LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
EXHIBIT 10.14
XXXXXX INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.
EXECUTION COPY
LICENSE, DEVELOPMENT AND COMMERCIALIZATION
AGREEMENT
AGREEMENT
This LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT (the “Agreement”) is entered into as
of December 15, 2010 (the “Effective Date”) by and between IMPAX LABORATORIES, INC., a Delaware
corporation with its principal place of business at 00000 Xxxxxxxx Xxxxxx, Xxxxxxx, XX 00000
(“Impax”), and GLAXO GROUP LIMITED, a company organized and existing under the laws of England and
having an office and place of business at Glaxo Xxxxxxxx Xxxxx, Xxxxxxxx Xxxxxx, Xxxxxxxxx,
Xxxxxxxxx, XX0 ONN, United Kingdom (“GSK”). Impax and GSK are sometimes referred to herein
individually as a “Party” and collectively as the “Parties.”
RECITALS
Whereas, Impax is developing a controlled release carbidopa-levodopa capsule product
for the treatment of Xxxxxxxxx’x disease;
Whereas, GSK possesses substantial resources and expertise in the development,
marketing, and commercialization of pharmaceutical products;
Whereas, GSK desires to collaborate with Impax on the further development of such
product, and to obtain commercialization rights to such product in Europe and certain other
countries, and Impax is willing to so collaborate and to grant such rights on the terms and
conditions hereof; and
Whereas, GSK and Impax are also entering into a separate supply agreement of even
date hereof (the “Supply Agreement”) pursuant to which GSK will be purchasing its requirements of
such product (in finished bulk form) from Impax and Impax will be supplying such product to GSK on
the terms and conditions set forth therein.
Now, Therefore, in consideration of the foregoing premises and the mutual promises,
covenants and conditions contained in this Agreement, the Parties agree as follows:
ARTICLE 1
DEFINITIONS
1.1 “Acquiror” has the meaning set forth in Section 14.5.
1.2 “Additional GSK Modifications” has the meaning set forth in Section 4.2(a)(ii).
1.3 “Affiliate” means, with respect to a particular person, any corporation or other person
which is directly or indirectly controlling, controlled by or under common control of such
particular person for so long as such control exists. For purposes of this definition, the word
“control” (including, with correlative meaning, the terms “controlled by” or “under common control
of”) mean the direct or indirect ownership of at least fifty percent (50%) of the outstanding
shares or other voting rights of the subject entity and/or having the power to direct the affairs
of the entity.
1.4 “Alliance Manager” has the meaning set forth in Section 3.1.
1.5 “Bankruptcy” has the meaning set forth in Section 12.6(a).
1.6 “Bankruptcy Code” has the meaning set forth in Section 12.6(b).
1.7 “Bioequivalence Study” means a study to be carried out by Impax, that is designed to show
that the Original Product Manufactured in Impax’s Manufacturing facility in Taiwan is bioequivalent
to the Original Product Manufactured in Impax’s Manufacturing facility in Hayward, California.
Without limiting the foregoing, the term “Bioequivalence Study” will include any number of such
studies to be carried out by Impax which are necessary to establish bioequivalence.
1.8 “Business Day” means a day on which banking institutions in New York, New York, are open
for business, but in any event excluding the nine (9) consecutive calendar days beginning on
December 24th and continuing through January 1st of each calendar year during the Term.
1.9 “Change of Control” of Impax means: (a) a sale of all or substantially all of the assets
of Impax in one or a series of integrated transactions not in the ordinary course of business to a
Third Party Competitor; (b) the acquisition of control (as defined in Section 1.3) of Impax by a
Third Party Competitor by means of any transaction or series of related transactions to which Impax
is a party (including, any stock acquisition, merger or consolidation); or (c) the occurrence of an
event defined under Section 2.6(a)(ii). For the purpose of this definition, Third Party Competitor
means a Third Party that, as of the date of Change of Control, is XXXXXX.
1.10 “Claims” has the meaning set forth in Section 10.1.
1.11 “CMC Information” means Information related to the chemistry, manufacturing and controls
of a Licensed Product, as specified by the FDA, EMA and other applicable Regulatory Authorities.
1.12 “Commercialization,” with a correlative meaning for “Commercialize” and
“Commercializing,” means all activities undertaken before and after obtaining Regulatory Approvals
relating specifically to the pre-launch, launch, promotion, detailing, medical education and
medical liaison activities, marketing, pricing, reimbursement, sale, and distribution of a Licensed
Product, including strategic marketing, sales force detailing, advertising, medical education and
liaison, and market and Licensed Product support, and all customer support, Licensed Product
distribution, invoicing and sales activities. For clarity, Commercialization shall exclude any
activities relating to the Manufacture of a Licensed Product; provided,
however, Commercialization shall include packaging and labeling of finished Licensed Product
for sale to distributors and end customers (including any necessary release testing of product or
any component or ingredient thereof, and other quality assurance activities) using bulk finished
Licensed Product Manufactured and supplied by Impax or Third Parties licensed or contracted by
Impax.
2.
1.13 “Commercialization Plan” has the meaning set forth in Section 6.2(a).
1.14 “Commercially Reasonable Efforts” means, with respect to a Party’s obligations under this
Agreement, the carrying out of such obligations with a level of efforts and resources consistent
with the commercially reasonable practices of Impax or GSK, as applicable and not taking into
account any assignment of this Agreement pursuant to Section 14.5, for the research, development or
commercialization of a similarly situated pharmaceutical product as a Licensed Product at a similar
stage of development or commercialization, taking into account efficacy, safety, patent and
regulatory exclusivity, anticipated or approved labeling, present and future market potential,
competitive market conditions, the profitability of the product in light of pricing and
reimbursement issues (but not considering any payments due to Impax pursuant to this Agreement or
the Supply Agreement), and all other relevant factors. Commercially Reasonable Efforts shall be
determined on a market-by-market and indication-by-indication basis, and it is anticipated that the
level of efforts required may be different for different markets and indications and may change
over time, reflecting changes in the status of a Licensed Product and markets involved.
Commercially Reasonable Efforts require that the Party: (a) promptly assign responsibility for such
obligations or tasks to specific employee(s) who are held accountable for progress and monitor such
progress on an on-going basis, (b) set and consistently seek to achieve specific and meaningful
objectives for carrying out such obligations, and (c) consistently make and implement decisions and
allocate resources designed to advance progress with respect to such objectives.
1.15 “Competing Product” has the meaning set forth in Section 2.6(a).
1.16 “Confidential Information” of a Party means any and all Information of such Party that is
disclosed to the other Party under this Agreement or the Supply Agreement, whether in oral,
written, graphic, or electronic form. All Information disclosed by either Party pursuant to the
Mutual Confidential Disclosure Agreement between the Parties dated September 21, 2009 (the
“Confidentiality Agreement”) shall be deemed to be such Party’s Confidential Information disclosed
hereunder.
1.17 “Control” means, with respect to any material, Information, or intellectual property
right, that a Party (a) owns or (b) has a license (other than a license granted to such Party under
this Agreement) to such material, Information, or intellectual property right and, in each case,
has the ability to grant to the other Party access, a license, or a sublicense (as applicable) to
the foregoing on the terms and conditions set forth in this Agreement without violating the terms
of any then-existing agreement with any Third Party.
1.18 “Courts” has the meaning set forth in Section 13.2.
3.
1.19 “CPI-U” means the Consumer Price Index for all Urban Consumers, San Francisco-Oakland-San
Jose, CA, (All Items 1982-84=100) issued by the United States Department of Labor, Bureau of Labor
Statistics, or any successor agency of the United States that issues such indexes or any successor
index.
1.20 “Develop” or “Development” means (a) all activities relating to research, non-clinical,
preclinical and clinical trials, toxicology testing, statistical analysis, publication and
presentation of research and study results and reporting, preparation and submission of
applications (including any CMC Information) for obtaining and maintaining Regulatory Approval of
the Original Product, and (b) if GSK exercises an Option, all activities (both prior to and after
GSK’s exercise of an Option) relating to research, non-clinical, preclinical and clinical trials,
toxicology testing, statistical analysis, publication and presentation of research and study
results and reporting, preparation and submission of applications (including any CMC-related
information) for obtaining and maintaining Regulatory Approval of the particular Improved Product
in question; provided, however, Develop and Development shall not include any activities that
involve the Commercialization of a Licensed Product.
1.21 “Development Costs” means the costs incurred by Impax or GSK, as calculated in accordance
with such Party’s accounting principles consistently applied, that are specifically identifiable
(or reasonably and consistently allocable) to the Development of an Improved Product or the
Original Product. The Development Costs shall include amounts, without xxxx-up, that Impax or GSK
pays to Third Parties involved in such Development and all internal costs incurred by Impax or GSK
in connection with such Development, which internal costs shall be calculated at the FTE Rate for
such Party. For clarity, Development Costs shall include the cost of Manufacturing the Original
Product or Improved Product, as applicable, for use in Development.
1.22 “Development Plan” has the meaning set forth in Section 4.3(a).
1.23 “Dispute” has the meaning set forth in Section 13.1.
1.24 “Dollar” means a U.S. dollar, and “$” shall be interpreted accordingly.
1.25 “EMA” means the European Medicines Agency or any successor entity.
1.26 “EU” or “European Union” means the European Union member states as then constituted. As
of the Effective Date, the European Union member states are Austria, Belgium, Bulgaria, Cyprus,
Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia,
Spain, Sweden, and United Kingdom.
1.27 “Executive Officers” has the meaning set forth in Section 13.1.
1.28 “Expert” has the meaning set forth in Section 3.2(e)(ii).
1.29 “FD&C Act” means the U.S. Federal Food, Drug and Cosmetic Act, as amended.
1.30 “FDA” means the U.S. Food and Drug Administration or any successor entity.
4.
1.31 “Field” means any and all human diagnostic, therapeutic and prophylactic uses of the
Licensed Products in any and all indications, including Xxxxxxxxx’x disease.
1.32 “First Commercial Sale” means, with respect to a particular Licensed Product, the first
sale to a Third Party of such Licensed Product in a given regulatory jurisdiction after Regulatory
Approval has been obtained in such jurisdiction.
1.33 “FTE” means the equivalent of a full-time individual’s work, at two thousand and eighty
(2080) hours per year, for a twelve (12)-month period, performing activities pursuant to this
Agreement or the Supply Agreement. For clarity, the Parties intend the FTE to be a unit of
measurement used to calculate the amount of time dedicated to the performance of this Agreement on
behalf of Impax or GSK. One FTE may constitute work performed by an individual whose time is
dedicated solely to this Agreement or may be comprised of the efforts of several individuals, each
of whom dedicates only part of his or her time to work under this Agreement.
1.34 “FTE Rate” means the cost of an FTE of Impax or GSK performing Development upon the
Original Product or an Improved Product, which rates, for Impax and GSK, are initially set forth on
Schedule 1.34. Each such rate shall be adjusted on January 1st of each calendar year, commencing
on January 1, 2012, by agreement of the Parties and if no such agreement can be reached, by a
percentage equal to the percentage by which the latest version of the CPI-U published as of such
date differs from the latest version of the CPI-U published as of the Effective Date.
1.35 “GAAP” has the meaning set forth in Section 7.8.
1.36 “Generic Product” means, with respect to a Licensed Product in a particular regulatory
jurisdiction, any pharmaceutical product that (i) contains the same qualitative and quantitative
composition of active pharmaceutical ingredients, or salts or esters thereof, as such Licensed
Product in the same pharmaceutical form as such Licensed Product; (ii) has obtained regulatory
approval in such jurisdiction (for an indication for which such Licensed Product obtained
Regulatory Approval from the applicable Regulatory Authority in such jurisdiction) on an expedited
or abbreviated basis in a manner that relied on or incorporated data submitted by GSK, its
Affiliates or sublicensees and, in the case of a product containing a salt or ester of an active
pharmaceutical ingredient contained in the Licensed Product, such approval was obtained without
reliance on or submission of additional safety or efficacy data; (iii) is bioequivalent to the
Licensed Product as determined by the applicable Regulatory Authority in such jurisdiction; and
(iv) is sold in such jurisdiction by a Third Party that is not a sublicensee of GSK or its
Affiliates and did not purchase such product in a chain of distribution that included any of GSK or
its Affiliates or sublicensees, excluding all pharmaceutical products marketed as of the Effective
Date containing levodopa and carbidopa. Without limiting the foregoing, or being limited thereby,
with respect to a Licensed Product in the EU Generic Product shall include any pharmaceutical
product that has been authorized with respect to such Licensed Product under the provisions of
Articles 10.1, 10.2, 10.3 or 10a of EU Pharma Directive 2001/83.
5.
1.37 “GCP” or “Good Clinical Practices” means the then-current standards, practices and
procedures promulgated or endorsed by the FDA as set forth in the guidelines entitled
“Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance,” including related
regulatory requirements imposed by the FDA and comparable regulatory standards, practices and
procedures promulgated by the EMA or other Regulatory Authority applicable to the Licensed
Territory, as they may be updated from time to time, including applicable quality guidelines
promulgated under the ICH.
1.38 “GLP” or “Good Laboratory Practices” means the then-current good laboratory practice
standards promulgated or endorsed by the FDA as defined in 21 C.F.R. Part 58, and comparable
regulatory standards promulgated by the EMA or other Regulatory Authority applicable to the
Licensed Territory, as they may be updated from time to time, including applicable quality
guidelines promulgated under the ICH.
1.39 “Governmental Authority” means any multi-national, federal, state, local, municipal,
provincial or other governmental authority of any nature (including any governmental division,
prefecture, subdivision, department, agency, bureau, branch, office, commission, council, court or
other tribunal).
1.40 “GSK Indemnitees” has the meaning set forth in Section 10.1.
1.41 “GSK Know-How” means all Information that is discovered, developed, invented or created
by or on behalf of GSK or its Affiliates through activities undertaken as contemplated by this
Agreement, or that has been used in the Development, use, sale, offer for sale, having sold, import
or any other Commercialization of any Licensed Product in the Licensed Territory. For clarity, GSK
Know-How excludes Information contained within the GSK Patents, and the use of “Affiliate” in this
definition shall exclude any Third Party that becomes an Affiliate after the Effective Date due to
an acquisition of, by or merger with GSK, subject to the terms of Section 14.5, unless such
Affiliate performs any activities under this Agreement or Information controlled by such Affiliate
is used in the Development, use, sale, offer for sale, having sold, import or any other
Commercialization of any Licensed Product in the Licensed Territory.
1.42 “GSK Modifications” has the meaning set forth in Section 4.2(a)(i).
1.43 “GSK Patent” means any Patent (other than a Joint Patent) that (a) claims an invention
that is discovered, developed, invented or created by or on behalf of GSK or its Affiliates through
activities undertaken as contemplated by this Agreement, and (b) covers the Development, use, sale,
offer for sale, having sold, import or any other Commercialization of any Licensed Product. For
clarity, the use of “Affiliate” in this definition shall exclude any Third Party that becomes an
Affiliate after the Effective Date due to an acquisition of, by or merger with GSK, subject to the
terms of Section 14.5, unless such Affiliate performs any activities under this Agreement.
1.44 “GSK Prosecuted Patents” has the meaning set forth in Section 8.3(b)(i).
1.45 “GSK Technology” means the GSK Know-How, GSK Patents and GSK’s interest in Joint Patents.
6.
1.46 “GSK Withholding Tax Action” has the meaning set forth in Section 7.9(d).
1.47 “ICH” means International Conference on Harmonization.
1.48 “IFRS” has the meaning set forth in Section 7.8.
1.49 “Impax Indemnitees” has the meaning set forth in Section 10.2.
1.50 “Impax Know-How” means all Information that is Controlled by Impax or its Affiliates as
of the Effective Date or during the Term having application in the Development, use, sale, offer
for sale, having sold, import or any other Commercialization of a Licensed Product, including
packaging and labeling of finished Licensed Product for sale to distributors and end customers
(including any necessary release testing of product or any component or ingredient thereof, and
other quality assurance activities) using bulk finished Licensed Product Manufactured and supplied
by Impax or Third Parties licensed or contracted by Impax. For clarity, Impax Know-How excludes
Information contained within the Impax Patents, and the use of “Affiliate” in this definition shall
exclude any Third Party that becomes an Affiliate after the Effective Date due to an acquisition
of, by or merger with Impax, subject to the terms of Section 14.5.
1.51 “Impax Patents” means any Patent (other than a Joint Patent) that (a) is Controlled by
Impax or its Affiliates as of the Effective Date or at any time during the Term, and (b) covers or
claims the composition of matter, Development, process or method for making Licensed Product, use,
sale, offer for sale, having sold, import, or any other Commercialization of a Licensed Product,
including, packaging and labeling of finished Licensed Product for sale to distributors and end
customers (including any necessary release testing of product or any component or ingredient
thereof, and other quality assurance activities) using bulk finished Licensed Product Manufactured
and supplied by Impax or Third Parties licensed or contracted by Impax, but is not directed solely
to the Manufacture of a Licensed Product. Impax Patents include, as of the Effective Date, such
Patents listed in the attached Schedule 1.51, which schedule may be updated by the consensus of JPC
from time to time during the Term. For clarity, the use of “Affiliate” in this definition shall
exclude any Third Party that becomes an Affiliate after the Effective Date due to an acquisition
of, by or merger with Impax, subject to the terms of Section 14.5.
1.52 “Impax Prosecuted Patents” has the meaning set forth in Section 8.3(a).
1.53 “Impax Technology” means the Impax Know-How, Impax Patents and Impax’s interest in Joint
Patents.
1.54 “Improved Product” means a XXXXXX. In the event that there is more than one Improved
Product, XXXXXX.
1.55 “Indemnified Party” has the meaning set forth in Section 10.3.
1.56 “Indemnifying Party” has the meaning set forth in Section 10.3.
1.57 “Indication” means any human disease or condition which can be treated, prevented or
cured or the progression of which can be delayed.
7.
1.58 “Information” means any data, results, technology, business or financial information or
information of any type whatsoever, in any tangible or intangible form, including know-how, trade
secrets, practices, techniques, methods, processes, inventions, developments, specifications,
formulations, formulae, materials or compositions of matter of any type or kind (patentable or
otherwise), software, algorithms, marketing reports, expertise, technology, test data (including
pharmacological, biological, chemical, biochemical, clinical test data and data resulting from
non-clinical studies), CMC Information, stability data and other study data and procedures.
1.59 “Infringement” has the meaning set forth in Section 8.4(a).
1.60 “INN” has the meaning set forth in Section 8.10.
1.61 “Joint Inventions” has the meaning set forth in Section 8.1.
1.62 “Joint Patents” has the meaning set forth in Section 8.1.
1.63 “Joint Patent Committee” or “JPC” means the committee formed by the Parties as described
in Section 3.3.
1.64 “Joint Steering Committee” or “JSC” means the committee formed by the Parties as
described in Section 3.2(a).
1.65 “Laws” means all laws, statutes, rules, regulations, ordinances and other pronouncements
having the effect of law of any federal, national, multinational, state, provincial, county, city
or other political subdivision, domestic or foreign.
1.66 “XXXXXX” has the meaning set forth in XXXXXX.
1.67 “Licensed Product” means (i) the Original Product, or (ii) from and after GSK’s exercise
of an Option and timely payment of the Option Exercise Fee, as provided in this Agreement, the
particular Improved Product for which such Option was exercised.
1.68 “Licensed Territory” means all countries of the world other than U.S. and Taiwan.
1.69 “Major Market Country” means the following: XXXXXX.
1.70 “Manufacture” with a correlative meaning for “Manufacturing,” means all activities
related to the manufacturing of the Original Product, and if GSK exercises an Option, all
activities (both prior to and after GSK’s exercise of such Option) related to the manufacturing of
the particular Improved Product in question, in each case in unlabeled bulk form for use in
Development or Commercialization, including in-process and finished product testing, release of
product or any component or ingredient thereof, quality assurance activities related to
manufacturing and release of product, ongoing stability and conformance testing, and regulatory
activities related to any of the foregoing, but excluding the limited use of CMC Information as
provided for under Article 5, which use is included in Development, and excluding packaging and
labeling of finished Licensed Product for sale to distributors and end customers (including
any necessary release testing of product or any component or ingredient thereof, and other
quality assurance activities) using bulk finished Licensed Product Manufactured and supplied by
Impax, which use is included in Commercialization.
8.
1.71 “Marketing Authorization Application” or “MAA” means an application to the appropriate
Regulatory Authority for approval to market a Licensed Product (but excluding Pricing Approval) in
any particular jurisdiction and all amendments and supplements thereto.
1.72 “NDA” means a New Drug Application (as more fully defined in 21 C.F.R. 314.5 et seq. or
its successor regulation) and all amendments and supplements thereto filed with the FDA.
1.73 “Net Sales” means the gross amounts invoiced by GSK, its Affiliates and their respective
sublicensees for sales of Licensed Product to unaffiliated Third Parties, less the following
deductions to the extent reasonable and customary provided to unaffiliated entities and actually
allowed and taken with respect to such sales:
(a) reasonable cash, trade or quantity discounts and charge-back payments, and rebates
actually granted to trade customers, managed health care organizations, pharmaceutical benefit
managers, group purchasing organizations and national, state, or local government; provided,
however, that in each case such amounts shall be applied in a normal and customary manner with
respect to other similarly situated products of GSK and not applied disproportionately to a
Licensed Product;
(b) credits, rebates or allowances actually allowed upon prompt payment or on account of
claims, damaged goods, rejections or returns of such Licensed Product, including in connection with
recalls;
(c) freight, postage, shipping, transportation and insurance charges, in each case actually
allowed or paid for delivery of Licensed Product, to the extent included in such invoice;
(d) taxes (other than income taxes), duties, tariffs or other governmental charges levied on
the sale of such Licensed Product, including VAT, excise taxes and sales taxes, to the extent
included in such invoice; and
(e) the lesser of: (i) two percent (2.0%) of the aggregate gross amount invoiced on sales of a
Licensed Product in the relevant country or (ii) the actual amount of any write-offs for bad debts
relating to such sales during the period in which there is an obligation to pay a royalty under
this Agreement.
Notwithstanding the foregoing, amounts received or invoiced by GSK, its Affiliates, or their
sublicensees for the sale of Licensed Product among GSK, its Affiliates or their respective
sublicensees for resale shall not be included in the computation of Net Sales hereunder. For
purposes of determining Net Sales, a Licensed Product shall be deemed to be sold when invoiced.
Net Sales shall be accounted for in accordance with standard GSK practices for operation by GSK,
its Affiliates or sublicensees, as practiced in the relevant country in the Licensed Territory, but
in any event in accordance with International Financial Reporting
Standards (“IFRS”), consistently applied in such country in the Licensed Territory. For clarity, a
particular item may only be deducted once in the calculation of Net Sales.
9.
With respect to any transfer of any Licensed Product in a given country for any substantive
consideration other than monetary consideration on arm’s length terms, for the purposes of
calculating the Net Sales under this Agreement, such Licensed Product shall be deemed to be sold
exclusively for money at the average Net Sales price charged to Third Parties for cash sales in
such country during the applicable reporting period (or if there were only de minimis cash sales in
such country, at the fair market value as determined by comparable markets).
GSK, its Affiliates, and their respective sublicensees shall sell a Licensed Product as a stand
alone product and will not sell a Licensed Product as a part of a bundle with other products or
offer packaged arrangements to customers that include a Licensed Product, except with Impax’s prior
written consent.
1.74 “Neuroscience Business” means GSK’s then existing assets or business relating to products
for the treatment of neurological diseases.
1.75 “Option” has the meaning set forth in Section 2.4(a).
1.76 “Option Exercise Fee” has the meaning set forth in Section 2.4(c).
1.77 “Original Product” means Impax’s oral, controlled release formulated pharmaceutical
product containing levodopa and carbidopa (LD-CD) at a ratio of 4:1 and additional excipients
including an organic acid, which product is referred to as IPX 066 and is generally described in
IND # 102,887, as such IND may be amended or updated from time to time.
1.78 “Other Shared Development Activities” has the meaning set forth in Section 4.2(a)(iii).
1.79 “Party Sublicense Agreement” has the meaning set forth in Section 2.3(b).
1.80 “Patents” means (a) provisional patent applications, pending patent applications, issued
patents, utility models and designs; (b) reissues, substitutions, confirmations, registrations,
validations, re-examinations, additions, continuations, continued prosecution applications,
continuations-in-part, divisions of or applications claiming priority to any of the foregoing; and
(c) extension, renew or restoration of any of the foregoing by existing or future extension, renew
or restoration mechanisms, including supplementary protection certificate, pediatric extensions or
the equivalent thereof.
1.81 “Pharmacovigilance Agreement” has the meaning set forth in Section 5.7(a).
1.82 “XXXXXX” means a XXXXXX.
1.83 “Phase III Clinical Trial” means a clinical trial of a Licensed Product on human
patients, which trial is designed to (a) establish that a drug is safe and efficacious for its
intended
use; and (b) support approval of an application to a Regulatory Authority for the commercial
marketing of such drug.
10.
1.84 “Pivotal Phase III Trials” means the B08-05, B09-02 and B09-06 Phase III Clinical Trials
for the Original Product, as set forth in Exhibit A.
1.85 “Pricing Approval” means such governmental approval, agreement, determination or decision
establishing prices for a Licensed Product that can be charged and/or reimbursed in regulatory
jurisdictions where the applicable Governmental Authorities approve or determine the price and/or
reimbursement of pharmaceutical products and where such approval, agreement, determination or
decision establishes prices for a Licensed Product that are acceptable to GSK in its sole
discretion, provided that GSK shall promptly notify Impax of any governmental approval, agreement,
determination or decision establishing prices for a Licensed Product (including any final decision
by a Governmental Authority which is the result of an appeal (whether formal or informal) by GSK of
a previous governmental approval, agreement, determination or decision establishing prices for a
Licensed Product) (each, a “Pricing Decision”) and shall notify Impax within thirty (30) Business
Days of the receipt of such Pricing Decision whether GSK intends to appeal such Pricing Decision
(where appeal is permitted in a particular market), accept such Pricing Decision, or reject (but
not appeal or further appeal (where appeal is permitted in a particular market)) a Pricing
Decision. A Pricing Decision which GSK has notified Impax that it does not intend to appeal (i.e.
whether GSK has accepted the Pricing Decision or rejected (without appealing) such Pricing
Decision) shall thereafter be considered a Pricing Approval. For the avoidance of doubt, if GSK
begins to commercially sell a Licensed Product under a Pricing Decision, then for purposes of this
Agreement, such Pricing Decision shall thereafter be considered a Pricing Approval. The concept of
“appeal” as used in relation to a Pricing Decision shall include both formal appeal processes as
well as entering into discussions with applicable Governmental Authorities regarding the Pricing
Decision and desired changes or adjustments to such Pricing Decision, in each case where such
appeal is permitted in a particular market, and “appeal” is considered concluded upon the cessation
of discussions between GSK and the applicable Governmental Authority, at which point the applicable
Governmental Authority shall be deemed to have made its final Pricing Decision with no possibility
for further appeal. Following GSK providing notice to Impax that GSK intends to appeal a Pricing
Decision, GSK shall use Commercially Reasonable Efforts to diligently prosecute such appeal and
shall keep the JSC regularly updated regarding the progress of such appeal.
1.86 “Product Marks” has the meaning set forth in Section 8.9.
1.87 “Prosecution and Maintenance” with a correlative meaning for “Prosecute and Maintain”
means, with respect to a Patent, the preparing, filing, maintenance and prosecution of such Patent,
as well as the conduct of interferences, Third Party oppositions, re-examination, re-issues and
other similar proceedings.
1.88 “Regulatory Approval” means all approvals, including Pricing Approvals, necessary for the
commercial sale of a Licensed Product in the Field in a given country or regulatory jurisdiction.
11.
1.89 “Regulatory Approval Application” means an application for all approvals necessary for
the commercial sale of a pharmaceutical product (excluding applications for pricing approval) in a
given country or regulatory jurisdiction following the completion of the applicable phase III
clinical studies.
1.90 “Regulatory Authority” means, in a particular country or jurisdiction, any applicable
Governmental Authority involved in granting Regulatory Approval in such country or jurisdiction.
1.91 “Regulatory Exclusivity” means any exclusive marketing rights or data exclusivity rights
conferred by any Governmental Authority with respect to a Licensed Product in a country or
jurisdiction in the Licensed Territory, other than a Patent right, including orphan drug
exclusivity, pediatric exclusivity, rights conferred in the EU under Directive 2001/83/EC, or
rights similar thereto in other countries or regulatory jurisdictions in the Licensed Territory.
1.92 “Regulatory Submissions” means regulatory applications, submissions, notifications,
communications, correspondence, registrations, Regulatory Approvals and/or other filings made to,
received from or otherwise conducted with a Regulatory Authority in order to Develop, Manufacture,
market, sell or otherwise Commercialize a Licensed Product in a particular country or jurisdiction.
1.93 “Reimbursement Study” means a clinical trial of the Original Product for reimbursement
purposes in the Licensed Territory, as described in the initial Development Plan.
1.94 “Remedial Action” has the meaning set forth in Section 5.8.
1.95 “Royalty Term” has the meaning set forth in Section 7.4(b).
1.96 “Sale of the Neuroscience Business” means any sale, divestment or other transfer of all
or substantially all of the Neuroscience Business, whether by asset sale, de-merger, spin-out,
public offering, reorganization or otherwise, and whether such sale, divestment or other transfer
is to (1) a Third Party or (2) an Affiliate.
1.97 “SEC” has the meaning set forth in Section 11.4(d).
1.98 “Selected Claim” has the meaning set forth in Section 3.2(a)(vi).
1.99 “Selected Major Market” means the following: XXXXXX.
1.100 “Senior Patent Counsel” has the meaning set forth in Section 3.3.
1.101 “Sensitive Information” has the meaning set forth in Section 14.6(a).
1.102 “Serious Adverse Event” has the meaning set forth in Section 5.7(b).
1.103 “Sole Inventions” has the meaning set forth in Section 8.1.
1.104 “Subcommittee” has the meaning set forth in Section 3.2(b).
12.
1.105 “Successful Completion” or “Successfully Completing” means for a Bioequivalence Study,
the occurrence of a positive outcome of a Bioequivalence Study demonstrating that the Original
Product Manufactured in Impax’s Manufacturing facility in Taiwan is bioequivalent to the Original
Product Manufactured in Impax’s Manufacturing facility in Hayward, California.
1.106 “Supply Agreement” has the meaning set forth in the Recitals.
1.107 “Term” has the meaning set forth in Section 12.1.
1.108 “Third Party” means any entity other than Impax or GSK or an Affiliate of either of
them.
1.109 “U.S.” means the United States of America, including all possession and territories
thereof.
1.110 “Valid Claim” means a claim of (a) an issued and unexpired patent (as may be extended
through supplementary protection certificate or patent term extension or the like) included within
the Impax Patents or Joint Patents, or (b) a pending patent application included within the GSK
Prosecuted Patents, to the extent such claim in the foregoing (a) or (b) has not been revoked,
finally rejected with no possibility of appeal or continued prosecution, held invalid or
unenforceable by a patent office, court or other governmental agency of competent jurisdiction in a
final and non-appealable judgment (or judgment from which no appeal was taken within the allowable
time period) and which claim has not been disclaimed, denied or admitted to be invalid or
unenforceable through reissue, re-examination or disclaimer or otherwise.
1.111 “Wind-down Period” has the meaning set forth in Section 12.7(d)(iii).
ARTICLE 2
LICENSES AND OPTION
2.1 Licenses to GSK under Impax Technology.
(a) Development License to GSK. Subject to the terms and conditions of this Agreement, Impax
hereby grants GSK an exclusive (even as to Impax except as provided in Section 2.1(d) below),
milestone-bearing license, with the right to sublicense solely as provided in Section 2.1(e) in a
manner consistent with Section 2.3(b), under the Impax Technology, to Develop Licensed Products in
the Field, solely for the purpose of obtaining and maintaining Regulatory Approval in the Licensed
Territory. For clarity, the foregoing license does not include a right for GSK to Manufacture or
have Manufactured Licensed Products for use in Development (except to label and package, for
Development purposes, Licensed Products supplied to GSK by Impax pursuant to the Supply Agreement);
GSK’s only rights under the Impax Technology to Manufacture or have Manufactured Licensed Products
are as expressly set forth in Section 2.10 and Section 12.3 of the Supply Agreement or in Section
12.1.
13.
(b) Commercial License To GSK. Subject to the terms and conditions of this Agreement, Impax
hereby grants GSK an exclusive (even as to Impax except as provided in Section 2.1(d) below),
royalty-bearing license, with the right to sublicense solely as provided in Section 2.1(e) in a
manner consistent with Section 2.3(b), under the Impax Technology, to use, sell, offer for sale,
have sold, import and otherwise Commercialize Licensed Products in the Field in the Licensed
Territory. For clarity, the foregoing license does not include a right for GSK to Manufacture or
have Manufactured Licensed Products for use in Commercialization (except to label and package, for
Commercialization purposes, Licensed Products supplied to GSK by Impax pursuant to the Supply
Agreement); GSK’s only rights under the Impax Technology to Manufacture or have Manufactured
Licensed Products are as expressly set forth in Section 12.3 of the Supply Agreement or in Section
12.1.
(c) Clarification Regarding Manufacturing Data. For further clarity, the foregoing licenses
in Section 2.1(a) and 2.1(b) shall include the right for GSK to incorporate in its Regulatory
Submission in the Licensed Territory any Manufacturing data supplied by Impax pursuant to Section
5.1(c) for the purpose of seeking and maintaining Regulatory Approval in the Licensed Territory.
(d) Impax Retained Rights. Notwithstanding the rights granted to GSK in Sections 2.1(a) and
2.1(b) and without limiting the generality of Section 2.6, Impax retains the following: (i) the
right to practice the Impax Technology in the Licensed Territory to fulfill its obligations under
this Agreement; (ii) the right to Develop a Licensed Product in the Field for the purpose of
obtaining or maintaining Regulatory Approval outside the Licensed Territory; (iii) the right to
Manufacture or have Manufactured a Licensed Product anywhere in the world and to sell such Licensed
Product for use outside the Licensed Territory or to GSK pursuant to the Supply Agreement; and (iv)
the right to practice and license the Impax Technology outside the scope of the licenses granted to
GSK in Sections 2.1(a) and 2.1(b); in each case of the foregoing (i) — (iv) (inclusive), subject
to and without prejudice to Section 2.6.
(e) Sublicense Rights of GSK. GSK shall have the right to grant a sublicense of the licenses
granted in Sections 2.1(a) and 2.1(b) only to (A) its Affiliate; provided, however, that such
sublicense shall automatically terminate if such person, corporation, partnership or entity ceases
to be an Affiliate of GSK, and (B) a Third Party subcontractor that performs part of GSK’s
obligations under this Agreement; provided, however, that GSK shall at all times sell, offer for
sale, distribute, import, export and otherwise Commercialize a Licensed Product in GSK’s or its
Affiliate’s name. GSK shall be solely responsible for all of its sublicensees’ activities and any
and all failures by its sublicensees to comply with the terms of this Agreement.
(f) Covenant Not to Xxx. Impax or its Affiliates will not assert any Patent covering
Manufacturing Inventions (as defined in the Supply Agreement), or any other Patent directed to the
Manufacture of the Licensed Product and Controlled by Impax or its Affiliates, against GSK, its
Affiliates or permitted sublicensees with respect to such parties’ use, sale, offer to sell, import
or other Commercialization of Licensed Product in the Licensed Territory during the Term as
permitted by this Agreement, provided that such Licensed Product has been (i) Manufactured by
Impax, its Affiliates, a Backup Manufacturer (as such term is defined in the
Supply Agreement) or a Third Party on behalf of Impax and (ii) supplied to GSK, its Affiliates
or permitted sublicensees under the Supply Agreement.
14.
2.2 License to Impax under GSK Technology. Subject to the terms and conditions of this
Agreement, GSK hereby grants to Impax a non-exclusive, perpetual, fully paid, royalty-free license,
with the right to sublicense in multiple tiers in a manner consistent with Section 2.3(b), under
the GSK Technology, to (a) Develop the Licensed Products solely for the purpose of obtaining or
maintaining Regulatory Approval outside the Licensed Territory and (b) use, sell, offer for sale,
import and otherwise Commercialize Licensed Products outside the Licensed Territory.
2.3 Negative Covenant; General Sublicense Terms.
(a) GSK covenants that it will not, and will not permit any of its Affiliates or sublicensees
to, use or practice any Impax Technology outside the scope of the licenses granted to it under
Sections 2.1(a) and 2.1(b). Impax covenants that it will not, and will not permit any of its
Affiliates or sublicensees to, use or practice any GSK Technology outside the scope of the license
granted to it under Section 2.2.
(b) A Party shall, within thirty (30) days after granting any sublicense hereunder, notify the
other Party of the grant of such sublicense and provide the other Party with a true and complete
copy of the sublicense agreement (each, a “Party Sublicense Agreement”). Each Party Sublicense
Agreement shall be consistent with the terms and conditions of this Agreement and shall include the
following additional terms and conditions:
(i) the sublicensee shall be bound by non-use and non-disclosure obligations no less stringent
than those set forth in this Agreement;
(ii) the sublicensee shall not have any right to grant sublicenses to the Impax Technology (if
a sublicensee GSK) or the GSK Technology (if a sublicensee of Impax) nor to engage subcontractors
to perform its obligations to the sublicensing Party;
(iii) if GSK is the sublicensing Party, GSK’s sublicensee shall not have any right to
Prosecute or Maintain any Impax Patents;
(iv) the sublicensee shall be required to provide all Licensed Product-related Information to
the sublicensing Party so that the sublicensing Party can comply with its obligations under this
Agreement;
(v) if GSK is the sublicensing Party, GSK shall own and Control all Regulatory Submissions
(including Regulatory Approvals) prepared or filed by GSK’s sublicensee;
(vi) the sublicensee shall provide copies of all Regulatory Submissions that it prepares or
files to the sublicensing Party so that the sublicensing Party can comply with its obligations
under this Agreement;
15.
(vii) the sublicensing Party shall own and Control all Information and Patents made by the
sublicensee in the course of conducting its activities under the Party Sublicense Agreement; and
(viii) if GSK is the sublicensing Party and this Agreement terminates, Impax shall have the
option, at its sole discretion, to (1) assume GSK’s rights and obligations under the Party
Sublicense Agreement, or (2) terminate the Party Sublicense Agreement in its entirety without any
penalty or other obligation to the sublicensee; and
(ix) if Impax is the sublicensing Party and GSK terminates this Agreement pursuant to Section
12.5 on account of Impax’s uncured material breach, GSK shall have the option, at its sole
discretion, to (1) assume Impax’s rights and obligations under the Party Sublicense Agreement, or
(2) terminate the Party Sublicense Agreement in its entirety without any penalty or other
obligation to the sublicensee.
2.4 Option.
(a) Grant. Impax hereby grants GSK an option to obtain an exclusive, royalty-bearing license
from Impax to develop and commercialize a particular Improved Product in the Field in the Licensed
Territory, which option may be exercised as set forth in Section 2.4(b) and is subject to
expiration as set forth in Section 2.4(b) (the “Option”).
(b) Exercise; Expiration. Impax shall keep GSK reasonably informed as to the timeline of its
Development efforts relating to each Improved Product, including the expected date of completion of
the XXXXXX for such Improved Product. Impax shall notify GSK promptly upon the completion of the
XXXXXX for each Improved Product and shall provide GSK with a report setting forth the XXXXXX. GSK
may exercise each Option by providing written notice to Impax within sixty (60) days after the
receipt of such report. If the exercise notice is not received by Impax within such sixty (60)-day
period, then the Option with respect to such Improved Product shall expire upon the end of such
sixty (60)-day period and, notwithstanding Section 2.6, Impax shall have the right to continue the
development and commercialization of such Improved Product, either on its own or in collaboration
with a Third Party, with no further obligations to GSK.
(c) Option Exercise Fee. Within ten (10) days after GSK’s timely exercise of each Option, GSK
shall pay to Impax a one-time payment of XXXXXX Dollars ($XXXXXX) (“Option Exercise Fee”). Such
payment shall be non-refundable but shall be creditable, as set forth in Section 7.2(c), against
GSK’s share of the Development Costs for the Improved Product for which such Option was exercised.
(d) After Payment of Option Exercise Fee. After GSK’s timely exercise of each Option and
timely payment of the Option Exercise Fee, the Improved Product for which such Option was exercised
shall automatically be deemed to be a “Licensed Product” and all terms of this Agreement that apply
to Original Product shall apply to such Improved Product, including without limitation the licenses
set forth in Sections 2.1(a) and 2.1(b), the diligence obligations set forth in Sections 4.5 and
6.4, and the payment obligations set forth in Sections 7.3 and 7.4. In addition, GSK shall
reimburse Impax pursuant to Section 7.2(c) an amount equal to
XXXXXX percent (XXXXXX%) of the Development Costs for such Improved Product that are incurred
by Impax before and after the exercise of the applicable Option; provided, however, GSK shall
credit the amount of the Option Exercise Fee paid to Impax with respect to such Improved Product
against such expense reimbursement, as described in Section 7.2(c).
16.
2.5 No Implied Licenses. Except as explicitly set forth in this Agreement, neither Party
shall be deemed by estoppel or implication to have granted the other Party any license or other
right to any intellectual property of such Party.
2.6 Exclusivity.
(a) Subject to the remainder of this Section 2.6, during the Term, other than with respect to
the Licensed Product, neither Party nor their respective Affiliates shall, either on its or their
own, or in collaboration with a Third Party, file a Regulatory Approval Application for or sell in
a Selected Major Market: (1) XXXXXX, or (2) XXXXXX (each pharmaceutical product described in (1) or
(2), a “Competing Product”); provided, however:
(i) Impax shall have the right to Develop any Improved Product through the completion of a
XXXXXX; provided, however, that Impax offers GSK an Option with respect thereto in accordance with
Section 2.4, and if such Option expires unexercised, notwithstanding the foregoing in this Section
2.6, Impax shall have the right to continue the development and commercialization of such Improved
Product anywhere in the world, either on its own or in collaboration with a Third Party, with no
further obligations to GSK;
(ii) If Impax is acquired by a Third Party that has filed a Regulatory Approval Application in
one or more Selected Major Markets for a Competing Product or is then selling a Competing Product
in one or more Selected Major Markets, whether alone or in collaboration with another Third Party,
then (A) such event shall be deemed to be a Change of Control of Impax and the provisions of
Section 14.6 shall apply, and in addition (B) such Third Party acquiror may continue to seek
regulatory approval and to commercialize such Competing Product in the Selected Major Markets,
without any obligations to GSK, including any obligation pursuant to Section 2.4; and
(iii) XXXXXX.
(b) If during the Term a Party or its Affiliates obtains ownership of or license to a
Competing Product in a Selected Major Market due to an acquisition of or by or a merger with a
Third Party that wishes to sell or is selling in a Selected Major Market, then such Party shall
promptly notify the other Party and, except for the situation described in Section 2.6(a)(ii)
above, the following shall apply:
(i) At the request of the Party having the Competing Product, the Parties shall discuss the
compatibility of the commercialization plans for the Competing Product with those for the Licensed
Product. Following such discussions, the Parties shall use good faith efforts to agree upon a
mutual written agreement (no later than ninety (90) days after the notice given in the foregoing in
this Section 2.6(b)) regarding the sale of the Competing Product in relation to the
Commercialization of the Licensed Products.
17.
(ii) If the Parties reach such mutual written agreement pursuant to Section 2.6(b)(i) above,
then notwithstanding Section 2.6(a), the Party having the Competing Product may undertake sales of
or continue to sell such Competing Product, as the case may be, in the manner that has been agreed
to by the Parties.
(iii) If the Parties are not able to reach a mutual written agreement pursuant to Section
2.6(b)(i) above, then unless otherwise agreed in writing by the Parties, XXXXXX.
(iv) During the XXXXXX (XXXXXX) month period after a Party has obtained ownership of or
license to a Competing Product in one or more Selected Major Markets due to an acquisition of or by
or a merger with a Third Party, the detailing, promotion, marketing, and/or sale of such Competing
Product in such Selected Major Markets shall not be in violation of this Section 2.6, provided,
however, XXXXXX.
(c) If GSK or its Affiliates obtains ownership of, or license or other rights to
commercialize, a Competing Product in any country in the Licensed Territory, GSK shall promptly
notify Impax in writing. Such notice shall specify the identity of the Competing Product and the
countries in which GSK or its Affiliates has obtained such ownership, license or other rights.
ARTICLE 3
GOVERNANCE
3.1 Alliance Managers. Within forty-five (45) days after the Effective Date, each Party shall
appoint and notify the other Party of the identity of a representative having the appropriate
qualifications, including a general understanding of pharmaceutical development and
commercialization issues, to act as its alliance manager under this Agreement (the “Alliance
Manager”). The Alliance Managers shall serve as the primary contact points between the Parties for
the purpose of providing each Party with information on the progress of each Party’s Development
and Commercialization of a Licensed Product. The Alliance Managers shall also be primarily
responsible for facilitating the flow of information and otherwise promoting communication,
coordination and collaboration between the Parties. Each Party may replace its Alliance Manager at
any time upon written notice to the other Party. The Alliance Managers shall attend each meeting
of the Joint Steering Committee as non-voting members.
3.2 Joint Steering Committee.
(a) Formation and Role. Within forty-five (45) days after the Effective Date, the Parties
shall establish a joint steering committee (the “Joint Steering Committee” or “JSC”) for the
overall coordination and oversight of the Parties’ activities under this Agreement. The role of
the JSC shall be:
(i) to review, coordinate, discuss and approve the overall strategy for the Development and
Commercialization of a Licensed Product in the Licensed Territory;
(ii) to review and discuss any amendments to the Development Plan before such amended plan is
adopted;
(iii) to review and discuss the Commercialization Plan and any amendments thereto;
18.
(iv) to discuss and attempt to resolve any deadlock issues submitted to it by any
Subcommittee;
(v) to review and discuss material issues relating to the Manufacture of the Licensed Product;
(vi) to discuss and attempt to resolve any claim by either Party that it believes in good
faith that an activity undertaken or to be undertaken by or on behalf of the other Party with
respect to a Licensed Product in the Licensed Territory (if such other Party is GSK) or outside the
Licensed Territory (if such other Party is Impax) is likely to have a material adverse effect upon
the procurement or maintenance of Regulatory Approval or Commercialization of a Licensed Product in
the other territory (such claim, an “Selected Claim”), and
(vii) to perform such other functions as appropriate to further the purposes of this
Agreement, as expressly set forth in this Agreement or as determined by the Parties in writing.
The JSC shall have only the powers expressly assigned to it in this Section 3.2 and elsewhere in
this Agreement. JSC shall have no power to amend, modify, or waive compliance with this Agreement.
(b) Subcommittee(s). From time to time, the JSC may establish subcommittees to oversee
particular projects or activities, as it deems necessary or advisable (each, a “Subcommittee”).
Each Subcommittee shall consist of such number of members as the JSC determines is appropriate from
time to time.
(c) Members. Each Party shall initially appoint three (3) representatives to the JSC, each of
whom will be an officer or employee of such Party having sufficient seniority within the applicable
Party to make decisions arising within the scope of the JSC’s responsibilities. The JSC may change
its size from time to time by mutual consent of its members and each Party may replace its
representatives at any time upon written notice to the other Party. The Alliance Managers shall
each have the ability to convene a meeting of the JSC in coordination with the other Alliance
Manager regarding the agenda and timing of the meeting. The Alliance Managers shall jointly
preside at the meeting of the JSC to ensure the preparation of meeting minutes but shall not vote
on any decisions of the JSC.
(d) Meetings. The JSC shall meet at least one (1) time per calendar quarter during the Term
unless the Parties mutually agree in writing to a different frequency for such meetings. Either
Party may also call a special meeting of the JSC (by videoconference or teleconference) by at least
ten (10) Business Days prior written notice to the other Party in the event such Party reasonably
believes that a significant matter must be addressed prior to the next regularly scheduled meeting,
and such Party shall provide the JSC no later than ten (10) Business
Days prior to the special meeting with materials reasonably adequate to enable an informed
decision. The JSC may meet in person, by videoconference or by teleconference; provided, however,
at least one (1) meeting per calendar year shall be in person unless the Parties mutually agree in
writing to waive such requirement in lieu of a videoconference or teleconference. The Alliance
Managers shall be jointly responsible for jointly preparing and circulating to the JSC, within ten
(10) Business Days after such meeting, reasonably detailed written minutes of all JSC meetings that
reflect, without limitation, all material decisions made at such meetings.
19.
(e) Decision Making. All decisions of the JSC shall be made by consensus, with each Party
having collectively one (1) vote in all decisions. If after reasonable discussion and good faith
consideration of both Party’s views on a particular matter before the JSC, the JSC is still unable
after a period of ten (10) Business Days to reach a unanimous decision on such matter, then either
Party may, by written notice to the other, have such matter referred to the Executive Officers of
the Parties for resolution in accordance with Section 13.1. If the Executive Officers are able to
resolve such matter within the thirty (30) day period set forth in Section 13.1, then such
resolution shall be deemed the decision of the JSC. If the Executive Officers are not able to
resolve such matter within such thirty (30) day period, then:
(i) Subject to the diligence obligations set forth in Sections 4.5 and 6.4, GSK’s JSC
representative shall have final decision-making authority with respect to such unresolved matter if
it is within the JSC’s authority, it is not a Selected Claim, and it pertains to: (A) XXXXXX; or
(B) XXXXXX;
(ii) If such unresolved matter is a Selected Claim, then such matter shall be resolved by an
independent Third Party expert experienced in the development and commercialization of
pharmaceutical products (the “Expert”). Within ten (10) Business Days after such thirty (30)-day
period, the JSC shall agree upon the Expert and, as promptly as possible thereafter, the Parties
shall jointly retain the Expert. The Parties shall bear all costs of the Expert equally. XXXXXX.
The determination of the Expert shall be binding on the Parties and the Parties shall act in
accordance with the Expert’s decision;
(iii) If such unresolved matter is referred to the JSC pursuant to Section 3.3 concerning the
patent prosecution or enforcement action by GSK in the Licensed Territory, then such matter shall
be resolved by an independent Third Party patent counsel experienced in the prosecution and
enforcement of patents for pharmaceutical products (the “Patent Expert”). Within ten (10) Business
Days after the thirty (30)-day period referenced in Section 3.3, the JSC shall agree upon the
Patent Expert and, as promptly as possible thereafter, the Parties shall jointly retain the Patent
Expert. The Parties shall bear all costs of the Patent Expert equally. XXXXXX. The determination
of the Patent Expert shall be binding on the Parties and the Parties shall act in accordance with
the Patent Expert’s decision; or
(iv) For any unresolved matter not addressed in subsection (i), (ii) or (iii) above, then the
status quo shall persist with respect to the unresolved matter unless either Party brings a
litigation in accordance with Section 13.2.
For clarity, once a Party has brought a Selected Claim or a patent prosecution or enforcement
action to the JSC, the other Party shall cease and shall not initiate any activity that is the
basis for
such Selected Claim or the patent prosecution or enforcement action in question until such time as
the JSC or Executive Officers have resolved the matter, or the Expert or the Patent Expert (as
applicable) has made a decision, in each case that allows such other Party to proceed.
20.
3.3 Joint Patent Committee. Within forty-five (45) days after the Effective Date, the Parties
shall establish a committee (the “Joint Patent Committee” or “JPC”) to be responsible for the
coordination of the Parties’ efforts in accordance with Article 8 of this Agreement, including, but
not limited to, the review and filing of patent applications and assessments of inventorship. The
JPC shall be comprised of an equal number of representatives from each of GSK and Impax and shall
meet on such dates and at such places and times agreed to by the Parties. All decisions of the JPC
on matters for which it has responsibility shall be made by consensus, with each Party having
collectively one (1) vote in all decisions. In the event that the JPC is unable to reach a
consensus decision within ten (10) Business Days after it has met and attempted to reach such
decision, then either Party may, by written notice to the other, have such issue submitted to the
chief patent counsel of GSK and of Impax (together, the “Senior Patent Counsel”), or such other
person holding a similar position designated by GSK or Impax (who may be a Third Party) from time
to time, for resolution. The Senior Patent Counsel shall meet promptly to discuss the matter
submitted and to determine a resolution. XXXXXX. Each Party will bear all expenses it incurs in
regard to participating in all meetings of the JPC, including all travel and living expenses.
ARTICLE 4
PRODUCT DEVELOPMENT
4.1 Overview. The Parties desire and intend to collaborate with respect to the Development of
a Licensed Product, as and to the extent set forth in this Agreement. As described in more detail
in this Article 4, Impax shall be responsible for conducting those Development activities
anticipated to be necessary to generate sufficient Information for GSK to file MAA in the EU via
the centralized procedure for Regulatory Approval for the Original Product (excluding Pricing
Approval), including the three (3) Pivotal Phase III Trials, the Successful Completion of the
Bioequivalence Study, and the appropriate process validation and stability study activities at the
designated manufacturing sites (including bulk shipping studies), but excluding (except as
otherwise expressly agreed in writing between the Parties) any Development activities that are not
necessary for obtaining Regulatory Approval for the Original Product in the U.S., and GSK shall be
responsible for conducting the Reimbursement Study and all other Development activities (except for
those Development activities expressly agreed to be performed or managed by Impax as set forth in a
Development Plan) that are necessary for obtaining Regulatory Approval for the Original Product
(including Pricing Approval) in the Licensed Territory but are not necessary for obtaining
Regulatory Approval for the Original Product in the U.S. If GSK exercises an Option, then, except
as otherwise expressly agreed in writing between the Parties, Impax shall thereafter be responsible
for conducting those Development activities that are necessary for obtaining Regulatory Approval
for the particular Improved Product in question in the U.S., which Development activities may also
be necessary for obtaining Regulatory Approval for such Improved Product in the Licensed Territory,
and GSK shall be responsible for conducting those Development activities that are necessary for
obtaining Regulatory Approval for such Improved Product (including Pricing Approval) in the
Licensed Territory but are not necessary for obtaining Regulatory Approval for such Improved
Product in the U.S.
21.
4.2 Development Responsibilities. Unless the Parties agree in writing upon an alternative
allocation of responsibilities, the Parties shall have the following rights and obligations with
respect to the Development of a Licensed Product:
(a) Impax Development Responsibilities.
(i) With respect to the Original Product, Impax shall be responsible for conducting the three
(3) Pivotal Phase III Trials, Successfully Completing the Bioequivalence Study, and the appropriate
process validation and stability study activities at the designated manufacturing sites (including
bulk shipping studies). Without limiting the foregoing, Impax shall, at its sole cost and expense,
undertake Development activities directed to Successfully Completing the Bioequivalence Study.
Impax has already incorporated into the descriptions of the Pivotal Phase III Trials set forth in
Exhibit A certain modifications requested by GSK prior to the Effective Date (such incorporated
modifications, the “GSK Modifications”). As of the Effective Date, the three (3) Pivotal Phase III
Trials, the Successful Completion of the Bioequivalence Study, and the appropriate process
validation and stability study activities at the designated manufacturing sites (including bulk
shipping studies) are the only Development activities that are expected to be necessary to generate
sufficient Information to obtain Regulatory Approval under Article 8.3 of Directive 2001/83/EC
(excluding Pricing Approval) for the Original Product in both the EU and in the U.S.
(ii) If it is subsequently determined that additional Development activities are needed to
generate Information that is necessary to obtain Regulatory Approval under Article 8.3 of Directive
2001/83/EC (excluding Pricing Approval) for the Original Product in the EU and if such additional
Development activities are also necessary to obtain Regulatory Approval for the Original Product in
the U.S., then Impax may elect, in its sole discretion, to carry out such additional Development
activities at its sole cost and expense. For clarity, Impax has no obligation to carry out any
such additional Development activities. If Impax so elects to carry out such additional
Development activities, Impax, through JSC, shall consider in good faith any modifications to such
additional Development activities, such as an increase in the size or scope of the trials, that are
suggested by GSK. If Impax agrees to incorporate any such modifications into the additional
Development activities (such incorporated modifications, “Additional GSK Modifications”), GSK
agrees to be responsible for the expense of implementing such Additional GSK Modifications as set
forth in Section 4.4(a).
(iii) With respect to additional Development activities that are not required to obtain
Regulatory Approval under Article 8.3 of Directive 2001/83/EC (excluding Pricing Approval) for the
Original Product in the EU and are not required to obtain Regulatory Approval in the U.S., (such
additional Development activities, the “Other Shared Development Activities”), if the Parties reach
mutual agreement in writing on undertaking such additional Development activities and sharing the
costs and expenses thereof, then the Parties shall allocate the responsibilities between the
Parties as mutually agreed and shall equally share in the costs and expenses of undertaking such
Other Shared Development Activities as specified in Section 4.4(b).
22.
(iv) If GSK exercises an Option, Impax shall thereafter be responsible for conducting those
Development activities that are necessary for obtaining Regulatory Approval for the particular
Improved Product in question in the U.S. and that are set forth in the Development Plan, which
Development activities may also be necessary for obtaining Regulatory Approval for such Improved
Product in the Licensed Territory. The Parties shall share the Development Costs with respect
thereto as specified in Section 4.4(c).
(v) Notwithstanding anything else to the contrary, as between GSK and Impax, Impax shall at
all times remain solely responsible for all costs and expenses incurred by Impax for all
Development activities that are necessary for obtaining Regulatory Approval for the Original
Product outside the Licensed Territory which Development activities are not necessary for obtaining
Regulatory Approval for the Original Product in the Licensed Territory.
(b) GSK Development Responsibilities.
(i) With respect to the Original Product, GSK shall be responsible for conducting all
Development activities, including the Reimbursement Study, that are necessary for obtaining
Regulatory Approval (including Pricing Approval) for the Original Product in the Licensed Territory
other than those described in Sections 4.2(a)(i), 4.2(a)(ii) and 4.2(a)(iii), as set forth in the
applicable Development Plan. GSK shall also be responsible for conducting any Other Shared
Development Activities allocated to GSK as mutually agreed by the Parties.
(ii) If GSK exercises an Option, GSK shall be responsible for conducting those Development
activities that are necessary for obtaining Regulatory Approval (including Pricing Approval) for
the particular Improved Product in question in the Licensed Territory other than those described in
Section 4.2(a)(iv), as set forth in the applicable Development Plan.
(iii) GSK shall also be responsible for seeking Regulatory Approval of all Licensed Products
in the Licensed Territory. All such Development and Regulatory Approval activities shall be
described in detail in the Development Plan and GSK shall perform such Development and Regulatory
Approval activities in accordance with the Development Plan.
4.3 Development Plan.
(a) General. Development of each Licensed Product with respect to the Licensed Territory
shall be conducted pursuant to a comprehensive written development plan (a “Development Plan”),
which shall specify all major Development activities, including all clinical trials of the Licensed
Product, to be conducted by or on behalf of GSK for such Licensed Product and the timeline
regarding such activities, as well as XXXXXX in which GSK is undertaking material Development
activities before GSK begins to conduct Development activities in such country. The Parties have
agreed upon an outline for the initial Development Plan for the Original Product, which is attached
to this Agreement as Exhibit B. Such outline for the initial Development Plan for the Original
Product only addresses at a high level the Development and Regulatory Approval activities for the
European Union, and shall be amended in calendar year 2011 to be a complete Development Plan and to
add Development and Regulatory Approval activities for all XXXXXX not addressed in the outline for
the initial
Development Plan. Promptly following GSK’s exercise of an Option, the Parties shall seek to
mutually agree, consistent with Sections 4.2 and 5.5, upon Phase III protocols and a Development
Plan for the Improved Product in question.
23.
(b) Amendments. From time to time during the Term (at least on an annual basis), GSK shall
prepare updates and amendments, as appropriate, to the then-current Development Plan for the
Original Product, including adding any planned Development activities for XXXXXX for which GSK had
not previously proposed Development activities. GSK shall submit such updates and amendments to
the JSC for review and discussion before such updates and amendments are adopted. If GSK exercises
an Option, GSK and Impax shall jointly prepare updates and amendments, as appropriate, to the
then-current Development Plan for the Improved Product in question. In addition, if a Regulatory
Authority in the Licensed Territory communicates to GSK that additional studies or material changes
to then-contemplated studies may be required for Regulatory Approval (including Pricing Approval)
of a Licensed Product, GSK shall promptly notify Impax, and the JSC shall promptly meet to discuss
such Regulatory Authority requirement.
(c) Performance. Each Party shall use Commercially Reasonable Efforts to conduct the
Development activities allocated to it under the Development Plan for the Original Product in a
timely and effective manner. If GSK exercises an Option: (i) GSK shall use Commercially Reasonably
Efforts to conduct the Development activities allocated to it under the Development Plan for the
particular Improved Product in question in a timely and effective manner; and (ii) Impax shall use
Commercially Reasonably Efforts to conduct the Development activities allocated to it (if any)
under the Development Plan for the particular Improved Product in question in a timely and
effective manner. No Development Plan may allocate responsibility for Development activities to
Impax without Impax’s agreement.
4.4 Development Costs. Each Party shall be solely responsible for the costs and expenses it
incurs to conduct the Development responsibilities assigned to it under Section 4.2, except that
(a) GSK shall be responsible for the additional Development Costs resulting from the Additional GSK
Modifications, (b) the Parties shall each be responsible for XXXXXX percent (XXXXXX%) of the
Development Costs for the Other Shared Development Activities, and (c) if GSK exercises an Option,
GSK shall be responsible for XXXXXX percent (XXXXXX%) of the Development Costs for the particular
Improved Product in question incurred by Impax both before and after the exercise of that Option.
GSK and Impax shall pay such Development Costs as set forth in Section 7.2.
24.
4.5 Diligence. With respect to the Original Product, following the completion of the Pivotal
Phase III Trials, and with respect to an Improved Product, following GSK’s exercise of the Option,
GSK shall use Commercially Reasonable Efforts to Develop each Licensed Product in each XXXXXX, to
prepare and file appropriate Regulatory Submissions for each Licensed Product in each XXXXXX, and
to obtain and maintain Regulatory Approval (including Pricing Approval) for each Licensed Product
in each XXXXXX; provided, however, that following GSK’s exercise of an Option, GSK may from time to
time elect in its sole discretion to discontinue or otherwise de-prioritize efforts on any Licensed
Product if it is otherwise in compliance with its diligence obligations hereunder with respect to
at least one other Licensed Product and such discontinuation or de-prioritization shall not, per
se, be a breach of this
Agreement; provided further, XXXXXX. Without limiting the foregoing, GSK shall use
Commercially Reasonable Efforts to actively Develop and seek Regulatory Approval in each XXXXXX and
to:
(a) XXXXXX;
(b) XXXXXX; and
(c) XXXXXX;
(d) XXXXXX; and
(e) XXXXXX.
For the purpose of this Section 4.5, “XXXXXX” means the XXXXXX.
4.6 Mutual Data Exchange and Use. In addition to its adverse event and safety data reporting
obligations pursuant to Section 5.7, each Party shall promptly provide the other Party with copies
of all data and results and all supporting documentation (e.g. protocols, CRFs, analysis plans)
generated from its Development activities under this Agreement. Each Party shall have the right to
use, without additional consideration, any and all data and results generated by or on behalf of
the other Party under this Agreement solely for obtaining and maintaining Regulatory Approval and
reimbursement for the Licensed Products and otherwise Commercializing the Licensed Products in
accordance with the terms of this Agreement, in the Licensed Territory for GSK and outside the
Licensed Territory for Impax. For clarity, such right shall include the use of such data and
results in connection with activities intended to produce sufficient Information for GSK to file
for Regulatory Approval in the EU via the centralized procedure for Regulatory Approval (EU
Regulation 726/2004).
4.7 Development Reports. Each Party shall provide the JSC with written reports detailing its
Development activities under this Agreement and the results of such activities at each regularly
scheduled JSC meeting. Without limiting the foregoing, GSK will provide Impax with the expected
timelines of each upcoming expected launch of the Licensed Products in each XXXXXX. The Parties
shall discuss the status, progress and results of each Party’s Development activities under this
Agreement at such JSC meetings.
4.8 Development Records. Each Party shall maintain complete, current and accurate records of
all Development activities conducted by it hereunder, and all data and other Information resulting
from such activities. Such records shall fully and properly reflect all work done and results
achieved in the performance of the Development activities in good scientific manner appropriate for
regulatory and patent purposes. Each Party shall document all non-clinical studies and clinical
trials in formal written study records according to applicable Laws, including applicable national
and international guidelines such as ICH, GCP and GLP. Each Party shall have the right to review
and copy such records maintained by the other Party at reasonable times and to obtain access to the
original to the extent necessary or useful for regulatory and patent purposes.
25.
4.9 Compliance with Laws. Each Party shall conduct its activities under this Agreement in
good scientific manner and in compliance in all material respects with all applicable Laws,
including applicable national and international guidelines such as ICH, GCP and GLP.
4.10 Transfer of Know-How. Impax shall work with GSK to facilitate the transfer to GSK of
Impax Know-How that is necessary for GSK to file MAA in the EU via the centralized procedure for
Regulatory Approval. Such transfer shall occur in a manner and following a reasonable schedule to
be established by the JSC. For clarity, Impax shall not have any obligation hereunder to transfer
or otherwise provide GSK with any Information Controlled by Impax that is necessary or useful for
the Manufacture of a Licensed Product but not necessary or useful for non-Manufacturing Development
or Commercialization activities
4.11 Impax’s Other Licensees. For clarity, if Impax grants a Third Party an exclusive license
to Develop and/or Commercialize a Licensed Product in any country outside the Licensed Territory,
then such licensee may directly exercise Impax’s rights pursuant to this Agreement with respect to
such Licensed Product in such country if such licensee agrees in writing to be bound by those
terms, conditions, rights and obligations of this Agreement that apply to Impax and that are
relevant to such licensee, given the scope of such licensee’s license from Impax with respect the
Licensed Product.
ARTICLE 5
REGULATORY MATTERS
5.1 Regulatory Responsibilities in the Licensed Territory.
(a) Except as set forth in Section 5.1(c) below, GSK shall own all Regulatory Submissions
(including Regulatory Approvals) for a Licensed Product in the Licensed Territory, and shall be
responsible for preparing and filing of any and all Regulatory Submissions for a Licensed Product
in the Licensed Territory at its sole expense, including in the Major Market Countries in
accordance with the Development Plan and in other countries in the Licensed Territory as and when
reasonably decided by GSK but otherwise in a manner consistent with this Agreement; provided,
however, XXXXXX. Impax shall assist and cooperate with GSK in connection with the preparation of
such Regulatory Submissions, as reasonably requested by GSK, including necessary information from
Impax suppliers. Impax shall be responsible for providing all regulatory submission-necessary
deliverables as generated from the development responsibilities in Section 4.2(a), including but
not limited to: planning documents, reports, QC documentation, case report tabulations (SAS
transport files, data definition tables, annotated CRFs), SAS programs, logs, macros and libraries
(required to re-run programs) according to a timeline agreed to by the Parties. All deliverables
shall comply with ICH M2 EWG eCTD Specifications, and be complete and quality-assured. All
clinical reports should be compliant with ICH E3 — Structure and Content of Clinical Reports
guidance. All statistical package deliverables must meet the standards and specifications set
forth by the FDA in their “Guidance for Industry: Providing Regulatory Submissions in Electronic
Format — NDAs,” ICH E9, and other pertinent regulatory guidances.
26.
(b) GSK shall keep Impax informed of regulatory developments relating to a Licensed Product in
the Licensed Territory and shall promptly notify Impax in writing of any decision by any Regulatory
Authority in the Licensed Territory regarding Regulatory Approval. GSK shall provide Impax for
review and comment all draft Regulatory Submissions (other than routine correspondence) at least
twenty (20) Business Days in advance of their intended date of submission to a Regulatory Authority
in the Licensed Territory and shall consider in good faith any comments thereto provided by Impax.
GSK shall promptly notify Impax of any Regulatory Submissions (other than routine correspondence)
submitted to or received from any Regulatory Authority in the Licensed Territory and shall provide
Impax with copies thereof within ten (10) Business Days after submission or receipt. GSK shall
provide Impax with reasonable advance notice of all meetings, conferences, and discussions
scheduled with any Regulatory Authority in the Licensed Territory concerning a Licensed Product,
and shall consider in good faith any input from Impax in preparing for such meetings, conferences
or discussion. To the extent permitted by applicable Laws, Impax shall have the right to
participate only as an observer in any such meetings, conferences or discussions and GSK shall
facilitate such participation. If Impax is not present for participation in such meetings,
conferences or discussions, GSK shall provide Impax with written summaries of such meetings,
conferences or discussions in English as soon as practicable after the conclusion thereof.
(c) Impax shall be responsible for compiling and providing to GSK the CMC Information that is
required for GSK to obtain and maintain Regulatory Approval of a Licensed Product in the Licensed
Territory, including (i) obtaining, from supplier(s) within the supply chain for a Licensed
Product, CMC Information that is necessary to obtain Regulatory Approval in the Licensed Territory
or, (ii) to the extent that Impax is not successful in obtaining such Information, facilitating
GSK’s direct contact with such supplier(s) for such purpose. GSK shall use the CMC Information
provided to it by Impax or such supplier(s) for the sole purpose of obtaining and maintaining
Regulatory Approval of a Licensed Product in the Licensed Territory and for no other purpose. Upon
GSK’s reasonable request, Impax shall provide reasonable assistance to GSK with respect to
communications with Regulatory Authorities in the Licensed Territory regarding the Manufacture of a
Licensed Product or the CMC Information.
(d) Unless the Parties otherwise agree in writing: (i) except as expressly contemplated by
Section 5.1(a), 5.1(b) or 5.1(c), Impax shall not communicate with respect to a Licensed Product
with any Regulatory Authority having jurisdiction in the Licensed Territory, unless so ordered by
such Regulatory Authority, in which case Impax shall immediately provide notice to GSK of such
order; and (ii) Impax shall not submit any Regulatory Submissions or seek Regulatory Approvals for
a Licensed Product in the Licensed Territory.
5.2 Regulatory Responsibilities outside the Licensed Territory.
(a) Impax shall own all Regulatory Submissions (including Regulatory Approvals) for a Licensed
Product outside the Licensed Territory, and shall be responsible for preparing and filing of any
and all Regulatory Submissions for a Licensed Product outside the Licensed Territory at its sole
expense. GSK shall assist and cooperate with Impax in connection with the preparation and filing
of such Regulatory Submissions, as reasonably requested by Impax.
27.
(b) Impax shall keep GSK informed of regulatory developments relating to a Licensed Product
outside the Licensed Territory through regular reports at the JSC meetings. Impax shall provide
GSK for review and comment all draft Regulatory Submissions (other than routine correspondence), at
least twenty (20) Business Days in advance of the intended date of submission to a Regulatory
Authority outside the Licensed Territory and shall consider in good faith any comments thereto
provided by GSK. Impax shall promptly notify GSK of any Regulatory Submissions (other than routine
correspondence) submitted to or received from any Regulatory Authorities and shall provide GSK with
copies thereof within ten (10) Business Days after submission or receipt. Impax shall provide GSK
with reasonable advance notice of all meetings, conferences, discussions, and inspections scheduled
with any Regulatory Authority outside the Licensed Territory concerning a Licensed Product, and
shall consider in good faith any input from GSK in preparing for such meetings, conferences
discussion, or inspections. To the extent permitted by applicable Laws, GSK shall have the right
to participate only as an observer in any such meetings, conferences discussions, or inspections
and Impax shall facilitate such participation. If GSK is not present for participation in such
meetings, conferences, discussions or inspections, Impax shall provide GSK with written summaries
of such meetings, conferences, discussions or inspections in English as soon as practicable after
the conclusion thereof.
(c) Unless the Parties otherwise agree in writing: (i) except as expressly contemplated by
Section 5.2(a) or 5.2(b), GSK shall not communicate with respect to a Licensed Product with any
Regulatory Authority having jurisdiction outside the Licensed Territory, unless so ordered by such
Regulatory Authority, in which case GSK shall immediately provide notice to Impax of such order;
and (ii) GSK shall not submit any Regulatory Submissions or seek Regulatory Approvals for a
Licensed Product outside the Licensed Territory.
5.3 Regulatory Costs. GSK shall be solely responsible for all costs and expenses related to
the preparation, filing and maintenance of all Regulatory Submissions and Regulatory Approvals for
a Licensed Product in the Licensed Territory.
5.4 Rights of Reference to Regulatory Submissions. Impax hereby grants to GSK a right of
reference to all Regulatory Submissions filed by or on behalf of Impax, which right of reference
GSK may use for the sole purpose of seeking, obtaining and maintaining Regulatory Approvals in the
Licensed Territory. GSK hereby grants to Impax and Impax’s licensees outside the Licensed
Territory a right of reference to all Regulatory Submissions filed by or on behalf of GSK, which
right of reference Impax may use for the sole purpose of seeking, obtaining and maintaining
Regulatory Approvals outside the Licensed Territory. Each Party shall support the other Party, as
reasonably requested by such other Party and at such other Party’s expense, in obtaining Regulatory
Approvals in such other Party’s territory, including providing necessary documents or other
materials required by applicable Laws to obtain Regulatory Approval in such territory, all in
accordance with the terms and conditions of this Agreement.
28.
5.5 Cooperation and Consistency. Without prejudice to the other provisions set forth in this
Agreement, and without giving rise to any fiduciary duty between the Parties, the Parties agree to
the following as set forth in this Section 5.5:
(a) Wherever practicable and commercially reasonable each Party shall seek to exercise its
rights and fulfill its obligations with respect to the Licensed Products within their territories
in manner that is consistent with and not harmful to the other Party’s exercise of its rights and
fulfillment of its obligations with respect to the Licensed Products in its territory.
(b) To the extent practicable and commercially reasonable, the Parties shall seek to establish
and maintain a Commercialization positioning strategy and activities for the Licensed Products that
is consistent worldwide, actively taking into account impact on the other Party’s territory through
one’s actions or omissions in one’s own territory. Similarly, to the extent practicable and
commercially reasonable, the Parties shall seek to establish and maintain a Development strategy
and activities for the Licensed Products that is consistent worldwide, actively taking into account
impact on the other Party’s territory through one’s actions or omissions in one’s own territory.
The Parties, acting through the Alliance Managers, shall communicate with one another and exchange
Information necessary and useful to facilitate the foregoing cooperation between the Parties.
5.6 Notification of Threatened Action. Each Party shall immediately notify the other Party of
any information it receives regarding any threatened or pending action, inspection or communication
by or from any Third Party, including without limitation a Regulatory Authority, which may affect
the Development, Commercialization or regulatory status of a Licensed Product. Without prejudice
to the other provisions set forth in this Agreement, upon receipt of such information, the Parties
shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking
appropriate action.
5.7 Adverse Event Reporting and Safety Data Exchange.
(a) Within ninety (90) days after the Effective Date, the Parties shall define and finalize
the actions that the Parties shall employ with respect to a Licensed Product to protect patients
and promote their well-being in a written pharmacovigilance agreement (the “Pharmacovigilance
Agreement”). These responsibilities shall include mutually acceptable guidelines and procedures
for the receipt, investigation, recordation, communication, and exchange (as between the Parties)
of adverse event reports, pregnancy reports, and any other information concerning the safety of any
Licensed Product. Such guidelines and procedures shall be in accordance with, and enable the
Parties to fulfill, local and national regulatory reporting obligations under applicable Laws.
Furthermore, such agreed procedure shall be consistent with relevant ICH guidelines, except where
said guidelines may conflict with existing local regulatory reporting safety reporting requirement,
in which case local reporting requirement shall prevail. GSK shall be responsible for reporting
quality complaints, adverse events and safety data related to a Licensed Product to applicable
Regulatory Authorities in the Licensed Territory, as well as responding to safety issues and to all
requests of Regulatory Authorities relating to a Licensed Product in the Licensed Territory. The
Pharmacovigilance Agreement shall also provide for a worldwide safety database to be maintained by
GSK at its cost. GSK shall provide Impax with information from the safety database in a manner
that is sufficient for Impax to comply with applicable Laws, including Impax’s obligation to report
to Regulatory Authorities or to respond to regulatory requests. Each Party hereby agrees to comply
with its respective obligations under such Pharmacovigilance Agreement and to cause its Affiliates
and permitted sublicensees to comply with such obligations.
29.
(b) Prior to the execution of such Pharmacovigilance Agreement, the Parties agree to
coordinate the pharmacovigilance procedures in connection with the Development of the Products, and
each Party shall submit to the other Party all safety information and reporting in a manner that
meets the reporting requirements under applicable Laws in the other Party’s territory. Each Party
shall notify the other Party within three (3) calendar days of any Serious Adverse Event. Each
Party shall also provide the other Party, on an annual basis and more frequently as reasonably
requested by the other Party, a summary report of Adverse Events. As used herein, unless defined
differently by the FDA, “Adverse Event” means any Licensed Product related, or potentially Licensed
Product related, side effect, injury, toxicity or sensitivity reaction, or any unexpected incident,
and the severity thereof. “Serious Adverse Event” means an Adverse Event which results in death,
is immediately life-threatening, results in persistent and significant disability/incapacity or
requires in-patient hospitalization or prolongation of existing hospitalization, is a congenital
anomaly or birth defect in the foetus/child or is an Important Medical Event (i.e., an Adverse
Event that may not be immediately life-threatening or result in death or hospitalisation but may
jeopardise the subject or require medical or surgical intervention).
5.8 Remedial Actions. Each Party will notify the other Party immediately, and promptly
confirm such notice in writing, if it obtains information indicating that a Licensed Product may be
subject to any recall, corrective action or other regulatory action with respect to a Licensed
Product taken by virtue of applicable Laws (a “Remedial Action”). The Parties will assist each
other in gathering and evaluating such information as is necessary to determine the necessity of
conducting a Remedial Action. Each Party shall, and shall ensure that its Affiliates and
sublicensees will, maintain adequate records to permit the Parties to trace the Manufacture,
distribution and use of a Licensed Product. In the event GSK determines that any Remedial Action
with respect to a Licensed Product in the Licensed Territory should be commenced or is required by
applicable Regulatory Authority, GSK shall have the right, at its expense, to control and
coordinate all efforts necessary to conduct such Remedial Action. In the event Impax determines
that any Remedial Action with respect to a Licensed Product outside the Licensed Territory should
be commenced or is required by applicable Regulatory Authority, Impax shall have the right, at its
expense, to control and coordinate all efforts necessary to conduct such Remedial Action.
Notwithstanding the foregoing, any Remedial Action that relates to the Manufacture and supply of a
Licensed Product by Impax to GSK shall be governed by the terms and conditions of the Supply
Agreement.
ARTICLE 6
COMMERCIALIZATION
6.1 Overview of Commercialization in the Licensed Territory. Subject to the terms and
conditions of this Article 6, as between the Parties, with respect to the Original Product,
following the payment from GSK to Impax pursuant to Section 7.3(a), and with respect to an Improved
Product, following GSK’s exercise of the Option, GSK will be responsible for all aspects of the
Commercialization of a Licensed Product in the Licensed Territory, including: (a) developing and
executing a commercial launch and pre-launch plan, (b) negotiating with applicable Governmental
Authorities regarding the price and reimbursement status of a Licensed Product; (c) marketing and
promotion; (d) booking sales and distribution and performance of
related services; (e) handling all aspects of order processing, invoicing and collection,
inventory and receivables; (f) providing customer support, including handling medical queries, and
performing other related functions; and (g) conforming its practices and procedures to applicable
Laws relating to the marketing, detailing and promotion of a Licensed Product in the Licensed
Territory. GSK shall bear all of the costs and expenses incurred in connection with such
Commercialization activities.
30.
6.2 Commercialization Plan for Licensed Territory.
(a) General. Following the payment from GSK to Impax pursuant to Section 7.3(a), GSK shall
Commercialize the Original Product and, if GSK exercises an Option, GSK shall Commercialize the
particular Improved Product in question, in the Licensed Territory pursuant to a plan prepared by
GSK (the “Commercialization Plan”). The Commercialization Plan shall include (i) a reasonably
detailed description of and anticipated timeline for GSK’s significant Commercialization activities
in each of the XXXXXX for the following XXXXXX (XXXXXX) years consistent with its obligations under
Section 6.4 and (ii) a list of all other countries in the Licensed Territory in which GSK is
Commercializing Licensed Products.
(b) Initial Plan and Amendments. The initial Commercialization Plan for a particular Licensed
Product shall be delivered to the JSC no later than nine (9) months prior to the anticipated date
of first Regulatory Approval of such Licensed Product in the Licensed Territory. GSK shall
periodically (at least on an annual basis) prepare updates and amendments to the Commercialization
Plan to reflect changes in its plans, including in response to changes in the marketplaces,
relative success of the Licensed Products and other relevant factors influencing such plans and
activities. GSK shall submit all updates and amendments to the Commercialization Plan to the JSC
for review and discussion. Neither the JSC nor Impax shall have approval authority over the
Commercialization Plan or any amendment thereto.
6.3 Pricing. GSK shall have the sole right to determine all pricing of Licensed Products in
the Licensed Territory; provided, however, XXXXXX. Impax shall not have any right to direct,
control, or approve GSK’s pricing of Licensed Products for the Licensed Territory.
6.4 Commercial Diligence.
(a) GSK shall use Commercially Reasonable Efforts to Commercialize each Licensed Product in
each XXXXXX in which it receives Regulatory Approval; provided, however, that following GSK’s
exercise of an Option, GSK may from time to time elect in its sole discretion to discontinue or
otherwise de-prioritize efforts on any Licensed Product if it is otherwise in compliance with its
diligence obligations hereunder with respect to at least one other Licensed Product and such
discontinuation or de-prioritization shall not, per se, be a breach of this Agreement. Without
limiting the foregoing, GSK shall achieve First Commercial Sale of each Licensed Product in a
XXXXXX within XXXXXX (XXXXXX) months after the Regulatory Approval (including Pricing Approval, if
required by applicable Laws) has been obtained in such country for such Licensed Product; provided,
however, such XXXXXX (XXXXXX) month period shall be extended to the extent that the achievement of
First Commercial Sale is delayed on account of Impax’s failure to supply Licensed Product ordered by
GSK pursuant to the Supply Agreement and GSK provides prompt notification of such failure.
31.
(b) Failure to Launch.
(i) In the event that a Licensed Product has not obtained Regulatory Approval in a particular
XXXXXX because GSK decides to reject a Pricing Decision, GSK shall notify Impax of its decision
within thirty (30) Business Days of the receipt of such Pricing Decision and shall provide Impax
with an explanation of such decision, including a financial analysis thereof. Where GSK’s decision
to reject such Pricing Decision in such country is founded on GSK’s good faith belief that the
Licensed Product is not commercially viable in such country, for example because of pricing and
reimbursement concerns or that the launch of the Licensed Product in such country would adversely
affect the amount of Net Sales that would be achieved in the Licensed Territory, Impax shall not
have the right to terminate this Agreement in such country, except as described in Sections
6.4(b)(ii) and 6.4(b)(iii). However, for the avoidance of doubt: (A) XXXXXX; (B) XXXXXX; and (C)
XXXXXX. The Parties hereby accept that the failure to launch a particular Licensed Product in any
country in which it has received Regulatory Approval shall not, per se, be deemed a breach of GSK’s
obligations pursuant to Section 6.4(a). For purposes of this Section 6.4(b)(i), if GSK decides to
appeal a Pricing Decision (in any country where appeal of a Pricing Decision is possible), GSK
shall not be deemed to have rejected the Pricing Decision until the appeal process is concluded and
GSK has elected not to accept the Pricing Decision resulting from such appeal process.
(ii) Notwithstanding anything else herein, where (A) GSK has decided under Section 6.4(b)(i)
that it will reject a Pricing Decision for any Licensed Product in XXXXXX, or (B) GSK has failed to
achieve First Commercial Sale of any Licensed Product in XXXXXX following a Pricing Approval within
the timeframe contemplated by Section 6.4(a), Impax has the right to terminate this Agreement in
all XXXXXX by giving GSK sixty (60) days written notice to that effect at any time thereafter;
provided, however, that GSK has not in the interim, prior to receipt of notice of termination from
Impax, notified Impax that it XXXXXX. For purposes of this Section 6.4(b)(ii), if GSK decides to
appeal a Pricing Decision (in any country where appeal of a Pricing Decision is possible), GSK
shall not be deemed to have rejected the Pricing Decision until the appeal process is concluded and
GSK elects not to accept the Pricing Decision resulting from such appeal process.
(iii) Notwithstanding anything else herein, where (A) GSK has decided under Section 6.4(b)(i)
that it will reject a Pricing Decision for any Licensed Product in XXXXXX, or (B) GSK has failed to
achieve First Commercial Sale any Licensed Product in XXXXXX following a Pricing Approval within
XXXXXX (XXXXXX) months after the Regulatory Approval (including Pricing Approval, if required by
applicable Laws) has been obtained in the relevant XXXXXX, Impax has the right to terminate this
Agreement in all XXXXXX by giving GSK sixty (60) days written notice to that effect at any time
thereafter; provided, however, that GSK has not in the interim, prior to receipt of notice of
termination from Impax, notified Impax that it XXXXXX; provided, further, such XXXXXX (XXXXXX)
month period shall be extended to the extent that the achievement of First Commercial Sale of a
Licensed Product is delayed on account of Impax’s failure to supply Licensed Product ordered by GSK
pursuant to the Supply Agreement and GSK provides prompt notification of such
failure. For purposes of this Section 6.4(b)(iii), if GSK decides to appeal a Pricing
Decision (in any country where appeal of a Pricing Decision is possible), GSK shall not be deemed
to have rejected the Pricing Decision until the appeal process is concluded and GSK elects not to
accept the Pricing Decision resulting from such appeal process.
32.
6.5 Cross-Territorial Restrictions. Each Party shall, and shall ensure that its Affiliates
and sublicensees will, use Commercially Reasonable Efforts to avoid directly or indirectly
distributing, selling or have sold any Licensed Product, including via internet or mail order, to
end customers into countries outside its territory. As to such countries outside its territory,
such Party shall not, and shall ensure that its Affiliates and sublicensees will not: (a) engage in
any advertising or promotional activities relating to any Licensed Product that are directed
primarily to customers or other purchasers of such Licensed Product located in such countries, (b)
solicit orders from any prospective purchaser located in such countries, or (c) sell or distribute
any Licensed Product to any person in its territory who intends to sell or has in the past sold
such Licensed Product in such countries. If a Party receives any order for a Licensed Product from
a prospective purchaser located in a country outside their territory, such Party shall refer that
order to the other Party and shall not accept any such orders. Each Party shall not deliver or
tender (or cause to be delivered or tendered) any Licensed Product into a country outside of its
territory.
6.6 Reports. GSK shall update the JSC periodically at each regularly scheduled JSC meeting
regarding GSK’s Commercialization activities with respect to the Licensed Products in the Licensed
Territory. Each such update shall be in a form to be reasonably agreed by the Parties and shall
summarize significant Commercialization activities with respect to the Licensed Products in the
Licensed Territory.
ARTICLE 7
COMPENSATION
7.1 Upfront Payment. Within five (5) Business Days after the Effective Date, GSK shall pay to
Impax a one-time, non-refundable and non-creditable initial payment of eleven million five hundred
thousand Dollars ($11,500,000).
7.2 Reimbursement of Development Costs.
(a) Within thirty (30) days after the end of each calendar quarter during which Impax has
incurred Development Costs resulting from an Additional GSK Modification, Impax shall submit to GSK
a reasonably detailed invoice setting forth all such Development Costs incurred in such calendar
quarter. Subject to Section 7.2(e), GSK shall pay to Impax the amount invoiced within sixty (60)
days after the receipt of such invoice.
(b) Within thirty (30) days after the end of each calendar quarter during which either Party
is conducting any Other Shared Development Activities, such Party shall submit to the other Party a
reasonably detailed invoice setting forth XXXXXX percent (XXXXXX%) of the Development Costs
incurred by such Party while conducting Other Shared Development
Activities in such calendar quarter. Subject to Section 7.2(e), the other Party shall pay to
such Party the amount invoiced within sixty (60) days after the receipt of such invoice.
33.
(c) GSK shall be responsible for XXXXXX percent (XXXXXX%) of the Development Costs for the
particular Improved Product incurred by Impax before and after the exercise of an Option. Within
thirty (30) days after the exercise of an Option and the end of each calendar quarter thereafter,
Impax shall submit to GSK a reasonably detailed invoice of the Development Costs incurred by Impax
before the exercise of an Option or in such calendar quarter, as applicable. Subject to Section
7.2(e), GSK shall pay to Impax the amount invoiced within sixty (60) days after the receipt of such
invoice; provided, however, GSK may credit the amount of Option Exercise Fee paid to Impax against
the payments due to Impax pursuant to this Section 7.2(c).
(d) All payments made pursuant to this Section 7.2 shall be non-refundable and non-creditable.
(e) If a Party disputes in good faith any portion of an invoice provided by the other Party
pursuant to this Section 7.2, such Party shall promptly notify the other Party and shall pay to the
other Party the undisputed portion of such invoice within sixty (60) days after the receipt of such
invoice, the Parties shall use good faith efforts to resolve such dispute expediently and, upon
resolution of such dispute, such Party shall pay to the other Party the amount of such formally
disputed portion that is resolved in the other Party’s favor within sixty (60) days after such
resolution.
7.3 Milestone Payments.
(a) XXXXXX. Impax shall notify GSK promptly upon the XXXXXX, and shall provide GSK (i) a
report setting forth the XXXXXX and (ii) an invoice for payment under this Section 7.3(a). Unless
GSK provides written notice of termination pursuant to Section 12.2(a) within forty-five (45) days
after receipt of such report and invoice, GSK shall pay to Impax a one-time, non-refundable and
non-creditable payment of XXXXXX Dollars ($XXXXXX) within sixty (60) days after such receipt.
(b) XXXXXX. GSK shall notify Impax promptly upon the XXXXXX and shall provide Impax with a
report setting forth the XXXXXX within ten (10) Business Days after the XXXXXX. If the XXXXXX,
Impax shall submit to GSK an invoice of XXXXXX Dollars ($XXXXXX) and GSK shall pay to Impax the
amount invoiced within sixty (60) days after the receipt of such invoice.
(c) XXXXXX. GSK shall notify Impax within five (5) Business Days after the XXXXXX. After the
receipt of such notice, Impax shall submit to GSK an invoice of XXXXXX Dollars ($XXXXXX) and GSK
shall pay to Impax the amount invoiced within sixty (60) days after the receipt of such invoice.
34.
(d) XXXXXX. GSK shall notify Impax within five (5) Business Days after the XXXXXX. After the
receipt of such notice, Impax shall submit to GSK an invoice of either:
(i) XXXXXX Dollars ($XXXXXX) if (A) XXXXXX, and (B) XXXXXX; or
(ii) XXXXXX Dollars ($XXXXXX) if either of the criteria set forth in subsection (i) above were
not met by the time of the XXXXXX.
GSK shall pay to Impax the amount invoiced within sixty (60) days after the receipt of such
invoice. For clarity, GSK shall only be obligated to make one payment, either under (i) or (ii),
pursuant to this Section 7.3(d).
(e) Additional Indications. GSK shall notify Impax within five (5) Business Days after the
receipt of Regulatory Approval in any country in the Licensed Territory for a new Indication for
which GSK had not previously obtained Regulatory Approval in any country in the Licensed Territory
for the applicable Licensed Product. After the receipt of such notice only with respect to any
such new Indication that is not Xxxxxxxxx’x disease or for the treatment of any symptom thereof,
Impax shall submit to GSK an invoice of XXXXXX Dollars ($XXXXXX) and GSK shall pay to Impax the
amount invoiced within sixty (60) days after the receipt of such invoice. For clarity, the payment
described in this Section 7.3(e) shall be owed once per new Indication per Licensed Product and
XXXXXX. For further clarity, no payments are due under this Section 7.3(e) with respect to any new
Indications for Xxxxxxxxx’x disease or for the treatment of any symptom thereof.
(f) Clarification. All payments made by GSK pursuant to this Section 7.3 shall be
non-refundable and non-creditable. The milestone payments set forth above in Sections 7.3(a) and
7.3(b) are specific to the Original Product and shall not be paid with respect to any Improved
Product. Each of the milestone payments set forth above in Sections 7.3(c), 7.3(d) and 7.3(e)
apply to both the Original Product and each Improved Product subject to an exercised Option;
provided, however, that the milestone payments set forth above in Sections 7.3(c) and 7.3(d) shall
only be paid with respect to the particular Improved Product in question if GSK exercises an Option
and such milestone payment has not been paid with respect to the Original Product.
7.4 Royalties and XXXXXX Payments.
(a) Royalty Rates. Subject to Sections 7.4(c) and 7.4(d) below, GSK shall pay to Impax
non-refundable, non-creditable royalties on the Net Sales of all Licensed Products (including the
Improved Products with respect to which GSK has exercised Options) in the Licensed Territory during
the Royalty Term, as calculated by multiplying the applicable royalty rate by the corresponding
amount of incremental, aggregated Net Sales of all Licensed Products in the Licensed Territory in
each calendar year.
| Annual Net Sales of all Licensed Products in the Licensed Territory | Royalty Rate | |||
For that portion of annual Net Sales less than or equal to XXXXXX Dollars ($XXXXXX) |
XXXXXX | % | ||
For that portion of annual Net Sales greater than XXXXXX
Dollars ($XXXXXX) but less than or equal to XXXXXX Dollars
($XXXXXX) |
XXXXXX | % | ||
For that portion of annual Net Sales greater than XXXXXX
Dollars ($XXXXXX) |
XXXXXX | % | ||
35.
(b) Royalty Term. Royalties shall be paid under this Section 7.4, on a country-by-country and
Licensed Product-by-Licensed Product basis, for Net Sales of Licensed Product made from the First
Commercial Sale of such Licensed Product in each country in the Licensed Territory until the latest
of: (i) the expiration of the last-to-expire Valid Claim in such country claiming the composition
of matter (including formulation) or method of use (including dosing regimens and the
pharmacokinetic or pharmacodynamic profile of one or more active pharmaceutical ingredients) of
such Licensed Product; or (ii) the expiration of Regulatory Exclusivity for such Licensed Product
in such country; or (iii) the tenth (10th) anniversary of the First Commercial Sale of such
Licensed Product in such country (the “Royalty Term”). For purposes of this Section 7.4, a Valid
Claim claims the composition of matter (including formulation) or method of use (including dosing
regimens and the pharmacokinetic or pharmacodynamic profile of one or more active pharmaceutical
ingredients) of such Licensed Product if such Valid Claim would be infringed (evaluating pending
patent claims as if already issued), but for a license, by the Commercialization of such Licensed
Product for its approved indication in such country.
(c) Royalty Reductions.
(i) If a Licensed Product is generating Net Sales in a country during the Royalty Term in such
country at a time when a Generic Product with respect to such Licensed Product is being sold in
such country, then the royalty rate applicable to Net Sales of such Licensed Product in such
country shall be reduced to XXXXXX percent (XXXXXX%) of the average royalty rate otherwise
applicable to all Net Sales for such Licensed Product in the Licensed Territory under Section
7.4(a), commencing with Net Sales made after the first calendar quarter during which the unit
volume of all such Generic Products sold by Third Parties in such country exceeds, in each month
during such calendar quarter, XXXXXX percent (XXXXXX%) of the combined unit volume of such Licensed
Product and such Generic Product sold in such month in such country and ending when such unit
volume no longer exceeds XXXXXX percent (XXXXXX%). All such determinations of unit volume shall be
based upon a mutually acceptable calculation method and using market share data provided by a
reputable and mutually agreed upon provider, such as IMS Health. By way of illustration of the
foregoing, if during the first calendar quarter of a particular calendar year, the Net Sales in
such calendar quarter with respect to which the royalty rate is not subject to deduction under this
Section 7.4(c)(i) are XXXXXX Dollars ($XXXXXX), and Net Sales in such calendar quarter with respect
to which the royalty rate is subject to deduction under this Section 7.4(c)(i) are XXXXXX Dollars
($XXXXXX), the following shall apply with respect to the royalty payment owed to Impax for such
calendar quarter: The royalty payment without regard to the reduced rate would be $XXXXXX x XXXXXX%
+ $XXXXXX x XXXXXX% + $XXXXXX x XXXXXX% = $XXXXXX. The average royalty rate would be $XXXXXX /
$XXXXXX = XXXXXX%. The royalty rate then applicable to the Net Sales subject to royalty reduction
would be XXXXXX% x XXXXXX% = XXXXXX%. Thus total royalty due would be $XXXXXX x XXXXXX% + $XXXXXX
x XXXXXX% = $XXXXXX.
36.
(ii) If it is necessary for GSK to obtain a license from a Third Party under any Patent in a
particular country in the Licensed Territory in order to use, import or sell a Licensed Product and
GSK obtains such a license, GSK may deduct, from the royalty payment that would otherwise have been
due pursuant to Section 7.4(a) with respect to Net Sales of such Licensed Product in such country
in a particular calendar quarter, an amount equal to XXXXXX percent (XXXXXX%) of the royalties paid
by GSK to such Third Party pursuant to such license on account of the sale of such Licensed Product
in such country during such calendar quarter.
(iii) If it is necessary for Impax to obtain a license from a Third Party under any Patent to
permit Impax, its Affiliates or a Backup Manufacturer to Manufacture a Licensed Product in the
country in which Impax is Manufacturing or having Manufactured such Licensed Product for the
purposes of supplying such Licensed Product to GSK, its Affiliates or permitted sublicensees
pursuant to the Supply Agreement, XXXXXX. For clarity, Impax shall be solely responsible for
seeking and maintaining any such license needed from a Third Party. Impax shall promptly notify
GSK of any Third Party Patent under which it intends to seek any such license, to enable GSK to
determine whether it is necessary under Section 7.4(c)(ii) above for GSK to obtain a license under
such Patent or any equivalent Patent in the Licensed Territory. Notwithstanding the foregoing, if
Impax obtains a license from a Third Party under any Patent to permit Impax, its Affiliates or a
Backup Manufacturer to Manufacture a Licensed Product in the country in which Impax is
Manufacturing or having Manufactured such Licensed Product for the purposes of supplying such
Licensed Product to GSK, its Affiliates or permitted sublicensees pursuant to the Supply Agreement
as a settlement of a dispute or litigation with a Third Party in which such Third Party alleged
that Impax’s Manufacture of the Licensed Product infringes such Third Party’s Patent(s), XXXXXX for
the Licensed Product under the Supply Agreement. In addition, in the event of a breach of a
representation or warranty made by Impax under Section 9.2(c), Impax shall be responsible for
obtaining and paying for any license that is necessary to cure or otherwise remedy such breach,
other than any license necessary to permit Impax, its Affiliates or a Backup Manufacturer to
Manufacture a Licensed Product in the country in which Impax is Manufacturing or having
Manufactured such Licensed Product for the purposes of supplying such Licensed Product to GSK, its
Affiliates or permitted sublicensees pursuant to the Supply Agreement.
(iv) Notwithstanding the foregoing, during any calendar quarter in the Royalty Term for a
Licensed Product in a particular country in the Licensed Territory, the operation of Sections
7.4(c)(i) or 7.4(c)(ii) individually or in combination shall not reduce by more than XXXXXX percent
(XXXXXX%) the royalties that would otherwise have been due under Section 7.4(a) with respect to Net
Sales of such Licensed Product in such country during such calendar quarter.
(d) Royalty Adjustment due to the Transfer Price of a Licensed Product. Notwithstanding
Sections 7.4(a) and 7.4(c), if the royalty payment that would otherwise be due to Impax pursuant to
Section 7.4(a), after application of all applicable royalty reductions in accordance with Sections
7.4(c)(i), (ii) and (iv), with respect to Net Sales of a Licensed Product made in a particular
country in the Licensed Territory during a particular calendar quarter in the Royalty Term for such
country, would, when added to the Transfer Price paid by GSK to Impax pursuant to the Supply
Agreement for the units of such Licensed Product sold in such country during such calendar quarter,
exceed XXXXXX percent (XXXXXX%) of such Net Sales, then
GSK shall make a royalty payment to Impax with respect to such Net Sales, equal to the greater
of: (i) XXXXXX percent (XXXXXX%) of such Net Sales minus XXXXXX paid by GSK to Impax pursuant to
XXXXXX for the units of such Licensed Product sold in such country during such calendar quarter; or
(ii) XXXXXX percent (XXXXXX%) of XXXXXX paid by GSK to Impax pursuant to XXXXXX for the units of
such Licensed Product sold in such country during such calendar quarter.
37.
(e) XXXXXX Payments. GSK shall make each of the following one-time, non-refundable,
non-creditable XXXXXX payments to Impax when the XXXXXX. GSK shall notify Impax within thirty (30)
days after the end of the calendar quarter in which XXXXXX. Following such notification from GSK,
Impax shall invoice GSK for the applicable amount due under this Section 7.4(e), and GSK shall pay
such amount due within thirty (30) days of the receipt of such invoice. For clarity, (i) XXXXXX,
(ii) XXXXXX, and (iii) XXXXXX.
| XXXXXX | XXXXXX Payment | |||
XXXXXX |
XXXXXX Dollars ($XXXXXX | ) | ||
XXXXXX |
XXXXXX Dollars ($XXXXXX | ) | ||
XXXXXX |
XXXXXX Dollars ($XXXXXX | ) | ||
XXXXXX |
XXXXXX Dollars ($XXXXXX | ) | ||
(f) Royalty Reports and Payments. Prior to the end of each calendar quarter, commencing with
the calendar quarter in which the First Commercial Sale of a Licensed Product is made in a Major
Market Country, GSK shall provide Impax with a report containing the actual Net Sales of the
Licensed Product in the Major Market Countries in the first two months in such calendar quarter.
Within sixty (60) days following the end of each calendar quarter, commencing with the calendar
quarter in which the First Commercial Sale of a Licensed Product is made anywhere in the Licensed
Territory, GSK shall provide Impax with a report containing the following information for the
applicable calendar quarter, on a country-by-country and, if GSK has exercised an Option, Licensed
Product-by-Licensed Product basis: (i) Net Sales and a calculation of the royalty payment due on
such sales, (ii) an accounting of the number of units and prices for a Licensed Product sold and
the Transfer Price paid by GSK to Impax pursuant to the Supply Agreement with respect to each such
unit, (iii) the exchange rate for such country, (iv) aggregate annual Net Sales of all Licensed
Products in the Licensed Territory in such calendar year and the amount of XXXXXX payment due and
(v) the application of the reduction and adjustment, if any, made in accordance with the terms of
Sections 7.4(c) and 7.4(d). Concurrent with the delivery of the applicable quarterly report, GSK
shall pay in Dollars all amounts due to Impax pursuant to Section 7.4 with respect to Net Sales by
GSK, its Affiliates and their respective sublicensees for such calendar quarter.
7.5 Blocked Currency. In each country in the Licensed Territory where the local currency is
blocked and cannot be removed from the country, royalties accrued on Net Sales in such country
shall be paid to Impax in the equivalent amount in Dollars.
38.
7.6 Foreign Exchange. The rate of exchange to be used in computing the amount of currency
equivalent in Dollars of Net Sales invoiced in other currencies shall be made using the average
exchange rates as calculated and utilized by GSK’s group reporting system and published accounts.
The current method is sourced from Reuters/Bloomberg, with U.S. spot
rates supplied on a daily basis. The cumulative year-to-date average rates are calculated as
the average of the preceding 31st December spot rate plus the closing spot rates of the relevant
months to date, using the following as input: (a) Dollar and Euro input to 4 decimal places and (b)
all other currencies to 3 significant places (or to the nearest round number if over 999). As an
example, the cumulative average rate for the five (5) months to May will be computed by taking the
sum of the spot rates of the preceding 31st December, plus the month-end spot rates for the five
(5) months to May, divided by 6. The resulting average rates are published to three (3)
significant figures (e.g. $1.44 for the Dollar, or Naira 168 for Nigeria ), or to the nearest round
number if the currency is more than 999 (e.g. Bolivar 1,302 for Venezuela). The rounding process
for a currency is that 0.5 is rounded up (e.g. $1.4350 is rounded up to $1.44). If changed, GSK
will notify Impax of revised method in advance of it being applied.
7.7 Payment Method; Late Payments. All payments due to Impax hereunder shall be made in
Dollars by wire transfer of immediately available funds into an account designated by Impax in
advance. If Impax does not receive payment of any sum due to it on or before the due date, simple
interest shall thereafter accrue on the sum due to Impax until the date of payment at the per annum
rate of two percent (2%) over the then-current prime rate reported in The Wall Street Journal or
the maximum rate allowable by applicable Laws, whichever is lower with the following exceptions: no
interest shall be due for any portion of payments that is subject to good faith dispute, provided
that GSK has paid any undisputed amounts.
7.8 Accounting; Records; Audits. All payments and other amounts under this Agreement shall be
accounted for in accordance with the International Financial Reporting Standards (“IFRS”)
accounting principles for GSK or U.S. Generally Accepted Accounting Principles (“GAAP”) accounting
principles for Impax, in each case applied on a consistent basis. GSK and its Affiliates and
sublicensees will maintain complete and accurate records in sufficient detail to permit Impax to
confirm the accuracy of the calculation of royalty payments and the achievement of milestone
events. Upon reasonable prior notice of at least sixty (60) days, such records shall be available
during regular business hours for a period of three (3) years from the end of the calendar year to
which they pertain for examination, and not more often than once each calendar year, by an
independent certified public accountant selected by Impax and reasonably acceptable to GSK, for the
sole purpose of verifying the accuracy of the financial reports furnished by GSK pursuant to this
Agreement. Any such auditor shall not disclose GSK’s Confidential Information, except to the
extent such disclosure is necessary to verify the accuracy of the financial reports furnished by
GSK or the amount of payments due by GSK to Impax under this Agreement. Any amounts shown to be
owed but unpaid shall be paid within sixty (60) days from the accountant’s report, plus interest
(as set forth in Section 7.7) from the original due date. Impax shall bear the full cost of such
audit unless such audit discloses an underpayment by the GSK of more than five percent (5%) of the
amount due, in which case GSK shall bear the full cost of such audit.
39.
7.9 Taxes.
(a) Taxes on Income; Withholding. The Parties agree that, as of the Effective Date, GSK is
not required by applicable Law to deduct and withhold any taxes on account of any royalties or
other payments payable to Impax under this Agreement. To the extent GSK becomes, on account of a
change in applicable Law or a change in Impax’s
residency for tax purposes, required by applicable Laws to deduct and withhold any taxes on
account of any royalties or other payments payable to Impax under this Agreement, GSK shall notify
Impax in writing, shall deduct such taxes from the amount of royalties or other payments otherwise
due to Impax and shall pay such taxes to the proper tax authority in a timely manner. GSK shall
secure and send to Impax proof of any such taxes withheld and paid by GSK for the benefit of Impax,
and shall, at Impax’s request, provide reasonable assistance to Impax in recovering such taxes.
Impax shall provide GSK with U.S. residency certification from U.S. Internal Revenue Service to
show that it is resident for tax purposes in the United States of America. Impax shall notify GSK
immediately in writing in the event that the Company ceases to be resident for tax purposes in the
United States of America. Pending receipt of formal certification from the UK Inland Revenue GSK
may pay royalty income and any other payments under this Agreement to Impax by deducting tax at a
rate specified in the double tax treaty between the UK and USA, which rate, as of the Effective
Date, is zero percent.
(b) Tax on Income. Each Party shall be solely responsible for the payment of all taxes
imposed on its share of income arising directly or indirectly from the efforts of the Parties under
this Agreement.
(c) Tax Cooperation. The Parties agree to cooperate with one another and use reasonable
efforts to reduce or eliminate tax withholding or similar obligations in respect of royalties,
milestone payments, and other payments made by GSK to Impax under this Agreement. Impax shall
provide GSK any tax forms that may be reasonably necessary in order for GSK not to withhold tax or
to withhold tax at a reduced rate under an applicable bilateral income tax treaty. Each Party
shall provide the other with reasonable assistance to enable the recovery, as permitted by
applicable Laws, of withholding taxes, value added taxes, or similar obligations resulting from
payments made under this Agreement, such recovery to be for the benefit of the Party bearing such
withholding tax or value added tax. GSK shall require its sublicensees in the Licensed Territory
to cooperate with Impax in a manner consistent with this Section 7.9(c).
(d) Taxes Resulting From GSK Action. If GSK is required to make a payment to Impax that is
subject to a deduction or withholding of tax, then (i) if such withholding or deduction obligation
arises as a result of any action by GSK, including any assignment or sublicense, any change in
GSK’s residency for tax purposes, any change in the entity making such payment, or any failure on
the part of GSK to comply with applicable Laws or filing or record retention requirements, that has
the effect of modifying the tax treatment of the Parties hereto (a “GSK Withholding Tax Action”),
then the sum payable by GSK (in respect of which such deduction or withholding is required to be
made) shall be increased to the extent necessary to ensure that Impax receives a sum equal to the
sum which it would have received had no such GSK Withholding Tax Action occurred, and (ii)
otherwise, the sum payable by GSK (in respect of which such deduction or withholding is required to
be made) shall be made to Impax after deduction of the amount required to be so deducted or
withheld, which deducted or withheld amount shall be remitted to the proper Governmental Authority
in accordance with applicable Laws.
40.
ARTICLE 8
INTELLECTUAL PROPERTY MATTERS
8.1 Ownership of Inventions. Inventorship shall be determined in accordance with U.S. patent
laws. The ownership of any and all inventions arising pursuant to this Agreement, which is
discovered, developed, invented or created solely by or on behalf of a Party or jointly by or on
behalf of GSK and Impax, shall be determined in accordance with inventorship, subject to the rights
and licenses expressly granted by one Party to the other Party under this Agreement. Each Party
shall own any inventions, whether or not patentable, made solely by its own employees, agents, or
independent contractors in the course of conducting its activities under this Agreement, together
with all intellectual property rights therein (“Sole Inventions”). The Parties shall jointly own
any inventions that are made jointly by employees, agents, or independent contractors of each Party
in the course of performing activities under this Agreement, together with all intellectual
property rights therein (“Joint Inventions”). All Manufacturing activities conducted with respect
to a Licensed Product shall be deemed conducted pursuant to the Supply Agreement rather than
pursuant to this Agreement; ownership of inventions made pursuant to the Supply Agreement is
addressed in the Supply Agreement. All Patents claiming jointly owned Joint Inventions shall be
referred to herein as “Joint Patents.” Except to the extent either Party is restricted by the
licenses granted to the other Party under this Agreement, each Party shall be entitled to practice
and exploit the Joint Inventions and Joint Patents without the duty of accounting or seeking
consent from the other Party.
8.2 Disclosure of Inventions. Each Party shall promptly disclose to the JPC all Sole
Inventions and Joint Inventions, including any invention disclosures, or other similar documents,
submitted to it by its employees, agents or independent contractors describing inventions that are
either Sole Inventions or Joint Inventions, and such Information relating to such inventions to the
extent necessary or useful for the preparation, filing and maintenance of any Patent with respect
to such invention.
8.3 Prosecution of Patents.
(a) Impax Prosecuted Patents. As between the Parties, Impax shall have the sole right to
Prosecute and Maintain Impax Patents and Joint Patent outside the Licensed Territory and any
Patents for which the responsibility for Prosecution and Maintenance has been assumed by Impax
pursuant to Section 8.3(b)(ii) or 8.3(b)(iii) below (the “Impax Prosecuted Patents”), at Impax’s
cost and expense. Impax shall provide GSK reasonable opportunity to review and comment on such
prosecution efforts regarding such Impax Prosecuted Patents, as follows. Impax shall promptly
provide GSK with copies of all material communications from any patent authority regarding such
Impax Prosecuted Patents, and shall provide GSK, for its review and comment, with drafts of any
material filings or responses to be made to such patent authorities at least five (5) Business Days
in advance of submitting such filings or responses. Impax shall consider in good faith any
reasonable comments thereto provided by GSK in connection with the prosecution of Impax Prosecuted
Patents.
41.
(b) GSK Prosecuted Patents.
(i) Subject to Sections 8.3(b)(ii) and 8.3(b)(iii) below, as between the Parties, GSK shall
have the first right to Prosecute and Maintain Impax Patents and any Joint Patents in the Licensed
Territory (the “GSK Prosecuted Patents”), at GSK’s cost and expense. GSK shall provide Impax
reasonable opportunity to review and comment on such prosecution efforts regarding such GSK
Prosecuted Patents, as follows. GSK shall promptly provide Impax with copies of all material
communications from any patent authority regarding such GSK Prosecuted Patents, and shall provide
Impax, for its review and comment, with drafts of any material filings or responses to be made to
such patent authorities at least five (5) Business Days in advance of submitting such filings or
responses. GSK shall consider in good faith any reasonable comments thereto provided by Impax in
connection with the prosecution of GSK Prosecuted Patents. If Impax reasonably determines that any
patent prosecution or enforcement action in the Licensed Territory is detrimental to the practice,
prosecution or enforcement of Impax Patents outside the Licensed Territory, Impax may submit such
action to the JPC for review and GSK shall not undertake such action until the JPC has rendered a
decision pursuant to Section 3.3.
(ii) If GSK decides to cease the Prosecution or Maintenance of any GSK Prosecuted Patents, it
shall notify Impax in writing sufficiently in advance so that Impax may, at its discretion, assume
the responsibility for the Prosecution or Maintenance of such Patents, at Impax’s cost and expense.
If Impax assumes such responsibility, then such Patents shall be included in the Impax Prosecuted
Patents and the terms of Section 8.3(a) shall apply to such Patents.
(iii) If GSK or its Affiliates obtains ownership of, or a license or other right to
commercialize in any country in the Licensed Territory: (1) XXXXXX, or (2) XXXXXX, then GSK shall
no longer have the first right to Prosecute and Maintain Impax Patents and any Joint Patents in
such country, and Impax may, at its discretion, assume the responsibility for the Prosecution or
Maintenance of such Patents, at Impax’s cost and expense. If Impax assumes such responsibility,
then such Patents shall be included in the Impax Prosecuted Patents and the terms of Section 8.3(a)
shall apply to such Patents.
(c) Cooperation. Each Party shall provide the other Party all reasonable assistance and
cooperation in the patent prosecution efforts provide above in this Section 8.3, including
providing any necessary powers of attorney and executing any other required documents or
instruments for such prosecution.
(d) Patent Term Extension. The Parties will cooperate with each other in gaining patent term
extension where applicable to Licensed Products. All filings for such extension will be made by
the holder of the Marketing Authorization Approval in the particular country. The Parties will
timely provide any documentation or other assistance required in order to obtain such patent term
extensions.
42.
8.4 Enforcement of Impax Patents and Joint Patents.
(a) Notification. If either Party becomes aware of any existing or threatened infringement of
the Impax Patents or Joint Patents in the Licensed Territory (“Infringement”), it shall promptly
notify the other Party in writing to that effect and the Parties will consult with each other
regarding any actions to be taken with respect to such Infringement.
(b) Enforcement Rights. For any Infringement, each Party shall share with the other Party all
Information available to it regarding such alleged infringement. GSK shall have the first right,
but not the obligation, to bring an appropriate suit or other action against any person or entity
engaged in such Infringement, at GSK’s cost and expense. GSK shall have a period of ninety (90)
days after its receipt or delivery of notice under Section 8.4(a) to elect to so enforce the Impax
Patents or Joint Patents in the Licensed Territory (or to settle or otherwise secure the abatement
of such Infringement). In this case, Impax shall take appropriate actions, at GSK’s cost, in order
to enable GSK to commence a suit or take the actions set forth in the preceding sentence. If GSK
fails to commence a suit to enforce the applicable Impax Patents or Joint Patents or to settle or
otherwise secure the abatement of such Infringement within such period, then Impax shall have the
right, but not the obligation, to commence a suit or take action to enforce such Impax Patents or
Joint Patents against such Infringement in the Licensed Territory at its own cost and expense. In
this case, GSK shall take appropriate actions, at Impax’s cost, in order to enable Impax to
commence a suit or take the actions set forth in the preceding sentence.
(c) Collaboration. Each Party shall provide to the enforcing Party reasonable assistance in
such enforcement, at such enforcing Party’s request and expense, including to be named in such
action if required by applicable Laws to pursue such action. The enforcing Party shall keep the
other Party regularly informed of the status and progress of such enforcement efforts, shall
reasonably consider the other Party’s comments on any such efforts, including, without limitation,
determination of litigation strategy, filing of material papers to the competent court, which shall
not be unreasonably withheld or delayed. The non-enforcing Party shall be entitled to separate
representation in such matter by counsel of its own choice and at its own expense, but such Party
shall at all times cooperate fully with the enforcing Party.
(d) Settlement. GSK shall not settle any claim, suit or action that it brought under Section
8.4(b) in any manner that would negatively impact the applicable Impax Patents or that would limit
or restrict the ability of Impax to Develop, make, use, import, offer for sale, sell or otherwise
Commercialize Licensed Products anywhere outside the Licensed Territory or to make or have made the
Licensed Product anywhere in the world, without the prior written consent of Impax, which consent
shall not be unreasonably withheld or delayed. Impax shall not settle any claim, suit or action
that it brought under Section 8.4(b) in any manner that would limit or restrict the ability of GSK
to sell Licensed Products for use in the Field, or impair the exclusivity of GSK’s license rights
under this Agreement, in each case without the prior written consent of GSK, which consent shall
not be unreasonably withheld or delayed.
(e) Expenses and Recoveries. The enforcing Party bringing a claim, suit or action under
Section 8.4(b) shall be solely responsible for any expenses incurred by such Party as a result of
such claim, suit or action. If such Party recovers monetary damages in such claim, suit or action,
such recovery shall be allocated first to the reimbursement of any expenses incurred by the Party
bringing suit, second to the reimbursement of any expenses incurred by the
other Party in such litigation, and XXXXXX; provided, however, that, in the event GSK is the
Party bringing suit, XXXXXX.
43.
8.5 Enforcement of GSK Patents. GSK shall have the sole right, but not the obligation, to
bring an appropriate suit or other action against any person or entity allegedly infringing any
Patents Controlled by GSK.
8.6 Patents Licensed From Third Parties. Each Party’s rights under this Article 8 with
respect to the Prosecution and Maintenance and enforcement of any Impax Patent that is licensed by
Impax from a Third Party shall be subject to the rights of such Third Party to Prosecute and
Maintain and enforce such Patent.
8.7 Infringement of Third Party Rights in the Licensed Territory. If any Licensed Product
used or sold by GSK, its Affiliates or sublicensees becomes the subject of a Third Party’s claim or
assertion of infringement of a Patent granted by a jurisdiction within the Licensed Territory, GSK
shall promptly notify Impax and the Parties shall promptly meet to consider the claim or assertion
and the appropriate course of action and may, if appropriate, agree on and enter into a “common
interest agreement” wherein the Parties agree to their shared, mutual interest in the outcome of
such potential dispute. Except to the extent that GSK is entitled to indemnification pursuant to
Section 10.1 of this Agreement or Section 11.1 of the Supply Agreement, GSK shall be solely
responsible for the defense of any such infringement claims brought against GSK, at GSK’s cost and
expense; provided, however, that the provisions of Section 8.4 shall govern the right of GSK to
assert a counterclaim of infringement of any Impax Patents or Joint Patents.
8.8 Patent Marking. If permissible under the applicable Laws of a country in the Licensed
Territory, and GSK decides to make it a standard practice to include patent numbers or indicia on
its other prescription products in such country in the Licensed Territory, then GSK will discuss
with Impax whether it is appropriate to include patent numbers or indicia on the Licensed Products,
and the Parties shall proceed on such matters as they may then mutually agree.
8.9 Trademarks. GSK shall have the right to brand the Licensed Products in the Licensed
Territory using GSK related trademarks and any other trademarks and trade names it determines
appropriate for the Licensed Products in consultation with Impax, which may vary by country or
within a country (“Product Marks”); provided, however, that GSK shall not, and shall ensure that
its Affiliates and sublicensees will not, make any use of the trademarks or house marks of Impax
(including Impax’s corporate name) or any trademark confusingly similar thereto without Impax’s
prior written consent. GSK or its Affiliates shall own all rights in the Product Marks, and all
goodwill in the Product Marks shall accrue to GSK or its Affiliates. GSK or its Affiliates shall
register and maintain, at their own cost and expense, the Product Marks in the countries and
regions in the Licensed Territory that GSK and its Affiliates determines reasonably necessary. GSK
and its Affiliates shall have the sole right to register domain names incorporating the Product
Marks at their own cost and expense. GSK and its Affiliates shall have the sole right to take
action to prosecute and defend its rights in the Product Marks (including in respect of oppositions
and infringement actions) as GSK and its Affiliates deem reasonably necessary.
44.
8.10 International Nonproprietary Name. If changes to the International Nonproprietary Name
(“INN”) for the Licensed Products are required by the Regulatory Authorities in future, Impax will
be responsible for the clearance and costs of obtaining a new generic name.
ARTICLE 9
REPRESENTATIONS AND WARRANTIES; COVENANTS
9.1 Mutual Representations and Warranties. Each Party hereby represents and warrants to the
other Party as follows:
(a) Corporate Existence. As of the Effective Date, it is a company or corporation duly
organized, validly existing, and in good standing under the Laws of the jurisdiction in which it is
incorporated.
(b) Corporate Power, Authority and Binding Agreement. As of the Effective Date: (i) it has
the corporate power and authority and the legal right to enter into this Agreement and perform its
obligations hereunder; (ii) it has taken all necessary corporate action on its part required to
authorize the execution and delivery of this Agreement and the performance of its obligations
hereunder; and (iii) this Agreement has been duly executed and delivered on behalf of such Party,
and constitutes a legal, valid, and binding obligation of such Party that is enforceable against it
in accordance with its terms.
9.2 Additional Representations and Warranties of Impax. Impax represents and warrants to GSK
as follows, as of the Effective Date:
(a) Title; Encumbrances. It has sufficient legal and/or beneficial title, ownership or
license, free and clear from any mortgages, pledges, liens, security interests, conditional and
installment sale agreement, encumbrances, charges or claim of any kind, of the Impax Technology to
grant the licenses to GSK as purported to be granted pursuant to this Agreement;
(b) Notice of Infringement or Misappropriation. It has not received any written notice from
any Third Party asserting or alleging that any research or development of a Licensed Product by
Impax prior to the Effective Date infringed or misappropriated the intellectual property rights of
such Third Party;
(c) Non-Infringement of Third Party Rights. To Impax’s knowledge, the Development and
Commercialization of a Licensed Product and the Manufacture of Licensed Product under the Supply
Agreement can be carried out in the manner reasonably contemplated as of the Effective Date without
infringing any issued patents owned or controlled by a Third Party;
(d) No Proceeding. There are no pending, and to Impax’s knowledge, no threatened, adverse
actions, suits or proceedings against Impax involving Impax Technology or a Licensed Product;
45.
(e) Other Agreements. Impax has no existing agreements, options, commitments, or rights with,
of, or to any person (other than GSK) to acquire, license or otherwise obtain any rights to the
Original Product in the Licensed Territory. As of the Effective Date, no Impax Patents or Impax
Know-How have been licensed to Impax from any Third Party;
(f) Certain Other Arrangements. Prior to the Effective Date, neither Impax nor its Affiliates
have directly or indirectly (i) been a party to a license, sublicense or other contractual
arrangement relating to, or (ii) entered into or otherwise benefitted from a license, sublicense or
other contractual arrangement relating to any intellectual property rights or other interests or
rights, including rights in non-clinical or clinical data, in any product (other than a Licensed
Product) containing carbidopa or levodopa (whether formulated individually or in combination) for
which an MAA had previously been approved;
(g) Prosecution of Impax Patents. To Impax’s knowledge, prior to the Effective Date, Impax
has not taken action or failed to undertake an action in connection with filing, prosecuting and
maintaining the Impax Patents in violation of any applicable law, statute or regulation.
9.3 Additional Representations and Warranties of GSK. GSK represents and warrants to Impax
that, to GSK’s knowledge as of the Effective Date, GSK does not Control any Patent that is
necessary to make, use, import, offer for sale or sell the Original Product in the Field.
9.4 Mutual Covenants.
(a) No Debarment. In the course of the Development of a Licensed Product, each Party shall
not use any employee or consultant who has been debarred by any Regulatory Authority, or, to such
Party’s knowledge, is the subject of debarment proceedings by a Regulatory Authority. Each Party
shall notify the other Party promptly upon becoming aware that any of its employees or consultants
has been debarred or is the subject of debarment proceedings by any Regulatory Authority.
(b) Conduct of Activities. Each Party’s Development of a Licensed Product shall be conducted
in a manner consistent with the following: (i) in the case of GSK, not adversely impacting Impax’s
or its Affiliates’ or Third Party partner’s Development or Commercialization efforts for a Licensed
Product outside the Licensed Territory; and (ii) in the case of Impax, not adversely impacting
GSK’s or its Affiliates’ or sublicensees’ Development or Commercialization efforts for a Licensed
Product in the Licensed Territory.
(c) Compliance. Each Party and its Affiliates shall comply in all material respects with all
applicable Laws in the Development and Commercialization of a Licensed Product and performance of
its obligations under this Agreement, including the statutes, regulations and written directives of
the FDA, the EMA and any Regulatory Authority having jurisdiction in the Licensed Territory, the
FD&C Act, the Prescription Drug Marketing Act, the Federal Health Care Programs Anti-Kickback Law,
42 U.S.C. 1320a-7b(b), the statutes, regulations and written directives of Medicare, Medicaid and
all other health care programs, as
defined in 42 U.S.C. § 1320a-7b(f), and the Foreign Corrupt Practices Act of 1977, each as may
be amended from time to time.
46.
9.5 Additional Covenants of Impax. The Parties acknowledge and agree that GSK desires to
obtain a ten-year period of data exclusivity in connection with the MAA approval for a Licensed
Product in the EU and that GSK could become ineligible to obtain such ten-year data exclusivity on
account of Impax’s activities. XXXXXX:
(a) XXXXXX,
(b) XXXXXX,
(c) XXXXXX,
(d) XXXXXX, or
(e) XXXXXX.
For clarity, the restrictions set forth in this Section 9.5 shall terminate upon the first MAA
approval of the Original Product by the European Commission or, if sooner, the first MAA approval
by the European Commission of an Improved Product for which GSK has exercised its Option. For
further clarity, this Section 9.5 shall not apply to XXXXXX.
9.6 Disclaimer. GSK understands that a Licensed Product is the subject of ongoing clinical
research and development and that Impax cannot assure the safety or usefulness of a Licensed
Product. In addition, Impax makes no warranties except as set forth in this Article 9 concerning
the Impax Technology.
9.7 No Other Representations or Warranties. EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT, NO
REPRESENTATIONS OR WARRANTIES WHATSOEVER, WHETHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, OR NON-MISAPPROPRIATION OF
THIRD PARTY INTELLECTUAL PROPERTY RIGHTS, ARE MADE OR GIVEN BY OR ON BEHALF OF A PARTY, AND ALL
REPRESENTATIONS AND WARRANTIES, WHETHER ARISING BY OPERATION OF LAW OR OTHERWISE, ARE HEREBY
EXPRESSLY EXCLUDED.
ARTICLE 10
INDEMNIFICATION
10.1 Indemnification by Impax. Impax shall defend, indemnify, and hold GSK and its Affiliates
and their respective officers, directors, employees, and agents (the “GSK Indemnitees”) harmless
from and against any and all Third Party claims, suits, proceedings, damages, expenses (including
court costs and reasonable attorneys’ fees and expenses) and recoveries (collectively, “Claims”) to
the extent that such Claims arise out of, are based on, or result from: (a) the Development or
Commercialization of a Licensed Product by or on behalf of Impax, (b) the failure by Impax to
timely obtain and maintain the license(s) required to be
secured by Impax pursuant to Section 7.4(c)(iii), (c) the breach of any of Impax’s obligations
under this Agreement, including Impax’s representations and warranties set forth herein, or (d) the
willful misconduct or gross negligence of Impax, its Affiliates, or the officers, directors,
employees, or agents of Impax or its Affiliates. The foregoing indemnity obligation shall not
apply to the extent that (i) the GSK Indemnitees fail to comply with the indemnification procedures
set forth in Section 10.3 and Impax’s defense of the relevant Claims is prejudiced by such failure,
or (ii) any Claim arises from, is based on, or results from any activity set forth in Section
10.2(a), 10.2(b) or 10.2(c) for which GSK is obligated to indemnify the Impax Indemnitees under
Section 10.2.
47.
10.2 Indemnification by GSK. GSK shall defend, indemnify, and hold Impax and its Affiliates
and their respective officers, directors, employees, and agents (the “Impax Indemnitees”) harmless
from and against any and all Claims to the extent that such Claims arise out of, are based on, or
result from (a) the Development or Commercialization of a Licensed Product by or on behalf of GSK
or its Affiliates or its or their sublicensees, or (b) the breach of any of GSK’s obligations under
this Agreement, including GSK’s representations and warranties set forth herein, or (c) the willful
misconduct or gross negligence of GSK, its Affiliates, or the officers, directors, employees, or
agents of GSK or its Affiliates. The foregoing indemnity obligation shall not apply to the extent
that (i) the Impax Indemnitees fail to comply with the indemnification procedures set forth in
Section 10.3 and GSK’s defense of the relevant Claims is prejudiced by such failure, or (ii) any
Claim arises from, is based on, or results from any activity set forth in Section 10.1(a), 10.1(b)
or 10.1(c) for which Impax is obligated to indemnify the GSK Indemnitees under Section 10.1.
10.3 Indemnification Procedures. The Party claiming indemnity under this Article 10 (the
“Indemnified Party”) shall give written notice to the Party from whom indemnity is being sought
(the “Indemnifying Party”) promptly after learning of such Claim. The Indemnified Party shall
provide the Indemnifying Party with reasonable assistance, at the Indemnifying Party’s expense, in
connection with the defense of the Claim for which indemnity is being sought. The Indemnified
Party may participate in and monitor such defense with counsel of its own choosing at its sole
expense; provided, however, the Indemnifying Party shall have the right to assume and conduct the
defense of the Claim with counsel of its choice. The Indemnifying Party shall not settle any Claim
without the prior written consent of the Indemnified Party, not to be unreasonably withheld or
delayed, unless the settlement involves only the payment of money. So long as the Indemnifying
Party is actively defending the Claim in good faith, the Indemnified Party shall not settle or
compromise any such Claim without the prior written consent of the Indemnifying Party. If the
Indemnifying Party does not assume and conduct the defense of the Claim as provided above, (a) the
Indemnified Party may defend against, consent to the entry of any judgment, or enter into any
settlement with respect to such Claim in any manner the Indemnified Party may deem reasonably
appropriate (and the Indemnified Party need not consult with, or obtain any consent from, the
Indemnifying Party in connection therewith), and (b) the Indemnifying Party shall remain
responsible to indemnify the Indemnified Party as provided in this Article 10.
10.4 Limitation of Liability. NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY SPECIAL,
CONSEQUENTIAL, INCIDENTAL, PUNITIVE, OR INDIRECT DAMAGES ARISING FROM OR RELATING TO ANY BREACH OF
THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH DAMAGES. NOTWITHSTANDING THE
FOREGOING, NOTHING IN THIS SECTION 10.4 IS INTENDED TO OR SHALL LIMIT OR RESTRICT THE
INDEMNIFICATION RIGHTS OR OBLIGATIONS OF ANY PARTY UNDER SECTION 10.1 OR 10.2, OR DAMAGES AVAILABLE
FOR A PARTY’S BREACH OF CONFIDENTIALITY OBLIGATIONS IN ARTICLE 11.
48.
10.5 Supply Agreement. The rights and obligations set forth in this Article 10 shall be in
addition to, and without prejudice to, indemnification, limitations of liability, insurance,
representations and warranties and other rights and obligations of the Parties provided for under
the Supply Agreement.
10.6 Insurance. Each Party shall procure and maintain insurance, including product liability
insurance, adequate to cover its obligations hereunder and consistent with normal business
practices of prudent companies similarly situated at all times during which any Licensed Product is
being clinically tested in human subjects or commercially distributed or sold by such Party. It is
understood that such insurance shall not be construed to create a limit of either Party’s liability
with respect to its indemnification obligations under this Article 10. Each Party shall provide
the other Party with written evidence of such insurance upon request. Each Party shall provide the
other Party with written notice at least thirty (30) days prior to the cancellation, non renewal or
material change in such insurance. GSK hereby represents and warrants to Impax that it is
self-insured against liability and other risks associated with its activities and obligations under
this Agreement.
ARTICLE 11
CONFIDENTIALITY
11.1 Confidentiality. Each Party agrees that, during the Term and for a period of five (5)
years thereafter, it shall keep confidential and shall not publish or otherwise disclose and shall
not use for any purpose other than as provided for in this Agreement or the Supply Agreement (which
includes the exercise of any rights or the performance of any obligations hereunder or thereunder)
any Confidential Information furnished to it by the other Party pursuant to this Agreement or the
Supply Agreement, except to the extent expressly authorized by this Agreement or the Supply
Agreement or otherwise agreed in writing by the Parties. The foregoing confidentiality and non-use
obligations shall not apply to any portion of the other Party’s Confidential Information that the
receiving Party can demonstrate by competent written proof:
(a) was already known to the receiving Party or its Affiliate, other than under an obligation
of confidentiality, at the time of disclosure by the other Party;
(b) was generally available to the public or otherwise part of the public domain at the time
of its disclosure to the receiving Party;
49.
(c) became generally available to the public or otherwise part of the public domain after its
disclosure and other than through any act or omission of the receiving Party in breach of this
Agreement;
(d) was disclosed to the receiving Party or its Affiliate by a Third Party who has a legal
right to make such disclosure and who did not obtain such information directly or indirectly from
the other Party; or
(e) was independently discovered or developed by the receiving Party or its Affiliate without
access to or aid, application, use of the other Party’s Confidential Information, as evidenced by a
contemporaneous writing.
11.2 Authorized Disclosure. Notwithstanding the obligations set forth in Section 11.1, a
Party may disclose the other Party’s Confidential Information and the terms of this Agreement to
the extent:
(a) such disclosure is required to be made (i) for the filing or prosecuting Patent rights as
contemplated by this Agreement or the Supply Agreement; (ii) to comply with the requirements of
Regulatory Authorities with respect to obtaining and maintaining Regulatory Approval of a Licensed
Product; or (iii) for the prosecuting or defending litigation as contemplated by this Agreement or
the Supply Agreement;
(b) such disclosure is required to be made to its employees, agents, consultants, contractors,
licensees or sublicensees on a need-to-know basis for the sole purpose of performing its
obligations or exercising its rights under this Agreement or the Supply Agreement; provided,
however, that in each case, the disclosees are bound by written obligations of confidentiality and
non-use consistent with those contained in this Agreement;
(c) such disclosure is required to be made to any bona fide potential or actual investor,
acquiror, merger partner, or other financial or commercial partner for the sole purpose of
evaluating an actual or potential investment, acquisition or other business relationship; provided,
however, that in connection with such disclosure, such Party shall use all reasonable efforts to
inform each disclosee of the confidential nature of such Confidential Information and cause each
disclosee to treat such Confidential Information as confidential; or
(d) such disclosure is required in order to comply with applicable Laws, including regulations
promulgated by applicable security exchanges, court order, administrative subpoena or order.
Notwithstanding the foregoing, in the event a Party is required to make a disclosure of the other
Party’s Confidential Information pursuant to Section 11.2(a) or 11.2(d), such Party shall promptly
notify the other Party such required disclosure and shall use reasonable efforts to obtain, or to
assist the other Party in obtaining, a protective order preventing or limiting the required
disclosure.
50.
11.3 Technical Publication.
(a) Subject to Section 11.3(b) below, GSK shall have the right to publish, in GSK’s Clinical
Trial Register, summaries of the results of all clinical trials of a Licensed Product conducted by
either Party under this Agreement.
(b) Neither Party may publish peer reviewed manuscripts, or give other forms of public
disclosure such as abstracts and presentations, of results of studies carried out under this
Agreement, without the opportunity for prior review by the other Party, except to the extent
required by applicable Laws. A Party seeking publication shall provide the other Party the
opportunity to review and comment on any proposed publication which relates to a Licensed Product
at least thirty (30) days prior to its intended submission for publication. The other Party shall
provide the Party seeking publication with its comments in writing, if any, within twenty (20) days
after receipt of such proposed publication. The Party seeking publication shall consider in good
faith any comments thereto provided by the other Party and shall comply with the other Party’s
request to remove any and all of such other Party’s Confidential Information from the proposed
publication. In addition, the Party seeking publication shall delay the submission for a period up
to sixty (60) days in the event that the other Party can demonstrate reasonable need for such
delay, including the preparation and filing of a patent application. If the other Party fails to
provide its comments to the Party seeking publication within such twenty (20)-day period, such
other Party shall be deemed not to have any comments, and the Party seeking publication shall be
free to publish in accordance with this Section 11.3(b) after the thirty (30)-day period has
elapsed. The Party seeking publication shall provide the other Party a copy of the manuscript at
the time of the submission. Each Party agrees to acknowledge the contributions of the other Party
and its employees in all publications as scientifically appropriate.
11.4 Publicity.
(a) The Parties agree that the material terms of this Agreement are the Confidential
Information of both Parties, subject to the special authorized disclosure provisions set forth in
this Section 11.4.
(b) The Parties shall make a joint public announcement of the execution of this Agreement in
the form attached as Exhibit C, which shall be issued on or promptly after the Effective Date.
(c) After release of such press release, if either Party desires to make a public announcement
concerning the material terms of this Agreement, such Party shall give reasonable prior advance
notice of the proposed text of such announcement to the other Party for its prior review and
approval (except as otherwise provided herein), such approval not to be unreasonably withheld or
delayed. A Party commenting on such a proposed press release shall provide its comments, if any,
within five (5) Business Days after receiving the press release for review. In addition, where
required by applicable Laws, including regulations promulgated by applicable security exchanges,
such Party shall have the right to make a press release announcing the achievement of each
milestone under this Agreement as it is achieved, and the achievements of Regulatory Approvals in
the Licensed Territory as they occur, subject only to the review procedure set forth in the
preceding sentence. In relation to the other Party’s review of such an announcement, such other
Party may make specific, reasonable comments on such proposed press release within the prescribed
time for commentary, but shall not withhold its consent to
disclosure of the information that the relevant milestone has been achieved and triggered a
payment hereunder. Neither Party shall be required to seek the permission of the other Party to
repeat any information regarding the terms of this Agreement that has already been publicly
disclosed by such Party, or by the other Party, in accordance with this Section 11.4; provided,
however, such information remains accurate as of such time.
51.
(d) The Parties acknowledge that either or both Parties may be obligated to file under
applicable Laws a copy of this Agreement with the U.S. Securities and Exchange Commission (“SEC”)
or other Governmental Authorities. Each Party shall be entitled to make such a required filing;
provided, however, that it requests confidential treatment of the commercial terms and sensitive
technical terms hereof and thereof to the extent such confidential treatment is reasonably
available to such Party. In the event of any such filing, each Party will provide the other Party
with a copy of this Agreement marked to show provisions for which such Party intends to seek
confidential treatment and shall reasonably consider and incorporate the other Party’s comments
thereon to the extent consistent with the legal requirements, with respect to the filing Party,
governing disclosure of material agreements and material information that must be publicly filed.
11.5 Equitable Relief. Each Party acknowledges that its breach of this Article 11 will cause
irreparable harm to the other Party, which cannot be reasonably or adequately compensated in
damages in an action at law. By reasons thereof, each Party agrees that the other Party shall be
entitled, in addition to any other remedies it may have under this Agreement or otherwise, to
preliminary and permanent injunctive and other equitable relief to prevent or curtail any actual or
threatened breach of the obligations relating to Confidential Information set forth in this Article
11 by the other Party.
ARTICLE 12
TERM AND TERMINATION
12.1 Term. This Agreement shall become effective on the Effective Date and, unless earlier
terminated pursuant to this Article 12, shall remain in effect on a country-by-country and, if GSK
exercises an Option, Licensed Product-by-Licensed Product basis, until the expiration of the
Royalty Term of a Licensed Product in such country (the “Term”). Upon the expiration of the
Royalty Term for a Licensed Product in a particular country in the Licensed Territory: (a) the
licenses granted by Impax to GSK under Sections 2.1(a) and 2.1(b) with respect to such Licensed
Product in such country shall become perpetual, irrevocable, fully-paid, royalty free and exclusive
and sublicenseable in multiple tiers; provided, however, that XXXXXX, and (b) Impax shall be deemed
to have granted to GSK, a non-exclusive, perpetual, irrevocable, fully-paid, royalty-free license
(with the right to grant sublicenses), under the Impax Manufacturing Technology, to make and have
made such Licensed Product solely for use and sale in the Field in such country. For the purposes
of this Section 12.1, the “Impax Manufacturing Technology” means (i) all Information Controlled by
Impax or its Affiliates as of the expiration of such Royalty Term that is necessary to Manufacture
such Licensed Product or was used by Impax pursuant to the Supply Agreement to Manufacture such
Licensed Product or (ii) all Patents Controlled by Impax or its Affiliates as of the expiration of
such Royalty Term that claim the composition of matter of, or a method of making, such Licensed
Product.
52.
12.2 Unilateral Termination by GSK.
(a) GSK may terminate this Agreement in its entirety or with respect to a particular country
upon ninety (90) days prior written notice to Impax at any time.
(b) GSK may terminate this Agreement in its entirety immediately upon written notice to Impax
within thirty (30) days after the date on which (i) there is an issuance of a negative EMA CHMP
opinion on the Original Product; (ii) the Original Product is approved by the European Commission
outside the provisions of Article 8.3 of Directive 2001/83/EC and therefore is not granted ten
years of data exclusivity; or (iii) the Reimbursement Study fails to meet its primary end point as
set forth in the Development Plan, as amended from time to time.
12.3 Unilateral Termination by Impax. In the event that GSK or its Affiliates or sublicensees
(directly or indirectly, individually or in association with any other person or entity) XXXXXX
except for a country in the Licensed Territory in which this Agreement has been terminated and GSK
did not, prior to such termination, exercise its first right to Prosecute and Maintain Impax
Patents and Joint Patents in such country (a “XXXXXX”), Impax shall have the right to terminate
this Agreement in its entirety upon providing written notice to GSK. However, Impax’s right to
terminate this Agreement under this Section 12.3 shall not apply to any Affiliate of GSK that first
becomes an Affiliate of GSK after the Effective Date of this Agreement in connection with a merger
or acquisition event, where such Affiliate of GSK was undertaking activities in connection with a
XXXXXX prior to such merger or acquisition event; provided, however, that GSK causes such XXXXXX to
terminate within forty-five (45) days after such merger or acquisition event. For the avoidance of
doubt, XXXXXX.
12.4 Termination Due to Termination of the Supply Agreement. This Agreement shall
automatically terminate upon termination of the Supply Agreement for any reason.
12.5 Termination for Breach.
(a) Each Party shall have the right to terminate this Agreement in its entirety immediately
upon written notice to the other Party if the other Party materially breaches its material
obligations under this Agreement or the Supply Agreement and, after receiving written notice
identifying such material breach in reasonable detail, fails to cure such material breach within
ninety (90) days from the date of such notice (or within thirty (30) days from the date of such
notice in the event such material breach is solely based on the breaching Party’s failure to pay
any amounts due hereunder or pursuant to the Supply Agreement). The right of either Party to
terminate this Agreement as provided in this Section 12.5(a) shall not be affected in any way by
such Party’s waiver or failure to take action with respect to any previous default.
(b) Notwithstanding Section 12.5(a), if GSK is the breaching Party and GSK’s material breach
only pertains to GSK’s diligence obligations with respect to a particular country in the Licensed
Territory that is not a XXXXXX, Impax shall not have the right to terminate this Agreement in its
entirety, but instead shall be limited in its remedies to terminating this Agreement only with
respect to such country.
(c) If GSK has the right to terminate this Agreement pursuant to Section 12.5(a) on account of
Impax’s uncured material breach, then, in lieu of its rights to terminate this
Agreement in its entirety but in addition to any other remedies that GSK may have, GSK may, in
its sole discretion, elect to put in effect the following changes to the Agreement and in such
event: (i) XXXXXX; and (ii) XXXXXX; provided, however, that GSK shall have the right to set off
against any payment obligations under Article 7 any amounts recovered by GSK in any litigation
resulting from Impax’s material breach of this Agreement.
53.
12.6 Termination for Insolvency.
(a) Either Party may terminate this Agreement in its entirety, if, at any time, the other
Party shall file in any court or agency pursuant to any statute or regulation of any state or
country, a petition in bankruptcy or insolvency or for reorganization or for an arrangement or for
the appointment of a receiver or trustee of the Party or of substantially all of its assets, or if
the other Party proposes a written agreement of composition or extension of substantially all of
its debts, or if the other Party shall be served with an involuntary petition against it, filed in
any insolvency proceeding, and such petition shall not be dismissed within ninety (90) calendar
days after the filing thereof, or if the other Party shall propose or be a party to any dissolution
or liquidation, or if the other Party shall make an assignment of substantially all of its assets
for the benefit of creditors, (“Bankruptcy”).
(b) All 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 Xxxxx 00, Xxxxxx Xxxxxx Code (the
“Bankruptcy Code”) licenses of rights to “intellectual property” as defined in Section 101(56) of
the Bankruptcy Code. The Parties shall retain and may fully exercise all of their respective
rights and elections under the Bankruptcy Code. Upon the bankruptcy of any Party, the non-bankrupt
Party shall further be entitled to a complete duplicate of, or complete access to, any such
intellectual property, and such, if not already in its possession, shall be promptly delivered to
the non-bankrupt Party, unless the bankrupt Party elects to continue, and continues, to perform all
of its obligations under this Agreement. Nothing in this Section 12.6(b) shall be interpreted as
giving any Party greater rights to the other Party’s intellectual property after the bankruptcy of
the other Party than such Party had prior to such bankruptcy.
12.7 Effect of Termination. Upon the termination of this Agreement with respect to a
particular country or countries in the Licensed Territory or the termination of this Agreement in
its entirety (i.e., with respect to all countries in the Licensed Territory) by GSK under Section
12.2, or by Impax under Section 12.3, or under Section 12.4, or under Section 12.5 due to GSK’s
uncured material breach, or under Section 12.6 due to GSK’s Bankruptcy, or by Impax under Section
6.4(b)(ii) or 6.4(b)(iii), this Agreement shall be terminated in its entirety with respect to the
terminated countries, including with respect to all licenses granted to GSK under Sections 2.1(a)
and 2.1(b), the covenant set forth in Section 2.1(f), and the obligations of the Parties under
Section 2.6, subject to the continued effect of the provisions expressly set forth to survive under
Section 12.8 and the following provisions (a) through (f) of this Section 12.7 which are to apply
with respect to such terminated countries:
(a) Regulatory Submissions; Data. To the extent permitted by applicable Laws, GSK shall
transfer and assign to Impax all Regulatory Submissions, Regulatory Approvals, data from clinical
and non-clinical studies conducted by or on behalf of GSK, its Affiliates or sublicensees on the
Licensed Products and pharmacovigilance data on the Licensed
Products, in each case relating to a Licensed Product in the terminated countries and only to
the extent any such data is owned by GSK.
54.
(b) GSK License. GSK hereby grants to Impax, effective upon such termination, a
non-exclusive, fully paid, royalty free, perpetual, irrevocable license (with the right to grant
sublicenses through multiple tiers), under the GSK Technology (to the extent not assigned to Impax
pursuant to Section 12.7(a)), to Develop, make, have made, use, sell, offer for sale, import and
otherwise Commercialize Licensed Products in the terminated countries.
(c) Trademarks. To the extent that GSK is commercializing any Licensed Product under any
Product Marks (excluding any such trademarks or trade names that include, in whole or part, any
corporate name or logo of GSK) that is neither (i) used for any other products in GSK’s portfolio
nor (ii) confusingly similar to any other trade xxxx used for any other products in GSK’s
portfolio, GSK shall, upon Impax’s request, promptly assign such Product Marks to Impax in the
terminated countries; provided, however, that before GSK assigns such Product Marks to Impax, Impax
shall reimburse GSK for all costs that have been incurred by GSK through the date of termination in
developing, registering and protecting such Product Marks.
(d) Transition Assistance.
(i) In the event of a termination of this Agreement in its entirety, GSK shall promptly return
to Impax, at no cost to Impax, all Impax Know-How, materials, and other data transferred by Impax
to GSK.
(ii) GSK shall reasonably cooperate with Impax to facilitate orderly transition of the
Development and Commercialization of the Licensed Products to Impax in the terminated countries,
including (A) assigning or amending as appropriate, upon request of Impax, any agreements or
arrangements with Third Party vendors (including distributors) to Develop, package, label,
distribute, sell or otherwise Commercialize the Licensed Product or, to the extent any such Third
Party agreement or arrangement is not assignable to Impax, reasonably cooperating with Impax to
arrange to continue to provide such services for a reasonable time after termination, not exceeding
XXXXXX (XXXXXX) months after termination; (B) to the extent that GSK or its Affiliate is performing
any activities described above in (A), reasonably cooperating with Impax to transfer such
activities to Impax and continuing to perform such activities on Impax’s behalf for a reasonable
time after termination until such transfer is completed, not exceeding XXXXXX (XXXXXX) months after
termination; and (C) transferring to Impax or its designee of Regulatory Authority reporting
responsibilities (including adverse event reporting) and the safety database for the Licensed
Product for the terminated countries.
(iii) To avoid a disruption in the supply of Licensed Products to patients, if the Agreement
is terminated in a country after the First Commercial Sale in such terminated country, GSK, its
Affiliates and sublicensees (as applicable) shall continue to distribute the Licensed Products in
such terminated countries, in accordance with the terms and conditions of this Agreement, until
XXXXXX (XXXXXX) months after the effective date of any termination of this Agreement (the
“Wind-down Period”); provided, however, that during such Wind-down Period, GSK’s and its
Affiliates’ and sublicensees’ rights with respect to the
Licensed Products in such terminated country shall be non-exclusive and, without limiting the
foregoing, Impax shall have the right to engage one or more other distributor(s) and/or licensee(s)
of the Licensed Products in such terminated country. Any Licensed Product sold or disposed by GSK,
its Affiliates and sublicensees in such terminated country during the Wind-down Period shall be
subject to applicable payment obligations under Article 7 above.
55.
(e) Ongoing Clinical Trials.
(i) GSK shall continue to be responsible for any additional Development Costs resulting from
any Additional GSK Modifications that are incurred by Impax after the termination of this Agreement
and shall reimburse Impax within sixty (60) days of receiving an invoice therefor.
(ii) GSK shall continue to be responsible for XXXXXX percent (XXXXXX%) of the previously
contemplated and budgeted Development Costs incurred by Impax while conducting Other Shared
Development Activities, and if GSK has exercised the Option, XXXXXX percent (XXXXXX%) of the
previously contemplated and budgeted Development Costs for the Improved Product incurred by Impax,
in each case up to the effective date of termination as well as during the period XXXXXX. In
addition, to the extent Impax seeks to cancel, during the period three (3) months after such
effective date of termination, previously contemplated and budgeted Development Costs, and Impax is
unable to do so after using commercially reasonable efforts, GSK shall further be responsible for
XXXXXX percent (XXXXXX%) of such previously contemplated and budgeted Development Costs which have
proven to be non-cancellable, and shall reimburse Impax within sixty (60) days of receiving an
invoice therefor. Except as expressly set forth in the foregoing two sentences, GSK shall have no
further liability for or responsibility for reimbursing Impax’s expenses incurred after the
effective date of termination relating to any Development Costs in such an event of termination of
this Agreement.
(iii) With respect to any ongoing clinical trials of the Licensed Products being conducted by
GSK for which Impax has notified GSK prior to the effective date of termination that it wishes to
assume responsibility, (A) each Party shall cooperate with the other Party to facilitate the
orderly transfer to Impax of the conduct of such clinical trials as soon as reasonably practicable
after the effective date of termination, (B) until such time as the conduct of such clinical trials
has been successfully transferred to Impax, GSK shall continue such clinical trials, (C) between
the effective date of termination and the date on which the conduct of such clinical trials has
been successfully transferred to Impax, Impax shall be responsible for, and shall reimburse GSK
with respect to, all costs and expenses reasonably incurred by GSK in the conduct of such clinical
trials, and (D) following the date on which the conduct of such clinical trials has been
successfully transferred to Impax, Impax shall be solely responsible for all costs and expenses of
such ongoing clinical trials.
(iv) With respect to any ongoing clinical trials of the Licensed Products being conducted by
GSK for which Impax has not notified GSK prior to the effective date of termination that it wishes
to assume responsibility, GSK shall, at GSK’s cost and expense, complete such clinical trial with
regard to those patients enrolled at the date of termination. Promptly after the completion of
such clinical trials, GSK shall provide Impax with copies of all
data and results and all supporting documentation (e.g. protocols, CRFs, analysis plans)
generated from such clinical trial and Impax shall have the right to use, without additional
consideration, any and all such data and results solely for obtaining and maintaining Regulatory
Approval and reimbursement of the Licensed Product and otherwise Commercializing the Licensed
Products in the terminated countries and outside the Licensed Territory.
56.
(v) Notwithstanding any of the foregoing in Sections 12.7(e)(iii) and 12.7(e)(iv), GSK may
prematurely suspend or terminate any such trial if (A) a priori protocol defined stopping rules are
met for safety or efficacy or (B) unacceptable safety signals are observed by GSK or the Data and
Safety Monitoring Board with respect to a Licensed Product that present an unacceptable risk to
patients participating in such trials.
(f) Inventories. In the event of such a termination of this Agreement in its entirety: (i)
Impax shall have the right to purchase from GSK any and all of the inventory of the Licensed
Products held by GSK as of the date of termination at a price equal to the XXXXXX; and (ii) XXXXXX.
12.8 Survival. Termination or expiration of this Agreement shall not affect rights or
obligations of the Parties under this Agreement that have accrued prior to the date of termination
or expiration. Notwithstanding anything to the contrary, the following provisions shall survive
any expiration or termination of this Agreement: Sections 2.2, 2.5, 4.8, 5.8 (with respect to
Licensed Product sold in the Licensed Territory prior to termination), 7.2 through 7.6 (solely with
respect to payments accrued before the effective date of termination), 7.7, 7.8, 7.9, 8.1, Articles
1, 9, 10, 11 (for five years following such termination), 12 (except for Section 12.3), 13 and 14
(except for Section 14.6).
ARTICLE 13
DISPUTE RESOLUTION
13.1 Disputes. The Parties recognize that disputes as to certain matters may from time to
time arise that relate to either Party’s rights and/or obligations hereunder, including the
interpretation, alleged breach, enforcement, termination or validity of this Agreement, including
matters within the JSC’s authority upon with the JSC does not reach consensus within the ten (10)
Business Day period set forth in Section 3.2(e), but excluding matters to be resolved under Section
3.3, (for the purposes of this Section 13.1 and Section 13.2, each a “Dispute”). It is the
objective of the Parties to establish procedures to facilitate the resolution of such Disputes
arising under this Agreement in an expedient manner by mutual cooperation. To accomplish this
objective, the Parties agree that, if such a Dispute arises under this Agreement, and the Parties
are unable to resolve such Dispute within twenty (20) Business Days after such Dispute is first
identified by either Party in writing to the other, the Parties shall refer such Dispute to the
Chief Executive Officer of Impax and a Senior Vice President of Research and Development of GSK (or
their respective designees) (the “Executive Officers”) for attempted resolution by good faith
negotiations within twenty (20) Business Days after such notice is received. If the Executive
Officers of the Parties are not able to resolve such Dispute within twenty (20) Business Days, then
the Parties agree to submit the dispute for non-binding mediation (with the understanding that the
role of the mediator shall not be to render a decision but to assist the Parties in reaching a
mutually acceptable resolution), which shall occur within a period of not more than twenty
(20) Business Days. If the dispute is not resolved within such twenty (20) Business Days, either
Party may commence litigation with respect to the subject matter of the dispute and with respect to
any other claims it may have and thereafter neither Party hereto shall have any further obligation
under this Section 13.1. Notwithstanding the foregoing, and without waiting for the expiration of
any such twenty (20)-Business Day periods, Impax and GSK shall each have the right to apply to any
court of competent jurisdiction for appropriate interim or provisional relief, as necessary to
protect the rights or property of that Party.
57.
13.2 Jurisdiction; Governing Law. If the Parties are unable to resolve any Disputes arising
under this Agreement through negotiations as described above in Section 13.1, then, subject to
Section 13.3, such Disputes shall be resolved by the federal or state court sitting in Wilmington,
Delaware (collectively, the “Courts”). Each Party hereby (a) irrevocably submits to the exclusive
jurisdiction of the Courts, for purposes of any action, suit or other proceeding relating to or
arising out of this Agreement, (b) agrees not to raise any objection at any time to the laying or
maintaining of the venue of any such action, suit or proceeding in any of the Courts, (c)
irrevocably waives any claim that such action, suit or proceeding has been brought in an
inconvenient forum, and (d) further irrevocably waives the right to object, with respect to such
action, suit or proceeding, that such Court does not have any jurisdiction over such Party. This
Agreement and all Disputes arising out of or related to this Agreement or any breach hereof shall
be governed by and construed under the laws of the State of Delaware, without giving effect to any
choice of law principles that would require the application of the laws of a different state.
13.3 Patent and Trademark Disputes. Notwithstanding Sections 13.1 and 13.2, any dispute,
controversy or claim relating to the scope, validity, enforceability or infringement of any Patent
or trademark rights outside the U.S. covering the Manufacture, use importation, offer for sale or
sale of a Licensed Product shall be submitted to the Joint Patent Committee. If after a period of
twenty (20) Business Days the Joint Patent Committee is unable to reach a unanimous decision on
such matter, then either Party may, by written notice to the other, have such matter referred to a
conflict free external patent counsel mutually agreed to by the Parties. If such patent counsel is
unable after a period of twenty (20) Business Days to reach a resolution on such matter that is
mutually acceptable to the Parties, then either Party may, by written notice to the other, have
such matter referred for non-binding mediation in accordance with Section 13.1.
ARTICLE 14
MISCELLANEOUS
14.1 Entire Agreement; Amendment. This Agreement, including the Exhibits hereto, sets forth
the complete, final and exclusive agreement and all the covenants, promises, agreements,
warranties, representations, conditions and understandings between the Parties hereto with respect
to the subject matter hereof and supersedes, as of the Effective Date, all prior and
contemporaneous agreements and understandings between the Parties with respect to the subject
matter hereof, including the Confidentiality Agreement. The foregoing shall not be interpreted as
a waiver of any remedies available to either Party as a result of any breach, prior to the
Effective Date, by the other Party of its obligations under the Confidentiality Agreement. There
are no covenants, promises, agreements, warranties, representations, conditions or
understandings, either oral or written, between the Parties other than as are set forth in
this Agreement. No subsequent alteration, amendment, change or addition to this Agreement shall be
binding upon the Parties unless reduced to writing and signed by an authorized officer of each
Party.
58.
14.2 Force Majeure. Both Parties shall be excused from the performance of their obligations
under this Agreement to the extent that such performance is prevented by force majeure and the
nonperforming Party promptly provides notice of the prevention to the other Party. Such excuse
shall be continued so long as the condition constituting force majeure continues and the
nonperforming Party takes reasonable efforts to remove the condition. For purposes of this
Agreement, force majeure shall include conditions beyond the control of the Parties, including an
act of God, war, civil commotion, terrorist act, labor strike or lock-out, epidemic, failure or
default of public utilities or common carriers, destruction of production facilities or materials
by fire, earthquake, storm or like catastrophe, and failure of plant or machinery (provided that
such failure could not have been prevented by the exercise of skill, diligence, and prudence that
would be reasonably and ordinarily expected from a skilled and experienced person engaged in the
same type of undertaking under the same or similar circumstances). Notwithstanding the foregoing,
a Party shall not be excused from making payments owed hereunder because of a force majeure
affecting such Party. If a force majeure persists for more than ninety (90) days, then the Parties
will discuss in good faith the modification of the Parties’ obligations under this Agreement in
order to mitigate the delays caused by such force majeure.
14.3 Notices. Any notice required or permitted to be given under this Agreement shall be in
writing, shall specifically refer to this Agreement, and shall be addressed to the appropriate
Party at the address specified below or such other address as may be specified by such Party in
writing in accordance with this Section 14.3, and shall be deemed to have been given for all
purposes (a) when received, if hand-delivered or sent by confirmed facsimile or a reputable courier
service, or (b) five (5) Business Days after mailing, if mailed by first class certified or
registered airmail, postage prepaid, return receipt requested.
If to Impax:
|
Impax Laboratories, Inc. 00000 Xxxxxxxx Xxxxxx Xxxxxxx, XX 00000 Attn: President, Impax Pharmaceuticals Fax: 000-000-0000 |
|
With copies to (which shall not constitute notice):
|
Impax Laboratories, Inc. 00000 Xxxxxxxx Xxxxxx Xxxxxxx, XX 00000 Attn: Legal Department Fax: 000-000-0000 Xxxxxx LLP Five Palo Alto Square 0000 Xx Xxxxxx Xxxx Xxxx Xxxx, XX 00000 Attn: Xxxxx X. Xxxxxxx, Ph.D. Fax: (000) 000-0000 |
59.
If to GSK:
|
Glaxo Group Limited Glaxo Xxxxxxxx Xxxxx, Xxxxxxxx Xxxxxx Xxxxxxxxx, Xxxxxxxxx XX0 0XX, Xxxxxxx Attn: Company Secretary Fax: 00 00 0 000 0000 |
|
With a copy to (which shall not constitute notice):
|
GlaxoSmithKline, LLC 0000 Xxxxxxxxxxx Xxxxxxxxx Mail Code XX0000 Xxxx xx Xxxxxxx, XX 00000 |
|
| Attn: Vice President and Associate General Counsel, Legal | ||
| Operations — Business Development | ||
| Fax: 000-000-0000 |
14.4 No Strict Construction; Headings. This Agreement has been prepared jointly by the
Parties and shall not be strictly construed against either Party. Ambiguities, if any, in this
Agreement shall not be construed against any Party, irrespective of which Party may be deemed to
have authored the ambiguous provision. The headings of each Article and Section in this Agreement
have been inserted for convenience of reference only and are not intended to limit or expand on the
meaning of the language contained in the particular Article or Section. Except where the context
otherwise requires, the use of any gender shall be applicable to all genders, and the word “or” is
used in the inclusive sense (and/or). The term “including” as used herein means including, without
limiting the generality of any description preceding such term.
14.5 Assignment. Subject to Section 4.11 and GSK’s right to grant sublicenses pursuant to
Section 2.1(e) in a manner consistent with Section 2.3(b), neither Party may assign or transfer
this Agreement or any rights or obligations hereunder without the prior written consent of the
other, except that a Party may make such an assignment without the other Party’s consent: (a) to
its Affiliates; or (b) to a Third Party successor to substantially all of the business of such
Party to which this Agreement relates (such Third Party, an “Acquiror”), whether in a merger, sale
of stock, sale of assets or other transaction, except that Impax’s prior written consent shall be
required for assignment by GSK in connection with any Sale of the Neuroscience Business unless the
proposed assignee has at least substantially the same commercial capabilities throughout the
Licensed Territory as the Neuroscience Business has prior to such Sale of the Neuroscience Business
(including all relevant GSK support functions, including sales representatives, that are made
available to the Neuroscience Business). Any successor or assignee of rights and/or obligations
permitted hereunder shall, in writing to the other Party, expressly assume performance of such
rights and/or obligations. The Impax Technology, in the case of Impax as assignor or transferor
shall exclude any Patents and Information Controlled by any Acquiror (or any Affiliate thereof,
excluding a Party hereto as a result of such transaction) prior to the acquisition or developed
outside of any activities under this Agreement. Any
permitted assignment shall be binding on the successors of the assigning Party. Any
assignment or attempted assignment by either Party in violation of the terms of this Section 14.5
shall be null, void and of no legal effect.
60.
14.6 Change of Control of Impax. From and after a Change of Control of Impax:
(a) GSK shall have the right to require Impax, including the Change of Control party, to adopt
reasonable procedures to be agreed upon in writing with GSK to limit the dissemination of Sensitive
Information to XXXXXX, including without limitation, XXXXXX. Without limiting the foregoing or
being limited thereby, at a minimum in such circumstances, no Sensitive Information shall be
disclosed to or used XXXXXX. For the purpose of this Section 14.6(a), “Sensitive Information”
means all Confidential Information of GSK with respect to: the Development Plan, as described in
Section 4.3; copies of data, results, or supporting documentation provided pursuant to Section 4.6;
written reports, timelines, or the status of Development activities provided pursuant to Section
4.7; information obtained pursuant to the right to review and copy Development records pursuant to
Section 4.8; information regarding regulatory developments and draft Regulatory Submissions
provided pursuant to Section 5.1; the Commercialization Plan, as described in Section 6.2;
financial assessments or other commercially-sensitive GSK information with respect to failure to
launch a Licensed Product provided pursuant to Section 6.4(b); reports provided pursuant to Section
6.6; invoice details or other commercially-sensitive GSK information provided pursuant to Section
7.2(b); reports regarding clinical trials provided pursuant to Section 7.3(b); royalty related
reports pursuant to Section 7.4(f); disclosure of Sole Inventions provided pursuant to Section 8.2;
information related to GSK prosecution efforts provided pursuant to Section 8.3(b); information
related to the status of GSK enforcement efforts or the status, progress or results of Development
activities provided pursuant to Section 8.4(c); information regarding publications provided
pursuant to Section 11.3(b).
(b) The governance structure, including the Alliance Manager, the JSC, the JPC and any
Subcommittee shall continue as set forth in Article 3; provided, however, XXXXXX.
14.7 Performance by Affiliates. Each Party may discharge any obligations and exercise any
right hereunder through any of its Affiliates. Each Party hereby guarantees the performance by its
Affiliates of such Party’s obligations under this Agreement, and shall cause its Affiliates to
comply with the provisions of this Agreement in connection with such performance. Any breach by a
Party’s Affiliate of any of such Party’s obligations under this Agreement shall be deemed a breach
by such Party, and the other Party may proceed directly against such Party without any obligation
to first proceed against such Party’s Affiliate.
14.8 Further Actions. Each Party agrees to execute, acknowledge and deliver such further
instruments, and to do all such other acts, as may be necessary or appropriate in order to carry
out the purposes and intent of this Agreement.
61.
14.9 Severability. If any one or more of the provisions of this Agreement is held to be
invalid or unenforceable by any court of competent jurisdiction from which no appeal can be or is
taken, the provision shall be considered severed from this Agreement and shall not serve to
invalidate any remaining provisions hereof. The Parties shall make a good faith effort to
replace any invalid or unenforceable provision with a valid and enforceable one such that the
objectives contemplated by the Parties when entering this Agreement may be realized.
14.10 No Waiver. Any delay in enforcing a Party’s rights under this Agreement or any waiver
as to a particular default or other matter shall not constitute a waiver of such Party’s rights to
the future enforcement of its rights under this Agreement, except with respect to an express
written and signed waiver relating to a particular matter for a particular period of time.
14.11 Independent Contractors. Each Party shall act solely as an independent contractor, and
nothing in this Agreement shall be construed to give either Party the power or authority to act
for, bind, or commit the other Party in any way. Nothing herein shall be construed to create the
relationship of partners, principal and agent, or joint-venture partners between the Parties.
14.12 English Language. This Agreement was prepared in the English language, which language
shall govern the interpretation of, and any dispute regarding, the terms of this Agreement.
14.13 Counterparts. This Agreement may be executed in one (1) or more counterparts, each of
which shall be deemed an original, but all of which together shall constitute one and the same
instrument.
62.
In Witness Whereof, the Parties have executed this License, Development and Commercialization
Agreement in duplicate originals by their duly authorized representatives as of the Effective Date.
| Glaxo Group Limited | Impax Laboratories, Inc. | |||||||||
| By: | /s/ Xxxx Xxxxxxxxxx | By: | /s/ Xxxxx Xxx | |||||||
| Name: | Xxxx Xxxxxxxxxx | Name: Xxxxx Xxx | ||||||||
| Title: | Authorised Signatory For and on behalf of Edinburgh Pharmaceutical Industries Limited Corporate Director | Title: President & CEO | ||||||||
EXHIBIT A
PIVOTAL PHASE III TRIALS AND GSK MODIFICATIONS
Phase 3, Study 1: IPX066 B08-05
Title: A Placebo-Controlled Study to Evaluate the Safety and Efficacy of IPX066 in Subjects with
Xxxxxxxxx’x disease
This is a randomised, placebo-controlled, fixed-dose, parallel-arm study of three doses of IPX066
versus placebo.
XXXXXX.
XXXXXX.
Phase 3 Study 2: IPX066 B09-02
Title: A Study to Evaluate the Safety and Efficacy of IPX066 in Advanced Xxxxxxxxx’x Disease
Subjects
This is a randomized, double-blind, active-control, parallel-group 13-week comparison of IPX066
versus immediate-release (IR) carbidopa-levodopa (CD-LD). XXXXXX.
XXXXXX.
XXXXXX.
Phase 3 Study 3: IPX066 B09-06
Title: A Study to Compare IPX066 and carbidopa/Levodopa/Entacapone (CLE) in Advanced Xxxxxxxxx’x
Disease
XXXXXX.
CONFIDENTIAL
EXHIBIT B
INITIAL DEVELOPMENT PLAN
XXXXXX.
XXXXXX
EXHIBIT C
JOINT PRESS RELEASE
[See attached]
| PRESS RELEASE |  |
GlaxoSmithKline and Impax Pharmaceuticals Enter Global Agreement to Develop and Commercialize
a late stage compound for Xxxxxxxxx’x Disease
a late stage compound for Xxxxxxxxx’x Disease
London & Hayward, Calif., December XX, 2010 — GlaxoSmithKline (GSK) and Impax
Pharmaceuticals, the brand products division of Impax Laboratories, Inc. (Impax), today announced
an agreement for the development and commercialization of IPX066, Impax’s novel extended release
carbidopa-levodopa product, outside the United States and Taiwan. IPX066, an investigational
product under development for the treatment of Xxxxxxxxx’x Disease (PD), is currently in Phase III
clinical trials.
Under the terms of the agreement, GSK will receive an exclusive license to sell IPX066 throughout
the world except in the U.S. and Taiwan. Impax will receive an $11.5 million upfront payment and is
eligible to receive potential payments of up to $175 million upon the successful achievement of
development and commercialization milestones. Impax will also receive tiered, double-digit royalty
payments on GSK sales of IPX066. Impax will manufacture and supply IPX066 to GSK.
Impax will complete the current Phase III program for IPX066, which includes the recently completed
APEX-PD trial in early PD. The results from the remaining Phase III study program are expected to
be available in 2011. In the U.S., Impax expects to file a New Drug Application for Xxxxxxxxx’x
Disease in late 2011 and will be responsible for commercialization. In other regions,
excluding Taiwan, GSK will be responsible for further development and registration of IPX066 and
commercialization of the product in those markets. A team structure with representatives from both
companies is being established to enable effective coordination of planned global regulatory and
commercialization activities.
“We are very pleased to announce this development and collaboration agreement with GSK, which is a
significant milestone in the development of Impax Pharmaceuticals and an important achievement in
the planned global commercialization for IPX066 for the treatment of Xxxxxxxxx’x Disease,” stated
Xxxxxxx Xxxxxx, President of Impax Pharmaceuticals. “GSK is an ideal partner for IPX066, combining
global best-in-class development, regulatory and commercial experience in Xxxxxxxxx’x Disease,
which will be an asset in the successful commercialization of IPX066.”
“We are excited by the opportunity IPX066 represents to patients,” commented, Xxxx Xxxxx, Senior
Vice President, Neurosciences Medicines Development Center, GSK. “There is a significant need for a
therapy which can improve on clinical symptom management and control in Xxxxxxxxx’x Disease. We
look forward to collaborating with Impax and hope to deliver an improved treatment option to the
millions of people living with this devastating disease.”
| PRESS RELEASE | |
About IPX066
IPX066 is an investigational extended release carbidopa-levodopa product with an
enhanced pharmacokinetic profile. The IPX066 pharmacokinetic profile has the potential to offer
reliable control of Xxxxxxxxx’x Disease symptoms, such as the reduction in “off time” throughout
the day, which has been observed in preliminary studies of IPX066.
“Off time” is the functional state when patients’ medication effect has worn off and there is a
return of Xxxxxxxxx symptoms.
The phase III clinical development program for the registration of IPX066 in the U.S. includes the
recently completed APEX-PD trial in early PD, the ADVANCE-PD study in advanced PD subjects, an open
label extension study for subjects from the ADVANCE-PD and APEX-PD studies. Additionally, for the
European application, Impax is conducting the ASCEND-PD comparative study of IPX066 and
carbidopa-levodopa and entacapone, which is currently enrolling subjects.
About Xxxxxxxxx’x Disease
Xxxxxxxxx’x Disease is a chronic neurodegenerative movement disorder affecting over three
million people in the U.S., Europe and Japan.
About Impax Laboratories, Inc.
Impax Laboratories, Inc. is a technology based specialty pharmaceutical company applying its
formulation expertise and drug delivery technology to the development of controlled-release and
specialty generics in addition to the development of branded products. Impax markets its generic
products through its Global Pharmaceuticals division and markets its branded products through the
Impax Pharmaceuticals division. Additionally, where strategically appropriate, Impax has developed
marketing partnerships to fully leverage its technology platform. Impax Laboratories is
headquartered in Hayward, California, and has a full range of capabilities in its Hayward,
Philadelphia and Taiwan facilities. For more information, please visit the Company’s Web site at:
xxx.xxxxxxxxx.xxx.
Impax Laboratories, Inc: Company Contact:
Xxxx Xxxxxxx
Sr. Director
Investor Relations and Corporate Communications
(000) 000-0000
xxx.xxxxxxxxx.xxx
Xxxx Xxxxxxx
Sr. Director
Investor Relations and Corporate Communications
(000) 000-0000
xxx.xxxxxxxxx.xxx
| PRESS RELEASE | |
GlaxoSmithKline — one of the world’s leading research-based pharmaceutical and healthcare
companies — is committed to improving the quality of human life by enabling people to do more,
feel better and live longer. For further information please visit xxx.xxx.xxx
GlaxoSmithKline Enquiries: |
||||||
UK Media enquiries: |
Xxxxx Xxxxxxxx | (000) 0000 0000 | ||||
| Xxxxxx Xxxxxx | (000) 0000 0000 | |||||
| Xxxxxxx Xxx | (000) 0000 0000 | |||||
| Xxxxxxxxx Xxxxxxxx | (000) 0000 0000 | |||||
| Xx Xxxxxx | (000) 0000 0000 | |||||
US Media enquiries: |
Xxxxx Xxxxxxx | (000) 000 0000 | ||||
| Xxxx Xxxx Xxxxx | (000) 000 0000 | |||||
| Xxxxx Xxxxxx | (000) 000 0000 | |||||
| Xxxxxxxx Xxxxxxxxx | (000) 000 0000 | |||||
European Analyst/Investor enquiries: |
Xxxxx Xxxxxxxx | (000) 0000 0000 | ||||
| Xxxx Xxxxxx | (000) 0000 0000 | |||||
| Xxxx Xxxxxx | (000) 0000 0000 | |||||
US Analyst/ Investor enquiries: |
Xxx Xxxxx | (000) 000 0000 | ||||
| Xxx Xxxx Xxxxxx | (000) 000 0000 |
Impax Laboratories, Inc.”Safe Harbor” statement under the Private Securities Litigation Reform
Act of 1995:
To the extent any statements made in this news release contain information that is not
historical, these statements are forward-looking in nature and express the beliefs and expectations
of management. Such statements are based on current expectations and involve a number of known and
unknown risks and uncertainties that could cause the Company’s future results, performance or
achievements to differ significantly from the results, performance or achievements expressed or
implied by such forward-looking statements. Such risks and uncertainties include the effect of
current economic conditions on the Company’s industry, business, financial position, results of
operations and market value of its common stock, the ability to maintain an effective system of
internal control over financial reporting, fluctuations in revenues and operating income,
reductions or loss of business with any significant customer, the impact of competitive pricing and
products and regulatory actions on the Company’s products, the ability to sustain profitability and
positive cash flows, the ability to maintain sufficient capital to fund operations, the ability to
successfully develop and commercialize pharmaceutical products, the uncertainty of patent
litigation, consumer acceptance and demand for new pharmaceutical products, the difficulty of
predicting FDA filings and approvals, the inexperience of the Company in conducting clinical trials
and submitting new drug applications, reliance on key alliance and collaboration agreements, the
availability of raw materials, the ability to comply with legal and regulatory requirements
governing the healthcare industry, the regulatory environment, exposure to product liability claims
and other risks described in the Company’s periodic reports filed with the SEC. Forward-looking
statements speak only as to the date on which they are made, and Impax undertakes no obligation to
update publicly or revise any forward-looking statement, regardless of whether new information
becomes available, future developments occur or otherwise.
GSK’s cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK
cautions investors that any forward-looking statements or projections made by GSK, including those
made in this announcement, are
subject to risks and uncertainties that may cause actual results to differ materially from those
projected. Factors that may affect GSK’ s operations are described under ‘Risk Factors’ in the
‘Business Review’ in the company’ s Annual Report on Form 20-F for 2009.
###
Schedule 1.34
FTE Rates
With respect to activities undertaken by Impax, an annual rate of $XXXXXX per FTE (which rate shall
include customary overhead).
With respect to activities undertaken by GSK, an annual rate of $XXXXXX per FTE (which rate shall
include customary overhead).
Schedule 1.51
List of Impax Patents
List of Impax Patents
Patent Family “A”
| Filing/Submission | ||||||||||
| Appl. No. | Country/Region | Date | Priority Date | Priority Application | Status | |||||
10/241,837
|
United States | September 12, 2002 | May 29, 2002 | USSN 10/158,412 | Issued (USPN 7,094,427) |
|||||
03756204.8
|
Europe | May 23, 2003 | May 29, 2002 | PCT/US03/016391 | Pending | |||||
2003/247409
|
Australia | May 23, 2003 | May 29, 2002 | PCT/US03/016391 | Granted (AUPN 2003247409) |
|||||
2,486,859
|
Canada | May 23, 2003 | May 29, 2002 | PCT/US03/016391 | Granted (CAPN 2,486,859) |
|||||
5107265.8
|
Hong Kong | May 23, 2003 | May 29, 2002 | PCT/US03/016391 | Pending | |||||
000000
|
Xxxxxx | May 23, 2003 | May 29, 2002 | PCT/US03/016391 | Granted (ILPN 164856) |
|||||
2004-508790
|
Japan | May 23, 2003 | May 29, 2002 | PCT/US03/016391 | Pending | |||||
00-0000-0000000
|
South Korea | May 23, 2003 | May 29, 2002 | PCT/US03/016391 | Pending |
Schedule 1.51
List of Impax Patents (cont.)
List of Impax Patents (cont.)
Patent Family “B”
| Filing/Submission | ||||||||||
| Appl. No. | Country/Region | Date | Priority Date | Priority Application | Status | |||||
12/599,668
|
United States | November 10, 2009 | December 28, 2007 | PCT/US08/014080 | Pending | |||||
2008343787
|
Australia | December 26, 2008 | December 28, 2007 | PCT/US08/014080 | Pending | |||||
2,711,014
|
Canada | December 26, 2008 | December 28, 2007 | PCT/US08/014080 | Pending | |||||
200880122755.1
|
China | December 26, 2008 | December 28, 2007 | PCT/US08/014080 | Pending | |||||
08866933.8
|
Europe | December 26, 2008 | December 28, 2007 | PCT/US08/014080 | Pending | |||||
000000
|
Xxxxxx | December 26, 2008 | December 28, 2007 | PCT/US08/014080 | Pending | |||||
1350/MUMN/2010
|
India | December 26, 2008 | December 28, 2007 | PCT/US08/014080 | Pending | |||||
100114775
|
Japan | December 26, 2008 | December 28, 2007 | PCT/US08/014080 | Pending | |||||
00-0000-0000000
|
South Korea | December 26, 2008 | December 28, 2007 | PCT/US08/014080 | Pending | |||||
MX/a2010/007207
|
Mexico | December 26, 2008 | December 28, 2007 | PCT/US08/014080 | Pending | |||||
586870
|
New Zealand | December 26, 2008 | December 28, 2007 | PCT/US08/014080 | Pending | |||||
Not yet known
|
Singapore | December 26, 2008 | December 28, 2007 | PCT/US08/014080 | Pending |
