Exhibit 10.16
EXECUTION COPY
DEVELOPMENT, COMMERCIALIZATION
AND MARKETING AGREEMENT
BETWEEN
ALTUS BIOLOGICS INC.
AND
XX. XXXX PHARMA GMBH
DECEMBER 23, 2002
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
DEVELOPMENT, COMMERCIALIZATION AND MARKETING AGREEMENT
This Development, Commercialization and Marketing Agreement ("Agreement")
dated as of December 23, 2002, by and between Altus Biologics Inc., a Delaware
corporation, with its principal office at 000 Xxxxxx Xxxxxx, Xxxxxxxxx, XX 00000
("ALTUS"), and Xx. Xxxx Pharma GmbH, a German corporation, with its principal
office at Xxxxxxxxxxxxxxx(Xxxx)x 0, 00000 Xxxxxxxx Xxxxxxx ("XXXX"). ALTUS and
XXXX are sometimes referred to herein individually as a "Party" and collectively
as the "Parties."
RECITALS
1. ALTUS has developed a certain pharmaceutical compound known as
TheraCLEC(TM)-Total (defined below) and has certain intellectual property rights
and development capabilities related thereto.
2. XXXX has development, marketing, distribution and sales capabilities in
many countries in the Territory (defined below).
3. ALTUS and XXXX wish to use their respective capabilities to conduct
development of TheraCLEC-Total in a collaborative fashion so that the resources
and expertise of each is put to good use.
4. By combining the development experience and expertise of both XXXX and
ALTUS, the Parties wish to expedite the regulatory approval of TheraCLEC-Total
as a significant new therapeutic in the Territory.
5. ALTUS wishes to grant to XXXX, and XXXX wishes to obtain, a license
under ALTUS' intellectual property rights with respect to TheraCLEC-Total to
permit XXXX to participate in collaborative TheraCLEC-Total product development
and market TheraCLEC-Total in the Field in the Territory under the terms and
conditions set forth below.
AGREEMENT
NOW, THEREFORE, in consideration of the premises and the mutual covenants
and agreements herein contained, and for other good and valuable consideration,
the receipt and sufficiency of which is hereby acknowledged, the Parties,
intending to be legally bound hereby, do hereby agree as follows:
ARTICLE 1.
DEFINITIONS
The following capitalized terms, whether used in the singular or the
plural, shall have the following meanings as used in this Agreement unless
otherwise specifically indicated:
1.1 "AFFILIATE" shall mean any corporation, firm, limited liability
company, partnership or other entity, which directly or indirectly controls or
is controlled by or is under common control with a Party to this Agreement. For
the purposes of this Section 1.1, "control" means ownership, directly or through
one or more Affiliates, of fifty percent (50%) or more of the shares of stock
entitled to vote for the election of directors, in the case of a corporation, or
fifty percent (50%) or more of the equity interests in the entity, in the case
of any other type of legal entity, status as a general partner in any
partnership, or any other arrangement whereby a party controls or has the right
to control the direction of the management or policies of an entity, whether
through the ownership of voting securities, by contract or
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
otherwise. For the avoidance of doubt, the Parties agree that a company is
deemed to be under "common control with" another company if the two companies
are owned or controlled by the same group of individuals.
1.2 "ALTUS BACKGROUND TECHNOLOGY" shall mean any inventions (whether
patentable or not) and Know-How owned or controlled by ALTUS prior to the
Effective Date.
1.3 "ALTUS DEVELOPMENT COSTS" shall have the meaning set forth in Exhibit C
to this Agreement.
1.4 "BASE PATENTS" shall have the meaning set forth in Section 1.29.
1.5 "CGMP" shall mean the regulatory requirements for current good
manufacturing practices promulgated (1) under the Common Technical Document for
the Registration of Pharmaceuticals for Human Use (ICH CTD) Guidelines and the
ICH Good Manufacturing Practice Guide, as the same may be amended from time to
time, and (2) by the United States Food and Drug Administration ("FDA") under
the U.S. Food, Drug and Cosmetic Act ("FD&C Act") and the regulations
promulgated thereunder, particularly 21 C.F.R. Section 210 et seq., and 21
C.F.R. Section 211 at seq., respectively, and related guidance documents, as the
same may be amended from time to time.
1.6 "CLINICAL SUPPLIES" shall mean supplies of the Licensed Product,
manufactured, packaged and labeled in such form and strength as agreed by the
Parties, and ready to be used for the conduct of human clinical trials of the
Licensed Product in the Field by the Parties.
1.7 "COMBINED PHASE III CLINICAL TRIAL" shall mean an international Phase
III clinical trial as set forth in 21 C.F.R. Section 312.21 et seq. which is
performed consistent with the ICH Guidelines and the guidelines of the United
States Food and Drug Administration ("FDA") and the EMEA.
1.8 "COMMERCIALLY REASONABLE AND DILIGENT EFFORTS" shall mean with respect
to development and commercialization, a Party's use of commercially reasonable
efforts and resources for a company of its size consistent with (i) the exercise
of prudent scientific and business judgment for a lead product of its type and
(ii) such Party's efforts with respect to other lead products in its product
pipeline, and in each case taking into consideration the impact of such efforts
and resources on the development and commercialization of the Licensed Product
in the Territory as a whole.
1.9 "CONTROLLED" with respect to the Licensed Product Patents or the
Licensed Product Know-how shall mean the ability of a Party to grant a license
or sublicense to such Licensed Product Patents or Licensed Product Know-how as
provided for herein without violating the terms of any agreement or other
arrangement with any Third Party existing and in effect at the time such Party
would be required hereunder to grant the other Party such license or sublicense.
1.10 "COVER" (including variations such as "Covered", "Covering" and the
like) shall mean that the manufacture, use, sale, offer for sale, or importation
of a particular product would infringe an issued or pending claim of a patent or
patent application (if that claim were to issue in a patent) in the absence of
rights under such patent, as determined on a country-by-country basis.
1.11 "DISTRIBUTOR" shall mean a Third Party that purchases the Licensed
Product from XXXX or its Affiliates at a price that is - on a
country-by-country-basis - less than or equal to [****] of the IMS-Price in the
country in which the Licensed Product shall be sold to end-user customers.
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
1.12 "DRUG APPROVAL APPLICATION" shall mean an application for Regulatory
Approval required for commercial sale or use of the Licensed Product as a drug
in the Field in the Territory.
1.13 "EFFECTIVE DATE" shall mean the date first written above.
1.14 "EMEA" means the European Medicines Evaluation Agency.
1.15 "EUROPEAN DEVELOPMENT AND COMMERCIALIZATION PLAN" shall mean the plan
for development and commercialization of the Licensed Product as set forth in
Section 2.2, as may be amended from time to time.
1.16 "XXXX BACKGROUND TECHNOLOGY" shall mean any inventions (whether
patentable or not) and Know-How owned or controlled by XXXX prior to the
Effective Date.
1.17 "XXXX DEVELOPMENT COSTS" shall have the meaning set forth in Exhibit C
to this Agreement.
1.18 "XXXX MARKETING COSTS" shall have the meaning set forth in Exhibit C
to this Agreement.
1.19 "FIELD" shall mean [**************************************************
***************************************].
1.20 "FIRST COMMERCIAL SALE" shall mean the first sale of the Licensed
Product in any particular country in the Territory by XXXX for use by the
general public after all required marketing and pricing approval has been
granted by the governing authorities of that country or, if no such approval is
required, the date of first commercial sale of the Licensed Product in such
country.
1.21 "GERMAN EX-FACTORY PRICE" shall mean the [****] sales price
(ex-factory in Germany) at which the Licensed Product is sold by XXXX or its
Affiliates to any non-Affiliated Third Party in Germany.
1.22 "ICH GUIDELINES" means the finalized published guidelines of the
International Conference on Harmonization of Technical Requirements for the
Registration of Pharmaceuticals for Human Use.
1.23 "IMS PRICE" shall mean the price - [************************] - at
which the Licensed Product is sold to wholesalers in a country in the Territory
as evidenced in the Intercontinental Medical Statistics ("IMS") for such
country.
1.24 "INVENTION" shall mean any invention (whether or not patentable) or
Know-how made after the Effective Date during the course of, in furtherance of,
and as a direct result of the activities of the Parties hereunder. An
"Invention" may be made by employees of ALTUS solely or jointly with a Third
Party, by employees of XXXX solely or jointly with a Third Party, or jointly by
employees of ALTUS and XXXX with or without a Third Party.
1.25 "KNOW-HOW" shall mean all proprietary information, trade secrets,
techniques, data (including Confidential Information as defined in Article 10
below), discoveries, formulae, materials, practices, methods, knowledge,
know-how, processes, experience, test data (including pharmacological,
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
toxicological and clinical information and test data), analytical and quality
control data, marketing, pricing, distribution, cost and sales data or
descriptions.
1.26 "THIRD PARTY LICENSED II" shall mean any patents; know-how and other
intellectual property licensed to ALTUS by a Third Party as of the Effective
Date, the practice of which is necessary to make, use or sell Licensed Product
in the Field in the Territory, including the intellectual property licensed to
ALTUS by [**********************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
*************************], in connection with the development of certain enzyme
materials and the manufacturing of pharmaceutical products known as
TheraCLECTota1(TM) (as defined below).
1.27 "LICENSED PRODUCT" shall mean any pharmaceutical form, dosage,
strength, or formulation of TheraCLEC-Total purchased from ALTUS.
1.28 "LICENSED PRODUCT KNOW-HOW" shall mean Know-how which: (a) is
Controlled by ALTUS as of the Effective Date or hereafter during the Term of
this Agreement, and (b) is necessary to manufacture, commercialize, market, sell
and distribute the Licensed Product in the Territory.
1.29 "LICENSED PRODUCT PATENTS" shall mean any and all patents and patent
applications, together with any extensions (including supplementary protection
certificates), registrations, reissues, continuations, divisions,
continuations-in-part, re-examinations, substitutions or renewals thereof, and
any patent issuing for any of the foregoing, owned or Controlled by ALTUS as of
the Effective Date or at any time during the Term of the Agreement that contain
one or more claims Covering a Licensed Product in the Field in the Territory.
The Licensed Product Patents as of the Effective Date (hereinafter, the "Base
Patents") are set forth on Exhibit A attached hereto and incorporated herein.
1.30 "MAJOR EUROPEAN COUNTRIES" shall mean [*******************************
*****************************************************************].
1.31 "NET SALES" means the amount of gross invoiced sales of [*************
********************************************************************************
***************************************], less the following amounts to the
extent included as part of the gross invoiced sales of the Licensed Product sold
by XXXX or its Affiliates (regardless of whether separately stated on the sales
invoice):
(A) any value added taxes ("VAT") charged to the purchaser and [******
***********************************************************];
(B) bad debt [*****************] by XXXX with respect to uncollected
and uncollectable invoiced amounts that have been written off by XXXX in
accordance with its general accounting policies and German Generally Accepted
Accounting Principles ("GAAP") consistently applied; provided that such amounts
shall not be deducted to the extent they exceed [**************] of the gross
invoiced sales of the Licensed Product in the Field in the Territory in the
aggregate on a quarterly basis;
(C) trade, quantity, cash and any government-mandated discounts
[**************] and taken, including without limitation, those granted on
account of billing errors, rejected and damaged goods and recall returns, and
ordinary and customary bona fide customer rebates to the extent such
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
discounts and rebates are consistent with industry practice, but not to the
extent such discounts and rebates could reasonably be attributable to marketing
expenses;
(D) [*******************] for returns (including allowances actually
given for spoiled, damaged, out-dated, rejected, or returned product sold,
withdrawals and recalls); and
(E) charges for shipping charges, insurance, freight, and other
transportation costs [************************] of the Licensed Product.
In determining the amounts to be deducted under (e) above, XXXX shall be
entitled to deduct up to [******************] of its gross invoiced sales of
Licensed Product for each quarter during the first three calendar quarters of a
given year as a reasonable approximation of the amounts to be deducted under (e)
above; provided that at the end of the fourth calendar quarter XXXX shall be
required to make up any difference or short-fall between the amounts actually
deducted by XXXX under (e) above during the first three calendar quarters, and
the amount actually allowed to be deducted for the year, which allowed amount
shall be calculated [***********************************************************
********************************************************************************
*************************************************]. Any shortfall due and owing
shall be paid by XXXX as part of the payment due for the last calendar quarter
each year. With respect to sales of Licensed Products sold by XXXX (or any of
its Affiliates) to a XXXX Affiliate prior to resale to a non-Affiliated Third
Party, the "Net Sales" attributable to such product shall be determined by [****
********************************************************************************
********************************************************************************
****].
1.32 "PARTY" shall mean XXXX or ALTUS, and, when used in the plural, shall
mean both of them.
1.33 "PHASE I CLINICAL TRIAL" shall have the meaning set forth in 21
C.F.R. Section 312.21 et seq.
1.34 "PHASE II CLINICAL TRIAL" shall have the meaning set forth in 21
C.F.R. Section 312.21 et seq.
1.35 "PHASE III ENABLING CLINICAL TRIAL" shall mean a Phase I or Phase II
Clinical Trial which has generated sufficient data to commence Combined Phase
III Clinical Trials.
1.36 "PHASE IV STUDIES" shall mean any post-Regulatory Approval
after-market studies required to be performed by any Regulatory Authority in
connection with the commercialization of the Licensed Product.
1.37 "REGULATORY APPROVAL" shall mean any approvals (including pricing and
reimbursement approvals), licenses, registrations or authorizations of any
national or international or local regulatory agency, department, bureau or
other governmental entity necessary for the manufacture and sale of the Licensed
Product in the Field in the Territory.
1.38 "REGULATORY AUTHORITY" shall mean any local, national or international
regulatory agency, department, bureau or other governmental authority whose
approval is required prior to commercializing the Licensed Product in the Field
in the Territory or any individual country therein.
1.39 "STEERING COMMITTEE" shall mean that body established pursuant to
Section 3.1 below.
1.40 "TERRITORY" shall mean the countries listed on Appendix 1 hereto.
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
1.41 "THERACLEC-TOTAL" shall mean commercial formulations of that product
currently known as TheraCLEC-Total consisting of the [************************
***], as disclosed in IND Application No. [*****] filed with the United States
Food and Drug ("FDA") Administration on May 28, 2002.
1.42 "THIRD PARTY" shall mean any entity other than ALTUS or XXXX.
1.43 "VALID CLAIM" shall mean an issued claim, or a pending claim that is
being prosecuted in good faith, of any Licensed Product Patent, that has not
been withdrawn, cancelled, disclaimed, abandoned, or held invalid, unpatentable
or unenforceable by a tribunal of competent jurisdiction in a final decision (i)
which is unappealable or (ii) from which all appeals have been exhausted. If a
Valid Claim is the subject of a final decision holding it not invalid,
unpatentable or unenforceable, the scope of the Valid Claim shall be interpreted
so as to reflect the construction placed upon it in the final decision.
ARTICLE 2.
SCOPE OF THE COLLABORATION
2.1 GLOBAL GOALS. The Parties agree, pursuant and subject to the terms of
this Agreement, to further develop the Licensed Product in the Field in the
Territory, with the goal of obtaining Regulatory Approval for the Licensed
Product as soon as reasonably practicable for commercial marketing and sale in
the Field in the Territory.
2.2 EUROPEAN DEVELOPMENT AND COMMERCIALIZATION PLAN. The overall strategy
for the development, commercialization and marketing of the License Product in
the Field in the Territory shall be set forth in a written plan (hereinafter,
the "European Development and Commercialization Plan"). The European Development
and Commercialization Plan shall include a Development Plan (to be provided by
ALTUS in accordance with Section 4.3 below) and a Commercialization Plan (to be
provided by XXXX in accordance with Section 5.3 below). The European Development
and Commercialization Plan will be reviewed periodically by the Steering
Committee and shall be discussed at Steering Committee meetings. Notwithstanding
the foregoing, in the event any provision set forth in the European Development
and Commercialization Plan conflicts with or is inconsistent with a provision of
this Agreement, the provisions of this Agreement shall control.
ARTICLE 3.
MANAGEMENT OF THE COLLABORATION
3.1 ESTABLISHMENT OF STEERING COMMITTEE. The Parties hereby establish a
Steering Committee for coordinating the development, commercialization, and
marketing of the Licensed Product in the Field in the Territory. The Steering
Committee will be composed of [*******] representatives of each Party, who shall
be appointed (and may be replaced at any time) by such Party on written notice
to the other Party in accordance with this Agreement. Such representatives shall
include individuals within the senior management of each Party with expertise
and responsibilities in the areas of clinical development, process sciences,
manufacturing, regulatory affairs or product development and marketing, as
applicable to the stage of development or commercialization of the Licensed
Product. One of the three representatives for each Party shall be designated as
that Party's General Manager. Although the members of the Steering Committee can
and should change as the life cycle of the Licensed Product changes, the Parties
will endeavor to keep the General Managers consistent for each Party throughout
the collaboration to maintain continuity in the collaboration. The initial
Steering Committee members, including the General Manager, from each Party are
listed on Exhibit D attached hereto to the extent identified therein. Any member
of the Steering Committee may designate a substitute to attend and perform the
functions of that member at any meeting of the Steering Committee. The Steering
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
Committee will meet at least [****] each year (face-to-face) during the Term of
this Agreement, or at any frequency agreed by the Steering Committee. In any
event, the Steering Committee will meet [************] after the execution of
this Agreement or as soon as practicable as mutually agreed by the Parties. Each
representative on the Steering Committee will have one vote in decisions
submitted to the Steering Committee. Unless otherwise specifically set forth in
this Agreement, all issues to be resolved by the Steering Committee shall be
resolved by the affirmative vote of [**********************] on the Steering
Committee (or such representative's designee). ALTUS shall also notify XXXX of
and shall use [************************************] to accommodate requests by
XXXX to participate in [********************************************************
********************].
3.2 RESPONSIBILITIES OF STEERING COMMITTEE. The Steering Committee shall,
subject to the provisions set forth in Article 4 and Article 5 hereinafter and
the dispute resolution procedures of Article 16, be the primary vehicle for
interaction between the Parties with respect to the development,
commercialization, and marketing of the Licensed Product in the Field in the
Territory. In particular, the Steering Committee shall perform the following
functions consistent with its objective of managing an effective and efficient
Combined Phase III Clinical Trial that satisfies the development, regulatory and
commercialization requirements of North America and the Territory and leverages
the clinical development activities in both territories:
(I) exchange of information and facilitation of cooperation and
coordination between the Parties as they exercise their respective rights and
meet their respective obligations under this Agreement;
(II) manage, review and monitor execution of the European
Development and Commercialization Plan;
(III) review, prepare and recommend changes to the European
Development and Commercialization Plan;
(IV) facilitate coordination of information flow, consistent with
the EU privacy directive, with respect to regulatory approvals from the
appropriate regulatory authorities in the Territory; and ensuring compliance in
all material respects with all applicable laws, regulations, and all other
requirements of applicable good laboratory practices;
(V) establish, monitor, review and modify all development time
lines to be adhered to by the Parties for all Phase III and Phase IV clinical
development and Regulatory Approval activities in the Territory;
(VI) approve all contracts, agreements, commitments and
undertakings with Third Parties regarding Phase III and Phase IV clinical
development activities in the Territory where the committed expenditures exceed
a threshold amount to be determined by the Steering Committee;
(VII) facilitate coordination of information flow with respect to
the Combined Phase III Clinical Trials and Phase IV Studies (if any) between the
EU and North America;
(VIII) facilitate coordination of supply of Clinical Supplies for
EU activities;
(IX) [**********] relating to material business, scientific,
clinical, medical, regulatory or management issues arising out of this Agreement
in accordance with Section 16.1; and
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
(X) perform such other functions as appropriate to further the
purposes of this Agreement, as determined by the mutual agreement of the
Parties.
3.3 STEERING COMMITTEE PROCEDURES. The representatives of the Steering
Committee shall designate a Chairperson who will serve as such. The Chairperson
shall send notices (not less than [*************] in advance of such meetings)
and agendas for all regular Steering Committee meetings to all Steering
Committee members. The location of regularly scheduled Steering Committee
meetings shall alternate among the offices of the Parties, unless otherwise
agreed. Meetings may be held telephonically, but each member shall attend at
least [***] meeting in person each year. The Party hosting any Steering
Committee meeting shall appoint one person (who need not be a member of the
Steering Committee) to attend the meeting and record the minutes of the meeting.
Such minutes shall be circulated to the Parties promptly following the meeting
for review, comment and distribution.
3.4 PRODUCTION REQUIREMENTS REPORTS. XXXX shall be responsible for
preparing and delivering to the Steering Committee and ALTUS an [**********]
Licensed Product production requirement report, which report shall be updated
[********************]. Such report shall be provided to the Steering Committee
and ALTUS within [*************] of the end of each [***************]
(beginning with the [*************] following the Phase III Enabling Clinical
Trial for the Licensed Product) and shall include the forecasted requirements
for Clinical Supplies, Licensed Product placebo and commercial supplies for the
subsequent [*****************] period.
3.5 DISPUTE RESOLUTION. Except as hereinafter provided, all issues that
come before the Steering Committee that require action, approval or resolution
and for which the Steering Committee is unable to reach agreement by a vote of a
majority of the representatives of the Steering Committee shall be resolved in
accordance with Article 16.
ARTICLE 4.
DEVELOPMENT
4.1 DEVELOPMENT EFFORTS. ALTUS shall be responsible for and shall
[*********************************************] to develop the Licensed Product
in the Field in the Territory in accordance with the terms of this Agreement.
ALTUS shall commit such of its resources as may be necessary to perform its
obligations as set forth herein or in the Development Plan (as defined below)
and shall use personnel with such skills and experiences as are designed to
accomplish efficiently and expeditiously the objectives of the development of
the Licensed Product as set forth herein or in the Development Plan and each
update thereof in good scientific manner and in compliance in all material
respects with all applicable laws, regulations, and all other requirements of
applicable good laboratory practices. In connection with the performance by
ALTUS of its obligations hereunder, ALTUS shall maintain and utilize such
scientific staff, laboratories, offices and other facilities as are reasonably
designed for such purposes. XXXX shall use [***********************************]
to perform those activities it is obligated to perform with respect to the
clinical development of the Licensed Product as are set forth in this Agreement
or that have been assigned to XXXX, with XXXX'x approval, by the Steering
Committee, and shall commit such of its resources as may be necessary to perform
such obligations and shall use personnel with such skills and experiences as are
designed to efficiently and expeditiously satisfy such obligations. Each Party
shall cooperate with and use Commercially Reasonable and Diligent Efforts to
support the other Party in the conduct of such development efforts.
4.2 DEVELOPMENT RESPONSIBILITIES. All decisions regarding the Combined
Phase III Clinical Trial in the Territory in the Field, including but not
limited to formulation of overall development plans, making overall decisions
regarding the design of all clinical trials in the Territory, management of
clinical team activity, and management of regulatory activity shall be made
through the Steering Committee,
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
subject to the dispute resolution mechanism set forth in Section 16.1 below.
Prior to the Combined Phase III Clinical Trial, ALTUS shall keep the Steering
Committee informed of the progress of the clinical development, including
development plans, time lines and process development work, and will discuss
with the Steering Committee developments and decisions that ALTUS anticipates
will have a significant impact on the Combined Phase III Clinical Trial and/or
Regulatory Approvals in the Territory.
4.3 DEVELOPMENT PLAN. Attached hereto as Exhibit B is a copy of the
development plan (hereinafter the "Development Plan") for the development of
Licensed Product in the Field in the Territory. From time to time, ALTUS shall
submit to the Steering Committee an updated Development Plan as appropriate, but
at least [******]. The Development Plan (and any updates thereto) shall become
part of and be incorporated into the European Development and Commercialized
Plan and shall be reviewed and discussed at the Steering Committee meetings.
4.4 CLINICAL TRIALS. The Steering Committee shall have responsibility for
and control over management of clinical trials for the Licensed Product in the
Field in the Territory and all decisions regarding such trials shall be made
jointly through the Steering Committee, subject to the dispute resolution
mechanism set forth in Section 16.1 below. The Parties may use one or more Third
Parties to assist in the performance of such clinical trials. All clinical data
and reports related to clinical trials for the Licensed Product shall be jointly
owned by the Parties and each Party shall have access to, and copies of; all
such data and reports related to clinical trials for the Licensed Product in the
Field in the Territory, and each Party may use such data in accordance with the
terms of this Agreement without [********************] to the other Party. Each
Party shall treat such data and reports as Confidential Information of the other
Party, and neither Party shall disclose or use such data or reports for any
purpose other than performing its obligations under this Agreement or as
otherwise expressly authorized in writing by the Steering Committee. All data,
database information and safety reports from such clinical trials shall be
centralized and held at ALTUS or by a Third Party selected by ALTUS and agreed
to by XXXX, provided, however, that XXXX shall be entitled to obtain and keep
copies of such information and reports. If a Party itself obtains data from a
clinical trial hereunder, it shall promptly transfer all of the clean, final
data for such trial to ALTUS or to such Third Party, as the case may be. The
Steering Committee shall coordinate the transfers of any such data. All Phase I
Clinical Trials, Phase II Clinical Trials, and Combined Phase III Clinical
Trials for the Licensed Product in the Field in the Territory shall be performed
in compliance with and conformity to both FDA and EMEA requirements and to ICH
Guidelines. At the completion of each Phase I Clinical Trial, Phase II Clinical
Trial and Combined Phase III Clinical Trial, ALTUS shall prepare a written
report, substantially in the form reasonably expected to be submitted to the
FDA, the EMEA or other applicable Regulatory Authority, summarizing the results
of such clinical trial, and containing an analysis of the clinical significance
of such results, which reports shall be submitted to XXXX and the Steering
Committee as soon as is reasonably practicable after completion of the relevant
clinical trial. Such reports shall be referred to herein as the "Phase I
Report," the "Phase II Report," and the "Phase III Report," respectively.
4.5 DRUG APPROVAL APPLICATIONS.
(A) XXXX [***************] for and shall use [************************
******************] in filing all Drug Approval Applications and seeking
Regulatory Approvals for the Licensed Product in the Territory in the Field;
provided that ALTUS shall assist XXXX in preparing and filing such Drug Approval
Applications and seeking such Regulatory Approvals. XXXX shall pay [*********]
associated with the preparation, filing, prosecution, meetings, communications,
and review by regulatory agencies of such Drug Approval Applications and
Regulatory Approvals (including the activities set forth in Section 4.5). The
Regulatory Approvals for the Licensed Product in the Territory shall be
prosecuted and obtained in the name of XXXX; provided that any such Regulatory
Approvals shall be obtained in the joint name of XXXX and ALTUS if permitted
under applicable rules and
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
regulations, and provided further that ALTUS shall be permitted to
cross-reference such Drug Approval Applications and Regulatory Approvals that
are in XXXX'x name. In the event that the laws or regulations in a country in
the Territory do not allow the Licensed Product to be registered solely in the
name of XXXX, XXXX shall register the Licensed Product at its discretion (i)
[*******************************************************] or (ii)
[***************************************************]. Prior to submitting any
Drug Approval Application, XXXX shall discuss with the Steering Committee the
scope and general content of such Drug Approval Application. The Steering
Committee may review and comment on all Drug Approval Applications, and such
comments will be ******** by XXXX to the [****************]. All Drug Approval
Applications to be filed by or on behalf of XXXX for the Licensed Product in the
Territory must be approved by ALTUS in advance in writing. Regulatory documents
or copies thereof for each filing shall be centralized and held at the offices
of ALTUS, provided, however, that XXXX shall be entitled to obtain and keep
copies of originals of any such documents but only for the uses specifically set
forth in this Agreement. Each Party will immediately notify the other Party of
any material developments relating to the clinical development of the Licensed
Product, including, without limitation, any material comments or concerns raised
by any Regulatory Authority.
(B) Each Party agrees to provide to the other Party a copy of any
documents or reports relating to the Licensed Product that are filed with any
regulatory authority in the Territory under this Agreement, including any Drug
Approval Applications. All such documents and reports shall be centralized and
held at ALTUS or by a Third Party selected by ALTUS and agreed to by XXXX,
provided however, that XXXX shall be entitled to obtain and keep copies of any
such documents and records. The Steering Committee shall coordinate the
transfers of any such documents or reports.
4.6 REGULATORY MEETINGS AND COMMUNICATIONS. XXXX shall be responsible for
conducting all meetings and discussions and routine telephone communications
with the EMEA or other Regulatory Authority, related to clinical studies, Drug
Approval Applications and Regulatory Approvals for the Licensed Product in the
Field in the Territory; provided that XXXX shall use [**********************
***************] to conduct such meetings and discussions to facilitate the
Regulatory Approval of the Licensed Product in the Field in the Territory. ALTUS
shall assist XXXX in these efforts. XXXX will keep ALTUS and the Steering
Committee apprised of all material communications with such regulatory
authorities, and ALTUS or its designee shall be entitled to attend all meetings
with Regulatory Authorities. XXXX shall [*****************] with respect to the
conduct of any inspections by any Regulatory Authority of XXXX'x site and
facilities related to the Licensed Product, and each Party shall be given the
opportunity to attend such site inspection and the summary, or wrap up, meeting
related to the Licensed Product with such regulatory authority at the conclusion
of such site inspection. To the extent either Party receives written or material
oral communication from any regulatory authority relating to the Licensed
Product in the Field in the Territory, the Party receiving such communication
shall notify the other Party and provide a copy of any written communication as
soon as reasonably practicable.
4.7 TRANSFER OF MATERIALS. During the development of the Licensed Product,
each Party may transfer certain of its proprietary materials to the other Party.
Each Party agrees that it will use such materials of the other Party only for
the purposes of this Agreement, and will not transfer such materials to any
non-Affiliated Third Party without the prior written consent of the other Party
hereunder. Except as expressly provided in this Agreement, the transfer of any
such proprietary materials by one Party to another shall not be deemed to be a
[***************] in the proprietary material. All right, title and interest in
and to all such proprietary materials (and any patent rights relating thereto)
shall remain in the Party transferring such materials.
4.8 DEVELOPMENT COSTS. All ALTUS Development Costs (as defined in Exhibit
C) shall be paid directly by [*****]. ALTUS shall send to XXXX a [**********]
for all XXXX Development Costs
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
(as defined in Exhibit C) incurred by ALTUS for such month in connection with
development work performed pursuant to this Agreement. XXXX shall [********]
ALTUS for all such XXXX Development Costs within [*********] of receipt of the
[*******] by XXXX; provided, however, that XXXX shall be entitled to pay its
share of costs related to clinical trials in the Field in the Territory which
have been contracted directly by XXXX directly to the relevant CRO (Contract
Research Organisation). Each Party shall keep complete and accurate books and
records pertaining to the Development Costs, which books and records shall be
retained until [***********] after the end of the period to which such books and
records pertain. Each Party shall have the right, at its expense, to have an
[*************************************] the books and records of the other
Party relating to the Development Costs, PROVIDED, HOWEVER, that neither Party
shall conduct more than one such [******************].
4.9 4.9 Safety Data Base. The Parties will, as soon as practical, organize
a serious adverse event data base (the "SAE Data Base"). ALTUS and XXXX shall
jointly own the SAE Data Base and all data contained therein, and the data from
the SAE Data Base shall be made available to both Parties.
ARTICLE 5.
COMMERCIALIZATION AND MARKETING IN THE TERRITORY
5.1 COMMERCIALIZATION AND MARKETING EFFORTS. XXXX shall use
[**************************************] to commercialize and market the
Licensed Product in the Field in the Territory in accordance with the terms of
this Agreement, and ALTUS shall [*********] with and use [**********************
*************] to support XXXX in XXXX'x conduct of such commercialization and
marketing efforts. During the term of this Agreement and with respect to sales
of Licensed Product in Germany, XXXX shall [************************************
*******].
5.2 COMMERCIALIZATION AND MARKETING RESPONSIBILITIES. XXXX shall have
[***************************] over the commercialization and marketing of the
Licensed Product in the Field in the Territory, including but not limited to
designing and implementing all product launch, promotion, marketing and sales
activities, handling the packaging and shipment of all commercial product,
booking sales, handling all returns, handling all aspects of order processing,
invoicing, collection, and receivables, collection of data for purposes of
satisfying applicable regulatory requirements, collection of data of sales to
hospitals and other end users, distribution, inventory, and warehousing. XXXX
will discuss with the Steering Committee any [********] commercialization and
marketing issues as may be appropriate. Notwithstanding anything in this
Agreement or the European Development and Commercialization Plan to the
contrary, XXXX shall have [****************************************************
******] under this Agreement. In particular, XXXX may [*************************
********************************************] within the Territory if
[**********************] that the commercialization in such country might
[*****************] the commercialization of the Licensed Product in the
Territory as a whole; provided that XXXX shall inform the Steering Committee of
any such decision and the reasons therefor.
5.3 COMMERCIALIZATION PLAN. Within a reasonable period of time after a
Phase III Enabling Clinical Trial with respect to the Licensed Product in the
Field in the Territory, XXXX shall submit to the Steering Committee a detailed
[*********] (the "Commercialization Plan") for the commercialization of the
Licensed Product in the Field in the Territory. The Commercialization Plan shall
include proposed [*****************] arrangements relating to sales of the
Licensed Product. XXXX shall submit to the Steering Committee an annual updated
Commercialization Plan on the first anniversary of the First Commercial Sale of
the Licensed Product and each [*********] thereafter. The Commercialization Plan
(and each update thereto) shall become part of and be incorporated into the
European Development and Commercialization Plan and shall be reviewed and
discussed at the Steering Committee meetings. [********************************]
after completion of a Phase III Enabling Clinical Trial for Licensed
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
Product in the Field in the Territory, XXXX will enter into an agreement with a
Third Party contractor covering the packaging of the Licensed Product. XXXX
shall also have identified a second source reasonably capable of packaging the
Licensed Product in the event such Third Party contractor is unable to do so.
5.4 COMMERCIALIZATION COSTS. Except as otherwise provided herein, all XXXX
Marketing Costs shall be paid for [***************], all as more fully provided
in Exhibit C.
5.5 PRODUCT TRADEMARKS. It is the intent of the Parties that one or more
product trademark(s) other than TheraCLEC, TheraCLEC-Total, or such other
trademark to be used in connection with sales of the Licensed Product in the
United States, shall be developed for use on and in connection with the Licensed
Product in the Territory (each, a "Product Trademark"). XXXX shall have the
[**********************] for developing and promoting the Product Trademark(s),
subject to the prior review and written approval of ALTUS and the Steering
Committee, which approval by ALTUS shall [*******************************] and
shall be required solely for the purpose of ensuring that the xxxx(s) proposed
by XXXX for use as the Product Trademark(s) are not confusingly similar to
TheraCLEC, TheraCLEC-Total, or such other trademark as is intended to be used in
connection with sales of the Licensed Product in the United States. If it is
determined that it is not possible to register or otherwise use one or more of
the Product Trademark(s) in any country within the Territory, then the Parties
shall agree on an appropriate trademark to use in each such country. XXXX shall
own the Product Trademark(s), and shall be responsible for procurement and
maintenance of trademark registrations for such trademark(s) in connection with
sales of the Licensed Product in the Field in the Territory. If XXXX elects not
to procure or maintain a trademark registration for any such trademark(s) in
connection with the Licensed Product in a country of the Territory, it shall so
inform ALTUS in writing in a reasonable time before any action is due thereon.
ALTUS shall then have the right but not the obligation to procure and maintain
such trademark(s) in such country at XXXX'x expense. The cost of filing,
prosecution and maintenance for the Product Trademark(s) shall be paid by XXXX
during the term of this Agreement.
5.6 MARKETING MATERIALS AND PACKAGING. The Licensed Product marketed and
sold in each country in the Territory pursuant to this Agreement shall be
marketed and sold under the particular Product Trademark applicable to sales of
the Licensed Product in such country, and the packaging used for the Licensed
Product shall identify ALTUS as the licensor of such product using the ALTUS
trademark and logo (collectively, the "XXXXX Xxxx"). ALTUS shall have
[***************] right to control the use of the XXXXX Xxxx in connection with
sales of the Licensed Product. XXXX'x use of the XXXXX Xxxx shall be in strict
compliance with the uses of the XXXXX Xxxx set forth in the most recent version
of the ALTUS Style Guide, a copy of which (together with any subsequent
revisions thereto) shall be furnished by ALTUS to XXXX. From time to time, as
reasonably requested by ALTUS, XXXX shall submit to ALTUS for ALTUS' review
copies of marketing materials, packaging, instruction booklets, printed
materials, advertisements, and any other documents containing the XXXXX Xxxx,
together with an English language translation thereof, if requested by ALTUS. In
the event ALTUS objects to XXXX'x use of the XXXXX Xxxx, ALTUS shall so notify
XXXX in writing, and XXXX shall cease using the XXXXX Xxxx or change its use of
the XXXXX Xxxx to the satisfaction of ALTUS as soon as practicable. XXXX agrees
that ALTUS shall be identified as licensor on all packaging and printed
literature and advertisements for Licensed Product sold by XXXX or its
distributors, subject to legal and commercial requirements on a
country-by-country basis and in a manner in accordance with such legal and
commercial requirements. The packaging and printed literature and advertisements
for the Licensed Product shall indicate that the Licensed Product is an
innovation of ALTUS and that such product is distributed under a license granted
by ALTUS. The packaging shall also contain the patent numbers of any Licensed
Product Patents where such marking is required or provided for under applicable
law. Such marking shall further conform to the laws and practices of the
jurisdiction in which the Licensed Product is manufactured, sold and/or
delivered. XXXX shall make copies of all marketing and promotional
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
materials for the Licensed Product available to ALTUS for filing with the
appropriate regulatory authorities, as required under applicable law.
ARTICLE 6.
XXXX PAYMENTS
6.1 FUNDING SUPPORT FOR DEVELOPMENT COSTS. Subject to the other terms and
conditions of this Agreement, and as consideration for the development work and
the development license rights granted to XXXX by ALTUS under this Agreement,
XXXX shall pay to ALTUS the following non-refundable, non-cancellable, and
non-creditable amounts upon the first occurrence of such event with respect to
the Licensed Product, which payments shall be required to be paid in order for
XXXX to maintain its development license in the Territory:
Event Payment
----- -------
(a) [*************************************]. [*********](1)
(b) [************************************** [*********](1)
**************************************
**************************************
*****************].
(c) [***************************************** [*********]
****************************************].
(d) [***************************************** [*********]
****************************************].
(e) [***************************************** [*********]
****************************************].
(f) [***************************************** [*********]
*****************************************
************************************].
(g) [**************************************** [*********]
*****************************************
*****************************************
*****************************************
*****************************************
***********************].
(h) [**************************************** [*********]
*****************************************
*****************************************
*****************************************
*****************************************
***********************].
----------
(1) [**************************************************************************
***************************************************************************
***************************************************************************
***************************************************************************
***************************************************************************
************************************************************************
****].
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
For purposes of the payments set forth in Section 6.l(c)-(f) above,
[********************************************************************] shall be
deemed to be [**********] when ALTUS has delivered to XXXX the
[****************************], or the [*************], respectively, as the
case may be.
6.2 Subject to the other terms and conditions of this Agreement, and as
consideration for the commercial license rights granted to XXXX by ALTUS under
this Agreement, XXXX shall pay to ALTUS the following nonrefundable,
non-cancellable, and non-creditable amounts upon the first occurrence of the
Licensed Product to reach such event, which payments shall be required to be
paid in order for XXXX to maintain its commercial license in the Territory:
(a) [**************************************** [*********]
*****************************************
*****************************************
*****************************************
*****************************************
***********************].
(b) [**************************************** [*********]
*****************************************
*****************************************
*****************************************
*****************************************
***********************].
6.3 The payments set forth in Section 6.1(c)-(h) and Section 6.2(a)-(b)
shall be paid by XXXX to ALTUS within [**********] days after the applicable
[*****************************]; provided, however that unless otherwise agreed
to by the Parties, any past due amounts shall bear interest at the rate that is
the lesser of (i) the [******************************************************]
as reported by Datastream (or a successor or similar organization) from time to
time, plus, at ALTUS' option, an additional [**************], or (ii) the
highest rate permitted by applicable law, in each case calculated on the number
of days such a payment is overdue.
6.4 ROYALTIES.
(A) ROYALTY.
(I) As consideration for the license rights granted to XXXX by
ALTUS under this Agreement, XXXX shall pay to ALTUS a royalty on Net Sales of
the Licensed Product sold by XXXX (or its Affiliates) at the following
[********] royalty rate (which rate [********] according to the total amount of
XXXX'x [************] Deemed Net Sales (defined below) invoiced since the
Effective Date):
[**********] Deemed Net
Sales euros ("E") (in
millions) [*********]
----------------------- -----------
[*******] [****]
[*******] [****]
[*******] [****]
[*******] [****]
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
[*******] [****]
[*******] [****]
[*******] [****]
By way of example, if XXXX'x [*******] Deemed Net Sales of the Licensed Product
since the Effective Date equal [***********], the total royalty owed by XXXX
would equal [*********], as set forth below.
[**********] Deemed Net
Example: Sales of (euro) 499 million
-------- ---------------------------
[*******] [*******************]
[*******] [*******************]
[*******] [*******************]
[*******] [*******************]
[*******] [*******************]
[*******] [***************]
(II) For purposes of this Section 6.4(a), XXXX'x "[*********]
Deemed Net Sales" as of the end of a particular calendar quarter shall be
determined as follows:
(1) If less than [********************] of XXXX'x xxxxx
invoiced sales for the calendar quarter are
attributable to sales to Distributors, XXXX'x
"[********] Deemed Net Sales" as of the end of that
calendar quarter shall equal: (a) [********************
*******************************************************
**********************]; and
(2) If [********************] or more of XXXX'x xxxxx
invoiced sales for the calendar quarter are
attributable to sales to Distributors (such gross
invoiced sales to Distributors in excess of such
[*******] hereinafter referred to as "Excess
Distributor Sales"), XXXX'x "[*********] Deemed Net
Sales" as of the end of that calendar quarter shall
equal: (a) [*******************************************
*******************************************************
*******************************************************
*******************************************************
*******************************************************
*****************************************].
In the event that during the term of this Agreement there is a
material change in the outline conditions in the Territory as they relate to the
question whether a Third Party should be considered a [*********] for the
purpose of this Agreement, the Parties undertake to renegotiate in good faith
and to adjust the definition in Section 1.11 above in order to reflect such
change in the outline conditions from the situation prevailing at the signing
hereof.
(III) XXXX shall pay royalties with respect to sales of the
Licensed Product on a country by country basis until the later of (i) the date
of expiration of the last to expire Valid Claim of a Base Patent Covering the
Licensed Product in such country, and (ii) [*************] from the First
Commercial Sale of the Licensed Product in such country.
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
(B) ROYALTY PAYMENT DATES. Royalties paid by XXXX pursuant to Section
6.3(a) shall be paid by XXXX within thirty (30) days after the end of each
calendar quarter in which Net Sales are made. All such payments shall be
accompanied by a statement showing the source of such revenues, including the
Net Sales of the Licensed Product in each country, a calculation of the
Cumulative Deemed Net Sales as of the end of that quarter, and a calculation of
the amount of payment due for each such jurisdiction. In the event royalties are
not paid within the time period set forth in this Section 6.3(b), unless
otherwise agreed to by the Parties, such royalties shall bear interest at the
rate that is the lesser of (i) the average one-month European Interbank Offered
Rate ("EURIBOR") as reported by Datastream (or a successor or similar
organization) from time to time, plus, at ALTOS' option, an additional
[**************], or (ii) the highest rate permitted by applicable law, in each
case calculated on the number of days such a payment is overdue.
(C) ACCOUNTING. All payments due to ALTUS by XXXX and royalties owed
to ALTUS shall be paid in euros. Whenever payment for the Licensed Product is
received by XXXX in a foreign currency other than euros, for the purpose of
calculating royalties on XXXX'x Net Sales, conversion from such foreign currency
into euros shall be made on the last day of each calendar quarter at the
applicable rate of conversion on that date as retrieved from the Reuters System
(or any other source agreed upon in writing by the parties) for the applicable
calendar quarter.
(D) TAXES. All sums due to ALTUS under this Agreement shall be paid in
full, subject to deduction for withholding taxes, charges and other duties
levied on account of such payment that may be imposed in the Territory save
insofar as ALTUS shall be capable of obtaining a credit therefore. The Parties
agree to co-operate in all respects necessary to take advantage of such double
taxation agreements as may be available. It is the understanding of XXXX, after
consultation with its tax advisors based on current law, that payments to ALTUS
hereunder can be made, subject to the fulfillment of applicable formal
requirements, without the requirement of taxes to be withheld, although XXXX
provides no warranty or assurance of such result. In the event that taxing
authorities assert a contrary result, the parties will cooperate in appropriate
proceedings to challenge such assertion. If XXXX is required to deduct or
withhold it will (i) promptly notify ALTUS of such requirement, (ii) pay to the
relevant authorities the full amount to be deducted or withheld promptly upon
the earlier of determining that such deduction or withholding is required or
receiving notice that such amount has been assessed against ALTUS and (iii) send
proof of payment to ALTUS by transmitting an official receipt (or certified
copy), or other documentation reasonably acceptable to ALTUS and obtainable by
XXXX evidencing such payments to such authorities. Any such required tax,
charges and other duties actually paid on ALTUS' behalf shall be deducted from
the sums due to ALTUS under this Agreement.
6.5 VALUE OF RIGHTS. ALTUS and XXXX understand and acknowledge that the
value of each of the rights granted by this Agreement might fluctuate while this
Agreement is in effect. Notwithstanding any such fluctuation, ALTUS and XXXX
have agreed to allocate the value of these rights in the manner represented by
the royalties and other payments contemplated hereunder and intend such
allocation to be binding and unchanging.
ARTICLE 7.
MANUFACTURING AND SUPPLY
7.1 SUPPLY OF THE LICENSED PRODUCT.
(A) CLINICAL SUPPLIES. ALTUS shall provide or cause to be provided all
Clinical Supplies of the Licensed Product for the completion of human clinical
trials for the Licensed Product in the Field in the Territory. ALTUS may enter
into one or more "manufacturing and supply agreement(s)"
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
with Third Party contract manufacturer(s) for such Clinical Supplies. The cost
of Clinical Supplies [*********************************************************
***************************].
(B) COMMERCIAL SUPPLIES. ALTUS shall be responsible for establishing
and shall use [*************************************] to establish a commercial
manufacturing process for, and making available, commercial supplies of the
Licensed Product at the scale and in the amounts required to [*************] for
the Licensed Product in the Field in the Territory. XXXX shall have the
[**************] its requirements for commercial supplies of the Licensed
Product from ALTUS. If XXXX takes advantage of such [********], the purchase
price shall be equal to [****] of the German Ex-Factory Price for the Licensed
Product; provided, however, that if ALTUS' aggregate fully-burdened
manufacturing costs for such Licensed Product exceeds [*****] of the German
Ex-Factory Price, [************************************************************
********************************************************************************
*******************************************************************************
******]. ALTUS shall keep full, true and accurate books of account containing
all particulars that may be necessary for the purpose of evidencing its fully
burdened manufacturing costs as a basis for the purchase price to be paid by
XXXX for Licensed Product. Such books and records shall be kept at ALTUS'
principal place of business. XXXX or its authorized independent accountant shall
have the right to [************] of such books and records of ALTUS that are
necessary to report on the purchase price for the commercial supplies of the
Licensed Product for the period or periods requested by XXXX and the correctness
of any purchase price payment made by XXXX to ALTUS. With regard to further
details of such [*****], the provisions in Section 13.4 hereinafter shall apply
mutatis mutandis. As soon as practicable after completion of a Phase III
Enabling Clinical Trial for the Licensed Product, ALTUS will enter into a
manufacturing and supply agreement with a Third Party contract manufacturer(s)
covering the manufacture, supply and quality control with respect to the
Licensed Product. ALTUS shall also ensure that [****************] for the
manufacture and supply of the Licensed Product. XXXX will be responsible for
paying [**********************************************************************
************************]. The terms of the supply of commercial supplies by
ALTUS, in particular regarding all packaging, handling, shipping, delivery,
insurance, tariffs, taxes and the like pertaining to delivery of the Licensed
Product to XXXX, will be governed by a "Supply and Distribution Agreement" to be
negotiated and entered into between the Parties, which agreement shall include
customary indemnification provisions relating to the quality of the manufactured
product and shall have terms consistent with this Agreement.
ARTICLE 8.
LICENSES
8.1 LICENSE TO XXXX. Subject to the terms hereof, ALTUS hereby grants to
XXXX a [***********************] (except pursuant to Section 17.1), [********]
license, with the right to [********], under the Licensed Product Patents to
[*******************************************************] the Licensed Product
in the Field in the Territory in accordance with the terms of this Agreement.
Subject to the terms hereof, ALTUS hereby grants to XXXX a [********************
***********] (except pursuant to Section 17.1), [*******************************
*******], under the Licensed Product Know-how to [******************************
**********************************] the Licensed Product in the Field in the
Territory in accordance with the terms of this Agreement.
8.2 THIRD PARTY LICENSED IP. In respect of the Third Party Licensed LP
licensed from [********] to ALTUS, ALTUS shall obtain for XXXX an acknowledgment
in writing from [*******] to the rights of XXXX under this Agreement whereby the
rights and licenses granted hereunder to the Third Party Licensed IP shall
continue (free of any payment) notwithstanding any termination of the rights of
ALTUS in respect of the Third Party Licensed IP, substantially in the form of
the document contained in
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
Schedule 8.2. In respect of any further Third Party Licensed IP licensed to
ALTUS, ALTUS shall use [**************************************] to obtain for
XXXX license rights to such Third Party Licensed IP as is necessary for XXXX to
undertake the actions contemplated hereby on terms and conditions similar to
those enjoyed by ALTUS; provided that under no circumstances shall ALTUS be
required to incur any additional financial or other obligations in order to
assist XXXX in obtaining such a license, and XXXX shall be responsible for
[**************************************] with respect to such license. Without
limiting the foregoing, in connection kith the negotiation of a commercial
supply agreement with [*******], if any, ALTUS shall use
[*************************] to obtain for XXXX without any additional obligation
of XXXX such license rights from [*********] as may be necessary for XXXX to
undertake the actions contemplated hereby.
8.3 RETENTION OF RIGHTS. Notwithstanding the license granted to XXXX in
Section 8.1, ALTUS shall retain the right within the Territory (i) to
[*************************] relating to the Licensed Product, (ii) to use at its
own cost the Licensed Product Patents and Licensed Product Know-how for its own
internal use and for non-commercial purposes, and (iii) to perform all other
activities contemplated by this Agreement.
8.4 EXCLUSIVITY. During the full Term of this Agreement (as defined in
Section 14.1) ALTUS agrees and obligates itself, and for five years from the
date hereof, XXXX agrees and obligates itself not to [**********************]
any other products that consist of [*******************************************
**********] in the Territory in the Field outside this collaboration.
ARTICLE 9.
TRADEMARKS
9.1 PRODUCT TRADEMARK. All of the Licensed Product shall be sold in the
Territory under the applicable Product Trademark and the XXXXX Xxxx as described
in Section 5.7.
9.2 GRANT OF LICENSE. ALTUS grants to XXXX, subject to compliance with the
other terms and conditions of this Agreement, a non-exclusive, royalty-free,
non-transferable license, with the right to sublicense, to use the XXXXX Xxxx
solely within the Territory and solely in connection with the sale of the
Licensed Product in the Field.
9.3 QUALITY CONTROL. XXXX shall apply the Product Trademark and the XXXXX
Xxxx only to the Licensed Product and only in accordance with the terms of this
Agreement. ALTUS shall have the right, at any time during regular business hours
but no more than one time per calendar year, to conduct an examination of the
Licensed Product to determine the quality of the Licensed Product. If at any
time, the Licensed Product shall, in the reasonable opinion of ALTUS, fail to
conform with the appropriate standards of quality as required under this
Agreement, ALTUS or its authorized representatives shall notify XXXX. Upon such
notification, the Parties shall discuss and implement actions to meet standards
of quality to the complete satisfaction of ALTUS.
9.4 ACKNOWLEDGMENT OF OWNERSHIP RIGHTS.
(A) XXXX acknowledges and agrees that ALTUS is the exclusive owner of
all right, title, and interest in and to the XXXXX Xxxx, and that all use of the
XXXXX Xxxx by XXXX will inure to the exclusive benefit of ALTUS. XXXX undertakes
to make use of the XXXXX Xxxx only in such a way that the rights of ALTUS in
said xxxx will not be diminished in any way. XXXX shall not use the XXXXX Xxxx
as all or part of any corporate name, trade name, trademark, service xxxx,
certification xxxx, collective membership xxxx, domain name, or any other
designation confusingly similar to the XXXXX Xxxx.
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
(B) ALTUS acknowledges and agrees that XXXX is the exclusive owner of
all right, title, and interest in and to the "Xx. XXXX" trademark and logo
(collectively, the "XXXX Xxxx"), and that all use of the XXXX Xxxx by ALTUS will
inure to the exclusive benefit of XXXX. ALTUS undertakes to make use of the XXXX
Xxxx only in such a way that the rights of XXXX in said xxxx will not be
diminished in any way. ALTOS shall not use the XXXX Xxxx as all or part of any
corporate name, trade name, trademark, service xxxx, certification xxxx,
collective membership xxxx, domain name, or any other designation confusingly
similar to the XXXX Xxxx.
9.5 USE OF TRADEMARK DESIGNATIONS. XXXX shall use the TM designation in
conjunction with any use of the XXXXX Xxxx within the Territory pursuant to this
Agreement until such time as the foreign registrations issue, unless otherwise
required by local trademark law. Once the foreign registrations issue, XXXX
shall use the (R) designation with all uses of the XXXXX Xxxx and any other
similar designation, unless otherwise required by local trademark law.
9.6 ACTIONS FOR INFRINGEMENT. Each Party shall notify the other promptly
upon learning of any actual, alleged, or threatened infringement of the Product
Trademark(s) or the XXXXX Xxxx applicable to the Licensed Product in the Field
in the Territory or of any unfair trade practices, trade dress imitation,
passing off of counterfeit goods, or like offenses in the Territory. Upon
learning of such offense from a Party, the Parties shall confer regarding the
defense of the Product Trademark(s) or the XXXXX Xxxx. XXXX shall have the first
right to respond to and defend any such infringement or offense with respect to
the Product Trademark(s). XXXX will keep ALTUS reasonably informed at all times
as to the status of the infringement or offense. In the event that XXXX elects,
within ninety (90) days, not to respond to or defend any such infringement or
offense or abandons such defense, then, in such event, ALTUS shall have the
option to do so, provided that XXXX shall cooperate with and provide reasonable
assistance to ALTUS. ALTUS shall have the sole right to respond to and defend
any such infringement or offense with respect to the XXXXX Xxxx.
9.7 COSTS OF DEFENSE OF TRADEMARKS. The Party bringing the action shall
bring such action or proceeding at its own cost and expense. Any damages or
other monetary awards recovered from settlement or judgment from such an action
shall be allocated first to reimburse the costs and expenses of the Party
bringing the action, then to reimburse the costs and expenses, if any, of the
other Party (except for costs associated with the other Party being represented
by counsel of its own choice). Any amounts remaining shall be paid to the Party
bringing such action.
ARTICLE 10.
CONFIDENTIALITY
10.1 CONFIDENTIALITY. Except to the extent expressly authorized by this
Agreement, the Parties agree that, for the Term of this Agreement and
thereafter, the receiving Party shall keep confidential and shall not publish or
otherwise disclose or use for any purpose other than as permitted under this
Agreement any proprietary information or materials furnished to it by the other
Party pursuant to this Agreement, including but not limited to any Know-how,
business plans, marketing plans, customer information, financial information or
patent applications (unless and until such applications are published pursuant
to applicable law) (collectively, "Confidential Information"), except to the
extent that it can be established by the receiving Party that such Confidential
Information:
(A) was already known to the receiving Party, other than under an
obligation of confidentiality, at the time of disclosure by the other Party as
demonstrated by pre-existing written records;
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
(B) was generally available to the public or otherwise part of the
public domain at the time of its disclosure to the receiving Party;
(C) became generally available to the public or otherwise part of the
public domain after its disclosure to the receiving Party other than through any
act or omission (i) of the receiving Party in breach of this Agreement, or (ii)
of any Third Party without authority to make such disclosure;
(D) was disclosed to the receiving Party, other than under an
obligation of confidentiality, by a Third Party who had no obligation to the
disclosing Party not to disclose such information to others; or
(E) was subsequently developed by the receiving Party without use of
the Confidential Information as demonstrated by pre-existing written records.
10.2 AUTHORIZED DISCLOSURE. Each Party may disclose Confidential
Information hereunder to the extent such disclosure is required to comply with
applicable laws or governmental regulations or to conduct pre-clinical or
clinical trials or to the extent ordered by a court of competent jurisdiction
(subject to entry of an appropriate protective order); provided, however, that
if a Party is required by law or regulation to make any such disclosure of the
other Party's Confidential Information, or such disclosure is required to
conduct pre-clinical or clinical trials, the disclosing Party will give, to the
extent practicable, reasonable advance notice to the other Party of such
disclosure requirement and will use its reasonable best efforts to secure
confidential treatment of such Confidential Information required to be
disclosed. In addition, each Party shall be entitled to disclose, under a binder
of confidentiality containing provisions substantially as protective as those of
this Article 10, Confidential Information to its consultants, clinical
investigators and contract manufacturer, if any, but only for any purposes
provided for in this Agreement and only to the extent required for the Parties
to perform their respective obligations under this Agreement.
10.3 SURVIVAL. This Article 10 shall perpetually survive the termination or
expiration of this Agreement.
10.4 PUBLICATIONS. Except as required by law, XXXX agrees that it shall not
publish or present the results of studies or clinical trials carried out by
either Party as part of the collaboration without the prior written consent of
the Steering Committee.
ARTICLE 11.
OWNERSHIP OF INTELLECTUAL PROPERTY AND PATENT RIGHTS
11.1 OWNERSHIP OF INVENTIONS. Any Inventions that relate to ALTUS
Background Technology or to the Licensed Product, its manufacture or its use,
including but not limited to any and all improvements, modifications, and
enhancements thereof in any form or formulation (hereinafter, "ALTUS
Inventions") shall be [***********************]. Any Inventions, excluding ALTUS
Inventions, that relate to XXXX Background Technology shall be [**************
**********]. XXXX will promptly disclose to ALTUS all ALTUS Inventions conceived
or reduced to practice by XXXX, alone or together with ALTUS or Third Parties.
XXXX shall assign all ALTUS Inventions to ALTUS and shall cooperate in the
filing and prosecution of any patent applications relating to ALTUS Inventions.
ALTUS will promptly disclose to XXXX all XXXX Inventions conceived or reduced to
practice by ALTUS, alone or together with XXXX or Third Parties. ALTUS shall
assign [***] XXXX Inventions to XXXX and shall cooperate in the filing and
prosecution of any patent applications relating to XXXX Inventions. For purposes
of this Section 11.1, inventorship shall be determined in accordance with
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
principles of U.S. patent law. In the event that there is a dispute between the
Parties as to ownership of Inventions, the Steering Committee shall establish a
procedure to resolve such dispute, which may include engaging a Third Party
patent attorney jointly selected by the parties who is completely unaffiliated
and independent of the Parties, as an expert to resolve such dispute. If the
Steering Committee is unable to establish a procedure to resolve such disputes,
either Party may seek to resolve such dispute in accordance with Article 16
hereof.
11.2 THIRD PARTY PATENTS. Each Party agrees to bring to the attention of
the other Party in a timely manner any Third Party patent or patent application
that has been brought to its attention by such Third Party, or of which it
otherwise becomes aware, that it believes would have a material affect on the
operations to be conducted by or on behalf of the Parties under this Agreement.
11.3 PATENT FILINGS.
(A) With respect to the patents and patent applications constituting
Base Patents that have been filed in the Field in the Territory, ALTUS shall (i)
be responsible for obtaining, prosecuting and maintaining such Base Patents;
(ii) keep XXXX apprised of the status of such patents and patent applications,
and (iii) share with XXXX all material information (including correspondence
with the various patent offices) relating thereto promptly after receipt of such
information. ALTUS shall be responsible for [*] costs incurred in connection
with the preparation, filing, prosecution, and maintenance of any patents and
patent applications constituting Base Patents that have been filed in the
Territory.
(B) At its sole discretion, ALTUS shall have the right to file,
prosecute, and maintain patent applications and patents for any and all ALTUS
Inventions in such countries worldwide as it may determine. All such patent
applications and patents Covering the Licensed Product for use in the Field that
are filed in the Territory shall be deemed to be Licensed Product Patents. XXXX
shall be responsible for all costs and expenses relating to the filing,
prosecution, and maintenance of the Licensed Product Patents on the ALTUS
Inventions in the Territory, if the ALTUS Inventions Cover the Licensed Product
or are, in XXXX'x scientific judgment, necessary or useful for the
commercialization and exploitation of the Licensed Product in the Territory. If
ALTUS elects not to file, prosecute or maintain any Licensed Product Patent on
the ALTUS Inventions in any Major European Country, ALTUS shall so inform XXXX
immediately. In each such case, XXXX may then file, prosecute and maintain any
such patents on an ALTUS Invention in such Major European Country as it may
determine at its own expense and discretion. The Party which is responsible
(pursuant to this Section 11.3(b)) for filing a patent application for such an
ALTUS Invention will be referred to herein as the "filing Party." For the Major
European Countries, the filing Party shall keep the other Party apprised of the
status of each such patent application and patent and shall seek the advice of
the other Party with respect to patent strategy and draft patent applications
and shall give reasonable consideration to any suggestions or recommendations
promptly provided by the other Party concerning the preparation, filing,
prosecution, and maintenance thereof. The Parties shall cooperate reasonably in
the prosecution of all such patent applications and patents on an ALTUS
Invention and shall share all material information relating thereto promptly
after receipt of such information. If, during the Term of this Agreement, the
filing Party intends to allow any patent or patent application for an ALTUS
Invention in any country of the world to lapse or become abandoned without
having first filed a substitute, the filing Party shall make reasonable efforts
to notify the other Party of such intention at least sixty (60) days prior to
the date upon which such patent application or patent shall lapse or become
abandoned, and the other Party shall thereupon have the right, but not the
obligation, to assume responsibility for the prosecution and maintenance
thereof.
11.4 INITIAL FILINGS IF MADE OUTSIDE OF THE U.S. The Parties agree to use
reasonable efforts to ensure that any patent filed outside of the U.S. prior to
a U.S. filing will be in a form sufficient to establish the date of original
filing as a priority date for the purposes of a subsequent U.S. filing.
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
11.5 ENFORCEMENT RIGHTS.
(A) NOTIFICATION OF INFRINGEMENT. If XXXX learns of any infringement
or threatened infringement by a Third Party of a Licensed Product Patent in any
country in the Territory, XXXX shall promptly notify ALTUS in writing and shall
provide ALTUS with all available evidence in XXXX'x possession of such
infringement.
(B) ENFORCEMENT. ALTUS shall have the right, but not the obligation,
to institute, prosecute and control (collectively, "bring") any action or
proceeding with respect to infringement in the Field in the Territory of any
Licensed Product Patent by counsel of its own choice, and XXXX shall have the
right, at its own expense, to be represented in any such action by counsel of
its own choice. XXXX shall be responsible for paying [****] of the reasonable
costs and expenses, including attorneys fees, relating to any such action if the
infringement is likely to have an adverse effect on the sale and distribution of
the Licensed Product in the Territory and shall inform ALTUS of its intention to
pay such costs and expenses prior to initiating the lawsuit. If ALTUS chooses
not to bring such an action or proceeding within sixty (60) days of being
notified of such infringement, then XXXX shall have the right (but not the
obligation) to bring such action. The Party not bringing such action or
proceeding agrees to be joined as a party plaintiff if necessary to prosecute
the action or proceeding and to give reasonable assistance and authority to file
and prosecute the action or proceeding. Any damages or other monetary awards or
amounts recovered from settlement or judgment from such an action or proceeding
shall be allocated first to reimburse the Part(ies) for the reasonable costs and
expenses of the action or proceeding (which amount shall be allocated pro rata
if insufficient to cover the totality of costs and expenses), with the remainder
to be paid to the party paying for the costs and expenses of the litigation;
provided that for purposes of determining the royalty amount payable to ALTUS
pursuant to Section 6.3, any amounts received by XXXX as damages that are
attributable to gross revenues of the infringer for infringing sales shall be
added to the Net Sales amount for the calendar quarter in which such damages,
awards or amounts are recovered.
(C) SETTLEMENT WITH A THIRD PARTY. The Party that brings suit to
enforce a given Licensed Product Patent in the Field in the Territory shall also
have the right to control settlement of such claim; provided, however, that if
one Party controls, no settlement shall be entered into without the express
written consent of the other Party. If there is no agreement between the Parties
regarding such settlement, then the dispute will be resolved pursuant to Article
16 below. If the dispute is not resolved pursuant to Article 16, then the case
may not be settled.
(D) In the event that a non-Affiliated Third Party institutes a
patent, trade secret or other infringement suit against XXXX or its Affiliates,
alleging that the manufacturing, use or sale of the Licensed Product in the
Territory infringes one or more Patents or other intellectual property rights
held by such Third Party (an "Action"), XXXX shall promptly notify ALTUS thereof
in writing and discuss with ALTUS the best way to respond. [*******] shall have
the [*******************************************] (subject to the last sentence
of this subparagraph (d)) [*****************************************************
**********************************************************************] not to
[******] such [*******************************************] of such [**********
*****] shall have [*****************************************] (subject to the
last sentence of this subparagraph (d)) [**************************************]
on such [***************************************************], PROVIDED,
HOWEVER, that [*****************************************************************
******************************] not to be [******************************]. In
connection with any such [******************************************************
********************************************************************************
*****************************] for any such [***********************************
********************************************
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
****************************************************]; provided that in no event
[*******************************************************] to this [*************
********************************************************************************
********************************************************************************
**************].
The foregoing shall not affect any liability of ALTUS under Article 12, arising
out of or in connection with any Action.
ARTICLE 12.
REPRESENTATIONS AND WARRANTIES
12.1 REPRESENTATIONS AND WARRANTIES OF ALTUS. As a material inducement to
XXXX to enter into this Agreement and to consummate the transactions
contemplated herein, ALTUS hereby represents and warrants to XXXX as follows:
(A) ORGANIZATION. ALTUS is a corporation duly incorporated, validly
existing and in good corporate standing under the Laws of the State of Delaware.
ALTUS has full corporate power and authority to own and lease its properties and
carry on its business and is duly qualified, registered or licensed as a foreign
corporation to do business and is in good standing in each jurisdiction in which
the ownership or leasing of its properties or the character of its operations
makes such qualification, registration or licensing necessary except where the
failure to be so qualified, registered or licensed would not have a material
adverse effect on the business of ALTUS.
(B) AUTHORITY. ALTUS has the corporate right, power and authority to
carry on its business and to execute and deliver this Agreement and to
consummate the transactions contemplated by this Agreement. The execution and
delivery of this Agreement and the consummation of the transactions contemplated
by this Agreement have been duly and validly authorized by all necessary
corporate action on the part of the ALTUS and no other corporate proceedings on
the part of ALTUS are necessary to authorize this Agreement or the consummation
of the transactions contemplated by this Agreement. This Agreement has been duly
and validly executed by ALTUS and constitutes a legal, valid and binding
obligation of ALTOS, enforceable against ALTUS except as limited by applicable
bankruptcy, insolvency, reorganization, moratorium or other laws of general
application affecting enforcement of creditors' rights.
(C) NO CONFLICT. Neither the execution and delivery of this Agreement
nor the consummation of the transactions contemplated hereby will violate, be in
conflict with, constitute a default (or an event which, with notice or lapse of
time or both, would constitute a default) under, result in the termination of,
accelerate or excuse the performance required by any person of any of its
obligations under, cause the acceleration of the maturity of any material amount
of debt or material obligation pursuant to or result in the creation or
imposition of any material encumbrance upon any property of ALTUS under, any
material contract to which ALTUS is a party or by which any of its property is
bound or subject such that any such occurrence will have a material adverse
effect on ALTUS.
(D) FINANCIAL STATEMENTS; UNDISCLOSED LIABILITIES; INDEBTEDNESS.
(I) (i) ALTUS has provided to XXXX copies of the audited balance
sheet of ALTUS for the year ended December 31, 2001 and the related audited
statements of operations, statements of stockholder's equity and statements of
cash flows, together with any related notes thereto, for the year ended December
31, 2001 and (ii) the unaudited balance sheet of ALTUS for the nine months ended
September 30, 2002 (collectively, the "Financial Statements"). Each of the
Financial Statements fairly present in all material respects, as the case may
be, the financial condition, assets and liabilities of
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
ALTUS as of date thereof, or ALTUS' results of operations and changes in ALTUS'
financial position for the period set forth therein. Each of the Financial
Statements was prepared in accordance with U.S. GAAP consistently applied during
the relevant period, except as otherwise set forth in the notes thereto and
subject, in the case of the unaudited Financial Statements, to normal and
recurring year-end adjustments and the omission of footnotes.
(II) As of the date hereof, ALTUS has not incurred any material
liabilities or material obligations of any nature, whether or not accrued,
absolute, contingent or otherwise, other than liabilities adequately provided or
reserved for in the Financial Statements or disclosed in any related notes
thereto.
(III) Since September 30, 2002, there has been no material
adverse change in the business of ALTUS, or any damage or impairment to, or
destruction or loss, sale, assignment, transfer, lapse or encumbrance of any
Licensed Product Patents or Licensed Product Know-How (whether or not covered by
insurance) that could reasonably be expected to have a material adverse effect
on the Agreement or the activities contemplated thereby.
(E) LITIGATION. There is no litigation, arbitration, claim, action,
suit, governmental or other proceeding (formal or informal) to which ALTUS is a
party or to the knowledge of ALTUS, investigation pending or, threatened against
or affecting ALTUS, its business or the Licensed Product Patents or Licensed
Product Know-How that could be expected to have an adverse effect on this
Agreement or the activities contemplated hereby or that could be expected to
affect in an adverse manner the ability of ALTUS to comply in all material
respects with its obligations under this Agreement.
(F) INTELLECTUAL PROPERTY.
(I) TRADEMARKS. Schedule 12.1(f) sets forth as of the date hereof
an accurate, correct and complete list of all United States trademarks,
trademark applications, trademark registrations, brand names, and trade names
owned or licensed by ALTUS that relate to the Licensed Product (the "ALTUS
Trademarks") and no other Person has been granted by ALTUS (or to the best
knowledge of ALTUS, has been granted by any other Person) any rights, or has any
interest, in such. ALTUS owns and possesses all right, title and interest, or
holds a valid license, in and to the ALTUS Trademarks. Except as set forth in
Schedule 12.1(f), no claim has been asserted or, threatened by any Person
regarding the use or licensing by ALTUS of the ALTUS Trademarks. To the best
knowledge of ALTUS, its use of the Trademarks does not violate or infringe, and
has not in the past violated or infringed, in each case in any material manner
the rights of any Person and no material claims have been asserted by ALTUS
against any other Person claiming infringement of its Trademarks.
(II) BASE PATENTS. Exhibit A sets forth as of the Effective Date
an accurate, correct and complete list of patents and patent applications owned
or licensed by ALTUS that constitute Base Patents. To the knowledge of ALTUS,
the Base Patents that are issued are valid and enforceable ALTUS owns and
possesses all right, title and interest, or holds a valid license, in and to the
Base Patents, free of any lien, charge or encumbrance and no other Person has
been granted by ALTUS any rights in such with respect to the Licensed Product in
the Territory. No claim has been asserted threatened by any person regarding the
use or licensing by ALTUS of the Base Patents. To the knowledge of ALTUS, its
use of the Base Patents does not violate or infringe, and has not in the past
violated or infringed the rights of any Third Party, and no claims have been
asserted by ALTUS against any other person claiming infringement of the Base
Patents. As of the Effective Date, ALTUS has no knowledge of any Third Party
patent or patent application that would be expected to have a material adverse
effect on the business and operations to be conducted by either Party as
contemplated by this Agreement; ALTUS is not aware of any Patents or Patent
applications that would prevent the development, use and sale of the Licensed
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
Product as contemplated by this Agreement. Additionally, as of the Effective
Date, ALTUS has not received written notice from any Third Party that
TheraCLEC-Total infringes on any patent or patent application owned by such
Third Party that would have an adverse effect on the operations to be conducted
in the Field in the Territory by the Parties under this Agreement.
(III) ADEQUACY OF RIGHTS. The rights and licenses to the Licensed
Product Patents and Licensed Product Know How that are necessary for the
commercialization of the Licensed Product in the Field in the Territory pursuant
to the terms of this Agreement have been licensed to XXXX pursuant to Sections
8.1 and 9.2 hereunder and the Licensed Patents and the Licensed Product Know-How
include all intellectual property, know how and confidential information in the
possession of ALTUS which is necessary for the commercialization of the Licensed
Product by XXXX under this Agreement. ALTUS has not previously granted, and will
not grant during the term of this Agreement, any right, license or interest that
is in conflict with the rights and licenses granted to XXXX under this
Agreement. There is no action or proceeding nor, so far as ALTUS is aware (due
inquiry having been made), any threat of an action or proceeding that would
materially and adversely affect the rights granted to XXXX herein in respect of
the Licensed Product.
(IV) THIRD PARTY LICENSED IP. All of the patents listed on
Exhibit A that have been licensed to ALTUS have been licensed upon terms
permitting the sublicense to XXXX under the terms of this Agreement and none of
such licenses are capable of termination by either party thereto at any time
during the term of this Agreement. [******************************************
***************************] in accordance with the [**************************
*******************************************************************************
*******************************************] under the terms of [**************
*******************************].
(G) SUBSIDIARIES. Attached on Schedule 12.1(g) is a complete list of
all subsidiaries of ALTUS. Each of the ALTUS Subsidiaries is in good standing
and is qualified to do business in all jurisdictions in which it conducts its
business.
(H) ASSETS. To ALTUS' knowledge, ALTUS owns or has a valid right to
use all material property that is used by ALTUS to conduct its business as
presently conducted except where the failure to own or have a valid right to use
would not have a material adverse effect on the business of ALTUS.
12.2 REPRESENTATIONS AND WARRANTIES OF XXXX. As a material inducement to
ALTUS to enter into this Agreement and to consummate the transactions
contemplated herein, XXXX hereby represents and warrants to ALTUS as follows:
(A) ORGANIZATION. XXXX is a corporation duly incorporated, validly
existing and in good corporate standing under the applicable laws of Germany.
XXXX has full corporate power and authority to own and lease its properties and
carry on its business and is duly qualified, registered or licensed as a foreign
corporation to do business and is in good standing in each jurisdiction in which
the ownership or leasing of its properties or the character of its operations
makes such qualification, registration or licensing necessary except where the
failure to be so qualified, registered or licensed would not have a material
adverse effect on the business of XXXX.
(B) AUTHORITY. XXXX has the corporate right, power and authority to
carry on its business and to execute and deliver this Agreement and to
consummate the transactions contemplated by this Agreement. The execution and
delivery of this Agreement and the consummation of the transactions contemplated
by this Agreement have been duly and validly authorized by all necessary
corporate action
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
on the part of the XXXX and no other corporate proceedings on the part of XXXX
are necessary to authorize this Agreement or the consummation of the
transactions contemplated by this Agreement. This Agreement has been duly and
validly executed by XXXX and constitutes a legal, valid and binding obligation
of XXXX, enforceable against XXXX except as limited by applicable bankruptcy,
insolvency, reorganization, moratorium or other laws of general application
affecting enforcement of creditors' rights.
(C) NO CONFLICT. Neither the execution and delivery of this Agreement
nor the consummation of the transactions contemplated hereby will violate, be in
conflict with, constitute a default (or an event which, with notice or lapse of
time or both, would constitute a default) under, result in the termination of,
accelerate or excuse the performance required by any person of any of its
obligations under, cause the acceleration of the maturity of any material amount
of debt or material obligation pursuant to or result in the creation or
imposition of any material encumbrance upon any property of XXXX under, any
material contract to which XXXX is a party or by which any of its property is
bound or subject such that any such occurrence will have a material adverse
effect on XXXX.
(D) FINANCIAL STATEMENTS; UNDISCLOSED LIABILITIES; INDEBTEDNESS.
(I) XXXX has provided to ALTUS financial information relating to
XXXX'x sales, net profit and EBITDA for the periods specified therein (the
"Financial Information"). The Financial Information was prepared in accordance
with German GAAP and is true and accurate in all material respects.
(II) As of the date hereof, XXXX has not incurred any material
liabilities or material obligations of any nature, whether or not accrued,
absolute, contingent or otherwise, other than liabilities adequately provided or
reserved for in the Financial Statements or disclosed in any related notes
thereto, and XXXX has sufficient cash or cash equivalents on hand to reasonably
be expected to be able to meet all of its financial obligations under this
Agreement.
(III) Since September 30, 2002, there has been no material
adverse change in the business of XXXX, or any damage or impairment to, or
destruction or loss, sale, assignment, transfer, lapse or encumbrance of any
intellectual property of XXXX (whether or not covered by insurance) that could
reasonably be expected to have a material adverse effect on the Agreement or the
activities contemplated thereby.
(E) LITIGATION. There is no litigation, arbitration, claim, action,
suit, governmental or other proceeding (formal or informal) to which XXXX is a
party or investigation pending or, to the knowledge of XXXX, threatened against
or affecting XXXX, its business or its intellectual property that could
reasonably be expected to have a material adverse effect on this Agreement or
the activities contemplated hereby or that could reasonably be expected to
affect in a material adverse manner the ability of XXXX to comply in all
material respects with its obligations under this Agreement.
(F) INTELLECTUAL PROPERTY; TRADEMARKS. Schedule 12.2(f) sets forth as
of the date hereof an accurate, correct and complete list of all trademarks,
trademark applications, trademark registrations, brand names, and trade names
owned or licensed by XXXX that relate to the XXXX Xxxx (the "XXXX Trademarks")
and no other Person has been granted by XXXX (or to the knowledge of XXXX, has
been granted by any other Person) any rights, or has any interest, in such XXXX
Trademarks. XXXX owns and possesses all right, title and interest, or holds a
valid license, in and to the XXXX Trademarks. Except as set forth in Schedule
12.2(f), no claim has been asserted or, to the knowledge of XXXX, threatened by
any person regarding the use or licensing by XXXX of the XXXX Trademarks. To the
knowledge of XXXX, its use of the XXXX Trademarks does not violate or infringe,
and has not in the past violated or infringed, in each case in any material
manner the rights of any person and no material
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
claims have been asserted by XXXX against any other person claiming infringement
of its XXXX Trademarks
(G) SUBSIDIARIES. Attached on Schedule 12.2(g) is a complete list of
all subsidiaries of XXXX. Each of the XXXX Subsidiaries is in good standing and
is qualified to do business in all jurisdictions in which it conducts its
business.
(H) ASSETS. To XXXX'x knowledge, XXXX owns or has a valid right to use
all material property that is used by XXXX to conduct its business as presently
conducted except where the failure to own or have a valid right to use would not
have a material adverse effect on the business of XXXX.
(I) DISTRIBUTION CHANNELS. As of the Effective Date of this Agreement,
XXXX employs direct sales personnel in [******************].
12.3 For purposes of the representations and warranties set forth in
Sections 12.1 and 12.2 above, the knowledge of ALTUS shall mean the knowledge of
the Chief Executive Officer, the Chief Financial Officer and the Director of
Commercial Development of ALTUS, and the knowledge of XXXX shall mean the
knowledge of the Chief Executive Officer, Development Director, and the Chief
Financial Officer of XXXX.
12.4 THE EXPRESS REPRESENTATIONS AND WARRANTIES STATED IN THIS AGREEMENT
ARE IN LIEU OF ALL OTHER REPRESENTATIONS AND WARRANTIES, EXPRESS OR IMPLIED,
INCLUDING WITHOUT LIMITATION, THE WARRANTIES OF MERCHANTABILITY, FITNESS FOR A
PARTICULAR PURPOSE, AND NON-INFRINGEMENT.
12.5 DISCLAIMER. EXCEPT WITH RESPECT TO THE REPRESENTATIONS AND WARRANTIES
RELATING TO INTELLECTUAL PROPERTY SET FORTH IN SECTION 12.1(f)(ii), (iii) and
(iv) ABOVE, NEITHER ALTUS NOR XXXX BE LIABLE FOR SPECIAL, INDIRECT, INCIDENTAL,
OR CONSEQUENTIAL DAMAGES, INCLUDING BUT NOT LIMITED TO LOST PROFITS, ARISING OUT
OF THIS AGREEMENT BASED ON CONTRACT, TORT OR ANY OTHER LEGAL THEORY.
ARTICLE 13.
INFORMATION AND REPORTS
13.1 INFORMATION. XXXX and ALTUS will disclose and make available to each
other in a timely manner all pre-clinical, clinical, regulatory, marketing and
other information concerning the Licensed Product for use in the Field in the
Territory known by XXXX or ALTUS at any time during the Term of this Agreement.
Each Party will use Commercially Reasonable and Diligent Efforts to disclose to
the other Party all significant information directly related to the Licensed
Product promptly after it is learned and its significance is appreciated. ALTUS
shall maintain a database of adverse drug experience information for the
commercial Licensed Product and shall be the owner of such database. As soon as
reasonably practicable after the execution of this Agreement, the Parties will
enter into one or more separate safety and adverse event reporting agreements
that will govern the reporting and other procedures related to adverse drug
experiences under this collaboration between ALTUS and XXXX.
13.2 PRODUCT COMPLAINTS. Each Party will maintain a record of all
non-medical and medical Licensed Product-related complaints and will notify the
other Party of any complaint in a sufficient time to allow the other Party to
comply with any regulatory requirements it may have with respect to such
complaint.
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
13.3 ADVERSE DRUG EVENTS. The Parties recognize that as the holder of a
Drug Approval Application, ALTUS will be required to submit information and file
reports to various governmental agencies on compounds under clinical
investigation, compounds proposed for marketing, or marketed drugs. Information
must be submitted at the time of initial filing for investigational use in
humans and at the time of a request for market approval of a new drug. In
addition, supplemental information must be provided on compounds at periodic
intervals and adverse drug experiences must be reported at more frequent
intervals depending on the severity of the experience. The specific obligations
of each Party with respect to adverse drug experiences will be governed by the
safety and adverse event reporting agreement(s) described in Section 13.1 above.
13.4 RECORDS OF NET SALES. XXXX and its Affiliates shall keep full, true
and accurate books of account containing all particulars that may be necessary
for the purpose of calculating all royalties payable to ALTUS. Such books of
accounts shall be kept at their principal place of business. ALTUS or its
authorized independent public accountant shall have the right to perform an
audit, conducted in accordance with German GAAP, of such books and records of
XXXX and its Affiliates that are necessary to report on Net Sales of the
Licensed Product for the period or periods requested by ALTUS and the
correctness of any report or payments made under this Agreement.
Upon timely request and at least [*****************] prior written notice
from ALTUS, such audit shall be conducted during XXXX'x regular business hours
in such a manner as to not unnecessarily interfere with XXXX'x normal business
activities, and shall be limited to results in the [*******************] prior
to audit notification. Such audit shall not be performed more frequently than
[********************] nor more frequently than [***] with respect to records
covering any specific period of time. All information, data documents and
abstracts herein referred to shall be used only for the purpose of verifying
royalty statements or compliance with this Agreement, shall be treated as XXXX
Confidential Information subject to the obligations of this Agreement and need
neither be retained more than [************] after completion of an audit
hereof, if an audit has been requested; nor more than [*********] from the end
of the calendar year to which each shall pertain; nor more than [***********]
after the date of expiration or termination of this Agreement. If the audit
reveals an underpayment, XXXX shall promptly make up such underpayment with
interest, to the extent permitted by applicable law, with such interest payment
calculated for each month during the delinquent period at the Prime rate
applicable on the last day of such month as reported in the Wall Street Journal
from time to time, plus, at ALTUS' option, an additional [*********], calculated
on the number of days such underpayment amount is overdue. If the audit reveals
that the royalties owed by XXXX to ALTUS for the countries specifically
requested and for any calendar year in total have been understated by more than
[*************], XXXX shall, in addition, pay the reasonable costs of such audit
work. The failure of ALTUS to request verification of any royalty calculation
within the period during which corresponding records must be maintained will be
deemed to be acceptance of the royalty reporting.
13.5 CONTRIBUTION OF INFORMATION. It is the intention of the Parties that
each will disclose to the other Party such information in its possession that is
useful to the development and commercialization of the Licensed Product in the
Field in the Territory.
13.6 PUBLICITY REVIEW.
(A) PRIOR TO FIRST COMMERCIAL SALE. Each of the Parties agree that
prior to the First Commercial Sale of the Licensed Product, neither Party will
issue any announcements, releases, statements or reports, or confirm any
statements made by Third Parties, pertaining to this Agreement or the
transactions contemplated hereby, unless agreed to in writing by the other
party, except as may be required by law or otherwise permitted herein. ALTUS and
XXXX will jointly discuss and must first agree in writing before making any
statement to the public regarding this Agreement and the results of
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
clinical studies conducted hereunder. When a Party elects to make any such
statement it will give the other Party at least five (5) business day's notice,
unless disclosure is required by law in a shorter period of time, and allow the
other Party to review and comment on such statement. The Parties acknowledge the
importance of supporting each other's efforts to publicly disclose results and
significant developments regarding the Licensed Product. The principles to be
observed by ALTUS and XXXX in such public disclosures will be: accuracy, the
requirements for confidentiality under Article 10, the advantage a competitor of
ALTUS or XXXX may gain from any public statements under this Section 13.6, and
the standards and customs in the biotechnology and pharmaceutical industries for
such disclosures by companies comparable to ALTUS and XXXX. The terms of this
Agreement may also be disclosed to (a) government agencies where required by
law, including filings required to be made by law with the Securities and
Exchange Commission, or any national securities exchange or quotation system,
(b) Third Parties with the prior written consent of the other Party, which
consent shall not be unreasonably withheld, and (c) investors and potential
investors, lenders and potential lenders, and any other sources of potential
financing for either Party; provided, however, that in the case of (b) and (c)
above, such disclosure is made under a binder of confidentiality at least as
restrictive as the confidentiality provisions in Section 10.1 above (in the case
of Third Parties), so long as highly sensitive terms and conditions such as
financial terms are extracted from the Agreement or not disclosed upon the
request of the other Party and the disclosing Party gives reasonable advance
notice of the disclosure under the circumstances requiring the disclosure.
(B) AFTER FIRST COMMERCIAL SALE. After the First Commercial Sale of
the Licensed Product, each Party agrees to provide the other Party with at least
48 hours (or sooner if required to comply with applicable law) prior written
notice of any proposed public announcement or press release regarding the
Licensed Product or this Agreement.
ARTICLE 14.
TERM AND TERMINATION
14.1 TERM. This Agreement shall commence as of the Effective Date. The
Parties have specifically provided elsewhere in this Agreement the term during
which certain rights and obligations hereunder shall apply. Unless sooner
terminated as provided in this Article 14, the remaining provisions of this
Agreement relating to activities in the Field in the Territory shall continue in
effect until the date on which ALTUS is no longer entitled to receive a royalty
on the Licensed Product (the "Term"). Upon expiration of this Agreement (other
than by termination by either party), the licenses set forth in Section 8.1
shall be deemed to be [******************] and XXXX shall thereafter be
[***************************] the Licensed Product, either by itself or through
its Affiliates or sublicensees, under the Licensed Product Patents and Licensed
Product Know-how in the Territory [****************] to ALTUS.
14.2 TERMINATION FOR MATERIAL BREACH (OTHER THAN NON-PAYMENT). In the event
there shall have occurred a material adverse breach of this Agreement or a
material adverse default in the observance or performance of any provision of
this Agreement (other than for non-payment of monies due) by a Party (the
"Defaulting Party"), the Party claiming the same (the "Non Defaulting Party")
shall promptly provide detailed notice thereof to the Defaulting Party. The
Defaulting Party shall have [*************] from the date of receipt of such
notice to cure the material adverse breach or material adverse default detailed
in such notice and, if the same is timely cured within such [**********] period
the provisions of this Agreement shall remain in full force and effect. In the
event that the material adverse breach or material adverse default detailed in
such notice (other than on account of nonpayment of monies owed) cannot with due
diligence be cured within such [**********] period and the Defaulting Party
promptly notifies the Non Defaulting Party of the period [*******************]
in which it anticipates that it can be cured, the time to cure such material
adverse breach or material adverse default shall be
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
extended for such period [************************] as may be necessary to cure
the same with all due diligence. This Agreement may be terminated forthwith by
service of notice in writing by the Non Defaulting Party in the event that the
Defaulting Party shall fail to cure such material adverse breach or material
adverse default within such initial or extended period. Upon such termination,
the Parties shall have no further rights or obligations under this Agreement
except as set forth in this Article 14 or as otherwise specifically provided in
this Agreement.
14.3 TERMINATION FOR NON-PAYMENT. If XXXX fails to make any of the payments
required under Section 6.1 (other than those set forth in Sections 6.1(a) and
(b)) and Section 6.2 within [*************] after such payment becomes payable,
or if XXXX fails to reimburse ALTUS for the XXXX Development Costs when due and
such failure is not remedied within [**************] after XXXX'x receipt of
written notice from ALTUS of such breach, or if XXXX fails to make the payments
set forth in either Section 6.1(a) or Section 6.1(b) when due, then ALTUS shall
have the right to terminate this Agreement; provided however that ALTUS shall
not be entitled to terminate the Agreement for XXXX'x failure to make any
payments (other than those set forth in Sections 6.1(a) and (b)) if (i) the
Parties have [***************] as to any event that would trigger such payment
to be made to ALTUS, (ii) either XXXX or ALTUS has initiated the dispute
resolution procedures set forth in Sections 16.1 and 16.2 in order to resolve
such disagreement, and (iii) XXXX has made payment of all such disputed amounts
into an escrow account pending resolution of such disagreement. If XXXX fails to
make royalty payments required under Section 6.4, then such failure shall only
be [*******************] if it relates to at least [*************************]
and such failure is not cured within [**********] of XXXX'x receipt of written
notice of such breach. In no event shall ALTUS be entitled to terminate this
Agreement for a failure of XXXX to make royalty payments if the Parties are in
disagreement as to the exact amount of royalties owed by XXXX to ALTUS, provided
that XXXX shall in this event pay the undisputed amount of royalties to ALTUS
and the disputed part shall be paid by XXXX into an escrow account pending and
subject to the dispute resolution process set forth in Sections 16.1 and 16.2.
For purposes of further clarification, it is hereby further expressly stated
that in the case of underpayment that has been revealed by performing an audit
pursuant to Section 13.4, then ALTUS shall only be entitled to the rights
provided under Section 13.4 and such underpayments shall not be grounds for
termination. The right of a Party to terminate this Agreement under this Section
14.3, shall not be affected in any way by its waiver or failure to take action
with respect to any prior breach or default and shall be without prejudice to
any other rights of the Non Defaulting Party in connection with any such
material adverse breach or material adverse default.
14.4 [RESERVED]
14.5 XXXX TERMINATION.
(A) Upon receipt by XXXX from ALTUS of the [************************
*****************], and for [***********] after receipt of the same, XXXX shall
have the right to terminate this Agreement on [*************] prior written
notice.
(B) In the event the manufacture, use, or sale of the Licensed Product
in the Field in the Territory is found to infringe a valid Third Party patent
and is enjoined by a court or tribunal of competent jurisdiction and neither
XXXX nor ALTUS is able to design around such infringement or negotiate a license
to such patent on commercially reasonable terms after using good faith efforts
to do so, XXXX shall have the right to terminate this Agreement immediately. In
order to terminate this Agreement under this Section 14.5, XXXX shall be
required to satisfy all of the requirements set forth in Sections 14.6(a) and
14.6(c)(i)-(v) below upon such termination, which requirements shall survive
termination of this Agreement.
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
14.6 EFFECT OF TERMINATION.
(A) Termination pursuant to Section 14.2, 14.3, 14.5 or 14.7 shall not
relieve either party of the performance of any obligations incurred or payments
due prior to the effective date of termination which is uncancellable.
(B) Notwithstanding the foregoing and save as provided otherwise in
Section 14.6(d) hereinunder, if this Agreement is terminated pursuant to
Sections 14.2 or 14.3, the following shall apply:
(I) XXXX shall use its [*************] to effect a smooth and
orderly transition of any already on-going clinical studies, Regulatory Approval
or pre-marketing efforts to ALTUS (including all data and reports in the
possession of XXXX);
(II) XXXX shall make its personnel and other resources reasonably
available to ALTUS as necessary to effect an orderly transition of any
development responsibilities, with the reasonable cost of such personnel and
resources to be borne by the defaulting Party after the effective date of
termination;
(III) all rights and licenses granted herein to XXXX shall revert
to ALTUS, for no additional consideration, and immediately terminate, and XXXX
shall assign all right, title and interest in and to the Product Trademark(s)
(worldwide) to ALTUS; and
(IV) XXXX shall provide and assign over to ALTUS, at the
defaulting Party's expense, all clinical data, Drug Approval Applications,
Regulatory Approvals and all other regulatory documentation specifically
relating to the Licensed Product that XXXX may have developed in its activities
under this Agreement.
(C) XXXX shall have the [************************] this Agreement at
any time upon [*************] written notice to ALTUS if there has been a
[********] imposed by a regulatory authority in Germany, United Kingdom or
France for at least [************]; provided, however, that XXXX complies with
the provisions of Section 14.6(b)(i)-(iv) above.
(D) In the event that ALTUS materially breaches its development
obligations under Section 4.1 hereinabove by making insignificant efforts to
satisfy such obligations and XXXX terminates the Agreement pursuant to Section
14.2 above, the following shall apply:
(I) XXXX shall be automatically granted by ALTUS a license to the
Licensed Product Patents and the Licensed Product Know-how to enable XXXX to
manufacture, develop, commercialize, market, sell and distribute the Licensed
Product in the Territory; provided, however, the royalty payable by XXXX to
ALTUS pursuant to Section 6.4 shall be [*******************************] and
XXXX shall have [***********************] pursuant to Sections 6.1 or 6.2 for
events achieved after the date of termination; and
(II) XXXX shall be entitled to continue to use, [***********],
all data and reports which have been generated in the course of the development
and all such data and reports shall be made available by ALTUS to XXXX.
14.7 BANKRUPTCY. Either Party may, in addition to any other remedies
available to it by law or in equity, terminate this Agreement, in whole or in
part as the terminating Party may determine, by written notice to the other
Party in the event the other Party shall have become bankrupt, or shall have
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
made an assignment for the benefit of its creditors or there shall have been
appointed a trustee or receiver of the other Party or for all or a substantial
part of its property or any case or proceeding shall have been commenced or
other action taken by or against the other Party in bankruptcy or seeking
reorganization, liquidation, dissolution, winding-up, arrangement, composition
or readjustment of its debts or any other relief under any bankruptcy,
insolvency, reorganization or other similar act or law of any jurisdiction now
or hereafter in effect and any such event shall have continued for ninety (90)
days undismissed, unbonded and undischarged. All rights and licenses granted
under to this Agreement by one Party to the other Party are, and shall otherwise
be deemed to be, for purposes of Section 365(n) of the Bankruptcy Code, licenses
of rights to "intellectual property" as defined under Section 101 (56) of the
Bankruptcy Code. The Parties agree that the licensing Party under this Agreement
shall retain and may fully exercise all of its rights and elections under the
Bankruptcy Code in the event of a bankruptcy by the other Party. The Parties
further agree that in the event of the commencement of a bankruptcy proceeding
by or against one Party under the Bankruptcy Code, the licensee shall be
entitled to complete access to any such intellectual property pertaining to the
rights granted in the licenses hereunder of the Party by or against whom a
bankruptcy proceeding has been commenced and all embodiments of such
intellectual property.
14.8 SURVIVING RIGHTS. Except as modified in this Article 14, the
obligations and rights of the Parties under Articles 10, 14, 15 and 16, and
Sections 11.1(a), 11.2, 13.4, 13.6 (but only regarding disclosures required by
law), 17.4, 17.5, 17.7, 17.8, 17.9, 17.10 and 17.14 of this Agreement will
survive any termination or expiration of this Agreement.
14.9 ACCRUED RIGHTS, SURVIVING OBLIGATIONS. Except as specifically provided
in this Agreement, termination, relinquishment or expiration of the Agreement
for any reason shall be without prejudice to any rights which shall have accrued
to the benefit of either Party prior to such termination, relinquishment or
expiration, including damages arising from any breach hereunder. Except as
specifically provided, such termination, relinquishment or expiration shall not
relieve either Party from obligations which are expressly indicated to survive
termination or expiration of the Agreement.
ARTICLE 15.
INDEMNIFICATION
15.1 INDEMNIFICATION BY XXXX. XXXX hereby agrees to. save, defend and hold
ALTUS and its agents and employees harmless from and against any and all losses,
damages, liabilities, settlements, penalties, fines, costs and expenses
(including, without limitation, reasonable attorneys' fees and expenses)
(collectively, "Losses") resulting or alleged to result from (i) any breach by
XXXX of any of the representations or warranties set forth in Section 12.2
above, or (ii) any actual or asserted violation of applicable law or regulation
by XXXX, its Affiliates and/or distributors by virtue of which the Licensed
Product advertised, marketed, handled, stored, distributed or sold by XXXX, its
Affiliates and/or distributors shall be alleged or determined to be adulterated,
mislabeled or otherwise not in compliance, in either case except to the extent
such Losses result from the [******************************] of ALTUS or its
employees or agents. This indemnification provision shall include any reasonable
attorney's fees incurred by ALTUS in connection with enforcing this
indemnification.
15.2 INDEMNIFICATION BY ALTUS. ALTUS hereby agrees to save, defend and hold
XXXX and its agents and employees harmless from and against any and all Losses
resulting or alleged to result from (i) any breach by ALTUS of any of the
representations or warranties set forth in Section 12.1 above, or (ii) any
actual or asserted violation of applicable law or regulation by ALTUS or its
Affiliates by virtue of which the Licensed Product manufactured, handled,
stored, distributed or sold by ALTUS or its Affiliates shall be alleged or
determined to be adulterated, mislabeled or otherwise not in compliance, in
either case except to the extent such Losses result from the [****************
***************] of
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
XXXX or its employees or agents. This indemnification provision shall include
any reasonable attorney's fees incurred by XXXX in connection with enforcing
this indemnification.
15.3 INDEMNIFICATION CONDITIONS. In the event that a Party is seeking
indemnification under Section 15.1 or 15.2 above, it shall inform the
indemnifying Party of a claim as soon as reasonably practicable after it
receives notice of the claim, shall permit the indemnifying Party to assume
direction and control of the defense of the claim (including the right to settle
the claim solely for monetary consideration), shall cooperate as requested (at
the expense of the indemnifying Party) in the defense of the claim, and shall
not settle or compromise the claim without the express written consent of the
indemnifying Party.
15.4 INSURANCE. Each Party agrees to maintain [*******] insurance coverage
with respect to all occurrences arising out of human clinical trials with
respect to the Licensed Product and all occurrences arising out of the sale of
the Licensed Product pursuant to this Agreement. Each Party shall furnish the
other Party with a copy of such insurance policies.
ARTICLE 16.
DISPUTE RESOLUTION
16.1 DISPUTES. The Parties recognize that disputes as to certain matters
may from time to time arise during the Term of this Agreement which relate to
either Party's rights and/or obligations hereunder. It is the objective of the
Parties to establish procedures to facilitate the resolution of disputes arising
under this Agreement in an expedient manner by mutual cooperation and without
resort to litigation. To accomplish this objective, the Parties agree to follow
the procedures set forth in this Article 16 if and when a dispute arises under
this Agreement.
Unless otherwise specifically recited in this Agreement, disputes among the
Parties relating to material business, scientific or management issues arising
out of this Agreement (other than issues for which either Party has sole and
exclusive responsibility and control under this Agreement) shall first be
presented to the [*****************] for resolution. If a majority of the
members of the [*******************] cannot agree on a resolution to the issue
within [****************] of being requested by a Party to resolve a dispute,
such dispute shall be presented to the [*************] of XXXX and of ALTUS, or
their respective designee, for resolution. In the event that the chief executive
officer of XXXX and ALTUS, or their respective designees, cannot resolve the
dispute within [*****************] of being requested by a Party to resolve a
dispute then the following shall apply: In the event the dispute directly or
indirectly relates to the clinical development of the Licensed Product, ALTUS
shall have [*************************] with respect to such clinical
development issues, notwithstanding anything in this Agreement to the contrary;
provided, however, any such decisions shall be based on [*********************]
that such decision is consistent with the objective of managing an effective and
efficient Combined Phase III Clinical Trial that satisfies the development,
regulatory and commercialization requirements of North America and the Territory
and leverages the clinical development activities in both territories. If the
dispute does not relate to the clinical development of the Licensed Product,
either Party may, by written notice to the other, invoke the provisions of
Section 16.2 hereinafter.
16.2 ARBITRATION. The Parties agree that any dispute, controversy or claim
arising out of or relating to this Agreement, or the breach, termination,
performance or invalidity thereof, other than disputes relating to the clinical
development of the Licensed Product, that cannot be resolved pursuant to Section
16.1 above shall be resolved through binding arbitration in accordance with the
Commercial Arbitration Rules of the American Arbitration Association ("AAA"),
except as modified herein. Each such arbitration shall be conducted before a
penal of three independent experts with relevant business, financial, scientific
or other experience based on the subject matter of the dispute. Each Party shall
select
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
one arbitrator and the arbitrators so elected shall appoint the third
arbitrator. In the event the arbitrators elected by the Parties cannot agree on
the third arbitrator, an arbitrator with the aforementioned qualifications shall
be selected by the AAA in accordance with the procedures set forth by the
Commercial Arbitration Rules of the AAA. A reasoned arbitration decision shall
be rendered in writing within thirty (30) days of the conclusion of the
arbitration hearing and shall be binding and not be appealable to any court in
any jurisdiction. The prevailing Party may enter such decision in any court
having competent jurisdiction. Each Party must bear its own attorney's fees and
associated costs and expenses. The arbitrators shall have the authority to grant
specific performance and shall allocate costs between the Parties (excluding
attorney's fees). Any such arbitration shall be held in Boston, Massachusetts.
Nothing in this Article 16.2 shall be construed to limit or preclude a Party
from bringing an action in any court of competent jurisdiction for injunctive or
other equitable relief including an action for specific Performance to compel
the other Party to perform its obligations under this Agreement.
ARTICLE 17.
MISCELLANEOUS
17.1 ASSIGNMENT. This Agreement may not be assigned by either Party without
the consent of the other, except that each Party may, without such consent,
assign this Agreement and the rights, obligations and interests of such Party,
in whole or in part, to any of its Affiliates, wholly-owned subsidiaries, to any
[***************************************************] to which this Agreement
pertains, or of all of its [************], or to any [******************]
resulting from any [******************] of such Party with or into such
corporation (collectively a [***********]) where such [***********] to a Party
could reasonably be expected to satisfy that Party's obligations hereunder,
provided, however, that in the case of an assignment to an Affiliate or a
subsidiary, the assigning Party shall remain fully responsible for all of its
obligations hereunder. This Agreement shall be binding upon and inure to the
benefit of the successors and permitted assigns of the Parties. Any attempt to
assign any portion of this Agreement in violation of this Section 17.1 shall be
void. Subject to the foregoing, any references to ALTUS and XXXX hereunder shall
be deemed to include the successors and permitted assigns thereof.
17.2 LEGAL COMPLIANCE. Each Party shall comply in all material respects
with all laws, rules and regulations applicable to the conduct of its business
pursuant to this Agreement.
17.3 FORCE MAJEURE. Neither Party shall lose any rights hereunder or be
liable to the other Party for damages or losses on account of failure of
performance by the defaulting Party if the failure is occasioned by government
action, war, terrorism, fire, explosion, flood, strike, lockout, embargo, act of
God, or any other cause beyond the control and without the fault or negligence
of the defaulting Party, provided that the Party claiming force majeure has
exerted all reasonable efforts to avoid or remedy such force majeure; provided,
however, that in no event shall a Party be required to settle any labor dispute
or disturbance. Such excuse shall continue as long as the condition preventing
the performance continues. Upon cessation of such condition, the affected Party
shall promptly resume performance hereunder. Each Party agrees to give the other
Party prompt written notice of the occurrence of any such condition, the nature
thereof, and the extent to which the affected Party will be unable to perform
its obligations hereunder. Each Party further agrees to use all reasonable
efforts to correct the condition as quickly as possible and to give the other
Party prompt written notice when it is again fully able to perform its
obligations.
17.4 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.
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
17.5 NO RIGHT TO USE NAMES. Except as otherwise provided herein, no right,
express or implied, is granted by either Party to the other to use in any manner
the name "ALTUS," "XXXX," "TheraCLEC," "ThereCLEC-Total," the "ALTUS" logo, the
"Xx. XXXX" logo, or any other trade name or trademark of ALTUS, XXXX or their
Affiliates in connection with the performance of the Agreement.
17.6 Notices. All notices hereunder shall. be in writing and shall be
deemed given if delivered personally or by registered or certified mail (return
receipt requested), postage prepaid, or sent by express courier service with
tracking service, to the Parties at the following addresses (or at such other
address for a Party as shall be specified by like notice; provided, that notices
of a change of address shall be effective only upon receipt thereof).
IF TO ALTUS TO: ALTUS BIOLOGICS INC.
000 Xxxxxx Xxxxxx
Xxxxxxxxx, XX. 00000
Attention: Xxxxxxx Xxxxxxx, Esq.
Corporate Counsel
Telecopy: 000-000-0000
WITH A COPY TO: XXXXX XXXXX XXXX XXXXXX XXXXXXX AND XXXXX, P.C.
000 Xxxxx Xxxxxx Xxx Xxxx, XX 00000
Attention: Xxxxxxx X. Xxxxxxx, Esq.
Telecopy: 212-983-3115
IF TO XXXX TO: XX. XXXX PHARMA GMBH
Xxxxxxxxxxxxxxxxxx 0
Xxxxxxxx 0000
00000 Xxxxxxxx
Xxxxxxx
Attention: Xxxxxx Xxxx, Managing Director
Telecopy: + 49-761-1514-356
WITH A COPY TO: HENNERKES, XXXXXXXXXXX & XXXX
(Attorneys at Law) Xxxxxxxxxx 00
X - 00000 Xxxxxxxxx
Attention: Xx. Xxxxxx Xxxx
Telecopy: + 00-000-00 57 920
17.7 WAIVER. Except as specifically provided for herein, the waiver from
time to time by either of the Parties of any of their rights or their failure to
exercise any remedy shall not operate or be construed as a continuing waiver of
same or of any other of such Party's rights or remedies provided in this
Agreement.
17.8 SEVERABILITY. If any term, covenant or condition of this Agreement or
the application thereof to any Party or circumstance shall, to any extent, be
held to be invalid or unenforceable, then (a) the remainder of this Agreement,
or the application of such term, covenant or condition to Parties or
circumstances other than those as to which it is held invalid or unenforceable,
shall not be affected thereby and each term, covenant or condition of this
Agreement shall be valid and be enforced to the fullest extent permitted by law;
and (b) the Parties hereto covenant and agree to renegotiate any such term,
covenant or application thereof in good faith in order to provide a reasonably
acceptable alternative to the term, covenant or condition of this Agreement or
the application thereof that is invalid or
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
unenforceable, it being the intent of the Parties that the basic purposes of
this Agreement are to be effectuated.
17.9 GOVERNING LAW. This Agreement shall be governed by and construed in
accordance with the laws of the Commonwealth of Massachusetts.
17.10 AMBIGUITIES. 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.
17.11 HEADINGS. All headings are for reference purposes only and shall not
in any way affect the meaning or interpretation of this Agreement.
17.12 COUNTERPARTS. This Agreement may be executed in two (2) or more
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.
17.13 ENTIRE AGREEMENT. This Agreement, including all Exhibits attached
hereto, which are hereby incorporated herein by reference, sets forth all the
covenants, promises, agreements, warranties, representations, conditions and
understandings between the Parties hereto with respect to the subject matter
hereof and supersedes and terminates all prior agreements and understandings
between the Parties. There are no covenants, promises, agreements, warranties,
representations, conditions or understandings, either oral or written, between
the Parties with respect to the subject matter hereof other than as set forth
herein. No subsequent alteration, amendment, change or addition to this
Agreement shall be binding upon the Parties hereto unless reduced to writing and
signed by the respective authorized officers of the Parties.
17.14 NO THIRD PARTY BENEFICIARY. Except as expressly provided herein, this
Agreement shall not confer any rights or remedies upon any Third Party other
than the Parties and their respective successors and permitted assigns.
[This space is intentionally left blank.]
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
IN WITNESS WHEREOF, the Parties have executed this Agreement in duplicate
originals by their proper officers as of the date and year first above written.
ALTUS BIOLOGICS, INC. XX. XXXX PHAMA GMBH
By: /s/ Xxxxx Xxxxxxxx By: /s/ Xxxxxx Xxxx
--------------------------------- ------------------------------------
Name: Xxxxx Xxxxxxxx Name: Xxxxxx Xxxx
Title: President & CEO Title: General director
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
EXHIBIT A
LICENSED PRODUCT PATENTS
APPENDIX 1
COUNTY SERIAL NO. FILING DATE STATUS PATENT NO. EXPIRES ASSIGNEE
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PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT.
COUNTY SERIAL NO. FILING DATE STATUS PATENT NO. EXPIRES ASSIGNEE
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PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT.
COUNTY SERIAL NO. FILING DATE STATUS PATENT NO. EXPIRES ASSIGNEE
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PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT.
Exhibit B
Development Plan
The purpose of this Development Plan (Plan) is to provide guidance on how
to define, organize and execute an effective path by which Altus and Xxxx will
effectively achieve the development and commercialization of the
TheraCLEC(TM)-Total Product. This Plan will be used to understand the role of
Xxxx and Altus' management systems and to begin to discuss the format and
contents of the Program along with the roles and responsibilities of both
parties. The central themes of the Plan will include those elements that are
critical to effective decision making and maximizing the long-term value of
TheraCLEC(TM)-Total in the European Union.
The Plan should be used by both Xxxx and Altus as a mechanism for
effective communication and creating a clear understanding of each parties
responsibilities. The Plan will capture, in a single place, timely information
currently found across many independent documents. The contents, style and
format of the Plan will evolve through the Steering Committee meetings. The
current estimated clinical timelines, non-clinical costs, formulation costs, and
Phase la and lb study synopsis and process development plans are outlined in
Appendix 2. Updates to the Plan are expected to be coordinated with major
milestones (e.g., Phase I, Phase II, Phase III clinical studies completion,
etc.). Additional updates may also be synchronized with the cycle of the
Steering Committee Team meetings. The Plan should have sections to present the
essential elements of each major functional area's implementation strategy. The
Plan should not be considered to be complete currently, but instead serve as a
template for effective communication and planning.
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT.
Phase I -
Xxxx Responsibilities -
Xxxx shall be responsible for providing input into the development of the Phase
II clinical study protocol to ensure that the study design and regulatory
aspects will be consistent with the European regulatory needs. Xxxx shall
cooperate in good faith with Altus' request to support the regulatory process
[***].
Altus Responsibilities -
Altus will be responsible for managing [***] the Phase I clinical trials. Altus
will have responsibility for control and development including but not limited
to formulating overall development plans, managing pre-clinical and non-clinical
activities, making overall decisions regarding the priority and design of all
clinical studies, managing the clinical team activities, management of
regulatory activity, determination of priority with respect to seeking
regulatory approvals. Altus will ensure that the clinical studies and data
conform to the International Committee on Harmonization (ICH) Guidelines to
enable the data to be transferable to a European Dossier submission. Altus will
also be responsible for all non-clinical product development aspects required by
the US Food and Drug Administration (FDA) and to ensure that these aspects will
be applicable to the European Dossier. Altus shall be responsible for the scale
up and manufacturing of the finished product for the clinical trials, and shall
provide Xxxx with the current product profile and a Target Product Profile.
Altus shall be responsible for managing formulation development and market
research for both the solid and liquid dosage forms and will seek input from the
Steering Committee on development issues that pertain to formulation
development, as appropriate. Altus shall be responsible for data collection of
non-clinical studies, and shall provide all relevant data to Xxxx. Altus shall
be responsible for filing the Orphan Drug Application and coordinating the
approval process with the EMEA Committee for Orphan Medicinal Products. Altus
shall be responsible for conducting all meetings, discussions, and routine
telephone communications, with the FDA, the EMEA, or other regulatory authority
related to clinical studies for all indications for TheraCLEC(TM)-Total. Altus
will look to involve Xxxx in such communication and both parties will keep the
Steering Committee Team apprised of all material communications with regulatory
authorities.
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT.
Post - Phase I -
Mutual Responsibilities -
Through the Steering Committee both companies will identify an integration
process for the clinical and regulatory programs. Xxxx and Altus will use all
resources to identify potential study investigators and thought leaders, for
their participation in development meetings. Altus will begin the process for
collaboration between Altus, Xxxx and the European Agency for the Evaluation of
Medicinal Products. Altus and Xxxx will work together to identify a publication
plan strategy. Altus will be responsible for all submission of data to
regulatory authorities and peer-reviewed journals but will work with Xxxx to
identify key participants for each Territory. Altus and Xxxx will work to
evaluate and understand TheraCLEC(TM)-Total's key product audience, current and
future competitors, and the promotional environment. These activities will
assist in and provide the necessary information for [***] This analysis should
include an evaluation of [***]. Both companies will collaborate to develop and
share through the Steering Committee an effective Marketing/Business plan for
their respective Territories, that will include: a [***].
Xxxx Responsibilities --
Xxxx shall work to identify potential clinical trial investigators and also to
develop a plan for [***]. Xxxx shall work through the Steering Committee
meetings to produce a Target Product Profile (to include a technical profile,
clinical profile and items related to pharmaceutical form). Since [***] for the
success of the clinical studies, [***] - Xxxx shall manage the [***] program
process to [***]clinical development and market acceptance.
Altus Responsibilities --
Altus will be responsible for managing [***] the Phase II clinical trials. Altus
will coordinate, as necessary, collaborative meetings between Altus, Xxxx and
the EMEA Committee for Orphan Medicinal Products. Altus shall provide Xxxx with
a list of key thoughts leaders from North America with whom it is coordinating
the clinical development program. Altus shall use best efforts to make all
necessary individuals available for program updates. Altus will continue
development work on [***]for both the Phase III clinical studies and
commercialization. Altus will be responsible for designing, managing [***] Phase
II dose ranging studies for both the solid and liquid formulations. These Phase
II studies will be compliant with the relevant ICH guidelines.
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT.
Phase II -
Mutual Responsibilities -
Xxxx will work with Altus to identify the necessary Contract Research
Organization (s) (CRO's) that will be used to conduct the Phase III clinical
studies. Xxxx will be responsible for collection, management and execution of EU
regulatory documentation and work closely with Altus in the control and
execution of such documentation. Xxxx will work with Altus to identify [***].
Xxxx and Altus shall work to develop a [***].
Xxxx Responsibilities -
Xxxx shall continue to identify target clinical sites and primary investigators
for the Phase III clinical study. Xxxx shall also provide the necessary
regulatory, medical, clinical, patient and logistical support for the
advancement of the program into Phase III study leading to a successful European
Dossier. Xxxx shall propose its initial recommended [***] strategy.
Altus Responsibilities -
Altus will be responsible for designing, coordinating [***] Phase III studies
for [***]. Altus will continue development work on [***] for both the Phase III
clinical studies and commercialization. These Phase III studies will be
compliant with the relevant ICH guidelines. Altus shall [***].
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT.
Post - Phase II -
Mutual Responsibilities -
Altus and Xxxx shall use their best efforts to update each other on all market
research, relevant marketing plans, training programs and promotional efforts
during Steering Committee meetings. Using the data generated during the previous
phase, both companies will update the Target Product Profile. Both companies
will plan to develop an integrated market research and thought leader
development program. To more effectively plan a targeted clinical program Xxxx
and Altus shall provide an assessment of [***] for each of the respective
Territories and discuss their findings with the Steering Committee to enable the
design of a targeted [***] clinical program. Altus will work with Xxxx (and
outside investigators) to design [***] Phase III clinical protocol, which [***].
Altus will ultimately be responsible to ensure that this protocol will be
compliant with ICH guidelines. Both companies shall look to identify [***]. Both
companies shall provide updates for [***] and strategy for post-Phase III. Xxxx
and Altus will work to identify companies with potential packaging capabilities
for the European Union. Xxxx and Altus will also work to develop a clinical
trial materials forecast for the Phase III/IIIb trial. Xxxx and Altus shall
identify a shipping mechanism for clinical sites in the European Union. Both
parties shall develop an effective planning mechanism to best manage [***] Phase
III clinical studies. The mechanism shall incorporate a relevant and timely
centralized procedure for accumulating necessary clinical and regulatory
information.
Xxxx Responsibilities -
Xxxx shall work to integrate all regulatory issues concerning clinical studies
and packaging vendors into the overall regulatory plan. Xxxx shall update the
marketing plan and [***]. Xxxx will update the thought leader development plan
as needed. [***] using the results of the investigation should be made for the
clinical and commercial phases of TheraCLEC(TM)-Total. Xxxx shall be responsible
for recruitment of participating investigators, sites and patients.
Altus Responsibilities -
Altus shall update Xxxx during Steering Committee meetings on all relevant
clinical, non-clinical and marketing activities and data. Altus will plan [***]
to help develop the necessary information for the clinical and commercial
programs. Altus will conduct an ICH compliant Phase III trial in North America
and develop material supply to ensure that sufficient material can be provided
for the Phase III study. Altus shall establish market research as it relates to
[***]. Altus shall submit to the appropriate [***]. Altus will continue
development work on the solid and liquid dosage forms for both the Phase III
clinical studies and commercialization.
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT.
Phase III -
Mutual Responsibilities
Xxxx and Altus will be responsible for coordinating and managing activities of
the CROs and clinical sites. Altus and Xxxx shall use their best efforts to
provide updates on all market research, relevant marketing plans, training
programs and promotional efforts during Steering Committee meetings. Xxxx and
Altus will work to more effectively define a Phase IIIb clinical study. Altus
and Xxxx will work to identify and carry out a strategy for regulatory meetings
to facilitate the EMEA approval process. Xxxx and Altus shall work to coordinate
an [***] as it becomes necessary. Both companies shall update their marketing
plans and coordinate logistics for an effective [***]. Altus and Xxxx shall
provide updates on the marketing plans to the Steering Committees for review.
Altus and Xxxx shall manage the Phase III regulatory documentation and provide
updates as available on the progress of the study. Xxxx and Altus will work to
begin the writing and submission planning of the European Dossier.
Xxxx Responsibilities -
Xxxx should complete the selection of a [***] so that all necessary regulatory
requirements can be addressed and they may enter into an agreement with a [***]
at this time. Xxxx shall provide updated forecasts on clinical material
requirements. Xxxx shall continue to update the thought leader base. Xxxx shall
submit a detailed annual plan for the commercialization of TheraCLEC(TM)-Total
to the Steering Committee. Based on [***] and trademark filings, Xxxx shall
obtain trademark approval for the Product trademark.
Xxxx shall be responsible for [***] of the Phase III study through the Phase III
program committee. Xxxx'x support of the studies shall include, but not be
limited to CRO [***].
Altus Responsibilities -
Altus shall update Xxxx during Steering Committee meetings on all non-clinical
protocols and activities. Altus shall be responsible for establishing a
commercial manufacturing process for - and supply of - TheraCLEC(TM)-Total. The
manufacturing process shall be [***] required to meet the [***]
TheraCLEC(TM)-Total in [***]. Altus may choose to establish [***]. Altus shall
be responsible for managing the European portion of the Phase III study through
a Phase III Program Committee to be established by the Steering Committee. Altus
responsibilities shall include, but not limited to protocol and CRO management,
physician and patient reimbursement, physician and patient care, data
collection, statistical support, coordination of clinical team activity and
coordination of regulatory activities. Altus shall be responsible for the
manufacture and testing of clinical material supply compliant with ICH
Guidelines.
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT.
Post - Phase III --
Mutual Responsibilities -
Xxxx will work with Altus to complete the writing and submission of the European
Dossier. Altus and Xxxx shall use their best efforts to provide updates on all
market research, relevant marketing plans, training programs and promotional
efforts during Steering Committee meetings. Using the data generated during the
previous phase, both companies should update the Target Product Profile. Altus
and Xxxx shall provide each other 3 copies of each marketing, promotional and
training piece, and shall establish a mechanism by which a [***] is established
that can serve as an effective mechanism for promotional material efforts. Xxxx
will work with Altus to determine the [***]. Both companies shall determine how
[***]. Xxxx and Altus shall provide the Steering Committee a pre-launch and
launch plan so that both companies can integrate data and resources.
Xxxx Responsibilities -
Xxxx shall complete and enter into an agreement with a [***]. Xxxx shall
finalize [***] that it plans on seeking through the regulatory authorities. Xxxx
shall coordinate country-to-country regulatory, distribution and [***]
requirements. Near, mid and long term forecasts for the commercial phase of
TheraCLEC(TM)-Total shall be made using the results of the Phase III
investigation. A [***] should be provided that is updated on a [***] basis. Xxxx
will maintain a record of all non-medical and medical related complaints and
will notify Altus of any complaint in a sufficient time to allow Altus to comply
with any regulatory requirements it may have with respect to such complaints.
Xxxx shall have responsibility for the commercialization and marketing of
TheraCLEC(TM)-Total in Europe. The responsibilities include but not limited to
handling, packaging and shipment of commercial product, designing and
implementing all product launch, promotion, marketing and sales activities,
booking sales, handling all returns, handling all aspects of order processing,
[***] receivables, providing customer medical information, collection of data of
sales to hospitals and other end users, distribution, inventory, and
warehousing. Consistent with regulatory requirements Xxxx will be responsible
for paying all packaging, distribution, sales and marketing, and collection
costs for TheraCLEC(TM)-Total. Xxxx may be asked to perform [***] post-marketing
commitments necessary for approval. Xxxx shall keep books of accounts containing
all particulars that may be necessary for the purpose of calculating royalties
payable to Altus. For the first [***] months after launch Xxxx shall provide
[***] sales updates.
Altus Responsibilities -
Altus shall make all data available to Xxxx for reference and launch preparation
activities in the Territory. Altus shall update Xxxx during Steering Committee
meetings on all clinical, non-clinical and marketing activities. Altus will
maintain a record of all non-medical and medical related complaints and will
notify Xxxx of any relevant complaint in a sufficient time to allow Xxxx to
comply with any regulatory requirements. Altus will plan [***] to help develop
necessary information for the clinical and commercial programs. Altus shall be
required to develop a [***]. Based on regulatory requirements Altus may be asked
to perform [***] commitments necessary for approval. As soon as practicable
after completion of the Phase III clinical study, Altus will enter into a [***]
of commercial supplies of TheraCLEC(TM)-Total for use in the Field in the
Territory. Altus shall also ensure that a second source exists for the
manufacture and supply of TheraCLEC.
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT.
APPENDIX 2 -- ESTIMATED DEVELOPMENT PLAN
A. ESTIMATED CLINICAL TIMELINE (OCTOBER 25, 2002)
START FINISH
----- ------
PHASE 1a TESTING
[***] [***] [***]
[***] [***] [***]
PHASE 1b STUDY
[***] [***] [***]
[***] [***] [***]
[***] [***] [***]
PHASE II STUDY -CAPSULE TESTING
[***] [***] [***]
[***] [***] [***]
PHASE II STUDY - LIQUID
[***] [***] [***]
[***] [***] [***]
PHASE III STUDY -TABLET [***] [***]
PHASE IV STUDY - TABLET [***] [***]
PHASE III STUDY - LIQUID [***] [***]
PHASE III STUDY - LIQUID [***] [***]
REGULATORY
[***] [***] [***]
[***] [***] [***]
[***] [***] [***]
[***] [***] [***]
[***] [***] [***]
[***] [***] [***]
[***] [***] [***]
B. NON-CLINICAL STUDY COST ESTIMATES (OCTOBER 25, 2002)
NONCLINICAL STUDIES
[***] [***] [***] [***]
[***] [***] [***] [***]
[***] [***] [***] [***]
[***] [***] [***] [***]
[***] [***] [***] [***]
[***] [***] [***] [***]
[***] [***] [***] [***]
[***] [***] [***] [***]
[***] [***] [***] [***]
TOTAL NONCLINICAL STUDIES [***]
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT.
C. ESTIMATED FORMULATION DEVELOPMENT / CLINICAL TRIAL MATERIAL
DEVELOPMENT COSTS (OCTOBER 25, 2002)
FORMULATION DEVELOPMENT/CLINICAL TRIAL MATERIAL
[***] $ [***]
[***] $ [***]
[***] $ [***]
[***] $ [***]
[***] $ [***]
[***] $ [***]
TOTAL FORMULATION DEVELOPMENT/CLINICAL TRIAL MATERIAL $ [***]
-------
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT.
D. PROTOCOL SYNOPSIS PHASE 1a
TITLE Open-Label Safety and Tolerability Study of Oral TheraCLEC(TM)-Total in Health
Volunteers
PHASE 1
INDICATION [***]
OBJECTIVE [***]
STUDY DESIGN [***]
NUMBER AND DESCRIPTION OF SUBJECTS [***]
SUBJECT CRITERIA [***]
EXCLUSION CRITERIA [***]
LENGTH OF STUDY [***]
INVESTIGATIONAL PRODUCT - [***] [***] [***] [***] [***] [***]
Medication Strength [***] [***] [***] [***] [***]
[***] [***] [***] [***] [***]
Route
Dose Levels
Regimen
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT.
EVALUATIONS - [***]
SCREENING
- [***]
- [***]
- [***]
- [***]
- [***]
- [***]
BASELINE ([***]) - [***]
ENROLLMENT ([***]) - [***]
TREATMENT PHASE - [***]
([***]) - [***]
[***]
[***]
[***] ([***]) [***]
[***] - [***]
([***])
STATISTICAL EVALUATIONS
SAFETY [***]
E. PROTOCOL SYNOPSIS PHASE 1b
TITLE [***]
INDICATION [***]
OBJECTIVES PRIMARY:
- [***]
SECONDARY:
- [***]
- [***]
- [***]
- [***]
STUDY DESIGN [***]
DRUG DOSAGE [***]
[***]
[***]
[***]
[***]
SAMPLE SIZE [***]
SUBJECT SELECTION [***]
OUTCOMES [***]
[***]
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT.
F. ESTIMATED YEARLY CLINICAL DEVELOPMENT COSTS (OCTOBER 25, 2002)
2002 2003 2004 2005 2006 2007
---- ---- ---- ---- ---- ----
PHASE 1A STUDY [***]
PHASE 1B STUDY [***] [***]
PHASE II STUDY-CAPSULE [***] [***]
PHASE II STUDY- LIQUID [***] [***]
PHASE III STUDY- TABLET [***] [***] [***]
PHASE IV STUDY- TABLET [***] [***]
PHASE III STUDY- LIQUID [***] [***] [***]
PHASE IV STUDY- LIQUID [***] [***]
TOTAL [***] [***] [***] [***] [***] [***]
G. PROCESS DEVELOPMENT PLAN (OCTOBER 25, 2002)
[***]
[***] [***] [***] [***]
[***]
[***] [***] [***] [***] [***]
DOCUMENTATION
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT.
EXHIBIT C
DEVELOPMENT COSTS AND PRODUCT LAUNCH COSTS
C.1 XXXX DEVELOPMENT COSTS.
XXXX shall be responsible for paying all XXXX Development Costs. "XXXX
Development Costs" shall mean all Direct Costs (as defined below), and [***] of
all Indirect Costs (as defined below), incurred after the Effective Date of the
Agreement through the date of expiration or termination hereof. For the purposes
hereof, [***] shall mean [***] costs, fees and expenses incurred by ALTUS or
XXXX that are primarily related to (x) the portion [***] include, but are not
limited to, the costs, fees and expenses associated with [***] [***] shall mean
[***] costs, fees and expenses (including the European and non-European Portion
of such costs, fees and expenses) by ALTUS or XXXX (other than Direct Costs)
related to [***] Notwithstanding the foregoing, the Parties agree that Direct
Costs and Indirect Costs shall [***] The Steering Committee shall have the
authority to determine whether particular costs, fees and expenses are to be
considered Direct Costs or Indirect Costs for the purposes of this Agreement.
The Clinical Supplies supplied by ALTUS to XXXX for use in the development of
the Licensed Product, shall be charged [***] Notwithstanding the foregoing, to
the extent that more than [***] of the participants enrolled in a [***] are
European participants (the number of European participants in [***]being
hereafter referred to as the [***] shall be responsible for [***] to the extent
such [***] would not have been [***] but for the fact that such [***] were
included in the [***] Notwithstanding the foregoing, to the extent that more
than [***] of the participants enrolled in a[***] are participants in the
non-European portion of [***] (the number of non-European participants in [***]
being hereafter referred to as the [***] shall be responsible for [***] to the
extent such [***] would have been included in [***] but for the fact that such
[***] were included in the [***] C.2 XXXX MARKETING COSTS.
XXXX shall be responsible for paying [***]. "XXXX Marketing Costs" shall
mean all [***].
In addition, XXXX, through the Xxxx Foundation e.V., shall organize [***].
C.3 ALTUS DEVELOPMENT COSTS.
ALTUS shall be responsible for paying all ALTUS Development Costs. "ALTUS
Development Costs" shall mean all direct and indirect costs attributable to the
following activities with respect to the Licensed Product in the Field in the
Territory incurred after the Effective Date of the Agreement but before the date
of expiration or termination of the Agreement:
(i) [***];
(ii) [***];
(iii) [***];
(iv) [***];
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT.
(v) [***];
(vi) [***];
(vii) [***]; and
(vii) [***].
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT.
EXHIBIT D
INITIAL STEERING COMMITTEE MEMBERS/GENERAL MANAGERS
ALTUS
1. [***]
2. [***]
3. [***]
XXXX
1. (General Manager)
2.
3.
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT.
APPENDIX 1
TERRITORY
1. EUROPE 2. EUROPE (CONTINUED)
Andorra
Albania Russia (including CIS countries)
Austria Armenia
Belgium Aserbaidschan
Bosnia-Herzegovina Belarus
Bulgaria Georgia
Croatia Kazakhstan
Cyprus Kirgisistan
Czech Republic Moldova
Denmark Russian Federation
Estonia Tadschikistan
Finland Turkmenistan
France Ukraina
Germany Uzbekistan
Xxxxxxxxx Xxxxxx Xxxxxxxx
Xxxxxx Xxxxxxxx
Xxxxxxx Xxxxx
Ireland Sweden
Iceland Switzerland
Italy Turkey
Latvia United Kingdom
Liechtenstein Republic of Yugoslavia
Lithuania
Luzembourg
Republic of Macedonia
Malta
Monaco 2. MIDDLE EAST
Netherlands Egypt
North Ireland Israel
Norway
Poland
Portugal
Romania
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT.
Schedule 8.2
Vertex Pharmaceuticals Incorporated
000 Xxxxxxx Xxxxxx
Xxxxxxxxx, XX 00000
December ___, 2002
Xx. Xxxx Pharma GmbH
Xxxxxxxxxxxxxxx(xxxx)x 0
00000 Xxxxxxxx Xxxxxxx
Ladies and Gentlemen:
Reference is made to that certain Development, Commercialization and
Marketing Agreement between Altus Biologics Inc., a Delaware corporation
("Altus"), and Xx. Xxxx Pharma GmbH a German corporation ("Xxxx"), of even date
herewith, a copy of which is attached hereto as Exhibit A (the
"Commercialization Agreement"), and to that certain Technology License Agreement
between Vertex Pharmaceuticals Incorporated, a Massachusetts corporation
("Vertex"), and Altus, dated as of February 1, 1999 (the "License Agreement").
The Commercialization Agreement as referenced in this letter shall refer to the
terms of the agreement set forth on Exhibit A, and not to any other terms
contained in any future alterations or amendments of that Agreement.
Vertex hereby agrees [***].
This Agreement shall be interpreted under the laws of the Commonwealth of
Massachusetts applicable to contracts performed therein. This Agreement sets
forth the entire understanding between the parties and supersedes any prior
agreements or understandings, whether written or oral, and may not be modified
except in writing, signed by both Vertex and Xxxx.
Sincerely yours,
VERTEX PHARMACEUTICALS
INCORPORATED, a Massachusetts
corporation
By:_______________________________
Its:______________________________
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT.
Agreed and Accepted,
XXXX:
XX. XXXX PHARMA GMBH, a German
corporation
By:_____________________________
Its:____________________________
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT.
