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WHEREVER CONFIDENTIAL INFORMATION IS OMITTED HEREIN (SUCH OMISSIONS ARE DENOTED
BY AN ASTERISK), SUCH CONFIDENTIAL INFORMATION HAS BEEN SUBMITTED SEPARATELY TO
THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT
Exhibit 10.1
LICENSE AGREEMENT
This is an Agreement dated as of the 24th day of July, 2000 by and between
Repligen Corporation, a Delaware corporation having its principal office at 117
Fourth Avenue, Needham, MA 02194 (hereinafter "Repligen"), and the Regents of
the University of Michigan, a constitutional corporation of the State of
Michigan having an office at 475 East Jefferson Street, Ann Arbor, Michigan
48109-1248 (hereinafter "UM").
WHEREAS, UM possesses certain intellectual property pertaining to immune
regulation mediated by B7, CD28, and CTLA-4; and
WHEREAS, UM and Repligen have previously entered an agreement, dated May 28,
1992, pursuant to which Repligen was granted exclusive rights to said
intellectual property, and
WHEREAS, Repligen transferred said intellectual property rights to Genetics
Institute (hereinafter "GI") and GI subsequently returned to Repligen, from said
intellectual property rights, certain sole and exclusive rights pertaining to
uses and compositions of CTLA-4, and
WHEREAS, UM wishes to acknowledge the specific and non-overlapping fields in
which rights to said intellectual property have been granted solely and
exclusively to each of Repligen and GI, and
WHEREAS, UM and Repligen further wish to ratify and amend the terms for the
exclusive license by UM to Repligen of the aforesaid CTLA4 rights;
NOW, THEREFORE, UM and Repligen agree as follows:
I. Definitions
1.1 "Parties" in singular or plural usage as required by the context, means
Repligen and/or UM.
1.2 "Licensed Field" means the Repligen Field as defined in the agreement
made by and between the Parties and GI on November 17, 1999 a copy of
which is attached hereto as Exhibit A. The
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1.3 Parties acknowledge and agree that GI has an exclusive and
non-overlapping license to the UM Patents outside of the Licensed
Field.
1.4 "Licensed Patents" means any of the following to the extent that UM
has, or at any time acquires, the right to grant licenses thereto:
1.3.1 any patent or patent application which claims priority from
any of the following patent applications (a) USSN 07/275,433,
filed 11/23/88; (b) USSN 07/864,805, filed 4/7/92; (c) USSN
07/864,866, filed 4/7/92; (d) USSN 07/864,807, filed 4/7/92;
including all foreign equivalent patent applications and
Patent Cooperation Treaty filings, and all patents issuing
therefrom in which UM has a property interest or under which
UM acquires licensing rights and any divisions or
continuations of the patents or patent applications set forth
above, including any reissue, reexamination or extension of
the above-described patents, any extended or restored term,
and any confirmation patent, registration patent, or patent of
addition,
1.3.2 the following rights, all to the extent covering inventions to
which inventive contributions were made as of May 28, 1992
(solely or jointly) by former UM faculty member Craig B.
Thompson in the scope of his duties for UM and the Howard
Hughes Medical Institute: U.S. Patent No. 5,434,131 (the "'131
Patent") and/or U.S. Patent No. 5,521,288 (the "'288 Patent")
and (a) any patent applications or patents issuing therefrom
claiming or entitled to priority from an application from
which the '131 Patent or '288 patent issued; (b) any patent
application or patent issuing therefrom claiming or entitled
to priority from any application from which the '131 Patent or
'288 Patent claims or is entitled to priority; (c) all foreign
equivalent patent applications of (a) or (b) above including
Patent Cooperation Treaty filings, and all patents issuing
therefrom; (d) any divisions or continuations (a), (b), or (c)
above, including any reissue, reexamination, or extension of
the above described patents, any extended or restored term,
and any confirmation patent, registration patent, or patent of
addition.
1.5 "Valid Claim(s)" means any claim (s) pending in a patent application or
in an unexpired patent included within the Licensed Patents which has
not been held unenforceable, unpatentable, or invalid by a decision of
a court or other governmental agency of competent jurisdiction,
unappealable or unappealed within the time allowed for appeal, and
which has not been admitted
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to be invalid or unenforceable through reissue or disclaimer. If in any
country there should be two or more such decisions conflicting with
respect to the validity of the same claim, the decision of the higher
or highest tribunal shall thereafter control; however, should the
tribunals be of equal rank, then the decision or decisions upholding
the claim shall prevail when the conflicting decisions are equal in
number, and the majority of decisions shall prevail when the
conflicting decisions are unequal in number.
1.6 "Licensed Product" means any product in the Licensed Field whose
manufacture, use or sale in any country would, but for either ownership
of or a license under the Licensed Patents, comprise an infringement,
including contributory infringement, of one or more Valid Claims in
such country.
1.7 "Combination Product" means any Licensed Product sold in combination
with a second discrete product containing one or more active
ingredients which are not Licensed Products.
1.8 "Sublicensee" means any person or entity (other than an Affiliate)
sublicensed by Repligen (or Affiliates, where authorized by Repligen)
to practice one or more Licensed Patent.
1.8 "Net Sales" means the sum of all amounts received and all other
consideration received (when in a form other than cash or its
equivalent, the fair market value thereof when received) by Repligen,
its Affiliates or Sublicensees, as the case may be, from persons or
entities who are not Affiliates or Sublicensees by reason of the sale,
distribution or use of Licensed Products, including Combination
Products, less the following deductions and offsets but in the case of
the deductions and offsets described in clauses (a) - (d) below only to
the extent the monies represented by such deductions and offsets have
actually been included in the sum referred to above
(a) trade quantity discounts actually allowed and taken;
(b) returns, rebates and allowances when actually taken;
(c) retroactive price reductions, if any, when actually
credited;
(d) uncollected invoices for Licensed Products, to the
extent written off as uncollectible on Repligen's
Affiliates' or Sublicensees' books, as the case may
be;
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(e) with regard to sales in the United States, four
percent (4%) of the amount invoiced and paid to cover
cash discounts, sales or excise taxes, transportation
and insurance charges; and with regard to sales
outside the United States six percent (6%) to include
the above and additional special packaging, duties,
and other governmental charges
1.9 "Territory" means all countries of the world.
1.10 "Affiliate (s)" means any individual, corporation, partnership,
proprietorship or other entity controlled by, controlling or under
common control with Repligen through equity ownership, ability to elect
directors, or by virtue of a majority of overlapping directors and
shall include any individual, corporation, partnership, proprietorship
or other entity directly or indirectly owning, owned by or under common
ownership with the party in question to the extent of fifty percent
(50%) or more of the equity or voting shares, including shares owned
beneficially by such party.
1.11 "Royalty Quarters" means the three (3) months ending on the last day of
March, June, September, and December of each year.
1.12 "Effective Date" means the date upon which this Agreement has been
entered into as mentioned in its introductory paragraph.
II. License Grant
2.1 Subject to the terms and conditions of this Agreement, UM grants to
Repligen an exclusive license of UM's interest under the Licensed
Patents for the purpose of making, having made, manufacturing,
importing, using, marketing and selling Licensed Products, solely
within the Licensed Field, in the Territory, with the right to grant
sublicenses to Affiliates and Sublicensees.
2.2 UM retains the right to grant to the Howard Hughes Medical Institute
("HHMI") a non-exclusive, irrevocable, royalty-free license, without
the right to grant sublicenses, to the Licensed Patents, as required by
UM's Patent and Intellectual Property Agreement with HHMI. UM retains
the right to use all aspects of the Licensed Patents, and to practice
the Licensed Patents by any means, solely for internal research and
education purposes.
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III. Representations, Warranties, and Covenants
3.1 UM represents and warrants to its knowledge that (i) it is the sole and
rightful assignee of the rights of former UM faculty member, Dr. Craig
B. Thompson during the period of his employment at and by UM for
inventive activity occurring within the scope of his employment, and
(ii) that it has the full right, power and authority to enter into this
Agreement and to grant the licenses under Article II hereof.
3.2 Repligen has agreed in the Letter Agreement of February 8, 2000 between
the Parties to reimburse to UM the expenses of a mutually agreeable
outside counsel to provide the services as described in Paragraph 3 of
that Letter Agreement. The expenses of such outside counsel will be
fully creditable toward earned royalties under this Agreement, subject
to Subsection 8.11 below.
3.3 UM has agreed to join Repligen in certain litigation as described in
the Letter Agreement of February 8, 2000 between the Parties, attached
hereto as Exhibit D. Repligen shall bear all the expense of such
litigation and all such actual documented expenses shall be fifty
percent (50%) creditable toward earned royalties payable to UM under
this Agreement, subject to Subsection 8.11 below.
IV. Patent Protection and Validity
4.1 UM (and/or its joint owner in the case of co-owned Licensed Patents)
shall control all aspects of prosecuting and maintaining the Licensed
Patents. UM shall not voluntarily relinquish its own right as a joint
owner to participate in the control of the prosecution and maintenance
of the Licensed Patents. UM shall promptly notify Repligen of all
information received by UM relating to the prosecution and maintenance
of Licensed Patents, including without limitation any lapse,
revocation, surrender, invalidation or abandonment of any of the
Licensed Patents.
4.2 Repligen agrees to ensure that UM is fully reimbursed for the costs
associated with prosecution and maintenance of Licensed Patents in the
Licensed Field in accordance with this Agreement and the agreement made
November 17, 1999 by and between the Parties and GI and attached hereto
as Exhibit A. Repligen acknowledges and agrees that UM is to be
reimbursed, in a matter
*CONFIDENTIAL TREATMENT REQUESTED
<PAGE>
appropriately apportioned between GI and Repligen, for all expenses of
all Licensed Patents. Unless and until otherwise arranged by the
Parties and GI, Repligen shall reimburse all expenses related to US
Applications 08/314,851, 08/475,741, and 08/385,194 and all related
filings (including continuations, foreign equivalents, and resulting
patents.
4.3 The Parties acknowledge that UM has paid a third party attorney $44,000
in respect of previously rendered services related to the correction of
certain patents within the Licensed Patents and agree that the
reimbursement of this expenditure is in dispute. Repligen agrees,
immediately upon the execution of this Agreement, to pay to UM 50% of
the aforesaid amount. The Parties agree to cooperate in the resolution
of the aforesaid dispute.
4.4 Fifty percent (50%) of Repligen's payments and expenses under
Subsections 4.2 and 4.3 hereof shall be credited against earned
royalties, subject to the limitations of Subsection 8.11, and amounts
so credited shall then be deemed recovered.
4.5 In the event either Party shall learn of any potential infringement of
a claim of any of the Licensed Patents, that Party shall immediately
supply the other Party and GI with written notice of such potential
infringement. The right of either Party or of GI to institute and
control actions brought for infringement shall be in accordance with
the terms and conditions of the License Agreement of May 28, 1992 (as
amended by an Agreement dated June 26, 1992 between UM and Repligen, an
Amendment dated August 31, 1995 between UM and Repligen, and an
Agreement dated August 30, 1995 between UM, Repligen, and GI) and
further modified by (i) an Agreement dated November 17, 1999 between
UM, Repligen, and GI and attached hereto as Exhibit A, (ii) an
Agreement dated June 8, 1999 between UM, Repligen, and GI and attached
hereto as Exhibit B, and (iii) an Agreement dated June 8, 1999 between
Repligen and GI and attached hereto as Exhibit C.
4.6 In the event either Party shall initiate or carry on legal proceedings
to enforce any of the Licensed Patents against an alleged infringer
according to the terms and conditions of this Agreement, the other
Party shall fully cooperate with, and supply all reasonable assistance
requested by, the Party initiating or carrying on such proceedings with
all expenses to be borne by the initiating Party.
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4.7 Any recovery obtained by either UM or Repligen as the result of legal
proceedings initiated and paid for by Repligen to enforce any of the
Licensed Patents against an alleged infringer, whether obtained by
settlement or otherwise, shall after payment of all otherwise
unrecovered expenses attributable to such action paid by Repligen or by
UM or by both Repligen and UM, including without limitation fees paid
to outside counsel or consultants, and reasonable travel expenses, but
not including any part of any UM employee's salary or Repligen
employee's salary, be paid 85% to Repligen and 15% to UM. Any recovery
obtained as the result of legal proceedings initiated and paid for by
UM to enforce any of the Licensed Patents against an alleged infringer
in the Licensed Field, whether obtained by settlement or otherwise,
shall after payment of all otherwise unrecovered expenses attributable
to such action paid by Repligen or by UM or by both Repligen and UM,
including without limitation fees paid to outside counsel or
consultants, and reasonable travel expenses, but not including any part
of any UM employee's salary or Repligen employee's salary, be paid 85%
to UM and 15% to Repligen.
4.8 The Parties shall cooperate with one another in gaining any patent term
extension that may be applicable to the Licensed Patents in the
Licensed Field, any and all filings for any such extension will be made
by and at the expense of Repligen after consultation with UM.
V. Sublicenses
5.1 Repligen shall have the exclusive right under the license granted in
Article II herein to grant sublicenses to Affiliates and Sublicensees
under Licensed Patents, provided:
(a) Repligen shall notify UM of every sublicense Agreement and
each amendment thereto, within thirty (30) days after their
execution, and indicate the name of the Sublicensee or
Affiliate, territory of the sublicense, scope of the
sublicense, and the nature, timing and amounts of all fees and
royalties to be paid thereunder;
(b) All sublicenses shall attach a copy of this Agreement as an
exhibit and shall be consistent with the terms of this
Agreement;
(c) All sublicenses shall contain acknowledgements of the
University's disclaimer of warranty and limitation on
liability as provided by Section 12 below; and
(d) All sublicenses shall require the Sublicensee or Affiliate to
accept duties equivalent to those accepted by Repligen herein
in Sections 4, 6, 7, 9, 10, 11, 12, 20, and 24.
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5.2 Any sublicense granted by Repligen shall provide for its termination
upon the termination of this Agreement, provided, however, that a
sublicense granted to any Sublicensee may permit such Sublicensee, by
written notice to UM within sixty (60) days of the Sublicensee's
receipt of written notice of such termination, to elect to continue its
sublicense. No such election will be valid unless such Sublicensee
agrees in writing at the time of election to assume in respect to UM
all of the obligations (including obligation for payment) contained in
its sublicense agreement with Repligen and this Agreement.
VI. Confidentiality
6.1 All technical information of either Party relating to the Licensed
Patents or Licensed Products, which is disclosed to the other Party
during the term of this Agreement, in a writing marked "CONFIDENTIAL"
(or, if initially orally disclosed, is confirmed in writing and
designated as "CONFIDENTIAL" within thirty (30) days of such initial
disclosure), shall be maintained in confidence by the receiving Party
for a period of five (5) years from receipt and shall not be disclosed
by the receiving Party during that period to any other person, firm or
agency, governmental or private, without the prior written consent of
the disclosing Party, except to the extent that the information:
(a) is known at the time of its receipt as documented in written
records, or
(b) is properly in the public domain, or
(c) is subsequently disclosed to the receiving Party by a third
party who may lawfully do so, or
(d) is required to be disclosed to governmental agencies in order
to gain approval to sell Licensed Products, or
(e) is necessary to be disclosed to agents, consultants,
Affiliates, Sublicensees and/or other third parties for the
research and development and/or marketing of Licensed Products
under this Agreement, which entities first agree to be bound
by confidentiality obligations contained in this Agreement, or
(f) is required to be disclosed by law or by court order.
(such confidential information to be maintained in confidence under
this section is referred to below as "Confidential Information".)
*CONFIDENTIAL TREATMENT REQUESTED
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6.2 Repligen recognizes that under UM policy, research relating to Licensed
Patents or Licensed Products must be publishable, subject to the terms
set forth herein. Repligen agrees that UM and HHMI researchers shall be
permitted to present their results at symposia, national, or regional
professional meetings, and to publish the results in journals, theses,
or dissertations, or otherwise of their own choosing, provided,
however, that Repligen shall have been furnished copies of any proposed
publication or presentation relating to Licensed Patents or Licensed
Products at least one month in advance of the submission of such
proposed publication or presentation to a journal editor or other third
party. Repligen shall have one month after receipt of said copies to
object to such proposed presentation or proposed publication because
there is patentable subject matter which needs protection or because it
contains Confidential Information of Repligen.
6.3 In the event that Repligen makes an objection under 6.2 above, said
researcher(s) shall, as the case may be, remove Repligen's Confidential
Information from such publication or presentation for a maximum of four
(4) months from date of receipt of such objection in order for UM or
Repligen to file patent application(s) with the United States Patent
and Trademark Office or foreign patent office(s) directed to the
patentable subject matter contained in the proposed publication or
presentation.
VII. Commercialization
7.1 It is understood that Repligen shall be responsible for obtaining any
governmental approvals which may be necessary to manufacture and/or
sell Licensed Products. If Repligen decides in its sole discretion that
it is feasible to manufacture and sell Licensed Products at an
acceptable profit, Repligen shall use its best efforts to obtain such
government approvals, and upon receipt thereof, to cause Licensed
Products to be manufactured and sold. For the purpose hereof, "best
efforts" shall mean the usual practice followed by Repligen in pursuing
commercialization of its products. In the event Repligen shall breach
any covenant set forth in this Section 7.1, UM's sole remedy with
respect to such breach shall be to terminate this Agreement under
Section 13.3.
7.2 Repligen shall keep UM informed in writing of any material developments
with respect to Licensed Products. Repligen shall promptly inform UM of
any patent applications, or similar
*CONFIDENTIAL TREATMENT REQUESTED
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applications, relating to Licensed Products or improvements thereon,
filed by or on behalf of Repligen or Affiliates anywhere in the world.
7.3 Repligen covenants to substantially manufacture and require Affiliates
and Sublicensees to substantially manufacture within the United States
all of their Licensed Products. Where domestic manufacture is not
commercially feasible, UM will cooperate with Repligen to obtain
appropriate waivers to this requirement from the United States
government..
VIII. Payments and Royalties
8.1 The license rights granted to Repligen herein are subject to Repligen's
payment of royalties to UM according to the provisions of this Article
VIII.
8.2 Upon execution of this Agreement, Repligen shall (i) pay * to UM, and
(ii) grant to UM 50,000 warrants to purchase common stock in Repligen
Corporation with the exercise price for such warrants to be set as the
closing price for RGEN stock averaged over the five days preceeding
the execution of this Agreement. Warrants may be exercised at any time
up until three years from the date of grant at which point they will
expire. The warrant agreement will be in a form mutually acceptable to
the Parties and will be completed within 45 days of the execution of
this Agreement.
8.3 With respect to each Royalty Quarter, Repligen shall pay UM a royalty
equal to * of Repligen's and Affiliates' Net Sales of Licensed Products
during such Royalty Quarter.
8.4 With respect to Combination Products, the fair market sales price of
the active ingredient(s) of the discrete product(s) which are not
themselves Licensed Products shall be subtracted from the selling price
used to calculate Net Sales with respect to such Combination Product;
provided that in the case of a Combination Product which includes one
or more Licensed Products which are also sold in non-Combination
Product form, the resulting Net Sales figure upon which UM's
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royalty is based shall not be reduced to less than the normal aggregate
Net Sales for such Licensed Product(s) when not sold as Combination
Product.
8.5 The obligation to pay UM a royalty under this Article VIII is imposed
only once with the respect to the same unit of Licensed Product
regardless of the number of Valid Claims or Licensed Patents covering
the same; however, for purposes of determination of payments due
hereunder, whenever the term Licensed Product may apply to a property
during various stages of manufacture, use or sale, Net Sales, as
otherwise defined shall be derived from the sale, distribution of such
Licensed Product by Repligen, Affiliates or Sublicensees, as the case
may be, at the stage of its highest invoiced value to unrelated third
parties.
8.6 With respect to each Royalty Quarter, Repligen shall pay UM * of any
royalties received during such Royalty Quarter by Repligen or
Affiliate(s) with respect to Net Sales of Sublicensee(s), and no other
royalties with respect to such Net sales of Sublicensee(s). In the
event that the royalty received by Repligen is less than *
Sublicensee(s) except and unless: (1) license fees are due to BMS from
either of Repligen or Repligen's Sublicensee(s) or (2) a royalty-free
sublicense has been granted to GI according to Paragraph 4.1 of the
Letter Agreement dated November 17, 1999 between the Parties and GI and
attached hereto as Exhibit A. In the event that license fees are due to
BMS, 50% of said fees shall be deducted from the payments due UM under
this Section 8.6, except that under no circumstances shall such
deduction result in UM's share being less than *. In the event that a
royalty-free sublicense has been granted to GI as described above, no
royalty shall be due or payable by Repligen to UM for such sublicense.
8.7 In addition, with respect to each Royalty Quarter, Repligen shall pay
to UM * of any upfront or lump sum payments which Repligen or its
Affiliates receives during such Royalty Quarter from any Sublicensee in
consideration of the grant of its sublicense. For the purpose hereof,
upfront or lump sum payments shall not include any payment made to
Repligen as a royalty on Net Sales of Sublicensee(s) or any Research
Milestone Payment or Clinical Milestone (as hereinafter defined).
8.8 (a) "Research Milestone Payment" means any payment received by Repligen
from any Sublicensee which is payable by reason of the attainment of a
research or development
*CONFIDENTIAL TREATMENT REQUESTED
<PAGE>
objective relating to technology described in Licensed Patent(s) or to
Licensed Product(s) themselves. With respect to each Royalty Quarter,
Repligen shall pay to UM * of each Research Milestone Payment received
during such Royalty Quarter.
(b) "Clinical Milestone Payment" means any payment received by
Repligen from any Sublicensee which is payable by reason of
the attainment of a clinical objective relating to one or more
Licensed Product(s). With respect to each Royalty Quarter,
Repligen shall pay to UM * of each Clinical Milestone Payment
received during such Royalty Quarter.
(c) Fifty percent (50%) of all amounts paid to UM under this
Section 8.8 shall be credited against earned royalties,
subject to the limitations contained in Section 8.11.
8.9 (a) If Repligen is required to pay an unrelated third party a
royalty in a given country in order to sell the Licensed
Products in that country, then fifty percent (50%) of that
royalty will be deducted from the royalty otherwise payable
hereunder for Net Sales of such Licensed Products in that
country, provided that the royalty thus payable by Repligen
shall not be reduced below * of Repligen's or Affiliates' Net
Sales of Licensed Products in that country unless Repligen is
required to pay Bristol-Meyers Squibb, Inc. a royalty in which
case the royalty thus payable by Repligen shall not be reduced
below * of Repligen's or Affiliates' Net Sales of Licensed
Products in that country. Upon the mutual Agreement of the
parties the royalty percentage for a particular Licensed
Product may be reduced based on specific indications and
associated market size and conditions.
(b) If Repligen is required to pay a royalty to the United States
Navy or to HHMI in order to obtain the exclusive right as to
the U.S. Navy or HHMI, to practice any of the patents or
patent applications included in Licensed Patents, in a given
country, then, in addition to any amounts deducted under
subparagraph (a) above, one-hundred percent (100%) of that
royalty may be deducted from the royalty otherwise payable
hereunder for Net Sales of Licensed Product in that country,
provided that: (i) in no event shall the amounts deducted
under this subparagraph (b) exceed * of the Net Sales of
Licensed Product in that country; and (ii) in no event shall
the royalty thus payable by Repligen, after all
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<PAGE>
deductions under this subparagraph (b) and subparagraph (a)
above, be reduced below * of Repligen's or Affiliates' Net
Sales of Licensed Product in that country.
8.10 One year following the execution of this Agreement and thereafter
annually, Repligen agrees to pay a minimum royalty of * to UM during
the term of this Agreement. All minimum royalties paid for a given year
which are in excess of that year's earned royalties shall be credited
against future earned royalties otherwise payable under this Agreement,
subject to the limitations in Section 8.11.
8.11 Notwithstanding anything to the contrary in this Agreement, the Parties
agree that in no event shall the aggregate reduction of earned
royalties on account of credits allowed by UM to Repligen under this
Agreement in any Royalty Quarter exceed fifty percent (50%) of the
earned royalties otherwise payable under this Agreement for such
Royalty Quarter. Any credits in excess of these limitations shall be
carried forward and applied against earned royalties in subsequent
Royalty Quarters until fully credited or until termination of this
Agreement. Upon termination of this Agreement, Repligen shall have no
right to recover unused credits except to the extent that they may
continue to be credited against up to fifty percent (50%) of the
royalties payable after termination, subject to the limitations set
forth herein.
8.12 If at any time or from time to time an unrelated third party in any
country shall, under right of a compulsory license granted or ordered
to be granted by a competent governmental authority, manufacture, use
or sell any Licensed Product with respect to which royalties shall be
payable pursuant to Section 8.3 herein, then Repligen, upon notice to
UM and during the period such compulsory license shall be effective,
shall have the right to reduce such royalty to UM on each unit of
Licensed Product sold in such country to an amount no greater than the
amount payable by said third party in consideration of its compulsory
license.
8.13 Repligen agrees to refrain from any business dealing relating to
Licensed Products in which a significant purpose or result would be to
lower UM's share of income or actual income resulting from this
Agreement or the sale, use or commercialization of Licensed Products.
This Section 8.13 shall not be construed in such a way as to (i)
enlarge Repligen's obligations under Section 7.1 or (ii) provide any
remedy to UM if Repligen terminates this Agreement under Section 13.4.
*CONFIDENTIAL TREATMENT REQUESTED
<PAGE>
IX. Reports
9.1 Within sixty (60) days after the close of each Royalty Quarter during
the term of this Agreement (including any Royalty Quarter which closes
following any termination of this Agreement), Repligen shall report to
UM all royalties or other payments accruing to UM under Article VIII
during such Royalty Quarter. Such quarterly reports shall indicate for
each Royalty Quarter the gross sales and Net Sales of Licensed
Products; such reports shall also indicate the source and amount of all
other revenues with respect to which payments are due to UM and the
amount of such payments, as well as the various calculations used to
arrive at said amounts, including the quantity, description
(nomenclature and type designation), country of sale and country of
manufacture of Licensed Products. In case no payment is due for any
such period, Repligen shall so report.
9.2 Repligen shall keep and it shall cause Affiliates and Sublicensees to
keep, true and accurate records and books of account containing data
reasonably required for the computation and verification of payments to
be made as provided by this Agreement, which records and books shall be
open for inspection upon reasonable notice during business hours by
either UM auditor(s) or an independent certified accountant selected by
UM, except one to whom Repligen has a reasonable objection, for the
purpose of verifying the amount of payments due and payable. Said right
of inspection may exercised not more than once in any calendar year,
but will exist for four (4) years from the date of origination of any
such record and this requirement and right of inspection shall survive
any termination of this Agreement. UM shall be responsible for all
expenses of its auditor(s) or independent accountants associated with
such inspection. However, in the event that such inspection reveals an
underpayment of royalties to UM in excess of ten percent (10%), then
said inspection shall be at Repligen's expense and such underpayment
shall become immediately due and payable to UM. If such inspection
reveals an overpayment of royalties to UM, at Repligen's election, UM
shall promptly reimburse Repligen to the extent of such overpayment or
credit such overpayment against Repligen's next royalty payment to UM.
9.3 The reports provided for hereunder shall be certified by an authorized
representative of Repligen to be correct to the best of Repligen's
knowledge and information.
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X. Time and Currencies of Payments
10.1 Payments accrued at the close of each Royalty Quarter shall be due and
payable in Ann Arbor, Michigan on the date each quarterly report,
provided for under Article IX above, is due and shall be paid in United
States dollars. Repligen agrees to make all payments due hereunder to
UM by check made payable to the Regents of the University of Michigan
and sent by prepaid, certified mail, return receipt requested, to the
address set forth in Article XVIII herein.
10.2 On all amounts outstanding and payable to UM, interest shall accrue
from the date such amounts are due and payable at a rate of two (2)
points above the prime lending rate as established by the Chase
Manhattan Bank, N. A. in New York City, New York, or at such lower rate
as may be required by law.
10.3 In the case of sales of Licensed Products transacted in foreign
currency, such foreign currency shall be converted into its equivalent
in United States dollars at the exchange rate of such currency as
reported (or if erroneously reported, as subsequently corrected) in the
Wall Street Journal on the last business day of the Royalty Quarter
during which such payments are received by Repligen, Affiliates or
Sublicensees, as the case may be (or if not reported on that date, as
quoted by the Chase Manhattan Bank, N.A. in New York City, New York).
10.4 Except as provided in the definition of Net Sales, all royalty payment
to UM under this Agreement shall be without deduction for sales, use,
excise, personal property or other similar taxes or other duties
imposed on such payments by the government of any country or any
political subdivision thereof; and any and all such taxes or duties
shall be assumed by and paid by Repligen. Repligen shall have no
liability for any income taxes levied against UM on account of
royalties or other payments received by UM under this Agreement. If
laws or regulations require that any such taxes be withheld by
Repligen, Repligen shall deduct such taxes from the payment due UM, pay
the taxes so withheld to the taxing authority, and send proof of
payment to UM within sixty (60) days following such payment.
*CONFIDENTIAL TREATMENT REQUESTED
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XI. Product Liability
11.1 Repligen, Affiliates, and Sublicensees assume all risk of damage or
injury to persons or property arising out of the clinical testing,
manufacture, use, distribution or sale of the Licensed Products by them
or authorized by them and shall hold harmless and indemnify UM, its
officers and employees from and against any and all personal injury,
property damage, product liability or similar claims, losses and
liabilities arising out or Repligen's, Affiliates' or Sublicensees' (or
any business associated of any of these) clinical testing, manufacture,
use, distribution or sale of the Licensed Products, including
reasonable attorneys fees and other costs or defense. UM shall,
promptly upon receipt of any claim that may be subject to
indemnification hereunder, give written notice to Repligen of such
claim, and Repligen shall assume the defense thereof, including the
employment of counsel reasonably satisfactory to UM. UM shall have the
right to employ separate counsel in any such action and to participate
in the defense thereof, but the fees and expenses thereof shall be at
UM's expense. Repligen shall not be liable for any settlement of any
such claim, action or proceeding effected without its written consent.
11.2 Repligen shall purchase and maintain, and require Affiliates and
Sublicensees to purchase and maintain, in effect a policy of product
liability insurance covering all claims with respect to any Licensed
Product used, manufactured, sold, licensed or otherwise distributed by
Repligen within the term of this Agreement, and shall specify UM as an
additional insured. Repligen shall furnish a certificate of such
insurance to UM, upon request.
XII. No Warranty; Limitations of Liability
12.1 EXCEPT AS PROVIDED IN SECTION 3.1, UM MAKES NO REPRESENTATIONS, EXTENDS
NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING BUT NOT
LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE. AND ASSUMES NO RESPONSIBILITIES WHATEVER WITH
RESPECT TO DESIGN, DEVELOPMENT, MANUFACTURE, USE, SALE OR OTHER
DISPOSITION BY REPLIGEN OR AFFILIATES OR SUBLICENSEES OF LICENSED
PRODUCT.
*CONFIDENTIAL TREATMENT REQUESTED
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12.2 THE ENTIRE RISK AS TO PERFORMANCE OF LICENSED PRODUCT IS ASSUMED BY
REPLIGEN AND AFFILIATES AND SUBLICENSEES. In no event shall UM be
responsible or liable for any direct, indirect, special, incidental, or
consequential damages or lost profits to Repligen, affiliates,
sublicensees, users or any other individual or entity regardless of
legal theory. The above limitations on liability apply even though UM
may have been advised of the possibility of such damage.
12.3 Repligen, Affiliates and Sublicensees shall make no statements,
representations or warranties or accept any liabilities or
responsibilities whatsoever to or with regard to any person or entity
which are inconsistent with any disclaimer or limitation included in
this Article XII.
XIII. Term and Termination
13.1 Upon any termination of this Agreement, and except as provided herein
to the contrary, all rights and obligations of the Parties hereunder
shall cease, except as follows:
13.1.1 Obligations to pay royalties and other sums accruing hereunder
up to the day of such termination;
13.1.2 The right to complete the manufacture and sale of Licensed
Product which qualify as "work in process" under generally accepted
cost accounting standards or which are in stock at the date of
termination, and the obligation to pay royalties on Net Sales of such
Licensed Product;
13.1.3 Obligation for record keeping and accounting reports for so
long as Licensed Product are sold pursuant to Paragraph 13.1.2 above.
At such time after termination of this Agreement when sales or other
dispositions of Licensed Product have ceased, Repligen shall render a
final report and royalty payment, if required;
13.1.4 UM's rights to inspect books and records as described in
Article IX;
13.1.5 Obligations of defense and indemnity under Article XI;
*CONFIDENTIAL TREATMENT REQUESTED
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13.1.6 Any cause of action or claim of Repligen or UM accrued or to
accrue because of any breach or default by the other Party hereunder;
13.1.7 All other terms, provisions, representations, rights and
obligations contained in this Agreement that by their sense and context
are intended to survive until performance thereof by either or both
Parties.
13.2 This Agreement will become effective on its Effective Date and, unless
terminated under another specific provision of this Agreement, will
remain in effect until, and terminate upon, the expiration of the last
to expire of Licensed Patents.
13.3 Upon any material breach by either Party under this Agreement, the
other Party may terminate this Agreement, the other Party may terminate
this Agreement by ninety (90) days' written notice to the breaching
Party, specifying the material breach, default or other defect. Without
limiting the generality of the foregoing, any default by Repligen in
the payment of any royalty or the making of any report hereunder, or
the insolvency of Repligen shall be deemed to be a material breach. The
termination shall become effective at the end of the ninety day period
unless the breaching Party cures the breach during the ninety (90) day
period.
13.4 Notwithstanding anything in this Agreement to the contrary, Repligen
may terminate this Agreement by giving UM a notice of termination,
which shall include a statement of the reasons, whatever they may be,
for such termination and the termination date established by Repligen,
which date shall not be sooner than ninety (90) days after the date of
the notice. Such notice shall be deemed by the Parties to be final and,
immediately upon receipt of such notice of termination, UM shall have
the right to begin negotiations, and enter into Agreements, with others
for the manufacture, sale and use of Licensed Product, and may, at its
option, disclose to said others any and all information related to
Licensed Product which UM, in its sole discretion, deems appropriate,
other than information which is subject to confidentiality under any
Agreement between UM and Repligen. During the period of time from the
notice of termination until termination pursuant to this provision,
Repligen shall
*CONFIDENTIAL TREATMENT REQUESTED
<PAGE>
continue any efforts ongoing immediately prior to the termination
notice to manufacture and sell Licensed Product.
XIV. Governing Law and Venue
This Agreement and the relationships between the Parties shall be
governed in all respects by the law of the State of Michigan
(notwithstanding any provisions governing conflict of laws under such
Michigan law to the contrary), except that questions affecting the
construction and effect to any patent shall be determined by the law of
the country in which the patent has been granted. The Parties
understand and expressly agree that any claims, demands, or actions
asserted against the Regents of the University of Michigan, its agents
or employees, shall be brought in the appropriate court of the State of
Michigan.
XV. Assignment and Non-Pledge for Security
Due to the unique relationship between the Parties, this Agreement
shall not be assignable by either Party without the prior written
consent of the other Party, which consent shall not be unreasonably
withheld; and any attempt to assign this Agreement without such consent
shall be void form the beginning. Notwithstanding the foregoing,
Repligen may assign this Agreement without UM's consent to any assignee
or purchaser of all or substantially all of Repligen's business
provided the intended assignee agrees in writing to accept all of the
terms and condition of this Agreement. Further, Repligen shall refrain
from pledging any of the license rights granted in this Agreement for
security for any creditor.
XVI. Registration or Recordation
16.1 If the terms of this Agreement, or any assignment of license under this
Agreement are or become such as to require that the Agreement or
license or any part thereof be registered with or reported to a
national or supranational agency of any area in which Repligen,
Affiliates or Sublicensees would do business, Repligen will, at its
expense, undertake such registration or report. Prompt
*CONFIDENTIAL TREATMENT REQUESTED
<PAGE>
notice and appropriate verification of the act of registration or
report of any agency ruling resulting from it will be supplied by
Repligen to UM.
16.2 Any formal recordation of this Agreement or any license herein granted
which is required by the law of any country as a prerequisite to
enforceability of the Agreement or license in the courts of any such
country of for other reasons shall also be carried out by Repligen at
its expense, and appropriately verified proof of recordation shall be
promptly furnished to UM.
XVII. Export Laws and Regulations of the United States
17.1 The Export Regulations of the United States Department of Commerce
prohibit the exportation from the United States of certain types of
technical data and commodities (listed in the Export Administration
Regulations), unless the exporter (e.g., Repligen, Affiliates or
Sublicensees) has received the required General License or Validated
License, whichever is applicable. In addition, the exporter may be
required to obtain certain written assurances regarding re-export from
the foreign importer for certain types of technical data and
commodities. Prior to its engaging in any export activity, Repligen has
advised UM that it will receive a copy of the then current Export
Administration Regulations of the United States Department of Commerce
and will arrange for a subscription under which it will receive
Supplementary Bulletins from the United States Department of Commerce
upon their issuance. Should the Export Administration Regulations apply
to the activities contemplated under this Agreement, Repligen hereby
agrees to comply with, and to required Affiliates to comply with, the
Export Administration Regulations of the Unites Department of Commerce;
and Repligen hereby gives UM the assurances called for in the Export
Administration Regulations, including the assurances called for in Part
779.4 and any successor provisions of such regulations.
17.2 This Agreement shall by subject to all United Stated Government laws
and regulations now or hereafter applicable to the subject matter of
this Agreement.
*CONFIDENTIAL TREATMENT REQUESTED
<PAGE>
XVIII. Notices
Any notice, request, report, or payment required or permitted to be
given or made under this Agreement by any Party shall be given by
sending such notice by certified mail, return receipt requested, to the
address set forth below or such other address as such party shall have
specified by written notice given in conformity herewith. Any notice
not so given shall not be valid unless and until actually received, and
any notice given in accordance the provisions of this section shall be
effective when mailed to:
Repligen Corporation
117 Fourth Avenue
Needham, MA 02194
Attn: President
Notice to UM shall be addressed to:
The University of Michigan
Technology Management Office
2071 Wolverine Tower
3003 S. State Street
Ann Arbor, Michigan 48109-1280
XIX. Invalidity
In the event that any term, provision, or covenant of this Agreement
shall be determined by a court of competent jurisdiction to be invalid,
illegal, or unenforceable, that term will be curtailed, limirted, or
deleted, but only to the extent necessary to remove such invalidity,
illegality or unenforceability, and the remaining terms, provisions,
and covenants shall not in any way be affected or impaired thereby. In
the event that the time period of any covenant shall be held
unenforceable as a matter of law, said covenant will be interpreted to
be effective for an enforceable time period.
*CONFIDENTIAL TREATMENT REQUESTED
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XX. Publicity
20.1 Each Party agrees to refrain from using (and in the case of Repligen to
require Affiliates and Sublicensees to refrain from using) the name of
the other Party in publicity or advertising without the prior written
approval of the other Party. Reports in scientific literature and
presentations of joint research and development work are not considered
publicity. If a Party wishes, but is not legally obligated, to use the
name of the other Party in financial disclosures, such Party must
obtain prior written approval from the other Party, which approval will
not be unreasonably withheld. Any disclosure which is required of a
Party by law will not require the prior approval of the other Party.
20.2 Any announcements or similar publicity with respect to this Agreement
or the transactions contemplated herein shall be at such time an in
such manner as UM and Repligen shall mutually agree, provided that
nothing herein shall prevent either Party from making such public
announcements as such party's legal obligations require.
XXI. Bankruptcy
The parties hereto intend that the Agreement shall not be deemed an
executory contract under the United States Bankruptcy Code. If during
the term of this Agreement, Repligen shall make an assignment for the
benefit of auditors, or if proceedings in voluntary or involuntary
bankruptcy shall be instituted in behalf of or against Repligen, and
not be dismissed within sixty (60) days after such proceedings are
instituted, or if a receiver or trustee shall be appointed for the
property of Repligen, UM may, at its option, terminate this Agreement
and revoke the license herein granted by written notice to Repligen.
XXII. Financing Statements
Repligen agrees to cooperate with UM in the execution and filing (not
earlier than 120 days after execution of this Agreement) of financial
statements under the Uniform Commercial Code, and
*CONFIDENTIAL TREATMENT REQUESTED
<PAGE>
of similar statements, providing notice of this License Agreement, in
the United States Patent and Trademark Office, or other federal agency
or court as deemed appropriate by UM.
XXIII. Force Majeure
No failure or omission by the Parties hereto in the performance of any
obligation of this Agreement shall be deemed a breach of this Agreement
or create any liability if the same shall arise from any cause or
causes beyond the control of the Parties, including, but not limited
to, the following: act of God; acts or omissions of any government; any
rules, regulations or orders issued by any governmental authority or by
any office, department, agency or instrumentality thereof; fire; storm;
flood; earthquake; accident; war; rebellion; insurrection; riot;
invasion; strikes, and lockouts and provided that such failure or
omission resulting from one of the above causes is cured as soon as is
practicable after the occurrence of one or more of the above-mentioned
causes.
XXIV. Product Marking
Repligen agrees to mark, and to require Affiliates and Sublicensees to
mark, Licensed Product with the appropriate patent notice as approved
by UM, such approval not to be unreasonably withheld.
XXV. Non-Waiver
No waiver, other than as agreed to in writing by the Parties, no matter
how long continuing or how many times extended, by either Party of a
breach of any term or condition of this Agreement shall be considered
as a permanent waiver or as an amendment to this instrument.
*CONFIDENTIAL TREATMENT REQUESTED
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XXVI. Article Headings
The Article headings herein are for purposes of convenient reference
only and shall not be used to construe or modify the terms written in
the text of this Agreement.
XIX. No Agency Relationship
Except as clearly and specifically provided under the terms and
provisions of this Agreement, neither Party shall be deemed to be an
agent of the other in connection with the exercise of any right or
authority to assume or create any obligations or responsibility on
behalf of the other.
IN WITNESS WHEREOF, the parties have caused this Agreement to be executed by
their duly authorized representatives as of the date first written above.
FOR THE REGENTS OF
FOR REPLIGEN CORPORATION The UNIVERSITY OF MICHIGAN
BY/s/Daniel P. Witt, Ph.D. By /s/Marvin G. Parnes
---------------------------------
Daniel P. Witt, Ph.D. Associate Vice President
Vice President Interim Director,
Busisness Development Technology Management Office
Date 7/24/00 Date 7/25/00
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*CONFIDENTIAL TREATMENT REQUESTED
