Bracketed information omitted and filed separately with the Securities and
Exchange Commission
Confidential Treatment Requested Under 17 C.F.R. Sections 200.80(b)(4), 200.83
and 240.24b-2
EXHIBIT 10.7
LICENSE AGREEMENT
This Agreement is entered into effective as of July 11, 1994 (the "Effective
Date"), between GENENTECH, INC., a Delaware corporation ("Genentech"), and
SENSUS DRUG DEVELOPMENT CORPORATION, a Delaware corporation ("Sensus").
WHEREAS:
Genentech is the sole owner or exclusive licensee of the Patent Rights and
Knowhow; and
Sensus wishes to obtain an exclusive license or sublicense to the Patent Rights
and Knowhow, and Genentech is willing to grant such a license or sublicense, on
the terms set forth in this Agreement.
Now, Therefore, in consideration of the mutual promises contained herein, the
parties agree as follows:
ARTICLE 1
DEFINITIONS
1.1 "AFFILIATE" shall mean, with respect to either Party, a legal entity
that directly or indirectly controls, is controlled by or is under common
control with, such Party. For purposes of this definition, "control" shall mean
the power, whether or not normally exercised, to direct the management and
affairs of a legal entity, directly and indirectly. In the case of a
corporation, the direct or indirect ownership of 50 percent or more of its
outstanding voting equity shall be deemed to confer "control".
1.2 "COMBINATION PRODUCT" shall mean a product consisting of a Licensed
Product and at least one other component which is biologically active.
1.3 "GROWTH HORMONE ANTAGONISTS" shall mean compounds which act as
antagonists of the human growth hormone receptor and which are either: (i)
compounds claimed or described in the patents and patent applications listed on
Exhibit "A" attached hereto; (ii) other compounds first identified by Genentech
during the three year period following the Effective Date; or (iii) homologs,
analogs and amino acid fragments of any of the foregoing compounds. "Growth
Hormone Antagonists" shall not, however, include orally available
peptidomimetics of any of the foregoing compounds, nor shall such defined term
include human growth hormone or any growth hormone agonist whose maximal
response is greater than 1 percent of that of human growth hormone in
Genentech's growth hormone receptor cell based assay, or whose EC50 is less than
3 nM in Genentech's growth hormone receptor cell based assay.
1.
1.4 "FIELD" shall mean the treatment of disease in humans whereby the
mechanism of action of such treatment is directed at blocking the interaction
between growth hormone and the growth hormone receptor or binding protein in
order to block the action of growth hormone, and shall further include the
diagnosis or prevention of any disease where such treatment is utilized.
1.5 "KNOWHOW" shall mean: (i) all information, technology or materials in
the possession or control of Genentech, including that which is described on
Exhibit "B" attached hereto, which constitute proprietary methods, processes,
techniques, assay methodology, data, inventions, formulations or biologically
active materials useful for the development, use or sale of Growth Hormone
Antagonists, excluding clinical data, marketing and sale data and regulatory
filings, except insofar as any of the foregoing relate to the pegylation of
growth hormone or Growth Hormone Antagonists; and (ii) that information
concerning the manufacture of Growth Hormone Antagonists which is identified on
Exhibit "C" attached hereto.
1.6 "LICENSED PRODUCT" shall mean a product useful in the Field which: (i)
contains a Growth Hormone Antagonist as an active ingredient, and (ii) could not
be manufactured, used or sold without the license from Genentech granted herein.
1.7 "NET SALES" shall mean the gross invoiced sales price charged for all
Licensed Products and Combination Products sold by Sensus and its sublicensees
to third parties, after deduction of the following items, provided and to the
extent such items are incurred, are included in the price charged and do not
exceed reasonable and customary amounts in the market in which such sales
occurred:
(I) trade and quantity discounts or rebates actually allowed and
taken to the extent, customary in the trade;
(II) credits or allowances given or made for rejection or return of
previously sold Licensed Products or Combination Products;
(III) any tax or governmental charge (other than an income tax)
levied on the sale, transportation or delivery of a Licensed Product or
Combination Product and borne by the seller thereof; and
(IV) any charges for freight or insurance borne by the seller.
1.8 "PARTY" shall mean Genentech or Sensus, and, when used in the plural,
shall mean both of them.
2.
1.9 "PATENT RIGHTS" shall mean all patent applications and patents in the
possession or control of Genentech as of the Effective Date to the extent they
claim or relate to the manufacture, use or sale of a Growth Hormone Antagonist
or a Licensed Product or Combination Product in the Field, as well as
substitutions, extensions, reissues, renewals, divisions, continuations,
continuations-in-part and foreign counterparts thereof or therefor. Exhibit "A"
attached hereto contains a partial list of patents and patent applications which
are part of Patent Rights existing as of the Effective Date.
ARTICLE 2
LICENSE GRANT
2.1 LICENSE GRANT.
2.1.1 Genentech hereby grants to Sensus the exclusive (even as to
Genentech), worldwide, royalty-bearing right and license under the Patent Rights
and Knowhow to make, have made, use and sell Licensed Products within the Field.
Notwithstanding the foregoing, Genentech shall retain the right to make, have
made, use and sell Licensed Products within the Field for research and other
non-commercial purposes.
2.1.2 Sensus may grant sublicenses [ * ]; provided, however, that
Sensus's right to sub-license the right to use or sell a Licensed Product [ * ]
shall be subject to Article V. In the event of a sublicense by Sensus, Sensus
guarantees to Genentech the performance by Sensus' sublicensee of Sensus'
obligations hereunder.
2.2 DUE DILIGENCE.
2.2.1 Sensus shall use its best efforts expeditiously to develop,
seek regulatory approval of and commercialize Licensed Products within the
Field.
2.2.2 Without limiting subsection 2.2.1, Sensus shall attain or
perform the milestones shown on Exhibit "D" attached hereto (the "Milestones")
by the dates shown. Sensus shall notify Genentech in writing when it achieves
each of the Milestones.
2.2.3 In the event that Sensus determines that it will be unable to
meet a Milestone due to an event beyond Sensus' control but within Genentech's
control, including, without limitation, delay in the performance by Genentech of
any of its obligations hereunder (e.g. the transfer of technology or materials),
Sensus will give prompt notice to Genentech of such inability and shall specify
the amount of delay Sensus believes
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3.
resulted from events within Genentech's control. If Genentech agrees with the
amount of such delay specified by Sensus, the milestone dates will automatically
be extended by the extent of the delay in Sensus's ability to meet the Milestone
which results from such event. If Genentech disagrees with the amount of such
delay specified by Sensus, the matter shall be resolved by arbitration pursuant
to Section 2.2.4, below.
2.2.4 In the event that Sensus determines that it will be unable to
meet a Milestone date due to issues beyond either Party's control (e.g. the need
to change clinical endpoints or occurrence of a serious and unexpected adverse
experience as defined in 21 C.F.R. Section 312.32), Sensus shall notify
Genentech of such inability, identifying the nature of the inability with
reasonable specificity and may ask for an extension of time in which to complete
such Milestone. If the Parties cannot agree on the need for such an extension or
the duration of the extension due to issues beyond Sensus's or Genentech's
control, the matter will be referred to a committee of three individuals
experienced in the issue in dispute (e.g. scientist or clinical researcher) for
resolution pursuant to the then-current Commercial Rules of the American
Arbitration Association (the "Rules"), pending which resolution this Agreement
shall remain in full force and effect. Such committee shall consist of an
individual selected by each of the Parties who shall not be an employee of
either, with at least five years relevant experience. The two individuals so
selected shall promptly select a third mutually agreeable arbitrator with like
qualifications. If the individuals chosen by the Parties are unable to agree on
the third member within 30 days after arbitration proceedings are initiated, the
third member shall be identified pursuant to the Rules. The committee shall
render a written opinion as to whether the inability to meet a Milestone date is
beyond either Party's control to the Parties within 30 days after selection of
the third arbitrator. If the committee finds that such inability was outside of
the control of Sensus, the opinion shall also set forth the duration of the
extension to which Sensus is entitled. Genentech and Sensus shall be bound by
such written opinion.
2.2.5 Except as set forth in Section 2.2.3 or 2.2.4, failure of
Sensus timely to achieve any one of the Milestones shall be considered a
material breach of this Agreement and Genentech shall have the rights set forth
in Section 7.2.3.
2.2.6 Beginning on the first anniversary of the Effective Date and every
six months thereafter until the first sale of a Licensed Product, Sensus shall
submit to Genentech a progress report covering Sensus's activities related to
the development of and securing of the requisite approvals to market Licensed
Products within [ * ] (each, a "Major Market"). Sensus shall advise Genentech of
the date of the first sale of the first Licensed Products in each Major Market
and, thereafter, of
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4.
the filing of a marketing application for each subsequent Licensed Product in
each Major Market.
ARTICLE 3
PATENTS AND KNOWHOW
3.1 OWNERSHIP. Genentech shall retain title to the Patent Rights and
Knowhow, and to any patent rights and knowhow related to Licensed Products
developed solely by Genentech in the future. Except as expressly provided
herein, each Party shall own and shall have the exclusive right to exploit all
intellectual property rights owned or acquired by such Party.
3.2 PATENT PROSECUTION.
3.2.1 Genentech shall be responsible for the prosecution and
maintenance of the Patent Rights, at Genentech's expense, in consultation with
Sensus. Genentech shall keep the other informed of the status of prosecution of
Patent Rights, in each country, on a timely basis.
3.2.2 Sensus shall assist Genentech in prosecuting and maintaining
the Patent Rights as contemplated by Section 3.2.1.
3.3 INFRINGEMENT.
3.3.1 If either Party learns that a third party is infringing the
Patent Rights, it shall promptly notify the other in writing. The Parties shall
use reasonable efforts in cooperation with each other to stop such infringement
without litigation.
3.3.2 Sensus will be given the first opportunity to take the
appropriate steps to remove the infringement of the Patent Rights which claim
specifically a Growth Hormone Antagonist or its manufacture, use or sale
including, without limitation, initiating suit. If Sensus decides not to take
such steps within 180 days of discovering or being notified of the infringement,
Genentech may do so. Each of the Parties agrees to provide reasonable assistance
to the other in taking such steps. Any legal action taken under this Section
3.3.2 will be at the expense of the Party by whom suit is filed and will be
controlled by the Party bringing suit. The Party not bringing suit may choose to
be represented in any such action by counsel of its own choice at its own
expense. Any damages or costs recovered shall be retained by the Party bringing
suit. If both Parties bring suit, equitable apportionment of the costs and
damages to be recovered shall be agreed upon before the filing of the suit.
5.
3.4 THIRD PARTY PATENT RIGHTS. If a notice of infringement is received by,
or a suit is initiated against, either of Sensus or Genentech with respect to
Licensed Products, the Parties will in good faith discuss the best way to
respond.
3.5 DISCLOSURE OF KNOWHOW. A goal of the Parties is to effect a prompt and
effective transfer of Knowhow from Genentech to Sensus to assist Sensus in the
satisfaction of its "due diligence" obligations hereunder. To this end, and
subject to Article VIII, below, within 90 days following the Effective Date,
Genentech shall disclose and transfer to Sensus all Knowhow and data
constituting or evidencing Knowhow, at no cost to Sensus. To facilitate such
disclosure and transfer of Knowhow, each Party shall appoint one or more
appropriate individuals to act on its behalf as the primary liaison(s) with the
other. Not withstanding the foregoing, Genentech's obligations with respect to
the disclosure and transfer of Knowhow related to the manufacture of Growth
Hormone Antagonists shall be limited to the scale and method of manufacture most
recently practiced by Genentech.
ARTICLE 4
EQUITY AND PAYMENTS
4.1 EQUITY AS CONSIDERATION FOR LICENSE.
4.1.1 (A) In consideration of the license granted to Sensus herein,
Genentech shall be compensated through equity participation in Sensus, [ * ]. In
each case, [ * ]. All shares to which Genentech is entitled shall be delivered
to Genentech at the time of the relevant closing(s).
(B) The total number of shares to which Genentech is entitled
under this Section 4.1.1 shall be equal to [ * ]. At each relevant closing,
Genentech shall be issued [ * ]
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6.
of the type of capital stock and/or other equity so issued. To the extent
necessary, at the time of the final closing which results in Sensus receiving
[ * ]. The provisions of this Section 4.1.1 shall survive any termination of
this Agreement pursuant to Section 7.0 except for a termination by Sensus
pursuant to Section 7.2.1 or 7.2.2.
4.1.2 It shall be a condition to the continued effectiveness of this
Agreement that Sensus close an equity financing of at least [ * ] within four
months of the Effective Date, and that Sensus close further equity financings
totaling in the aggregate at least an additional [*], in accordance with the
following schedule:
MONTHS AFTER EFFECTIVE DATE
WITHIN WHICH SECOND
AMOUNT RAISED IN FIRST CLOSING CLOSING TO OCCUR
[ * ] [ * ]
4.2 ROYALTIES.
4.2.1 Sensus shall pay Genentech a royalty in the amount of [ * ] of
Net Sales of each Licensed Product in each country wherein the manufacture, use
or sale of the Growth Hormone Antagonist component of such Licensed Product is
within the scope of a valid claim of a Patent Rights in such country, and [ * ]
of Net Sales in all other instances. As used herein, "valid claim" shall mean a
claim included in a pending patent application or issued patent included within
the Patent Rights, which claim has not expired or been declared invalid in a
final decision by a court of competent jurisdiction.
4.2.2 The above royalty payments shall be made in U.S. dollars by
wire transfer to such accounts as Genentech may from time to time designate and
shall be made within 90 days at the end of each calendar quarter for Net Sales
made during such quarter. At the time of making such royalty payment, Sensus
shall also provide Genentech with a statement showing the gross sales of
Licensed Product in each country and the corresponding Net Sales and a
calculation of the royalties payable hereunder with respect to all Net Sales
including documentation of applicable currency conversions. Sensus shall also
provide Genentech notice that a wire transfer is being made at least five days
before its initiation including a brief statement that such transfer is in
payment of royalties due under this Agreement. Such notice shall be directed to
the attention of the Treasurer at the address set
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7.
forth for Genentech in Section 9.10. Any royalty payment not paid on or before
the payment date due shall bear interest, to the extent permitted by applicable
law, at the then current LIBOR rate, plus [ * ] percent, calculated on the
number of days the payment is delinquent.
4.2.3 Net Sales shall first be calculated in the currency in which
the sales were made and then converted into U.S. Dollars at the spot exchange
rate reported in the U.S. Edition of the Wall Street Journal (or other
publication chosen by the Parties by mutual consent from time to time) for the
last business day of the quarterly period for which such payment is due.
4.2.4 Royalty payments shall be made without set off and free and
clear of any taxes, duties, levies fees or charges, except for withholding taxes
(to the extent applicable). Sensus shall take all reasonable steps (including
applicable implementation of competent authority procedures) as may be required
by Genentech to (i) avoid or minimize any such withholding; (ii) take advantage
of such international taxation treaties or other double taxation agreements as
may be available; or (iii) take advantage of any tax credit with respect to such
withholding; provided that Sensus shall not be required to incur any material
costs or expenses in so doing.
4.2.5 Sensus and its sublicensees shall keep complete and accurate
records of the latest four calendar years of Net Sales with respect to which a
royalty is payable under this Agreement. Genentech shall have the right, at its
sole expense, to have an independent, certified public accountant, reasonably
acceptable to Sensus, review Sensus's (and its sublicensees') records upon
reasonable notice and during reasonable business hours for the purposes of
verifying the royalty payments made pursuant to this Agreement. If an error in
favor of Genentech of more than [ * ] percent of the total royalty amount due
hereunder for the fiscal year being reviewed is discovered, then the reasonable
fees and expenses of the accountant shall be borne by Sensus. Any amounts found
due as a result of such review shall be promptly paid to the Party entitled
thereto, together with interest thereon at the then-current LIBOR rate plus [ *
] percent. This provision shall survive any termination of this Agreement.
4.2.6 In determining the Net Sales of Combination Products, Net Sales
shall first be calculated in accordance with the definition of Net Sales and
then multiplied by the percentage value of Licensed Product contained in the
Combination Product, such percentage value being the quotient obtained by
dividing the current market value of the Licensed Product by the sum of the
separate current market values of the Licensed Product and other biologically
active ingredients contained in the Combination Product. When no current market
value is available for such an ingredient, Sensus shall calculate a hypothetical
market value for such ingredient, allocating the same proportions of costs,
overhead
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8.
and profit as are then allocated to similar substances saving an ascertainable
market price.
4.2.7 If Sensus is required (pursuant to court order, settlement or
contract) to pay royalties or other consideration to a third party for the
license or other acquisition of a patent right which is necessary in order to
manufacture, use or sell a Licensed Product within the Field, Sensus shall have
the right to offset [ * ] with respect to such Licensed Product; provided,
however, that the royalties payable to Genentech hereunder shall not thereby be
decreased or offset to a rate below [ * ] percent of Net Sales of each Licensed
Product per annum.
ARTICLE 5
RIGHT OF FIRST OFFER
Sensus grants to Genentech a "right of first offer" whereby Sensus shall first
notify Genentech in writing if it wishes to sublicense to any non-Affiliate
third party the right to use and sell a Licensed product in [ * ]. Along with
such notice to Genentech, Sensus shall provide Genentech with reasonable access
to all Sensus data related to the subject matter of the proposed sublicense, to
assist Genentech in making an informed decision regarding the exercise of its
rights under this Article V. Genentech shall notify Sensus within 45 days after
receiving such notice whether it wishes to exercise this right. If Genentech
does not so notify Sensus, Sensus may grant the rights specified in the original
notice to a third party. If Genentech does so notify Sensus, Sensus shall
negotiate exclusively with Genentech with respect to such rights for a period
not to exceed 45 days. If an agreement is not reached within such period,
Sensus may grant such rights to a third party on terms no more favorable to the
third party than those last offered to Genentech. However, if Sensus cannot
reach agreement with any third party within nine months after concluding
negotiations with Genentech, it shall again offer Genentech such rights before
offering such rights to a third party.
ARTICLE 6
CONFIDENTIALITY
6.1 NON-DISCLOSURE.
The Parties acknowledge that during the term of this Agreement they
will each receive from the other information which is proprietary, confidential
and of significant commercial value to the disclosing Party. Except to the
extent expressly authorized by this Agreement, for the term of this Agreement
and for five years thereafter, the receiving Party shall keep confidential and
shall not publish or
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9.
otherwise disclose and shall not use for any purpose (except those related to or
permitted by this Agreement) any information furnished to it by the other Party
pursuant to this Agreement, including knowhow, except to the extent that it can
be established by the receiving Party by competent proof that such information:
(a) was already known to the receiving Party, other than under an
obligation of confidentiality, at the time of disclosure by the other Party;
(B) was generally available to the public or otherwise part of the
public domain at the time of its disclosure to the receiving Party;
(C) became generally available to the public or otherwise part of the
public domain after its disclosure and other than through any act or omission of
the receiving Party in breach of this Agreement;
(D) was subsequently lawfully disclosed to the receiving Party by a
third party; or
(E) was independently developed by the receiving Party as can be
established by written records.
Each Party may disclose the other's information to Affiliates, and to third
parties to the extent such disclosure is reasonably necessary in prosecuting or
defending litigation, filing patent applications, complying with applicable
governmental regulations or conducting clinical trials; provided, however, that
if a Party is required to make any disclosure of the other Party's confidential
information it will give reasonable advance notice to the other Party of such
disclosure requirement and, except to the extent inappropriate in the case of
patent applications, will use its best efforts to secure confidential treatment
of the information to be disclosed. The disclosure of one Party's confidential
information by the other in connection with the filing or prosecution of a
patent application may be made only with the consent of the other Party, which
consent may not be unreasonably withheld. Sensus may further disclose
confidential information to the extent reasonably required to secure financing,
in the course of merger or acquisition negotiations, or to negotiate a
sublicense permitted hereunder; provided, however, that the entity to receive
such confidential information shall first execute a binding confidentiality
agreement of term and scope at least coextensive with the terms of this Section
6.1, and which confidentiality agreement shall expressly provide that Genentech
is intended to be a third-party beneficiary thereof.
10.
6.2 PUBLICATION.
Sensus may publish the results of activities related to this Agreement
to the extent it will not result in the disclosure of confidential information,
but Sensus may not publish Knowhow without the prior written consent of
Genentech. Sensus shall provide a copy of any proposed manuscript or summary of
any proposed presentation containing Knowhow to Genentech at least 30 days prior
to the proposed date of submission to a publisher or presentation. Sensus shall
incorporate all reasonable changes suggested by Genentech and to delete any
confidential information at Genentech's request.
ARTICLE 7
TERM AND TERMINATION
7.1 TERM. Unless otherwise terminated earlier, the licenses and the
royalty obligations under this Agreement will automatically expire on a country-
by-country basis on the later of either: (i) 12 years from the first commercial
sale of a Licensed Product in the country, or (ii) the expiration (or
revocation) of the last to expire (or to be revoked) of the Patent Rights in
each country. After the expiration of the term of the license in each country,
Sensus shall have a fully paid, non-revocable, non-exclusive license under the
Knowhow in that country.
7.2 TERMINATION.
7.2.1 Failure by either Party to comply with any of the material
obligations contained in this Agreement (including Section 2.2 hereof) shall
entitle the other Party to give to the Party in default notice specifying the
nature of the default and requiring it to make good such default. If such
default is not cured within 60 days after the receipt of such notice, the
notifying Party shall be entitled, without prejudice to any of its rights
hereunder or at law or equity, to terminate this Agreement by giving notice to
take effect within 30 days after such notice, unless the defaulting Party shall
cure within such further 30 day period.
7.2.2 Either Party may terminate this Agreement by notice to the
other in the event that the latter Party shall have become insolvent or
bankrupt, or shall have made an assignment for the benefit of creditors, or
there shall have been appointed a trustee or receiver of the latter Party for
all or a substantial part of its property, or any case or proceeding shall have
been commenced or other action taken by or against the latter Party in
bankruptcy or seeking reorganization, liquidation, dissolution, winding-up,
arrangement, composition or readjustment of its debts or any other similar
relief, and any such event shall have continued for more than 180 days
undismissed, unbonded and undischarged.
11.
7.2.3 (A) If Sensus fails to achieve any one of the Milestones set
forth in Exhibit "D" attached hereto within the applicable time specified in
Exhibit "D", as adjusted pursuant to Section 2.2, Genentech shall have the
option to terminate this Agreement and the license granted to Sensus herein (the
"Termination Option"), on notice to Sensus at any time within 90 days following
the date on which the Milestone in question was to have been attained. If
Genentech exercises the Termination Option, or otherwise terminates this
Agreement pursuant to section 7.2.1 or 7.2.2, Genentech shall automatically be
granted a non-exclusive, worldwide, sublicenseable license to the results of the
efforts made by Sensus and its sublicensees between the Effective Date and the
date on which the Termination Option was exercised, with respect to the
development of Growth Hormone Antagonists and Licensed Products in the Field.
Such license shall include all regulatory submissions made by Sensus and its
sublicensees for Licensed Products ("Submissions") and all patent rights and
knowhow of Sensus and its sublicensees related to Growth Hormone Antagonists or
Licensed Products and developed by Sensus or its sublicensees as part of the
development of a Licensed Product hereunder, but only to the extent that such
license can be granted by Sensus (or its sublicensee) without: (i) violating
contractual obligations to third parties (other than sublicensees hereunder), or
(ii) making payment to third parties (other than sublicensees hereunder), unless
Genentech agrees to make all such payments which are contractually required of
Sensus or its sublicensees.
(B) Such license to Genentech shall bear a commercially
reasonable royalty, taking into account the value of the rights so licensed to
Genentech on a non-exclusive basis, the amounts expended by Sensus and its
sublicensees in the development or acquisition of such rights, and the ability
of Sensus to license such rights to others. However, in no case shall the
royalty due to Sensus be greater than
(I) [ * ] percent of net sales of Growth Hormone Antagonist
products by Genentech or its sublicensees if, at the time the license is
granted, Sensus has a Growth Hormone Antagonist that has at least been the
subject of clinical trials, or
(II) [ * ] percent of net sales of such products by
Genentech or its sublicensees otherwise.
If the parties are unable to agree upon a commercially reasonable royalty, the
determination of such royalty may be referred to arbitration in the manner
provided in Section 2.2.4.
(C) Upon Genentech's exercise of the Termination Option, or
other termination of this Agreement by Genentech pursuant to Section 7.2.1 or
7.2.2, Sensus and its sublicensees shall promptly provide Genentech with all
documentation and materials to which Genentech is entitled pursuant to this
Section 7.2.3 including, without limitation, copies of all Submissions. Such
transfer shall be made in a timely and orderly fashion and in a manner such that
the value
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12.
of what is being transferred is preserved in all material respects. Sensus and
its sublicensees shall, further, promptly take all appropriate and necessary
actions, including actions before involved regulatory agencies, to confirm
Genentech's rights with respect to the Submissions, including the right to
reference such Submissions. Upon such transfer and the completion of all such
appropriate and necessary actions, Genentech shall reimburse Sensus and its
sublicensees for their actual out-of-pocket expenses incurred as a result
thereof.
7.2.4 Sensus may terminate this Agreement, effective on 90 days prior
notice to Genentech.
ARTICLE 8
SUPPLY OF MATERIALS
Within 30 days following the Effective Date, Genentech shall supply to
Sensus, at no cost to Sensus, those materials described on Exhibit "E" attached
hereto.
ARTICLE 9
MISCELLANEOUS
9.1 SOLICITATION OF EMPLOYEES. For a period of [ * ] after the Effective
Date, Sensus will not solicit any of Genentech's then-current employees to leave
their employment without the prior written consent of Genentech.
9.2 ASSIGNMENTS. Except as otherwise provided herein, neither this
Agreement or any interest hereunder shall be assignable by either Party by
operation of law or otherwise without the prior written consent of the other;
provided, however, that either Party may assign this Agreement to an Affiliate
or to any successor by merger or sale of all or substantially all of its assets
in a manner such that the assignee becomes liable and responsible for the
performance and observance of all duties and obligations hereunder. This
Agreement shall be binding upon the successors and permitted assigns of the
Parties and the name of a Party appearing herein shall be deemed to include the
names of such Party's successor's and permitted assigns to the extent necessary
to carry out the intent of this Agreement. Any assignment not in accordance with
this Section 9.2 shall be void.
9.3 REPRESENTATIONS AND WARRANTIES. (A) Each Party represents and warrants
to the other that, to the best of its knowledge; (i) it is free to enter into
this Agreement and (ii) in so doing it will not violate any other agreement to
which it is a party.
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
13.
Genentech represents and warrants to Sensus that: (i) it currently has the
right to grant the licenses granted hereunder and is unaware of any pending or
threatened litigation or alleging the invalidity of any of the Patent Rights or
misappropriation by Genentech of any of the Knowhow, and (ii) that none of the
Growth Hormone Antagonists licensed to Sensus hereunder has been developed in
violation of the patent rights of any third party including, without limitation,
patent rights related to so-called [ * ].
9.4 FORCE MAJEURE. Neither Party shall be liable to the other for loss or
damages or shall have any right to terminate this Agreement for any default or
delay attributable to any act of God, flood, fire, explosion, strike, lockout,
labor dispute, casualty or accident, war, revolution, civil commotion, act of
public enemies, blockage or embargo, injunction, law, order, proclamation,
regulation, ordinance, demand or requirement of any government or subdivision,
authority or representative of any such government, or any other cause beyond
the reasonable control of such Party, if the Party affected shall give prompt
notice of any such cause to the other Parties. The Party given such notice shall
thereupon be excused from such of its obligations hereunder as it is so disabled
and for 30 days thereafter.
9.5 NO TRADEMARK RIGHTS. No right, express or implied, is granted by this
Agreement to use in any manner any trade name or trademark of Genentech in
connection with the performance of this Agreement or the exploitation of any
license granted hereunder.
9.6 PUBLIC ANNOUNCEMENTS. Except as required by law, Sensus shall obtain
Genentech's consent (which consent shall not be unreasonably withheld) before
making any public announcement concerning the terms of this Agreement or
Sensus's relationship with Genentech.
9.7 ENTIRE AGREEMENT AND AMENDMENT. Except for that certain letter
agreement attached hereto as Exhibit "F", this Agreement contains and
constitutes the entire understanding and agreement of the Parties and cancels
and supersedes any and all prior negotiations, correspondence, understandings
and agreements, whether verbal or written, between the Parties respecting the
subject matter hereof. No waiver, modification or amendment of any provision of
this Agreement shall be valid or effective unless made in writing and signed by
a duly authorized officer of each of the Parties.
9.8 SEVERABILITY. In the event any one or more of the provisions of this
Agreement should for any reason be held by any court or authority having
jurisdiction over this Agreement or either of the Parties to be invalid, illegal
or unenforceable, such provision or provisions shall be validly reformed by
addition or deletion of wording as appropriate to avoid such result and as
nearly as possible approximate the intent of the Parties and, if
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
14.
unreformable, shall be divisible and deleted in such jurisdiction; elsewhere,
this Agreement shall not be affected.
9.9 CAPTIONS. The captions to this Agreement are for convenience only,
and are to be of no force or effect in construing or interpreting any of the
provisions of this Agreement.
9.10 NOTICE AND DELIVERY. Any notice, requests, delivery, approval or
consent required or permitted to be given under this Agreement shall be in
writing and shall be deemed to have been sufficiently given if delivered in
person, transmitted by telegraph or telecopier (with confirmed answer-back) or
sent by registered air mail letter to the Party to whom it is directed at its
address shown below or such other address as such party shall have last given by
notice to the other Party.
If to Sensus, addressed to:
Sensus Drug Development Corporation
San Jacinto Center Suite 430
00 Xxx Xxxxxxx Xxxx.
Xxxxxx, XX 00000
Attn: President
If to Genentech, addressed to:
Genentech, Inc.
000 Xxxxx Xxx Xxxxx Xxxxxxxxx
Xxxxx Xxx Xxxxxxxxx, XX 00000
Attention: Corporate Secretary
9.11 INDEMNIFICATION.
9.11.1 Sensus shall indemnify and hold Genentech harmless from any
and all damages, costs and liabilities resulting or alleged to result from any
negligent or willful act or omission of Sensus in connection with researching,
developing, selling, using or manufacturing a Licensed Product or sublicensing
another to do so (including, without limitation, reasonable attorney's fees),
except to the extent that such damages, costs or liabilities result or are
alleged to result from any negligent or willful act or omission on the part of
Genentech or any employee or agent of Genentech. In the event that suit is
brought or claim made against Genentech which might give rise to a claim of
indemnification hereunder, Genentech shall promptly notify Sensus. At its own
expense, Sensus shall have the right to participate fully in the resolution of
such suit or claim, by intervention or otherwise. No settlement of any suit or
claim which may give rise to a claim for indemnification hereunder shall be made
without the prior consent of Sensus.
15.
9.11.2 Genentech shall indemnify and hold Sensus harmless from any
and all damages, costs and liabilities resulting or alleged to result from: (i)
any negligence or willful misconduct on the part of Genentech or its
sublicensees, or (ii) any act or omission of Genentech or any sublicensee of
Genentech in the use or sale of any Licensed Product, except to the extent that
such damages, costs or liabilities result or are alleged to result from any
negligence or willful act or omission on the part of Sensus or any employee or
agent of Sensus. If suit is brought or claim made against Sensus which give rise
to a claim of indemnification hereunder, Sensus shall promptly notify Genentech.
At its own expense, Genentech shall have the right to participate fully in the
resolution of such suit or claim, by intervention or otherwise. No settlement of
any suit or claim which may give rise to a claim for indemnification hereunder
shall be made without the prior consent of Genentech.
9.12 APPLICABLE LAW. This Agreement shall be governed by the laws of the
State of California, without regard to its conflicts of laws principles.
9.13 ACCESS TO GENENTECH EMPLOYEES. (A) Genentech shall use its best
efforts to assure that for two years following the Effective Date Xxxxx X.
Xxxxx, Ph.D. ("Xxxxx") and Xxxxxxx X. Xxxxxx, Ph.D. ("Xxxxxx") shall at Sensus'
request serve as a member of Sensus' Scientific Advisory Board ("SAB"). Neither
Xxxxx nor Xxxxxx shall receive compensation or any other payment directly or
indirectly from Sensus for the services he provides Sensus while he is a
Genentech employee. Such obligation of Genentech as to each of Xxxxx and Xxxxxx
shall terminate upon the termination of the employment of each with Genentech.
If so requested, Xxxxx and Xxxxxx shall serve on the SAB pursuant to Sensus'
standard confidentiality and non-use agreement, a copy of which is attached
hereto as Exhibit "G", except that such confidentiality agreement such have no
effect to the extent that either Xxxxx or Xxxxxx are acting in their capacity as
either employees of or consultants to Genentech. For one year from the Effective
Date, Genentech shall also allow Sensus reasonable access to other Genentech
employees for up to eight hours per month, to the limited extent necessary to
achieve the transfer of Knowhow contemplated hereunder.
(B) Genentech will have no objection to Sensus retaining Xxxxx Xxxxx as
a consultant to Sensus and using knowledge and expertise which he obtained as a
Genentech employee solely to the extent required to scale up Licensed Products
from the scale disclosed by Genentech to the commercial scale reasonably
required by Sensus.
9.14 SURVIVAL. Except as otherwise provided herein, Sections 4.1.1, 4.2,
6.1, 9.10, 9.11 and 9.12 shall survive the termination or expiration of the term
of this Agreement.
16.
IN WITNESS WHEREOF, the Parties have caused this Agreement to be
executed by their respective duly authorized officers as of the day and year
first above written, each copy of which shall for all purposes be deemed to be
an original.
SENSUS DRUG DEVELOPMENT CORPORATION
By [SIGNATURE]
-----------------------------------
Title CEO
--------------------------------
GENENTECH, INC.
By [SIGNATURE]
-----------------------------------
Title Senior V.P.
--------------------------------
17.
EXHIBIT A
[ * ]
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
[ * ]
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
[ * ]
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
EXHIBIT B
NON-MANUFACTURING KNOWHOW
[ * ]
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
EXHIBIT C
MANUFACTURING KNOWHOW
. Manufacturing processes and procedures as available for producing licensed
products, including but not limited to details of the following operations:
[ * ]
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
EXHIBIT "D"
MILESTONES
[ * ]
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
EXHIBIT "E"
MATERIALS LIST
[ * ]
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
EXHIBIT F
ID/2/
Innovations in Drug Development
San Jacinto Center
00 Xxx Xxxxxxx Xxxxxxxxx Xxxxx 000
Xxxxxx, Xxxxx 00000
Tel 000-000-0000
FAX 000-000-0000
Xxxx X. Xxxxxxxx, M.D.
President / CEO
July 1, 1994
Xx. Xxxx Xxxx
Genentech Inc.
Building 24
000 Xxxxx Xxx Xxxxx Xxxxxxxxx
Xxxxx Xxx Xxxxxxxxx, XX 00000
Dear Xxxx:
I am writing with respect to Genentech's concerns regarding the transfer of
certain rights currently held by id/2/-I, L.P. pursuant to a Biotechnology
Licensing and Transfer Agreement dated January 18, 1993 between Drug Development
Investment Corporation ("DDIC") and Ohio University (the "DDIC Agreement" and a
subsequent Assignment Agreement between DDIC and id/2/-I, L.P. dated March 26,
1993. By way of clarification, DDIC is the Managing (and sole) General Partner
of id/2/-I, L.P., and directs its management and business affairs.
Within four weeks following the effective date of the contemplated license
agreement between Sensus Drug Development Corporation ("Sensus") and Genentech
regarding Growth Hormone Antagonists (as defined therein), Sensus will secure
from id/2/-I, L.P. all of the rights of id/2/-I, L.P. and/or DDIC which relate
to the manufacture, use or sale of Growth Hormone Antagonists. Within one week
following the end of such four week period, Sensus will provide Genentech with
reasonable documentation evidencing the foregoing. No payment will be due
id/2/-I, L.P. or DDIC from Sensus for the transfer of these rights. However,
Sensus will be required to assume all responsibilities related to the
transferred technology as a sublicensee under the DDIC Agreement.
In the event that Sensus has not secured the foregoing rights and provided
reasonable documentation thereof to Genentech within the time period provided
above, the license agreement between Genentech and Sensus shall be immediately
voidable by Genentech on notice to Sensus, but Genentech shall be entitled to
retain all rights thereunder to which Genentech would otherwise be entitled in
the event of termination of such license agreement by virtue of breach on the
part of Sensus.
Please let me know immediately if the foregoing is not consistent with your
understanding.
Sincerely,
Xxxx X Xxxxxxxx, M.D.
President/CEO
XXX/km
cc: X. Xx Xxxxxxx
X. Xxxxxxxxxx
EXHIBIT "G"
CONFIDENTIALITY AGREEMENT
THIS CONFIDENTIALITY AGREEMENT, effective ______________________, 19__,
("Effective Date"), by and between _______________________________, having an
address at ________________________, ("_____________________") and
________________________, having an address at __________________________
("____________________"), shall govern the conditions of disclosure by
__________________ to ___________________ of confidential technical and business
information, whether written or oral, ("Information") during or relative to the
performance of services by ___________________ on behalf of ___________________.
With regard to Information, _______________________ hereby agrees (i) not
to use any Information except for the purpose of _____________________'s
performance of services for _________________________, and (ii) not to disclose
Information to others without the express written permission of
__________________________, except that ________________________ shall not be
prevented from using or disclosing Information:
(A) which is approved in writing by ____________________________________
for release by _______________________ without restrictions; or
(B) which ________________________________ can demonstrate by written
records was previously known to _______________________; or
(C) which is now public knowledge, or becomes public knowledge in the
future, other than through acts or omissions of
_____________________________ in violation of this Confidentiality
Agreement; or
(D) which is lawfully obtained by ____________________ from sources
independent of ____________________ who have a lawful right to
disclose such Information.
It is further agreed that ____________________________'s furnishing of
Information to _____________________________________ shall not constitute any
grant, option, or license to ___________________________________ under any
patent or other intellectual property rights now or hereinafter held by
____________________________.
This Agreement shall be governed by, and construed and interpreted in
accordance with, the laws of the State of California, United States of America,
without reference to conflict of laws principles or statutory rules of
arbitration.
This Agreement constitutes the entire and exclusive agreement between
the parties with respect to the subject matter hereof and supersedes and cancels
all previous registrations, agreements, commitments and writings in respect
thereof.
The obligations of ____________________________ under the terms of this
Agreement shall continue full force and effect for 5 years after the Effective
Date.
____________________________ _________________________________
("______________________") ("__________________________")
By: ________________________ By: _____________________________
____________________________ _________________________________
Print Name Print Name
Title: _____________________ Title: __________________________
AMENDMENT OF LICENSE AGREEMENT
THIS AMENDMENT OF LICENSE AGREEMENT (the "Amendment") is entered into
effective as of December 21, 1994 (the "Effective Date"), by and between
GENENTECH, INC., Delaware corporation ("Genentech") and SENSUS DRUG DEVELOPMENT
CORPORATION, a Delaware corporation ("Sensus").
RECITALS
A. Genentech and Sensus entered into that certain License Agreement dated as
of July 11, 1994, as amended previously (the "Agreement"), pursuant to
which Genentech granted Sensus licenses under certain patent rights and
know-how of Genentech;
B. Genentech and Sensus wish to amend the Agreement to provide for Genentech
to perform certain manufacturing process development and clinical product
supply services on behalf of Sensus, and to modify the equity investment
and payment terms of the Agreement;
NOW, THEREFORE, in consideration of the mutual promises contained herein,
the parties agree as follows:
1. AMENDMENT OF ARTICLE 1. Article I of the Agreement is hereby amended
by adding the following Sections to the Article:
"1.10 "FULLY BURDENED MANUFACTURING COSTS" shall mean the [ * ].
1.11 "MANUFACTURING INFORMATION" shall mean all information,
technology or materials developed by Genentech pursuant to the process
development efforts in Article VIII that constitute proprietary methods,
processes, techniques, data, inventions, formulations or biologically
active materials specifically relating to or useful for the manufacture of
Growth Hormone Antagonists, excluding clinical data, marketing and sales
data and regulatory filings, except insofar as any of the foregoing relate
to the pegylation of growth hormone or Growth Hormone Antagonists.
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
1
1.12 "MANUFACTURING PATENTS" shall mean all patent applications and
patents issuing therefrom to the extent that they claim or relate to any
aspect of the Manufacturing Information.
1.13 "MATERIAL" shall mean Growth Hormone Antagonists described in
Exhibit H that Genentech shall produce and supply to Sensus as contemplated
under Article VIII for pre-clinical and Phase I/Phase II clinical use.
2. AMENDMENT OF EQUITY AND PAYMENT PROVISIONS. The provisions of Article
IV of the Agreement relating to "Equity and Payment" are amended and modified as
follows:
2.1. A new Section 4.1.3 is added to the Agreement, reading in its
entirety as follows:
"4.1.3. Genentech agrees to purchase [ * ] ($[ * ]) in
Sensus capital stock in the next Sensus Private Placement Equity
Financing, on the same terms as the other investors in such financing,
provided that such financing closes by February 28, 1995 and that the
total amount invested in such financing in Sensus (including the
Genentech investment) is at least [ * ] Dollars ($[ * ]). Any equity
investment by Genentech under this Section 4.1.3 shall not count
toward either (i) the $[ * ] or $[ * ] equity financing goals set
forth in Section 4.1.2, or (ii) the [ * ]% equity ownership of
Genentech set forth in Section 4.1.1."
2.2. In consideration of Genentech's effort with respect to the
Project, as set forth in Article VIII of the Agreement (as amended by this
Amendment), including delivery of all Materials required to be supplied to
Sensus thereunder in compliance with the Specifications (as defined in Section
8.4(a) of the Agreement as amended), the royalty provisions in Section 4.2 of
the Agreement are amended and modified as follows:
(A) The first sentence of Section 4.2.1 is amended and restated as
follows:
"Sensus shall pay Genentech a royalty in the amount of [ * ]% of Net
Sales of each Licensed Product in each country wherein the manufacture, use
or sale of the Growth Hormone Antagonist component of such Licensed Product
is within the scope of a valid claim of a Patent Right in such country, and
[ * ]% of such Net Sales of each Licensed Product in all other countries."
(B) In Section 4.2.7 of the Agreement, the phrase "to a rate below
[ * ] percent" is amended to read "to a rate below [ * ]%".
3. PROCESS DEVELOPMENT TERMS. The existing Article VIII in the Agreement
is deleted in its entirety and a new Article VIII, set forth in full below, is
substituted in its place.
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2
ARTICLE VIII
PROCESS DEVELOPMENT AND SUPPLY OF MATERIALS
8.1 PROCESS DEVELOPMENT PROJECT. Subject to the terms of this
Agreement, Sensus hereby engages Genentech to use its commercially
reasonable best efforts to undertake and perform process development
relating to Growth Hormone Antagonists, with the intent of developing a GMP
process for producing [ * ] bulk quantities of such compounds. Genentech
shall use its commercially reasonable best efforts to perform the specific
process development and Materials supply tasks set forth on the attached
Exhibit H, as such tasks may be more fully described or modified by written
agreement of the parties from time to time during the performance of such
tasks (the "Project"). Genentech and Sensus acknowledge that the services
provided by Genentech under this Article VIII are experimental in nature.
8.2 SENSUS PARTICIPATION IN PROJECT. Genentech shall involve
Sensus on a continuing and active basis during the Project. In particular,
Genentech shall meet and consult regularly with Sensus to discuss the
results of the Project and to agree on further refinement or specification
of the tasks, as set forth on Exhibit H, to be performed under the Project.
8.3 PROJECT TIME LINE. Subject to the terms of this Agreement,
Genentech shall use its commercially reasonable best efforts to complete
the Project, including supply of Materials to be supplied thereunder. The
Parties agree to meet, at an appropriate time but not less than 6 months
prior to the anticipated completion of the Project, to discuss possible
terms for extending the development and supply arrangement to the scaleup
and production of material for phase III clinical trial and commercial use.
Genentech, however, is under no obligation to agree to such an extension.
8.4 MATERIALS SUPPLY.
(A) Genentech shall supply the specific Materials described in
Exhibit H, according to such schedule and in such quantities to be agreed
by the Parties. Sensus shall compensate Genentech for supply of Materials
an amount equal to [ * ] of such Materials. The Materials supplied by
Genentech hereunder shall conform to such specifications, including release
and QA/QC specifications, as will be mutually agreed to by the Parties and
attached hereto as Exhibit I (the "Specifications"). The Parties agree
that, under the Project, Genentech shall develop manufacturing processes
for the Growth Hormone Antagonists sufficient to supply Sensus with batches
of Material [ * ] for pre-clinical and phase I/phase II clinical use. At
the beginning of each calendar quarter, Genentech and Sensus will mutually
agree upon a Material production and delivery schedule for such quarter.
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3
(B) Upon receipt of each batch of Material to be provided by
Genentech pursuant to Section 8.4(a), Sensus shall confirm that such
product meets the Specifications by performing pertinent analytical tests.
In the event that Sensus determines that such Material does not comply with
the Specifications in Exhibit I, Sensus shall so inform Genentech within
ten business days of receipt of such Material, describing in detail the
failure to meet the Specifications. If Sensus does not so inform Genentech
of any such non-compliance with the Specifications within ten business days
of Sensus's receipt of the Material, the Material shall be deemed to meet
such Specifications. If Genentech agrees that the delivered Material does
not meet the Specifications, Genentech shall thereafter use its
commercially reasonable best efforts, at Sensus's own cost, to produce the
required amount of Material complying with the Specifications in as short a
time as commercially reasonably practicable. If Genentech disputes Sensus's
determination that the product fails to comply with the Specifications, the
parties shall proceed under Section 8.4(c) hereof. If Genentech is unable
to produce any required batch of Material in compliance with the
Specifications within 4 weeks following the date required for delivery of
such batch under the schedule agreed to by the parties under Section
8.4(a), then Sensus may terminate this Agreement, and upon such termination
Sensus shall be responsible for payment of any fees therefor accrued
through the date of termination
(C) In the event that Genentech disputes Sensus's
determination that any batch of Material delivered by Genentech hereunder
fails to meet the Specifications, and Genentech gives Sensus written notice
of such dispute within ten business days of receiving notice from Sensus of
its determination, Sensus shall submit samples of the product delivered by
Genentech that is the subject of the dispute (the "Disputed Product") to an
independent laboratory mutually agreed upon by the parties in good faith,
for testing as to conformity with the Specifications. The determination of
such independent laboratory shall be final with regard to the question of
whether such Disputed Product delivered by Genentech hereunder complies
with the Specifications. In the event that the Disputed Product is
determined not to comply with the Specifications by this procedure, such
product shall be returned to Genentech, Genentech shall pay all costs of
the independent laboratory analysis performed on such Disputed Product, and
Genentech shall provide Sensus conforming Material as soon as reasonable
practicable. In the event that the Disputed Product is determined to comply
with the Specifications by this procedure, such product shall be returned
to Sensus, and Sensus shall pay all costs of the independent laboratory
analysis performed on such Disputed Product.
8.5 PAYMENTS. Upon the closing of Sensus' first financing of at
least $[ * ] (including the financing referred to in Section 4.1.3), Sensus
shall simultaneously pay Genentech $[ * ] in non-refundable consideration
for the performance of the Project. In addition, Sensus shall pay Genentech
$[ * ] annually per each FTE (based upon expending 235 days per year in
performing his or her services) or in proportion for parts of such FTEs
dedicated to and actually conducting work on the Project and other work
related to the Project, payable quarterly, provided that Genentech shall
not be required to dedicate during the term of this Agreement more than a
total of eight FTE's
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4
to the Project. Genentech shall provide quarterly invoices thirty (30) days
after the end of such quarter for the cost of the Genentech employees
dedicated to performing the Project in the prior quarter, which invoices
shall include a detail of the person days worked and PARTICULAR aspects of
the Project performed during such time. Sensus will remit such invoiced
amount to Genentech within thirty (30) days of receipt of such invoice.
8.6 TRANSFER OF MANUFACTURING INFORMATION.
(A) Regularly throughout the performance of the Project, but
in no event less frequently than once every calendar quarter, Genentech
shall provide Sensus a written report summarizing the results and
developments of the Project and characterizing the nature of all new
Manufacturing Information developed since the last report hereunder. At
Sensus' reasonable request, Genentech shall provide Sensus copies of
Genentech documents describing or setting forth the Manufacturing
Information.
(B) For use pursuant to Section 8.7, Genentech shall transfer
the Manufacturing Information to Sensus or a third party manufacturer of
Sensus's choice not less than 30 days after the anticipated completion or
termination of the Project if Genentech decides not to extend the Project
to include the scaleup and production of Material for a phase III clinical
trial or commercial use, as provided for in Section 8.3.
8.7 INTELLECTUAL PROPERTY. Genentech hereby grants Sensus a
nonexclusive, worldwide license, with the right to sublicense, during the
term of the Agreement to use the Manufacturing Information and to practice
the Manufacturing Patents solely in connection with the licenses granted
under Section 2.1 of this Agreement and so long as Sensus is meeting its
obligations under the Agreement, as amended. Royalties for this license are
included within the royalties described in Section 4.2.1.
8.8 REGULATORY SUBMISSIONS AND REVIEWS.
(A) Promptly after Sensus's request, Genentech shall,
consistent with appropriate regulatory practices, supply Sensus such
regulatory information specifically relating to the process for
manufacturing Growth Hormone Antagonists developed by Genentech under this
Article VIII as is necessary to file a Investigational New Drug application
for any such Growth Hormone Antagonist (the "IND"), naming Genentech as
supplier for Phase I, II and perhaps Phase III clinical trials of such
compound (the "Trial Material").
(B) After Genentech has completed the Project, Genentech shall
provide Sensus any additional information or data reflecting any changes to
the data and information relating to Trial Material or its manufacture as
provided pursuant to Section 8.8(a) above.
5
(C) For any Drug Master File relating to Trial Material
("DMF"), Genentech shall submit to FDA a letter, signed by a duly
authorized representative, authorizing Sensus to reference the DMF. Sensus
shall have a right of reference to all DMFs relevant to Growth Hormone
Antagonists.
(D) Promptly after Sensus's reasonable request, Genentech
shall, consistent with appropriate regulatory practices, supply Sensus such
information in Genentech's possession specifically relating to the Growth
Hormone Antagonists and the process for manufacturing same as is necessary
for Sensus to submit or obtain regulatory applications or approvals
required in a foreign country for Sensus to conduct clinical trials of or
market such compounds. Genentech agrees to provide Sensus access to all
documents and information of Genentech specifically relating to the Growth
Hormone Antagonists and the process for manufacturing same as is necessary
for any regulatory submissions by Sensus covering such Growth Hormone
Antagonists.
(E) All costs of compiling, filing and maintaining DMFs and
any other regulatory documents that Genentech is required to submit to any
regulatory authority shall be at Sensus's expense, and consistent with the
FTE restrictions of Section 8.5.
(F) In the event that FDA or any other national, state, or
local regulatory authority shall make any inquiries or request or require
any information relating to an IND for Growth Hormone Antagonists which
relates to work performed by Genentech under this Article VIII, Genentech,
to the extent possible, shall assist Sensus in responding fully and
completely to such inquiry or request.
(G) At any time that representatives of FDA or of any
national, state or local regulatory authority advise Genentech that there
will be an inspection of Genentech's facility or facilities where a Growth
Hormone Antagonist, is, or will be, manufactured and which inspection
specifically relates to Genentech's manufacture of Growth Hormone
Antagonists, Genentech shall immediately notify Sensus of the date and time
at which such inspection is scheduled to occur.
(H) Genentech shall immediately advise Sensus in writing of
any and all regulatory actions involving its facilities or products or
process that relate or impact in any material manner to the manufacturing
process for a Growth Hormone Antagonist or production thereof, including
without limitation governmental inspection reports, findings and
disciplinary actions against Genentech and all corrective or remedial
actions taken in response thereto. Genentech shall also advise Sensus in
writing immediately upon discovering any material problems at its
facilities relating to the production of Growth Hormone Antagonist,
including contamination or manufacturing errors, and any other action or
omission that did, or could, adversely affect the safety, efficacy, quality
or stability of the Growth Hormone Antagonist, together with a statement of
all corrective or remedial action taken.
6
(I) This Section 8.8 shall survive termination or expiration
of this Agreement.
8.9 MANUFACTURING WARRANTY. Genentech hereby represents and
warrants to Sensus that it will manufacture the Materials in accordance
with current Good Manufacturing Practices rules and regulations.
8.10 OBLIGATION UPON FINANCING. Genentech shall have no obligation
to begin the Project until Sensus receives the [ * ] Dollars ($[ * ])
described in Section 4.1.3.
8.11 TERMINATION. Except as otherwise provided, all of Genentech's
obligations under Article VIII shall terminate upon the completion of the
Project. Sensus may terminate its obligations under Article VIII as
provided in Section 8.4(b).
4. AMENDMENT OF SECTION 9.11.2. Section 9.11.2 of the Agreement is
hereby amended by adding to the first sentence of the Section, after the phrase
"sale of any Licensed Product," the following phrase: "or (iii) any negligence
or willful misconduct on the part of Genentech in the manufacture of Growth
Hormone Antagonists".
5. MISCELLANEOUS.
5.1 REPRESENTATIONS AND WARRANTIES. Each Party represents and
warrants to the other that, to the best of its knowledge, (i) it is free to
enter into this Amendment and (ii) in so doing it will not violate any other
agreement to which it is a party.
5.2 ENTIRE AGREEMENT AND AMENDMENT. Except as modified by this
Amendment and for that certain letter agreement attached to the Agreement as
Exhibit "F", the Agreement, as amended, remains in full force and effect and the
Agreement and Amendment contain and constitute the entire understanding and
agreement of the Parties and cancels and supersedes any and all prior
negotiations, correspondence, understanding and agreements, whether verbal or
written, between the parties respecting the subject matter hereof. No waiver,
modification or amendment of any provision of this Amendment shall be valid or
effective unless made in writing and signed by a duly authorized officer of each
of the Parties.
5.3 SEVERABILITY. In the event any one of the provisions of this
Amendment should for any reason be held by any court or authority having
jurisdiction over this Amendment or either of the Parties to be invalid, illegal
or unenforceable, such provision or provisions shall be validly reformed by
addition or deletion of wording as appropriate to avoid such result and as
nearly as possible approximate the intent of the Parties and, if unreformable,
shall be divisible and deleted in such jurisdiction; elsewhere, this Amendment
shall not be affected.
5.4 CAPTIONS. The captions to this Amendment are for convenience
only, and are to be of no force or effect in construing or interpreting any of
the provisions of this Amendment.
5.5 APPLICABLE LAW. This Amendment shall be governed by the laws
of the State of California, without regard to its conflicts of laws principles.
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
7
IN WITNESS THEREOF, the Parties have caused this Amendment to be
executed by their respective duly authorized officers as of the day and year
first above written, each copy of which shall for all purposes be deemed to be
an original
GENENTECH, INC. SENSUS DRUG DEVELOPMENT CORPORATION
By:____________________________ By: [sig.]
--------------------------------
Title:_________________________ Title: President / COO
-----------------------------
8
EXHIBIT H
---------
SENSUS CORPORATION - GENENTECH, INC.
PHARMACEUTICAL DEVELOPMENT/MANUFACTURING SERVICES
SCOPE OF WORK
[ * ]
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
9
V. [ * ]
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
10
IX. [ * ]
X. ESTABLISH & CHARACTERIZE [ * ]
. Coordinate with Sensus' designated QC contractor
XI. OTHER
. Provide samples of [ * ] if available
. Provide Sensus with appropriate documentation/records of above
services
. Meet with Sensus as required to monitor progress
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
11
EXHIBIT I
SPECIFICATIONS
(To be appended by parties)
12
[*] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
AMENDMENT OF LICENSE AGREEMENT
THIS AMENDMENT OF LICENSE AGREEMENT (the "Amendment") is entered into
effective as of February 03, 1995 (the "Effective Date"), by and between
GENENTECH, INC., Delaware corporation ("Genentech") and SENSUS DRUG DEVELOPMENT
CORPORATION, a Delaware corporation ("Sensus").
RECITALS
A. Genentech and Sensus entered into that certain. License Agreement dated as
of July 11, 1994, as amended previously on November 4, 1994 (the "Agreement"),
pursuant to which Genentech granted Sensus Licenses under certain patent rights
and know-how of Genentech;
B. Genentech and Sensus wish to amend the Agreement to provide for Genentech
to perform certain manufacturing process development and clinical product supply
services on behalf of Sensus, and to modify the equity investment and payment
terms of the Agreement;
NOW, THEREFORE, in consideration of the mutual promises contained herein,
the parties agree as follows:
1. AMENDMENT OF ARTICLE I. Article I of the Agreement is hereby amended
by adding the following Sections to the Article:
"1.10 "FULLY BURDENED MANUFACTURING COSTS" shall mean the [ * ].
1.11 "MANUFACTURING INFORMATION" shall mean all information,
technology or materials developed by Genentech pursuant to the process
development efforts in Article 8 that constitute proprietary methods,
processes, techniques, data, inventions, formulations or biologically
active materials specifically relating to or useful for the manufacture of
Growth Hormone Antagonists, excluding clinical data, marketing and sales
data and regulatory filings, except insofar as any of the foregoing relate
to the pegylation of growth hormone or Growth Hormone Antagonists.
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
1.
1.12 "MANUFACTURING PATENTS" shall mean all patent applications and
patents issuing therefrom to the extent that they claim or relate to any
aspect of the Manufacturing Information.
1.13 "MATERIAL" shall mean Growth Hormone Antagonists described in
Exhibit H that Genentech shall produce and supply to Sensus as contemplated
under Article 8 for pre-clinical and Phase I/Phase II clinical use."
2. AMENDMENT OF EQUITY AND PAYMENT PROVISIONS. The provisions of Article
4 of the Agreement relating to "Equity and Payment" are amended and modified as
follows:
2.1. Section 4.1.2 of the License Agreement is hereby amended as
follows:
the phrase "by February 28, 1995" in Section 4.1.2 is deleted and
replaced with the phrase "by March 3l, 1995."
2.2. A new Section 4.1.3 is added to the Agreement, reading in its
entirety as follows:
"4.1.3. Genentech agrees to purchase [ * ] Dollars ($[ * ]) in
Sensus [ * ], on the same terms as the other investors in such financing,
provided that such financing closes by March 31, 1995 and that the total
amount invested in such financing in Sensus (including the Genentech
investment) is at least [ * ] Dollars ($[ * ]). Any equity investment by
Genentech under this Section 4.1.3 shall not count toward either (i) the $[
* ] or $[ * ] equity financing goals set Forth in Section 4.1.2, or (ii)
the [ * ]% equity ownership of Genentech set forth in Section 4.1.1."
2.3. In consideration of Genentech's effort with respect to the
Project, as set forth in Article 8 of the Agreement (as amended by this
Amendment), including delivery of all Materials required to be supplied to
Sensus thereunder in compliance with the Specifications (as defined in Section
8.4(a) of the Agreement as amended), the royalty provisions in Section 4.2 of
the Agreement are mended and modified as follows:
(a) The first sentence of Section 4.2.1 is amended and restated as
follows:
"Sensus shall pay Genentech a royalty in the amount of [ * ]% of Net
Sales of each Licensed Product in each country wherein the manufacture, use
or sale of the Growth Hormone Antagonist component of such Licensed Product
is within the scope of a valid claim of a Patent Right or any Manufacturing
Patent in such country, and [ * ]% of such Net Sales of each Licensed
Product in all other countries."
(b) In Section 4.2.7 of the Agreement, the phrase "to a rate below
[ * ] percent" is amended to read "to a rate below [ * ] %".
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
2.
3. PROCESS DEVELOPMENT TERMS. The existing Article 8 in the Agreement is
deleted in its entirety and a new Article 8, set forth in full below, is
substituted in its place.
ARTICLE VIII
PROCESS DEVELOPMENT AND SUPPLY OF MATERIALS
8.1 PROCESS DEVELOPMENT PROJECT. Subject to the terms of this
Agreement. Sensus hereby engages Genentech to use its commercially
reasonable best efforts to undertake and perform process development
relating to Growth Hormone Antagonists, with the intent of developing a GMP
process for producing [ * ] bulk quantities of such compounds. Genentech
shall use its commercially reasonable best efforts to perform the specific
process development and Materials supply tasks set forth on the attached
Exhibit H, as such tasks may be more fully described or modified by written
agreement of the parties from time to time during the performance of such
tasks (the "Project"). Genentech and Sensus acknowledge that the services
provided by Genentech under this Article 8 are experimental in nature and
may not achieve the desired result.
8.2 SENSUS PARTICIPATION IN PROJECT. Genentech shall involve
Sensus on a continuing and active basis during the Project. In particular,
Genentech shall meet and consult regularly with Sensus to discuss the
results of the Project and to agree on further refinement or specification
of the tasks, as set forth on Exhibit H, to be performed under the Project.
8.3 PROJECT TIME LINE. Subject to the terms of this Agreement,
Genentech shall use its commercially reasonable best efforts to complete
the Project, including supply of Materials to be supplied thereunder. The
Parties agree to meet, at an appropriate time prior to the anticipated
completion of the Project, to discuss possible terms for extending the
development and supply arrangement to the scaleup and production of
material for phase III clinical trial and commercial use. Genentech,
however, is under no obligation to agree to such an extension.
8.4 MATERIALS SUPPLY.
(a) Genentech shall use its commercially reasonable best efforts to
supply the specific Materials described in Exhibit H, according to such
schedule and in such quantities to be agreed by the Parties. Sensus shall
pay Genentech for supply of Materials an amount [ * ] of such Materials.
Such payments shall be made within thirty (30) days of receipt of an
invoice from Genentech. The Materials supplied by Genentech hereunder shall
conform to such specifications, including release and QA/QC specifications,
as will be mutually agreed to by the Parties and attached hereto as Exhibit
I (the "Specifications"). The Parties agree that, under the Project,
Genentech shall develop manufacturing processes for the Growth Hormone
Antagonists sufficient to supply Sensus with batches of Material
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
3.
sufficient for pre-clinical and phase I/phase II clinical use. At the
beginning of each calendar quarter, Genentech and Sensus will mutually
agree upon a Material production and delivery schedule for such quarter.
(b) Upon receipt of each batch of Material to be provided by
Genentech pursuant to Section 8.4,(a), Sensus shall confirm that such
product meets the Specifications by performing pertinent analytical tests.
In the event that Sensus determines that such Material does not comply with
the Specifications in Exhibit I. Sensus shall so inform Genentech in
writing within a reasonable period of time not to exceed 90 days from
receipt of such Material, describing in detail the failure to meet the
Specifications. If Sensus does not so inform Genentech of any such non-
compliance with the Specifications within ten business days of Sensus'
receipt of the Material, the Material shall be deemed to meet such
Specifications. If Genentech agrees that the delivered Material does not
meet the Specifications, Genentech shall thereafter use its commercially
reasonable best efforts, at Sensus's cost, to produce the required amount
of Material complying with the Specifications in as short a time as
commercially reasonably practicable. In no event shall Sensus be relieved
of the obligation to pay for the non-complying Material. If Genentech
disputes Sensus's determination that the product fails to comply with the
Specifications, the parties shall proceed under Section 8.4(c) hereof. If
Genentech is unable to produce any required batch of Material in compliance
with the Specifications within a reasonable period of time following the
date required for delivery of such batch under the production and delivery
schedule agreed to by the parties under Section 8.4(a), then Sensus may
terminate this Agreement, and upon such termination Sensus shall be
responsible for payment of all fees and costs accrued through the date of
termination.
(c) In the event that Genentech disputes Sensus' determination that
any batch of Material delivered by Genentech hereunder fails to meet the
Specifications, and Genentech gives Sensus written notice of such dispute
within ten business days of receiving notice from Sensus of its
determination, Sensus shall submit samples of the product delivered by
Genentech that is the subject of the dispute (the "Disputed Product") to an
independent laboratory mutually agreed upon by the parties in good faith,
for testing as to conformity with the Specifications. The determination of
such independent laboratory shall be final with regard to the question of
whether such Disputed Product delivered by Genentech hereunder complies
with the Specifications. In the event that the Disputed Product is
determined not to comply with the Specifications by this procedure, such
product shall be returned to Genentech, Genentech shall pay all costs of
the independent laboratory analysis performed on such Disputed Product, and
Genentech shall provide Sensus conforming Material as soon as reasonably
practicable. In the event that the Disputed Product is determined to comply
with the Specifications by this procedure, such product shall be returned
to Sensus, and Sensus shall pay all costs of the independent laboratory
analysis performed on such Disputed Product. In the event the Disputed
Product does not comply with the Specifications, Sensus shall pay for the
Disputed Product and any replacement Material.
4.
8.5 PAYMENTS. Upon the closing of Sensus' first financing of at
least $[ * ] (including the financing referred to in Section 4.1.3), Sensus
shall simultaneously pay Genentech $[ * ] in non-refundable consideration
for Genentech agreeing to undertake the Project. In addition, Sensus shall
pay Genentech $[ * ] annually per each FTE (based upon expending 235 days
per year in performing his or her services) or in proportion for parts of
such FTEs dedicated to and actually conducting work on the Project and
other work related to the Project, payable quarterly, provided that
Genentech shall not be required to dedicate during the term of this
Agreement more than a total of twelve FTEs to the Project, excluding
manufacturing personnel. Genentech shall provide quarterly invoices thirty
(30) days after the end of each quarter for the cost of the Genentech
employees dedicated to performing the Project in the prior quarter, which
invoices shall include a detail of the person days worked and particular
aspects of the Project performed during such time. Sensus will remit such
invoiced amount to Genentech within thirty (30) days of receipt of such
invoice.
8.6 TRANSFER OF MANUFACTURING INFORMATION.
(a) Regularly throughout the performance of the Project, but in
no event less frequently than once every calendar quarter, Genentech shall
provide Sensus a written report summarizing the results and developments of
the Project and characterizing the nature of all new Manufacturing
Information developed since the last report hereunder. At Sensus"
reasonable request, Genentech shall provide Sensus copies of Genentech
documents describing or setting forth the Manufacturing Information.
(b) For use pursuant to Section 8.7, Genentech shall transfer the
Manufacturing Information to Sensus or a third party manufacturer of
Sensus' choice (who executes a confidentiality agreement reasonably
satisfactory to Genentech, which agreement shall not prevent such party
from using the Manufacturing Information on Sensus' behalf) not more than
60 days after the anticipated completion or termination of the Project if
Genentech decides not to extend the Project to include the scaleup and
production of Material for a phase III clinical trial or commercial use, as
provided for in Section 8.3.
8.7 INTELLECTUAL PROPERTY. Genentech hereby grants Sensus a
nonexclusive, worldwide license, with the right to sublicense, during the
term of the Agreement to use the Manufacturing Information and to practice
the Manufacturing Parents solely in connection with the licenses granted
under Section 2.1 of this Agreement and so long as Sensus is meeting its
obligations under the Agreement, as amended. Royalties for this license are
included within the royalties described in Section 4.2.1.
8.8 REGULATORY SUBMISSIONS AND REVIEWS.
(a) Promptly after Sensus' request, Genentech shall, consistent
with appropriate regulatory practices, supply Sensus such regulatory
information specifically relating to the process for manufacturing Growth
Hormone Antagonists developed by
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5.
Genentech under this Article 8 as is necessary to file an Investigational New
Drug application for any such Growth Hormone Antagonist (the "IND"), naming
Genentech as supplier for Phase I, II and perhaps Phase III clinical trials of
such compound (the "Trial Material").
(b) After Genentech has completed the Project, Genentech shall, consistent
with appropriate regulatory-practices, provide Sensus any additional information
or data reflecting any changes to the data and information relating to Trial
Material as provided pursuant to Section 8.8(a) above.
(c) Promptly after Sensus's reasonable request, Genentech shall consistent
with appropriate regulatory practices, supply Sensus such information in
Genentech's possession specifically relating to the process for manufacturing
Growth Hormone Antagonists developed by Genentech under this Article 8 as is
necessary for Sensus to submit or obtain regulatory applications or approvals
required in a foreign country for Sensus to conduct clinical trials of or market
such compounds. Genentech agrees to provide Sensus access to all documents and
information of Genentech specifically relating to the Growth Hormone Antagonists
and the process for manufacturing same as is necessary for any regulatory
submissions by Sensus covering such Growth Hormone Antagonists.
(d) All costs of compiling, filing and maintaining any regulatory
documents that Genentech is required to submit to any regulatory authority shall
be at Sensus' expense, and consistent with the FTE restrictions of Section 8.5.
(e) In the event that FDA or any other national, state, or local
regulatory authority shall make any inquiries or request or require any
information relating to an IND for Growth Hormone Antagonists which relates to
work performed by Genentech under this Article 8, Genentech, to the extent
possible, shall assist Sensus in responding fully and completely to such inquiry
or request. Any effort expended by Genentech hereunder in assisting Sensus shall
be at Sensus' expense and consistent with the FTE restrictions of Section 8.5.
(f) At any time that representatives of FDA or of any national, state or
local regulatory authority advise Genentech that there will be an inspection of
Genentech's facility or facilities where a Growth Hormone Antagonist, is, or
will be, manufactured and which inspection specifically relates to Genentech's
manufacture of Growth Hormone Antagonists, Genentech shall immediately notify
Sensus of the date and time at which such inspection is scheduled to occur.
(g) Genentech shall immediately advise Sensus in writing of any and all
regulatory actions involving its facilities or products or process that relate
or impact in any material manner to the manufacturing process for a Growth
Hormone Antagonist or production thereof, including without limitation
governmental inspection reports, findings and disciplinary actions against
Genentech and all corrective or remedial actions
6.
taken in response thereto. Genentech shall also advise Sensus in writing
immediately upon discovering any material problems at its facilities relating to
the production of Growth Hormone Antagonist, including contamination or
manufacturing errors, and any other action or omission that did, or could,
adversely affect the safety, efficacy, quality or stability of the Growth
Hormone Antagonist, together with a statement of all corrective or remedial
action taken.
8.9 MANUFACTURING WARRANTY. Genentech hereby represents and warrants to
Sensus that it will manufacture the Materials for use in Phase I & Phase II
clinical trials in accordance with current Good Manufacturing Practices rules
and regulations.
8.10 OBLIGATION UPON FINANCING. Genentech shall have no obligation to begin
the Project until Sensus receives the [ * ] Dollars ($[ * ]) described in
Section 4.1.3.
8.11 TERMINATION. Except as otherwise provided, all of Genentech's
obligations under Article 8 shall terminate upon the earlier of (i) the
completion of the Project or (ii) the expenditure by Genentech of twelve FTE's,
excluding manufacturing personnel. If Genentech's obligations terminate under
clause (i) of the preceding sentence or Sensus terminates the Agreement pursuant
to Section 8.4(b), Genentech's obligations under Sections 8.6(b), 8.7 and 8.8
shall survive such termination. If Genentech's obligations terminate under
clause (ii) of the preceding sentence, Genentech's obligations under Sections
8.6(b) and 8.7 shall survive such termination. Sensus may terminate its
obligations under Article 8 as provided in Section 8.4(b)."
4. AMENDMENT OF SECTION 9.11.2. Section 9.11.2 of the Agreement is
hereby amended by adding to the first sentence of the Section, after the phrase
"sale of any Licensed Product," the following phrase: "or (iii) any negligence
or willful misconduct on the part of Genentech in the manufacture of Growth
Hormone Antagonists".
5. MISCELLANEOUS
5.1 REPRESENTATIONS AND WARRANTIES. Each Party represents and
warrants to the other that, to the best of its knowledge, (i) it is free to
enter into this Amendment and (ii) in so doing it will not violate any other
agreement to which it is a party.
5.2 ENTIRE AGREEMENT AND AMENDMENT. Except as modified by this
Amendment and for that certain letter agreement attached to the Agreement as
Exhibit "F", the Agreement, as amended, remains in full force and effect and the
Agreement and Amendment contain and constitute the entire understanding and
agreement of the Parties and cancels and supersedes any and all prior
negotiations, correspondence, understanding and agreements, whether verbal or
written, between the parties respecting the subject matter hereof. No waiver,
modification or amendment of any provision of this Amendment shall be valid or
effective unless made in writing and signed by a duly authorized officer of each
of the Parties.
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
7.
5.3 SEVERABILITY. In the event any one of the provisions of this
Amendment should for any reason be held by any court or authority having
jurisdiction over this Amendment or either of the Parties to be invalid, illegal
or unenforceable, such provision or provisions shall be validly reformed by
addition or deletion of wording as appropriate to avoid such result and as
nearly as possible approximate the intent of the Parties and, if unreformable,
shall be divisible and deleted in such jurisdiction; elsewhere, this Amendment
shall not be affected.
5.4 CAPTIONS. The captions to this Amendment are for convenience only,
and are to be of no force or effect in construing or interpreting any of the
provisions of this Amendment.
5.5 APPLICABLE LAW. This Amendment shall be governed by the laws of the
State of California, without regard to its conflicts of laws principles.
IN WITNESS THEREOF, the Parties have caused this Amendment to be executed
by their respective duly authorized officers as of the day and year first above
written, each copy of which shall for all purposes be deemed to be an original.
GENENTECH, INC. SENSUS DRUG DEVELOPMENT CORPORATION
By [SIGNATURE] By: [SIGNATURE]
----------------------------- ---------------------------
Title: Senior Vice President Title: President & COO
-------------------------
8.
EXHIBIT H
SENSUS CORPORATION - GENENTECH, INC.
PHARMACEUTICAL DEVELOPMENT/MANUFACTURING SERVICES
SCOPE OF WORK
[ * ]
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
1.
[ * ]
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
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2.
[ * ]
X. ESTABLISH & CHARACTERIZE [ * ]
. Coordinate with Sensus' designated QC contractor
XI. OTHER
. Provide samples of [ * ] if available
. Provide Sensus with appropriate documentation/records of above
services
. Meet with Sensus as required to monitor progress
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
3.
AMENDMENT OF LICENSE AGREEMENT
THIS AMENDEMENT OF LICENSE AGREEMENT (the "Amendment") is entered into
effective as of March 31, 1995 (the "Effective Date"), by and between GENENTECH,
INC., a Delaware corporation ("Genentech") and SENSUS DRUG DEVELOPMENT
CORPORATION, a Delaware corporation ("Sensus").
RECITALS
A. Genentech and Sensus entered into that certain License Agreement dated as
of July 11, 1994, as amended previously on November 4, 1994 and February 3,
1995, (the "Agreement") pursuant to which Genentech granted Sensus licenses
under certain patent rights and know-how of Genentech:
B. Genentech and Sensus wish to amend the Agreement to modify the equity
investment and payment terms of the Agreement:
NOW, THEREFORE, in consideration of the mutual promises contained herein,
the parties agree as follows:
1. AMENDMENT OF EQUITY AND PAYMENT PROVISIONS. The provisions of Article IV
of the Agreement relating to "Equity and Payment" are amended and modified as
follows:
1.1 Section 4.1.1 (b) of the Agreement is hereby amended as follows:
(A) Each reference to "[ * ]" in Section 4.1.1 (b) is hereby
changed to "[ * ]".
1.2 Section 4.1.2 of the Agreement is hereby amended as follows:
(A) The phrase "by March 31, 1995" in Section 4.1.2 is hereby
deleted and replaced with the phrase "by July 15, 1995".
(B) The table in section 4.1.2 is hereby deleted and replaced
with the following schedule
Months After February 3, 1995
Within Which Second
Amount Raised in First Closing Closing to Occur
------------------------------ -----------------------------
[ * ] [ * ]
(C) The phrase "at least $[ * ]" in Section 4.1.2 is hereby
deleted and replaced with the phrase "at least $[ * ]".
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
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1.
(D) The phrase "an additional [ * ]" in Section 4.1.2 is hereby
deleted and replaced with the phrase "an additional $[ * ]".
1.3 Section 4.1.3 of the Agreement is hereby amended as follows:
(A) The phrase "by March 31, 1995" is hereby deleted and
replaced by the phrase "by July 15, 1995".
(B) The phrase "at least [ * ] Dollars ($[ * ])" in Section
4.1.3 is hereby deleted and replaced with the phrase "at
least [ * ] Dollars ($[ * ])".
(C) The phrase "the $[ * ]" in section 4.1.3 is hereby deleted
and replaced by the phrase "the $[ * ]".
(D) The reference to "[ * ]" in Section 4.1.3 is changed to
"[ * ]".
2. AMENDMENT OF PROCESS DEVELOPMENT AND MATERIAL SUPPLY PROVISIONS. The
provisions of Article VIII of the Agreement relating to "Process
Development and Supply of Materials" are amended and modified as follow:
2.1 Section 8.5 of the Agreement is hereby amended as follows:
(A) The phrase "at least $[ * ]" in Section 8.5 is hereby
deleted and replaced by the phrase "at least $[ * ]".
2.2 Section 8.10 is hereby amended as follows:
(A) The phrase "[ * ] Dollars ($[ * ])" in Section 8.10 is
hereby deleted and replaced by the phrase "[ * ] dollars
($[ * ])".
IN WITNESS THEREOF, the Parties have caused this Amendment to be
executed by their respective duly authorized officers as of the day and year
first above written, each copy of which shall for all purposes be deemed to be
at original.
GENENTECH, INC. SENSUS DRUG DEVELOPMENT CORPORATION
By: [SIGNATURE] By: [SIGNATURE]
--------------------------- ---------------------------------
Title: SR VP Title: President/CEO
------------------------ ------------------------------
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
2.
FOURTH AMENDMENT TO LICENSE AGREEMENT
THIS AMENDMENT TO LICENSE AGREEMENT (the "Amendment") is entered into
effective as of __________, 1998 (the "Effective Date"), by and between
GENENTECH, INC., a Delaware corporation ("Genentech") and SENSUS DRUG
DEVELOPMENT CORPORATION, a Delaware corporation ("Sensus").
RECITALS
A. Genentech and Sensus entered into that certain License Agreement dated as
of July 11, 1994, as amended previously on November 4, 1994, February 3,
1995 and March 31, 1995 (the "Agreement") pursuant to which Genentech
granted Sensus licenses under certain patent rights and know-how of
Genentech;
B. Sensus wishes to obtain the [ * ] from Genentech to support their current
studies with the human growth hormone antagonist;
C. Genentech is willing to supply the [ * ] to Sensus on the terms and subject
to conditions set forth below;
D. Genentech and Sensus wish to amend the Agreement to modify the Material
List contained in Exhibit E of the Agreement;
NOW, THEREFORE, in consideration of the mutual promises contained herein,
the parties agree as follows:
1. AMENDMENT OF EXHIBIT E. Exhibit E of the Agreement is hereby amended
by adding the following to the Material List:
[ * ]
2. MISCELLANEOUS.
2.1 CONDITIONS. As a condition to adding the above material to
Exhibit E of the Agreement, Sensus agrees that such material will constitute
confidential information under Article VI of the Agreement, and that Sensus will
use such material solely for animal or in vitro studies to further understand
the role of the [ * ].
Notwithstanding the foregoing, Sensus may transfer such material to
third parties for purification or other purposes relating to the processing of
the
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
material, so long as any such third party is bound by confidentiality provisions
no less stringent than those set forth in the Agreement.
2.2 ENTIRE AGREEMENT AND AMENDMENT. Except as modified by this
Amendment, the Agreement, remains in full force and effect and the Agreement and
Amendment contain and constitute the entire understanding and agreement of the
Parties and cancels and supersedes any and all prior negotiations,
correspondence, understanding and agreements, whether verbal or written, between
the parties respecting the subject matter hereof. No waiver, modification or
amendment of any provision of this Amendment shall be valid or effective unless
made in writing and signed by a duly authorized officer of each of the Parties.
IN WITNESS THEREOF, the Parties have caused this Amendment to be executed
by their respective duly authorized officers as of the day and year first above
written, each copy of which shall for all purposes be deemed to be an original.
GENENTECH, INC. SENSUS DRUG DEVELOPMENT CORPORATION
By: [SIGNATURE] By: [SIGNATURE] 2-9-98
--------------------------- -----------------------------
Title: VP Process Sciences Title: Sr. VP Research, Mfg.
------------------------ ------------------------
--------------------------------------------------------------------------------
2.
[*] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
FIFTH AMENDMENT TO LICENSE AGREEMENT
THIS AMENDMENT TO LICENSE AGREEMENT (the "Amendment") is entered into
effective as of May 19, 1998 (the "Effective Date"), by and between
GENENTECH, INC., a Delaware corporation ("Genentech") and SENSUS DRUG
DEVELOPMENT CORPORATION, a Delaware corporation ("Sensus").
RECITALS
A. Genentech and Sensus entered into that certain License Agreement dated
as of July 11, 1994, as amended previously on November 4, 1994, February 3,
1995, March 31, 1995, and February 9, 1998 (the "Agreement") pursuant to which
Genentech granted Sensus licenses under certain patent rights and know-how of
Genentech;
B. Sensus wishes to obtain certain [ * ] from Genentech to support their
current studies with the human growth hormone antagonist;
C. Genentech is willing to supply the [ * ] to Sensus on the terms and
subject to conditions set forth below;
D. Genentech and Sensus wish to amend the Agreement to modify the
Material List contained in Exhibit E of the Agreement;
NOW, THEREFORE, in consideration of the mutual promises contained herein,
the parties agree as follows:
1. AMENDMENT OF EXHIBIT E. Exhibit E of the Agreement is hereby amended
by adding the following to the Material List:
[ * ] used for gauging the purity of [ * ] products (specifically,
[ * ]) expressed in [ * ]
2. MISCELLANEOUS.
2.1 CONDITIONS. As a condition to adding the above material to
Exhibit E of the Agreement, Sensus agrees that such material will constitute
confidential information under Article VI of the Agreement, and that Sensus will
use such material solely for animal or in vitro studies to further understand
the role of the growth hormone receptor in physiology and disease.
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
Notwithstanding the foregoing, Sensus may transfer such material to third
parties for purification or other purposes relating to the processing of the
material, so long as any such third party is bound by confidentiality provisions
no less stringent than those set forth in the Agreement.
2.2 ENTIRE AGREEMENT AND AMENDMENT. Except as modified by this
Amendment, the Agreement, remains in full force and effect and the Agreement and
Amendment contain and constitute the entire understanding and agreement of the
Parties and cancels and supersedes any and all prior negotiations,
correspondence, understanding and agreements, whether verbal or written, between
the parties respecting the subject matter hereof. No waiver, modification or
amendment of any provision of this Amendment shall be valid or effective unless
made in writing and signed by a duly authorized officer of each of the Parties.
IN WITNESS THEREOF, the Parties have caused this Amendment to be executed
by their respective duly authorized officers as of the day and year first above
written, each copy of which shall for all purposes be deemed to be an original.
GENENTECH, INC. SENSUS DRUG DEVELOPMENT CORPORATION
By: [SIGNATURE] By: [SIGNATURE]
------------------------------ ---------------------------------
Title: VP Process Sciences Title: Sr. VP
--------------------------- ------------------------------
2.
