Exhibit 10.14
EXECUTION COPY
STRATEGIC ALLIANCE AGREEMENT
Dated as of February 22, 2001
by and between
ALTUS BIOLOGICS INC.
and
CYSTIC FIBROSIS FOUNDATION THERAPEUTICS, INC.
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
TABLE OF CONTENTS
Page
----
ARTICLE I. DEFINITIONS................................................... 1
1.1 USE OF DEFINED TERMS.......................................... 7
1.2 ACCOUNTING TERMS.............................................. 7
1.3 SECTIONS, EXHIBITS AND SCHEDULES.............................. 7
1.4 MISCELLANEOUS TERMS........................................... 7
ARTICLE II. ALLIANCE AND THE ALLIANCE GRANT FUNDING...................... 7
2.1 THE ALLIANCE.................................................. 7
2.2 MANAGEMENT OF THE ALLIANCE.................................... 8
2.3 OBLIGATIONS OF THE COMPANY.................................... 10
2.4 OBLIGATIONS OF CFFTI.......................................... 12
2.5 FUNDINGS...................................................... 13
2.6 LICENSE FEE................................................... 14
ARTICLE III. REPRESENTATIONS AND WARRANTIES OF THE COMPANY............... 14
3.1 ORGANIZATION.................................................. 14
3.2 AUTHORITY..................................................... 15
3.3 CAPITALIZATION................................................ 15
3.4 NO CONFLICT................................................... 16
3.5 FINANCIAL STATEMENTS; UNDISCLOSED LIABILITIES; INDEBTEDNESS... 16
3.6 LITIGATION.................................................... 17
3.7 INTELLECTUAL PROPERTY......................................... 17
ARTICLE IV. REPRESENTATIONS AND WARRANTIES OF CFFTI...................... 18
4.1 ORGANIZATION; AUTHORIZATION; NO CONFLICT...................... 18
4.2 INVESTMENT REPRESENTATIONS.................................... 19
4.3 CFFTI'S ACKNOWLEDGMENT AS TO INFORMATION...................... 19
4.4 LITIGATION.................................................... 19
ARTICLE V. LICENSES...................................................... 20
5.1 CFFTI LICENSE................................................. 20
5.2 COMPANY SUBLICENSE............................................ 21
5.3 JOINT LICENSE................................................. 21
5.4 RETAINED RIGHTS OF THE COMPANY................................ 21
5.5 PROSECUTION; ENCUMBRANCES; OTHER MATTERS...................... 21
5.6 FURTHER ASSURANCES............................................ 22
ARTICLE VI. EVENTS OF DEFAULT............................................ 22
6.1 COMPANY DEFAULT............................................... 22
6.2 CONSEQUENCES OF A COMPANY DEFAULT............................. 23
6.3 CFFTI DEFAULT................................................. 23
6.4 CONSEQUENCES OF A CFFTI DEFAULT............................... 24
ARTICLE VII. CONFIDENTIALITY; PUBLICATIONS; PUBLICITY.................... 25
7.1 CONFIDENTIALITY............................................... 25
7.2 PUBLIC ANNOUNCEMENTS.......................................... 25
7.3 PUBLICATIONS.................................................. 25
ARTICLE VIII. INDEMNIFICATION AND INSURANCE.............................. 26
8.1 CFFTI INDEMNIFICATION......................................... 26
8.2 COMPANY INDEMNIFICATION....................................... 26
8.3 PROCEDURE..................................................... 26
ARTICLE IX. CONDITIONS PRECEDENT......................................... 27
9.1 CONDITIONS TO OBLIGATIONS OF THE COMPANY AT THE INITIAL GRANT
FUNDING.................................................... 27
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
9.2 CONDITIONS TO OBLIGATIONS OF CFFTI AT THE INITIAL ALLIANCE
GRANT FUNDING.............................................. 28
ARTICLE X. TERMINATION................................................... 29
10.1 CFFTI RIGHT TO TERMINATE...................................... 29
10.2 COMPANY'S RIGHT TO TERMINATE.................................. 30
10.3 OTHER TERMINATIONS OF AGREEMENT............................... 30
10.4 CONSEQUENCES OF TERMINATION................................... 30
ARTICLE XI. MISCELLANEOUS................................................ 31
11.1 NOTICES....................................................... 31
11.2 CAPTIONS...................................................... 32
11.3 EXPENSES...................................................... 32
11.4 NO WAIVER..................................................... 32
11.5 SEVERABILITY; INTEGRATED TRANSACTION.......................... 32
11.6 ENTIRE AGREEMENT.............................................. 32
11.7 AMENDMENT..................................................... 32
11.8 LIMITATION ON ASSIGNMENT...................................... 32
11.9 GOVERNING LAW................................................. 32
11.10 ARBITRATION................................................... 32
11.11 COUNTERPARTS.................................................. 33
11.12 FORCE MAJEURE................................................. 34
11.13 INDEPENDENT CONTRACTORS....................................... 34
11.14 FURTHER ASSURANCES............................................ 34
11.15 SURVIVAL...................................................... 34
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.
2
EXECUTION COPY
STRATEGIC ALLIANCE AGREEMENT
This STRATEGIC ALLIANCE AGREEMENT, is made as of February 22, 2001
("Agreement"), by and between Altus Biologics Inc, a Massachusetts corporation
(the "Company"), and Cystic Fibrosis Foundation Therapeutics, Inc., a Maryland
corporation ("CFFTI" and collectively, with the Company, the "Parties," and each
a "Party").
WHEREAS, CFFTI has, as one of its principal objectives, the development of
therapies that will improve the quality of life for patients suffering from
cystic fibrosis and has developed an extensive network of medical providers,
researchers, and patients who participate in this effort, and the Company
possesses certain skills and technology which can aid in this objective; and
WHEREAS, the Company and CFFTI wish to collaborate with respect to the
farther development, testing, and marketing of a new drug developed by the
Company to treat pancreatic insufficiency in cystic fibrosis patients in North
America, based on technology developed by the Company and using the expertise
and contacts of CFFTI including CFFTI's Therapeutic Development Network; and
WHEREAS, the Company and CFFTI desire that CFFTI provide grant funding to
an aggregate total of Twenty Five Million Dollars ($25,000,000) to fund the
Company's development and marketing of TheraCLEC Total(TM) to treat pancreatic
insufficiency in cystic fibrosis patients in North America, on the terms and
subject to the conditions set forth in this Agreement; and
WHEREAS, the Company desires to issue to CFFTI, and CFFTI desires that the
Company issue it, warrants to acquire up to four hundred thousand (400,000)
shares of the Company's common stock, par value $.0l per share (the "Common
Stock"), on the terms and subject to the conditions set forth in this Agreement;
and
NOW, THEREFORE, in consideration of the foregoing and of the respective
covenants and undertakings hereunder and for other good and valuable
consideration, the receipt and adequacy of which are hereby acknowledged, the
Parties hereto do hereby agree as follows:
ARTICLE I
DEFINITIONS
As used in this Agreement, the following terms have the meanings set forth
below.
"AAA" shall have the meaning set forth in Section 11.10 hereof.
"Affiliate" shall mean any Person that, directly or indirectly, through one
or more intermediaries, controls, is controlled by or is under common control
with any other Person and, for purposes of this Agreement, control shall include
the power to elect a majority of the board of directors.
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.
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"Deadlock Event" shall mean a failure of the ASC to reach agreement on a
Material ASC Matter within the period set forth in Section 2.2 (d) hereof.
"Development Activities" shall mean activities related to the development
and marketing of the Products in North America, which shall include research,
development, animal tests, clinical trials and other testing, seeking applicable
approvals of governmental bodies and others, manufacturing, marketing,
promotion, sales, and distribution activities and any other act or acts required
or reasonably necessary to obtain FDA approval for the marketing and
distribution of the Products to treat pancreatic insufficiency in cystic
fibrosis patients or to otherwise market and sell the Products in compliance
with any applicable Law for such treatment, in each case in North America.
"Encumbrance" shall mean any security agreement, properly filed financing
statement, mortgage, lien (statutory or otherwise), or other consignment or
bailment given for security purposes, or other title retention agreement, with
respect to any material asset of such Person, or, in the case of intellectual
property rights, any license materially affecting such rights, whether direct,
indirect, accrued or contingent, except for transfer restrictions imposed by the
Securities Act, the Securities Exchange Act of 1934, as amended, and/or state
securities Laws.
"Entity" shall mean any corporation, partnership, limited liability
company, joint venture, trust, association, unincorporated organization, group
or other corporate or non-corporate entity.
"Fair Market Value" of any shares of Common Stock issued or issuable upon
exercise of the Warrants shall mean the fair market value of such shares on the
date of determination, which shall be determined as follows:
(a) if the Common Stock is listed on any domestic securities exchange
or quoted in the NASDAQ System or the over-the-counter market, the average of
the closing prices of the sales of shares of Common Stock on all securities
exchanges on which Common Stock may at the time be listed, or, if there have
been no sales on any such exchange on any day, the average of the highest bid
and lowest asked prices on all such exchanges, or, if on any day shares of
Common Stock are not so listed, the average of the representative bid and asked
prices quoted in the NASDAQ System as of 4:00 P.M., New York City time, or, if
on any day shares of Common Stock are not quoted in the NASDAQ System, the
average of the highest bid and lowest asked prices in the domestic
over-the-counter market as reported by the National Quotation Bureau
Incorporated, or any similar successor organization, as applicable, averaged
over the 20 consecutive trading days prior to the date of determination;
provided however that notwithstanding the foregoing, the Fair Market Value of
the shares of Common Stock issued or issuable upon exercise of the Warrants
shall be reduced if and to the extent that a block sale of all of such shares is
reasonably likely, in the good faith judgment of a registered broker-dealer who
is affiliated with a reputable, nationally recognized brokerage house (and who
is independent, that is, has to interest in the contemplated block sale and is
not the regular broker-dealer for either CFFTI or the Company), to depress the
trading price of shares of Common Stock and the Fair Market Value of the shares
of Common Stock issued or issuable upon exercise of the Warrants; 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.
2
(b) if at any time the Common Stock is not listed on any domestic
securities exchange or quoted in the NASDAQ System or the domestic
over-the-counter market, then the Fair Market Value of the shares of Common
Stock issued of issuable upon exercise of the Warrants shall be determined by an
Independent Appraiser (taking into account, among such other factors as
appraisers commonly consider, the lack of a public market for such shares, the
minority nature and size of stake of such shares, general market conditions and
market conditions in the private equity markets related to the Company's
business, and any pending bona fide written offer to buy the Shares that CFFTI
has received from an unrelated third party) who shall determine and report to
the Company and CFFTI the fair market value of the Common Stock not later than
30 days after the date such Independent Appraiser is selected. The Independent
Appraiser shall be selected jointly by the Company and CFFTI not later than five
days after the Appraisal Date; provided however that if the Company and CFFTI
cannot agree on the selection of such an Independent Appraiser within such
period, then the Independent Appraiser will be selected by the Company's
auditors not later than eight days after the Approval Date.
"FDA" means the United States Food and Drug Administration, or any
successor thereto.
"Financial Statements" shall have the meaning set forth in Section 3.5
hereof.
"GAAP" shall mean generally accepted accounting principles of the United
States of America.
"Grace Period" shall mean with respect to a specified Milestone Achievement
Date, the number of days that lapsed between such specified Milestone
Achievement Date and the immediately preceding Milestone Achievement Date,
multiplied by [**].
"Grant" shall mean $25,000,000 to be funded by CFFTI subject to the
conditions and in accordance with the terms of this Agreement.
"Improvements" means all developments to, enhancements in, and new versions
or improvements of the intellectual Property, whether or not patentable, which
are invented, developed, discovered or otherwise acquired by or for the Company
as a result of the Development Activities hereunder,
"Independent Appraiser" shall mean one of the nationally recognized
accounting firms that regularly engages or has significant experience in the
valuation of companies similar to the Company, which has not been engaged by
either the Company or CFFTI at any time during the three year period immediately
prior to the date on which the Independent Appraiser is selected pursuant to
this Agreement.
"Initial Alliance Grant Funding" shall have the meaning set forth in
Section 2.5(a) hereof.
"Initial Alliance Grant Funding Date" shall mean the date on which the
Initial Grant Funding Amount is paid by CFFTI to the Company.
"Initial Grant Funding Amount" shall have the meaning set forth in Section
2.5(a) herof.
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.
3
"Intellectual Property" shall mean all, patents, patent applications,
rights acquired through patent licenses, Trademarks, trade secrets, software,
copyrights, copyright applications, inventions, technologies, know-how,
formulae, processes, all other intellectual property and applications for any of
the foregoing, owned, leased, licensed, used or held for use, directly or
indirectly, by, on behalf of or for the account of the Company and all
proprietary rights to such Intellectual Property, which are used or useful for
the manufacture, use or sale of the Products owned, leased, licensed used or
held for use, directly or indirectly, by, on behalf of or for the account of the
Company.
"Joint License Event" shall have the meaning set forth in Section 5.3
hereof.
"Judgment" shall mean any unsatisfied judgment, decree, or order of any
governmental body having competent jurisdiction.
"Law" shall mean any statute, ordinance, code, rule, regulation or order
enacted, adopted, or promulgated, by any governmental body.
"License Fee" shall have the meaning set forth in Section 2.6 hereof.
"Licensed Products" shall have the meaning set forth in Section 5.1 hereof.
"Material ASC Matter" means a determination by the ASC as to whether a
specified Milestone has been met, or as to whether a Technical Failure has
occurred, or as to whether the Milestone Grant Funding Plan should be amended
pursuant to Section 2.2(b)(i) hereof.
"Milestone" shall mean a milestone set forth in the Milestone Grant Funding
Plan and which has a corresponding Milestone Achievement Date and Grant Funding
Amount, each of which is set forth in the Milestone Grant Funding Plan opposite
such milestone, as amended from time to time by the ASC. For purposes of the
Milestone Grant Funding Plan, the achievement of a Milestone shall include the
transmittal of data resulting from Development Activities related to the said
Milestone.
"Milestone Achievement Date" shall mean [******************] specified in
the Milestone Grant Funding Plan on which a related Milestone is to be
completed, as amended from time to time by the ASC.
"Milestone Grant Funding Plan" shall mean the Milestone Grant Funding Plan
attached hereto as Exhibit 1.1, as the same shall be amended and modified from
time to time pursuant to approval of the ASC in accordance with Section 2.2
hereof.
"Net Sales" shall mean [**************************************************]
in arm's length sales to unrelated third parties, less the following amounts
incurred in the ordinary course of business with respect to such sale to the
extent separately included in the invoice for the Product as part of the gross
invoiced sales price:
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.
4
(c) trade, cash and quantity discounts or rebates [*******************
****];
(d) credits or allowances given or made for rejection of or return of,
and for uncollectible amounts on, previously sold Products or for retroactive
price reductions [**************************************************************
**];
(e) charges for insurance, freight and other transportation costs
[******************************] of Product; and
(f) sales, transfer and other excise taxes levied on the sale or
delivery of a Product (including any tax such as a value added or similar tax or
government charge) borne by the seller thereof, [*******************************
************************].
"Party" and "Parties" shall have the meaning set forth in the preamble of
this Agreement.
"Person" shall mean any individual, Entity or governmental body.
"Phase IIb Milestone Date" shall mean the last day of the quarter specified
in the Milestone Grant Funding Plan within which Phase IIb is to be completed
and all [**********] associated with the Phase IIb transmitted by the Company to
CFFTI in accordance with the Milestone Grant Funding Plan.
"Products" shall mean the pharmaceutical products developed by or on behalf
of the Company, currently identified by the Company as "TheraCLEC Total(TM)",
and any derivatives thereof, which contain the [***********************] and
either or both of the [***************************], and [*****], and which are,
in either case, designed to treat pancreatic insufficiency in cystic fibrosis
patients.
"Property" shall mean any interest in any kind of property or asset,
whether real, personal or mixed, or tangible or intangible.
"Registration Rights Agreement" shall have the meaning set forth in Section
2.3(c) hereof.
"Regular Rate" shall mean the rate announced by Fleet Bank from time to
time as its prime rate of interest plus [**************].
"Securities Act" shall mean the Securities Act of 1933, as amended.
"Shares" shall mean the shares of Common Stock issued or issuable upon
exercise of the Warrants.
"TDN" shall have the meaning set forth in Section 2.4(d) hereof.
"Team Leader" shall have the meaning set forth in Section 2.2(a) hereof.
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.
5
"Technical Failure" means that (a) none of the Products
[************************************] as determined by the ASC, (b) the
Products' toxicity levels exceed FDA standards and cannot be corrected within a
scientifically reasonable period of time as determined by the ASC, or (c) the
ASC has reasonably determined that, [*******************************************
**************] developed or marketed.
"Trademarks" shall mean all trademarks, trademark applications, brand
names, and trade names used, owned or licensed by the Company that are used or
intended to be used in association with the Products.
"Unresolved Deadlock Event" shall mean a Deadlock Event that is not
resolved after completion of the resolution procedures set forth in Section
2.2(d) hereof.
"Warrants" shall have the meaning set forth in Section 2.3(b) hereof.
"Work Plan" shall mean the work plan attached hereto as Exhibit 1.2,
as the same shall be amended and modified from time to time in accordance with
Section 2.2 hereof.
1.1 Use of Defined Terms. Any defined term used in the plural shall
refer to all members of the relevant class, and any defined term used in the
singular shall refer to any one or more of the members of the relevant class.
The use of either gender shall be applicable to both genders.
1.2 Accounting Terms. All accounting terms not otherwise defined in
this Agreement shall be construed in conformity with GAAP.
1.3 Sections, Exhibits and Schedules. References in this Agreement to
Sections, Exhibits and Schedules are to Sections, Exhibits and Schedules of and
to this Agreement. The Exhibits and Schedules to this Agreement are hereby
incorporated herein by this reference as if fully set forth herein.
1.4 Miscellaneous Terms. The term "or" shall not be exclusive. The
terms "herein," "hereof," "hereto," "hereunder" and other terms similar to such
terms shall refer to this Agreement as a whole and not merely to the specific
article, section, paragraph or clause where such terms may appear. The term
"including" shall mean including, but not limited to unless such qualification
already appears.
ARTICLE II
ALLIANCE AND THE ALLIANCE GRANT FUNDING
2.1 The Alliance.
(1) Formation of the Alliance. The Parties hereto hereby agree to associate
themselves for the purpose of collaborating on the development, testing,
manufacturing, marketing, and promoting of the Products for use in North America
with respect to the treatment of pancreatic insufficiency in cystic fibrosis
patients (the "Alliance"). The Alliance shall be conducted,
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.
6
operated and administered in accordance with the terms of this Agreement, and no
separate or jointly owned corporate or other entity or entities shall be
established for the purpose of conducting or administering the joint efforts and
endeavors of the Parties hereunder.
(2) Relationship of the Parties. The Parties hereto understand
and agree that the Alliance is limited to the development, testing, and
marketing of the Products for use in North America with respect to the treatment
of pancreatic insufficiency in cystic fibrosis patients and to the activities,
rights and obligations as set forth in this Agreement. Nothing in this Agreement
shall be construed to create or imply a general partnership, limited partnership
or other legal entity between the Parties, to make either Party the agent of the
other for any purpose, to alter, amend, supersede or vitiate any other
arrangements between the Parties with respect to any subject matters not covered
hereunder, to give either Party the right to bind the other, to create any
duties or obligations between the Parties except as expressly set forth in or
arising from this Agreement, or to, grant any direct or implied licenses or any
other right other than as expressly set forth herein.
(3) Ethical Conduct. In carrying out its responsibilities under
this Agreement, each Party agrees that, in all material respects, its activities
will be conducted in compliance with all applicable Laws, including the U.S.
Food, Drug and Cosmetic Act and the regulations promulgated pursuant thereto or
any equivalent applicable Laws pertaining to the subject matter of such Act in
other jurisdictions. Neither Party will engage the services of any Person
debarred by any relevant governmental body from conducting or participating in
any of the activities to be conducted under this Agreement.
2.2 Management of the Alliance.
(a) Membership on the ASC. The Parties shall establish an alliance
steering committee (the "ASC") consisting of [**] members, [***] of whom shall
be appointed (and may be removed by the Company and whose expenses shall be
borne by the Company, and [***] of whom shall be appointed by (and may be
removed) by CFFTI and whose expenses shall be borne by CFFTI. Each of the
members of the ASC shall be required to enter into a confidentiality agreement
reasonably acceptable to the Company and CFFTI in connection with their
appointment to the ASC. The Company and CFFTI shall each appoint one of its
members on the ASC as its "Team Leader". The goal of the ASC shall be to
facilitate the Company's development of the Products, its regulatory approval,
and the commercial launch of the Products.
(b) Duties of the ASC. The ASC shall have responsibility for the
following activities:
(i) determining whether Milestones have been met in accordance with the
Milestone Grant Funding Plan; provided that, in the event the Company does not
satisfy a specified Milestone by the associated
[************************************************] associated therewith, other
than [********************], the ASC may reasonably amend the Milestone
Achievement Date, upon a reasonable showing by the Company that A)
[***********************************************] and B) the Company has
exercised and will continue to exercise good faith, reasonable efforts to
achieve said Milestones and has made and will continue to apply appropriate
resources to such efforts;
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.
7
(ii) determining whether a Technical Failure has occurred;
(iii) reviewing and approving the Work Plan and the Milestone Grant
Funding Plan and recommending and approving all amendments thereto; provided
that the ASC shall cause the Milestone Grant Funding Plan to be amended to take
into account any Grace Periods afforded the Company or CFFTI hereunder and any
period during which funding by CFFTI was deferred pursuant to the provisions of
Section 2.5(b); and provided further that if any Milestone Achievement is
amended by the ASC, all future Milestone Achievement Dates and Funding Amounts
shall be adjusted to reflect the said amendments;
(iv) ensuring that Development Activities are monitored in accordance
with legal and regulatory requirements; and
(v) making recommendations regarding the following matters: clinical
trials, the acquisition and use of resources including the application for
necessary approvals from governmental bodies, patent applications or
controversies, and priorities among the various Development Activities.
(c) Meetings; Voting. The ASC shall meet in connection with each
Milestone Achievement Date and as needed to determine whether the related
Milestone has been achieved, but in any event no fewer than [**] times per year,
at the place and in the manner determined jointly by the Team Leaders. All
decisions of the ASC shall be made by the affirmative vote of the members
appointed by the Company (who shall each be entitled to cast one vote) and the
members appointed by CFFTI (who shall each be entitled to cast one vote), and
the ASC may act so long as at least two members appointed by the Company and two
members appointed by CFFTI are present at a meeting or execute a written
consent, in lieu thereof. Decisions of the ASC are binding on the Parties and
may be made at (i) a regularly scheduled meeting (including via teleconference
or video conference) or (ii) at a special meeting called by the Team Leaders or
(iii) by written consent of at least two members appointed by the Company and
two members appointed by CFFTI. Persons other than members of the ASC may be
present at meetings of the ASC (and their expenses shall be borne by the Party
requesting such Person's presence) if [************************] or the ASC
determines that it is necessary or appropriate and, if requested by either
Party, provided such Person or Persons agree to execute appropriate
confidentiality agreements in a form agreed upon by the Parties prior to
attendance at such meeting.
(d) Deadlock Events. In the event that the ASC is unable to agree with
respect to any Material ASC Matter within [*******************], then on the
[********************] a Deadlock Event shall be deemed to have occurred, and
the determination of the said Material ASC Matter will be accelerated
[*************************************]. If the [*********************] cannot
reach resolution within [***************], then each Party will [************
***************] (who shall not be [*******************************************]
of such Party or a member of the ASC) to meet and negotiate in good faith to
reach a fair and reasonable resolution to the controversy. If such board members
cannot reach resolution within [***************], then the Parties shall
promptly participate in mediation before an impartial mediator certified by the
AAA and mutually agreeable to the Parties. Such mediation shall take place at a
location
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.
8
agreed upon by the Parties, and if they do not agree, the first such mediation
shall take place in Washington, D.C., and the second such mediation shall take
place in Boston, Massachusetts and thereafter the locations shall continue to
alternate. The expenses of such mediator shall be shared by the Parties equally.
Any decision made pursuant to this Section shall be binding on the Parties. If
no decision is reached [***************] after mediation has occurred, then such
Deadlock Event shall continue and be deemed an Unresolved Deadlock Event for
purposes of this Agreement.
(i) If a Deadlock Event occurs then CFFTI [*************************]
CFFTI Funding Amount that [*******************] during the period in which the
resolution procedures set forth in Section 2.2(d) are occurring with respect to
the related Deadlock Event, and the Company [**********************************]
Development Activities in support thereof;
(ii) If an Unresolved Deadlock Event occurs and
[**********************] Development Activities, this Agreement shall be
terminated as set out in Section 10.3.
(iii) If an Unresolved Deadlock Event occurs, and the Company
determines to proceed thereafter with Development Activities, then CFFTI
[***************************] CFFTI Funding Amount that
[**************************] the end of the applicable Grace Period after the
effective date of the Unresolved Deadlock Event, which shall be determined
[******************] between the Milestone Achievement Date of the next
Milestone to be achieved and the Milestone Achievement Date of the last
Milestone that was achieved according to the ASC, at which time such CFFTI
Funding Amount [**********************], provided however, thereafter, after a
Milestone has been achieved, the CFFTI Funding Amount shall be due
[**************] after receipt of an invoice from the Company and CFFTI shall
promptly pay such amounts, or be in default under Section 6.3.
(iv) If an Unresolved Deadlock Event occurs and CFFTI determines to
proceed thereafter with funding of Development Activities, then the Company
[************************] if it does not achieve the said Milestone within the
applicable Grace Period, determined by [***************] between the Milestone
Achievement Date of the next Milestone to be achieved and the Milestone
Achievement Date of the last Milestone that was achieved according to the ASC,
provided CFFTI [********************************] under the Milestone Grant
Funding Plan.
(e) Minutes. The ASC shall keep minutes of its deliberations that
record in reasonable detail all actions recommended or taken. Drafts of the
minutes shall be delivered to each of the Team Leaders within a reasonable time
not to exceed fifteen business days after the meeting. The Party hosting the
meeting or a member of the ASC designated by the Team Leaders as secretary of
such meeting, as applicable, shall be responsible for the preparation and
circulation of the draft minutes. Draft minutes may be edited by the Team
Leaders and shall be issued in final form within a reasonable time not to exceed
[********] days after the meeting only with their approval and agreement as
evidenced by their signatures on the minutes.
2.3 Obligations of the Company. Subject to the terms and conditions of this
Agreement, the Company 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.
9
(a) authorize the execution and delivery of this Agreement, the
Warrants and the Registration Rights Agreement, and the performance of its
obligations hereunder and thereunder;
(b) upon execution of this Agreement, issue and deliver to CFFTI
warrants to acquire an aggregate of four hundred thousand (400,000) shares of
Common Stock in the form of Warrant 5-A ("Warrant A") and Warrant 5-B ("Warrant
B"), attached hereto as Exhibit 2.3(b)(i) and (ii) respectively (together the
"Warrants");
(c) execute and deliver to CFFTI the Registration Rights Agreement in
the form attached hereto as Exhibit 2.3(c) (the "Registration Rights
Agreement");
(d) grant to CFFTI the licenses set forth in Article V herein below;
(e) control and be primarily responsible for the conduct of the
Development Activities, engage in Development Activities at all times during the
term of this Agreement and, without limiting the foregoing, use
[**********************] (i) to develop the Products and bring the Products to
market in North America [**********************], and in any event in accordance
with the Milestone Grant Funding Plan and the Work Plan, (ii) to obtain all
necessary approvals of applicable governmental bodies for the marketing and
distribution of the Products in North America, and (iii) market and distribute
the Products in North America after such approvals are obtained. Development
Activities will be conducted by the Company, or the Company will cause its
subcontractor to conduct Development Activities, in accordance with accepted
ethical principles and regulatory requirements in facilities selected by the
Company which are reasonable and adequate for the conduct of Development
Activities;
(f) use the Grant funds received hereunder to fund Development
Activities, and to the extent that additional resources and funding in excess of
the Grant amounts funded by the CFFTI under this Agreement are required for the
Company to satisfy the next succeeding Milestone set forth on the Milestone
Grant Funding Plan, the Company shall provide all such additional resources and
funds, and together with the invoice to be delivered pursuant to Section 2.5(b)
in connection with the funding of the Grant next following a Milestone
Achievement Date, the Company will provide the ASC with a summary of the
Company's plans for funding or providing resources equivalent to the amount set
forth on the Milestone Grant Funding Plan under the heading "Company Funding
Amount", on a [*******] basis during the period from the date of such Milestone
Achievement Date until the next occurring Milestone Achievement Date;
(g) provide the ASC with a written report within [*********] following
the end of each fiscal quarter, documenting in reasonable detail the Development
Activities conducted by the Company during such quarter, and indicating (i)
whether any Milestone identified on the Milestone Grant Funding Plan has been
achieved during such quarter, (ii) any material deviation from the schedule of
work shown in the Work Plan, and (iii) the Company's analysis as to whether the
next succeeding Milestone is likely to be satisfied by the related Milestone
Achievement Date or, if not, by the end of the related Grace Period, and if not,
the identified reason or reasons for the anticipated delay;
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.
10
(h) consult from time to time with the ASC, CFFTI, and the TDN
concerning the Development Activities and use the TDN, at the sole expense of
the Company (which expense may be satisfied using the Grant funding to be
provided by CFFTI hereunder), in conducting clinical trials needed in connection
with the Development Activities and the Products;
(i) pay the License Fees to CFFTI as set out in Section 2.6 or the
royalties provided in Section 10.1(c) hereinbelow if applicable;
(j) keep records of amounts expended on Development Activities that
are complete and accurate in all material respects, and permit CFFTI, with
reasonable written notice to the Company, to cause an independent, certified
public accountant reasonably acceptable to the Company to audit such records not
more than [************] at the place or places of business where such records
are customarily kept at a mutually convenient time and subject to execution by
the accountant of a reasonable confidentiality agreement acceptable to the
Company, in order to verify the reasonable accuracy of the reports of amounts
spent in respect of Development Activities; provided that CFFTI
[**********************] of such audit unless such audit discloses that the
Company has materially misstated the amount(s) expended on Development
Activities, in which event, the Company [****************************] of such
audit;
(k) permit the members of the ASC appointed by CFFTI, upon reasonable
notice and at reasonable intervals and during normal business hours, to confer
with the financial, legal, technical, scientific and accounting representatives
of the Company and be furnished all relevant documents, records and other
information concerning the Products and the Development Activities that such
persons, with the consent or approval of the ASC, may reasonably request;
(l) participate in the ASC [****************]; and
(m) prior to the initial public offering of the Company's Common
Stock, deliver to CFFTI (i) as soon as practicable after the end of each fiscal
year of the Company, and in any event on or within [*********************] days
thereafter, an unaudited balance sheet of the Company as of the end of such year
and unaudited statements of income and stockholders' equity for such year; and
(ii) as soon as practicable after the end of each fiscal quarter (except the
last fiscal quarter of each fiscal year), and in any event on or before or
within [************] days thereafter, an unaudited balance sheet of the Company
as of the end of such quarter, and an unaudited statement of income for each
quarter and for the current fiscal year to date, and, if available, audited
statements and any other financial statements or reports provided generally to
holders of the Company's securities in the ordinary course of business.
2.4 Obligations of CFFTI. Subject to the terms and conditions of this
Agreement, CFFTI shall:
(a) authorize the execution and delivery of this Agreement, the
Registration Rights Agreement and the Warrants and the performance of its
obligations hereunder and thereunder, and obtain the authorization and approval
of any Affiliate that will provide funds to be used in the Grant;
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
(b) effective as of December 31, 2000 commit to provide the Grant and
thereafter provide non-refundable grant funding to the Company in accordance
with Section 2.5 in the total amount of twenty five million dollars
($25,000,000) to support the development and testing of the Products;
(c) use [*********************] to cause the Company to be provided
with the names of prospective patients and medical providers who may participate
in the development of the Products and in clinical testing;
(d) provide the Company with reasonable access to its Therapeutic
Development Network of medical providers, patients, researchers, and others who
are involved in the care and treatment of cystic fibrosis patients ("TDN") and
use reasonable efforts to promote the involvement of TDN in the development and
testing of the Products, in each case in a manner and consistent with the
recommendation of the ASC;
(e) grant to the Company the sublicense set forth in Article V;
(f) participate in the ASC [****************]; and
(g) provide reasonable assistance and cooperation requested by the
Company in support of the expeditious development, testing, regulatory approval
and market launch of the Products, in a manner and consistent with the
recommendation of the ASC in support of Development Activities.
2.5 Fundings.
(a) Upon satisfaction (or waiver) of the conditions thereto set forth
in this Agreement, the closing of the issuance of the Warrants and the first
payment of the Grant (the "Initial Alliance Grant Funding") shall take place at
the offices of Xxxxxxx Berlin Shereff Xxxxxxxx, LLP, 0000 X Xxxxxx, XX,
Xxxxxxxxxx, XX 00000, on February 20, 2001 or at such other place and date as
the Parties may agree in writing, but in no event later than February 22, 2001.
At the Initial Alliance Grant Funding, the Parties shall deliver the documents
and agreements they are required to deliver pursuant to Article IX hereof CFFTI
shall pay [*****************************************************] of the Grant
by wire transfer of immediately available funds to the account specified in
Schedule 2.5(a) (the "Initial Grant Funding Amount"), and the Parties shall
deliver such other documents, agreements and certificates as a Party may
reasonably request in connection with the Initial Alliance Grant Funding.
(b) Subject to the terms and conditions of this Agreement, CFFTI shall
make additional Grant payments to the Company within [*********] after receipt
of an invoice from the Company therefore delivered in accordance with the
Milestone Grant Funding Plan (but in no event shall CFFTI be required to make a
Grant payment prior to [************************************] specified on the
Milestone Grant Funding Plan) by paying the specified CFFTI Funding Amount by
wire transfer of immediately available funds to the account specified in
Schedule 2.5(a) attached hereto provided that no Technical Failure shall have
occurred as of the date of such payment; and provided, further:
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.
12
(i) If CFFTI has paid the Initial Grant Funding Amount and each of the
CFFTI Funding Amounts previously invoiced and due in accordance with the terms
hereof, and the Company [***************************************************
***********], then CFFTI will not be obligated to [***************************]
of the Grant or any further CFFTI Funding Amounts that would otherwise be due
pursuant to invoices provided by the Company in accordance with the Milestone
Grant Funding Plan until [************************], at which time CFFTI's
obligation to make [*******] payments of the CFFTI Funding Amounts shall resume
in accordance with the Milestone Grant Funding Plan as revised to reflect the
extension of time, provided CFFTI shall not be relieved of paying any amounts on
the Milestone Grant Funding Plan;
(ii) If a Company Default [****************] then CFFTI shall not be
obligated to fund any CFFTI Funding Amount that would otherwise be due; and
(iii) With respect to each CFFTI Funding Amount due immediately
following a Milestone Achievement Date, the invoice related to such CFFTI
Funding Amount shall be accompanied by a certificate on behalf of the Company
stating that the previous related Milestone has been achieved.
2.6 License Fee. On the date on which the Company obtains approval from the FDA
to market and distribute the Products in North America (the "Approval Date"),
the Company shall be obligated to pay to CFFTI an amount in cash in United
States dollars equal to the amount by which [***************************]
exceeds the [********************************] (such excess is referred to
herein as the "License Fee") and upon payment in full of the License Fee, the
license granted to CFFTI under Section 5.1 and all sublicenses thereunder shall
terminate, and CFFTI shall be obligated to transmit to the Company all products
and information and promotional or marketing materials and data relating to the
Products that are in the possession of CFFTI or any sublicensees of CFFTI other
than the Company. The License Fee shall be paid as follows: (i) [*********]
after the Approval Date, the Company shall pay by wire transfer of immediately
available funds to an account designated in writing by CFFTI an amount equal to
the greater of (a) [********] or (b) [******************] of the License Fee,
whichever is higher, and (ii) [******************************], the Company
shall pay by wire transfer of immediately available funds to an account
designated in writing by CFFTI an amount equal to the greater of (a) [********]
or (b) [******************] of the License Fee, whichever is higher (plus
interest accrued through such date on [***] of the License Fee) until the
License Fee (plus all accrued interest thereon) has been paid in full. Interest
on the outstanding balance of the License Fee shall be
[******************************] on the outstanding balance of the License Fee
at [************]. If a Company Default occurs following the Approval Date, the
entire unpaid License Fee shall become immediately due and payable without any
action of CFFTI, and the Company shall immediately pay such amount to CFFTI, and
such overdue amounts shall bear interest at a rate equal to
[********************************].
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
ARTICLE III
REPRESENTATIONS AND WARRANTIES OF THE COMPANY
As a material inducement to CFFTI to enter into this Agreement and to
consummate the transactions contemplated herein, the Company represents and
warrants to CFFTI as follows:
3.1 Organization. The Company is a corporation duly incorporated, validly
existing and in good corporate standing under the Laws of the Commonwealth of
Massachusetts. The Company 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 the Company. The
Company has previously delivered to CFFTI true, correct and complete copies of
its Charter Documents, as amended to date and as currently in effect.
3.2 Authority. The Company has the corporate right, power and authority to
carry on the Business and to execute and deliver this Agreement, the Warrants
and each of the other Company Closing Documents required to be executed and
delivered at the Initial Alliance Grant Funding and to consummate the
transactions contemplated by this Agreement. The execution and delivery of this
Agreement and each of the other Company Closing Documents required to be
executed at the Initial Alliance Grant Funding 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 Company and no
other corporate proceedings on the part of the Company are necessary to
authorize this Agreement, any of the other Company Closing Documents required to
be executed at the Initial Alliance Grant Funding or the consummation of the
transactions contemplated by this Agreement. This Agreement and each of the
other Company Closing Documents required to be executed at the Initial Alliance
Grant Funding have been duly and validly executed by the Company and constitute
legal, valid and binding obligations of the Company, enforceable against the
Company except as limited by applicable bankruptcy, insolvency, reorganization,
moratorium or other laws of general application affecting enforcement of
creditors' rights.
3.3 Capitalization.
(a) Immediately prior to the Initial Alliance Grant Funding, (i) the
authorized capital of the Company consist of 15,000,000 shares of Common Stock
and 537,500 shares of Preferred Stock, of which 2,836,787 of Common Stock,
450,000 shares of Redeemable Preferred Stock and 87,500 shares of Convertible
Preferred Stock are issued and outstanding. The Company holds no shares of
capital stock of the Company in its treasury. The Company has reserved 3,000,000
shares of Common Stock for issuance under option plans. All of the issued and
outstanding shares of capital stock of the Company are duly authorized, validly
issued, fully paid and non-assessable.
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
(b) From the date hereof, until such time as the Warrants is
exercised, the Company will have authorized and reserved a sufficient number of
shares of Common Stock for issuance upon exercise of the Warrants.
(c) Except as set forth on Schedule 3.3(c), upon issuance to CFFTI in
accordance with the terms of the Warrants, the Shares will be duly authorized,
validly issued, fully paid, and non-assessable and will be free and clear of any
Encumbrances, preemptive rights, restrictions on use, voting or transfer rights
created by or through the Company other than as set forth in this Agreement, the
Warrants, or the Charter Documents or that arise or exist as a result of Law.
(d) Except as set forth on Schedule 3.3(d), there are (i) no
outstanding rights, conversion rights, agreements, commitments or preemptive or
other similar rights of any kind relating to the issuance, sale, purchase,
redemption, voting or transfer of any shares of capital stock or other
securities of the Company to which the Company is a party, and (ii) no
outstanding registration rights or voting rights agreements to which the Company
is a party. The Company is not an "investment company" within the meaning of the
Investment Company Act of 1940, as amended.
(e) Assuming the truth and accuracy in all respects of CFFTI's
representations and warranties set forth in the Investor's Representation Letter
and in Sections 4.2 and 4.3 below as of the date of the Initial. Alliance Grant
Funding, and assuming the truth and accuracy in all respects of CFFTI's
representations and warranties set forth in the Investor's Representation Letter
and in Sections 4.2 and 4.3 below as of the date of issuance of the Shares by
the Company to CFFTI pursuant to the Warrants, the issuance of the Warrants and
the Warrant Shares to CFFTI, are or will be, as the case may be, exempt from the
registration requirements of the Securities Act and the securities laws of the
Commonwealth of Massachusetts and the State of Maryland as such Laws are in
effect as of the date hereof.
3.4 No Conflict. Except as set forth on Schedule 3.4, neither the execution
and delivery of this Agreement or the Company Closing Documents nor the
consummation of the transactions contemplated hereby and thereby will (a)
violate any provision of the Charter Documents of the Company, (b) 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 the Company under,
any material contract to which the Company 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 the Company, or (c) subject to compliance with applicable
requirements of the Xxxx-Xxxxx-Xxxxxx Antitrust Improvements Act of 1976, as
amended (the "HSR Act"), and except for compliance with federal and state
securities laws which are separately addressed in Section 3.3(e) above, violate
in any material manner any Material Law or Judgment applicable to the Company or
its Properties.
3.5 Financial Statements; Undisclosed Liabilities; Indebtedness.
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.
15
(a) The Company's Confidential Offering Memorandum dated [**********]
(the "PPM") contains copies of the audited balance sheets of the Company for the
year ended December 31, 1999 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, 1999 and (ii) the
unaudited balance sheet of the Company as of September 30, 2000 for the nine
months ended September 30, 2000 (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 the Company as of
date thereof or the Company's results of operations and changes in the Company's
financial position for the period set forth therein. Each of the Financial
Statements was prepared in accordance with 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.
(b) Except as disclosed in Schedule 3.5(d), as of the date hereof the
Company 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.
(c) Since September 30, 2000, there has been no material adverse
change in the Business of the Company, or any damage or impairment to, or
destruction or loss, sale, assignment, transfer, lapse or Encumbrance of any
Intellectual Property (whether or not covered by insurance) that could
reasonably be expected to have a material adverse effect on the Development
Activities.
3.6 Litigation. There is no litigation, arbitration, claim, action, suit,
governmental or other proceeding (formal or informal) to which the Company is a
party or to the knowledge of the Company, investigation pending or, threatened
against or affecting the Company, its Business or the Intellectual Property that
could reasonably be expected to have a material adverse effect on the
Development Activities or that could reasonably be expected to affect in a
material adverse manner the ability of the Company to comply in all material
respects with its obligations under this Agreement.
3.7 Intellectual Property.
(a) Trademarks. Schedule 3.7(a) 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 the Company that relate to the Products (the "Trademarks") and no
other Person has been granted by the Company (or to the knowledge of the
Company, has been granted by any other Person) any rights, or has any interest,
in such. The Company owns and possesses all right, title and interest, or holds
a valid license, in and to the Trademarks. No claim has been asserted or, to the
knowledge of the Company, threatened by any Person regarding the use or
licensing by the Company of the Trademarks. To the knowledge of the Company, its
use of the Trademarks does not violate or infringe, and has not in the past
violated or infringed, in each ease in any material manner the rights of any
Person and no material claims have been asserted by the Company against any
other Person claiming infringement of its Trademarks.
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.
16
(b) Patents and Know-how. Schedule 3.7(b) sets forth as of the date
hereof an accurate, correct and complete list of patents and patent applications
owned or licensed by the Company that are reasonably necessary to the
development, testing or use of the Products (the "Patent Rights"). The Company
owns and possesses all right, title and interest, or holds a valid license, in
and to the Patent Rights. No claim has been asserted or, to the knowledge of the
Company, threatened by any Person regarding the use or licensing by the Company
of the Patent Rights. To the knowledge of the Company, its use of the Patent
Rights 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 the Company against any other Person
claiming infringement of the Patent Rights.
(c) All rights and licenses to the Intellectual Property and
Improvements that are reasonably necessary or useful for making, using or
selling the Products have been licensed to CFFTI pursuant to Section 5.1
hereunder.
(d) Other than as set forth in (a) (b) and (c) hereinabove, the
Company makes no representations or warranties with respect to the Intellectual
Properly. Without limiting the generality of the foregoing, the Company does not
warrant the results of the Development Activities or that the Patent Rights or
Intellectual Property will be fit for a particular purpose or merchantable or
will not violate or infringe the rights of any third parties.
3.8 No Brokers, Finders or Investment Bankers. Neither the Company nor to
its knowledge any of its executive officers or directors has employed any broker
or finder or investment banker or incurred any liability which remains
unsatisfied for any brokerage or finder's fees or commissions or similar
payments in connection with this Agreement or the transactions contemplated by
this Agreement for which CFFTI could become liable.
3.9 Subsidiaries. Other than Altus Biocatalysis, Inc., a Delaware
corporation ("Altus Biocatalysis"), the Company has no subsidiaries. Altus
Biocatalysis was incorporated as a wholly owned subsidiary of the Company. Altus
Biocatalysis is not currently engaged in and has never been engaged in any
business nor does it own any assets or property.
3.10 Compliance with Law. The Company has conducted its Business in all
material respects in compliance with applicable.
3.11 Assets. To the Company's knowledge, the Company owns or has a valid
right to use all material Property that is used by the Company 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 the
Company.
3.12 Affiliates. Except for contracts and transactions with [*******
**************************] or its officers or directors described in the PPM or
listed on Schedule 3.3(d) or 3.5(b) and for employment or employment related
benefits, the Company is not party to any material contracts with any
Affiliates.
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
ARTICLE IV
REPRESENTATIONS AND WARRANTIES OF CFFTI
As a material inducement to the Company to enter into this Agreement and to
consummate the transactions contemplated herein, CFFTI represents and warrants
to the Company as follows:
4.1 Organization; Authorization; No Conflict. CFFTI is a corporation duly
incorporated, validly existing and in good standing under the Laws of the State
of Maryland. CFFTI is an Affiliate of the Cystic Fibrosis Foundation ("CFF").
CFFTI has full corporate, right, power and authority to execute and deliver this
Agreement, the Registration Rights Agreement, and the Warrants and to consummate
the transactions contemplated hereby and thereby. The execution and delivery of
this Agreement, the Registration Rights Agreement and the Warrants and the
consummation of the transactions contemplated hereby and thereby and the
acceptance of the Warrants have been duly and validly authorized by all
necessary corporate action on the part of CFFTI and the CFF and no other
proceedings are necessary on the part of CFFTI or the CFF to authorize this
Agreement, the Registration Rights Agreement, or the Warrants or the
consummation of the transactions contemplated by this Agreement, the Warrants or
the Registration Rights Agreement. This Agreement, the Registration Rights
Agreement and the Warrants and have been duly and validly executed by CFFTI and
constitute the legal, valid and binding obligations of CFFTI enforceable against
CFFTI in accordance with their respective terms. The execution, delivery and
performance of this Agreement, the Registration Rights Agreement and the
Warrants by CFFTI and the consummation of the transactions contemplated hereby
and thereby do not and will not (a) require the consent of any Person that has
not been obtained; (b) violate any provision of the Charter Documents of CFFTI;
(c) violate, conflict with or 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 CFFTI
under, any material contract to which CFFTI is a party or by which it or its
Property is bound or subject such that any such occurrence will have a material
adverse effect on CFFTI or violate in any material manner any material Law or
any Judgment applicable to CFFTI or its Properties. CFFTI has previously
provided to the Company true, correct and complete copies of its Charter
Documents, as amended to date and as currently in effect.
4.2 Investment Representations. CFFTI is acquiring the Warrants and the
Shares for its own account, for investment, and not with a view to, or for sale
in connection with, the distribution thereof or of any interest therein. CFFTI
is an accredited investor as such term is defined in Rule 501(a) of the
Regulation D promulgated under the Securities Act. Without limiting the
foregoing, CFFTI has adequate net worth and means of providing for its current
needs and contingencies and is able to sustain a complete loss of the investment
in the Company as contemplated by this Agreement and in the Warrants, has no
need for liquidity in such investment and its illiquid investments are not
excessive given its liabilities, current needs, net worth and business. CFFTI
was not formed for the purpose of acquiring the Warrants or the Shares. CFFTI
has sufficient knowledge and experience in financial and business matters to 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.
18
capable of evaluating the merits and risks of an investment in the Company as
contemplated by this Agreement and the investment represented by the Warrants
and the Shares, and CFFTI has evaluated the merits and risks of the investment
in the Company as contemplated by this Agreement and investment represented by
Warrants and the Shares. CFFTI understands that the offer and sale of the
Warrants and the Shares has not been and will not be registered under the
Securities Act, that the Warrants and the Shares have not been and will not be
registered under applicable state securities Laws and that the Warrants and the
Shares may not be sold or otherwise disposed of unless registered under the
Securities Act and applicable state securities Laws or disposed of pursuant to
an exemption thereto.
4.3 CFFTI's Acknowledgment as to Information. CFFTI has received from the
Company such information as CFFTI has deemed necessary and relevant in
connection with the transactions contemplated by this Agreement, the Warrants,
and the Warrant Shares and CFFTI has had the opportunity to ask questions of and
receive answers from persons acting on behalf of the Company necessary to verify
the information so obtained.
4.4 Litigation. There is no litigation, arbitration, claim, action, suit,
governmental or other proceeding (formal or informal), to which CFFTI or CFF is
a party or to the knowledge of CFFTI, investigation pending or, threatened
against or affecting CFFTI or CFF, the business of CFFTI as currently conducted
or as proposed to be conducted in the future and the operations, and assets of
CFFTI or CFF that could reasonably be expected to have a material adverse effect
on the funding of the Grant or that could reasonably be expected to affect in a
material adverse manner the ability of CFFTI to comply in all material respects
with its obligations under this Agreement.
4.5 No Brokers, Finders or Investment Bankers. Neither CFFTI nor to its
knowledge any of its Affiliates, executive officers or directors has employed
any broker or finder or investment banker or incurred any liability which
remains unsatisfied for any brokerage or finder's fees or commissions or similar
payments in connection with this Agreement or the transactions contemplated by
this Agreement for which CFFTI could become liable.
ARTICLE V
LICENSES
5.1 CFFTI License.
(a) Grant of License to CFFTI. Subject to all the terms and conditions
of this Agreement, the Company hereby confers upon CFFTI an exclusive,
[*************************] license to practice and use the Intellectual
Property and all Improvements thereon in order to make, use, or sell the
Products (the "Licensed Products"), for all uses and in all applications and
indications within North America, and except as provided in Section 5.2, the
Company shall not use the Licensed Products within North America for any
purpose. The license granted in this Section 5.1 includes [*****************
***********************************************************************] within
North America, subject to the conditions on CFFTI's license under Section 5.1 of
this Agreement and retained rights of the Company under Section 5.4 of this
Agreement. To the extent that the
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.
19
Licensed Products includes copyrights in software and other documentation, CFFTI
shall have the right to make, retain and use such copies of the software and
documentation as are reasonably necessary to exercise its rights hereunder.
(b) Conditions of License. As a material condition of the license
granted in this Section 5.1, CFFTI shall, and shall require any of its
sublicensees to provide the Company with copies of any clinical data that the
Company does not already have, which results from testing, use or sale of the
Products in North America, within [********] of the receipt of such data by
CFFTI or its sublicensee, and throughout the term of this license, the Company
shall provide CFFTI with [******************************], use, or sale of the
Products outside of North America, and in North America, if the sublicense
granted under Section 5.2 is in effect, within sixty days of the preparation or
receipt of such data by the Company or its sublicensee.
(c) Termination of License. The license granted in this Section 5.1
shall terminate on the first to occur of (i) [********************************
*************], (ii) [***************************************] (iii) the date on
which CFFTI terminates this Agreement under Section 10.1(c), (iv) the date on
which a [****************************], (v) the date on which the Patties
mutually agree not to proceed with Development Activities following the
occurrence of an Unresolved Deadlock Event, or (vi) upon the occurrence of a
[*************************] with respect to [***].
5.2 Company Sublicense. Subject to all the terms and conditions of this
Agreement, CFFTI, hereby confers upon the Company an exclusive
[********************] sublicense of equal scope to the license in Section 5.1
hereinabove, to make, use, or sell the Licensed Products for
[*******************************] within North America [*************]. The
sublicense granted in this Section 5.2 shall terminate on the first to occur of
(a) [******] on which the [****************************] terminates, or (b) the
date of a [*************]. Any sublicense granted hereunder shall be restricted
by the restrictions and conditions of this Company sublicense.
5.3 Joint License. Subject to the terms and conditions of this Agreement,
each of CFFTI and the Company agree that upon termination of the license and
sublicense granted pursuant to Sections 5.1 and 5.2, respectively, because of a
Technical Failure or because the Parties mutually agree following the occurrence
of an Unresolved Deadlock Event not to proceed with Development Activities (a
"Joint License Event"), the Licensed Products shall be licensed jointly, and
hereby is exclusively licensed jointly, to each of CFFTI and the Company
[**************************************************] within North America. All
actions and decisions with respect to the Licensed Products following a Joint
License Event shall be made [******************************], and in the event
that the Licensed Products is sublicensed, sold, or otherwise transferred for
value by mutual agreement of the Parties, all proceeds received or receivable in
such transaction shall be allocated and distributed as follows:
(a) First, [******************] has received an amount in cash and/or
cash equivalents equal to [********************************************] as of
the date of such Joint License Event (the "Funded Grant Amount");
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.
20
(b) Second, [**************************] has received an amount in
cash and/or cash equivalents equal to [*****************************************
*********] during the term of this Agreement for the Products and Development
Activities as of the date of such Joint License Event;
(c) Third, [****************] has received an amount in cash and/or
cash equivalents equal to (i) [**********************], less (ii) [***********
****************] as of the date of the initial disbursements under this Section
5.3(c) and (B) [*********************], and
(d) Fourth, all remaining proceeds shall be distributed to the
[*****].
5.4 Retained Rights of the Company. Notwithstanding the grant of any
license to CFFTI under Section 5.1 or 5.3, or the termination of the Sublicense
granted to the Company under Section 5.2, the Company shall retain all rights,
title, licenses and interest in and to the Intellectual Property and
Improvements outside of CFFTI's license to the Licensed Products for North
America. or the Joint License, respectively, if either of such licenses is in
effect, and the Company shall retain the right to use the Licensed Products and
all data relating to or arising from the Licensed Products for all uses and in
all applications and indications, provided that any products resulting therefrom
shrill be distributed or sold by the Company solely outside of North America,
and the Company shall retain the rights to use Trademarks for products and
purposes unrelated to the Licensed Products.
5.5 Prosecution; Encumbrances; Other Matters. Until the sublicense granted
pursuant to Section 5.2 terminates, (a) the Company shall pursue, prosecute and
maintain any Intellectual Property protections, including registrations, with
respect to the Licensed Products in the United States [*******************
*****************************], (b) the Company shall not create, permit or
suffer to exist, and will defend the Licensed Products against and take such
other action as is reasonably necessary to remove any Encumbrance on the
Licensed Products created by or through the Company (other than any Encumbrances
created by this Agreement or disclosed to CFFTI in Schedule 5.5 hereto), or
created in the ordinary course of business of the Company; (c) the Company shall
be required to make [*********] payments with respect to the Licensed Products
(including without limitation, payments in respect of licenses, regulatory
filings and applications, taxes, royalties and other sums that may become due in
respect of the Licensed Products), and (d) CFFTI may, but shall not be required
to, take any steps CFFTI reasonably deems necessary or appropriate to preserve
any Licensed Products or any rights against third parties to any of the Licensed
Products, at any time when the Company has failed to do so, provided CFFTI has
first provided the Company with written notice of the action CFFTI reasonably
deems necessary or appropriate to preserve any Licensed Products or any rights
against third parties to any of the Licensed Products, and [**************], or
such earlier time as is necessary in order that CFFTI rights are not prejudiced
by delay the Company has not taken the said action or a reasonable alternative
course of action, and the [************************************************],
all documented, reasonable expenses incurred in connection therewith. Until the
license granted pursuant to Section 5.1 terminates CFFTI shall not create,
permit or suffer to exist, and will defend the Licensed Products against and
take such other action as is necessary to remove any Encumbrance on the
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.
21
Licensed Products created by or through CFFTI other than the Encumbrances
created by this Article V or in the ordinary course of business of CFFTI.
5.6 Further Assurances. Each of the Parties shall give, execute, deliver,
file and/or record such notices, instruments, documents, agreements or other
papers that may be necessary or desirable (in the reasonable judgment of the
other Party) to create, preserve, perfect or validate the license, sublicense
and, if applicable, joint license granted pursuant hereto or to enable each of
the Parties to exercise and enforce its respective rights under this Article V.
ARTICLE VI
EVENTS OF DEFAULT
6.1 Company Default. For purposes of this Agreement, a "Company Default"
shall occur upon any of the following events:
(a) specified Milestone to have been satisfied by a specified
Milestone Achievement Date (as amended from time to time by the ASC pursuant to
Section 2.2(b)(i) hereinafter) is not satisfied other than [******
****************************************************************************].
A Company Default will not occur if after the Company's failure to satisfy a
Milestone by the end of the applicable Grace Period, this Agreement has not been
terminated pursuant to and in accordance with its terms and [******
********************************************] with respect to the specified
Milestone;
(b) an Unresolved Deadlock Event shall have occurred, and, provided
that no Technical Failure then exists and the Parties have not agreed in writing
to terminate this Agreement, thereafter the Company determines not to proceed
with Development Activities;
(c) any material default by the Company in the performance of any of
its covenants or agreements in this Agreement that is not cured within
[*************] after written notice from CFFTI of the same (it shall be a
material default under this section if the license purported to be granted by
Section 5.1 shall fail to be exclusive or otherwise in full force or effect in
all material respects (other than in accordance with the terms of this
Agreement));
(d) a case or proceeding under the bankruptcy Laws of the United
States of America now or hereafter in effect is filed against the Company or all
or substantially all its Property and such petition or application is not
dismissed within [******] after the date of its filing or the Company shall file
any answer admitting or not contesting such petition or application; or
(e) a case or proceeding under the bankruptcy Laws of the United
States of America now or hereafter in effect or under any insolvency,
reorganization, receivership, readjustment of debt, dissolution or liquidation
Law or statute of any jurisdiction now or hereafter in effect (whether at a law
or equity) is filed by the Company for all or substantially all of its Property.
6.2 Consequences of a Company Default. Upon the occurrence of a Company
Default, and at any time thereafter unless and until such Company Default has
been waived by
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.
22
CFFTI or cured to the reasonable satisfaction of CFFTI, CFFTI may terminate the
sublicense in Section 5.2 immediately, and CFFTI may take any such action as
CFFTI may have been afforded expressly hereunder or under any other contract or
agreement at any time and exercise such other rights as CFFTI may have pursuant
to applicable Laws, including without limitation a legal action seeking damages
pursuant to the arbitration provisions set forth in Section 11.10.
Notwithstanding a Company Default, CFFTI shall retain all rights to the
Warrants, and all licenses in and to Licensed Products in North America granted
pursuant to Section 5.1 hereunder, subject to the conditions set out in Section
5.1 and the Company's retained rights as set out in Section 5.4 hereunder.
6.3 CFFTI Default. For purposes of this Agreement, a "CFFTI Default" shall
occur upon any of the following events:
(a) CFFTI shall fail to make any Grant payment on the date due after
giving effect to the provisions of Section 2.5(b);
(b) any other material default by CFFTI in the performance of any of
its covenants or agreements in this Agreement that is not cured within
[*************] after notice from the Company of the same (it shall be a
material default under this section if the sublicense purported to be granted by
Section 5.2 shall fail to be exclusive or otherwise in full force or effect in
all material respects (other than in accordance with the terms of this
Agreement));
(c) a case or proceeding under the bankruptcy Laws of the United
States of America now or hereafter in effect is filed against CFFTI or all or
substantially all its Property and such petition or application is not dismissed
within [******] after the date of its filing or CFFTI shall file any answer
admitting or not contesting such petition or application; or
(d) a case or proceeding under the bankruptcy Laws of the United
States of America now or hereafter in effect or under any insolvency,
reorganization, receivership, readjustment of debt, dissolution or liquidation
Law or statute of any jurisdiction now or hereafter in effect (whether at a law
or equity) is filed by the Company for all or substantially all of its Property.
6.4 Consequences of a CFFTI Default. Upon the occurrence of a CFFTI Default
and at any time thereafter unless and until such CFFTI Default has been waived
by the Company or cured to the reasonable satisfaction of the Company, (i) the
license granted by the Company pursuant to Section 5.1 hereunder shall
immediately terminate and the Company may, in its sole discretion, assume or
terminate any sublicenses granted thereunder by CFFTI, (ii) all rights to
[***************************************************************************
******] shall terminate immediately, and (iii) the Company may take any such
other action that the Company may have been afforded expressly hereunder or
under any other contract or agreement at any time and exercise such other rights
as the Company may have pursuant to applicable Law, including without
limitation, a legal action seeking damages pursuant to the arbitration
provisions set forth in Section 11.10 hereof.
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.
23
ARTICLE VII
CONFIDENTIALITY; PUBLICATIONS ; PUBLICITY
7.1 Confidentiality. Each of the Parties hereto acknowledges that it may
have access to materials and information of the other Party that is
confidential, and that certain data, results, plans, and information arising
from and relating to the Development Activities and the Products may be
confidential (the "Confidential Material"). Each Party receiving Confidential
Material agrees to keep confidential the Confidential Material and all
information therein, and agrees to treat the same with the same degree of
protection it would afford to its own Confidential Material, and shall require
its employees, agents and representatives to do so, and neither Party shall use
or disclose the Confidential Material or the information therein in any way or
for any purposes other than as is reasonably necessary to accomplish the
purposes of this Agreement. Notwithstanding the foregoing, the term Confidential
Material does not include information that (a) is or becomes publicly available
other than through breach of this provision, (b) is already known to a Party at
the time of disclosure or is independently developed by a Party without
reference to the Confidential Material as demonstrated by business records, (c)
is received by a Party from a third party not under a duty of confidentiality to
the other Party. Each of the Parties agrees to take reasonable precautions to
safeguard the Confidential Material from disclosure to anyone other than
appropriate employees, officers, directors, partners and representatives,
including auditors and attorneys, of such Party, which Persons shall be advised
of the confidential nature of the material. In the event that a Party or any of
its representatives receives a request or demand to disclose all or any part of
the Confidential Material under the terms of a subpoena or order issued by a
court of competent jurisdiction or otherwise, the receiving Party shall notify
the other Party of the existence, terms and circumstances surrounding such
request or demand so that the other Party may seek a protective order or other
appropriate relief or remedy or waive compliance with the terms hereof and if,
in the opinion of receiving Party's counsel, disclosure by receiving Party of
all or any part of the Confidential Material is required by Law, the receiving
Party shall notify the other Party of the proposed disclosure, and disclose only
such Confidential Material which is required by Law (in the reasonable opinion
of the disclosing Party's counsel) to be disclosed.
7.2 Public Announcements. The Company and CFFTI shall consult with, and
obtain the prior approval of the other, which shall not be unreasonably withheld
or delayed, before issuing any press release or otherwise making any public
statements with respect to the Product, CFFTI or the transactions contemplated
hereby. Notwithstanding the foregoing, this Section 7.2 shall not preclude any
Party from issuing such press releases, making such other public statements or
making such filings with or applications to governmental bodies with respect to
the transactions contemplated hereby, as such Party in, good faith believes to
be required under applicable Law; provided that reasonable prior notice of the
content thereof and of the basis for such belief shall be provided to the other
Party.
7.3 Publications. Subject to Sections 7.1 and 7.2, in the event the Parties
hereto wish to publish any research papers relating to the Product or the
Development Activities, representatives of the Parties may be co-authors of such
papers, subject to customary scientific practices; provided however, each
Party's contribution to the research described in such papers will be
acknowledged in all such papers, regardless of authorship. To afford each of the
Parties
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.
24
an opportunity to determine that no Confidential Material of such Party is
disclosed in any proposed publications, whether written or oral (including
without limitation, presentations to a journal or editor or other written
materials, abstracts, presentations to a seminar, meeting or other third party
or any other oral disclosure or abstract) and that patent filings or other
Intellectual Property Rights will not be jeopardized, and to keep each Party
informed of upcoming disclosures, each Party will provide the other with an
advance copy of any proposed publication or abstract relating to the Products at
least [**************] prior to submission of such manuscript or [**************
**] prior to presentation if such publication is to be made orally. At the
non-publishing Party's request, the publishing Party will delay submitting such
manuscripts and will cooperate by making any such redactions or revisions to the
proposed publications that will allow the non-publishing Party to take such
steps it deems necessary to file patent applications or otherwise protect its
Confidential Material and Intellectual Property Rights.
ARTICLE VIII
INDEMNIFICATION AND INSURANCE
8.1 CFFTI Indemnification. CFFTI agrees to defend, indemnify and hold the
Company and its Affiliates and their respective directors, officers, employees,
agents and shareholders, harmless from and against any losses, costs, claims,
liabilities or expenses (including reasonable attorney's fees and expenses of
litigation) claimed by Persons not covered by this indemnification arising out
of or in connection with the research and development, manufacture, use,
promotion, marketing, sale or other distribution of the Products by CFFTI or its
Affiliates or licensees if the sublicense granted pursuant to Section 5.2 is
terminated pursuant to Section 5.2(b), except to the extent that such claims
result from the negligence or willful misconduct of the Company or its
Affiliates and any of their respective officers, directors, employees or agents.
8.2 Company Indemnification. The Company agrees to defend, indemnify and
hold CFFTI and its Affiliates and their respective directors, officers,
employees and agents, harmless from and against any losses, costs, claims,
liabilities or expense (including reasonable attorney's fees and expenses of
litigation) claimed by Persons not covered by this indemnification arising out
of or in connection with the research and development, manufacture, use,
promotion, marketing, sale, or other distribution of the Products by the Company
or its Affiliates, except to the extent that such claims result from the
negligence or willful misconduct of CFFTI or its Affiliates and any of their
respective officers, directors, employees or agents, it being the intent of the
Parties that the Company be the developer and study sponsor of the Products and
that CFFTI shall have no legal or other obligations to any Person in respect of
the development or use of the Products unless and until the sublicense granted
pursuant to Section 5.2 is terminated pursuant to Section 5.2(b).
8.3 Procedure. The Parties agree to promptly notify each other of any claim
or liability subject to this Article 8. The indemnifying Party will have the
right to [*****] the defense thereof with counsel of its choice; provided
however, that the indemnified Party will have the right to retain
[*************] at its own expense for any reason. The indemnified party will
cooperate with the indemnifying Party and its legal representatives in the
investigation
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.
25
of any action, claim or liability covered by this Article 8. The indemnified
Party will not, except at its own cost, voluntarily make any payment or incur
any expense with respect to any claim or suit or settle any indemnified action,
claim or liability covered by this Article 8 without the prior written consent
of the indemnifying Party.
8.4 Insurance. The Parties will maintain insurance with financially sound
and reputable insurance companies or associations in such amounts and covering
such risks as are usually carried by companies engaged in a similar business and
owning similar Properties in the same general geographical areas in which the
respective Parties operate.
ARTICLE IX
CONDITIONS PRECEDENT
9.1 Conditions to Obligations of the Company at the Initial Grant Funding.
The obligation of the Company to consummate the transactions which pursuant to
the terms hereof shall be effected at the Initial Alliance Grant Funding is
subject to the satisfaction or waiver at the Initial Alliance Grant Funding of
the conditions set forth below. The benefit of these conditions is for the
Company only and may be waived in writing by the Company at any time in its sole
discretion.
(a) Accuracy of Representations and Warranties of CFFTI. Each of the
representations and warranties of CFFTI contained herein shall be true and
correct in all material respects at and as of the Initial Alliance Grant Funding
Date.
(b) Performance by CFFTI. At or before the Initial Alliance Grant
Funding, CFFTI shall have performed, satisfied and complied with, in all
material respects, all covenants, agreements and conditions required to be
performed by it under this Agreement at or before the Initial Alliance Grant
Funding.
(c) Deliveries by CFFTI at the Initial Alliance Grant Funding. At or
before the Initial Alliance Grant Funding, CFFTI will deliver, or cause to be
delivered, to the Company, against delivery of a certificate representing the
Warrants duly registered in the name of CFFTI,
(i) the Initial Grant Funding Amount in accordance with Section
2.5(a);
(ii) a copy of the Registration Rights Agreement duly executed by
CFFTI;
(iii) a copy of the warrants duly executed by CFFTI;
(iv) a copy of the Certificate of Incorporation of CFFTI, certified by
the Secretary of State of Maryland not more than thirty (30) days prior to the
Initial Alliance Grant Funding Date;
(v) a certificate, dated as of the Initial Alliance Grant Funding
Date, executed by the Secretary of CFFTI and certifying (A) that the Certificate
of Incorporation of CFFTI has not been amended since the date of the certified
copy of such Certificate of Incorporation delivered pursuant to (iv) above; (B)
that attached thereto are (x) true, complete and correct
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.
26
copies of the by-laws of CFFTI, as in full force and effect on the Initial
Alliance Grant Funding Date and (y) true, complete and correct copies of the
resolutions of the Board of Directors of CFFTI authoring the execution, delivery
and performance of this Agreement, the Registration Rights Agreement, the
Warrants and the transactions contemplated by this Agreement and by such other
agreements, which resolutions were duly adopted, are in full force and effect
and have not been rescinded or amended as of the Initial Alliance Grant Funding
Date; and (C) as to the incumbency and specimen signatures of officers of CFFTI
who shall have executed instruments, agreements and other documents in
connection with the transactions contemplated by this Agreement;
(vi) a certificate, dated as of the Initial Alliance Grant Funding
Date, executed by the Secretary of the CFFTI and certifying (i) true, complete
and correct copies of the resolutions of the Board of Directors of CFFTI
authorizing the execution, delivery and performance by CFFTI of this Agreement,
the Registration Rights Agreement, the Warrants and the transactions
contemplated by this Agreement and by such other agreements and evidencing the
commitment of CFF to lend assistance to CFFTI in the performance of CFFTI's
obligation under the Agreement including a commitment to fund CFFTI in a manner
sufficient to enable CFFTI to perform its payment obligations under this
Agreement and (ii) the Affiliate relationship between CFF and CFFTI, which
resolutions were duly adopted, are in full force and effect and have not been
rescinded or amended as of the Initial Alliance Grant Funding Date;
(vii) an opinion of counsel to CFFTI in form and substance reasonably
satisfactory to the Company dated as of the Initial Alliance Grant Funding Date;
and
(viii) and the Investor's Representation Letter dated as of the
Initial Alliance Grant Funding Date (in the form of Exhibit 9.1 hereto) duly
executed by CFFTI.
9.2 Conditions to Obligations of CFFTI at the Initial Alliance Grant
Funding. The obligation of CFFTI to consummate the transactions which pursuant
to the terms hereof shall be effected at the Initial Alliance Grant Funding is
subject to the satisfaction or waiver at or as of the Initial Alliance Grant
Funding of the conditions set forth below. The benefit of these conditions is
for CFFTI only and may be waived in writing by CFFTI at any time in its sole
discretion.
(a) Accuracy of Representations and Warranties of the Company. Each of
the representations and warranties of the Company contained herein shall be true
and correct in all material respects at and as of the Initial Alliance Grant
Funding Date.
(b) Performance by the Company. At or before the Initial Alliance
Grant Funding, the Company shall have performed, satisfied and complied with, in
all material respects, all covenants, agreements and conditions required to be
performed by it under this Agreement at or before the Initial Alliance Grant
Funding.
(c) Registration Rights Agreement. The Company and CFFTI shall have
entered into a registration rights agreement in form and substance as set forth
in Exhibit 8.3(d) attached hereto (the "Registration Rights Agreement"), and
such Registration Agreement shall be in full force and effect as of the Initial
Alliance Grant Funding.
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.
27
(d) Warrants. The Company and CFFTI shall have executed and the
Company shall deliver the Warrants to CFFTI and such Warrants shall be in full
force and effect as of the Initial Grant Alliance Funding.
(e) Documents and Deliveries by the Company at the Initial Alliance
Grant Funding. At or before the Initial Alliance Grant Funding, the Company
shall have delivered to CFFTI each of the following:
(i) a certificate, dated as of the Initial Alliance Grant Funding
Date, executed the President of the Company, certifying that (A) the
representations and warranties of the Company set forth in this Agreement are
true and correct as of the Initial Alliance Grant Funding Date, and (B) the
Company has performed and complied with all agreements, covenants and conditions
contained in this Agreement required to be performed and complied with by it at
or prior to the Initial Alliance Grant Funding;
(ii) a copy of the Certificate of Incorporation of the Company,
certified by the Secretary of State of the Commonwealth of Massachusetts not
more than thirty (30) days prior to the Initial Alliance Grant Funding Date;
(iii) a certificate, dated as of the Initial Alliance Grant Funding
Date, executed by the Assistant Clerk of the Company and certifying (A) that the
Certificate of Incorporation of the Company has not been amended since the date
of the certified copy of such Certificate of Incorporation delivered pursuant to
(ii) above; (B) that attached thereto are (x) true, complete and correct copies
of the by-laws of the Company, as in full force and effect on the Initial
Alliance Grant Funding Date and (y) true, complete and correct copies of the
resolutions of the Board of Directors of the Company authorizing the execution,
delivery and performance of this Agreement, each of the other Company Closing
Documents and the transactions contemplated by this Agreement, which resolutions
were duly adopted, are in full force and effect and have not been rescinded or
amended as of the Initial Alliance Grant Funding Date; and (C) as to the
incumbency and specimen signatures of officers of the Company who shall have
executed instruments, agreements and other documents in connection with the
transactions contemplated by this Agreement; and
(iv) an opinion of counsel to the Company in form and substance
reasonably satisfactory to CFFTI dated, as of the Initial Alliance Grant Funding
Date.
ARTICLE X
TERMINATION
10.1 CFFTI Right to Terminate. Notwithstanding anything to the contrary set
forth in this Agreement, subject to Section 10.4, CFFTI's obligations under this
Agreement (including without limitation its obligations to fund the Grant or any
particular CFFTI Funding Amount) may be terminated by CFFTI by written notice to
the Company as follows:
(a) if all the conditions to the Initial Alliance Grant Funding shall
not have occurred or been waived by February 22, 2001; 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.
28
(b) at any time upon the occurrence of a Company Default that has not
been cured by the Company or waived by CFFTI; provided however that upon the
occurrence of a Bankruptcy Event of Default with respect to the Company, CFFTI's
obligation to fund the Grant and any particular CFFTI Funding Amount hereunder
shall terminate immediately without any further action of CFFTI.
(c) within [**************] after the Phase IIb Milestone Date, CFFTI
may terminate this Agreement in its sole discretion without cause by sending a
written notice of termination to the Company. Such termination shall not be
deemed a CFFTI Default provided that: (i) CFFTI pays the Company within
[**************] of the date of such notice, an amount that is the [************
********************************************] Warrant B and in the form attached
hereto as Exhibit 2.3(b)(ii) as of the date of such termination, or (ii) the
Parties agree in writing to a reasonable alternative course of action. Upon such
termination, CFFTI's license under Section 5.1 and rights to License Fees will
terminate immediately, provided however, after the Approval Date, in the event
of sales of the Products, the Company will pay royalties
[**********************************************] to CFFTI, by paying to CFFTI
[****************] of Net Sales, provided, however, if the Company sells or
distributes the Products through [***********************************], the
Company will pay CFFTI [*****************] of any royalties on Net Sales
received therefrom by the Company, in either case pursuant to a payment schedule
to be agreed upon by the Parties. Each payment made by the Company to CFFTI
hereunder shall be accompanied by a written report summarizing the data used to
calculate the amounts paid, including the amount of Net Sales and supporting
information reasonably necessary to determine royalties due.
10.2 Company's Right to Terminate. Notwithstanding anything to the contrary
set forth in this Agreement, subject to Section 10.4, the Company's obligations
under this Agreement may be terminated by the Company by written notice to CFFTI
as follows:
(a) upon the occurrence of a CFFTI Default that has not been cured by
CFFTI or waived by the Company provided however, that upon the occurrence of a
Bankruptcy Event of Default with respect to CFFTI this Agreement and the license
under Section 5.1 shall immediately terminate without any further action of the
Company.
10.3 Other Terminations of Agreement. Notwithstanding anything to the
contrary set forth in this Agreement but subject to Section 10.4 hereinbelow:
(a) The Company and CFFTI may terminate this Agreement by mutual
written consent (whether after an Unresolved Deadlock Event shall have occurred
the Parties determine not to proceed with Development Activities or otherwise);
(b) This Agreement shall automatically terminate and have no further
force and effect upon the occurrence of a Technical Failure.
10.4 Consequences of Termination. In the event of a termination pursuant to
Section 10.1, 10.2 or 10.3, this Agreement shall terminate in its entirety and
be of no further force or effect; provided however that the provisions of
Articles VII, VIII (other than Section 8.4), and this Section 10.4 shall survive
any such termination; and provided further that in the event of a
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.
29
termination pursuant to Section 10.1(b), Article V and Article VI (with respect
to the consequences of such termination) and Section 11.10 (with respect to the
consequences of such termination) shall also survive such termination; and
provided further that in the event of a termination pursuant to Section 10.1(c),
Section 10.1(c) shall survive any such termination and provided further that in
the event of a termination pursuant to Section 10.2, Article VI (with respect to
the consequences of such termination) and Section 11.10 (with respect to the
consequences of such termination) shall also survive such termination; and
provided further that in the event of a termination pursuant to Section 103(b)
or if after an Unresolved Deadlock Event shall have occurred the Parties
determine not to proceed with Development Activities, Article V shall survive
such termination.
ARTICLE XI
MISCELLANEOUS
11.1 Notices. Any notice, request, information or other document to be
given under this Agreement to any Party by any other Party shall be in writing
and delivered personally, sent by registered or certified mail, postage prepaid,
delivered by a nationally recognized overnight courier service or transmitted by
facsimile machine to such Party at the following addresses or facsimile numbers
(or at such other address or facsimile numbers that a Party may specify by like
notice):
If to the Company, to:
Altus Biologics Inc.
000 Xxxxxx Xxxxxx
Xxxxxxxxx, XX 00000
Attention: Xxxxx Xxxxxxxx, President
Telephone No.: (000) 000-0000
Telecopier No.: (000) 000-0000
with a copy to:
Mintz Xxxxx Xxxx Xxxxxx Xxxxxxx and Xxxxx, PC
Xxx Xxxxxxxxx Xxxxxx
Xxxxxx, Xxxxxxxxxxxxx 00000
Attention: Xxx X. Xxxxxxxxxx
Telephone No.: (000) 000-0000
Telecopier No.: (000) 000-0000
If to CFFTI:
Cystic Fibrosis Foundation Therapeutics, Inc.
0000 Xxxxxxxxx Xxxx
Xxxxxxxx, XX 00000
Attention: Xx. Xxxxxx Xxxxx, President
Telephone No.: (000) 000-0000
Telecopier No.: (000) 000-0000
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.
30
with a copy to:
Xxxxxxx Berlin Shereff Xxxxxxxx, LLP
0000 X Xxxxxx, X.X., Xxxxx 000
Xxxxxxxxxx, XX 00000
Attention: Xxxxxxx X. Xxxxxxx, Esq.
Telephone No.: (000) 000-0000
Telecopier No.: (000) 000-0000
11.2 Captions. The captions in this Agreement are for convenience of
reference only and shall not be given any effect in the interpretation of this
Agreement.
11.3 Expenses. Except as otherwise provided herein, each Party agrees to
pay all costs incurred by it in connection with the negotiation, execution and
closing of any of the transactions contemplated by this Agreement, including
without limitation, all out-of-pocket costs, accounting fees and legal fees.
11.4 No Waiver. The failure of a Party to insist upon strict adherence to
any term of this Agreement on any occasion shall not be considered a waiver or
deprive that Party of the right thereafter to insist upon strict adherence to
that term or any other term of this Agreement. Any waiver must be in writing.
11.5 Severability; Integrated Transaction. In the event any one or more
provisions of this Agreement is held to be invalid or unenforceable in any
respect, in whole or in part, such illegality or unenforceability shall not
affect the validity or enforceability of the other provisions hereof and such
other provisions shall remain in full force and effect, unaffected by such
invalidity or unenforceability; provided however that the Parties intend that
the transactions contemplated by this Agreement be treated as one integrated
transaction and that this Agreement not be subdivided for any purpose into
separately assignable agreements.
11.6 Entire Agreement. This Agreement contains the entire agreement between
the Parties hereto with respect to the matters contemplated herein and
supersedes all prior agreements or understandings among the Parties related to
such matters.
11.7 Amendment. Except as otherwise provided herein with respect to the
Work Plan and the Milestone Grant Funding Plan attached hereto, this Agreement
may not be amended or modified except by a written instrument signed by the
Parties.
11.8 Limitation on Assignment. The terms, representations, warranties and
covenants contained in this Agreement shall be binding upon, and shall inure to
the benefit of, and be enforceable by, the Company and CFFTI and their
respective successors, transferees and permitted assigns. This Agreement will
not be assignable by either Party to any third party without the prior written
consent of the other Party; except that either Party may assign this Agreement
without such consent to an Affiliate of such Party provided that,
notwithstanding such assignment, the assigning Party shall retain its
obligations pursuant to this Agreement. Without limiting the foregoing, CFFTI
acknowledges that the Company intends to enter into a migratory merger for the
purpose of changing the Company's jurisdiction of incorporation from
Massachusetts to Delaware and consents to such migratory merger.
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.
31
11.9 Governing Law. This Agreement shall be construed in accordance with,
and governed by, the internal laws of the Commonwealth of Massachusetts, without
giving effect to the principles of conflict of laws thereof.
11.10 Arbitration. The Parties recognize the disputes as to certain matters
may from time to time arise during the term of this Agreement other than matters
within the purview of the ASC as set out in Section 2.2 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 such disputes arising
under this Agreement in an expedient manner by mutual cooperation and without
resorting to arbitration or litigation; except as set forth herein below. The
Parties agree that prior to any arbitration concerning this Agreement, they will
pursue the same dispute resolution procedures set out in Section 2.2, whereby
disputes will be elevated first to a member of CFFTI's senior management and the
Company's president or CEO, who will meet and attempt in good faith to resolve
any disputes concerning this Agreement, and thereafter any unresolved disputes
will be elevated to members of the Parties' respective Boards of Directors, and
thereafter, any unresolved disputes will be referred to mediation. Thereafter,
in the event a dispute other than matters within the purview of the ASC as set
out in Section 2.2 shall remain unresolved, within thirty (30) days of a formal
request by either Party to the other, any Party may, by written notice to the
other, have such dispute referred for final and binding arbitration to be
conducted in Washington, D.C. if the arbitration is requested by the Company, or
in Boston, Massachusetts if the arbitration is requested by CFFTI, unless the
Parties agree otherwise on a location. The arbitration will be conducted under
the then current Commercial Arbitration Rules of the American Arbitration
Association ("AAA"), by three (3) arbitrators who are knowledgeable in the
subject matter that is at issue in the dispute. One arbitrator will be selected
by CFFTI and one arbitrator will be selected by the Company and the third
arbitrator will be appointed by the AAA. In conducting the arbitration, the
arbitrators will determine what discovery will be permitted, consistent with the
goal of limiting the cost and time which the Parties must expend for discovery
(and provided that the arbitrators will permit such discovery they deem
necessary to permit an equitable resolution of the dispute) and will be able to
decree any and all relief of an equitable nature, including but not limited to
such relief as a temporary restraining order, a preliminary injunction, a
permanent injunction, or specific performance. The arbitrators will also be able
to award actual or general damages (taking into account the agreements of the
Parties contained herein) and attorney's fees and expenses and other reasonable
costs incurred in by the prevailing Party in such arbitration, and shall give
effect to any liquidated damages provisions contained herein in making such
award. The arbitrators will not award any other form of damage (e.g.,
consequential, punitive or exemplary damages). During the course of the
arbitration neither Party may fail to perform its obligations under this
Agreement. The Parties will share equally the arbitrator's fees and expenses
pending the resolution of the arbitration unless the arbitrators require the
non-prevailing Party to bear all or any portion of the costs of the prevailing
Party. The decision of the arbitrators will be final and binding and may be
enforced by the Party in whose favor it runs in any court of competent
jurisdiction at the option of such Party. Notwithstanding anything to the
contrary in this Section 11.10, either Party may seek immediate injunctive or
other interim relief from any court of competent jurisdiction with respect to
any breach of Article V or Article VII hereof, or otherwise to enforce and
protect the patent rights, copyrights, trademarks, or other intellectual
property rights owned or controlled by such Party. In no event will a demand for
arbitration be made after
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.
32
the date when the institution of a legal or equitable proceeding based on such
claim, dispute or other matter in question would be barred by the applicable
statute of limitations.
11.11 Counterparts. This Agreement may be executed in counterparts, each of
which shall be deemed an original, and all of which together shall constitute a
single agreement. Facsimile transmissions of any executed original document
and/or retransmission of any executed facsimile transmission shall be deemed to
be the same as the delivery of an executed original.
11.12 Force Majeure. Neither Party will be liable to the other for failure
or delay in the performance of any of its obligations under this Agreement for
the time and to the extent such failure or delay is caused by earthquake, riot,
civil commotion, war, hostilities between nations, Law, Judgment embargo, action
by the governmental body, act of God, storm, fire, accident, labor dispute or
strike, sabotage, explosion, or other similar or different contingencies, in
each case, beyond the reasonable control of the respective Party.
11.13 Independent Contractors. The relationship between the Parties will be
that of independent contracting parties and nothing in this Agreement will be
construed to create any other relationship between CFFTI and the Company. Except
as expressly provided herein, no Party will have the right, power or authority
to assume, create or incur any expense, liability or obligation, express or
implied, on behalf of any of the other Parties.
11.14 Further Assurances. At any time and from time to time, upon the
written request of CFFTI and at the sole expense of the Company, the Company
will promptly and duly execute and deliver any and all such further instruments,
documents and agreements and take such further actions as CFFTI may reasonably
require in order for CFFTI to obtain the full benefits of this Agreement
excluding any filings or actions required under the Xxxx Xxxxx Xxxxxx Act of
1974, as amended, in connection with the licenses provided under Article V or
the exercise of the Warrants and excluding any filings or actions required to
register the Warrants or the Shares under the Securities Act other than any such
filings or actions as are required pursuant to the terms of the Registration
Rights Agreement. At any time and from time to time, upon the written request of
the Company and at the sole expense of CFFTI, CFFTI will promptly and duly
execute and deliver any and all such further instruments, documents and
agreements and take such further actions as the Company may reasonably require
in order for the Company to obtain the full benefits of this Agreement and the
Warrants.
11.15 Survival. The representations or warranties of the Company and CFFTI
contained herein, or in other instruments or agreements delivered or to be
delivered at or prior to the Initial Alliance Grant Funding shall survive the
Initial Alliance Grant Funding and in the event of a material default thereof
the non-breaching Party may exercise such rights as it may have pursuant to
applicable Law, including without limitation, a legal action seeking damages
pursuant to the arbitration provisions set forth in Section 11.10 hereof.
[END OF PAGE]
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.
33
IN WITNESS WHEREOF, the Parties hereto have executed this Strategic
Alliance Agreement as of the date first above written.
ALTUS BIOLOGICS INC.
By: /s/ Xxxxx Xxxxxxxx
------------------------------------
Xxxxx Xxxxxxxx
President
CYSTIC FIBROSIS FOUNDATION THERAPEUTICS,
INC.
By:
------------------------------------
Xx. Xxxxxx Xxxxx
President
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.
34
IN WITNESS WHEREOF, the Parties hereto have executed this Strategic
Alliance Agreement as of the. date first above written.
ALTUS BIOLOGICS INC.
By:
------------------------------------
Xxxxx Xxxxxxxx
President
CYSTIC FIBROSIS FOUNDATION THERAPEUTICS,
INC.
By: /s/ Xx. Xxxxxx Xxxxx
------------------------------------
Xx. Xxxxxx Xxxxx
President
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.
35
This First Amendment to Strategic Alliance Agreement, is made as of
September 26, 2001 (this "First Amendment Agreement"), by and between Altus
Biologics Inc., a Delaware corporation (the "Company"), and Cystic Fibrosis
Foundation Therapeutics, Inc., a Maryland corporation ("CFFTI" and collectively,
with the Company, the "Parties," and each a "Party"). Capitalized terms used and
not otherwise defined herein shall have the respective meanings ascribed to them
in the Strategic Alliance Agreement dated as of February 22, 2001 (the
"Agreement").
WHEREAS, CFFTI and the Company's predecessor, Altus Biologics Inc., a
Massachusetts corporation ("Altus Massachusetts"), were parties to the
Agreement;
WHEREAS, Altus Massachusetts was merged with and into the Company for the
purpose of reincorporating Altus Massachusetts as a Delaware corporation, and as
a result of such migratory merger, to which CFFTI had previously consented
pursuant to Section 11.8 of the Agreement, the Company succeeded to all of the
rights and obligations of Altus Massachusetts under the Agreement and the
related Warrants (Nos. W-5A and W-5B) and Registration Rights Agreement, each
dated February 22, 2001, between CFFTI and Altus Massachusetts, to the same
extent as if the Company were the original party thereto;
WHEREAS, the Company is pursuing a financing transaction whereby it intends
to raise working capital through the issuance of Series B Convertible Preferred
Stock (the "Series B Stock"), and the prospective purchasers of the Series B
Stock (the "Series B Investors") require certain amendments to the Agreement as
a condition to their investment in the Company; and
WHEREAS, the Parties desire to amend the Agreement hereby and provide for
the cancellation of the Registration Rights Agreement and inclusion of CFFTI as
a party to the new registration rights agreement to be entered into by the
Company and the purchasers of the Series B Stock;
NOW, THEREFORE, for good and valuable consideration, the receipt and
sufficiency of which is hereby acknowledged, the Parties hereby agree as
follows:
1. AMENDMENTS.
1.1 New Definitions. In Article I of the Agreement, the following new
definitions are added to the definitions list in the appropriate alphabetical
order:
"Base Exercise Price" shall have the meaning assigned to such
term in Section 2.8 below.
"Call Option" shall have the meaning assigned to such term in
Section 2.8 below.
"Combined Net Sales" shall mean the gross invoiced sales price of
any Products and Other Products sold by the Company, its Affiliates or its
sublicensees [**********************************************], less the
following amounts incurred
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.
36
in the ordinary course of business with respect to such sales to the extent
separately included in the invoice for the Products and Other Products as part
of the gross invoiced sales price:
(a) trade, cash and quantity discounts or rebates [*******************
***];
(b) credits or allowances given or made for rejection of or return of,
and for uncollectible amounts on, previously sold Products or Other Products or
for retroactive price reductions [**********************************************
*************];
(c) charges for insurance, freight, and other transportation costs
[**************************] of Products and Other Products; and
(d) sales, transfer and other excise taxes levied on the sale or
delivery of Products or Other Products (including any tax such as a value added
or similar tax or government charge) borne by the seller thereof, [*************
**********************************].
"First Amendment Agreement" shall mean the First Amendment to the Agreement
dated as of September 26, 2001 by and between the Company and CFFTI.
"Other Products" shall mean pharmaceutical products developed by or on
behalf of the Company, currently identified by the Company as "TheraCLEC
Total(TM)", and any derivatives thereof, which contain the [********************
****], and either or both of the [***************************************], and
which are, in either case, designed to treat any other indication other than
[***********************************].
"Other Product Development Activities" shall mean activities related to the
development and marketing of the Other Products, which shall include research,
development, animal tests, clinical trials and other testing, seeking applicable
approvals of governmental bodies and others, manufacturing, marketing,
promotion, sales, and distribution activities, and any other act or acts
required or reasonably necessary to obtain the necessary approvals for the
marketing and distribution of Other Products or to otherwise market and sell the
Other Products in compliance with any applicable Law.
"Success Fee" shall mean, as of the date of determination, the sum of (i)
the [******************************************] during the period from the
effective date of the Agreement through such date of determination,
[****************************************] and (ii) the [**********************
********************************************************************************
**************************************] with respect to each incremental CFFTI
Funding Amount comprising the cumulative CFFTI Funding Amount from and after the
date CFFTI actually funds each such incremental CFFTI Funding Amount; provided,
however, that the Success Fee shall not exceed [******************************
***].
"Warrant C" shall mean the Company's warrant to acquire an aggregate of two
hundred thousand (200,000) shares of Common Stock in the form of Warrant 5-C
issued and delivered to CFFTI pursuant to the First Amendment 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.
37
1.2 Amendment of Certain Definitions. In Article I of the Agreement, the
following definitions are amended as indicated:
(a) The definition of "Approval Date" is deleted in its entirety and
the following new definition is inserted in lieu thereof:
"Approval Date" shall mean (i) in the case of Products that are regulated
as drugs by the FDA, the earlier of the date on which the Company receives from
the FDA an approvable letter under 21 CFR Section 314.110 or an approval letter
under 21 CFR Section 314.105, or (ii) in the case of Products that are regulated
as biologics by the FDA, the earlier of the date on which the Company receives
from the FDA an approval letter or biologics license under 21 CFR Section 601.4.
(e) The definition of "Common Stock" is deleted in its entirety and
the following new definition is inserted in lieu thereof:
"Common Stock" shall mean the Class A Common Stock, $.01 par value per
share, of the Company, as authorized pursuant to Article FOURTH of the Amended
and Restated Certificate of Incorporation of the Company to be filed with the
Secretary of State of the State of Delaware and made effective as of the date of
the initial closing of the issuance of Series B Stock.
(f) The term "Company" shall have the meaning set forth in the
preamble of the First Amendment Agreement.
(g) The definition of "Warrants" is deleted in its entirety and the
following new definition is inserted in lieu thereof:
"Warrants" shall mean, collectively, Warrant A, Warrant B and Warrant C.
1.3 Section 2.3(b) of the Agreement is amended by deleting the text
"(together the "Warrants")" appearing at the end of such Section.
1.4 Section 2.3 of the Agreement is amended to add clause (n) at the end
thereof which shall read in its entirety as follows:
(n) following the Approval Date until exercise by the Company of the
Call Option and payment in full of all amounts due in respect thereof, control
and be primarily responsible for the conduct of the Other Product Development
Activities, and use good faith, commercially reasonable efforts, consistent with
the Company's business plan, to develop the Other Products and bring the Other
Products to market in [**********************] as soon as reasonably
practicable, including obtaining all necessary approvals of applicable
governmental bodies for the marketing and distribution of the Other Products in
[**********************]. Other Product Development Activities will be conducted
by the Company, or the Company will cause its subcontractor(s) to conduct Other
Product Development Activities, in accordance with accepted ethical principles
and regulatory requirements in facilities selected by the Company which are
reasonable and adequate for the conduct of Other Product Development Activities.
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.
38
1.5 Section 2.6 of the Agreement is deleted in its entirety and the
following new Section 2.6 is inserted in lieu thereof:
"2.6 License Fee
(a) On the Approval Date, the Company shall be obligated to pay to
CFFTI an amount in cash in United States dollars equal to the amount by which
the Succecs Fee exceeds the Fair Market Value of the Shares as of the Approval
Date (such excess is referred to herein as the "License Fee").
(h) The License Fee shall be paid as follows: (i) [*********] after
the Approval Date, the Company shall pay by wire transfer of immediately
available funds to an account designated in writing by CFFTI an amount equal to
the greater of (A) [********] or (B) [***********************] of the License
Fee, whichever is higher, and (ii) [*****************] of such date, the Company
shall pay by wire transfer of immediately available funds to an account
designated in writing by CFFTI an amount equal to the greater of (A) [********]
or (B) [***********************] of the License Fee, whichever is higher
[*****************************************************************] until the
License Fee (plus all accrued interest thereon) has been paid in full. Interest
on the outstanding balance of the License Fee shall be compounded annually and
accrue on the outstanding balance of the License Fee at the Regular Rate. If a
Company Default occurs following the Approval Date, the entire unpaid License
Fee shall become immediately due and payable without any action of CFFTI, and
the Company shall immediately pay such amount to CFFTI, and such overdue amounts
shall bear interest at a rate equal to the Regular Rate plus [***************]."
(i) The license granted to CFFTI under Section 5.1 and all sublicenses
thereunder shall terminate upon either the exercise by the Company of the Call
Option and payment in full of all amounts due in respect thereof or, if later,
upon payment in full of the License Fee. Upon such termination, CFFTI shall
promptly transmit to the Company all products and information and promotional or
marketing materials and data relating to the Products or Other Products that are
in the possession of CFFTI or any sublicensees of CFFTI other than the Company.
1.6 The following new Section 2.7 is added to the Agreement:
"2.7 Royalties on Combined Net Sales. After the Approval Date (or, if the
Approval Date has not occurred but the Company is selling Other Products) and
until exercise of the Call Option, and provided (a) CFFTI has not exercised its
right to terminate under Section 10.1 and (b) CFFTI has funded the full amount
of the Grant in accordance with the terms of this Agreement, the Company will
pay royalties to CFFTI in the amount of [******************************] of
Combined Net Sales until the later of either (x) [******************************
************] of any United States patent covering the Products or Other
Products, including patents granted after the date of the First Amendment
Agreement, or (y) [******************************************] of the United
States patents that [*********************************************************]
(which are
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.
39
Patent No. [*******]; Patent No. [*******]; Patent No. [*******]; Patent No.
[*******]; Patent No. [*******]; and Patent No. [********]. Royalties under this
Section 2.7 shall be payable on a [*******] basis within [**************]
following the end of each [**************] for which royalties are due. Each
payment made by the Company to CFFTI under this Section 2.7 shall be accompanied
by a written report summarizing the data used to calculate the amounts paid,
including the amount of Combined Net Sales worldwide on a country by country
basis and supporting information reasonably necessary to determine the amount of
royalties due under this Section 2.7. Upon the written request of CFFTI, and no
more frequently than [***] in any calendar year, the Company shall permit an
independent certified public accountant selected by CFFTI to have access during
normal business hours to such records of the Company as may be reasonably
necessary to verify the accuracy of royalties payable and reports made
hereunder. If such audit reveals that any additional royalty was required during
the audited period, such royalty shall be paid promptly to CFFTI. The fees
charged by such accountant shall be paid by CFFTI, unless the audit discloses
that the royalties for the audited period are deficient by more than
[***************], in which case the Company shall pay the
[**************************] charged by the independent certified public
accountant."
1.7 The following new Section 2.8 is added to the Agreement:
"2.8 Call Option. On and after the Approval Date, the Company shall have
the right and option to purchase (the "Call Option") the royalty stream
described in Section 2.7 above from CFFTI at an exercise price determined as
follows:
(a) On or prior to the [****************] after the Approval Date, the
exercise price shall be [************]: the sum of: (1) the [*********], and (2)
the amount, if any, [**********************************************************
**********], and (3) [******************************************************],
discounted back to the Approval Date at an annual discount rate equal to
[***************] (such amount the "Base Exercise Price");
(j) From and after the [*****************] day after the Approval Date
through the third anniversary of the Approval Date, the exercise price shall be
the sum of: (X) the [**************] and (Y) a premium amount equal to
[**********************************]; and
(k) From and after the third anniversary of the Approval Date, the
exercise price shall be the sum of: (X) the [*****************] and (Y) a
premium amount equal to the [**********************************], where the
[****************************************************] for each year (or
partial year) that has elapsed since the third anniversary of the Approval Date.
By way of example, if the Approval Date is April 12, 2004 and the exercise
of the Call Option occurs on July 20, 2009, a date five years and three months
after the Approval Date, the Applicable Percentage would be
[******************].
2. MISCELLANEOUS. Except as amended hereby, the Agreement remains in full
force and effect and all references contained in the Agreement to "this
Agreement" shall be deemed to
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.
40
include this First Amendment Agreement. This First Amendment Agreement may be
executed in one or more counterparts, including via facsimile, each of which
shall be deemed an original. This First Amendment Agreement may not be amended
except by a written agreement executed by each of the Parties.
3. WARRANT C. Upon execution of this Agreement, the Company shall issue and
deliver to CFFTI a warrant to acquire an aggregate of two hundred thousand
(200,000) shares of Common Stock substantially in the form of Exhibit A attached
hereto.
4. REGISTRATION RIGHTS AGREEMENT. The Company and CFFTI agree that the
Registration Rights Agreement is terminated. The Company shall cause CFFTI to be
included as a party to that certain Investor Rights Agreement of even date
herewith by and between the Company, Vertex Pharmaceuticals Incorporated and the
Series B Investors, such Agreement to be substantially in the form previously
provided to CFFTI as modified in the manner requested by CFFTI and otherwise in
form and substance satisfactory to CFFTI. All of the 600,000 shares of common
stock issuable in respect of the three warrants issued to CFFTI (Warrant 5A
dated February 22, 2001, Warrant 513 dated February 22, 2001 and Warrant 5C of
even date herewith) shall be included as Registrable Shares (as defined in such
Agreement) under such Agreement.
5. EXPENSES. The Company shall pay and indemnify CFFTI against the
reasonable fees and expenses (including legal fees and expenses) incurred by
CFFTI in connection with the negotiation and execution of this First Amendment
Agreement and the documents and agreements referred to herein. Such amount shall
be paid within five (5) days after CFFTI provides the Company with the full
amount of such fees and expenses.
6. ENTIRE AGREEMENT. This First Amendment Agreement, together with the
Agreement, contain the entire agreement between the Parties hereto with respect
to the matters contemplated herein and therein and supersedes all prior
agreements or understandings among the Parties related to such matters.
IN WITNESS WHEREOF, the Parties have caused this First Amendment to
Strategic Alliance Agreement to be executed by their respective duly authorized
representatives.
ALTUS BIOLOGICS L,NC.
By: /s/ Xxxxx Xxxxxxxx
-----------------------------------
Xxxxx Xxxxxxxx
President and CEO
CYSTIC FIBROSIS FOUNDATION
THERAPEUTICS, INC.
By:
-----------------------------------
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.
41
Name: Xxxxxx X. Xxxxx, Ph.D.
Title: President & CEO
IN WITNESS WHEREOF. the Parties have caused this First Amendment to Strategic
Alliance Agreement to be executed by their respective duly authorized
representatives.
ALTUS BIOLOGICS L,NC.
By:
-----------------------------------
Xxxxx Xxxxxxxx
President and CEO
CYSTIC FIBROSIS FOUNDATION
THERAPEUTICS, INC.
By: /s/ Xxxxxx X. Xxxxx, Ph.D.
-----------------------------------
Name: Xxxxxx X. Xxxxx, Ph.D.
Title: President & CEO
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.
42
EXECUTION COPY
This Second Amendment to Strategic Alliance Agreement is made as of
December 22, 2003 (this "Second Amendment Agreement"), by and between Altus
Biologics Inc, a Delaware corporation (the "Company"), and Cystic Fibrosis
Foundation Therapeutics, Inc., a Maryland corporation ("CFFTI" and collectively,
with the Company, the "Parties," and each a "Party"). Capitalized terms used and
not otherwise defined herein shall have the respective meanings ascribed to them
in the Strategic Alliance Agreement dated as of February 22, 2001, as amended by
the First Amendment to Strategic Alliance Agreement dated as of September 26,
2001 (the "Agreement").
WHEREAS, the Company has requested that CFFTI advance [**********] of
payments that would not otherwise be due from CFFTI in respect of the Grant
until completion of the Pediatric Phase II milestone and CFFTI has agreed to
make such advance on the terms set forth herein;
WHEREAS, the Milestone Grant Funding Plan has been modified by the Parties
to account for the development plan of the Products and requires further
modification to provide for the advance described herein; and
WHEREAS, certain amendments to the Agreement are necessary or desirable in
connection with the foregoing.
NOW, THEREFORE, for good and valuable consideration, the receipt and
sufficiency of which is hereby acknowledged, the Parties hereby agree as
follows:
1. AMENDMENTS.
1.1 New Definitions. In Article I of the Agreement, the following new
definitions are added to the definitions list in the appropriate alphabetical
order:
"Pediatric Payment" shall have the meaning set forth in Section 2(b)(i) of
the Second Amendment Agreement.
"Phase II Milestone Date" shall mean the last day of the quarter specified
in the Milestone Grant Funding Plan within which Phase II is to be completed and
[*****************] associated with the Phase II transmitted by the Company to
CFFTI in accordance with the Milestone Grant Funding Plan.
"Second Amendment Agreement" means the Second Amendment to Strategic
Alliance Agreement dated as of December 22, 2003 between the Company and CFFTI.
1.2 Amendment of Certain Definitions. In Article I of the Agreement, the
following definitions are amended as indicated:
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.
43
(a) The definition of "Milestone Grant Funding Plan" is deleted in its
entirety and the following new definition is inserted in lieu thereof:
"Milestone Grant Funding Plan" shall mean the revised Milestone Grant
Funding Plan attached to the Second Amendment Agreement as Exhibit 1, as the
same shall be amended and modified from time to time pursuant to the approval of
the ASC in accordance with Section 2.2 of the Agreement.
(b) The definition of "Phase IIb Milestone Date" is deleted in its
entirety.
1.3 Sections 2.6(a) and (b) of the Agreement are deleted in their entirety
and the following new Sections 2.6(a) and (b) are inserted in lieu thereof
"2.6 License Fee.
(a) On the first Approval Date to occur, the Company shall be
obligated to pay to CFFTI an amount in cash in United States dollars [**********
********************************************************************************
*********************] (such excess is referred to herein as the "License Fee").
(b) The License Fee shall be paid as follows: (i) [*********] after
the first Approval Date to occur, the Company shall pay by wire transfer of
immediately available funds to an account designated in writing by CFFTI an
amount equal to the greater of (A) [********] or (B) [**************************
****************], whichever is higher, and (ii) [*****************] of such
date, the Company shall pay by wire transfer of immediately available funds to
an account designated in writing by CFFTI an amount equal to the greater of (A)
[********] or (B) [******************************************], whichever is
higher ([**************************************************************]) until
the License Fee (plus all accrued interest thereon) has been paid in full.
Interest on the outstanding balance of the License Fee shall be compounded
annually and accrue on the outstanding balance of the License Fee at the Regular
Rate. If a Company Default occurs following the first Approval Date to occur,
the entire unpaid License Fee shall become immediately due and payable without
any action of CFFTI, and the Company shall immediately pay such amount to CFFTI,
and such overdue amounts shall bear interest at a rate equal to the Regular Rate
plus [***************]."
1.4 Section 2.7 of the Agreement is deleted in its entirety and the
following new Section 2.7 is inserted in lieu thereof:
"2.7 Royalties on Combined Net Sales. After the first Approval Date to
occur (or, if an Approval Date has not occurred but the Company is selling Other
Products) and until exercise of the Call Option, and provided (a) CFFTI has not
exercised its right to terminate under Section 10.1 and (b) CFFTI has funded all
of the Grant that has become due prior to such Approval Date (or the date such
Other Products are first sold, as applicable) in accordance with the terms and
subject to the conditions set forth in this Agreement, the Company will pay
royalties to CFFTI in the amount of [********************] of Combined Net Sales
until the
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.
44
later of either (x) [**********************************************************
***] covering the Products or Other Products, including patents granted after
the date of the First Amendment Agreement or (y) [************************
******************] of the United States patents that have issued [*************
*********************************] (Patent No. [*******]; Patent No. [*******];
Patent No. [*******]; Patent No. [*******]; Patent No. [*******]; and Patent No.
[*******]). Royalties under this Section 2.7 shall be payable on a quarterly
basis within [*********] days following the end of each [**************] for
which royalties are due. Each payment made by the Company to CFFTI under this
Section 2.7 shall be accompanied by a written report summarizing the data used
to calculate the amounts paid, including the amount of Combined Net Sales
worldwide on a country by country basis and supporting information reasonably
necessary to determine the amount of royalties due under this Section 2.7. Upon
the written request of CFFTI, and no more frequently than [***] in any calendar
year, the Company shall permit an independent certified public accountant
selected by CFFTI to have access during normal business hours to such records of
the Company as may be reasonably necessary to verify the accuracy of royalties
payable and reports made hereunder. If such audit reveals that any royalty was
required during the audited period, such royalty shall be paid promptly to CFFTL
The fees charged by such accountant shall be paid by CFFTI, unless the audit
discloses that the royalties for the audited period are deficient by more than
[***************], in which case the Company shall pay the [********************
******] charged by the independent certified public accountant."
1.5 Section 2.8 of the Agreement is deleted in its entirety and the
following new Section 2.8 is inserted in lieu thereof:
"2.8 Call Option. On and after the first Approval Date to occur, the
Company shall have the right and option to purchase (the "Call Option") the
royalty stream described in Section 2.7 above from CFFTI at an exercise price
(which shall be paid upon exercise of the Call Option) determined as follows:
(a) On or prior to the [******************] after such Approval Date,
the exercise price shall be [***************]: the sum of: (1) the [*********],
and (2) the amount, if any, by which [*****************************************
***********], and (3) [*******************] CFFTI through the date of exercise
under Section 2.7 of the Agreement (and [**************************************
********************] of the Second Amendment Agreement), discounted back to
such Approval. Date at an annual discount rate equal to [***************] (such
amount the "Base Exercise Price");
(b) From and after the [*****************] day after such Approval
Date through the third anniversary of such Approval Date, the exercise price
shall be the sum of: (X) the [*****************] and (Y) a premium amount equal
to [******************************************]; and
(c) From and after the [***************] of such Approval Date, the
exercise price shall be the sum of: (X) the [*****************] and (Y) a
premium amount equal to the [*******************************], where the
"Applicable Percentage" 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.
45
equal to [**************************************************************] of
such Approval Date.
By way of example, if the first Approval Date occurs on April 12, 2004 and the
exercise of the Call Option occurs on July 20, 2009, a date five years and three
months after such Approval Date, the Applicable Percentage would be
[******************]."
1.6 Section 10.1(c) of the Agreement is deleted in its entirety and the
following new Section 10.1(c) is inserted in lieu thereof:
"(c) within thirty (30) days after the Phase II Milestone Date, CFFTI
may terminate this Agreement in its sole discretion without cause by sending a
written notice of termination to the Company. Such termination shall not be
deemed a CFFTI Default provided that: (i) CFFTI pays the Company within
[**************] of the date of such notice, an amount that is the lesser of
[******************************************************] and in the form
attached hereto as Exhibit 2.3(b)(ii) as of the date of such termination, or
(ii) the Parties agree in writing to a reasonable alternative course of action.
Upon such termination, CFFTI's license under Section 5.1 and rights to License
Fees will terminate immediately, provided however, after the first Approval Date
to occur, in the event of sales of Products, the Company will pay royalties not
to exceed the cumulative total of [*********************************************
**************] to CFFTI, by paying to CFFTI [****************] of Net Sales,
provided, however, if the Company sells or distributes the Products through a
sublicensee and does not sell directly, the Company will pay CFFTI
[*****************] of any royalties on Net Sales received therefrom by the
Company, in either case pursuant to a payment schedule to be agreed upon by the
Parties. Each payment made by the Company to CFFTI hereunder shall be
accompanied by a written report summarizing the data used to calculate the
amounts paid, including the amount of Net Sales and supporting information
reasonably necessary to determine royalties due."
2. ADVANCE. Notwithstanding any provision in the Agreement to the contrary,
the Company and CFFTI agree as follows:
(a) CFFTI shall fund [********] of the Grant prior to December 31,
2003, which amount, the parties acknowledge, would not otherwise have become due
until completion of the Pediatric Phase II milestone under the Milestone Grant
Funding Plan in effect prior to the date of this Second Amendment Agreement. The
date on which the Advance is actually paid to the Company is referred to herein
as the Advance Date.
(b) In consideration of CFFTI's agreement to make the advance
described in Section 2(a) of this Second Amendment Agreement:
(i) The amount of the Grant payable upon completion of the
Pediatric Phase II milestone shall be equal to the excess of (A) [*************]
(B) the sum of (1) [*************] (2) the product of [*************************
*****************************************************] that have elapsed from
and after December 31, 2003 through (and including) the date payment in respect
of the Pediatric Phase II milestone is
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.
46
due under the Agreement (such excess amount is referred to as the "Pediatric
Payment"). For purposes of the calculation required by clause (2) of this
Section 2(b)(i)(B), the quarter in which the payment in respect of the Pediatric
Phase II milestone is due under the Agreement shall be included, thus by way of
example if such milestone were achieved on May 1, 2005, the amount calculated
under such clause (2) would be equal to [******]; and
(ii) Upon payment of the Pediatric Payment in accordance with the
applicable provisions of Section 2.5 of the Agreement, the entire Grant shall be
deemed funded and CFFTI shall have no further obligation to make payments in
respect of the Grant under the Agreement or otherwise; and
(iii) Within [*****] following the first Approval Date to occur,
the Company shall pay to CFFTI, as an additional royalty and in addition to any
amounts due under Section 2.7 of the Agreement, an amount equal to [********] by
wire transfer of immediately available funds.
3. MISCELLANEOUS. Except as amended by the First Amendment Agreement and
this Second Amendment Agreement, the Agreement remains in full force and effect,
and all references contained in the Agreement to "this Agreement" shall be
deemed to include this Second Amendment Agreement. This Second Amendment
Agreement may be executed in one or more counterparts, including via facsimile,
each of which shall be deemed an original. This Second Amendment Agreement may
not be amended except by a written agreement executed by each of the Parties.
4. EXPENSES. The Company shall pay and indemnify CFFTI against the
reasonable fees and expenses (including legal fees and expenses) incurred by
CFFTI in connection with the execution of this Second Amendment Agreement. Such
amount shall be paid within five (5) days after CFFTI provides the Company with
the full amount of such fees and expenses.
5. ENTIRE AGREEMENT. This Second Amendment Agreement, together with the
Agreement and the First Amendment Agreement, contain the entire agreement
between the Parties hereto with respect to the matters contemplated herein and
therein and supersede all prior agreements or understandings among the Parties
related to such matters.
[END OF PAGE]
[SIGNATURE PAGE FOLLOWS]
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.
47
IN WITNESS WHEREOF, the Parties have caused this Second Amendment to
Strategic Alliance Agreement to be executed by their respective duly authorized
representatives.
ALTUS BIOLOGICS L,NC.
By: /s/ Xxxxx Xxxxxxxx
-----------------------------------
Xxxxx Xxxxxxxx
President and CEO
CYSTIC FIBROSIS FOUNDATION
THERAPEUTICS, INC.
By: /s/ Xxxxxx X. Xxxxx, Ph.D.
-----------------------------------
Name: Xxxxxx X. Xxxxx, Ph.D.
Title: President & CEO
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.
48
