elect to have GNE equipment removed and returned to
GNE under 13.3.4(c)(i) herein, at SurModics’ election, SurModics may request GNE enter
negotiations for the sale of such GNE equipment to SurModics prior to GNE making an election under
13.3.4(c)(ii) or 13.3.4(c)(iii).

     13.3.5 Costs Incurred in Decommissioning. Prior to Decommissioning, and during the period of
any Decommissioning, the JMT shall meet, discuss in good faith and agree upon a plan and budget for
such Decommissioning. The actual costs and expenses incurred by SurModics in performing the
activities identified in Section 13.3.4 shall be borne by the Parties as follows:

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED
WITH RESPECT TO THE OMITTED PORTIONS.

14

 

          (a) [*]

          (b) [*]

          (c) [*]

     13.3.6 No Conflict. The foregoing rights and obligations are not meant to limit any rights or
obligations (including other payments or reimbursements due to SurModics) of either Party set forth
in Article 12 of the License Agreement.

     13.3.7 [*]

     13.3.8 Transition of Manufacturing and Supply. Notwithstanding any provision of this MSA to
the contrary, upon an early termination by GNE pursuant to Sections 12.3 or 12.5 of the License
Agreement, or Section 13.2 of this MSA (for SurModics’ material breach or bankruptcy), SurModics
agrees to extend the term of any SOW at GNE’s written request (which shall be at least [*] prior to
the date that this MSA with respect to such SOW would terminate or expire) in order to continue
Manufacturing and Supply of Product to GNE under such SOW for a reasonable period after the date
the MSA as to such SOW would have terminated. If, in connection with a termination of this MSA as
to a SOW, the Parties enter into arbitration in accordance with Article 15 of the License
Agreement, then the effective date of termination for purposes of this Section shall not be earlier
than the final resolution thereof, unless expressly agreed otherwise in writing by the Parties.
GNE shall give SurModics at least [*] prior written notice of the date after which Genentech will
no longer require SurModics to perform the Manufacturing and Supply of Product under such SOW.

13.4 Survival. In addition to provisions that survive pursuant to the License Agreement, the
following provisions shall survive termination of this MSA: Articles 1, 9, 10, 12, 14, and Sections
13.3 and 13.4.

ARTICLE 14

DISPUTE RESOLUTION

The provisions contained in Article 15 of the License Agreement are hereby incorporated by
reference as if set forth herein in full.

ARTICLE 15

MISCELLANEOUS

15.1 In General. The provisions contained in Article 16 of the License Agreement are hereby
incorporated by reference as if set forth herein in full, except that Section 16.3 of the License
Agreement shall not apply and instead the terms of Section 15.2 shall govern this Agreement.

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED
WITH RESPECT TO THE OMITTED PORTIONS.

15

 

15.2 Force Majeure.

     15.2.1 Effect of Force Majeure Event. Neither Party shall be deemed to have breached this
Agreement for failure to perform its obligations under this Agreement to the extent such failure
results from acts of God, earthquakes, fires, floods, embargoes, wars, acts of terrorism,
insurrections, riots, civil commotions or similar events (each a “Force Majeure Event”).

     15.2.2 Notice of Force Majeure. If a Force Majeure Event occurs, the Party unable to perform
shall promptly notify the other Party of the occurrence of such event, and the JMT shall meet (in
person or telephonically) promptly thereafter to discuss in good faith the circumstances relating
thereto and possible ways to mitigate any adverse consequences arising out of the Party’s failure
to perform. The Party unable to perform shall (a) provide reasonable status updates to the other
Party from time to time, (b) use Commercially Reasonable Efforts to mitigate any adverse
consequences arising out of its failure to perform and (c) resume performance as promptly as
possible.

     15.2.3 Recovery from Force Majeure. If a Force Majeure Event prevents SurModics from
Manufacturing or supplying Product under this Agreement, the Parties shall in good faith discuss
changes to scheduling and production to so as to remedy any shortfall, shortage or delay.
SurModics shall use Commercially Reasonable Efforts to accommodate any such changes to scheduling
and production. Notwithstanding the foregoing, in the event the Force Majeure Events affects
SurModics’ other customers, the changes to scheduling and production agreed upon by GNE and
SurModics shall be no less favorable to GNE than those arrangements provided by SurModics to any
other of its customers.

**********

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED
WITH RESPECT TO THE OMITTED PORTIONS.

16

 

IN WITNESS WHEREOF, the Parties hereto have caused this MSA to be executed by their duly
authorized representatives as set forth below.

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	SurModics, Inc.	 	 	 	Genentech, Inc.	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	By:	 	/s/ Bruce J Barclay	 	 	 	By:	 	[*]	 	 
	 	 	 	 	 	 	 	 	 	 	 
	 

	 	Name:
	 	Bruce J Barclay
	 	 
	 	 	 	Name:
	 	[*]
	 	 
	 

	 	Title:
	 	President and CEO
	 	 	 	 	 	Title:
	 	[*]	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	F. Hoffmann-La Roche Ltd	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	By:	 	[*]	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	 	 	 	 	Name:
	 	[*]	 	 
	 

	 	 	 	 	 	 	 	 	 	Title:
	 	[*]	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	By:	 	[*]	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	 	 	 	 	Name:
	 	[*]	 	 
	 

	 	 	 	 	 	 	 	 	 	Title:
	 	[*]	 	 

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

 

 

EXHIBIT A

FORM OF SOW

     This statement of work (the “Exhibit”) is entered into pursuant to the Master Service
Agreement by and between Genentech, Inc. (“Genentech”) and SurModics, Inc. (“SurModics”) dated
<Insert Date> (the “Agreement”), and is effective as of <Insert Date> (the “Exhibit
Effective Date”). Capitalized terms used in this Exhibit and not otherwise defined will have the
same meaning as set forth in the Agreement.

     The parties hereby agree as follows:

     1. Exhibit. This document constitutes an Exhibit to the Agreement, and the Services to be
provided hereunder are subject to the terms and conditions of the Master Service Agreement.

     2. Services and Payments of Fees and Expenses. The specific Services contemplated by this
Exhibit are set forth on the following attachments, which are incorporated herein by reference.
[*]

	 	 	 
	Scope of Work, Timeline and Budget

	 	ATTACHMENT I
	 
	 	 
	Project Specific Compensation Terms

	 	ATTACHMENT II
	 
	 	 
	Change Order Process

	 	ATTACHMENT III

     3. Term. The term of this Exhibit will commence on the Exhibit Effective Date set forth above
and will continue until the Services described on Attachment II are complete or this Exhibit is
terminated in accordance with the Agreement.

     4. Affiliates and Subcontractors. Genentech agrees that SurModics may use the services of its
Affiliates or subcontractors to fulfill SurModics’s obligations under this Exhibit. SurModics will
be responsible to Genentech for the performance of such Affiliates and subcontractors, and all such
performance will be in accordance with the terms and conditions of the Agreement and this Exhibit.

     Subcontractors: [List as needed]

     5. Contact Information

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

 

 

     SurModics Pharmaceuticals

	 	 	 	 	 	 	 	 	 
	Contact Name	 	Site	 	Department	 	Telephone	 	Email
	 

	 	 	 	Proposal Administration	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 

	 	 	 	Project Management	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 

	 	 	 	Business Development	 	 	 	 

     Genentech

	 	 	 	 	 	 	 
	Contact Name	 	Address	 	Telephone	 	Email
	<Manufacturing 

Collaborations Site 

Manager>

	 	1 DNA Way

South San Francisco

CA 94080	 	 	 	 

     6. Amendments. No modification, amendment, or waiver of this Exhibit shall be effective
unless in writing and signed by a duly authorized representative of each party, in accordance with
the Change Order process described in ATTACHMENT III to this Exhibit.

     ACCEPTED AND AGREED:

	 	 	 	 	 
	SurModics Pharmaceuticals:

	 	Genentech, Inc.:	 	 
	 
	 	 	 	 
	 

	 	[Insert Signature Blocks]	 	 

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

 

 

Attachment I: SOW Scope & Budget

INSERT PROPOSAL TASKS HERE

INSERT PROPOSAL TIMELINE HERE

Attachment II: Project Specific Compensation & Terms

	1)	 	Project Budget and Total Compensation

[*]

	2)	 	Payments

     SURMODICS shall submit (email) all invoices for this contract as follows:

Send Attn:

<Genentech Project Contact>

1 DNA Way, MS <#>

South San Francisco, CA 94080

Email / Carbon Copy: <Genentech Relationship Manager>

     All invoices must reference the PO number assigned to this contract. The purchase
order number will be sent via email after the contract is executed.

     Genentech shall forward payment to SurModics as follows:

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

 

 

          Attachment III: Change Order Process

15.3 Scope Change Form (SCF)

Genentech / SurModics Exhibit #______

SOW #______

Change Order Form

          (a)

Change Order Number: [#________]

 

(i) Description of Change(s) and Assumptions

          (b)

           

[*]

          (c)

Total Contract Budget Summary

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Document	 	Effective Date	 	Labor Amount	 	Expenses Amount	 	Total Contract
	Exhibit [#]
	 	 	 	 	 	$	 —	 	 	$	 —	 	 	$	 —	 
	Change Order #1
	 	 	 	 	 	$	—	 	 	$	—	 	 	$	—	 
	Change Order #2
	 	 	 	 	 	$	—	 	 	$	—	 	 	$	—	 
	Change Order #3, etc.
	 	 	 	 	 	$	—	 	 	$	—	 	 	$	—	 
	Total Revised Contract:
	 	 	 	 	 	 	 	 	 	 	 	 	 	$	—	 

          (d) Payment Schedule Revision

     Is
a revised payment schedule required? o YES, It is included as an Attachment.
o NO

     If NO, please explain:

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

 

15.3.2 CHANGE ORDER APPROVAL

	 	 	 
	SurModics

	 	Genentech, Inc.

	 	 	 	 	 	 	 	 	 	 	 
	Print Name:

	 	 
	 	 	Print Name:
	 	 	 	 
	 

	 	 

	 	 
	 	 	 	 

	 	 

	 	 	 	 	 	 	 	 	 	 	 
	Signature:

	 	 	 	 	 	Signature:
	 	 	 	 
	 

	 	 

	 	 
	 	 	 	 

	 	 

	 	 	 
	Approval Date: __/__/_____

	 	Approval Date: __/__/_____

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

 

 

EXHIBIT B

QUALITY AGREEMENT

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

 

 

GOOD MANUFACTURING PRACTICE

TECHNICAL QUALITY AGREEMENT

Between

Genentech, Inc.

(Contract Giver)

and

SurModics, Inc.

(Contract Acceptor)

We the undersigned, agree to the terms, conditions, roles and responsibilities described in
this Quality Agreement and its appendices.

	 	 	 	 	 	 	 
	Genentech, Inc.

	 	 	 	SurModics, Inc.	 	 
	 
	 	 	 	 	 	 
	[*]

	 	9/30/09
	 	/s/ Michael Shoup
	 	10/1/09
	 

	 	 	 	 	 	 
	[*]

	 	DATE
	 	Michael Shoup,
	 	DATE
	[*]

	 	 	 	Vice President Quality, Regulatory and	 	 
	[*].

	 	 	 	Clinical Affairs SurModics, Inc.	 	 
	 
	 	 	 	 	 	 
	 

	 	 	 	[*]
	 	10/1/09
	 

	 	 	 	 	 	 
	 

	 	 	 	[*]
	 	DATE
	 

	 	 	 	[*]	 	 
	 

	 	 	 	[*]	 	 

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

Confidential and Proprietary — Handle Accordingly

 

 

Quality Agreement Number- QAC-SUR-01/01

Page 2 of 21 

TABLE OF CONTENTS

	 	 	 	 	 	 	 	 	 	 	 
	1.0	 	 	GENERAL INFORMATION	 	 	3	 
	 

	 	 	1.1	 	 	Introduction
	 	 	3	 
	 

	 	 	1.2	 	 	Parties to Agreement
	 	 	3	 
	 

	 	 	1.3	 	 	Scope
	 	 	3	 
	 

	 	 	1.4	 	 	Duration, Review and Changes to this Agreement
	 	 	4	 
	 

	 	 	1.5	 	 	Ultimate Quality Responsibility
	 	 	4	 
	 

	 	 	1.6	 	 	Quality Oversight and Person-in-Plant (PIP)
	 	 	5	 
	 

	 	 	1.7	 	 	GMP Commissioning
	 	 	5	 
	 

	 	 	1.8	 	 	Execution of Responsibilities
	 	 	6	 
	2.0	 	 	LICENSES	 	 	6	 
	 

	 	 	2.1	 	 	Establishment License
	 	 	6	 
	 

	 	 	2.2	 	 	Product Licenses
	 	 	6	 
	3.0	 	 	GOVERNING REGULATIONS, RULES AND PROCEDURES	 	 	6	 
	 

	 	 	3.1	 	 	Governing Regulations and Rules
	 	 	6	 
	 

	 	 	3.2	 	 	SurModics Procedures
	 	 	7	 
	4.0	 	 	MATERIALS	 	 	7	 
	 

	 	 	4.1	 	 	Sources
	 	 	7	 
	 

	 	 	4.2	 	 	Suppliers
	 	 	7	 
	 

	 	 	4.3	 	 	Receipt, Testing, Control and Release
	 	 	8	 
	5.0	 	 	PROCESSING OF PRODUCT	 	 	8	 
	 

	 	 	5.1	 	 	Batch Numbering
	 	 	8	 
	 

	 	 	5.2	 	 	Holding, Shipping, and Destruction of Samples
	 	 	8	 
	 

	 	 	5.3	 	 	Reprocessing and Reworking
	 	 	9	 
	6.0	 	 	QUALITY CONTROL TESTING	 	 	9	 
	 

	 	 	6.1	 	 	Analytical Methods
	 	 	9	 
	 

	 	 	6.2	 	 	Quality Control Testing and Approval
	 	 	9	 
	 

	 	 	6.3	 	 	Stability Testing
	 	 	10	 
	 

	 	 	6.4	 	 	Out of Specification (OOS) Quality Control Testing Results
	 	 	10	 
	7.0	 	 	GENERAL QUALITY SYSTEMS	 	 	10	 
	 

	 	 	7.1	 	 	Disposition of Product
	 	 	10	 
	 

	 	 	7.2	 	 	Deviations
	 	 	11	 
	 

	 	 	7.3	 	 	Validation
	 	 	13	 
	 

	 	 	7.4	 	 	Change Control
	 	 	13	 
	 

	 	 	7.5	 	 	New Product Introduction
	 	 	14	 
	 

	 	 	7.6	 	 	Product Complaints, Adverse Events, and other Post-Release Issues
	 	 	14	 
	 

	 	 	7.7	 	 	Document Retention
	 	 	15	 
	 

	 	 	7.8	 	 	Sub-contracting
	 	 	15	 
	 

	 	 	7.9	 	 	QA Reserve Samples
	 	 	15	 
	8.0	 	 	COMPLIANCE AUDITS AND INSPECTIONS	 	 	16	 
	 

	 	 	8.1	 	 	Compliance Audits
	 	 	16	 
	 

	 	 	8.2	 	 	Regulatory Authority Inspections
	 	 	16	 
	 

	 	 	8.3	 	 	Regulatory Agency Contacts
	 	 	17	 
	Appendix I — Glossary	 	 	22	 
	Appendix II — Change History Log	 	 	25	 

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

			
	 	 	 
	Version 01
	 	Confidential and Proprietary — Handle Accordingly

 

 

Quality Agreement Number- QAC-SUR-01/01

Page 3 of 21 

	1.0	 	GENERAL INFORMATION
	 
	1.1	 	Introduction

	 	1.1.1	 	Genentech, Inc. is a leading biotechnology company engaged in the manufacture,
marketing and sales of pharmaceutical products. It operates under one common quality
management system in compliance with current Good Manufacturing Practices (cGMP).
	 
	 	1.1.2	 	SurModics, Inc. is a leading pharmaceutical and biotechnology company engaged
in the contractual manufacture of pharmaceutical and medical device products. It
operates under one common quality management system in compliance with cGMP.
	 
	 	1.1.3	 	Genentech Inc. (“GNE”) desires to entrust SurModics, Inc. (“SurModics”) to
perform activities related to the manufacture of GNE Products. GNE and SurModics are to
define their roles and responsibilities hereunder according to the intentions of the
GMP regulations. The manufacturing arrangements relating to the manufacture of the
Product are governed under the Master Service Agreement between GNE and SurModics
effective September 30, 2009 (the “Master Service Agreement”).
	 
	 	1.1.4	 	Capitalized terms not defined in the Glossary attached as Appendix I shall
have the meaning set forth in the Master Services Agreement.

	1.2	 	Parties to Agreement

	 	1.2.1	 	This GMP Technical Quality Agreement (the “Quality Agreement”) is hereby
entered into by and between GNE, a Delaware corporation, and SurModics, a Minnesota
corporation, and must be adhered to in the processing of the Product for GNE governed
by the Master Service Agreement. SurModics and Genentech are each referred to herein
individually as a “Party” and collectively as the “Parties.” The addresses of the
Parties are:

	 	 	 
	GENENTECH, Inc.

	 	SurModics, Inc.
	1 DNA Way

	 	9924 West 74th Street
	South San Francisco, CA 94080

	 	 Eden Prairie, MN 55344

	1.3	 	Scope

	 	1.3.1	 	Subject to Section 1.3.4, this Quality Agreement is applicable to the
manufacturing, processing, testing, and storage of the Product by SurModics for GNE.
	 
	 	1.3.2	 	The appendices and enclosures to this Quality Agreement are an integral part
of this Quality Agreement and are incorporated into this Quality Agreement by this
reference.
	 
	 	1.3.3	 	In addition to this Quality Agreement, SurModics and GNE shall create,
approve, and maintain a document that details Product specific requirements
(hereinafter referred to as the “PSR Document”) for each Product. This

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

			
	 
	Version 01
	 	Confidential and Proprietary — Handle Accordingly

 

 

Quality Agreement Number- QAC-SUR-01/01

Page 4 of 21 

	 	 	 	document shall,
at a minimum, contain contact information for designated
representatives from SurModics and GNE who shall oversee the respective obligations
regarding the Product and this Agreement, a process overview of the Product, a list
of raw materials and suppliers required to produce the Product, disposition cycle
times, list of batch documentation, any special shipping and handling requirements,
and any additional applicable information as required per this Quality Agreement or
deemed necessary by both parties.
	 
	 	1.3.4	 	This Quality Agreement pertains to the processing of the Products for
administration to humans as governed by clinical trial authorizations and marketing
authorizations (e.g. Investigational New Drug applications and Biologics License
applications). It does not pertain to the supply of Products for research and
development use. The mutual roles and responsibilities between GNE and SurModics
related to the Quality system requirements for, as well as the Product-specific Quality
requirements are defined.

	1.4	 	Duration, Review and Changes to this Agreement

	 	1.4.1	 	This Quality Agreement shall be effective as of the last date all required
signatures are appended above (the “Effective Date”) and shall expire at the
termination of the Master Service Agreement for the Product. The following sections
shall survive termination of the Master Service Agreement until such time as defined in
this Quality Agreement: sections 7.6, 7.7, 7.8, 7.9, 8.2, 8.3, and such other sections
that by their terms are understood to survive the termination of the Master Service
Agreement. The Parties acknowledge and agree that a similar quality agreement will be
executed upon termination of the Master Service Agreement in the event an agreement for
the manufacture of Phase III/IV material or commercial Product is negotiated between
the Parties.
	 
	 	1.4.2	 	This Quality Agreement shall be reviewed for accuracy and compliance with the
GMP regulations by both parties on at least a biennial cycle. Changes or supplements to
this Quality Agreement or to the appendices and enclosures can only be made by mutual
consent of amendments in writing. Such amendments to the Quality Agreement will be
recorded and filed in APPENDIX II: — Change History Log, with each subsequent revision.
	 
	 	1.4.3	 	It is the responsibility of both parties to replace a superseded provision
with an approved amendment. Superseded copies may be retained for historical records,
but should be marked to appropriately indicate the historical status of the document.
	 
	 	1.4.4	 	It is the responsibility of both parties to ensure that their staff is
adequately informed and any procedural or documentary changes resulting from an
amendment are implemented in the areas affected by the changes.

	1.5	 	Ultimate Quality Responsibility

	 	1.5.1	 	In the event of a conflict between this Quality Agreement and the Master
Service Agreement, the Master Service Agreement shall govern, except to the extent such
provisions are in violation of the GMP regulations. Notwithstanding the foregoing, this
Quality Agreement shall govern with respect to the assignment of responsibilities and
obligations of each party to

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

			
	 
	Version 01
	 	Confidential and Proprietary — Handle Accordingly

 

 

Quality Agreement Number- QAC-SUR-01/01

Page 5 of 21 

	 	 	 	undertake those measures to assure the Quality of the Products and with respect to
determinations of ability for release.
	 
	 	1.5.2	 	GNE’s Quality Unit has sole authority for final disposition of Product for
clinical use.
	 
	 	1.5.3	 	SurModics has the responsibility to implement and operate all quality systems
as required by GMP regulations where the Product will be distributed. SurModics shall
ensure that all quality systems operated by SurModics are compliant for GMP production
and that they operate to a standard mutually agreed upon by both parties.
	 
	 	1.5.4	 	If not otherwise defined in this Quality Agreement, the provisions of
SurModics’ Quality management systems and Standard Operating Procedures shall be
applied to these operations.

	1.6	 	Quality Oversight and Person-in-Plant (PIP)

	 	1.6.1	 	GNE shall have the right to provide GNE employees on SurModics’ premises (the
GNE employees hereinafter referred to as the “PIP”) for the purpose of providing advice
and coordinating reviews, approvals or other actions required by this Quality Agreement
upon reasonable notice and as mutually agreed upon. Such GNE employees shall conduct
themselves in accordance with SurModics’ visitor policy. The GNE PIP activities, at
the discretion of GNE, can also be performed remotely.
	 
	 	1.6.2	 	SurModics shall provide adequate space for the PIP when on site and shall
ensure that the PIP is kept fully informed of all issues that arise that may affect the
Quality of the Product. The PIP shall act as a single liaison between SurModics and GNE
for Quality issues.
	 
	 	1.6.3	 	[*]

	1.7	 	GMP Commissioning

	 	1.7.1	 	GMP Commissioning is a process for approving the initiation of GMP activities
at SurModics for a new manufacturing facility or a new manufacturing process related to
the Product.
	 
	 	1.7.2	 	Prior to the initiation of GMP production, SurModics shall allow the GNE
Quality Unit to perform GMP commissioning activities. This commissioning exercise is
to document that the facility, process, procedures and personnel are ready to initiate
GMP production as it relates to the Product.
	 
	 	1.7.3	 	The commissioning checklist and acceptance criteria shall be drafted by GNE
and approved by both SurModics and GNE prior to execution.
	 
	 	1.7.4	 	SurModics shall not perform new GMP activities for the Product until the GMP
Commissioning is complete and approved by the GNE and SurModics Quality Units.

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

			
	 
	Version 01
	 	Confidential and Proprietary — Handle Accordingly

 

 

Quality Agreement Number- QAC-SUR-01/01

Page 6 of 21 

	1.8	 	Execution of Responsibilities

	 	1.8.1	 	In the execution of their relevant responsibilities, both Parties agree to
conduct the necessary reviews, approvals, rejections and consents in a timely manner
and within the time limits specified. Where any party requires the consent of the
other, such consent will not be unreasonably withheld or delayed.
	 
	 	1.8.2	 	In this Agreement, “approval,” “authorization,” or “written communication”
shall mean on official letterhead or approved forms, and signed by the authoring
party’s Quality Assurance (QA) representative. Transmission of such written
documentation may be by mail or electronic system (i.e., facsimile, scan).

	2.0	 	LICENSES
	 
	2.1	 	Establishment License

	 	2.1.1	 	If applicable, SurModics shall obtain and maintain a valid manufacturer’s
license for the facilities [*].

	2.2	 	Product Licenses

	 	2.2.1	 	GNE shall, in accordance with applicable regulations, have sole authority for
applying for any Product licenses with the regulatory agencies per section 5.1 of
License and Option Agreement. GNE shall inform the appropriate regulatory authorities
of any change to the approved licenses for the Product through supplements or
amendments and informing SurModics of the same.
	 
	 	2.2.2	 	Upon request of any governmental or regulatory authority, both Parties shall
provide to each other, any data and information relating to the Product which may be
necessary for regulatory approval and maintenance efforts with respect to the licenses.

	3.0	 	GOVERNING REGULATIONS, RULES AND PROCEDURES
	 
	3.1	 	Governing Regulations and Rules

	 	3.1.1	 	SurModics shall ensure that the systems for the manufacture, processing,
testing, packing, holding and shipping of the Product at SurModics comply with:

	 	•	 	Current Good Manufacturing Practice, including but not limited to US 21 CFR
Part 11, 210, 211, and if applicable 820.
	 
	 	•	 	The requirements of this Quality Agreement.
	 
	 	•	 	The approved master documentation records (i.e., production records,
specifications).
	 
	 	•	 	Any additional regulations adopted by the regulatory authorities where the
Product will be distributed. GNE shall inform SurModics, in advance, of any
other countries where the Product will be distributed and any registration
differences.

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

			
	 
	Version 01
	 	Confidential and Proprietary — Handle Accordingly

 

 

Quality Agreement Number- QAC-SUR-01/01

Page 7 of 21 

	 	3.1.2	 	GNE shall have the right to ensure SurModics’ compliance with Section 3.1.1
above as described per Section 1.6 (PIP) and Section 8.1 (Compliance audits).

	3.2	 	SurModics Procedures

	 	3.2.1	 	SurModics shall create and maintain Quality systems compliant with cGMP, with
associated Standard Operating Procedures that enable both Parties to execute their
roles and responsibilities under the terms and conditions as described herein.
	 
	 	3.2.2	 	SurModics shall provide GNE with copies of effective Standard Operating
Procedures related to the manufacture, processing, testing, packing and holding of the
Product upon reasonable request by GNE.

	4.0	 	MATERIALS
	 
	4.1	 	Sources

	 	4.1.1	 	SurModics and/or GNE shall supply all materials required for the Product in
accordance with the MSA and certify that their Quality is in compliance with the
current “Note for Guidance on minimizing the risk of transmitting spongiform
encephalopathy agents via human and veterinary medicinal products” EMEA/410/01, Rev. 2
or update (“TSE Guidelines”).
	 
	 	4.1.2	 	GNE shall provide the bulk drug substance to SurModics for further processing
in accordance with the MSA. GNE certifies that the provided bulk will be processed
according to GMP and the materials used in its processing will be sourced in compliance
with the TSE Guidelines.

	4.2	 	Suppliers

	 	4.2.1	 	[*]
	 
	 	4.2.2	 	SurModics shall perform, or arrange to have performed, assessments of
suppliers of raw materials and components required for GNE Products to ensure that the
supplier’s Quality and manufacturing system are compliant with cGMPs.
	 
	 	4.2.3	 	[*]
	 
	 	4.2.4	 	SurModics shall notify the GNE Quality Unit when a supplier’s qualification
status changes. Upon request by GNE, SurModics shall request from its suppliers
permission to allow GNE to review SurModics audit reports.
	 
	 	4.2.5	 	If GNE supplies any raw materials and components to SurModics for use in
processing of the Product, SurModics will rely on GNE’s certification that the
supplier’s Quality systems are adequate.

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

			
	 
	Version 01
	 	Confidential and Proprietary — Handle Accordingly

 

 

Quality Agreement Number- QAC-SUR-01/01

Page 8 of 21 

	4.3	 	Receipt, Testing, Control and Release

	 	4.3.1	 	SurModics/GNE shall receive, sample, test, control and release components and
raw materials for the Product in accordance with the approved material specifications.
	 
	 	4.3.2	 	SurModics shall implement and maintain approved material specifications,
analytical methods, inspection methods, and sampling plans as required per each
material required for GNE Products. The GNE Quality Unit’s prior written approval of
such documentation is required. GNE’s approval of the material specifications,
analytical methods, inspection methods, and sampling plans shall be performed via
SurModics’ quality control system.

	5.0	 	PROCESSING OF PRODUCT
	 
	5.1	 	Batch Numbering

	 	5.1.1	 	SurModics shall use the GNE batch numbering system for all GMP Product
produced by SurModics.
	 
	 	5.1.2	 	GNE shall issue batch numbers to SurModics, who shall assign a batch number to
each Product batch. For purposes of tracking, SurModics may assign an internal
SurModics batch number in addition.
	 
	 	5.1.3	 	SurModics shall record the GNE batch number onto the appropriate production
records. SurModics shall keep track of GNE batch numbers to ensure batch numbers are
assigned appropriately.
	 
	 	5.1.4	 	SurModics shall record the GNE batch number on the appropriate Product Batch
labeling (i.e., vial label, shippers)

	5.2	 	Holding, Shipping, and Destruction of Samples

	 	5.2.1	 	SurModics shall hold the Product and raw materials in storage according to the
PSR and cGMP requirements. SurModics shall ensure that appropriate cGMP controls are
in place to prevent cross-contamination, theft, interference, or mix-up with any other
materials.
	 
	 	5.2.2	 	SurModics shall ship the Product according to GNE shipping requirements per
approved procedures. GNE shall communicate the shipping requirements to SurModics in
writing.
	 
	 	5.2.3	 	Upon receipt of the Product from GNE for further processing, SurModics shall
read the temperature monitors and report any temperature Deviations to the GNE Quality
Unit within [*].
	 
	 	5.2.4	 	Any temperature Deviations observed during shipment and/or holding of the
Product at SurModics will be handled per Section 7.2. SurModics shall investigate the
root cause and identify appropriate corrective actions for Deviations that occur while
the Product is under SurModics’ control.

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

			
	 
	Version 01
	 	Confidential and Proprietary — Handle Accordingly

 

 

Quality Agreement Number- QAC-SUR-01/01

Page 9 of 21 

	 	5.2.5	 	GNE shall be responsible for assessing the impact on Product as a result of
temperature Deviations either during Product shipment and/or during holding of the
Product at SurModics.
	 
	 	5.2.6	 	SurModics shall destroy Product rejects (for example, inspection rejects, bulk
waste, and rejected batches) per SurModics’ procedures. SurModics shall ensure that
proper handling, segregation, and documentation of any destruction is performed.

	5.3	 	Reprocessing and Reworking

	 	5.3.1	 	Prior to any Product batch being reprocessed or reworked, SurModics must
obtain approval of the GNE Quality Unit in advance. Reprocessing and reworking are
considered Significant Deviations and shall be handled in accordance to Section 7.2.
[*]
	 
	 	5.3.2	 	[*]

	6.0	 	QUALITY CONTROL TESTING
	 
	6.1	 	Analytical Methods

	 	6.1.1	 	SurModics shall implement and maintain in-process material and final Product
analytical methods.
	 
	 	6.1.2	 	The GNE Quality Unit’s prior written approval for all Product-specific
analytical methods is required.

	6.2	 	Quality Control Testing and Approval

	 	6.2.1	 	SurModics shall sample and test in-process and final Product batches according
to the approved specifications, sampling plans and analytical methods.
	 
	 	6.2.2	 	SurModics shall report all quality control results on a “Certificate of
Analysis” (COA). SurModics shall include all in-process results with the batch
records.
	 
	 	6.2.3	 	SurModics shall not destroy any QC retain samples until the Product batch has
been dispositioned by GNE.
	 
	 	6.2.4	 	GNE shall provide reference materials and critical reagents to SurModics to be
used in the testing of the Product.
	 
	 	6.2.5	 	For testing performed at GNE, SurModics shall collect the samples,
appropriately label and store the samples, and ship the samples per the current
validated shipping procedure to GNE within [*] of collecting the samples.
	 
	 	6.2.6	 	GNE QC shall perform a review of raw quality control data for in-process and
final Product batches to ensure quality standards are being maintained until such time
that GNE can qualify SurModics to perform independent data review as defined per GNE
procedure.

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

			
	 
	Version 01
	 	Confidential and Proprietary — Handle Accordingly

 

 

Quality Agreement Number- QAC-SUR-01/01

Page 10 of 21 

	6.3	 	Stability Testing

	 	6.3.1	 	SurModics shall be responsible for maintaining a routine stability testing
program for the Product per approved procedures.
	 
	 	6.3.2	 	SurModics shall write, approve and submit stability protocols for the Product
to GNE for approval.
	 
	 	6.3.3	 	SurModics shall provide GNE with the results of stability testing in support
of the approved shelf life within [*] of completion of the stability testing.
	 
	 	6.3.4	 	SurModics shall communicate any out of specification results obtained during
stability testing of the Product to the GNE Quality Unit in accordance with Section
7.2.
	 
	 	6.3.5	 	GNE shall determine and approve the expiry and/or retest period, storage, and
shipping conditions based on formal stability studies conducted for the Product.

	6.4	 	Out of Specification (OOS) Quality Control Testing Results

	 	6.4.1	 	In the event that SurModics obtains an initial OOS result, a preliminary lab
assessment shall be conducted per SurModics’ approved procedures. This assessment will
include at a minimum, a review of all equipment used, sample and reagent preparation,
and documentation associated with the test session. No additional testing of the
Product shall be conducted during this preliminary lab assessment.
	 
	 	6.4.2	 	If no determinate error is identified in the assessment conducted pursuant to
Section 6.4.1, then SurModics shall notify the GNE Quality Unit per the Section 7.2.
No additional analysis shall be conducted on the Product prior to notifying the GNE
Quality Unit.
	 
	 	6.4.3	 	The GNE Quality Unit shall approve OOS investigations and associated
corrective and preventative actions, unless an analytical error is identified in the
assessment as described in section 6.4.1 and the results are invalidated and testing is
repeated on a new sample

	7.0	 	GENERAL QUALITY SYSTEMS
	 
	7.1	 	Disposition of Product

	 	7.1.1	 	The SurModics Quality Unit must certify in writing that each batch of Product
has been manufactured, tested, packaged and stored in accordance with cGMPs, the Master
Batch Production Record (MBPR) and applicable SOPs.
	 
	 	7.1.2	 	The SurModics Quality Unit shall review and approve all batch documentation
according to SurModics’ approved procedures prior to release of the Product batch to
GNE.
	 
	 	7.1.3	 	All Deviations must be clearly identified in batch records, and must be fully
investigated and completed prior to the approval of batch records. SurModics

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

			
	 
	Version 01
	 	Confidential and Proprietary — Handle Accordingly

 

 

Quality Agreement Number- QAC-SUR-01/01

Page 11 of 21 

	 	 	 	shall perform a cumulative assessment of all Deviations that occurred during the
manufacturing, holding, and testing of the Product.
	 
	 	7.1.4	 	GNE has the sole authority for final disposition of the Product. SurModics
shall notify the GNE Quality Unit of any Product batch being considered for rejection
by SurModics prior to any formal reject disposition. For Product assigned a reject
disposition by SurModics, GNE shall have the right to take possession of the Product.
GNE shall authorize the destruction of any rejected Product batches.
	 
	 	7.1.5	 	SurModics shall not release any batches with open Major Changes or validations
that are lot-release impacting.
	 
	 	7.1.6	 	Any problem discovered by GNE that would result in the rejection of a Product
batch shall be communicated to SurModics as soon as practical, but in all cases within
[*] following receipt of the release documentation.

	7.2	 	Deviations

	 	7.2.1	 	Any Deviation shall be documented and approved by personnel designated by
SurModics from each of the relevant departments and by the SurModics Quality Unit, in
accordance with SurModics’ approved procedure for Deviation management.
	 
	 	7.2.2	 	Significant Deviations require notification of the GNE Quality Unit within [*]
of discovery.

	 	•	 	Significant Deviations are defined as events that are observed during
production, quality control testing including out-of-specification (OOS)
results as described in section 6.4.2 above, and/or batch record review that
may reasonably result in a Deviation from Product specifications, that may
adversely impact the safety, identity, strength, purity or quality of the
Product, and/or violate cGMPs or the Product license that could impact the
releasability of the Product. Examples of Significant Deviations include:

	 	•	 	Failure of Product to meet certificate of analysis (COA) specifications
	 
	 	•	 	Operations outside of validated limits
	 
	 	•	 	Suspected introduction of adventitious agents/contaminants in the
Product
	 
	 	•	 	Excursions to environmental conditions (EM) in the primary filling area
	 
	 	•	 	Incorrect or unsuitable raw materials, components, or equipment used
during the manufacturing of the Product
	 
	 	•	 	Reprocessing and reworking of the Product, [*]
	 
	 	•	 	Process discrepancies that adversely impact other Product process
steps, lots, or Products batches whether distributed or not
	 
	 	•	 	Media fill and sterility positives/failures

	 	7.2.3	 	SurModics shall obtain GNE Quality Unit approval for all Significant Deviations.

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

			
	 
	Version 01
	 	Confidential and Proprietary — Handle Accordingly

 

 

Quality Agreement Number- QAC-SUR-01/01

Page 12 of 21 

	 	7.2.4	 	SurModics shall inform the GNE Quality Unit within [*] of any Significant
Deviation relating to other products, produced using the same equipment train as that
used for the Product, if the Deviation could have an impact on the Product. SurModics
will provide as much detail as possible regarding the Deviation. In the event that
customer confidentiality agreements regarding other products prevent SurModics from
providing certain documentation or detail, SurModics may provide redacted copies of
documentation or a summary of the Deviation.
	 
	 	7.2.5	 	SurModics shall be responsible for investigating all Deviations per its
approved procedures. SurModics will allow the GNE Quality Unit to actively participate
in the development of investigation action plans related to Significant Deviations
related directly to the Product or that could have impact on the Product. All
investigation plans should be approved prior to implementation and should include at
minimum:

	 	•	 	Lots impacted
	 
	 	•	 	Description of action to be taken
	 
	 	•	 	Rationale for this action
	 
	 	•	 	Individual/department responsible for the action
	 
	 	•	 	Target completion date
	 
	 	•	 	Pre-approval by SurModics’ QA

	 	7.2.6	 	SurModics shall submit investigation plans before their implementation for all
Significant Deviations. Those plans shall be evaluated by the GNE Quality Unit. Any
additional testing required to support an investigation, including OOS investigations,
must be pre-approved by the GNE Quality Unit.
	 
	 	7.2.7	 	When necessary, GNE shall provide a technical assessment or other data to
support the investigation.
	 
	 	7.2.8	 	Significant Deviation reports shall include a description of the event,
impacted lots, determination of cause, quality impact assessment, and identification of
corrective and preventive actions. Quality impact assessments should determine the
impact of the event on the safety, Quality, identify, potency and purity of the
Product, other lots of the Product, validation, and GMP compliance.
	 
	 	7.2.9	 	After completion of the report related to Significant Deviations, SurModics
shall submit to GNE a copy of a completed report. This report shall be reviewed by the
GNE Quality Unit. Within [*], the GNE Quality Unit will either approve the Significant
Deviation, or notify SurModics of additional information or actions required before
approval of the Significant Deviation report.
	 
	 	7.2.10	 	SurModics shall [*] notify the GNE Quality Unit of any problems that are discovered
that may have impact to Product batches previously shipped to GNE. Notice shall be made
within [*] of the discovery of a potential quality problem with a released batch of
Product.

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

			
	 
	Version 01
	 	Confidential and Proprietary — Handle Accordingly

 

 

Quality Agreement Number- QAC-SUR-01/01

Page 13 of 21 

	7.3	 	Validation

	 	7.3.1	 	SurModics shall maintain systems that demonstrate manufacturing processes,
facilities, utilities, equipment, and automation will reliably and repeatedly perform
their intended function in the manufacture and testing of the Product.
	 
	 	7.3.2	 	As applicable, SurModics shall maintain a Validation Master Plan (VMP), which
includes the validation program overview and requirements for the facility and
equipment required to manufacture and test the Product. This VMP must be acceptable to
GNE.
	 
	 	7.3.3	 	SurModics shall periodically re-validate, as appropriate, facilities,
utilities, equipment, and automation per the VMP and other approved procedures.
	 
	 	7.3.4	 	GNE shall have the right to review all validation reports related to the
manufacturing and testing of the Product. These validations must be acceptable to GNE.
[*]

	7.4	 	Change Control

	 	7.4.1	 	SurModics shall utilize a change control system to ensure appropriate review
of all changes.
	 
	 	7.4.2	 	The GNE Quality Unit shall approve any change to the following master
documentation maintained by SurModics for GNE Products:
	 
	 	 	 	[*]
	 
	 	7.4.3	 	SurModics shall review all changes to determine if the change is a Major Change
(as defined in the Glossary). If there is any doubt regarding whether a change is a
Major Change, SurModics shall contact the GNE Quality Unit, and the parties shall
jointly make this determination. It is understood between parties that changes as a
result of pharmacopoeia test methods updates are not Major Changes.
	 
	 	7.4.4	 	In addition to Major Changes, SurModics shall notify the GNE Quality Unit in
writing of any Minor Changes that affect GNE specific documents, equipment or
processes, on at a minimum quarterly basis. Such notification shall contain a
description of the change, the implementation date of the change, and the status of the
change. Minor changes may be implemented by SurModics prior to such notification to
GNE.
	 
	 	7.4.5	 	SurModics shall notify the GNE Quality Unit in writing of any Major Changes
that may impact the Product Quality, validated status and/or have regulatory impact to:
	 
	 	 	 	[*]
	 
	 	7.4.6	 	Such notifications shall be communicated in writing in a timely manner so as to
allow GNE to evaluate the affect of the change on Product Quality and/or obtain
appropriate regulatory approvals prior to implementation.
	 
	 	7.4.7	 	At a minimum, such notification will contain a description of the change, the
rationale for the change, the proposed implementation date, the qualification,

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

			
	 
	Version 01
	 	Confidential and Proprietary — Handle Accordingly

 

 

Quality Agreement Number- QAC-SUR-01/01

Page 14 of 21 

	 	 	 	validation, and/or comparability testing and acceptance criteria to prove that the
Major Change does not adversely affect Product Quality.
	 
	 	7.4.8	 	SurModics shall provide all documentation of a Major Change to GNE for review
and approval. This includes, but is not limited to, the description and rationale of
the change and supporting documentation such as validations or technical assessments.
	 
	 	7.4.9	 	GNE’s review and approval/rejection of Major Changes prior to implementation
is required. Within [*], GNE shall approve the change, request additional information,
or provide justification for the rejection of a change.
	 
	 	7.4.10	 	After completion of a Major Change, SurModics shall provide the GNE Quality Unit in
writing with supporting data and reports that demonstrate the Major Change is valid and
have been found acceptable by SurModics.
	 
	 	7.4.11	 	Emergency changes are changes that must be performed prior to the receipt of GNE
approval in order to avoid Product loss or to eliminate a safety hazard. Emergency
changes must be categorized and documented as previously described and notification
must be provided to the GNE Quality Unit for evaluation within [*] of the change
implementation.
	 
	 	7.4.12	 	For changes proposed by GNE, GNE shall notify SurModics in writing of any
Product-related changes. SurModics shall implement these changes in a timely manner
and in accordance with SurModics procedures and the Master Service Agreement.

	7.5	 	New Product Introduction

	 	7.5.1	 	SurModics shall not use the same facilities and/or equipment used for
processing the Product for the processing of beta-lactams, e.g. penicillin or
cephalosporins.
	 
	 	7.5.2	 	SurModics shall inform the GNE Quality Unit in writing per the change control
Section 7.4, when [*]. For confidentiality reasons, SurModics shall only be required
to provide detail to the level of the class of product.
	 
	 	7.5.3	 	Prior to introduction of a new product into the line, SurModics shall perform
a cleaning verification/validation according to SurModics’ procedures in order to
exclude cross contamination of the Product from other product campaigns.

	7.6	 	Product Complaints, Adverse Events, and other Post-Release Issues

	 	7.6.1	 	GNE shall have sole authority for resolving all customer complaints and
adverse events, related to the Product.
	 
	 	7.6.2	 	It is expected that most product complaints and adverse events for the Product
shall be received by GNE. Any reports received by SurModics shall be forwarded to the
GNE Quality Unit within [*].
	 
	 	7.6.3	 	If GNE requests a technical evaluation, documentation review, or sample
inspection from SurModics to support a Product complaint/adverse event,

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

			
	 
	Version 01
	 	Confidential and Proprietary — Handle Accordingly

 

 

Quality Agreement Number- QAC-SUR-01/01

Page 15 of 21 

	 	 	 	SurModics shall report any findings to GNE in writing, signed, within [*] of
notification by GNE, or as required per section 8.3.6. SurModics shall provide GNE
with an update as to the progress of the investigation within [*] of notification by
GNE.
	 
	 	7.6.4	 	SurModics shall notify the GNE Quality Unit within [*] of any other complaint
with any other products manufactured by SurModics that by nature of similarity of
material or manufacturing, that has reasonable potential to adversely impact the
Product.
	 
	 	7.6.5	 	If the Product in any batch fails to comply with the agreed Quality standards,
either upon receipt or during the shelf-life of the Product (i.e., during stability
testing), as a result of operations conducted at SurModics, GNE will contact SurModics
in writing to assist with the investigation.

	7.7	 	Document Retention

	 	7.7.1	 	SurModics shall maintain the original Batch records consisting of
manufacturing, packaging, Quality Control, release, storage and delivery documentation,
Raw Data and records for each Batch of Product in a secure location for a period of
[*].
	 
	 	7.7.2	 	Prior to the destruction of any Product records at SurModics, SurModics shall
notify the GNE Quality Unit and the records shall be sent to GNE, unless otherwise
directed in writing by the GNE Quality Unit.

	7.8	 	Sub-contracting

	 	7.8.1	 	Consistent with Section 4.5 of the Master Services Agreement, SurModics shall
not subcontract to a Third Party any of the work entrusted under this Quality
Agreement, without the GNE Quality Unit’s prior written approval.
	 
	 	7.8.2	 	In the event that SurModics, with the written permission of the GNE Quality
Unit, sub-contracts any operation under this Quality Agreement to a Third Party,
SurModics shall ensure that it enters into a written agreement with the sub-contractor
that sets out the respective technical and quality responsibilities of each party [*].
	 
	 	7.8.3	 	SurModics may use contract laboratory testing facilities to support the
testing of the Product. SurModics shall only use testing facilities that have been
approved by the SurModics Quality Unit per SurModics’ procedures. Quality Agreements
between SurModics and those facilities must be in place.

	7.9	 	QA Reserve Samples

	 	7.9.1	 	SurModics shall maintain and inspect the reserve samples as required per cGMP
regulations.
	 
	 	7.9.2	 	SurModics shall provide GNE with a summary of the results of the annual
inspection of the reserve samples within [*] of completion. In the event any
deterioration is observed during this inspection, SurModics shall contact GNE in
accordance to the Deviation section 7.2.

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

			
	 
	Version 01
	 	Confidential and Proprietary — Handle Accordingly

 

 

Quality Agreement Number- QAC-SUR-01/01

Page 16 of 21 

	8.0	 	COMPLIANCE AUDITS AND INSPECTIONS
	 
	8.1	 	Compliance Audits

	 	8.1.1	 	SurModics shall permit GNE to conduct preparatory audits for the initiation of
GMP manufacture of the Product, pre-approval audits, for cause audits, and routine and
follow-up compliance audits upon reasonable notice and as mutually agreed upon. Such
audits are intended to assure GNE that SurModics maintains adequate premises, equipment
and staff with sufficient knowledge and experience to carry out all operations relating
to the Products. Such GNE auditors shall conduct themselves in accordance with all
applicable SurModics’ policies and procedures and in such a manner as not to disturb
SurModics operations.
	 
	 	8.1.2	 	SurModics shall allow GNE to review all relevant records required to perform
such audits during normal business hours. The start date and duration of the audits
shall be agreed upon by both Parties. [*]
	 
	 	8.1.3	 	GNE shall provide a written report to SurModics of all observations after the
completion of the audit.
	 
	 	8.1.4	 	SurModics shall provide a written response to GNE within [*] of receipt of the
audit report. Such response shall describe in detail the corrective actions to be
implemented by SurModics. SurModics may request an extension of time to provide a
written response when necessary to prepare a comprehensive corrective action plan.
Such an extension request will propose an appropriate timeframe in which to submit a
final response along with justification for the extension request.
	 
	 	8.1.5	 	For-cause audits, by nature, will require scheduling as soon as possible.
SurModics will make concerted efforts to schedule all such audits promptly.

	8.2	 	Regulatory Authority Inspections

	 	8.2.1	 	SurModics shall [*] notify the GNE Quality Unit of any regulatory authority
contact, including facility inspections, sample requests, and written contact related
to the Product.
	 
	 	8.2.2	 	[*]
	 
	 	8.2.3	 	[*]
	 
	 	8.2.4	 	SurModics shall refer any GNE submission and GNE-specific related queries from
regulatory agencies about the Product to GNE.
	 
	 	8.2.5	 	Any deficiencies noted during a GNE territory regulatory authority inspection
of SurModics premises, which relate directly or indirectly to the manufacturing,
testing, storage, or quality systems related to the Product, must be brought to the
attention of the GNE Quality Unit within [*].
	 
	 	8.2.6	 	SurModics shall secure GNE’s written agreement prior to making any commitments
to a regulatory authority regarding the Product.

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

			
	 
	Version 01
	 	Confidential and Proprietary — Handle Accordingly

 

 

Quality Agreement Number- QAC-SUR-01/01

Page 17 of 21 

	 	8.2.7	 	SurModics shall provide GNE a redacted copy (i.e., redacted for information
pertaining to other products) of any regulatory inspection report related to the
Product and SurModics’ response to the inspection reports.

	8.3	 	Regulatory Agency Contacts

	 	8.3.1	 	[*] SurModics shall promptly provide GNE with a copy of any regulatory
correspondence relevant to the Product.
	 
	 	8.3.2	 	GNE shall notify SurModics [*] in writing of any regulatory issues that GNE
knows shall impact SurModics’ ability to manufacture the Product.
	 
	 	8.3.3	 	SurModics shall maintain a Drug Master File (DMF) for their facilities and
allow GNE to reference such files upon request. SurModics shall inform the GNE Quality
Unit in writing any time the DMF is updated (i.e., a new product introduction).
	 
	 	8.3.4	 	GNE shall have sole authority for preparing and filing any regulatory
submissions per section 5.1 of License and Option Agreement.
	 
	 	8.3.5	 	GNE shall have sole authority, as between the parties, for filing applicable
reports to regulatory agencies, such as Field Alerts and Biological Product Deviation
Reports related to the Product.
	 
	 	8.3.6	 	Regulatory reporting may be required for problems such as stability failures,
out of specification results, Significant Deviations, product complaints, or adverse
events for the Product. When requested by GNE, SurModics shall work collaboratively
with GNE for filing any such report thought to be due to operations conducted by
SurModics. Investigations at SurModics shall be conducted in accordance with
regulatory reporting requirements. GNE and SurModics shall mutually agree upon a
timeframe for completion of the investigation on a case-by-case basis.
	 
	 	8.3.7	 	Regardless of which Party receives the initial contact or inquiry from a GNE
territory regulatory authority regarding the Product, such receiving party will [*]
inform the other party. GNE and SurModics shall agree, on a case-by-case basis, which
party shall respond to such contact/inquiry. All correspondence with a GNE territory
regulatory authority regarding the Product will be shared with GNE prior to it being
sent to the GNE territory regulatory authority. Copies of all correspondence by one
party shall be provided to the other party.

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

			
	 
	Version 01
	 	Confidential and Proprietary — Handle Accordingly

 

 

Quality Agreement Number- QAC-SUR-01/01

Page 18 of 21

Genentech, Inc. 

APPENDIX I: — Glossary 

Capitalized terms used but not defined herein shall have the meanings set forth in the License
Agreement or the MSA. As used in this Quality Agreement, the following terms, whether used in the
singular or the plural, shall have the meanings set forth in this Article

	 	 	 
	Word/Phrase	 	Meaning
	 
	 	 
	Analytical Method:

	 	A document describing the procedure
for sample and standard
preparation, instrument parameters,
system suitability requirements (as
necessary), testing, calculation
and reporting of results.
	 
	 	 
	Annual Report:

	 	Annual Reports are annual updates
submitted to the FDA after an IND
goes into effect (ref.: 21 CFR
312.33) or a New Drug Application
or Biological License Application
is approved (ref.: 21 CFR 314.81).
	 
	 	 
	Audit:

	 	An appraisal that determines the
degree of adherence to pre-defined
criteria and results in a judgment.
Examples are audits of systems and
documentation. Audits are typically
performed by someone not involved
in the activity being audited in
order to give the audit a degree of
independence.
	 
	 	 
	Batch or Lot:

	 	A specific quantity of a drug or
other material that is intended to
have uniform character and quality,
within specified limits, and is
produced according to a single
manufacturing order during the same
cycle of manufacture.
	 
	 	 
	Quality Control Master Document
(QCMD)/Certificate of Analysis
(COA):

	 	 The Quality Control Master Document
 is equivalent to a Certificate of
Analysis is the listing of all
tests performed to release a batch
and the results.
	 
	 	 
	Deviation:

	 	Event in the manufacturing process,
testing and/or support system that
is outside of approved operating
parameters, the Product license,
approved procedures, policies,
standards, or specifications, or a
departure from accepted cGMP’s.
	 
	 	 
	Final Drug Product:

	 	A finished dosage form, for
example, tablet, capsule, solution,
etc., that contains an active drug
ingredient generally, but not
necessarily, in association with
inactive ingredients. The term also
includes a finished dosage form
that does not contain an active
ingredient but is intended to be
used as a placebo.
	 
	 	 
	Field Alert or Biological Product 

Deviation Report:

	 	 All drug manufacturers with
approved New Drug Applications or
Biological License Applications are
required to submit Field Alert
Reports or Biological Product
Deviation Reports, respectively, to
the FDA if they find any
significant problems with an
approved drug (ref.: 21 CFR 314.81
or 600.14).
	 
	 	 
	Good Manufacturing Practice (GMP)

 or  cGMP:

	 	That part of quality assurance
aimed at ensuring that products are
consistently manufactured to a
quality appropriate to their
intended use, the regulations for
which are encoded in the US Code of
Federal Regulations, Title 21,
Sections 210, 211, 600 and the EU
Commission Directive 2003/94/EC
(the ‘GMP Directive’).

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

			
	 
	Version 01
	 	Confidential and Proprietary — Handle Accordingly

 

 

Quality Agreement Number- QAC-SUR-01/01

Page 19 of 21

Genentech, Inc. 

	 	 	 
	Word/Phrase	 	Meaning
	 
	 	 
	In-Process Material:

	 	Any material fabricated,
compounded, blended, or derived by
chemical reaction that is produced
for, and used in, the preparation
of the Drug Product.
	 
	 	 
	Lot
Number or Batch Number:

	 	 Any distinctive combination of
letters, numbers, or symbols, or
any combination of them, from which
the complete history of the
manufacture, processing, packing,
holding, and distribution of a
Batch or Lot of Drug Product or
other material can be determined.
	 
	 	 
	Major Change:

	 	A change that may impact the
Product Quality or validated
status, and/or may require
regulatory action (for example,
changes requiring an Annual Report
or pre-approval submission).
	 
	 	 
	Minor Change:

	 	A change that does not impact the
validated status, Product Quality,
or Product License.
	 
	 	 
	Master Batch Production Record

(MBPR):

	 	 A pre-approved record that includes
the formulation and describes the
procedure to be followed when
manufacturing and/or packaging
Products. Once approved the MBPR is
reproduced in a controlled manner
and the reproduction is used to
record the actual processing of
each batch. This reproduced record
is referred to as a production or
batch record or batch ticket.
	 
	 	 
	Quality:

	 	The totality of features and
characteristics of a product or
service that affect its ability to
satisfy a given need. Essential
elements of Product quality are the
identity, strength, purity, potency
and safety. These elements are
primarily controlled by Testing
Monographs and Master Processing
Records.
	 
	 	 
	Quality Assurance (QA):

	 	The sum total of the organized
arrangements made with the purpose
of ensuring that the product meets
the specifications and is of the
quality required for its intended
use and shall specifically include,
without limitation, all activities
as set forth in this Quality
Agreement.
	 
	 	 
	Quality Control (QC):

	 	The sampling,
specification-setting, testing,
documentation and analytical
procedures that provide independent
results of required tests, which
contribute to the evaluation of the
quality of a material.
	 
	 	 
	Quality Unit

	 	The organizational entity, at
either GNE or SurModics, that has
been identified to the other party
as having responsibility for
activities or approvals described
in this Quality Agreement.
	 
	 	 
	Raw Data:

	 	Any original laboratory worksheets,
records, memoranda, note, document,
or exact copies thereof, which are
the result of original observations
that are necessary for
reconstruction and evaluation of
processing, Quality Control or
Quality Assurance activities. Raw
data may include photographs,
microfilm or microfiche copies,
computer printouts, magnetic media,
including dictated observations,
and recorded data from automated
instruments.
	 
	 	 
	Recall:

	 	Tracing and recovery, as far as
possible, of every item of a
particular batch or of several
batches of finished products after
they have left the manufacturer.

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

			
	 
	Version 01
	 	Confidential and Proprietary — Handle Accordingly

 

 

Quality Agreement Number- QAC-SUR-01/01

Page 20 of 21

Genentech, Inc. 

	 	 	 
	Word/Phrase	 	Meaning
	 
	 	 
	Reprocessing:

	 	The repeating of an individual
step, as identified in a relevant
SOP, in order to fulfill the
intended purpose of that step which
was either completed or not
completed originally, and to bring
the Product into conformance with
specifications.
	 
	 	 
	Reworking:

	 	The repeating of one or more step
within the process or the
performance of any additional
process steps not covered in
approved license in order to bring
the Product into conformance with
specifications.
	 
	 	 
	Shelf Life:

	 	The period of time during which the
Product is designed to meet all
registered safety, efficacy and
quality requirements if stored in
the prescribed manner. The re-test
and/or expiry date are calculated
by adding this period of time to
the date of manufacture (with or
without rounding to the end of the
calculated month).
	 
	 	 
	Specification:

	 	A formally approved document
listing the tests, Analytical
Methods and acceptance criteria
specific to material. It is used to
determine the Quality of a
material.
	 
	 	 
	Standard
Operating Procedure (SOP):

	 	  A document, approved by appropriate
management, describing stepwise
procedures for compliance with a
regulation, policy or system.
Compliance with an SOP is required,
and Deviations must be documented.

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

			
	 
	Version 01
	 	Confidential and Proprietary — Handle Accordingly

 

 

SurModics/GNE Quality Agreement

21 of 21 

Genentech, Inc. 

APPENDIX II: — Change History Log

	 	 	 
	Revision #	 	Description of, and Rationale for Changes
	 
	 	 
	1.0

	 	New Quality Agreement

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

			
	 
	Version 01
	 	Confidential and Proprietary — Handle Accordingly

 

 

CONFIDENTIAL

EXHIBIT B

[*]

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

 

 

CONFIDENTIAL

EXHIBIT C

SURMODICS PATENTS

[*]

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

 

 

CONFIDENTIAL

EXHIBIT D

FORM OF FEASIBILITY STUDY

	I.	 	Introduction

This Feasibility Study, dated as of [INSERT DATE], describes the general responsibilities and work
to be performed by Genentech and SurModics in the development of Microparticles [*]
incorporating a molecule [*]. The Feasibility Study includes (a) a description of the
specific activities to be performed by Genentech and SurModics [*], (b) a description of
the SurModics Project Deliverables to be provided to Genentech, and (c) a Program Budget. This
Feasibility Study shall be conducted pursuant to the terms of the License and Development Agreement
between Genentech and SurModics dated as of October 5th, 2009 (the “License
Agreement”).

	II.	 	Scope
	 
	 	 	[DESCRIBE THE SCOPE OF THE FEASIBILITY STUDY HERE]
	 
	III.	 	Objective
	 
	 	 	[DESCRIBE THE OBJECTIVE OF THE FEASIBILITY STUDY HERE]
	 
	IV.	 	General Areas

[*]

	V.	 	Responsibilities

	 	1.	 	SurModics
	 
	 	 	 	[Describe SurModics’ responsibilities here]
	 
	 	2.	 	Genentech
	 
	 	 	 	[Describe Genentech’s responsibilities here]

	VI.	 	Deliverables

[*]

	VII.	 	Plan of Work
	 
	 	 	[*]     

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

 

 

CONFIDENTIAL

	VIII.	 	Business Section

	 	1.	 	Work plan schedule
	 
	 	 	 	[*]
	 
	 	2.	 	Program Budget
	 
	 	 	 	[*]

	IX.	 	General Terms.
	 
	 	 	The Parties expressly acknowledge and agree that the provisions of the License Agreement
are incorporated by reference herein, or by their terms otherwise apply hereto, and further
agree that such provisions shall be given full effect in interpreting and enforcing this
Feasibility Study. In the event of any inconsistency between this Feasibility Study and
the License Agreement, the License Agreement shall control. This Feasibility Study may be
executed (by facsimile or otherwise) in one or more counterparts, each of which shall for
all purposes be deemed an original and all of which shall constitute one and the same
agreement.

*******

IN WITNESS WHEREOF, the Parties have executed this Feasibility Study as of the date first set forth
above.

	 	 	 	 	 	 	 	 	 
	GENENTECH, INC.	 	SURMODICS, INC.	 	 
	 
	 	 	 	 	 	 	 	 
	By:

	 	 	 	By:	 	 	 	 
	 

	 	 

	 	 	 	 

	 	 
	 
	 	 	 	 	 	 	 	 
	Name:

	 	 	 	Name:	 	 	 	 
	 

	 	 

	 	 	 	 

	 	 
	 
	 	 	 	 	 	 	 	 
	Title:

	 	 	 	Title:	 	 	 	 
	 

	 	 

	 	 	 	 

	 	 

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

 

 

CONFIDENTIAL

EXHIBIT E

Genentech’s requirements for Phase I/II GMP manufacturing

[*]

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

 

 

CONFIDENTIAL

EXHIBIT F

Press Release

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

 

 

EXHIBIT F

FOR IMMEDIATE RELEASE

SurModics Enters Ophthalmic License and Development Agreement with Roche and Genentech

Includes Development and Commercialization of a Sustained Drug Delivery
 Formulation of Lucentis® and Potentially Other Genentech Compounds

EDEN PRAIRIE, Minnesota — October 6, 2009 — SurModics, Inc. (Nasdaq: SRDX), a leading provider of
drug delivery and surface modification technologies to the healthcare industry, announced today
that it has signed a License and Development Agreement with Roche (SIX: RO, ROG; OTCQX: RHHBY) and
Genentech, Inc., a wholly-owned member of the Roche Group. Under this agreement, Roche and
Genentech have obtained an exclusive license to use SurModics’ proprietary biodegradable
microparticles drug delivery system to develop and commercialize a sustained drug delivery
formulation of Lucentis® (ranibizumab injection). The agreement further provides Roche and
Genentech with opportunities to develop additional compounds for the treatment of ophthalmic
diseases.

Under the terms of the agreement, SurModics will receive an up-front licensing fee of $3.5 million.
In addition, SurModics could be eligible to receive up to approximately $200 million in fees and
milestone payments in the event of the successful development and commercialization of multiple
products. Roche and Genentech will pay SurModics for its development services and have the right to
obtain manufacturing services from SurModics. Also, SurModics will receive undisclosed royalties on
product sales.

“This agreement represents yet another major advancement toward realizing our strategic vision of
developing technologies that address important clinical needs in the large and growing
ophthalmology market,” said Bruce Barclay, president and CEO of SurModics. “We believe that
partnering with Genentech, among the world’s largest and most prominent biotechnology companies and
an established market leader in ophthalmology, serves to validate our critically enabling
technologies. The agreement,

 

 

which includes Lucentis and potentially other products, addresses a wide range of ophthalmic
diseases and leverages our expertise and technology platforms in ophthalmology, employs our
proprietary biodegradable microparticles drug delivery system from SurModics Pharmaceuticals, and
will utilize our new world-class cGMP manufacturing facility in Birmingham, Alabama.”

Barclay added, “This agreement has the opportunity to provide both near- and long-term value to
SurModics’ shareholders. The combination of the up-front payment, R&D and manufacturing fees and
contingent milestone payments underscore the unique advantages and power of our business model. The
prospect of developing a sustained delivery formulation for a known, approved and highly successful
drug in Lucentis, is a tremendous opportunity for SurModics.”

Live Webcast

SurModics will host a webcast at 10:00 a.m. ET (9:00 a.m. CT) today to discuss the license and
development agreement. To access the webcast, go to the investor relations portion of the Company’s
website at www.surmodics.com, and click on the corresponding webcast icon. If you do not have
access to the Internet and want to listen to the audio or participate in the conference call by
phone, dial 877-941-2332 (conference ID# 4167942). A replay of this conference call will be
available by dialing 800-406-7325 and entering the previously stated conference call ID. The audio
replay will be available beginning at noon CT on Tuesday, October 6, until noon CT on Tuesday,
October 13.

About Lucentis

Lucentis® is a vascular endothelial growth factor (VEGF) inhibitor approved by the U.S. Food and
Drug Administration (FDA) for the treatment of neovascular (wet) age-related macular degeneration
(AMD). Lucentis is the only FDA-approved therapy for wet AMD, which in clinical trials showed an
improvement in vision of three lines or more on the study eye chart in up to 41 percent of patients
at two years.

 

 

Lucentis is designed to bind to and inhibit VEGF-A, a protein that is believed to play a critical
role in the formation of new blood vessels (angiogenesis) and the hyperpermeability (leakiness) of
the vessels.

Lucentis was discovered at Genentech and is being developed by Genentech and the Novartis
Ophthalmics Business Unit for diseases or disorders of the eye. Genentech retains commercial rights
in the United States and Novartis has exclusive commercial rights for the rest of the world.

Lucentis is a prescription medication given by injection into the eye. Lucentis has been associated
with detached retina and serious eye infection and should not be used in patients who have an
infection in or around the eye. Increases in eye pressure have been seen within one hour of an
injection. Although uncommon, conditions associated with eye- and non-eye-related blood clots
(arterial thromboembolic events) may occur. Serious side effects included inflammation inside the
eye and, rarely, effects related to the injection procedure such as cataract. The most common
non-eye-related side effects were nose and throat infection, headache, and respiratory and urinary
tract infections. The most common eye-related side effects were the feeling that something is in a
patient’s eye, and increased tears. If a patient’s eye becomes red, sensitive to light, painful, or
has a change in vision, they should seek immediate care from their eye doctor.

Please see the Lucentis Full Prescribing Information on http://www.gene.com.

 

 

About SurModics, Inc. 

SurModics’ vision is to extend and improve the lives of patients through technology innovation. The
Company partners with the world’s foremost medical device, pharmaceutical and life science
companies to develop and commercialize innovative products that result in improved diagnosis and
treatment for patients. Core offerings include: drug delivery technologies (coatings,
microparticles, nanoparticles, and implants); surface modification coating technologies that impart
lubricity, prohealing, and biocompatibility capabilities; and components for in vitro diagnostic
test kits and specialized surfaces for cell culture and microarrays. SurModics is headquartered in
Eden Prairie, Minnesota and its SurModics Pharmaceuticals subsidiary is located in Birmingham,
Alabama. For more information about the Company, visit www.surmodics.com. The content of SurModics’
website is not part of this release or part of any filings the Company makes with the SEC.

Safe Harbor for Forward Looking Statements

This press release contains forward-looking statements. Statements that are not historical or
current facts, including statements about beliefs and expectations, such as our expectations about
our pipeline, the potential of biodegradable microparticles in combination with Lucentis or other
compounds as a treatment for retinal diseases, are forward-looking statements. Forward-looking
statements involve inherent risks and uncertainties, and important factors could cause actual
results to differ materially from those anticipated, including the following: (1) realizing the
full potential benefits of the Company’s agreement with Genentech requires the development of new
products and applications of technology, and the successful build-out of our Alabama facility in
compliance with current Good Manufacturing Practice and other regulations; (2) our reliance on
third parties (including our customers and licensees) and their failure to successfully develop,
obtain regulatory approval for, market and sell products incorporating our technologies may
adversely affect our business operations and our ability to realize the full potential of our
pipeline; (3) costs or difficulties relating to the integration of the businesses of SurModics
Pharmaceuticals, and the drug delivery assets and collaborative programs acquired from PR
Pharmaceuticals, Inc., with SurModics’ business may be greater than expected and may adversely
affect the Company’s results of operations and financial condition; (4) developments in the
regulatory environment, as well as market and economic conditions, may adversely

 

 

affect our business operations and profitability; and (5) other factors identified under “Risk
Factors” in Part I, Item 1A of our Annual Report on Form 10-K for the fiscal year ended September
30, 2008, and updated in our subsequent reports filed with the SEC. These reports are available in
the Investors section of our website at www.surmodics.com and at the SEC website at www.sec.gov.
Forward-looking statements speak only as of the date they are made, and we undertake no obligation
to update them in light of new information or future events.

Contact

SurModics, Inc.

Phil Ankeny, Senior Vice President and Chief Financial Officer

(952) 829-2700exv10w2

Exhibit 10.2

MASTER SERVICE AGREEMENT

by and between

Genentech, Inc.,

F. Hoffmann-La Roche, Ltd.

and

SurModics, Inc.

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED
WITH RESPECT TO THE OMITTED PORTIONS.

 

 

MASTER SERVICE AGREEMENT

by and between

Genentech, Inc. and SurModics.

THIS MASTER SERVICE AGREEMENT (the “MSA”) is entered into as of the 5th day of October
2009 (“Effective Date”) by and between Genentech, Inc., a Delaware corporation, with offices
located at 1 DNA Way, South San Francisco, CA 94080 (“GNE”) and F. Hoffmann-La Roche, Ltd.,
Grenzacherstrasse 124, CH 4070 Basel, Switzerland (“Roche”) (GNE and Roche together
referred to as “Genentech”) and SurModics, Inc. a Minnesota corporation with a principal place of
business at 9924 West 74th Street, Eden Prairie, MN 55344 (SurModics, Inc. together with
its Affiliates hereinafter referred to as “SurModics”) (each individually a “Party” and
collectively, the “Parties”).

RECITALS

WHEREAS, the Parties have entered into a License and Development Agreement effective as of the date
hereof (the “License Agreement”); and

WHEREAS, as part of the License Agreement, Genentech desires to purchase from SurModics, and
SurModics desires to supply to Genentech, Product and Raw Materials (as hereinafter defined) in the
Territory (as hereinafter defined) pursuant to the terms set forth herein.

NOW, THEREFORE, in consideration of the premises and the undertakings of the Parties hereinafter
set forth, the Parties agree as follows:

ARTICLE 1

DEFINITIONS

     Capitalized terms used but not defined herein shall have the meanings set forth in the License
Agreement. As used in this MSA, the following terms, whether used in the singular or the plural,
shall have the meanings set forth in this Article:

1.1 “Acceptance Criteria” shall be defined in the applicable SOW.

1.2 “Acquisition Cost” is defined in Section 13.3.4(b).

1.3 “Approved Suppliers” is defined in Section 5.5.2.

1.4 “BLA” means a Biologics License Application and amendments thereto filed pursuant to the
requirements of the FDA, as defined in 21 C.F.R. § 600 et seq., for FDA approval of a therapeutic
biological product.

1.5 “Decommissioning” is defined in Section 13.3.4.

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED
WITH RESPECT TO THE OMITTED PORTIONS.

 

 

1.6 “EMEA” means the European Union European Medicines Evaluation Agency, or any successor agency.

1.7 “European Union” means the countries of Austria, Belgium, Cyprus, Czech Republic, Denmark,
Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg,
Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Switzerland, Sweden,
United Kingdom and any additional countries that may subsequently become members of the European
Union.

1.8 “Facility” means the SurModics’ manufacturing facility at the location specified under the
applicable SOW, or such other manufacturing facility of SurModics as Genentech may approve in
writing.

1.9 “FDA” means the United States Food and Drug Administration, or any successor agency thereto.

1.10 “GNE Materials” means any physical embodiments, supplies or materials provided to SurModics by
or on behalf of GNE in connection with the Services, including the Compounds.

1.11 “Good Manufacturing Practices”, “GMP” or “cGMP” means current Good Manufacturing Practices
pursuant to the U.S. Food, Drug and Cosmetic Act and any U.S. regulations found in Title 21 of the
U.S. Code of Federal Regulations (including Parts 11, 210 and 211) and other regulations, policies,
or guidelines, as applicable to the Manufacture of Products hereunder.

1.12 “Joint Management Team” or “JMT” is defined in Section 3.2.

1.13 “Manufacture,” “Manufactured” or “Manufacturing” means, except as otherwise provided in a SOW,
the manufacture, inspection, storage and/or packaging of Product.

1.14 “Manufacturing Documentation” means all data, documents and records describing or otherwise
related to the Manufacturing Process (or any part thereof) provided to SurModics by or on behalf of
GNE or provided to GNE by or on behalf of SurModics as required by, and in connection with, this
MSA or the Quality Agreement [*].

1.15 “Manufacturing Process” means the process for the Manufacture of Product pursuant to this MSA,
the Quality Agreement and the Manufacturing Documentation, as such process may be changed from time
to time in accordance with this MSA.

1.16 “Manufacturing Joint Steering Committee” or “Manufacturing JSC” is defined in Section 3.3.

1.17 “Non-Conforming” means, (a) with respect to a Product, a Product Manufactured by SurModics
pursuant to this MSA that (i) fails to conform to the Specifications or Acceptance Criteria; or
(ii) was not Manufactured in compliance with the Specifications,

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED
WITH RESPECT TO THE OMITTED PORTIONS.

2

 

cGMPs, the Manufacturing Documentation, the Quality Agreement, the Standard Operating Procedures
and all applicable laws and (b) with respect to any other deliverable, a deliverable that fails to
conform to the requirements of this MSA or the Quality Agreement.

1.18 “PFSB” means the Japan Pharmaceutical and Food Safety Bureau of the Ministry of Health,
Labour, and Welfare and its review agency, the Pharmaceutical and Medical Devices Agency, or any
successor agency thereto.

1.19 “Product” means the Licensed Product or the SurModics Raw Material specified in the applicable
SOW.

1.20 “Quality Agreement” means that certain quality agreement entered into by the Parties, as the
same may be amended from time to time by the Parties.

1.21 “Raw Materials” means the materials used in the Manufacturing Process, including, but not
limited to, chemicals, reagents, chromatography resins, and filters; and any materials used for
testing, validation, qualification or other activities required to implement and support the
Manufacturing Process at the Facility. Raw Materials include the SurModics Raw Materials.

1.22 “Regulatory Authority” means any national (e.g., the FDA), supra-national (e.g., the EMEA),
regional, state or local regulatory agency, department, bureau, commission, council or other
governmental entity, in any jurisdiction of the world, involved in the granting of Regulatory
Approval.

1.23 “Services” means the activities in support of GXP compliant Development and/or Manufacturing
of a Product, including: manufacturing, process development and scale-up, bulk production and
fill/finish work associated with the supply of such Product for research, preclinical and clinical
studies and related quality assurance and quality control activities, packaging, storage,
stability, release testing, and/or quality control services and other related services provided by
SurModics to GNE with respect to such Product under this MSA, as further defined in the applicable
SOW.

1.24 “Specifications” are defined in the applicable SOW and/or Quality Agreement.

1.25 “Standard Operating Procedures” or “SOPs” means the standard operating procedures established
by SurModics generally.

1.26 “Term” is defined in Section 13.1.

1.27 “United States” means the United States of America, its territories and possessions, Guam and
the Commonwealth of Puerto Rico.

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED
WITH RESPECT TO THE OMITTED PORTIONS.

3

 

ARTICLE 2

RELATED AGREEMENTS AND EXHIBITS

2.1 Statements of Work.

     2.1.1 In General. A description of the Services to be performed and the Product to be
Developed and/or Manufactured and supplied by SurModics for each project agreed upon by the Parties
(each, a “Project”) shall be contained in individual appendices to this MSA (each, a “SOW”, a form
of which is attached hereto as Exhibit A), executed by a duly authorized officer of each Party.
Each SOW shall include all applicable process requirements, a list of any deliverables, regulatory
compliance requirements, the anticipated period of performance, a Program Budget for Services [*],
delivery schedules, [*], and quantity requirements. The Parties agree to negotiate, in good faith,
payment criteria for each task in a SOW under a Program Budget [*]. Each SOW shall be subject to
and deemed a part of this MSA. No SOW, or any modification thereto, shall be attached to or made a
part of this MSA without first being executed by the Parties hereto in a writing which specifically
references this MSA. To the extent any terms set forth in a SOW conflict with the terms set forth
in this MSA, the terms of this MSA shall control unless otherwise expressly agreed by the Parties
in such SOW.

     2.1.2 Changes to a SOW. Except as otherwise provided in Section 5.8 below for changes related
to regulatory requirements, if GNE reasonably determines that modifications to a SOW are required,
GNE shall communicate those proposed modifications to SurModics and the reasons therefore in
writing, and the Parties shall negotiate in good faith to implement mutually acceptable
modifications in an amended SOW, including any change in the timelines, budget and fees.

     2.1.3 Change Order Process.

          (a) Any change in the scope of work, timeline, the corresponding Program Budget, and/or the
Project specific compensation terms or payment schedule for an individual Project will require a
written amendment to the applicable SOW (“Change Order”). For clarity, Change Orders amend only
the applicable SOW and not the terms and conditions of this MSA. Each Change Order will detail the
requested changes to the applicable scope of work, timeline, corresponding Program Budget, Project
specific compensation terms, or payment schedule. Both Parties agree to act in good faith and
promptly when considering a Change Order requested by the other Party.

          (b) If the scope of a Project does not change but SurModics must perform additional work in
order to perform the Services for the Project in accordance with the applicable SOW (i.e. in
compliance with the Manufacturing Process), and such additional work is due to circumstances
primarily within SurModics’ control, SurModics will perform the additional work at no charge to
GNE. For clarity, and except as set forth in Section 6.2.2 below, Genentech will be responsible
for the cost of any additional GNE Material required in the performance of such additional work,.
The Parties agree that termination of either a Project or some of the Services to be performed in
furtherance of the completion of a Project, in each case before the completion of

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED
WITH RESPECT TO THE OMITTED PORTIONS.

4

 

the Project, are changes in Project scope, and the affected Project budget and payment
schedule shall be modified accordingly.

2.2 Quality Agreement. The Parties have entered into a Quality Agreement effective as of the date
hereof (attached hereto as Exhibit B) that governs the responsibilities related to quality systems
and defines quality requirements for the Product, including quality control, testing and release of
the Product.

ARTICLE 3

MANAGEMENT OF PROJECT

3.1 In General. Each Party will be responsible for its internal decision making process and for
reasonably informing the other Party of decisions made affecting the Services in a regular and
timely manner. Without limiting the foregoing, the Parties shall establish the joint team set
forth herein to advise the Parties and execute on certain matters relating to the Services under
this MSA.

3.2 Joint Management Team (JMT)

     3.2.1 Formation. Within thirty (30) days of the Effective Date, the Parties will establish a
joint management team (the “Joint Management Team” or “JMT”) to oversee and manage the Services
under each SOW. If there are multiple SOWs hereunder the Parties may specify separate JMT’s in the
applicable SOW’s, and each reference herein to “the JMT” or “the Joint Management Team” shall be a
reference to the JMT applicable to each SOW. The Joint Management Team shall consist of such
number of representatives of each Party as are reasonably necessary to accomplish the goals of the
SOW. Each Party shall promptly notify the other Party of its initial appointees to each JMT.
Subject to Section 3.2.2 (a), each Party shall be free to change its JMT representatives effective
upon written notice to the other Party.

     3.2.2 Management Team Leader.

          (a) Appointment. Within thirty (30) days of the Effective Date, each Party shall appoint an
employee to act as a primary contact for such Party in connection with this MSA, including without
limitation, all SOWs and any Services and other activities conducted under any Project (each, a
“Management Team Leader”). The GNE Management Team Leader will be responsible for overall
leadership of the Joint Management Team. A Party may replace its Management Team Leader at any
time by providing written notice of the change to the other Party: provided, SurModics shall have
good faith consultation with GNE prior to the change and provided further, any such new
representative shall be no less qualified than the representative being replaced and shall be
mutually agreed to by the Parties. GNE shall not unreasonably withhold its agreement to any such
new representative proposed by SurModics.

          (b) Responsibilities. The Joint Management Team, led by the Management Team Leaders, will be
responsible for [*]. The Management Team Leaders will dialog regularly
about the progress of the Services and use good faith efforts to resolve any difficult issues

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED
WITH RESPECT TO THE OMITTED PORTIONS.

5

 

regarding the Services addressed by the Joint Management Team as well as facilitate expeditious
resolution of any issues escalated to the Manufacturing JSC.

3.3 Manufacturing Joint Steering Committee (Manufacturing JSC).

     3.3.1 Formation. Within thirty (30) days of the Effective Date, the Parties will establish a
Manufacturing Joint Steering Committee (the “Manufacturing Joint Steering Committee” or
“Manufacturing JSC”) to give direction and advice to the Joint Management Team (or Teams if more
than one Project is being worked on by SurModics) relating to the Services. The Manufacturing
Joint Steering Committee will be made up of at least two senior level members from each Party,
representing functions within each Party directly involved in the Services; provided, however, that
no Party’s representative will serve on both the Manufacturing JSC and either a JMT or JSC
established under the License Agreement. Either Party may replace any or all of its
representatives at any time by providing written notice to the other Party.

     3.3.2 Responsibilities. The Manufacturing Joint Steering Committee will be responsible for
[*].

3.4 Meetings.

     3.4.1 JMT Meetings. The JMT shall meet at least monthly during the course of any SOW. These
meetings may be called on a more frequent basis as reasonably determined by the GNE Management Team
Leader. These meetings may be held via teleconference or videoconference but should be held face
to face at least two times per year, alternating between the Parties facilities or at such other
location as the Parties may otherwise agree. Each Party shall be responsible for all of its own
expenses of traveling to and participating in any of the JMT meetings. SurModics will assume the
project management responsibility for each Project; documenting meetings, maintaining a project
timeline, enabling risk management planning and resource forecasting, and otherwise tracking the
progress of the Services under each Project for the Joint Management Team.

     3.4.2 Manufacturing JSC Meetings. The Manufacturing JSC shall meet at least two (2) times per
year during the term of this MSA. These meetings shall be held face to face, alternating between
the Parties facilities or at such other location as the Parties may otherwise agree. By mutual
agreement of the Parties, meetings may also be held via teleconference or videoconference. Each
Party shall be responsible for all of its own expenses associated with travel to and participating
in any of Manufacturing JSC meetings.

3.5 Decisions.

     3.5.1 In General. The Management Team Leaders will be responsible for making all decisions on
day to day activities that do not materially impact critical milestones, Program Budgets, or supply
of materials. These decisions may be made in the context of discussion at the Joint Management Team; [*].
Notwithstanding the foregoing, either Management Team Leader may
escalate material issues and disputes to the Manufacturing JSC.

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED
WITH RESPECT TO THE OMITTED PORTIONS.

6

 

     3.5.2 GNE Decisions. Notwithstanding anything to the contrary in the License Agreement, this
MSA and/or the Quality Agreement, with respect to issues relating to: (i) interpretation of quality
or cGMPs, (ii) acceptability of validation results, (iii) acceptability of Product testing
(including in-process testing), results or procedures, (iv) disposition of any Product (including
Non-Conforming Product) and/or (v) changes to a Manufacturing Process and/or Specifications, in
each case, [*]. SurModics shall use Commercially Reasonable Efforts to effect any such
implementation in accordance with a timeline approved by GNE. [*]

3.6 Disputes. If the Manufacturing JSC is unable to resolve a material issue or dispute presented
to it, then either Party’s Manufacturing JSC representative may escalate such Dispute to the JSC
established under the License Agreement, and such dispute shall be resolved in accordance with
ARTICLE 3 of the License Agreement.

3.7 Committee Term Limits. Either Party may, at its sole discretion, terminate its participation
on the JMT or the Manufacturing JSC at any time [*] of the Effective Date by providing [*] written
notice to the other Party. Should either Party elect to terminate its JMT or Manufacturing JSC
participation, the Parties will amend the respective decision making and disclosure rights and
obligations enumerated in this Agreement to preserve the Parties’ respective decision making and
disclosure rights and obligations in the absence of participation through the JMT or Manufacturing
JSC.

3.8 No Deliverables. The Parties acknowledge and agree that the Manufacturing JSC under this
Agreement is strictly for the purposes of decision making and governance of the activities
conducted under a SOW to this MSA, and does not in any way include any significant deliverable of
either Party.

ARTICLE 4

SERVICES

4.1 General Obligations. Subject to the terms and conditions set forth in this MSA and the License
Agreement, during the Term, GNE hereby retains SurModics to perform the Services specified in the
SOW(s).

4.2 Compliance with Law; Facility Permits and Licenses. SurModics shall, and shall ensure that its
Project Personnel, perform the Services in accordance with all applicable laws and regulations,
including, without limitation applicable GXPs. SurModics shall be responsible for obtaining and
maintaining all applicable licenses and permits required for it to perform the Services hereunder.

4.3 Manufacturing Facility. Unless otherwise expressly agreed by the Parties in writing (including
in a SOW), all Services shall be performed by SurModics at the Facility or by other SurModics’
personnel at SurModics’ locations. [*]

4.4 Project Personnel. It is understood that GNE is entering into this MSA, each SOW and the
Quality Agreement in reliance on the commitment by SurModics to staff the Facility

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED
WITH RESPECT TO THE OMITTED PORTIONS.

7

 

with managers,
supervisors, engineers, technicians, inspectors, and other personnel including, but not limited to,
temporary employees, consultants and sub-contractors (in accordance with Section 4.5 below), as
SurModics deems necessary, in each case having sufficient technical expertise to perform its
obligations under this MSA and the Quality Agreement (collectively, “Project Personnel”). Without
limiting any other provision of this MSA, so long as such Project Personnel remain employed by
SurModics, SurModics will ensure that such individuals (not specific individuals but individuals
with similar functional expertise) are available to perform the obligations, as appropriate, to be
provided by SurModics hereunder. In addition, SurModics shall ensure that the Management Team
Leader and Project Personnel have read, understood and agreed to be bound by obligations of
confidentiality and non-use at least as restrictive as those applicable to this MSA.

4.5 Subcontracting. SurModics shall not subcontract all or any portion of its obligations under
this MSA without GNE’s prior written approval and in accordance with the Quality Agreement. In the
event of such approval, the applicable subcontract shall be consistent with the terms and
conditions of this MSA. [*]For the avoidance of doubt, SurModics may [*] to the extent such [*]
are under the general supervision of SurModics’ Project Personnel, and have sufficient technical
expertise, and SurModics is responsible to Genentech for their performance.

4.6 [*]

ARTICLE 5

FACILITY MODIFICATIONS, EQUIPMENT, MATERIALS, DOCUMENTATION AND

IMPLEMENTATION

5.1 In General. Modification of the Facility and/or transfer of equipment, materials and/or
processes to be carried out in order to perform the Services at the Facility, are summarized below
and may be further described in detail in a SOW, if applicable.

5.2 [*]

5.3 [*]

5.4 GNE Materials. GNE shall transfer to SurModics the GNE Materials and any Manufacturing
Documentation in Genentech’s Control necessary to perform the Services as specified in the
applicable SOW. Such transfer will be in accordance with the applicable SOW. GNE and SurModics
will make their personnel available at the Facility and/or other facilities to enable the transfer
and implementation of each of the foregoing. Prior to delivery of GNE
Materials to SurModics, GNE shall provide documentation similar to that described in the Quality
Agreement and a Certificate of Analysis or other documentation (i.e. certificate of testing, etc)
as appropriate for the development stage of the GNE Material for SurModics’ review and approval.
SurModics shall approve or reject such documents not more than [*] after receipt thereof, and may
reject such documents only as specifically set forth in the applicable Quality Agreement. Upon
SurModics’ approval of such documents, SurModics shall release GNE Material for delivery to
SurModics and GNE shall deliver the GNE Material to SurModics

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED
WITH RESPECT TO THE OMITTED PORTIONS.

8

 

in accordance with the terms and
conditions of this MSA. The provisions set forth in the Quality Agreement regarding release shall
control the procedures and standards for release. For purposes hereof, “Certificate of Analysis”
means, as further specified in the Quality Agreement, for each shipment of GNE Material, a document
prepared by GNE: (a) listing the Manufacturing date(s) of such GNE Material, and (b) certifying
that all GNE Material in the shipment conform to the specifications and were Manufactured in
compliance with specifications, cGMPs, the Quality Agreement, standard operating procedures and all
applicable laws. The Parties shall from time to time agree upon a format or formats for the
Certificate of Analysis to be used under this MSA.

5.5 Raw Materials & Change Parts.

     5.5.1 Raw Materials. [*] Specifications for the Raw Materials shall be set forth in the
SOW(s).

     5.5.2 [*]

     5.5.3 Testing and Evaluation of Raw Materials. SurModics shall perform all testing and
evaluation of the Raw Materials as required by the applicable SOW, Specifications, Manufacturing
Documentation, cGMPs, the Quality Agreement and Standard Operating Procedures.

     5.5.4 [*]

5.6 Product Documentation. SurModics will maintain and retain true and accurate books, records,
test and laboratory data, validation data, reports and copies of all other information related to
the Services, including all information required to be maintained and retained under the License
Agreement, this MSA, the Quality Agreement or applicable law (including cGMPs) (the “Records”).
SurModics will maintain all Records in separate forms and notebooks to the extent reasonably
possible (i.e., not commingled with other information) and will maintain Records for at least that
period specified in the License Agreement and the Quality Agreement (or longer if required by law).
GNE shall have the right to review the Records at the Facility during the time such Records are
required to be maintained, as part of any audit conducted pursuant to Section 7.2.

5.7 Changes to the Manufacturing Process. Except as otherwise expressly set forth in the Quality
Agreement, in the event that GNE is required by a Regulatory Authority to change the Manufacturing
Process, SurModics shall use Commercially Reasonable Efforts to accommodate such required change,
provided, that if any such change to the Manufacturing
Process renders obsolete or unusable any Raw Materials used to manufacture the Product, and to the
extent such Raw Materials can not be utilized by SurModics for its other manufacturing operations,
GNE shall reimburse SurModics for the documented costs of such materials and disposal costs, if
any.

5.8 Regulatory Requirements for the Manufacturing Process and the Product. In accordance with the
terms of this MSA and the License Agreement, GNE shall be responsible

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED
WITH RESPECT TO THE OMITTED PORTIONS.

9

 

for obtaining and maintaining
all Regulatory Approvals required to Develop and Manufacture Product at the Facility; provided that
SurModics shall use Commercially Reasonable Efforts to timely prepare, assist and enable GNE with
obtaining and maintaining such Regulatory Approvals, including, without limitation, by preparing,
filing and maintaining IND amendments to any existing FDA licenses held by SurModics.

ARTICLE 6

SUPPLY

6.1 In General. During the Term, and subject to the terms and conditions of this MSA and the
License Agreement (including, without limitation, for supply of Licensed Product [*], SurModics
agrees to supply to GNE, and GNE agrees to purchase from SurModics, such amounts of Product and
other deliverables as set forth in the applicable SOW.

6.2 Acceptance of Product and Other Deliverables.

     6.2.1 Acceptance.

          (a) Product. Prior to delivery of Product to GNE, SurModics shall provide Genentech with [*].
Upon GNE’s approval of such documents, GNE shall release the Product for delivery in accordance
with the Quality Agreement, and SurModics shall deliver the Product in accordance with the terms
and conditions of this MSA. The provisions set forth in the Quality Agreement regarding release
shall control the procedures and standards for release. For purposes hereof, “Certificate of
Analysis” means, as further specified in the Quality Agreement, for each shipment of Product, a
document prepared by SurModics: [*]. The Parties shall from time to time agree upon a format or
formats for the Certificate of Analysis to be used under this MSA.

          (b) Other Deliverables. Upon receipt of any deliverable specified in an SOW other than
Products, GNE (or its designee) shall, as appropriate, perform any testing and review required for
such deliverable per any Acceptance Criteria in the SOW, and for the requirements of the Quality
Agreement. Such testing and review will be completed within [*] of its receipt or such other
period of time specified in a SOW.

     6.2.2 Non-Conforming Product. In accordance with Section 7.1 of the Quality Agreement, GNE
will notify SurModics of any claim that Product is Non-Conforming upon GNE discovering such Product
is Non-Conforming, but no later than [*] after receipt of such Product and its associated
Manufacturing Documentation by GNE from SurModics. [*]

     6.2.3 Replacement Product. [*]

6.3 Delivery of Product.

     6.3.1 Shipping; Title.

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED
WITH RESPECT TO THE OMITTED PORTIONS.

10

 

          (a) SurModics shall ship the Product (and any other deliverables) to such destinations chosen
by GNE to the extent that such shipments are permitted by law for SurModics given the regulatory
requirements of the exporting and the importing countries. Unless otherwise requested by GNE,
SurModics shall arrange for the delivery of Product (or such other deliverables) from the Facility
to such permitted destinations by carriers acceptable to, and in accordance with, GNE’s shipping
instructions on [*].

          (b) SurModics will provide customary export documentation, as specified by GNE or by separate
delivery and shipment documentation instructions, together with each shipment of Product (or such
other deliverables). At SurModics’ request, GNE shall assist SurModics with export consultant
expertise regarding shipment of Product. SurModics shall also provide GNE with all relevant
shipping information (e.g., carrier, shipment details, scheduled arrival date, quantity) prior to
or coincident with shipping any Product (or such other deliverables) to GNE. SurModics shall also
provide GNE with all relevant storage and handling instructions for such Product with each shipment
and GNE agrees to comply with such instructions.

          (c) GNE shall be the importer of record of each shipment of Product (or such other
deliverables) shipped to GNE. In conjunction therewith, prior to shipping any Product (or such
other deliverables), GNE shall obtain all appropriate approvals and consents of any governmental
authority necessary for the import, transportation or shipment of such Product (or such other
deliverables).

          (d) Any customs, freight, insurance and other shipping expenses, as well as any special
packaging expense incurred by SurModics prior to delivery to GNE shall be paid by GNE upon delivery
to GNE (or its designee) at the Facility. GNE shall also bear all applicable taxes, duties and
similar charges that may be assessed against the Product (or such other deliverables) after
delivery to GNE (or its designee) at the Facility.

     6.3.2 Storing, Packaging and Shipping Containers. SurModics shall provide sufficient and
suitable cGMP storage facilities that meet the Specifications for storage of Product for a period
of up [*] after release thereof. SurModics shall store, package, label and ship the Product
according to the Specifications, the Quality Agreement, and according to procedures and using
storage containers mutually agreed upon by GNE and SurModics in writing. [*]

ARTICLE 7

QUALITY COMPLIANCE

7.1 Quality Agreement. Both Parties are obligated to adhere to the provisions of the Quality
Agreement and agree that all elements of quality assurance, quality control and the like shall be
governed by the terms and conditions of the Quality Agreement. In the event of a conflict between
this MSA and the Quality Agreement, this MSA shall prevail over those of the Quality Agreement,
with the exception of quality-related matters and provisions that are in violation of cGMPs.

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED
WITH RESPECT TO THE OMITTED PORTIONS.

11

 

7.2 Compliance Audits. Genentech will have the right to perform compliance audits as set forth in
Section 8.1 of the Quality Agreement.

7.3 Responsibility for Recalled Products. GNE shall notify SurModics promptly if any Product
manufactured by SurModics is the subject of a threatened or actual recall, market withdrawal or
correction attributable to any activities conducted by of SurModics. The responsibility for any
such recall shall be as set forth in the Quality Agreement.

ARTICLE 8

CONSIDERATION

8.1 Pricing. [*]

8.2 Invoices. SurModics shall invoice GNE for Services performed under this MSA in accordance with
Section 7.2 of the License Agreement or the applicable SOW. [*]

8.3 Payment Terms. The provisions contained in Section 7.2 and Article 8 of the License Agreement
are hereby incorporated by reference as if set forth herein in full

ARTICLE 9

OWNERSHIP OF INTELLECTUAL PROPERTY, MATERIALS AND EQUIPMENT

9.1 Equipment and Materials. [*]

9.2 Intellectual Property. The provisions contained in Articles 10 and 11 of the License Agreement
are hereby incorporated by reference as if set forth herein in full.

ARTICLE 10

CONFIDENTIALITY

The provisions contained in Article 9 of the License Agreement are hereby incorporated by reference
as if set forth herein in full.

ARTICLE 11

REPRESENTATIONS AND WARRANTIES

11.1 General Representations and Warranties. The provisions contained in Article 13 of the License
Agreement are hereby incorporated by reference as if set forth herein in full. In addition:

     11.1.1 SurModics Representations and Warranties. SurModics represents and warrants that all
Product, at the time of delivery to GNE’s designated carrier, shall: [*].

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED
WITH RESPECT TO THE OMITTED PORTIONS.

12

 

     11.1.2 GNE Manufacturing Representations and Warranties. GNE represents and warrants to
SurModics that: [*].

     11.1.3 Services Warranties SurModics represents and warrants that: (a) the Services shall be
performed and completed in a good and workmanlike manner; and (b) SurModics, and SurModics’
employees and/or subcontractors assigned to perform the Services, are qualified and equipped
therefor, have the requisite expertise and have all rights, licenses, permits and consents
necessary to perform the Services hereunder.

     11.1.4 Compliance with Anti-Corruption Practices. SurModics represents and warrants that
SurModics and its directors, officers, employees and permitted subcontractors will not, directly or
indirectly, pay, promise to pay, or authorize the payment of any money, or give, promise to give,
or authorize the giving of anything of value to any official or employee of any government, or of
any agency or instrumentality of any government (including any official or employee of any
government-controlled hospital or other healthcare organization) in connection with any Services
except in exchange for legitimate services provided by such official, employee, agency, or
instrumentality to achieve the purposes of this MSA. In the event that SurModics learns of any
activities in violation of this Section 11.1.4, it shall immediately notify GNE and provide
detailed information about the nature and extent of such activities.

ARTICLE 12

INDEMNIFICATION, INSURANCE, LIMITATION OF LIABILITY

The provisions contained in Article 14 of the License Agreement are hereby incorporated by
reference as if set forth herein in full.

ARTICLE 13

TERM AND TERMINATION

13.1 Term. This MSA shall commence on the Effective Date and, unless earlier terminated in
accordance with the provisions of this Article 13, shall continue in full force and effect until
terminated by mutual agreement of the Parties (the
“Term”).

13.2 Termination. This MSA may be terminated in accordance with Article 12 of the License Agreement
(in its entirety or as to any SOW). In addition, either Party may terminate any SOW for any
material breach of the MSA or such SOW by the other Party, provided, however, that the nonbreaching
Party shall give the breaching Party written notice detailing such
breach and indicating its intent to terminate, and, if the breaching Party fails to cure or dispute
in good faith, that breach within (a) [*] after receipt of written notice of breach of an
obligation to make a payment under this MSA and (b) [*] after receipt of written notice of any
other breach, or a longer period of time not to exceed [*] if the breaching Party is working
diligently to cure such breach.

13.3 Effect of Expiration or Termination.

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED
WITH RESPECT TO THE OMITTED PORTIONS.

13

 

     13.3.1 In General. In the event of any termination of this MSA, or any SOW to the MSA, the
terms of Sections 12.6, 12.7, and 12.8 of the License Agreement shall apply (as applicable). In
addition:

     13.3.2 Effect of Termination. Following any termination of this MSA, Product or other
deliverables that has been, or is in the process of being, Manufactured as of the date of notice of
such termination (or which result from Manufacturing initiated prior to delivery of such notice),
shall remain subject to the terms and conditions of this MSA, and such terms and conditions shall
continue to survive with respect to such Product.

     13.3.3 Return of Materials. In the event of termination of this MSA or any SOW to this MSA
for any reason, SurModics agrees promptly to surrender and deliver to GNE (a) all applicable GNE
Materials, Product and deliverables, and (b) records, materials, equipment, drawings, documents,
data and any work product of any nature in each case directly pertaining to applicable GNE
Confidential Information, Product, deliverables and/or Genentech Project IP Rights, or Joint
Project IP Rights, excluding original notebooks, and all other materials belonging to GNE, in
SurModics’ possession. Notwithstanding the foregoing, (i) SurModics may retain and continue to use
copies of such records, as required to comply with all applicable laws, and (ii) SurModics’ legal
department may retain one (1) copy of the foregoing, in each case, subject to its continuing
obligation of confidentiality related to this MSA.

     13.3.4 Decommissioning. Upon termination of the License Agreement, this MSA or any SOW for
any reason, unless otherwise provided in this Section 13.3.4, SurModics shall promptly perform the
Decommissioning, taking into account that such actions may be delayed to the extent necessary for
SurModics to fulfill any obligations continuing as of the date of such termination. As used
herein, “Decommissioning” means the process of verifying that all GNE contractual commitments
applicable to such termination have been met, including the requirements related to the return of
information and material set forth in Section 13.3.3. In addition, Decommissioning shall include
the following actions by SurModics:

          (a) Cease and refrain from all Services for GNE applicable to the termination;

          (b) [*]

          (c) Any GNE equipment in SurModics’ possession shall, at GNE’s election and cost, either be
(i) removed and returned to GNE, (ii) removed and destroyed, or (iii) rendered inoperable. In the
event GNE does not elect to have GNE equipment removed and returned to
GNE under 13.3.4(c)(i) herein, at SurModics’ election, SurModics may request GNE enter
negotiations for the sale of such GNE equipment to SurModics prior to GNE making an election under
13.3.4(c)(ii) or 13.3.4(c)(iii).

     13.3.5 Costs Incurred in Decommissioning. Prior to Decommissioning, and during the period of
any Decommissioning, the JMT shall meet, discuss in good faith and agree upon a plan and budget for
such Decommissioning. The actual costs and expenses incurred by SurModics in performing the
activities identified in Section 13.3.4 shall be borne by the Parties as follows:

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED
WITH RESPECT TO THE OMITTED PORTIONS.

14

 

          (a) [*]

          (b) [*]

          (c) [*]

     13.3.6 No Conflict. The foregoing rights and obligations are not meant to limit any rights or
obligations (including other payments or reimbursements due to SurModics) of either Party set forth
in Article 12 of the License Agreement.

     13.3.7 [*]

     13.3.8 Transition of Manufacturing and Supply. Notwithstanding any provision of this MSA to
the contrary, upon an early termination by GNE pursuant to Sections 12.3 or 12.5 of the License
Agreement, or Section 13.2 of this MSA (for SurModics’ material breach or bankruptcy), SurModics
agrees to extend the term of any SOW at GNE’s written request (which shall be at least [*] prior to
the date that this MSA with respect to such SOW would terminate or expire) in order to continue
Manufacturing and Supply of Product to GNE under such SOW for a reasonable period after the date
the MSA as to such SOW would have terminated. If, in connection with a termination of this MSA as
to a SOW, the Parties enter into arbitration in accordance with Article 15 of the License
Agreement, then the effective date of termination for purposes of this Section shall not be earlier
than the final resolution thereof, unless expressly agreed otherwise in writing by the Parties.
GNE shall give SurModics at least [*] prior written notice of the date after which Genentech will
no longer require SurModics to perform the Manufacturing and Supply of Product under such SOW.

13.4 Survival. In addition to provisions that survive pursuant to the License Agreement, the
following provisions shall survive termination of this MSA: Articles 1, 9, 10, 12, 14, and Sections
13.3 and 13.4.

ARTICLE 14

DISPUTE RESOLUTION

The provisions contained in Article 15 of the License Agreement are hereby incorporated by
reference as if set forth herein in full.

ARTICLE 15

MISCELLANEOUS

15.1 In General. The provisions contained in Article 16 of the License Agreement are hereby
incorporated by reference as if set forth herein in full, except that Section 16.3 of the License
Agreement shall not apply and instead the terms of Section 15.2 shall govern this Agreement.

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED
WITH RESPECT TO THE OMITTED PORTIONS.

15

 

15.2 Force Majeure.

     15.2.1 Effect of Force Majeure Event. Neither Party shall be deemed to have breached this
Agreement for failure to perform its obligations under this Agreement to the extent such failure
results from acts of God, earthquakes, fires, floods, embargoes, wars, acts of terrorism,
insurrections, riots, civil commotions or similar events (each a “Force Majeure Event”).

     15.2.2 Notice of Force Majeure. If a Force Majeure Event occurs, the Party unable to perform
shall promptly notify the other Party of the occurrence of such event, and the JMT shall meet (in
person or telephonically) promptly thereafter to discuss in good faith the circumstances relating
thereto and possible ways to mitigate any adverse consequences arising out of the Party’s failure
to perform. The Party unable to perform shall (a) provide reasonable status updates to the other
Party from time to time, (b) use Commercially Reasonable Efforts to mitigate any adverse
consequences arising out of its failure to perform and (c) resume performance as promptly as
possible.

     15.2.3 Recovery from Force Majeure. If a Force Majeure Event prevents SurModics from
Manufacturing or supplying Product under this Agreement, the Parties shall in good faith discuss
changes to scheduling and production to so as to remedy any shortfall, shortage or delay.
SurModics shall use Commercially Reasonable Efforts to accommodate any such changes to scheduling
and production. Notwithstanding the foregoing, in the event the Force Majeure Events affects
SurModics’ other customers, the changes to scheduling and production agreed upon by GNE and
SurModics shall be no less favorable to GNE than those arrangements provided by SurModics to any
other of its customers.

**********

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED
WITH RESPECT TO THE OMITTED PORTIONS.

16

 

IN WITNESS WHEREOF, the Parties hereto have caused this MSA to be executed by their duly
authorized representatives as set forth below.

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	SurModics, Inc.	 	 	 	Genentech, Inc.	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	By:	 	/s/ Bruce J Barclay	 	 	 	By:	 	[*]	 	 
	 	 	 	 	 	 	 	 	 	 	 
	 

	 	Name:
	 	Bruce J Barclay
	 	 
	 	 	 	Name:
	 	[*]
	 	 
	 

	 	Title:
	 	President and CEO
	 	 	 	 	 	Title:
	 	[*]	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	F. Hoffmann-La Roche Ltd	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	By:	 	[*]	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	 	 	 	 	Name:
	 	[*]	 	 
	 

	 	 	 	 	 	 	 	 	 	Title:
	 	[*]	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	By:	 	[*]	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	 	 	 	 	Name:
	 	[*]	 	 
	 

	 	 	 	 	 	 	 	 	 	Title:
	 	[*]	 	 

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

 

 

EXHIBIT A

FORM OF SOW

     This statement of work (the “Exhibit”) is entered into pursuant to the Master Service
Agreement by and between Genentech, Inc. (“Genentech”) and SurModics, Inc. (“SurModics”) dated
<Insert Date> (the “Agreement”), and is effective as of <Insert Date> (the “Exhibit
Effective Date”). Capitalized terms used in this Exhibit and not otherwise defined will have the
same meaning as set forth in the Agreement.

     The parties hereby agree as follows:

     1. Exhibit. This document constitutes an Exhibit to the Agreement, and the Services to be
provided hereunder are subject to the terms and conditions of the Master Service Agreement.

     2. Services and Payments of Fees and Expenses. The specific Services contemplated by this
Exhibit are set forth on the following attachments, which are incorporated herein by reference.
[*]

	 	 	 
	Scope of Work, Timeline and Budget

	 	ATTACHMENT I
	 
	 	 
	Project Specific Compensation Terms

	 	ATTACHMENT II
	 
	 	 
	Change Order Process

	 	ATTACHMENT III

     3. Term. The term of this Exhibit will commence on the Exhibit Effective Date set forth above
and will continue until the Services described on Attachment II are complete or this Exhibit is
terminated in accordance with the Agreement.

     4. Affiliates and Subcontractors. Genentech agrees that SurModics may use the services of its
Affiliates or subcontractors to fulfill SurModics’s obligations under this Exhibit. SurModics will
be responsible to Genentech for the performance of such Affiliates and subcontractors, and all such
performance will be in accordance with the terms and conditions of the Agreement and this Exhibit.

     Subcontractors: [List as needed]

     5. Contact Information

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

 

 

     SurModics Pharmaceuticals

	 	 	 	 	 	 	 	 	 
	Contact Name	 	Site	 	Department	 	Telephone	 	Email
	 

	 	 	 	Proposal Administration	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 

	 	 	 	Project Management	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 

	 	 	 	Business Development	 	 	 	 

     Genentech

	 	 	 	 	 	 	 
	Contact Name	 	Address	 	Telephone	 	Email
	<Manufacturing 

Collaborations Site 

Manager>

	 	1 DNA Way

South San Francisco

CA 94080	 	 	 	 

     6. Amendments. No modification, amendment, or waiver of this Exhibit shall be effective
unless in writing and signed by a duly authorized representative of each party, in accordance with
the Change Order process described in ATTACHMENT III to this Exhibit.

     ACCEPTED AND AGREED:

	 	 	 	 	 
	SurModics Pharmaceuticals:

	 	Genentech, Inc.:	 	 
	 
	 	 	 	 
	 

	 	[Insert Signature Blocks]	 	 

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

 

 

Attachment I: SOW Scope & Budget

INSERT PROPOSAL TASKS HERE

INSERT PROPOSAL TIMELINE HERE

Attachment II: Project Specific Compensation & Terms

	1)	 	Project Budget and Total Compensation

[*]

	2)	 	Payments

     SURMODICS shall submit (email) all invoices for this contract as follows:

Send Attn:

<Genentech Project Contact>

1 DNA Way, MS <#>

South San Francisco, CA 94080

Email / Carbon Copy: <Genentech Relationship Manager>

     All invoices must reference the PO number assigned to this contract. The purchase
order number will be sent via email after the contract is executed.

     Genentech shall forward payment to SurModics as follows:

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

 

 

          Attachment III: Change Order Process

15.3 Scope Change Form (SCF)

Genentech / SurModics Exhibit #______

SOW #______

Change Order Form

          (a)

Change Order Number: [#________]

 

(i) Description of Change(s) and Assumptions

          (b)

           

[*]

          (c)

Total Contract Budget Summary

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Document	 	Effective Date	 	Labor Amount	 	Expenses Amount	 	Total Contract
	Exhibit [#]
	 	 	 	 	 	$	 —	 	 	$	 —	 	 	$	 —	 
	Change Order #1
	 	 	 	 	 	$	—	 	 	$	—	 	 	$	—	 
	Change Order #2
	 	 	 	 	 	$	—	 	 	$	—	 	 	$	—	 
	Change Order #3, etc.
	 	 	 	 	 	$	—	 	 	$	—	 	 	$	—	 
	Total Revised Contract:
	 	 	 	 	 	 	 	 	 	 	 	 	 	$	—	 

          (d) Payment Schedule Revision

     Is
a revised payment schedule required? o YES, It is included as an Attachment.
o NO

     If NO, please explain:

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

 

15.3.2 CHANGE ORDER APPROVAL

	 	 	 
	SurModics

	 	Genentech, Inc.

	 	 	 	 	 	 	 	 	 	 	 
	Print Name:

	 	 
	 	 	Print Name:
	 	 	 	 
	 

	 	 

	 	 
	 	 	 	 

	 	 

	 	 	 	 	 	 	 	 	 	 	 
	Signature:

	 	 	 	 	 	Signature:
	 	 	 	 
	 

	 	 

	 	 
	 	 	 	 

	 	 

	 	 	 
	Approval Date: __/__/_____

	 	Approval Date: __/__/_____

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

 

 

EXHIBIT B

QUALITY AGREEMENT

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

 

 

GOOD MANUFACTURING PRACTICE

TECHNICAL QUALITY AGREEMENT

Between

Genentech, Inc.

(Contract Giver)

and

SurModics, Inc.

(Contract Acceptor)

We the undersigned, agree to the terms, conditions, roles and responsibilities described in
this Quality Agreement and its appendices.

	 	 	 	 	 	 	 
	Genentech, Inc.

	 	 	 	SurModics, Inc.	 	 
	 
	 	 	 	 	 	 
	[*]

	 	9/30/09
	 	/s/ Michael Shoup
	 	10/1/09
	 

	 	 	 	 	 	 
	[*]

	 	DATE
	 	Michael Shoup,
	 	DATE
	[*]

	 	 	 	Vice President Quality, Regulatory and	 	 
	[*].

	 	 	 	Clinical Affairs SurModics, Inc.	 	 
	 
	 	 	 	 	 	 
	 

	 	 	 	[*]
	 	10/1/09
	 

	 	 	 	 	 	 
	 

	 	 	 	[*]
	 	DATE
	 

	 	 	 	[*]	 	 
	 

	 	 	 	[*]	 	 

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

Confidential and Proprietary — Handle Accordingly

 

 

Quality Agreement Number- QAC-SUR-01/01

Page 2 of 21 

TABLE OF CONTENTS

	 	 	 	 	 	 	 	 	 	 	 
	1.0	 	 	GENERAL INFORMATION	 	 	3	 
	 

	 	 	1.1	 	 	Introduction
	 	 	3	 
	 

	 	 	1.2	 	 	Parties to Agreement
	 	 	3	 
	 

	 	 	1.3	 	 	Scope
	 	 	3	 
	 

	 	 	1.4	 	 	Duration, Review and Changes to this Agreement
	 	 	4	 
	 

	 	 	1.5	 	 	Ultimate Quality Responsibility
	 	 	4	 
	 

	 	 	1.6	 	 	Quality Oversight and Person-in-Plant (PIP)
	 	 	5	 
	 

	 	 	1.7	 	 	GMP Commissioning
	 	 	5	 
	 

	 	 	1.8	 	 	Execution of Responsibilities
	 	 	6	 
	2.0	 	 	LICENSES	 	 	6	 
	 

	 	 	2.1	 	 	Establishment License
	 	 	6	 
	 

	 	 	2.2	 	 	Product Licenses
	 	 	6	 
	3.0	 	 	GOVERNING REGULATIONS, RULES AND PROCEDURES	 	 	6	 
	 

	 	 	3.1	 	 	Governing Regulations and Rules
	 	 	6	 
	 

	 	 	3.2	 	 	SurModics Procedures
	 	 	7	 
	4.0	 	 	MATERIALS	 	 	7	 
	 

	 	 	4.1	 	 	Sources
	 	 	7	 
	 

	 	 	4.2	 	 	Suppliers
	 	 	7	 
	 

	 	 	4.3	 	 	Receipt, Testing, Control and Release
	 	 	8	 
	5.0	 	 	PROCESSING OF PRODUCT	 	 	8	 
	 

	 	 	5.1	 	 	Batch Numbering
	 	 	8	 
	 

	 	 	5.2	 	 	Holding, Shipping, and Destruction of Samples
	 	 	8	 
	 

	 	 	5.3	 	 	Reprocessing and Reworking
	 	 	9	 
	6.0	 	 	QUALITY CONTROL TESTING	 	 	9	 
	 

	 	 	6.1	 	 	Analytical Methods
	 	 	9	 
	 

	 	 	6.2	 	 	Quality Control Testing and Approval
	 	 	9	 
	 

	 	 	6.3	 	 	Stability Testing
	 	 	10	 
	 

	 	 	6.4	 	 	Out of Specification (OOS) Quality Control Testing Results
	 	 	10	 
	7.0	 	 	GENERAL QUALITY SYSTEMS	 	 	10	 
	 

	 	 	7.1	 	 	Disposition of Product
	 	 	10	 
	 

	 	 	7.2	 	 	Deviations
	 	 	11	 
	 

	 	 	7.3	 	 	Validation
	 	 	13	 
	 

	 	 	7.4	 	 	Change Control
	 	 	13	 
	 

	 	 	7.5	 	 	New Product Introduction
	 	 	14	 
	 

	 	 	7.6	 	 	Product Complaints, Adverse Events, and other Post-Release Issues
	 	 	14	 
	 

	 	 	7.7	 	 	Document Retention
	 	 	15	 
	 

	 	 	7.8	 	 	Sub-contracting
	 	 	15	 
	 

	 	 	7.9	 	 	QA Reserve Samples
	 	 	15	 
	8.0	 	 	COMPLIANCE AUDITS AND INSPECTIONS	 	 	16	 
	 

	 	 	8.1	 	 	Compliance Audits
	 	 	16	 
	 

	 	 	8.2	 	 	Regulatory Authority Inspections
	 	 	16	 
	 

	 	 	8.3	 	 	Regulatory Agency Contacts
	 	 	17	 
	Appendix I — Glossary	 	 	22	 
	Appendix II — Change History Log	 	 	25	 

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

			
	 	 	 
	Version 01
	 	Confidential and Proprietary — Handle Accordingly

 

 

Quality Agreement Number- QAC-SUR-01/01

Page 3 of 21 

	1.0	 	GENERAL INFORMATION
	 
	1.1	 	Introduction

	 	1.1.1	 	Genentech, Inc. is a leading biotechnology company engaged in the manufacture,
marketing and sales of pharmaceutical products. It operates under one common quality
management system in compliance with current Good Manufacturing Practices (cGMP).
	 
	 	1.1.2	 	SurModics, Inc. is a leading pharmaceutical and biotechnology company engaged
in the contractual manufacture of pharmaceutical and medical device products. It
operates under one common quality management system in compliance with cGMP.
	 
	 	1.1.3	 	Genentech Inc. (“GNE”) desires to entrust SurModics, Inc. (“SurModics”) to
perform activities related to the manufacture of GNE Products. GNE and SurModics are to
define their roles and responsibilities hereunder according to the intentions of the
GMP regulations. The manufacturing arrangements relating to the manufacture of the
Product are governed under the Master Service Agreement between GNE and SurModics
effective September 30, 2009 (the “Master Service Agreement”).
	 
	 	1.1.4	 	Capitalized terms not defined in the Glossary attached as Appendix I shall
have the meaning set forth in the Master Services Agreement.

	1.2	 	Parties to Agreement

	 	1.2.1	 	This GMP Technical Quality Agreement (the “Quality Agreement”) is hereby
entered into by and between GNE, a Delaware corporation, and SurModics, a Minnesota
corporation, and must be adhered to in the processing of the Product for GNE governed
by the Master Service Agreement. SurModics and Genentech are each referred to herein
individually as a “Party” and collectively as the “Parties.” The addresses of the
Parties are:

	 	 	 
	GENENTECH, Inc.

	 	SurModics, Inc.
	1 DNA Way

	 	9924 West 74th Street
	South San Francisco, CA 94080

	 	 Eden Prairie, MN 55344

	1.3	 	Scope

	 	1.3.1	 	Subject to Section 1.3.4, this Quality Agreement is applicable to the
manufacturing, processing, testing, and storage of the Product by SurModics for GNE.
	 
	 	1.3.2	 	The appendices and enclosures to this Quality Agreement are an integral part
of this Quality Agreement and are incorporated into this Quality Agreement by this
reference.
	 
	 	1.3.3	 	In addition to this Quality Agreement, SurModics and GNE shall create,
approve, and maintain a document that details Product specific requirements
(hereinafter referred to as the “PSR Document”) for each Product. This

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

			
	 
	Version 01
	 	Confidential and Proprietary — Handle Accordingly

 

 

Quality Agreement Number- QAC-SUR-01/01

Page 4 of 21 

	 	 	 	document shall,
at a minimum, contain contact information for designated
representatives from SurModics and GNE who shall oversee the respective obligations
regarding the Product and this Agreement, a process overview of the Product, a list
of raw materials and suppliers required to produce the Product, disposition cycle
times, list of batch documentation, any special shipping and handling requirements,
and any additional applicable information as required per this Quality Agreement or
deemed necessary by both parties.
	 
	 	1.3.4	 	This Quality Agreement pertains to the processing of the Products for
administration to humans as governed by clinical trial authorizations and marketing
authorizations (e.g. Investigational New Drug applications and Biologics License
applications). It does not pertain to the supply of Products for research and
development use. The mutual roles and responsibilities between GNE and SurModics
related to the Quality system requirements for, as well as the Product-specific Quality
requirements are defined.

	1.4	 	Duration, Review and Changes to this Agreement

	 	1.4.1	 	This Quality Agreement shall be effective as of the last date all required
signatures are appended above (the “Effective Date”) and shall expire at the
termination of the Master Service Agreement for the Product. The following sections
shall survive termination of the Master Service Agreement until such time as defined in
this Quality Agreement: sections 7.6, 7.7, 7.8, 7.9, 8.2, 8.3, and such other sections
that by their terms are understood to survive the termination of the Master Service
Agreement. The Parties acknowledge and agree that a similar quality agreement will be
executed upon termination of the Master Service Agreement in the event an agreement for
the manufacture of Phase III/IV material or commercial Product is negotiated between
the Parties.
	 
	 	1.4.2	 	This Quality Agreement shall be reviewed for accuracy and compliance with the
GMP regulations by both parties on at least a biennial cycle. Changes or supplements to
this Quality Agreement or to the appendices and enclosures can only be made by mutual
consent of amendments in writing. Such amendments to the Quality Agreement will be
recorded and filed in APPENDIX II: — Change History Log, with each subsequent revision.
	 
	 	1.4.3	 	It is the responsibility of both parties to replace a superseded provision
with an approved amendment. Superseded copies may be retained for historical records,
but should be marked to appropriately indicate the historical status of the document.
	 
	 	1.4.4	 	It is the responsibility of both parties to ensure that their staff is
adequately informed and any procedural or documentary changes resulting from an
amendment are implemented in the areas affected by the changes.

	1.5	 	Ultimate Quality Responsibility

	 	1.5.1	 	In the event of a conflict between this Quality Agreement and the Master
Service Agreement, the Master Service Agreement shall govern, except to the extent such
provisions are in violation of the GMP regulations. Notwithstanding the foregoing, this
Quality Agreement shall govern with respect to the assignment of responsibilities and
obligations of each party to

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

			
	 
	Version 01
	 	Confidential and Proprietary — Handle Accordingly

 

 

Quality Agreement Number- QAC-SUR-01/01

Page 5 of 21 

	 	 	 	undertake those measures to assure the Quality of the Products and with respect to
determinations of ability for release.
	 
	 	1.5.2	 	GNE’s Quality Unit has sole authority for final disposition of Product for
clinical use.
	 
	 	1.5.3	 	SurModics has the responsibility to implement and operate all quality systems
as required by GMP regulations where the Product will be distributed. SurModics shall
ensure that all quality systems operated by SurModics are compliant for GMP production
and that they operate to a standard mutually agreed upon by both parties.
	 
	 	1.5.4	 	If not otherwise defined in this Quality Agreement, the provisions of
SurModics’ Quality management systems and Standard Operating Procedures shall be
applied to these operations.

	1.6	 	Quality Oversight and Person-in-Plant (PIP)

	 	1.6.1	 	GNE shall have the right to provide GNE employees on SurModics’ premises (the
GNE employees hereinafter referred to as the “PIP”) for the purpose of providing advice
and coordinating reviews, approvals or other actions required by this Quality Agreement
upon reasonable notice and as mutually agreed upon. Such GNE employees shall conduct
themselves in accordance with SurModics’ visitor policy. The GNE PIP activities, at
the discretion of GNE, can also be performed remotely.
	 
	 	1.6.2	 	SurModics shall provide adequate space for the PIP when on site and shall
ensure that the PIP is kept fully informed of all issues that arise that may affect the
Quality of the Product. The PIP shall act as a single liaison between SurModics and GNE
for Quality issues.
	 
	 	1.6.3	 	[*]

	1.7	 	GMP Commissioning

	 	1.7.1	 	GMP Commissioning is a process for approving the initiation of GMP activities
at SurModics for a new manufacturing facility or a new manufacturing process related to
the Product.
	 
	 	1.7.2	 	Prior to the initiation of GMP production, SurModics shall allow the GNE
Quality Unit to perform GMP commissioning activities. This commissioning exercise is
to document that the facility, process, procedures and personnel are ready to initiate
GMP production as it relates to the Product.
	 
	 	1.7.3	 	The commissioning checklist and acceptance criteria shall be drafted by GNE
and approved by both SurModics and GNE prior to execution.
	 
	 	1.7.4	 	SurModics shall not perform new GMP activities for the Product until the GMP
Commissioning is complete and approved by the GNE and SurModics Quality Units.

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

			
	 
	Version 01
	 	Confidential and Proprietary — Handle Accordingly

 

 

Quality Agreement Number- QAC-SUR-01/01

Page 6 of 21 

	1.8	 	Execution of Responsibilities

	 	1.8.1	 	In the execution of their relevant responsibilities, both Parties agree to
conduct the necessary reviews, approvals, rejections and consents in a timely manner
and within the time limits specified. Where any party requires the consent of the
other, such consent will not be unreasonably withheld or delayed.
	 
	 	1.8.2	 	In this Agreement, “approval,” “authorization,” or “written communication”
shall mean on official letterhead or approved forms, and signed by the authoring
party’s Quality Assurance (QA) representative. Transmission of such written
documentation may be by mail or electronic system (i.e., facsimile, scan).

	2.0	 	LICENSES
	 
	2.1	 	Establishment License

	 	2.1.1	 	If applicable, SurModics shall obtain and maintain a valid manufacturer’s
license for the facilities [*].

	2.2	 	Product Licenses

	 	2.2.1	 	GNE shall, in accordance with applicable regulations, have sole authority for
applying for any Product licenses with the regulatory agencies per section 5.1 of
License and Option Agreement. GNE shall inform the appropriate regulatory authorities
of any change to the approved licenses for the Product through supplements or
amendments and informing SurModics of the same.
	 
	 	2.2.2	 	Upon request of any governmental or regulatory authority, both Parties shall
provide to each other, any data and information relating to the Product which may be
necessary for regulatory approval and maintenance efforts with respect to the licenses.

	3.0	 	GOVERNING REGULATIONS, RULES AND PROCEDURES
	 
	3.1	 	Governing Regulations and Rules

	 	3.1.1	 	SurModics shall ensure that the systems for the manufacture, processing,
testing, packing, holding and shipping of the Product at SurModics comply with:

	 	•	 	Current Good Manufacturing Practice, including but not limited to US 21 CFR
Part 11, 210, 211, and if applicable 820.
	 
	 	•	 	The requirements of this Quality Agreement.
	 
	 	•	 	The approved master documentation records (i.e., production records,
specifications).
	 
	 	•	 	Any additional regulations adopted by the regulatory authorities where the
Product will be distributed. GNE shall inform SurModics, in advance, of any
other countries where the Product will be distributed and any registration
differences.

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

			
	 
	Version 01
	 	Confidential and Proprietary — Handle Accordingly

 

 

Quality Agreement Number- QAC-SUR-01/01

Page 7 of 21 

	 	3.1.2	 	GNE shall have the right to ensure SurModics’ compliance with Section 3.1.1
above as described per Section 1.6 (PIP) and Section 8.1 (Compliance audits).

	3.2	 	SurModics Procedures

	 	3.2.1	 	SurModics shall create and maintain Quality systems compliant with cGMP, with
associated Standard Operating Procedures that enable both Parties to execute their
roles and responsibilities under the terms and conditions as described herein.
	 
	 	3.2.2	 	SurModics shall provide GNE with copies of effective Standard Operating
Procedures related to the manufacture, processing, testing, packing and holding of the
Product upon reasonable request by GNE.

	4.0	 	MATERIALS
	 
	4.1	 	Sources

	 	4.1.1	 	SurModics and/or GNE shall supply all materials required for the Product in
accordance with the MSA and certify that their Quality is in compliance with the
current “Note for Guidance on minimizing the risk of transmitting spongiform
encephalopathy agents via human and veterinary medicinal products” EMEA/410/01, Rev. 2
or update (“TSE Guidelines”).
	 
	 	4.1.2	 	GNE shall provide the bulk drug substance to SurModics for further processing
in accordance with the MSA. GNE certifies that the provided bulk will be processed
according to GMP and the materials used in its processing will be sourced in compliance
with the TSE Guidelines.

	4.2	 	Suppliers

	 	4.2.1	 	[*]
	 
	 	4.2.2	 	SurModics shall perform, or arrange to have performed, assessments of
suppliers of raw materials and components required for GNE Products to ensure that the
supplier’s Quality and manufacturing system are compliant with cGMPs.
	 
	 	4.2.3	 	[*]
	 
	 	4.2.4	 	SurModics shall notify the GNE Quality Unit when a supplier’s qualification
status changes. Upon request by GNE, SurModics shall request from its suppliers
permission to allow GNE to review SurModics audit reports.
	 
	 	4.2.5	 	If GNE supplies any raw materials and components to SurModics for use in
processing of the Product, SurModics will rely on GNE’s certification that the
supplier’s Quality systems are adequate.

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

			
	 
	Version 01
	 	Confidential and Proprietary — Handle Accordingly

 

 

Quality Agreement Number- QAC-SUR-01/01

Page 8 of 21 

	4.3	 	Receipt, Testing, Control and Release

	 	4.3.1	 	SurModics/GNE shall receive, sample, test, control and release components and
raw materials for the Product in accordance with the approved material specifications.
	 
	 	4.3.2	 	SurModics shall implement and maintain approved material specifications,
analytical methods, inspection methods, and sampling plans as required per each
material required for GNE Products. The GNE Quality Unit’s prior written approval of
such documentation is required. GNE’s approval of the material specifications,
analytical methods, inspection methods, and sampling plans shall be performed via
SurModics’ quality control system.

	5.0	 	PROCESSING OF PRODUCT
	 
	5.1	 	Batch Numbering

	 	5.1.1	 	SurModics shall use the GNE batch numbering system for all GMP Product
produced by SurModics.
	 
	 	5.1.2	 	GNE shall issue batch numbers to SurModics, who shall assign a batch number to
each Product batch. For purposes of tracking, SurModics may assign an internal
SurModics batch number in addition.
	 
	 	5.1.3	 	SurModics shall record the GNE batch number onto the appropriate production
records. SurModics shall keep track of GNE batch numbers to ensure batch numbers are
assigned appropriately.
	 
	 	5.1.4	 	SurModics shall record the GNE batch number on the appropriate Product Batch
labeling (i.e., vial label, shippers)

	5.2	 	Holding, Shipping, and Destruction of Samples

	 	5.2.1	 	SurModics shall hold the Product and raw materials in storage according to the
PSR and cGMP requirements. SurModics shall ensure that appropriate cGMP controls are
in place to prevent cross-contamination, theft, interference, or mix-up with any other
materials.
	 
	 	5.2.2	 	SurModics shall ship the Product according to GNE shipping requirements per
approved procedures. GNE shall communicate the shipping requirements to SurModics in
writing.
	 
	 	5.2.3	 	Upon receipt of the Product from GNE for further processing, SurModics shall
read the temperature monitors and report any temperature Deviations to the GNE Quality
Unit within [*].
	 
	 	5.2.4	 	Any temperature Deviations observed during shipment and/or holding of the
Product at SurModics will be handled per Section 7.2. SurModics shall investigate the
root cause and identify appropriate corrective actions for Deviations that occur while
the Product is under SurModics’ control.

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

			
	 
	Version 01
	 	Confidential and Proprietary — Handle Accordingly

 

 

Quality Agreement Number- QAC-SUR-01/01

Page 9 of 21 

	 	5.2.5	 	GNE shall be responsible for assessing the impact on Product as a result of
temperature Deviations either during Product shipment and/or during holding of the
Product at SurModics.
	 
	 	5.2.6	 	SurModics shall destroy Product rejects (for example, inspection rejects, bulk
waste, and rejected batches) per SurModics’ procedures. SurModics shall ensure that
proper handling, segregation, and documentation of any destruction is performed.

	5.3	 	Reprocessing and Reworking

	 	5.3.1	 	Prior to any Product batch being reprocessed or reworked, SurModics must
obtain approval of the GNE Quality Unit in advance. Reprocessing and reworking are
considered Significant Deviations and shall be handled in accordance to Section 7.2.
[*]
	 
	 	5.3.2	 	[*]

	6.0	 	QUALITY CONTROL TESTING
	 
	6.1	 	Analytical Methods

	 	6.1.1	 	SurModics shall implement and maintain in-process material and final Product
analytical methods.
	 
	 	6.1.2	 	The GNE Quality Unit’s prior written approval for all Product-specific
analytical methods is required.

	6.2	 	Quality Control Testing and Approval

	 	6.2.1	 	SurModics shall sample and test in-process and final Product batches according
to the approved specifications, sampling plans and analytical methods.
	 
	 	6.2.2	 	SurModics shall report all quality control results on a “Certificate of
Analysis” (COA). SurModics shall include all in-process results with the batch
records.
	 
	 	6.2.3	 	SurModics shall not destroy any QC retain samples until the Product batch has
been dispositioned by GNE.
	 
	 	6.2.4	 	GNE shall provide reference materials and critical reagents to SurModics to be
used in the testing of the Product.
	 
	 	6.2.5	 	For testing performed at GNE, SurModics shall collect the samples,
appropriately label and store the samples, and ship the samples per the current
validated shipping procedure to GNE within [*] of collecting the samples.
	 
	 	6.2.6	 	GNE QC shall perform a review of raw quality control data for in-process and
final Product batches to ensure quality standards are being maintained until such time
that GNE can qualify SurModics to perform independent data review as defined per GNE
procedure.

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

			
	 
	Version 01
	 	Confidential and Proprietary — Handle Accordingly

 

 

Quality Agreement Number- QAC-SUR-01/01

Page 10 of 21 

	6.3	 	Stability Testing

	 	6.3.1	 	SurModics shall be responsible for maintaining a routine stability testing
program for the Product per approved procedures.
	 
	 	6.3.2	 	SurModics shall write, approve and submit stability protocols for the Product
to GNE for approval.
	 
	 	6.3.3	 	SurModics shall provide GNE with the results of stability testing in support
of the approved shelf life within [*] of completion of the stability testing.
	 
	 	6.3.4	 	SurModics shall communicate any out of specification results obtained during
stability testing of the Product to the GNE Quality Unit in accordance with Section
7.2.
	 
	 	6.3.5	 	GNE shall determine and approve the expiry and/or retest period, storage, and
shipping conditions based on formal stability studies conducted for the Product.

	6.4	 	Out of Specification (OOS) Quality Control Testing Results

	 	6.4.1	 	In the event that SurModics obtains an initial OOS result, a preliminary lab
assessment shall be conducted per SurModics’ approved procedures. This assessment will
include at a minimum, a review of all equipment used, sample and reagent preparation,
and documentation associated with the test session. No additional testing of the
Product shall be conducted during this preliminary lab assessment.
	 
	 	6.4.2	 	If no determinate error is identified in the assessment conducted pursuant to
Section 6.4.1, then SurModics shall notify the GNE Quality Unit per the Section 7.2.
No additional analysis shall be conducted on the Product prior to notifying the GNE
Quality Unit.
	 
	 	6.4.3	 	The GNE Quality Unit shall approve OOS investigations and associated
corrective and preventative actions, unless an analytical error is identified in the
assessment as described in section 6.4.1 and the results are invalidated and testing is
repeated on a new sample

	7.0	 	GENERAL QUALITY SYSTEMS
	 
	7.1	 	Disposition of Product

	 	7.1.1	 	The SurModics Quality Unit must certify in writing that each batch of Product
has been manufactured, tested, packaged and stored in accordance with cGMPs, the Master
Batch Production Record (MBPR) and applicable SOPs.
	 
	 	7.1.2	 	The SurModics Quality Unit shall review and approve all batch documentation
according to SurModics’ approved procedures prior to release of the Product batch to
GNE.
	 
	 	7.1.3	 	All Deviations must be clearly identified in batch records, and must be fully
investigated and completed prior to the approval of batch records. SurModics

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

			
	 
	Version 01
	 	Confidential and Proprietary — Handle Accordingly

 

 

Quality Agreement Number- QAC-SUR-01/01

Page 11 of 21 

	 	 	 	shall perform a cumulative assessment of all Deviations that occurred during the
manufacturing, holding, and testing of the Product.
	 
	 	7.1.4	 	GNE has the sole authority for final disposition of the Product. SurModics
shall notify the GNE Quality Unit of any Product batch being considered for rejection
by SurModics prior to any formal reject disposition. For Product assigned a reject
disposition by SurModics, GNE shall have the right to take possession of the Product.
GNE shall authorize the destruction of any rejected Product batches.
	 
	 	7.1.5	 	SurModics shall not release any batches with open Major Changes or validations
that are lot-release impacting.
	 
	 	7.1.6	 	Any problem discovered by GNE that would result in the rejection of a Product
batch shall be communicated to SurModics as soon as practical, but in all cases within
[*] following receipt of the release documentation.

	7.2	 	Deviations

	 	7.2.1	 	Any Deviation shall be documented and approved by personnel designated by
SurModics from each of the relevant departments and by the SurModics Quality Unit, in
accordance with SurModics’ approved procedure for Deviation management.
	 
	 	7.2.2	 	Significant Deviations require notification of the GNE Quality Unit within [*]
of discovery.

	 	•	 	Significant Deviations are defined as events that are observed during
production, quality control testing including out-of-specification (OOS)
results as described in section 6.4.2 above, and/or batch record review that
may reasonably result in a Deviation from Product specifications, that may
adversely impact the safety, identity, strength, purity or quality of the
Product, and/or violate cGMPs or the Product license that could impact the
releasability of the Product. Examples of Significant Deviations include:

	 	•	 	Failure of Product to meet certificate of analysis (COA) specifications
	 
	 	•	 	Operations outside of validated limits
	 
	 	•	 	Suspected introduction of adventitious agents/contaminants in the
Product
	 
	 	•	 	Excursions to environmental conditions (EM) in the primary filling area
	 
	 	•	 	Incorrect or unsuitable raw materials, components, or equipment used
during the manufacturing of the Product
	 
	 	•	 	Reprocessing and reworking of the Product, [*]
	 
	 	•	 	Process discrepancies that adversely impact other Product process
steps, lots, or Products batches whether distributed or not
	 
	 	•	 	Media fill and sterility positives/failures

	 	7.2.3	 	SurModics shall obtain GNE Quality Unit approval for all Significant Deviations.

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

			
	 
	Version 01
	 	Confidential and Proprietary — Handle Accordingly

 

 

Quality Agreement Number- QAC-SUR-01/01

Page 12 of 21 

	 	7.2.4	 	SurModics shall inform the GNE Quality Unit within [*] of any Significant
Deviation relating to other products, produced using the same equipment train as that
used for the Product, if the Deviation could have an impact on the Product. SurModics
will provide as much detail as possible regarding the Deviation. In the event that
customer confidentiality agreements regarding other products prevent SurModics from
providing certain documentation or detail, SurModics may provide redacted copies of
documentation or a summary of the Deviation.
	 
	 	7.2.5	 	SurModics shall be responsible for investigating all Deviations per its
approved procedures. SurModics will allow the GNE Quality Unit to actively participate
in the development of investigation action plans related to Significant Deviations
related directly to the Product or that could have impact on the Product. All
investigation plans should be approved prior to implementation and should include at
minimum:

	 	•	 	Lots impacted
	 
	 	•	 	Description of action to be taken
	 
	 	•	 	Rationale for this action
	 
	 	•	 	Individual/department responsible for the action
	 
	 	•	 	Target completion date
	 
	 	•	 	Pre-approval by SurModics’ QA

	 	7.2.6	 	SurModics shall submit investigation plans before their implementation for all
Significant Deviations. Those plans shall be evaluated by the GNE Quality Unit. Any
additional testing required to support an investigation, including OOS investigations,
must be pre-approved by the GNE Quality Unit.
	 
	 	7.2.7	 	When necessary, GNE shall provide a technical assessment or other data to
support the investigation.
	 
	 	7.2.8	 	Significant Deviation reports shall include a description of the event,
impacted lots, determination of cause, quality impact assessment, and identification of
corrective and preventive actions. Quality impact assessments should determine the
impact of the event on the safety, Quality, identify, potency and purity of the
Product, other lots of the Product, validation, and GMP compliance.
	 
	 	7.2.9	 	After completion of the report related to Significant Deviations, SurModics
shall submit to GNE a copy of a completed report. This report shall be reviewed by the
GNE Quality Unit. Within [*], the GNE Quality Unit will either approve the Significant
Deviation, or notify SurModics of additional information or actions required before
approval of the Significant Deviation report.
	 
	 	7.2.10	 	SurModics shall [*] notify the GNE Quality Unit of any problems that are discovered
that may have impact to Product batches previously shipped to GNE. Notice shall be made
within [*] of the discovery of a potential quality problem with a released batch of
Product.

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

			
	 
	Version 01
	 	Confidential and Proprietary — Handle Accordingly

 

 

Quality Agreement Number- QAC-SUR-01/01

Page 13 of 21 

	7.3	 	Validation

	 	7.3.1	 	SurModics shall maintain systems that demonstrate manufacturing processes,
facilities, utilities, equipment, and automation will reliably and repeatedly perform
their intended function in the manufacture and testing of the Product.
	 
	 	7.3.2	 	As applicable, SurModics shall maintain a Validation Master Plan (VMP), which
includes the validation program overview and requirements for the facility and
equipment required to manufacture and test the Product. This VMP must be acceptable to
GNE.
	 
	 	7.3.3	 	SurModics shall periodically re-validate, as appropriate, facilities,
utilities, equipment, and automation per the VMP and other approved procedures.
	 
	 	7.3.4	 	GNE shall have the right to review all validation reports related to the
manufacturing and testing of the Product. These validations must be acceptable to GNE.
[*]

	7.4	 	Change Control

	 	7.4.1	 	SurModics shall utilize a change control system to ensure appropriate review
of all changes.
	 
	 	7.4.2	 	The GNE Quality Unit shall approve any change to the following master
documentation maintained by SurModics for GNE Products:
	 
	 	 	 	[*]
	 
	 	7.4.3	 	SurModics shall review all changes to determine if the change is a Major Change
(as defined in the Glossary). If there is any doubt regarding whether a change is a
Major Change, SurModics shall contact the GNE Quality Unit, and the parties shall
jointly make this determination. It is understood between parties that changes as a
result of pharmacopoeia test methods updates are not Major Changes.
	 
	 	7.4.4	 	In addition to Major Changes, SurModics shall notify the GNE Quality Unit in
writing of any Minor Changes that affect GNE specific documents, equipment or
processes, on at a minimum quarterly basis. Such notification shall contain a
description of the change, the implementation date of the change, and the status of the
change. Minor changes may be implemented by SurModics prior to such notification to
GNE.
	 
	 	7.4.5	 	SurModics shall notify the GNE Quality Unit in writing of any Major Changes
that may impact the Product Quality, validated status and/or have regulatory impact to:
	 
	 	 	 	[*]
	 
	 	7.4.6	 	Such notifications shall be communicated in writing in a timely manner so as to
allow GNE to evaluate the affect of the change on Product Quality and/or obtain
appropriate regulatory approvals prior to implementation.
	 
	 	7.4.7	 	At a minimum, such notification will contain a description of the change, the
rationale for the change, the proposed implementation date, the qualification,

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

			
	 
	Version 01
	 	Confidential and Proprietary — Handle Accordingly

 

 

Quality Agreement Number- QAC-SUR-01/01

Page 14 of 21 

	 	 	 	validation, and/or comparability testing and acceptance criteria to prove that the
Major Change does not adversely affect Product Quality.
	 
	 	7.4.8	 	SurModics shall provide all documentation of a Major Change to GNE for review
and approval. This includes, but is not limited to, the description and rationale of
the change and supporting documentation such as validations or technical assessments.
	 
	 	7.4.9	 	GNE’s review and approval/rejection of Major Changes prior to implementation
is required. Within [*], GNE shall approve the change, request additional information,
or provide justification for the rejection of a change.
	 
	 	7.4.10	 	After completion of a Major Change, SurModics shall provide the GNE Quality Unit in
writing with supporting data and reports that demonstrate the Major Change is valid and
have been found acceptable by SurModics.
	 
	 	7.4.11	 	Emergency changes are changes that must be performed prior to the receipt of GNE
approval in order to avoid Product loss or to eliminate a safety hazard. Emergency
changes must be categorized and documented as previously described and notification
must be provided to the GNE Quality Unit for evaluation within [*] of the change
implementation.
	 
	 	7.4.12	 	For changes proposed by GNE, GNE shall notify SurModics in writing of any
Product-related changes. SurModics shall implement these changes in a timely manner
and in accordance with SurModics procedures and the Master Service Agreement.

	7.5	 	New Product Introduction

	 	7.5.1	 	SurModics shall not use the same facilities and/or equipment used for
processing the Product for the processing of beta-lactams, e.g. penicillin or
cephalosporins.
	 
	 	7.5.2	 	SurModics shall inform the GNE Quality Unit in writing per the change control
Section 7.4, when [*]. For confidentiality reasons, SurModics shall only be required
to provide detail to the level of the class of product.
	 
	 	7.5.3	 	Prior to introduction of a new product into the line, SurModics shall perform
a cleaning verification/validation according to SurModics’ procedures in order to
exclude cross contamination of the Product from other product campaigns.

	7.6	 	Product Complaints, Adverse Events, and other Post-Release Issues

	 	7.6.1	 	GNE shall have sole authority for resolving all customer complaints and
adverse events, related to the Product.
	 
	 	7.6.2	 	It is expected that most product complaints and adverse events for the Product
shall be received by GNE. Any reports received by SurModics shall be forwarded to the
GNE Quality Unit within [*].
	 
	 	7.6.3	 	If GNE requests a technical evaluation, documentation review, or sample
inspection from SurModics to support a Product complaint/adverse event,

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

			
	 
	Version 01
	 	Confidential and Proprietary — Handle Accordingly

 

 

Quality Agreement Number- QAC-SUR-01/01

Page 15 of 21 

	 	 	 	SurModics shall report any findings to GNE in writing, signed, within [*] of
notification by GNE, or as required per section 8.3.6. SurModics shall provide GNE
with an update as to the progress of the investigation within [*] of notification by
GNE.
	 
	 	7.6.4	 	SurModics shall notify the GNE Quality Unit within [*] of any other complaint
with any other products manufactured by SurModics that by nature of similarity of
material or manufacturing, that has reasonable potential to adversely impact the
Product.
	 
	 	7.6.5	 	If the Product in any batch fails to comply with the agreed Quality standards,
either upon receipt or during the shelf-life of the Product (i.e., during stability
testing), as a result of operations conducted at SurModics, GNE will contact SurModics
in writing to assist with the investigation.

	7.7	 	Document Retention

	 	7.7.1	 	SurModics shall maintain the original Batch records consisting of
manufacturing, packaging, Quality Control, release, storage and delivery documentation,
Raw Data and records for each Batch of Product in a secure location for a period of
[*].
	 
	 	7.7.2	 	Prior to the destruction of any Product records at SurModics, SurModics shall
notify the GNE Quality Unit and the records shall be sent to GNE, unless otherwise
directed in writing by the GNE Quality Unit.

	7.8	 	Sub-contracting

	 	7.8.1	 	Consistent with Section 4.5 of the Master Services Agreement, SurModics shall
not subcontract to a Third Party any of the work entrusted under this Quality
Agreement, without the GNE Quality Unit’s prior written approval.
	 
	 	7.8.2	 	In the event that SurModics, with the written permission of the GNE Quality
Unit, sub-contracts any operation under this Quality Agreement to a Third Party,
SurModics shall ensure that it enters into a written agreement with the sub-contractor
that sets out the respective technical and quality responsibilities of each party [*].
	 
	 	7.8.3	 	SurModics may use contract laboratory testing facilities to support the
testing of the Product. SurModics shall only use testing facilities that have been
approved by the SurModics Quality Unit per SurModics’ procedures. Quality Agreements
between SurModics and those facilities must be in place.

	7.9	 	QA Reserve Samples

	 	7.9.1	 	SurModics shall maintain and inspect the reserve samples as required per cGMP
regulations.
	 
	 	7.9.2	 	SurModics shall provide GNE with a summary of the results of the annual
inspection of the reserve samples within [*] of completion. In the event any
deterioration is observed during this inspection, SurModics shall contact GNE in
accordance to the Deviation section 7.2.

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

			
	 
	Version 01
	 	Confidential and Proprietary — Handle Accordingly

 

 

Quality Agreement Number- QAC-SUR-01/01

Page 16 of 21 

	8.0	 	COMPLIANCE AUDITS AND INSPECTIONS
	 
	8.1	 	Compliance Audits

	 	8.1.1	 	SurModics shall permit GNE to conduct preparatory audits for the initiation of
GMP manufacture of the Product, pre-approval audits, for cause audits, and routine and
follow-up compliance audits upon reasonable notice and as mutually agreed upon. Such
audits are intended to assure GNE that SurModics maintains adequate premises, equipment
and staff with sufficient knowledge and experience to carry out all operations relating
to the Products. Such GNE auditors shall conduct themselves in accordance with all
applicable SurModics’ policies and procedures and in such a manner as not to disturb
SurModics operations.
	 
	 	8.1.2	 	SurModics shall allow GNE to review all relevant records required to perform
such audits during normal business hours. The start date and duration of the audits
shall be agreed upon by both Parties. [*]
	 
	 	8.1.3	 	GNE shall provide a written report to SurModics of all observations after the
completion of the audit.
	 
	 	8.1.4	 	SurModics shall provide a written response to GNE within [*] of receipt of the
audit report. Such response shall describe in detail the corrective actions to be
implemented by SurModics. SurModics may request an extension of time to provide a
written response when necessary to prepare a comprehensive corrective action plan.
Such an extension request will propose an appropriate timeframe in which to submit a
final response along with justification for the extension request.
	 
	 	8.1.5	 	For-cause audits, by nature, will require scheduling as soon as possible.
SurModics will make concerted efforts to schedule all such audits promptly.

	8.2	 	Regulatory Authority Inspections

	 	8.2.1	 	SurModics shall [*] notify the GNE Quality Unit of any regulatory authority
contact, including facility inspections, sample requests, and written contact related
to the Product.
	 
	 	8.2.2	 	[*]
	 
	 	8.2.3	 	[*]
	 
	 	8.2.4	 	SurModics shall refer any GNE submission and GNE-specific related queries from
regulatory agencies about the Product to GNE.
	 
	 	8.2.5	 	Any deficiencies noted during a GNE territory regulatory authority inspection
of SurModics premises, which relate directly or indirectly to the manufacturing,
testing, storage, or quality systems related to the Product, must be brought to the
attention of the GNE Quality Unit within [*].
	 
	 	8.2.6	 	SurModics shall secure GNE’s written agreement prior to making any commitments
to a regulatory authority regarding the Product.

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

			
	 
	Version 01
	 	Confidential and Proprietary — Handle Accordingly

 

 

Quality Agreement Number- QAC-SUR-01/01

Page 17 of 21 

	 	8.2.7	 	SurModics shall provide GNE a redacted copy (i.e., redacted for information
pertaining to other products) of any regulatory inspection report related to the
Product and SurModics’ response to the inspection reports.

	8.3	 	Regulatory Agency Contacts

	 	8.3.1	 	[*] SurModics shall promptly provide GNE with a copy of any regulatory
correspondence relevant to the Product.
	 
	 	8.3.2	 	GNE shall notify SurModics [*] in writing of any regulatory issues that GNE
knows shall impact SurModics’ ability to manufacture the Product.
	 
	 	8.3.3	 	SurModics shall maintain a Drug Master File (DMF) for their facilities and
allow GNE to reference such files upon request. SurModics shall inform the GNE Quality
Unit in writing any time the DMF is updated (i.e., a new product introduction).
	 
	 	8.3.4	 	GNE shall have sole authority for preparing and filing any regulatory
submissions per section 5.1 of License and Option Agreement.
	 
	 	8.3.5	 	GNE shall have sole authority, as between the parties, for filing applicable
reports to regulatory agencies, such as Field Alerts and Biological Product Deviation
Reports related to the Product.
	 
	 	8.3.6	 	Regulatory reporting may be required for problems such as stability failures,
out of specification results, Significant Deviations, product complaints, or adverse
events for the Product. When requested by GNE, SurModics shall work collaboratively
with GNE for filing any such report thought to be due to operations conducted by
SurModics. Investigations at SurModics shall be conducted in accordance with
regulatory reporting requirements. GNE and SurModics shall mutually agree upon a
timeframe for completion of the investigation on a case-by-case basis.
	 
	 	8.3.7	 	Regardless of which Party receives the initial contact or inquiry from a GNE
territory regulatory authority regarding the Product, such receiving party will [*]
inform the other party. GNE and SurModics shall agree, on a case-by-case basis, which
party shall respond to such contact/inquiry. All correspondence with a GNE territory
regulatory authority regarding the Product will be shared with GNE prior to it being
sent to the GNE territory regulatory authority. Copies of all correspondence by one
party shall be provided to the other party.

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

			
	 
	Version 01
	 	Confidential and Proprietary — Handle Accordingly

 

 

Quality Agreement Number- QAC-SUR-01/01

Page 18 of 21

Genentech, Inc. 

APPENDIX I: — Glossary 

Capitalized terms used but not defined herein shall have the meanings set forth in the License
Agreement or the MSA. As used in this Quality Agreement, the following terms, whether used in the
singular or the plural, shall have the meanings set forth in this Article

	 	 	 
	Word/Phrase	 	Meaning
	 
	 	 
	Analytical Method:

	 	A document describing the procedure
for sample and standard
preparation, instrument parameters,
system suitability requirements (as
necessary), testing, calculation
and reporting of results.
	 
	 	 
	Annual Report:

	 	Annual Reports are annual updates
submitted to the FDA after an IND
goes into effect (ref.: 21 CFR
312.33) or a New Drug Application
or Biological License Application
is approved (ref.: 21 CFR 314.81).
	 
	 	 
	Audit:

	 	An appraisal that determines the
degree of adherence to pre-defined
criteria and results in a judgment.
Examples are audits of systems and
documentation. Audits are typically
performed by someone not involved
in the activity being audited in
order to give the audit a degree of
independence.
	 
	 	 
	Batch or Lot:

	 	A specific quantity of a drug or
other material that is intended to
have uniform character and quality,
within specified limits, and is
produced according to a single
manufacturing order during the same
cycle of manufacture.
	 
	 	 
	Quality Control Master Document
(QCMD)/Certificate of Analysis
(COA):

	 	 The Quality Control Master Document
 is equivalent to a Certificate of
Analysis is the listing of all
tests performed to release a batch
and the results.
	 
	 	 
	Deviation:

	 	Event in the manufacturing process,
testing and/or support system that
is outside of approved operating
parameters, the Product license,
approved procedures, policies,
standards, or specifications, or a
departure from accepted cGMP’s.
	 
	 	 
	Final Drug Product:

	 	A finished dosage form, for
example, tablet, capsule, solution,
etc., that contains an active drug
ingredient generally, but not
necessarily, in association with
inactive ingredients. The term also
includes a finished dosage form
that does not contain an active
ingredient but is intended to be
used as a placebo.
	 
	 	 
	Field Alert or Biological Product 

Deviation Report:

	 	 All drug manufacturers with
approved New Drug Applications or
Biological License Applications are
required to submit Field Alert
Reports or Biological Product
Deviation Reports, respectively, to
the FDA if they find any
significant problems with an
approved drug (ref.: 21 CFR 314.81
or 600.14).
	 
	 	 
	Good Manufacturing Practice (GMP)

 or  cGMP:

	 	That part of quality assurance
aimed at ensuring that products are
consistently manufactured to a
quality appropriate to their
intended use, the regulations for
which are encoded in the US Code of
Federal Regulations, Title 21,
Sections 210, 211, 600 and the EU
Commission Directive 2003/94/EC
(the ‘GMP Directive’).

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

			
	 
	Version 01
	 	Confidential and Proprietary — Handle Accordingly

 

 

Quality Agreement Number- QAC-SUR-01/01

Page 19 of 21

Genentech, Inc. 

	 	 	 
	Word/Phrase	 	Meaning
	 
	 	 
	In-Process Material:

	 	Any material fabricated,
compounded, blended, or derived by
chemical reaction that is produced
for, and used in, the preparation
of the Drug Product.
	 
	 	 
	Lot
Number or Batch Number:

	 	 Any distinctive combination of
letters, numbers, or symbols, or
any combination of them, from which
the complete history of the
manufacture, processing, packing,
holding, and distribution of a
Batch or Lot of Drug Product or
other material can be determined.
	 
	 	 
	Major Change:

	 	A change that may impact the
Product Quality or validated
status, and/or may require
regulatory action (for example,
changes requiring an Annual Report
or pre-approval submission).
	 
	 	 
	Minor Change:

	 	A change that does not impact the
validated status, Product Quality,
or Product License.
	 
	 	 
	Master Batch Production Record

(MBPR):

	 	 A pre-approved record that includes
the formulation and describes the
procedure to be followed when
manufacturing and/or packaging
Products. Once approved the MBPR is
reproduced in a controlled manner
and the reproduction is used to
record the actual processing of
each batch. This reproduced record
is referred to as a production or
batch record or batch ticket.
	 
	 	 
	Quality:

	 	The totality of features and
characteristics of a product or
service that affect its ability to
satisfy a given need. Essential
elements of Product quality are the
identity, strength, purity, potency
and safety. These elements are
primarily controlled by Testing
Monographs and Master Processing
Records.
	 
	 	 
	Quality Assurance (QA):

	 	The sum total of the organized
arrangements made with the purpose
of ensuring that the product meets
the specifications and is of the
quality required for its intended
use and shall specifically include,
without limitation, all activities
as set forth in this Quality
Agreement.
	 
	 	 
	Quality Control (QC):

	 	The sampling,
specification-setting, testing,
documentation and analytical
procedures that provide independent
results of required tests, which
contribute to the evaluation of the
quality of a material.
	 
	 	 
	Quality Unit

	 	The organizational entity, at
either GNE or SurModics, that has
been identified to the other party
as having responsibility for
activities or approvals described
in this Quality Agreement.
	 
	 	 
	Raw Data:

	 	Any original laboratory worksheets,
records, memoranda, note, document,
or exact copies thereof, which are
the result of original observations
that are necessary for
reconstruction and evaluation of
processing, Quality Control or
Quality Assurance activities. Raw
data may include photographs,
microfilm or microfiche copies,
computer printouts, magnetic media,
including dictated observations,
and recorded data from automated
instruments.
	 
	 	 
	Recall:

	 	Tracing and recovery, as far as
possible, of every item of a
particular batch or of several
batches of finished products after
they have left the manufacturer.

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

			
	 
	Version 01
	 	Confidential and Proprietary — Handle Accordingly

 

 

Quality Agreement Number- QAC-SUR-01/01

Page 20 of 21

Genentech, Inc. 

	 	 	 
	Word/Phrase	 	Meaning
	 
	 	 
	Reprocessing:

	 	The repeating of an individual
step, as identified in a relevant
SOP, in order to fulfill the
intended purpose of that step which
was either completed or not
completed originally, and to bring
the Product into conformance with
specifications.
	 
	 	 
	Reworking:

	 	The repeating of one or more step
within the process or the
performance of any additional
process steps not covered in
approved license in order to bring
the Product into conformance with
specifications.
	 
	 	 
	Shelf Life:

	 	The period of time during which the
Product is designed to meet all
registered safety, efficacy and
quality requirements if stored in
the prescribed manner. The re-test
and/or expiry date are calculated
by adding this period of time to
the date of manufacture (with or
without rounding to the end of the
calculated month).
	 
	 	 
	Specification:

	 	A formally approved document
listing the tests, Analytical
Methods and acceptance criteria
specific to material. It is used to
determine the Quality of a
material.
	 
	 	 
	Standard
Operating Procedure (SOP):

	 	  A document, approved by appropriate
management, describing stepwise
procedures for compliance with a
regulation, policy or system.
Compliance with an SOP is required,
and Deviations must be documented.

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

			
	 
	Version 01
	 	Confidential and Proprietary — Handle Accordingly

 

 

SurModics/GNE Quality Agreement

21 of 21 

Genentech, Inc. 

APPENDIX II: — Change History Log

	 	 	 
	Revision #	 	Description of, and Rationale for Changes
	 
	 	 
	1.0

	 	New Quality Agreement

CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

			
	 
	Version 01
	 	Confidential and Proprietary — Handle Accordingly

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00168-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00168-of-00352.parquet"}]]