Exhibit 10.2

 

CERTAIN MATERIAL (INDICATED BY [***]) HAS BEEN OMITTED FROM THIS DOCUMENT
PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT.  THE OMITTED MATERIAL HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

 

SETTLEMENT AND LICENSE AGREEMENT

 

This SETTLEMENT AND LICENSE AGREEMENT (this “Agreement”) is made as of
February 22, 2012, by and between Depomed, Inc. (“Depomed”), a California
corporation having its principal place of business at 1360 O’Brien Drive, Menlo
Park, CA 94025, and Santarus, Inc. (“Santarus”), a Delaware corporation having
its principal place of business at 3721 Valley Centre Drive, Suite 400, San
Diego, CA 92130, on the one hand, and each of Lupin Pharmaceuticals, Inc., a
Virginia corporation having its principal place of business at 111 South Calvert
Street 21st floor, Harborplace Tower, Baltimore, MD 21202, and Lupin Limited, an
Indian corporation having its principal place of business at B/4 Laxmi Towers,
Bandra Kurla Complex, Bandra (E), Mumbai 400 051 India (collectively, “Lupin”),
on the other hand (each a “Party” and collectively, the “Parties”).

 

RECITALS

 

WHEREAS, Depomed and Lupin are parties to a good faith patent infringement
litigation captioned, Depomed, Inc., v. Lupin Pharmaceuticals, Inc. et al. (Case
4:09-cv-05587-PJH) pending in the United States District Court for the Northern
District of California before the Honorable Phyllis J. Hamilton (the
“Litigation”);

 

WHEREAS, Glumetza® brand metformin tablets (500 mg and 1000 mg dosages) are
manufactured and marketed under Santarus’ New Drug Application (“NDA”)
No. 021748, as amended, supplemented or replaced (the “Depomed Products”);

 

WHEREAS, Depomed has obtained patents issued by the U.S. Patent and Trademark
Office containing claims covering the Depomed Products;

 

WHEREAS, on July 27, 2009, Lupin filed Abbreviated New Drug Application
No. 91-664 with the Food and Drug Administration (the “FDA”), which contained a
certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (“Lupin’s p(IV)
certification”), seeking approval to market generic versions of 500 mg and 1000
mg tablets of metformin products before the expiration of the Depomed Patents
(as hereinafter defined);

 

WHEREAS, in response to Lupin’s p(IV) certification, Depomed lawfully commenced
the Litigation and asserted infringement of the Depomed Patents in good faith;

 

WHEREAS, the Parties wish to fully and finally settle the Litigation upon the
terms and subject to the conditions set forth below;

 

WHEREAS, settlement of the Litigation will permit the Parties to avoid the
substantial costs, uncertainty and risk involved with prolonged
patent-infringement litigation, trial and appeal; and

 

WHEREAS, settlement of the Litigation will permit the management of the Parties
to refocus on running their respective companies rather than devoting
substantial time and resources to the Litigation;

 

1

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

 

ARTICLE 1
DEFINITIONS

 

Section 1.1.           Certain Defined Terms.  The following terms, when used
with initial capital letters, shall have the meanings set forth below:

 

“‘280 Patent” means United States Patent No. 6,635,280.

 

“‘475 Patent” means United States Patent No. 6,340,475.

 

“‘962 Patent” means United States Patent No. 6,488,962.

 

[***]

 

“Affiliate” means any entity controlling, controlled by or under common control
with a Party, but only as long as such control continues, where “control” means:
(i) the ownership of at least fifty percent (50%) of the equity or beneficial
interest of such entity, or the right to vote for or appoint a majority of the
board of directors or other governing body of such entity; or (ii) the power to
directly or indirectly direct or cause the direction of the management and
policies of such entity by any means whatsoever.

 

“Authorized Generic” means a metformin product that is sold in the Territory
pursuant to NDA No. 021748 (including any supplements or amendments thereto),
but not under the Glumetza® trademark.

 

“Depomed Patents” means, collectively, the ‘280 Patent, the ‘475 Patent, and the
‘962 Patent, together with all reissues, reexaminations, continuations,
continuations-in-part, divisionals, and patent and regulatory extensions
thereof.

 

[***]

 

“Effective Date” has the meaning set forth in Section 6.8(e).

 

“Execution Date” shall be the date representatives from all the Parties execute
and deliver this Agreement.

 

“Final Court Decision” means a decision of a United States Court from which no
appeal has been or can be taken, other than a petition to the Supreme Court for
a review of certiorari.

 

“Generic Equivalent” means a pharmaceutical product that has received FDA
approval for marketing in the Territory pursuant to an abbreviated new drug
application (“ANDA”) (or equivalent regulatory mechanism) as a generic,
therapeutic equivalent to the Depomed Products.

 

 

Confidential Information, indicated by [***] has been omitted from this filing
and filed separately with the Securities and Exchange Commission.

 

2

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[***]

 

“License Effective Date” means February 1, 2016.

 

“Licensed Products” means Lupin’s ANDA Products.

 

“Losses” means all pending and potential claims, demands, all manner of actions,
causes of action, suits, debts, liabilities, losses, damages, attorneys’ fees,
costs, expenses, judgments, settlements, interest, punitive damages and other
damages or costs of whatever nature, whether known or unknown, pending or
future, certain or contingent.

 

“Lupin’s ANDA Products” means the products that are the subject of Lupin’s ANDA,
as amended, supplemented or replaced.

 

“Lupin’s ANDA” means ANDA No. 91-664, filed with the FDA on July 27, 2009, as
amended, supplemented or replaced.

 

“Market”,  “Marketed” and “Marketing” mean to offer to sell or sell a
pharmaceutical product; provided, however, “Market”, “Marketed” and “Marketing”
do not include:  (a) engaging in discussions with potential customers to make
them aware of the upcoming availability of products any earlier than [***] prior
to availability of the products; or (b) importing products into the Territory
starting any earlier than [***] prior to their availability so as to have
sufficient quantities of inventory of product.

 

“Orange Book” means the FDA’s publication Approved Drug Products with
Therapeutic Equivalence Evaluations (or any successor publication thereto).

 

[***]

 

“Person” means any individual, firm, corporation, partnership, limited liability
company, trust, joint venture, governmental authority, or other entity or
organization.

 

“Proceeding” means any administrative, judicial or legislative action, audit,
litigation, investigation, suit or other proceeding in any tribunal.

 

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

 

“Third Party” means any Person other than Depomed, Santarus, Lupin, their
Affiliates, and their subsidiaries.

 

ARTICLE 2
SETTLEMENT AND RELEASE

 

Section 2.1.           Mutual Release.  Upon the terms and subject to the
conditions of this Agreement and the Consent Injunction and Dismissal Order
(attached as Exhibit A), each Party, on behalf of itself and its Affiliates and
subsidiaries hereby releases, acquits and forever discharges the other Party and
its Affiliates and subsidiaries, and their respective directors,

 

 

Confidential Information, indicated by [***] has been omitted from this filing
and filed separately with the Securities and Exchange Commission.

 

3

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officers, employees, agents, representatives, suppliers, customers,
distributors, marketing partners, heirs, assigns, predecessors and successors
(“Related Parties”) from any and all Losses arising out of, derived from,
predicated upon or relating to infringement of the Depomed Patents or any other
patent that Depomed or Santarus or any of their Affiliates or subsidiaries owns,
or will own, or controls or licenses, or will control or license, in whole or in
part, that is, or could be alleged to be, infringed by the Licensed Products,
and the actions underlying the Litigation, or otherwise related to the Lupin
ANDA or Lupin’s ANDA Products.  Notwithstanding the foregoing, nothing in this
Agreement shall prevent or impair the right of either Party to bring a
Proceeding in court or any other forum for breach of this Agreement (including,
without limitation, any claim for infringement of any intellectual property
based upon activities that are not the subject of the license granted hereunder)
or any representation, warranty or covenant herein.  Notwithstanding the
foregoing, the releases provided herein shall not apply to products other than
Lupin’s ANDA Products that are the subject of the Lupin ANDA, and nothing in
this Agreement shall prevent or impair the right of Lupin to challenge the
infringement, validity and/or enforceability of the Depomed Patents in any
Proceeding involving future Lupin products other than Lupin’s ANDA Products that
are the subject of the Lupin ANDA.

 

Section 2.2.           Final Dismissal of Patent Litigation.  The Parties agree
to the entry of the Consent Injunction and Dismissal Order attached hereto as
Exhibit A.  To effectuate this final settlement, by no later than the first
(1st) business day following the Effective Date, the Parties shall cause the
Consent Injunction and Dismissal Order attached hereto as Exhibit A (each Party
acknowledging that the approval of the court is required in order to make such
Consent Injunction and Dismissal Order effective) to be filed with the United
States District Court for the Northern District of California and shall take all
other necessary actions to obtain the settlement and dismissal of the
Litigation.

 

Section 2.3.           Patent Validity and No Challenge.

 

(a)           Lupin acknowledges and agrees for itself and its Affiliates that
[***].

 

(b)           Lupin for itself and its Affiliates, agrees:  (i) not to challenge
and not to assist others, whether directly or indirectly, in challenging the
validity, enforceability, or patentability of the Depomed Patents in conjunction
with the Lupin ANDA Products or any other Generic Equivalent; and (ii) not to
assert that the Lupin ANDA Products or any other Generic Equivalent would not
infringe the Depomed Patents, in any court or administrative agency having
jurisdiction to consider the issue.  Nothing herein will prevent Lupin or its
Affiliates from responding to subpoenas from courts or administrative agencies. 
Notwithstanding the foregoing, nothing herein shall prevent or impair the right
of Lupin to challenge the infringement, validity and/or enforceability of the
Depomed Patents in any Proceeding involving future Lupin products other than
Lupin’s ANDA Products that are the subject of the Lupin ANDA and any Generic
Equivalent.

 

(c)           Nothing herein shall be construed as an admission or waiver as to
any factual or legal matter by any Party or their Affiliates with respect to any
jurisdiction outside of the Territory.

 

Section 2.4.           Mutual Agreements.  Each Party acknowledges and agrees
that:

 

 

Confidential Information, indicated by [***] has been omitted from this filing
and filed separately with the Securities and Exchange Commission.

 

4

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It may have sustained Losses that are presently unknown and unsuspected, and
that such Losses might give rise to Losses in the future.  Nevertheless, each
Party acknowledges and agrees that this Agreement has been negotiated and agreed
upon, notwithstanding the existence of such possible Losses, all of which have
been hereby released under Section 2.1 hereof.

 

If any fact relating to this Agreement or the Litigation now believed to be true
is found hereafter to be other than, or different from, that which is now
believed, each Party expressly assumes the risk of such difference in fact and
agrees that this Agreement shall be, and will remain, effective notwithstanding
any such difference in fact, subject to each Party’s right to bring a Proceeding
for a breach of any representation, warranty or covenant herein.

 

This Agreement may be pleaded as a full and complete defense to, and used as a
basis for injunction against, any Proceeding that may be instituted, prosecuted
or attempted in breach hereof.

 

Section 2.5.           [***]

 

ARTICLE 3
LICENSE

 

Section 3.1.           License Grant.  Effective upon the License Effective
Date, Depomed hereby grants to Lupin, and Santarus hereby consents to and
authorizes the grant to Lupin of, a fully paid up, royalty free, non-exclusive
(except as otherwise provided herein) license with respect to the Depomed
Patents, with the right to grant sublicenses to Affiliates, (i) to make, have
made, use, promote, offer to sell, sell, import, or otherwise dispose of
Licensed Products in or for the Territory, and (ii) to make and have made the
Licensed Products outside the Territory only for use, sale and importation in or
for the Territory.  Further, in connection with the Depomed Products, Santarus
and Depomed agree to waive and hereby waive, for themselves and their
Affiliates, any and all regulatory exclusivities (including, without limitation,
pediatric exclusivity) vis-à-vis the Licensed Products only that may prevent the
approval of the Licensed Products in the Territory under the Lupin ANDA on or
after the License Effective Date, as may be accelerated pursuant to the terms
herein.  At Lupin’s request, Santarus and Depomed shall confirm to the FDA (in a
form acceptable to all the Parties) the licenses and waivers granted by Santarus
and Depomed hereunder, and shall do so within [***] Lupin’s request.

 

Section 3.2.           Covenant Not To Sue.  With respect to the Licensed
Products, and effective on the Effective Date (subject to Lupin’s compliance
with this Agreement, including Section 3.3), Depomed, Santarus and their
Affiliates covenant not to sue Lupin and its/or their Affiliates, Related
Parties, and their manufacturers, importers, suppliers, distributors, marketing
partners and customers, or support or encourage any Third Party to sue, for
infringement of any Depomed Patents, or any United States or foreign patent
application or any other issued United States or foreign patent owned, licensed
or controlled by Depomed, Santarus or their Affiliates now or in the future
purporting to cover the Licensed Products, based on Lupin’s and/or any
Affiliate’s making, using, importing, selling, or offering for sale in or for
the Territory, or making or having made outside the Territory only for
importation, use, sale or offering for sale into or for the Territory, the
Licensed Products (“Covenant Not To Sue”).  Depomed, Santarus and their
Affiliates will impose the foregoing Covenant Not To Sue on any Third Party to
whom

 

 

Confidential Information, indicated by [***] has been omitted from this filing
and filed separately with the Securities and Exchange Commission.

 

5

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Depomed, Santarus or their Affiliates may assign, exclusively license, or
otherwise transfer any of the Depomed Patents or any other United States or
foreign patents purporting to cover the Licensed Products.  Depomed, Santarus
and their Affiliates further covenant that for any patent owned, licensed or
controlled by Depomed, Santarus or their Affiliates listed in the future in the
Orange Book for the Depomed Products, the foregoing Covenant Not To Sue shall
hereby be treated to also be in the form of a non-exclusive license limited to
the Licensed Products, for the sole purpose of permitting Lupin and its
Affiliates to file a “Paragraph IV Certification” against such patents under 21
U.S.C. § 355(j)(2)(A)(vii)(IV) (as amended or replaced).  Lupin shall have the
right to maintain its existing “Paragraph IV Certification” under 21 U.S.C.
§ 355(j)(2)(A)(vii)(IV) (as amended or replaced) against the Depomed Patents and
as to any other patent listed in the FDA’s Orange Book in connection with the
Depomed Products.  Lupin also shall have the right to file a new Paragraph IV
Certification against any patents listed in the future in the FDA’s Orange Book
for the Depomed Products and still be covered by the Covenant Not To Sue
provided for in this Section 3.2.

 

Section 3.3.           Restrictions Prior to License Effective Date.  Except as
permitted by this Section 3.3, Lupin and their Affiliates and Related Parties
shall not make, have made, import into, distribute, offer to sell, or sell in
the Territory any Licensed Products prior to the License Effective Date.  Lupin
agrees that any breach by either or both of them, or their Affiliates and/or
Related Parties, of this Section 3.3 shall cause irreparable harm to Depomed and
Santarus, and Lupin and their Affiliates, and their Related Parties consent
irrevocably and unconditionally to specific performance, or immediate entry of a
temporary restraining order, preliminary injunction, and permanent injunction,
to enforce this Section 3.3.  Notwithstanding anything to the contrary, Lupin,
their Affiliates and their Related Parties consent irrevocably and
unconditionally to personal jurisdiction and venue in the United States District
Court for the Northern District of California for the purpose of enforcing this
provision.  Notwithstanding the foregoing, Lupin shall have the right and
license under this Agreement to engage in the following activities:

 

(a)           [***] and

 

(b)           [***]

 

Section 3.4.           Impact of Granting Certain Licenses To Third Parties.  In
the event that Depomed or Santarus or any of their Affiliates enters into an
agreement with any Third Party or an Affiliate granting such party a license,
sublicense, covenant or other agreement or authorization, as applicable, to
Market in the Territory a Generic Equivalent of the Depomed Products prior to
[***] after [***], then the License Effective Date in this Agreement shall
automatically be amended to be the date that is [***] prior to the date such
Third Party or Affiliate is permitted to Market such Generic Equivalent of the
Depomed Products in the Territory under the license, sublicense, covenant or
other agreement or authorization from Depomed, Santarus and/or their
Affiliates.  For avoidance of doubt, Depomed, Santarus and their Affiliates
shall not enter into any agreement with any Third Party or Affiliate granting
such party a license, sublicense, covenant or other agreement or authorization,
as applicable, to Market in the Territory a Generic Equivalent of the Depomed
Products any earlier than [***] after the License Effective Date (as such
License Effective Date may be accelerated pursuant to this Agreement).  Depomed
and Santarus shall provide Lupin with reasonable advance notice of any

 

 

Confidential Information, indicated by [***] has been omitted from this filing
and filed separately with the Securities and Exchange Commission.

 

6

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Third Party or Affiliate permitted a Marketing date that is earlier than [***]
after [***], and in no event less than [***] prior to such Third Party or
Affiliate permitted Marketing date.

 

Section 3.5.           [***].

 

Section 3.6.           [***]  Notwithstanding the provisions of Sections 3.4 and
3.5, Depomed and Santarus shall have the right to:  [***]

 

Section 3.7.           Impact Of Final Court Decision.  In the event of a Final
Court Decision in a proceeding involving a Third Party proposing to market a
Generic Equivalent prior to the License Effective Date of invalidity and/or
unenforceability and/or non-infringement of each of the unexpired claims of the
Depomed Patents asserted and adjudicated in such proceeding, then the License
Effective Date shall automatically be accelerated and amended to the date of
such Final Court Decision.

 

Section 3.8.           No Interference But No Consent for FDA Approval.  Depomed
and Santarus shall not, and shall not cause any Affiliate or Third Party to:
(a) initiate any activity (including but not limited to the filing of any
citizen petitions or litigation against the FDA) to interfere with or obstruct
Lupin’s efforts to (i) obtain FDA approval of the Lupin ANDA, or (ii) launch
Lupin’s ANDA Products as of the date and under the terms provided by this
Agreement; and/or (b) unless required by law, (i) delist or cancel the Depomed
Products or NDA No. 21-748 with the FDA, (ii) delist or remove any Depomed
Patents, or the Depomed Products or NDA 21-748, from the FDA’s Orange Book,
(iii) seek or otherwise undertake any action with the FDA to withdraw the
Depomed Products from the market, or (iv) delete, remove, designate as
“obsolete” or cancel any National Drug Code(s) or any other relevant code(s) for
the Depomed Products from the applicable National Drug Data File maintained by
First Databank (or any successor or equivalent organization), or from any other
pricing database.  Neither this Agreement nor this Section shall be interpreted
as Depomed’s or Santarus’ consent to approval from the FDA or any other
applicable regulatory authority for Lupin to market a product containing
metformin in the Territory.  As Lupin may reasonably request, Depomed and
Santarus will submit, or will cause their Affiliates to submit, appropriate and
reasonable documentation to the FDA evidencing this Agreement.  Notwithstanding
the above, this Section does not preclude Depomed, Santarus and/or their
Affiliates from taking any action necessary or commencing a Proceeding to secure
or maintain their statutory rights under 21 U.S.C. §355a.

 

Section 3.9.           Limited Use of Agreement Outside Territory. Depomed,
Santarus and Lupin agree that neither will use this Agreement or the Consent
Injunction and Dismissal Order outside of the Territory for any purpose except
to enforce the Agreement.

 

Section 3.10.         Effect of Third Party Launch After Trial Court Decision. 
If, prior to the License Effective Date, any Third Party launches any Generic
Equivalent after a trial court enters a final judgment holding that each of the
unexpired asserted and adjudicated claims of the Depomed Patents is invalid or
unenforceable or not infringed (a “Third Party At-Risk Launch”), Lupin has the
option of launching Lupin’s ANDA Products at that time (“Lupin At-Risk Launch”)
only under the following conditions:

 

 

Confidential Information, indicated by [***] has been omitted from this filing
and filed separately with the Securities and Exchange Commission.

 

7

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(a)           Lupin agrees that during such Lupin At-Risk Launch, if Depomed
and/or Santarus obtains a court order from any court requiring, or if Depomed
and/or Santarus and any Third Party enter into an agreement that requires, the
cessation of sales of the Generic Equivalent that is the subject of the Third
Party At-Risk Launch, Lupin will cease further shipping and At-Risk sales of
Lupin’s ANDA Products and any other infringing activities until the occurrence
of the License Effective Date (including any acceleration of the License
Effective Date under the terms of this Agreement) or until the occurrence of
another Third-Party At-Risk Launch.

 

(b)           Notwithstanding Section 2.1 above, in the event of a Final Court
Decision as to the foregoing Third Party launching the Generic Equivalent that
any claims of the Depomed Patents asserted in the Third Party proceeding are not
invalid and not unenforceable and that such claims are infringed, [***], and
Lupin reserves all rights to contest and defend against, and to assert any and
all defenses to, such a claim except that Lupin may not contest and may not
raise as a defense the invalidity or unenforceability of any asserted Depomed
Patent claim that such Final Court Decision affirms as valid and/or enforceable.

 

Section 3.11.         Effect of Third Party Launch Before Trial Court Decision. 
If, prior to the License Effective Date, any Third Party launches any Generic
Equivalent prior to a trial court entering a final judgment holding that each of
the unexpired asserted and adjudicated claims of the Depomed Patents is invalid
or unenforceable or not infringed (a “Third Party True At-Risk Launch”), Lupin
has the option of launching Lupin’s ANDA Products (“Lupin True At-Risk Launch”)
only under the following conditions:

 

(a)           Lupin may commence Lupin True At-Risk Launch no earlier than [***]
after the Third Party True At-Risk Launch, and only after providing Depomed and
Santarus written notice [***] before any intended True At-Risk Launch.

 

(b)           Lupin agrees that during any such Lupin True At-Risk Launch, if
(i) Depomed obtains a court order from any court requiring, or Depomed and/or
Santarus and any Third Party enter into an agreement that requires, the
cessation of sales of the Generic Equivalent that is the subject of the Third
Party True At-Risk Launch or (ii) the Third Party ceases sales of the Generic
Equivalent that is the subject of the Third Party True At-Risk Launch, by
agreement or otherwise, before the expiration of the [***] period in
Section 3.11(a), Lupin will cease any shipping and True At-Risk sales of Lupin’s
ANDA Products and any other infringing activity until the occurrence of the
License Effective Date (including any acceleration of the License Effective Date
under the terms of this Agreement), or until the occurrence of another
Third-Party True At-Risk Launch.  For the avoidance of doubt, this paragraph
does not terminate Lupin’s right to invoke the provisions of Sections 3.7 and/or
3.10 if they become applicable before the License Effective Date.

 

(c)           Notwithstanding Section 2.1 above, in the event there is a Final
Court Decision with the Third Party launching the Generic Equivalent under this
Section 3.11 that any claims of the Depomed Patents asserted in the Third Party
proceeding are not invalid and not unenforceable and that such claims are
infringed, [***] and before any reliance by Lupin on the provisions of Sections
3.7 and/or 3.10, and Lupin reserves all rights to contest and defend against,
and to assert any and all defenses to, such a claim except that Lupin may not
contest and

 

 

Confidential Information, indicated by [***] has been omitted from this filing
and filed separately with the Securities and Exchange Commission.

 

8

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may not raise as a defense the invalidity or unenforceability of any asserted
Depomed Patent claim that such Final Court Decision affirms as valid and/or
enforceable.

 

Section 3.12.         Reservation of Rights.  All rights not expressly granted
to Lupin hereunder are expressly reserved to Depomed and Santarus, and neither
Depomed nor Santarus has any obligation to make available any intellectual
property rights or to take any other actions other than as expressly set forth
herein.  Except as expressly provided herein, nothing in this Agreement shall be
construed as granting Lupin or their Affiliates, subsidiaries or Related Parties
any rights: (a) with respect to any Licensed Products outside the Territory;
(b) with respect to any product other than Licensed Products; or (c) to make,
have made, use, offer to sell, sell, import, or otherwise dispose of any generic
version of any Depomed Products covered by Depomed Patents at any time prior to
the License Effective Date.

 

Section 3.13.         [***]

 

(a)           [***]  During each calendar quarter, commencing on the Effective
Date and terminating on the date that is three (3) months prior to the License
Effective Date, [***]

 

(b)           [***]  During each calendar year (and prorated for any partial
calendar years), commencing on the Effective Date and terminating on the date
that is three (3) months prior to the License Effective Date, [***]

 

(c)           Reporting.  Commencing on the Effective Date and terminating on
the date that is three (3) months prior to the License Effective Date (the
“Reporting Period”), Santarus or Depomed shall provide Lupin with the following
periodic reports:  (i) within [***] following the end of each calendar quarter
during the Reporting Period, a report of the [***] and (ii) within [***]
following the end of each calendar year during the Reporting Period, a report of
the [***].

 

(d)           [***]  In the event that Santarus and/or Depomed:  (i) fail to
perform the aggregate [***] obligations set forth in Section 3.13(a) during any
calendar quarter during the Reporting Period; or (ii) fail to perform the
aggregate [***] obligations set forth in Section 3.13(b) during any calendar
year period during the Reporting Period (each, a “Failure Event”), then Lupin
shall provide each of Depomed and Santarus with written notice specifying the
alleged Failure Event (the “Lupin Notice”).  Santarus and/or Depomed shall have
an opportunity to dispute the facts underlying the alleged Failure Event (or
provide evidence of a cure, as described below) by providing written notice to
Lupin within [***] following the date of the Lupin Notice (the “Response
Notice”).  In the event that Santarus and/or Depomed does not provide a Response
Notice, the License Effective Date shall be accelerated to the date that is
[***] following the date of the Lupin Notice.  In the event that Santarus and/or
Depomed does provide a Response Notice, then, notwithstanding the provisions of
Section 6.2, Lupin may commence arbitration proceedings in accordance with
Section 3.13(e) to determine whether a Failure Event has occurred by delivering
a written notice to Depomed and Santarus within [***]  after delivery of such
Response Notice.  If a Failure Event is determined to have occurred pursuant to
Section 3.13(e) below or by agreement among the Parties, the License Effective
Date will be accelerated to the date of such determination.  Notwithstanding the
foregoing, in the event Santarus and/or Depomed decide [***], Santarus and/or
Depomed shall notify Lupin of such decision within [***] thereof [***], and the
License Effective Date will be accelerated to

 

 

Confidential Information, indicated by [***] has been omitted from this filing
and filed separately with the Securities and Exchange Commission.

 

9

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the date of such [***].  Also notwithstanding the foregoing, a Failure Event
shall not be deemed to have occurred in the event that Santarus and/or Depomed
specifies its intent to cure the alleged breach in the Response Notice and
provides written evidence to Lupin that the applicable [***] obligations were
reinitiated at the rates required by Sections 3.13(a) and 3.13(b) as of the date
of the Response Notice.

 

(e)           Failure Event Arbitration Proceedings.  Any dispute regarding
whether a Failure Event has occurred pursuant to Section 3.13(d) shall be
resolved by arbitration before a single arbitrator in accordance with the
Commercial Arbitration Rules of the American Arbitration Association (“AAA”)
then pertaining (available at http://www.adr.org), except where those
rules conflict with this provision, in which case this provision controls.  Any
court with jurisdiction shall enforce this clause and enter judgment on any
final determination.  The AAA shall select the arbitrator within [***] from
commencement of the arbitration from the AAA’s National Roster of Arbitrators
pursuant to agreement or through selection procedures administered.  Within
[***] of initiation of arbitration, the Parties shall reach agreement upon and
thereafter follow procedures, including without limitation limits on discovery,
assuring that the arbitration will be concluded and the final determination
rendered within no more than [***]  from selection of the arbitrator or, failing
agreement, procedures meeting such time limits will be designed by the AAA and
adhered to by the Parties.  The arbitration shall be held in San Francisco,
California and the arbitrator shall apply the substantive law of California,
except that the Federal Arbitration Act shall govern the interpretation and
enforcement of this arbitration provision.  Prior to appointment of the
arbitrator or thereafter if he is unavailable, emergency relief is available
from any court to avoid irreparable harm.

 

(f)            [***]

 

ARTICLE 4
REPRESENTATIONS, WARRANTIES AND COVENANTS

 

Section 4.1.           Mutual Representations.  Each Party hereby represents and
warrants to the other Party as of the Effective Date as follows:

 

(a)           Due Authorization.  Such Party is an entity duly organized and in
good standing as of the Effective Date, and the execution, delivery and
performance of this Agreement by such Party have been duly authorized by all
necessary action on the part of such Party.

 

(b)           Due Execution.  This Agreement has been duly executed and
delivered by such Party and, with due authorization, execution and delivery by
the other Party, constitutes a legal, valid and binding obligation of such
Party, enforceable against such Party in accordance with its terms.

 

(c)           No Conflict.  Such Party’s execution, delivery and performance of
this Agreement do not: (i) violate, conflict with or result in the breach of any
provision of the charter or by-laws (or similar organizational documents) of the
Party; (ii) conflict with or violate any law or governmental order applicable to
the Party or any of its assets, properties or businesses; or (iii) conflict
with, result in any breach of, constitute a default (or event which with the
giving of notice or lapse of time, or both, would become a default) under,
require any consent under, or

 

Confidential Information, indicated by [***] has been omitted from this filing
and filed separately with the Securities and Exchange Commission.

 

10

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give to others any rights of termination, amendment, acceleration, suspension,
revocation or cancellation of any note, bond, mortgage or indenture, contract,
agreement, lease, sublease, license, permit, franchise or other instrument or
arrangement to which it is a party.

 

Section 4.2.                                 Depomed and Santarus
Representations and Warranties.  Depomed and Santarus represent and warrant to
Lupin that, as of the Effective Date, Depomed and Santarus:  (i) have the right
to grant to Lupin the licenses granted hereunder with respect to the Depomed
Patents; (ii) have the right to grant the Covenant Not To Sue; and (iii) have
the right to settle the Litigation under and pursuant to the terms in this
Agreement.  Depomed and Santarus further warrant, represent and agree that, if
Depomed, Santarus or their Affiliates enter into any agreement, license,
sublicense, settlement, covenant, waiver or other authorization of any kind with
any Third Party or an Affiliate involving a Generic Equivalent Product or
Authorized Generic (“Third Party Agreement”), and such Third Party Agreement
contains any more favorable terms regarding [***], then the applicable terms in
the Agreement shall be automatically amended to provide such more favorable
terms to Lupin, as amended to conform to any additional rights granted to Lupin
under, without limitation, Sections 3.4 and 3.5 hereof.  Depomed and Santarus
shall inform Lupin within ten (10) days of any amendment to the applicable terms
in the Agreement, as applicable.

 

Section 4.3.                                 Lupin Representations and
Warranties.  Lupin represents and warrants to Depomed that, as of the Effective
Date:  (i) Lupin or its Affiliates own all right, title and interest in, to and
under the Lupin ANDA, and Lupin and its Affiliates have not granted or assigned
to any Third Party, directly or indirectly, any rights under or to the Lupin
ANDA or Lupin’s ANDA Products; (ii) Lupin and its Affiliates will not transfer
ownership, in whole or in part, of said Lupin ANDA, except to an Affiliate of
Lupin or to a successor to all or substantially all of the business to which
this Agreement pertains (i.e., Lupin’s ANDA and Lupin’s ANDA Products), until
the expiration of the license granted herein; and (iii) Lupin has the right to
settle the Litigation under and pursuant to the terms in this Agreement.  Lupin
holds, and shall use all reasonable efforts to maintain, the first-filer 180-day
exclusivity with regard to the Lupin ANDA and the Lupin ANDA Products.

 

Section 4.4.                                 Lupin’s Covenant Not to Sue Depomed
Products.  With respect to Depomed Products, Lupin covenants not to sue Depomed
and/or Santarus and their respective Affiliates, Related Parties, and their
importers, suppliers, distributors, and customers, or support or encourage any
Third Party to sue, for infringement of any patent owned, licensed, or
controlled by Lupin, their Affiliates, and their Related Parties.

 

Section 4.5.                                 Disclaimer.  EXCEPT AS EXPRESSLY
PROVIDED IN THIS AGREEMENT, NO PARTY MAKES ANY REPRESENTATIONS OR WARRANTIES,
EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF APPLICABLE LAW, AND EACH
PARTY HEREBY EXPRESSLY DISCLAIMS SUCH WARRANTIES.

 

ARTICLE 5
INDEMNIFICATION

 

Section 5.1.                                 Depomed and Santarus
Indemnification.  Depomed and Santarus shall indemnify and hold harmless Lupin,
their Affiliates, and their Related Parties (“Lupin

 

 

Confidential Information, indicated by [***] has been omitted from this filing
and filed separately with the Securities and Exchange Commission.

 

11

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Indemnitees”) from and against any liabilities, damages, costs, or expenses,
including reasonable attorneys’ fees and expert fees, incurred by any Lupin
Indemnitee that arise from any claims, actions, demands, suits, or other cause
of action by a Third Party arising out of or related to any breach of Depomed’s
or Santarus’ representations, warranties and covenants set forth in this
Agreement.

 

 

Section 5.2.                                 Lupin Indemnification.  Lupin shall
indemnify and hold harmless each of Depomed and Santarus, and their respective
Affiliates and Related Parties (“Depomed/Santarus Indemnitees”) from and against
any liabilities, damages, costs, or expenses, including reasonable attorneys’
fees and expert fees, incurred by any Depomed/Santarus Indemnitee that arise
from any claims, actions, demands, suits or other cause of action by a Third
Party arising out of or related to any breach of Lupin’s, as applicable,
representations, warranties and covenants set forth in this Agreement.

 

Section 5.3.                                 Indemnification Procedures.  The
obligations to indemnify, defend, and hold harmless set forth in Section 5.1 and
Section 5.2 shall be contingent upon the Party seeking indemnification (the
“Indemnitee”): (i) notifying the indemnifying Party of a claim, demand or suit
within fifteen (15) calendar days of receipt thereof; provided, however, that
the Indemnitee’s failure or delay in providing such notice shall not relieve the
indemnifying Party of its indemnification obligation except to the extent the
indemnifying Party is prejudiced thereby; (ii) allowing the indemnifying Party
and/or its insurers the right to assume direction and control of the defense of
any such claim, demand or suit; (iii) cooperating with the indemnifying Party
and/or its insurers in the defense of such claim, demand or suit at the
indemnifying Party’s expense; and (iv) agreeing not to settle or compromise any
claim, demand or suit without prior written authorization of and a release from
the indemnifying Party.  The Indemnitee shall have the right to participate in
the defense of any such claim, demand or suit referred to in this
Article utilizing attorneys of its choice, at its own expense, provided,
however, that the indemnifying Party shall have full authority and control to
handle any such claim, demand or suit.

 

ARTICLE 6
MISCELLANEOUS

 

Section 6.1.                                 Assignment.  None of the Parties
hereto may assign any of its rights or obligations under this Agreement, except
to an Affiliate or successor to all or substantially all of the business of the
Party to which this Agreement pertains (i.e., Santarus’ New Drug Application NDA
No. 021748 and the Depomed Products or Lupin’s ANDA and Lupin’s ANDA Products,
as the case may be), without the prior written consent of the other Parties. 
Any Party may assign this Agreement without the prior written consent of the
other Parties to an Affiliate or in connection with a merger, reorganization,
change of control or sale of all or substantially all of the applicable business
of such Party, in each case, on written notice to the other Parties, provided
that the successor Person agrees in writing to adhere to all of the terms and
conditions of this Agreement.  Any purported assignment in violation of the
foregoing shall be null and void and of no force or effect.  No assignment of
this Agreement will relieve the assigning Party from any of its obligations
hereunder.  In the event of a permitted assignment, this Agreement shall be
binding upon and inure solely to the benefit of the Parties and their respective
successors and permitted assigns.

 

 

Confidential Information, indicated by [***] has been omitted from this filing
and filed separately with the Securities and Exchange Commission.

 

12

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Section 6.2.                                 Dispute Resolution.  Except for
Failure Event Arbitration Proceedings under Sections 3.13(d) and (e), any
dispute, controversy or claim arising out of or relating to this Agreement (a
“Dispute”) shall be attempted to be settled by the Parties, in good faith, by
submitting each such Dispute to the Chief Executive Officers of each Party by
written notice from one Party to the other Parties specifying the terms of such
Dispute in reasonable detail.  Within ten (10) calendar days of receipt of such
notice, the Chief Executive Officers of each Party involved in the Dispute or a
member of management designated by the respective Chief Executive Officer, shall
meet in person (at a mutually agreed upon time and location) or by telephone for
the purpose of resolving such Dispute.  They will discuss the problems and/or
negotiate for a period of up to twenty (20) calendar days in an effort to
resolve the Dispute or negotiate an acceptable interpretation or revision of the
applicable portion of this Agreement mutually agreeable to all Parties, without
the necessity of formal procedures relating thereto.  If the problem is not
resolved within the period set forth above, each Party shall be free to pursue
all available remedies, at law or in equity, consistent with the terms of this
Agreement.  Notwithstanding the foregoing, any Party may apply to a court of
competent jurisdiction for a temporary restraining order, preliminary
injunction, or other equitable relief, where such relief is necessary to protect
its interests.

 

Section 6.3.                                 Governing Law and Venue.  This
Agreement shall be governed by and construed in accordance with the laws of the
State of California, without giving effect to its conflict of laws principles. 
The Parties hereby consent to the exclusive jurisdiction of the federal courts
located in the State of California, and expressly waive any objections or
defenses based on lack of personal jurisdiction or venue in connection with any
dispute arising out of or relating to this Agreement.

 

Section 6.4.                                 Bankruptcy.  All rights and
licenses granted under or pursuant to any Section of this Agreement are, and
shall otherwise be deemed to be, for purposes of Section 365(n) of the U.S.
Bankruptcy Code (the “Bankruptcy Code”), licenses of “intellectual property” as
defined under the Bankruptcy Code.  The Parties shall retain and may fully
exercise all of their respective rights and elections under the Bankruptcy Code.

 

Section 6.5.                                 Confidentiality.  Depomed,
Santarus, Lupin, their Affiliates and Related Parties shall not use or disclose
to Third Parties any information received from any other Party or otherwise
developed or obtained by any Party in the performance of activities under this
Agreement without first obtaining the written consent of the disclosing Party,
except as may be otherwise provided in, or required in order for a Party to
exercise its rights or fulfill its obligations under, this Agreement.  This
confidentiality obligation shall not apply to information that:  (i) is or
becomes a matter of public knowledge (other than by breach of this Agreement by
the receiving Party); (ii) is required by law, regulation or order of a court or
administrative agency of competent jurisdiction, to be disclosed; (iii) the
receiving Party can establish was already known to it or was in its possession
at the time of disclosure; (iv) the receiving Party can establish was
independently developed by Persons in its employ who had no contact with and
were not aware of the content of the confidential information; (v) is disclosed
to the receiving Party by a Third Party having no obligation of confidentiality
to the disclosing Party with respect to such information; or (vi) is necessary
for Lupin to disclose to the FDA in order to secure and/or maintain approval of
the Lupin ANDA and Lupin’s ANDA Products.  The Parties shall

 

 

Confidential Information, indicated by [***] has been omitted from this filing
and filed separately with the Securities and Exchange Commission.

 

13

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take reasonable measures to assure that no unauthorized use or disclosure is
made by others to whom access to such information is granted.

 

Section 6.6.                                 Publicity.  Except as consistent
with a press release mutually agreed by all the Parties prior to the execution
and delivery of this Agreement, no public announcement or other disclosure to
Third Parties concerning the existence of or terms of this Agreement shall be
made, either directly or indirectly, by any Party without first obtaining the
written approval of each member of the other Parties to this Agreement and
agreement upon the nature, text and timing of such announcement or disclosure;
provided, however, any Party shall have the right to make any such public
announcement or other disclosure required by law after such Party has provided
to the other Parties a copy of such announcement or disclosure and an
opportunity to comment thereon.  Each Party agrees that it shall cooperate fully
with the others with respect to all disclosures regarding this Agreement to the
Securities and Exchange Commission (“SEC”) and any other governmental or
regulatory agencies, including requests for confidential treatment of
proprietary information of any member of the Parties included in any such
disclosure.  None of the Parties shall be required to provide to any other Party
any advance notice of any public announcements or other disclosures related to
periodic, routine financial reporting unless such announcement or other
disclosure will include non-routine information relating to the Licensed
Products and this Agreement.  The Parties are aware that each of Depomed and
Santarus are obligated to generally describe the terms of this Agreement and to
file a redacted version of this Agreement with its periodic reports pursuant to
applicable regulations of the SEC, and each of Depomed and Santarus agrees to
seek confidential treatment of the terms of the Agreement to the extent
permitted under applicable laws and to provide Lupin with a reasonable
opportunity to review and comment on the confidential treatment request prior to
submission to the SEC.

 

Section 6.7.                                 Cooperation.  Subject to
confidentiality restrictions that may be reasonably requested, the Parties shall
use their respective commercially reasonable efforts to:

 

(a)                                 Make all required filings with all
governmental authorities and obtain all necessary approvals in connection with
this Agreement to the extent required under applicable laws.  Subject to
confidentiality restrictions that may be reasonably requested and to the extent
permissible by law, the Parties shall coordinate and exchange all filings and
documents submitted to all government authorities regarding this Agreement;

 

(b)                                 Cooperate with each other in any review,
investigation, inquiry or proceeding regarding the Agreement by any government
authority.  Subject to such confidentiality restrictions as may be reasonably
requested and to the extent permissible by law, the Parties will render
reasonable assistance as the others may request in connection with this
Agreement and coordinate and cooperate with one another in exchanging
information, permitting reasonable access to each Party’s and their Affiliates
documents, officials, and data in connection with any such review,
investigation, inquiry or proceeding by any governmental authority;

 

(c)                                  Promptly inform the others of any material
communication made to, or received by a Party from any governmental authority
regarding this Agreement;

 

(d)                                 Without limiting any other provision of this
Agreement, take all actions and do all things reasonably necessary or proper (at
its own cost and expense), including under

 

 

Confidential Information, indicated by [***] has been omitted from this filing
and filed separately with the Securities and Exchange Commission.

 

14

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applicable law to make effective and further the intent and purposes of the
transactions contemplated by this Agreement, including executing any further
instruments reasonably requested by any other Party, and to resist and to
contest any proposals or efforts to materially alter the terms of the Agreement
so as to permit the Parties to fulfill their obligations under and to obtain the
full benefits contemplated by the Agreement; and

 

(e)                                  The Parties agree that the entering into of
this Agreement and the performance of their respective obligations hereunder
shall be in compliance with all applicable federal, state and local laws, rules,
guidelines and regulations.

 

Section 6.8.                                 Government Proceedings.

 

(a)                                 Upon execution of this Agreement, the
Parties shall promptly inform the District Court that an agreement settling the
Litigation has been executed and request that proceedings be stayed to permit
the review provided for in this Section prior to termination of the Litigation.

 

(b)                                 By no later than the [***] following the
Execution Date, the Parties shall each file or cause to be filed with the U.S.
Federal Trade Commission, Bureau of Competition (“FTC”) and the Antitrust
Division of the U.S. Department of Justice (“DOJ”) this Agreement and any
notifications to be filed pursuant to Title XI of the Medicare Prescription Drug
Improvement and Modernization Act (Subtitle B — Federal Trade Commission Review)
and any other applicable law, and shall request confidential treatment of any
such submissions under all applicable law, rules and regulations.

 

(c)                                  The Parties shall use all commercially
reasonable efforts to coordinate the foregoing filings and any responses
thereto, to make such filings promptly and in good faith and to respond promptly
and in good faith to any requests for additional information made by either of
such agencies, and to coordinate any necessary or desirable joint
presentations.  Each Party reserves the right to communicate with the FTC or DOJ
regarding such filings as it believes appropriate.  Each Party shall keep the
other Parties informed of such communications and shall not disclose any
confidential information of the other Parties without such other Parties’
consent, which will not be unreasonably withheld or delayed.

 

(d)                                 If, within the [***] period after the
Parties have submitted this Agreement to the FTC and DOJ (the “FTC Review
Period”), the FTC (or its staff) or the DOJ raises an objection or expresses a
concern as to the provisions of this Agreement and if the FTC (or its staff) or
DOJ indicates that the objections or concerns are likely to result in an
investigation or a judicial or administrative proceeding against any of the
Parties in relation to this Agreement that will continue beyond the FTC Review
Period (a “Negative Response”), unless the Parties agree otherwise following
review of the Negative Response, the Parties shall use their commercially
reasonable efforts to overcome such Negative Response within the FTC Review
Period (or such extended period as the Parties may agree), including using their
commercially reasonable efforts to promptly meet in good faith to modify this
Agreement and resubmit it for approval pursuant to subsection 6.8(b) above (a
“Resubmission”); provided, however, that the License Effective Date shall not be
subject to modification, and in no event shall any Party be required to agree to
any

 

 

Confidential Information, indicated by [***] has been omitted from this filing
and filed separately with the Securities and Exchange Commission.

 

15

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modification of this Agreement that materially affects the economic value of the
transactions contemplated hereby.

 

(e)                                  The effective date of this Agreement (the
“Effective Date”) shall be the earlier of the date of expiration of the FTC
Review Period in which no Negative Response was received or the date of the
expiration, if applicable, of an additional FTC Review Period following a
Resubmission with regard to which no Negative Response was received.  In no
event will Lupin launch the Lupin ANDA Products prior to completion of the
review provided for in this Section 6.8.

 

Section 6.9.                                 Notices.  All notices required or
permitted under this Agreement must be in writing and must be given by
addressing the notice to the address for the recipient set forth below or at
such other address as the recipient may specify in writing under this
procedure.  Notices will be deemed to have been given (a):  three (3) business
days after deposit in the mail with proper postage for first class registered or
certified mail prepaid, return receipt requested; or (b) one (1) business day
after sending by nationally recognized overnight delivery service.

 

If to Depomed:

 

If to Lupin:

 

 

 

Depomed, Inc.

Attention: Legal Department

1360 O’Brien Drive

Menlo Park, CA 94025

Facsimile: (650) 462-9993

 

Lupin Limited

Attention: Managing Director

B/4 Laxmi Towers

Bandra Kurla Complex

Bandra (E)

Mumbai 400 051

India

 

 

 

 

 

Lupin Pharmaceuticals, Inc.

Attention: Vinita Gupta, Chief Executive Officer

Harborplace Tower

111 South Calvert Street 21st floor

Baltimore, MD 21202

 

 

 

With a copy (which shall not constitute notice hereunder) to:

 

With a copy (which shall not constitute notice hereunder) to:

 

 

 

William Gaede

McDermott, Will & Emery LLP

275 Middlefield Rd., Suite 100

Menlo Park, CA 94025

Facsimile: (650) 815-7401

 

William A. Rakoczy

Rakoczy Molino Mazzochi Siwik LLP

6 West Hubbard Street, Suite 500

Chicago, Illinois, 60654

Facsimile: (312) 222-6321

 

If to Santarus:

 

 

 

 

Confidential Information, indicated by [***] has been omitted from this filing
and filed separately with the Securities and Exchange Commission.

 

16

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Santarus, Inc.

 

 

Attention:  Chief Executive Officer

 

 

3721 Valley Centre Dr., Suite 400

 

 

San Diego, CA 92130

 

 

Facsimile:  (858) 314-5701

 

 

 

 

 

With a copy (which shall not constitute notice hereunder) to:

 

 

 

 

 

Santarus, Inc.

 

 

Attention:  Legal Department

 

 

3721 Valley Centre Dr., Suite 400

 

 

San Diego, CA 92130

 

 

Facsimile:  (858) 314-5702

 

 

 

Section 6.10.                          Amendment.  This Agreement may not be
amended or modified except by an instrument in writing signed by authorized
representatives of each of Depomed, Santarus and Lupin.

 

Section 6.11.                          No Waiver.  The failure of any Party to
enforce at any time for any period the provisions of or any rights deriving from
this Agreement shall not be construed to be a waiver of such provisions or
rights or the right of such Party thereafter to enforce such provisions.

 

Section 6.12.                          Severability.  If any term or other
provision of this Agreement is invalid, illegal or incapable of being enforced
by any law or public policy, all other terms and provisions of this Agreement
shall nevertheless remain in full force and effect so long as the economic or
legal substance of the transactions contemplated hereby is not affected in any
manner materially adverse to any Party.

 

Section 6.13.                          Headings.  The descriptive headings
contained in this Agreement are for convenience of reference only and shall not
affect in any way the meaning or interpretation of the Agreement.

 

Section 6.14.                          Counterparts.  This Agreement may be
executed in one or more counterparts, and by the respective Parties in separate
counterparts, each of which when executed shall be deemed to be an original but
all of which taken together shall constitute one and the same Agreement.

 

Section 6.15.                          Entire Agreement.  This Agreement
constitutes the entire agreement between the Parties with respect to the subject
matter hereof, and no oral or written statement that is not expressly set forth
in this Agreement may be used to interpret or vary the meaning of the terms and
conditions hereof.  This Agreement supersedes any prior or contemporaneous
agreements and understandings, whether written or oral, between the Parties with
respect to the subject matter hereof.

 

 

Confidential Information, indicated by [***] has been omitted from this filing
and filed separately with the Securities and Exchange Commission.

 

17

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Section 6.16.                          Third Party Beneficiaries.  Except as
expressly provided herein, nothing in this Agreement, either express or implied,
is intended to or shall confer upon any Third Party any legal or equitable
right, benefit or remedy of any nature whatsoever under or by reason of this
Agreement.

 

Section 6.17.                          Scope of Agreement. The mutual releases
and licenses set forth in this Agreement shall be limited to the Lupin ANDA and
Lupin’s ANDA Products, and shall be without prejudice to, shall have no
preclusive effect as to, and shall not be admissible in any proceedings
pertaining to any future or different product(s) or ANDA(s).

 

Section 6.18.                          Force Majeure.  In the event of any
failure or delay in the performance by a Party of any provision of this
Agreement due to acts beyond the reasonable control of such Party (such as, for
example, fire, explosion, strike or other difficulty with workmen, shortage of
transportation equipment, supply disruption, accident, act of God, declared or
undeclared wars, acts of terrorism), then such Party shall have such additional
time to perform as shall be reasonably necessary under the circumstances.  In
the event of such failure or delay, the affected Party will use its diligent
efforts, consistent with sound business judgment and to the extent permitted by
law, to correct such failure or delay as expeditiously as possible.  In the
event that a Party is unable to perform by a reason described in this
Section 6.18, its obligation to perform under the affected provision of this
Agreement shall be suspended during such time of nonperformance.

 

Section 6.19.                          Right to Seek Injunctive Relief. 
Notwithstanding anything in this Agreement to the contrary, a Party may seek a
temporary restraining order or a preliminary injunction from any court of
competent jurisdiction in order to prevent immediate and irreparable injury,
loss, or damage on a provisional basis, pending the decision of the
arbitrator(s) on the ultimate merits of any dispute, controversy, or claim.

 

[Remainder of Page Intentionally Left Blank; Signature Page Follows]

 

 

Confidential Information, indicated by [***] has been omitted from this filing
and filed separately with the Securities and Exchange Commission.

 

18

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IN WITNESS WHEREOF, this Agreement has been executed by the Parties as of the
date first written above.

 

DEPOMED, INC.

LUPIN PHARMACEUTICALS, INC.

 

 

By:

/s/ James A. Schoeneck

 

By:

/s/ Vinita Gupta

 

 

 

 

 

Name:

James A. Schoeneck

 

Name:

Vinita Gupta

 

 

 

 

 

Title:

President & CEO

 

Title:

CEO

 

 

 

 

 

 

 

 

 

 

SANTARUS, INC.

 

LUPIN LIMITED

 

 

 

 

 

By:

/s/ Gerald T. Proehl

 

By:

/s/ Nilesh Gupta

 

 

 

 

 

Name:

Gerald T. Proehl

 

Name:

Nilesh Gupta

 

 

 

 

 

Title:

President & CEO

 

Title:

Group President

 

 

Confidential Information, indicated by [***] has been omitted from this filing
and filed separately with the Securities and Exchange Commission.

 

19

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EXHIBIT A

 

UNITED STATES DISTRICT COURT

NORTHERN DISTRICT OF CALIFORNIA

 

DEPOMED, INC.,

Plaintiff,

v.

 

LUPIN PHARMACEUTICALS, INC.,

 

Civil Action No. C 09-5587 PJH

 

Defendants.

 

CONSENT INJUNCTION AND DISMISSAL ORDER

 

This action for alleged patent infringement (the “Litigation”) has been brought
by Plaintiff Depomed, Inc. (“Depomed”) against Defendants Lupin
Pharmaceuticals, Inc. and Lupin Limited (collectively, “Lupin”) for alleged
infringement of United States Patent Nos. 6,635,280, 6,340,475, and 6,488,962
(collectively the “Depomed Patents”).  Depomed’s commencement of the Litigation
was based on its receipt of notice from Lupin Limited that Lupin Limited had
filed Abbreviated New Drug Application (“ANDA”) No. 91-664 with the United
States Food and Drug Administration containing a certification pursuant to 21
U.S.C. § 355(j)(2)(A)(vii)(IV) directed to the Depomed Patents and seeking
approval to market 500 mg and 1000 mg metformin tablets as a generic version of
Glumetza®.

 

Depomed and Lupin have agreed to enter into a good faith final settlement
agreement (the “Settlement and License Agreement”) regarding this Litigation on
the expectation and belief that this would eliminate the substantial litigation
costs that would otherwise be incurred by both Depomed and Lupin during the
Litigation, while also serving the public interest by saving judicial resources
and avoiding the risks to each of the parties associated with infringement.  The

 

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Settlement and License Agreement will afford Depomed and Lupin the
procompetitive opportunity to more productively use money and other resources
that would have been spent in the continued prosecution and defense of this
Litigation, to the benefit of the parties and consumers alike, such as by
investing more money in pharmaceutical research and development.

 

Each of Depomed and Lupin acknowledge there is significant risk to each of them
associated with the continued prosecution of this Litigation and have consented
to entry of this order through a final settlement as reflected herein.  The
Court, upon the consent and request of Depomed and Lupin, hereby issues the
following Order.

 

Depomed and Lupin now consent to this Consent Injunction and Dismissal Order and

 

IT IS HEREBY ORDERED that:

 

1.             Subject matter jurisdiction, personal jurisdiction, and venue are
all proper in this Court.

 

2.             In this Litigation, Depomed has charged Lupin with infringement
of the Depomed Patents in connection with Lupin Limited’s submission of ANDA
No. 91-664 directed to generic tablets containing 500 mg or 1000 mg of metformin
per tablet to the U.S. Food and Drug Administration (“FDA”).

 

3.             In response to Depomed’s charges of patent infringement, Lupin
has alleged certain defenses and counterclaims, including that the Depomed
Patents are invalid or not infringed.  The Court has not adjudicated Depomed’s
charges of patent infringement or Lupin’s defenses and counterclaims.

 

4.             Lupin has agreed that each of the defenses and counterclaims set
forth in its Answer, Affirmative Defenses and Counterclaims, including the
allegations and averments contained therein, should be dismissed, without
prejudice.

 

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5.             Lupin, their officers, agents, servants, employees and attorneys,
and those persons in active concert or participation with them who receive
actual notice of this Order by personal service or otherwise, are hereby
enjoined from manufacturing, using, offering to sell or selling within the
United States and its territories and possessions, including the Commonwealth of
Puerto Rico (the “Territory”), or importing into the Territory, any generic
tablet product containing 500 mg or 1000 mg of metformin per tablet that is the
subject of ANDA No. 91-664 until:

 

(a)   February 1, 2016; or

 

(b)   at such earlier date as may be permitted by the Settlement and License
Agreement that the Parties have entered into.

 

6.             Depomed and Lupin each expressly waives any right to appeal or
otherwise move for relief from this Consent Injunction and Dismissal Order.

 

7.             All claims and defenses as between Depomed and Lupin are hereby
dismissed without prejudice.

 

8.             This Court retains jurisdiction over Depomed and Lupin for
purposes of enforcing this Consent Injunction and Dismissal Order.

 

9.             The Clerk of the Court is directed to enter this Consent
Injunction and Dismissal Order forthwith.

 

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IT IS SO STIPULATED:

 

 

 

 

Attorneys for Plaintiff
Depomed

 

Attorneys for Defendants
Lupin

 

 

 

 

 

 

Of Counsel:

 

Of Counsel:

 

 

SO ORDERED:

 

This                  day of                  , 2012

 

 

 

 

HONORABLE PHYLLIS J. HAMILTON

 

UNITED STATES DISTRICT JUDGE

 

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