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EXHIBIT 10.10
COLLABORATION & LICENSE AGREEMENT
SCHERING AKTIENGESELLSCHAFT
AND
IDEC PHARMACEUTICALS CORPORATION
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COLLABORATION & LICENSE AGREEMENT
THE COLLABORATION AGREEMENT is made effective as of the 9th day of June,
1999 (the "Effective Date") by and between IDEC PHARMACEUTICALS CORPORATION, a
Delaware corporation, having its principal place of business at 00000 Xxxxxxxxx
Xxxx, Xxx Xxxxx, Xxxxxxxxxx 00000 ("IDEC") and SCHERING AKTIENGESELLSCHAFT, a
German corporation, having its principal place of business at Xxxxxxxxxxxxx 000,
X-00000 Xxxxxx, Xxxxxxx ("SCHERING"). IDEC and SCHERING are sometimes referred
to herein individually as a "Party" and collectively as the "Parties," and
references to IDEC and SCHERING shall include its Affiliates.
RECITALS
1. IDEC is currently conducting U.S. registration clinical trials
of a radiolabeled monoclonal antibody to the human CD20 antigen designated
IDEC-Y2B8 ("Y2B8") for treatment of B-cell lymphomas. IDEC has established the
infrastructure for development, manufacture, marketing and sales of biological
products. Thus, IDEC intends to seek registration and market Y2B8 in the United
States territory.
2. SCHERING has worldwide expertise in the area of development,
registration, manufacturing, distribution and marketing of pharmaceutical
products.
3. IDEC desires to grant to SCHERING, and SCHERING desires to
obtain, rights to market Y2B8 worldwide with the exception of the United States,
all on the terms and conditions set forth herein.
ARTICLE 1.
DEFINITIONS
"2B8" means the unlabeled monoclonal antibody to CD20 positive B- cells
more particularly described on EXHIBIT B to this Collaboration Agreement.
"AFFILIATE" means an entity which, directly or indirectly, through one or
more intermediaries, controls, is controlled by, or is under common control with
IDEC or SCHERING, as the case may be. As used in this definition, "control"
means the direct or indirect ownership of fifty percent (50%) or more of the
stock, having the right to vote for directors thereof, or the possession of the
power to direct or cause the direction of the management and policies of an
entity, whether through the ownership of the outstanding voting securities or by
contract or otherwise.
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"ALLOCABLE OVERHEAD" means costs incurred by a Party or for its account
which are attributable to a Party's supervisory services, occupancy costs, and
its payroll, information systems, human relations and purchasing functions and
which are allocated to company departments based on space occupied or headcount
or other activity-based method, excluding compensation related to a Party's
stock option program or any program that replaces such program. Allocable
Overhead shall not include any costs attributable to general corporate
activities including, by way of example, executive management, investor
relations, business development, legal affairs and finance.
"ANTIBODY CONJUGATE" means 2B8 conjugated with MxDTPA
"ANTIBODY MANUFACTURING COST" means IDEC's direct costs and charges,
including Allocable Overhead, related to the manufacture, packaging and shipment
of 2B8, and shall exclude costs and charges related to or occasioned by unused
manufacturing capacity, the manufacture of other products at IDEC's facilities,
amortization of property, plant or equipment not specifically related to
manufacturing 2B8, and any employee costs associated with equity incentive
plans. EXHIBIT D to this Agreement sets out a breakdown of IDEC's current
Antibody Manufacturing Cost.
"BUSINESS DAY" means a day on which banking institutions are open for
business in California, U.S.A. and Berlin, Germany.
"COLLABORATION AGREEMENT" means this Collaboration & License Agreement
dated the Effective Date between IDEC and SCHERING.
"COMBINATION PRODUCT ADJUSTMENT" means the following: in the event a Kit
is sold in the form of a combination product containing one or more active
ingredients in addition to a Kit , Net Sales for such combination product will
be adjusted by multiplying actual Net Sales of such combination product by the
fraction *_____* where A is the *_____* and B is the *_____*. If, on a
country-by-country basis, the other active component or components in the
combination are not sold separately in said country, Net Sales shall be
calculated by multiplying actual Net Sales of such combination product by the
fraction *_____* where A is *_____* and C *_____*. If, on a country-by-country
basis, neither the Kit nor the other active component or components of the
combination product is sold separately in said country, Net Sales shall be
determined by the Parties in good faith.
"COMMERCIALLY REASONABLE AND DILIGENT" means those efforts consistent
with the exercise of prudent scientific and business judgement, as applied to
other pharmaceutical products of similar potential and market size by the Party
in question.
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*_____* Indicates that material has been omitted and confidential treatment has
been requested therefor. All such omitted material has been filed separately
with Secretary of the Commission in the Company's Application Requesting
Confidential Treatment pursuant to Rule 24b-2 under the Securities Exchange Act
of 1934, as amended.
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"CONTROL" or "CONTROLLED" means possession of the ability to grant a
license or sublicense as provided for herein without violating the terms of any
agreement or other arrangement with any Third Party.
"COST OF GOODS SOLD" shall mean the total of: (i) Antibody Manufacturing
Cost; (ii) Non-Antibody Components Supply Cost; and (iii) Manufacturing
Royalties.
"DEVELOPMENT COSTS" means costs, including Allocable Overhead, required
to obtain the marketing authorization and/or ability to manufacture, formulate,
fill, ship and/or sell a Licensed Product in the Field in commercial quantities.
Development Costs shall include but are not limited to the cost of supplies of
antibody, chelate, and isotopes, the cost of studies on the toxicological,
pharmacokinetic, metabolic or clinical aspects of a Licensed Product conducted
internally or by individual investigators, or consultants necessary for the
purpose of obtaining and/or maintaining Regulatory Approval of a Licensed
Product in the Field, and costs for preparing, submitting, reviewing or
developing data or information for the purpose of submission to a governmental
authority to obtain and/or maintain approval of a Licensed Product in the Field.
Development Costs shall include expenses for compensation, benefits and travel
and other employee-related expenses, as well as data management, statistical
designs and studies, document preparation, and other expenses associated with
the clinical testing program and the preparation, filing, and presentation of
Drug Approval Applications to the regulatory authorities for marketing approval
of the Licensed Product.
"DEVELOPMENT PLAN" means the comprehensive plan for the development of
the Licensed Product as set out on EXHIBIT A, designed to generate the
preclinical, process development/manufacturing scale-up, clinical and regulatory
information required to obtain Regulatory Approval in the United States. The
Development Plan shall refer to all activities related to preclinical testing,
toxicology, formulation, selection criteria of contract manufacturers, clinical
and commercial product supply plans, quality assurance/quality control, clinical
studies and regulatory affairs for Licensed Product in connection with obtaining
Regulatory Approvals of such Product in the United States.
"DRUG APPROVAL APPLICATION" means an application that a Party reasonably
believes in good faith is sufficient to obtain Regulatory Approval required for
commercial sale or use of the Licensed Product as a drug in the Initial
Indication in a regulatory jurisdiction, including: (1) in the case of Drug
Approval Applications for Regulatory Approval in the United States, Biologic
License Application(s) and all supplements filed pursuant to the requirements of
the FDA and related to the Initial Indication (including all documents, data and
other information concerning a Licensed Product which are necessary for, or
included in, FDA approval to market the Licensed Product); and, (2) in the case
of Drug Approval Applications for Regulatory Approval in the European Union, the
counterparts to the Drug Approval Applications and supplements described in (1)
above for Regulatory Approval to EMEA.
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"EFFECTIVE DATE" means June ___, 1999.
"EMEA" means the European Medicines Evaluation Agency.
"*_____*".
"FDA" means the United States Food and Drug Administration.
"FIELD" means the use of Licensed Product for the diagnosis, prevention
and therapy of all diseases, conditions and disorders in humans.
"*_____* DRUG APPROVAL APPLICATION" means the *_____* the Drug Approval
Applications to be submitted to the FDA relating to the treatment of *_____*
further designated as the *_____* in the Development Plan and in Section 4.2 of
the Collaboration Agreement.
"*_____*".
"*_____*".
"IDEC" means IDEC Pharmaceuticals Corporation, a Delaware corporation,
and its Affiliates.
"IDEC KNOW-HOW" means all Information, whether currently existing or
developed or obtained during the course of the Collaboration Agreement, and
whether or not patentable or confidential, that is now Controlled or hereinafter
becomes Controlled by IDEC or its Affiliates and that relates to the research,
development, utilization, manufacture or sale of the Licensed Product.
Notwithstanding anything herein to the contrary, IDEC Know-how shall exclude
IDEC Patents.
"IDEC PATENT" means any Patent owned or Controlled by IDEC or its
Affiliates including its interest in any Patents owned jointly by the Parties as
provided hereunder either at the Effective Date or at any time during the term
of the Collaboration Agreement which covers the research, development,
manufacture, use, importation, sale or offer for sale of the Licensed Product.
"*_____*".
"IN2B8" means that certain *_____* more particularly described on
EXHIBIT B to the Collaboration Agreement.
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*_____* Indicates that material has been omitted and confidential treatment has
been requested therefor. All such omitted material has been filed separately
with Secretary of the Commission in the Company's Application Requesting
Confidential Treatment pursuant to Rule 24b-2 under the Securities Exchange Act
of 1934, as amended.
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"INFORMATION" means techniques and data relating to the Licensed
Product, including, but not limited to, biological materials, inventions,
practices, methods, knowledge, know-how, skill, experience, test data (including
pharmacological, toxicological and clinical test data), analytical and quality
control data, marketing, pricing, distribution, cost, sales, manufacturing,
patent data or descriptions.
"Initial Indication" means the treatment of *_____*.
"KIT" means an *_____* that includes: *_____*.
"LICENSED PRODUCT(S)" means either: Antibody Conjugate alone or Antibody
Conjugate plus Non-Antibody Components or Y2B8; or, *_____* (a) developed by
IDEC or (b) the intellectual property rights to which are owned or Controlled,
in whole or in part, by IDEC, in either (a) or (b) as of the Effective Date or
during the term of the Collaboration Agreement.
"LICENSED TERRITORY" means all countries in the world, excluding the
United States.
"MAJOR EUROPEAN COUNTRY" means the *_____*.
"MANUFACTURING ROYALTIES" shall mean the royalties payable by IDEC to
Third Parties for licenses to manufacture or have manufactured 2B8, Antibody
Conjugate, and Non-Antibody Components, for as long as such royalties are
payable. The royalties currently payable by IDEC are listed in EXHIBIT F to this
Agreement.
"NET SALES" means the amount invoiced by SCHERING, its Affiliates or its
sublicensees on account of sales of the Kit to Third Parties in the Licensed
Territory, less reasonable and customary deductions applicable to the Kit for
(i) transportation charges and charges such as insurance relating thereto paid
by the selling party; (ii) sales and excise taxes or customs duties paid by the
selling party and any other governmental charges imposed upon the sale of the
Kit and paid by the selling party; (iii) distributors fees or rebates or
allowances actually granted, allowed or incurred in the ordinary course of
business in connection with the sale of the Kit in an arms length transaction;
(iv) quantity discounts, cash discounts or chargebacks actually granted, allowed
or incurred in the ordinary course of business in connection with the sale of
the Kit; and (v) allowances or credits to customers in the ordinary course of
business in connection with the sale of the Kit, not in excess of the selling
price of such Kit, on account of governmental requirements, rejection,
outdating, recalls or return of the Kit.
For the purpose of calculating Net Sales, the Parties recognize that (a)
a Party's customers may include persons in the *_____* who enter into agreements
with a Party as to *_____* even though *_____* and even though payment for such
Kit is not made *_____* and (b) in such
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*_____* Indicates that material has been omitted and confidential treatment has
been requested therefor. All such omitted material has been filed separately
with Secretary of the Commission in the Company's Application Requesting
Confidential Treatment pursuant to Rule 24b-2 under the Securities Exchange Act
of 1934, as amended.
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cases, *_____* paid by a *_____* can be *_____* in order to calculate Net Sales.
*_____*.
Any deductions listed above which involve a payment by a Party shall be
taken as a deduction against aggregate sales for the period in which the payment
or deduction is made. Sales of the Kit between SCHERING and its Affiliates or
sublicensees shall be excluded from the computation of Net Sales except where
any such Affiliate or sublicensee is an end user of Kit or Licensed Product. Net
Sales shall be accounted for in accordance with International Accounting
Standards consistently applied. The amount obtained by deducting (i) through (v)
from the gross amount invoiced shall then be adjusted by the Combination Product
Adjustment, if applicable.
"NON-ANTIBODY COMPONENTS" shall means all components of the Kit other
than the Antibody Conjugate.
"NON-ANTIBODY COMPONENTS SUPPLY COST" shall mean the invoiced costs and
charges of the suppliers of Non-Antibody Components to IDEC together with the
invoiced costs of the Third Party manufacturer for manufacture of Antibody
Conjugate from 2B8 provided by IDEC, negotiated at an arm's-length basis in
accordance with the terms of this Agreement.
"PARTIES" means IDEC and SCHERING.
"PARTY" means IDEC or SCHERING, as applicable.
"PATENT(S)" means (i) valid and enforceable letters patent, including
any extension, registration, confirmation, reissue, re-examination or renewal
thereof and (ii) pending applications for letters patent, including provisional
applications and any continuation, division or continuation-in-part.
"PATENT COSTS" means the fees and expenses paid to outside legal counsel
and experts, and filing and maintenance expenses, incurred after the Effective
Date in connection with the establishment and maintenance of rights under
Patents covering any Licensed Product, including costs of patent interference,
reexamination, reissue, opposition and revocation proceedings.
"REGULATORY APPROVAL" means any approvals, product and/or establishment
licenses, BLAs, BLA Equivalents, registrations or authorizations of any federal,
state or local regulatory agency, department, bureau or other governmental
entity, necessary for the commercial manufacture, use, storage, import, export,
transport, marketing or sale of a Licensed Product in a regulatory jurisdiction.
"*_____*".
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*_____* Indicates that material has been omitted and confidential treatment has
been requested therefor. All such omitted material has been filed separately
with Secretary of the Commission in the Company's Application Requesting
Confidential Treatment pursuant to Rule 24b-2 under the Securities Exchange Act
of 1934, as amended.
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"SCHERING" means Schering Aktiengesellschaft, a German corporation.
"SCHERING KNOW-HOW" means all Information, whether currently existing or
developed or obtained during the course of the Collaboration Agreement, and
whether or not patentable or confidential, that is now Controlled or hereinafter
becomes Controlled by SCHERING or its Affiliates and that relates to the
research, development, utilization, manufacture or sale of the Licensed Product.
Notwithstanding anything herein to the contrary, SCHERING Know-how shall exclude
SCHERING Patents.
"SCHERING PATENT" means any Patent owned or Controlled by SCHERING or
its Affiliates including its interest in any Patents owned jointly by the
Parties as provided hereunder either at the Effective Date or at any time during
the term of the Collaboration Agreement which covers the research, development,
manufacture, use, importation, sale or offer for sale of the Licensed Product.
"*_____* DRUG APPROVAL APPLICATION" means the *_____* the Drug Approval
Applications to be submitted to the FDA relating to the treatment of *_____* as
further designated as the *_____* in the Development Plan and in Section 4.2 of
the Collaboration Agreement.
"STEERING COMMITTEE" means that committee established pursuant to
Section 3.1 of the Collaboration Agreement.
"SUPPLY AGREEMENT" means the Supply Agreement between SCHERING and IDEC
of even date.
"THIRD PARTY" means any entity other than IDEC or SCHERING.
"THIRD PARTY ROYALTIES" means royalties payable by either Party to a
Third Party in connection with the manufacture, use or sale of Licensed Product
in a particular jurisdiction.
"UNITED STATES" means the United States of America, its territories and
possessions.
"VALID AND ENFORCEABLE PATENT" means an issued/granted unexpired IDEC
Patent that has not been held invalid or unenforceable in an unappealed or
unappealable decision of a court or competent body having jurisdiction thereof;
provided, that such IDEC Patent would, but for the licenses granted under this
Collaboration Agreement, be infringed by the manufacture, use, sale or import of
Kits, Kit Components, or Licensed Product.
"Y2B8" means that certain yttrium-labeled monoclonal antibody to B cells
more particularly described on EXHIBIT B to the Collaboration Agreement.
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*_____* Indicates that material has been omitted and confidential treatment has
been requested therefor. All such omitted material has been filed separately
with Secretary of the Commission in the Company's Application Requesting
Confidential Treatment pursuant to Rule 24b-2 under the Securities Exchange Act
of 1934, as amended.
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ARTICLE 2.
SCOPE OF COLLABORATION
2.1 DEVELOPMENT COSTS AND DATA TRANSFER.
(a) IDEC shall carry out, and, at its own expense, shall
bear all Development Costs for carrying out the Development Plan to seek
Regulatory Approval of Licensed Product in the Field in the United States
through the date of Regulatory Approval of Licensed Product in the United
States.
(b) IDEC shall provide SCHERING with a complete copy of all
documents filed with the FDA to support the Drug Approval Applications. Unless
otherwise agreed by the Parties under Section 3.1(c), IDEC's obligation shall
not include any post-Regulatory Approval Drug Approval Applications submitted by
IDEC in the Initial Indication, e.g., any Phase IV studies.
(c) In consideration of IDEC's development efforts, transfer
of the Drug Approval Application(s) registration dossiers and for the licenses
granted in this Collaborative Agreement, SCHERING agrees to fund IDEC for
carrying out the Development Plan to the extent outlined below in this Section
2.1(c). The Development Plan represents a good faith estimate by IDEC, as of the
Effective Date, of IDEC's timeline associated with carrying out the Licensed
Product development in the United States.
Accordingly, SCHERING shall fund IDEC's development efforts with fixed
*_____* payments *_____* as follows, and IDEC will use such funds to support the
development of the Licensed Product:
*_____*
(d) SCHERING shall bear any additional Development Costs
which may be necessary for development of the Licensed Product to obtain
Regulatory Approval to market the Licensed Product in the Field in the Licensed
Territory, subject to the determination of the scientific and commercial
potential of the Licensed Product as further described in Section 5.1.
ARTICLE 3.
MANAGEMENT OF THE DEVELOPMENT ACTIVITIES IN THE
UNITED STATES AND LICENSED TERRITORY
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*_____* Indicates that material has been omitted and confidential treatment has
been requested therefor. All such omitted material has been filed separately
with Secretary of the Commission in the Company's Application Requesting
Confidential Treatment pursuant to Rule 24b-2 under the Securities Exchange Act
of 1934, as amended.
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3.1 STEERING COMMITTEE.
(a) Within *_____* of the Effective Date, the Parties will
establish the Steering Committee. The Steering Committee will be composed of
*_____*. Such representatives will include individuals with expertise and
responsibilities in areas such as preclinical development, clinical development,
process sciences, manufacturing, marketing or regulatory affairs. Either Party
may replace any or all of its representatives at any time upon written notice to
the other Party. The Steering Committee will meet (in person, telephonically, or
via videoconference) at least once each calendar quarter, or more frequently, as
agreed to by the Steering Committee.
(b) The Steering Committee shall: (i) coordinate development
of the Licensed Product in the United States and in the Licensed Territory, in
the Field, as envisaged in the Collaboration Agreement, including the
coordination of activities and exchange of information regarding ongoing and new
clinical studies, regulatory strategy and commercial development (including
pricing and product positioning issues) and the establishment of the relevant
timelines; (ii) coordinate the expedited development of Licensed Product to
obtain *_____* Regulatory Approval in the United States as set forth in Article
4; (iii) discuss the need, desirability of, structure and/or allocation of costs
of any clinical studies or other development efforts relating to the Licensed
Product to be carried out in the United States and/or the Licensed Territory;
(iv) discuss actions planned by either Party in respect of the Licensed Product
where such actions could reasonably be expected to have a material impact on the
Licensed Product in the other Party's territory; and (v) discuss collaboration
in the development of the Licensed Product for indications other than the
Initial Indication.
(c) The general principles relating to clinical studies
(other than those studies required by the FDA for Regulatory Approval in the
United States for the Initial Indication, the results of which will be made
available by IDEC to SCHERING without charge) shall be as follows:
(i) Where the Parties agree, prior to commencement
of such a study, that the results of such study are to be used for regulatory or
commercial purposes in both the United States and the Licensed Territory the
costs of the study shall be shared by the Parties and the cost allocation,
structure, timelines and other details of the study shall be agreed between the
Parties in good faith taking account of the relative importance and value to
each Party of the study in question.
(ii) Where a study is required by a regulatory
authority in the Licensed Territory the costs of such a study shall be borne,
and its organization and structure shall be determined, solely by SCHERING.
Where a study is required by the FDA the costs of such a study shall be borne,
and its organization and structure shall be determined, solely by IDEC. If,
however, any regulatory authority in the Licensed Territory subsequently
requires the results of IDEC's FDA-
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*_____* Indicates that material has been omitted and confidential treatment has
been requested therefor. All such omitted material has been filed separately
with Secretary of the Commission in the Company's Application Requesting
Confidential Treatment pursuant to Rule 24b-2 under the Securities Exchange Act
of 1934, as amended.
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required study or the results of a study with the same characteristics as the
FDA-required study, and/or SCHERING determines that it wishes to provide such
results to the regulatory authority in question, IDEC shall provide the results
of its study to SCHERING on payment of a proportion of the costs of the study,
the proportion to be determined *_____*. The same principles shall apply where
the FDA requires the results of a regulatory authority-required SCHERING study
or the results of a study with the same characteristics.
(d) The Steering Committee shall consider amendments and
modifications to the Development Plan and update it from time-to-time. *_____*
may modify or amend and update the Development Plan provided that: (i) *_____*
(ii) any such updates, modifications or amendments are made *_____*.
(e) While both parties recognize the benefit of a unified
and coordinated Licensed Product positioning due to the global oncology
community, it is IDEC's intention to provide SCHERING maximum latitude with
respect to product marketing and regulatory decisions in the Licensed Territory
so as to enable SCHERING to maximize Licensed Product sales. Therefore, while
IDEC may comment on development in the Licensed Territory and such comments
shall be considered in good faith, SCHERING shall have authority over
development in the Licensed Territory. *_____*.
3.2 COLLABORATION CHAIRPERSON. Within ten (10) days of the Effective
Date, each Party shall designate a Collaboration Chairperson. Such Collaboration
Chairperson shall be part of senior management and shall serve as a member of
the Steering Committee. The Chairpersons shall work together to be responsible
to set the agenda, call, and take minutes of meetings of the Steering Committee.
ARTICLE 4.
DEVELOPMENT AND COMMERCIALIZATION
IN THE UNITED STATES
4.1 DEVELOPMENT EFFORTS. IDEC agrees to use Commercially Reasonable
and Diligent efforts to develop Licensed Product in the Field and to bring
Licensed Product to market in the Field in the United States as soon as
practicable. IDEC further agrees to execute and perform the Development Plan in
all material respects consistent with United States Regulatory Approval.
4.2 DRUG APPROVAL APPLICATIONS. Consistent with the Development Plan
*_____* IDEC currently intends to file *_____* Drug Approval Application *_____*
and shall file, *_____* Drug Approval Application *_____* studies. It is
intended as of the Effective Date that the *_______* Drug Approval Application
will be submitted by IDEC with a package which includes
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*_____* Indicates that material has been omitted and confidential treatment has
been requested therefor. All such omitted material has been filed separately
with Secretary of the Commission in the Company's Application Requesting
Confidential Treatment pursuant to Rule 24b-2 under the Securities Exchange Act
of 1934, as amended.
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the results of clinical studies *__________*. IDEC shall own all regulatory
submissions including all Drug Approval Applications for Licensed Product filed
by it in the United States. SCHERING shall be notified of any meetings between
IDEC and the FDA relating to the Licensed Product; where appropriate based on
IDEC's judgment of its relationship with the FDA, one representative of SCHERING
shall be entitled to attend, as an observer, at SCHERING's expense and on the
dates agreed to by the FDA and IDEC; any such meeting which will deal with
issues which may affect the Licensed Territory.
4.3 DELIVERY OF FDA DRUG APPROVAL APPLICATIONS. Unless otherwise
agreed by the Parties in writing, IDEC shall deliver to SCHERING only the Drug
Approval Applications and other relevant documentation filed on Licensed Product
with the FDA in the *_____* Indication *_____*. In order to enable SCHERING to
begin as early as possible preparatory work for filing Drug Approval
Applications in Europe, IDEC shall provide parts of application documentation
and individual reports relating to the Drug Approval Applications for the
Initial Indication as soon as such become available. After filing Drug Approval
Applications in the United States, IDEC will keep SCHERING informed of all
questions raised by the FDA and will provide copies of all responses by IDEC
thereto. All information to be provided hereunder will be provided in electronic
form if available.
4.4 MARKETING IN THE U.S. IDEC will use Commercially Reasonable and
Diligent Efforts to maintain Regulatory Approval for Licensed Product in the
United States for as long as SCHERING is paying royalties to IDEC on Net Sales
in the Licensed Territory. *_____*.
ARTICLE 5.
DEVELOPMENT AND COMMERCIALIZATION IN LICENSED TERRITORY
5.1 SCHERING'S DEVELOPMENT EFFORTS. SCHERING will use Commercially
Reasonable and Diligent efforts to develop the Licensed Product in the Licensed
Territory, including pursuing preclinical development (if necessary) and
clinical development of Licensed Product and obtaining Regulatory Approvals
therefor in all countries in the Licensed Territory *_____*. SCHERING shall bear
all regulatory costs in the Licensed Territory, including but not limited to
purchasing supplies of Licensed Product as Kits from IDEC, coordinating the
supply of yttrium *_____* for Licensed Product, and conducting and funding all
clinical studies required for Licensed Product approval in the Territory subject
to the principles outlined in Section 3.1(c). It is the Parties' intent to
cooperate on study design and share study costs if the study is determined by
the Parties to be of mutual commercial value, as further described in Section
3.1. During the clinical phase, SCHERING shall purchase Kits from IDEC at
*_____* and during the commercial phase, SCHERING shall purchase Kits from IDEC
at *_____* subject to Section 5.1(b) of Supply Agreement.
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*_____* Indicates that material has been omitted and confidential treatment has
been requested therefor. All such omitted material has been filed separately
with Secretary of the Commission in the Company's Application Requesting
Confidential Treatment pursuant to Rule 24b-2 under the Securities Exchange Act
of 1934, as amended.
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Within one hundred and twenty (120) days of the Effective Date, SCHERING
agrees to provide IDEC with a written development plan for Licensed Product in
the Licensed Territory. It is the Parties' understanding and expectation that a
Drug Approval Application will be filed by SCHERING in the European Union in
accordance with the centralized procedure described in Council Regulation (EEC)
No. 2309/93 within *_____* after receipt from IDEC of both the *_____* Drug
Approval Application. IDEC shall be notified of any meetings relating to
Licensed Product between SCHERING and any regulatory authorities in the Licensed
Territory; where appropriate based on SCHERING's judgment of its relationship
with the regulatory agency, one representative of IDEC shall be entitled to
attend, as an observer, at IDEC's expense and on the dates agreed to by the
regulatory authorities and SCHERING; any such meeting which will deal with
issues which may affect the United States.
5.2 MARKETING EFFORTS. SCHERING will use Commercially Reasonable and
Diligent efforts to commercialize Licensed Product in each country in the
Licensed Territory in which Regulatory Approval is granted, *_____*.
5.3 DEVELOPMENT COSTS AND MARKETING COSTS. SCHERING shall bear all
Development Costs and marketing costs related to the development and
commercialization of Licensed Product in the Licensed Territory. SCHERING shall
have the sole responsibility for and right to make all decisions regarding all
development and marketing activities in the Licensed Territory. At SCHERING's
request, IDEC shall provide SCHERING with reasonable support and cooperation in
the form of consulting services directed toward securing and maintaining
Regulatory Approval of Licensed Product in the Licensed Territory. Subject as
hereinafter provided in this Section 5.3, IDEC shall be reimbursed for time and
expenses at the FTE rates set forth in EXHIBIT G. In the *_____* IDEC shall
provide *_____* of such consulting services *_____* and for the next *_____*
thereafter *_____* will be provided *_____*. Travel time associated with
rendering such services shall be included as consulting time (no greater than 8
hours per day). The Parties agree that membership of the Steering Committee is
not deemed to be the provision of consulting services and SCHERING shall not
reimburse any costs related to participation in the Steering Committee.
Furthermore, if SCHERING requires consulting services of *_____* as the case may
be, in any month, it shall not be entitled to carry over the unused hours to
subsequent months. SCHERING shall reimburse IDEC for reasonable out-of-pocket
costs (such as travel, meals and lodging) associated with provision of such
consulting services.
5.4 COOPERATION ON DEVELOPMENT EFFORTS. To facilitate cooperation
between the Parties on the worldwide development and marketing of Licensed
Product, each Party shall keep the other Party fully informed of all substantive
development activities in the Licensed Territory and the United States, as the
case may be. The Parties agree that they will do nothing during Licensed Product
development activities to imperil early Regulatory Approvals in any country in
----------
*_____* Indicates that material has been omitted and confidential treatment has
been requested therefor. All such omitted material has been filed separately
with Secretary of the Commission in the Company's Application Requesting
Confidential Treatment pursuant to Rule 24b-2 under the Securities Exchange Act
of 1934, as amended.
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the Licensed Territory or in the United States, *_____*. The foregoing
restrictions shall not apply to activities specified in the Development Plan as
of the Effective Date.
ARTICLE 6.
MILESTONES, ROYALTIES AND OTHER PAYMENTS
6.1 PAYMENTS UPON EXECUTION. SCHERING shall pay IDEC via wire
transfer $13 million as a non-refundable, non-creditable license issue fee,
within *_____* of the Effective Date.
6.2 MILESTONE PAYMENTS. SCHERING shall make the following
non-refundable, non-creditable payments to IDEC, upon the first achievement of
each of the corresponding milestones:
MILESTONE PAYMENTS
*_____*
The Parties agree that the foregoing milestone payments are payable only
once.
6.3 ROYALTIES. SCHERING shall pay IDEC a royalty on Net Sales of
Licensed Product in the Licensed Territory as follows:
(a) The royalty rate shall be *_____* of Net Sales in the
Licensed Territory, subject to Sections 6.3(c), 6.3(d), 6.3(e) and 14.5.
(b) Existing Patents/Applications. Prior to the Effective
Date, IDEC has provided SCHERING full review of patent status to the best of
IDEC's knowledge pertaining to Licensed Product in the Licensed Territory (as
well as the United States), including the scope and terms of Patent licenses
secured by IDEC. SCHERING shall evaluate the Patent status of Licensed Product
in the Licensed Territory and determine, in its sole discretion after
consultation with IDEC, if and when any Patent licenses should be secured by
SCHERING in the Licensed Territory. SCHERING shall pay any Third Party royalties
owed based on patents or applications published as of the Effective Date *_____*
on account of import, sale or use of Licensed Product in the Licensed Territory.
*_____*. SCHERING will pay for, or reimburse IDEC for, all consideration paid
under any such licenses required in the Licensed Territory (including fees,
milestones and minimum annual royalties) while such a license is needed in the
Licensed Territory or part of it. In the event both Parties determine that
securing a license to a particular Patent(s) in both the Licensed Territory and
the United States is desirable, IDEC and SCHERING shall discuss in good faith
via the Steering Committee the merits of securing a single license granting
rights to both Parties versus the
----------
*_____* Indicates that material has been omitted and confidential treatment has
been requested therefor. All such omitted material has been filed separately
with Secretary of the Commission in the Company's Application Requesting
Confidential Treatment pursuant to Rule 24b-2 under the Securities Exchange Act
of 1934, as amended.
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Parties securing individual licenses and sharing costs equitably for such a
single license. Each Party shall immediately notify the other if it becomes
aware of any risk that the sale of the Licensed Product in the United States or
in the Licensed Territory could infringe any Third Party Patents or that any
Third Party has claimed that such infringement could occur.
(c) In the event any Third Party Patents or applications are
published after the Effective Date that SCHERING determines in good faith are
necessary or desirable to license for the commercialization of the Licensed
Product in the Licensed Territory, SCHERING shall notify IDEC in writing of such
Patents and provide the rationale for the licensing decision. *_____*. After
discussion at the Steering Committee, SCHERING may secure any such license(s) as
it deems necessary for commercialization of Licensed Product in the Licensed
Territory and SCHERING shall be responsible for any and all license issue fees,
milestone payments and minimum annual royalties under such Third Party Patent
license(s).
*_____*
6.4 MONTHLY SALES REPORTS AND ROYALTY PAYMENT REPORTS. In order to
assist IDEC in planning, SCHERING shall provide IDEC with written unaudited
monthly sales of License Product in the Territory within ten (10) days of
receipt of such data by SCHERING. Royalty payments under the Collaboration
Agreement shall be made in United States Dollars to IDEC quarterly within thirty
(30) days following the end of each calendar quarter for which royalties are
due. Each royalty payment shall be accompanied by a report summarizing the Net
Sales in units sold during the relevant three-month period.
6.5 TERM OF ROYALTY OBLIGATIONS.
(a) SCHERING shall pay royalties hereunder with respect to
Net Sales in each country in the Licensed Territory through *_____* or *_____*
from the date of first commercial sale of Licensed Product in such country,
whichever is longer.
(b) Upon expiration of the royalty term for Licensed Product
in a country as described above or in Sections 14.5(b) and (c), SCHERING shall
thereafter have an exclusive, fully paid-up, irrevocable license to use,
manufacture or have manufactured, sell, offer for sale, have sold and import the
Licensed Product (including all necessary licenses to IDEC Patents, IDEC
Know-how and IDEC trademarks) in that country.
6.6 TAXES. IDEC shall pay any and all taxes levied on account of, or
measured exclusively by, any royalty payment it receives under the Collaboration
Agreement. If laws or regulations require that taxes be withheld, SCHERING will
(i) deduct those taxes from the remittable royalty, (ii) timely pay the taxes to
the proper taxing authority, and (iii) send proof of payment to IDEC within
sixty (60) days following that payment.
----------
*_____* Indicates that material has been omitted and confidential treatment has
been requested therefor. All such omitted material has been filed separately
with Secretary of the Commission in the Company's Application Requesting
Confidential Treatment pursuant to Rule 24b-2 under the Securities Exchange Act
of 1934, as amended.
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6.7 FOREIGN EXCHANGE. For the purpose of computing Net Sales for
Licensed Product sold in a currency other than United States Dollars, such
currency shall be converted into United States Dollars in accordance with
SCHERING's customary and usual translation procedures consistently applied.
6.8 PAYMENTS TO OR REPORTS BY AFFILIATES. Any payment required under
any provision of the Collaboration Agreement to be made to either Party or any
report required to be made by either Party shall be made to or by an Affiliate
of that Party if designated by that Party as the appropriate recipient or
reporting entity.
6.9 SALES BY SUBLICENSEES. In the event SCHERING grants licenses or
sublicenses to others to make or sell Licensed Product in the Licensed
Territory, such licenses or sublicenses shall include an obligation for the
licensee or sublicensee to account for and report its Net Sales of such Licensed
Product on the same basis as if such sales were Net Sales by SCHERING, and
SCHERING shall pay royalties to IDEC as if the Net Sales of the sublicensee were
Net Sales of SCHERING.
ARTICLE 7.
MANUFACTURE AND SUPPLY
7.1 MANUFACTURE AND SUPPLY OF LICENSED PRODUCT. IDEC shall supply
SCHERING with Licensed Product as Kits pursuant to the terms of the Supply
Agreement.
In the event IDEC is no longer selling Licensed Product in the United
States and *_____* is greater than *_____* SCHERING may *_____*
7.2 TRANSFER OF MATERIALS AND KNOW-HOW. If, in the circumstances
referred to in Section 7.1 above, *_____* IDEC shall *_____*. IDEC shall
*_____*.
ARTICLE 8.
LICENSES
8.1 LICENSES TO SCHERING WITHIN THE FIELD. IDEC grants to SCHERING a
worldwide (except the United States) exclusive (even as to IDEC) license, with a
right to sublicense, under the IDEC Patents, IDEC Know-how and Joint Patents, to
use, develop, manufacture (only under provisions of Section 7.1 of this
----------
*_____* Indicates that material has been omitted and confidential treatment has
been requested therefor. All such omitted material has been filed separately
with Secretary of the Commission in the Company's Application Requesting
Confidential Treatment pursuant to Rule 24b-2 under the Securities Exchange Act
of 1934, as amended.
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Collaboration Agreement and Section 6 of the Supply Agreement), have
manufactured (only under provisions of Section 7.1 of this Collaboration
Agreement and Section 6 of the Supply Agreement), market, sell, import for sale,
and distribute the Licensed Product for all indications in the Field.
8.2 NONEXCLUSIVE LICENSE TO IDEC. SCHERING grants to IDEC a
royalty-free, non-exclusive, license in the United States to use SCHERING
Know-how and SCHERING Patents in the Field solely for the purposes of
developing, manufacturing, having manufactured, using, selling, offering for
sale and importing Licensed Product in the United States. IDEC covenants and
agrees not to develop, make, have made, use, sell, offer for sale, have sold or
import any product using any of the SCHERING Know-how or SCHERING Patents except
as expressly permitted under this Section 8.2. If SCHERING is sublicensing any
Third Party Patents under this grant, SCHERING will provide IDEC with written
notice thereof, and IDEC shall pay any royalties owed to any such Third Party on
account of the manufacture, use or sale of any Licensed Product by IDEC in the
United States. With respect to manufacture of Licensed Product by IDEC in the
United States for transfer to SCHERING under the Supply Agreement, any such
royalties paid by IDEC under such sublicenses shall be included by IDEC in its
Cost of Goods Sold.
8.3 SUBLICENSING. It is the intention of the Parties and the
expectation of IDEC that SCHERING will deploy its sales force to actively market
and sell Licensed Product in the Licensed Territory. *_____*.
8.4 SHARED INFORMATION. All of the information described in Section
13.1 below shall be deemed IDEC Know-how and SCHERING Know-how for purposes of
this Article 8 and the licenses granted herein. The Parties agree that the
provisions of this Article 8 do not constitute an obligation on either Party to
transfer or permit the use of clinical data or other data relevant to drug
approval applications other than as provided for under Section 3.1(c) above.
8.5 *_____*.
ARTICLE 9.
TRADEMARKS
----------
*_____* Indicates that material has been omitted and confidential treatment has
been requested therefor. All such omitted material has been filed separately
with Secretary of the Commission in the Company's Application Requesting
Confidential Treatment pursuant to Rule 24b-2 under the Securities Exchange Act
of 1934, as amended.
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9.1 LICENSED PRODUCT TRADEMARKS. All Licensed Product shall be sold
in the United States under trademarks selected by IDEC and owned by IDEC in the
United States. The Steering Committee shall use best efforts to select a
worldwide trademark. IDEC shall control preparation, prosecution and maintenance
of applications related to such trademarks. IDEC shall bear the costs in the
United States and SCHERING shall reimburse IDEC for the costs incurred in the
Licensed Territory. IDEC hereby grants SCHERING an exclusive license to the
trademarks in the Licensed Territory.
9.2 INFRINGEMENT OF TRADEMARKS. Each Party shall notify the other
and the Steering Committee promptly upon learning of any actual, alleged or
threatened infringement of a trademark applicable to a Licensed Product (the
"Trademark") or of any unfair trade practices, trade dress imitation, passing
off of counterfeit goods, or like offenses. Upon learning of such an offense
from a Party regarding a Trademark owned solely by one of the Parties, the
Parties shall confer regarding the defense of such Trademark. The decision
whether and how to defend such a Trademark owned solely by one Party will rest
with such Party. The procedure described in Section 11.5(c) relating to Patents
shall apply; Mutatis mutandis, to the infringement of Trademarks.
ARTICLE 10.
CONFIDENTIALITY
10.1 CONFIDENTIALITY; EXCEPTIONS. Except to the extent expressly
authorized by the Collaboration Agreement or otherwise agreed in writing, the
Parties agree that, for the term of the Collaboration Agreement and for *_____*
years thereafter, the receiving Party shall keep confidential and shall not
publish or otherwise disclose or use for any purpose other than as provided for
in the Collaboration Agreement any Information and other information and
materials furnished to it by the other Party pursuant to the Collaboration
Agreement (collectively, "Confidential Information"), except to the extent that
it can be established by the receiving Party that such Confidential Information:
(a) was already known to the receiving Party, other than
under an obligation of confidentiality, at the time of disclosure by the other
Party;
(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 the Collaboration Agreement;
----------
*_____* Indicates that material has been omitted and confidential treatment has
been requested therefor. All such omitted material has been filed separately
with Secretary of the Commission in the Company's Application Requesting
Confidential Treatment pursuant to Rule 24b-2 under the Securities Exchange Act
of 1934, as amended.
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(d) was disclosed to the receiving Party, other than under
an obligation of confidentiality, by a Third Party who had no obligation to the
disclosing Party not to disclose such information to others; or
(e) was subsequently developed by the receiving Party
without use of the Confidential Information as demonstrated by competent written
records.
10.2 AUTHORIZED DISCLOSURE. Each Party may disclose Confidential
Information hereunder to the extent that such disclosure is reasonably necessary
for exercising its rights and carrying out its obligations under the
Collaboration Agreement and in filing or prosecuting patent applications,
prosecuting or defending litigation, complying with applicable governmental
regulations or conducting preclinical or clinical trials, provided that if a
Party is required by law or regulation to make any such disclosure of the other
Party's Confidential Information it will, except where impracticable for
necessary disclosures (for example, in the event of medical emergency), 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 reasonable efforts to secure confidential treatment of such Confidential
Information required to be disclosed. In addition, each Party shall be entitled
to disclose, under a binder of confidentiality containing provisions as
protective as those of this Article 10, Confidential Information to consultants
and other Third Parties only for any purpose provided for in the Collaboration
Agreement. Nothing in this Article 10 shall restrict any Party from using for
any purpose any Information developed by it during the course of the
collaboration hereunder.
10.3 SURVIVAL. This Article 10 shall survive the termination or
expiration of the Collaboration Agreement for a period of *_____* years.
10.4 TERMINATION OF PRIOR AGREEMENT. The Collaboration Agreement
supersedes the Confidentiality Agreement between the Parties dated 21 December
1998. All Information exchanged between the Parties under that Agreement shall
be deemed Confidential Information and shall be subject to the terms of this
Article 10.
10.5 CORPORATE COMMUNICATIONS AND PUBLICATIONS. Each Party shall
provide to the other the opportunity to review any proposed abstracts,
manuscripts or presentations (including information to be presented verbally)
which relate to the Field at least thirty (30) days prior to their intended
submission for publication and such submitting Party agrees, upon written
request from the other Party, not to submit such abstract or manuscript for
publication or to make such presentation until the other Party is given a
reasonable period of time to seek patent protection for any material in such
publication or presentation which it believes is patentable. The Licensed
Product in all such publications shall be referred to as "IDEC-Y2B8" and/or
"IDEC-In2B8" until
----------
*_____* Indicates that material has been omitted and confidential treatment has
been requested therefor. All such omitted material has been filed separately
with Secretary of the Commission in the Company's Application Requesting
Confidential Treatment pursuant to Rule 24b-2 under the Securities Exchange Act
of 1934, as amended.
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tradenames are selected by the Parties, whereupon the Licensed Product shall be
referred to by both or all tradenames.
ARTICLE 11.
OWNERSHIP OF INTELLECTUAL PROPERTY AND PATENT RIGHTS
11.1 MODIFIED DEFINITIONS. For purposes of this Article 11, IDEC
Patents and SCHERING Patents shall not include Patents owned jointly by the
Parties; such "Joint Patents" shall mean Patents owned jointly by the Parties
which cover the manufacture, use or sale of Licensed Product.
11.2 OWNERSHIP OF INTELLECTUAL PROPERTY. IDEC shall own all
inventions made under the Collaboration Agreement solely by it or its employees.
SCHERING shall own all inventions made under the Collaboration Agreement solely
by it or its employees. All inventions made under the Collaboration Agreement
jointly by at least one employee of IDEC and at least one employee of SCHERING
will be owned jointly by IDEC and SCHERING and each Party shall retain full
ownership under any Patents resulting therefrom, with full ownership rights in
any field, subject to the licenses granted in Article 8, the right to sublicense
without the consent of the other Party and without accounting. The laws of the
United States with respect to joint ownership of inventions (joint and several)
shall apply in all jurisdictions giving force and effect to the Collaboration
Agreement.
11.3 DISCLOSURE OF PATENTABLE INVENTIONS. In addition to the
disclosures required under Article 13, each Party shall provide to the other,
any written invention disclosure submitted to a Party's patent department in the
normal course which discloses an invention made under the Collaboration
Agreement that is useful in the Field. Such invention disclosures shall be
provided to the other Party within thirty (30) days after the Party commences
preparation of a patent application based on such disclosure.
11.4 PROSECUTION OF EXISTING PATENTS. IDEC shall disclose or has
disclosed to SCHERING the complete texts of all IDEC Patents filed by IDEC prior
to the Effective Date which claim the manufacture, use or sale of the Licensed
Product as well as all information received concerning the institution or
possible institution of any interference, opposition, re-examination, reissue,
revocation, nullification or any official proceeding involving an IDEC Patent
anywhere in the United States or the Licensed Territory. SCHERING shall have the
right to review all such IDEC Patents and all proceedings related thereto and
make recommendations to IDEC concerning them and their conduct and IDEC shall
consider in good faith for the United States and take into account for the
Licensed Territory SCHERING's reasonable comments related thereto. IDEC agrees
to keep SCHERING fully informed of the course of patent prosecution or other
proceedings
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of such IDEC Patents including by providing SCHERING with copies of substantive
communications, search reports and third party observations submitted to or
received from patent offices within the United States or Licensed Territory.
SCHERING shall provide such patent consultation to IDEC related to such IDEC
Patents at no cost to IDEC. IDEC agrees to prosecute and maintain in force in
the United States and the Licensed Territory all existing IDEC Patents described
in the first sentence of this Section 11.4. All reasonable costs that IDEC
incurs after the Effective Date in filing, prosecuting and maintaining IDEC
Patents in the United States shall be borne by IDEC. All such reasonable costs
which IDEC will incur in the Licensed Territory shall be reimbursed by SCHERING
within 30 days of submission of an invoice by IDEC. SCHERING shall hold all
information disclosed to it under this Article 11 as confidential subject to the
provisions of Article 10 of the Collaboration Agreement. SCHERING shall have the
right to assume responsibility in the Licensed Territory for any IDEC Patent or
any part of any such Patent which IDEC intends to abandon or otherwise cause or
allow to be forfeited provided that the claims of such IDEC Patent covers
Licensed Product or formulations, methods of manufacture or methods of use
thereof.
11.5 PROSECUTION OF NEW PATENTS.
(a) SCHERING shall have the first right, using in-house or
outside legal counsel selected at SCHERING's sole discretion, to prepare, file,
prosecute, maintain and obtain extensions of SCHERING Patents in countries of
SCHERING's choice throughout the world. SCHERING shall bear the costs relating
to such activities in the Licensed Territory at all times and in the United
States. SCHERING shall use reasonable efforts to solicit IDEC's advice and
review of the nature and text of SCHERING Patents and material prosecution
matters related thereto in reasonably sufficient time prior to filing thereof,
and SCHERING shall consider in good faith IDEC's reasonable comments related
thereto.
(b) IDEC shall have the first right, using in-house or
outside legal counsel selected at IDEC's sole discretion, to prepare, file,
prosecute, maintain and obtain extensions of IDEC Patents and Joint Patents
filed after the Effective Date throughout the world. IDEC shall use reasonable
efforts to solicit SCHERING's advice and review of the nature and text of such
IDEC Patents and material prosecution matters related thereto in reasonably
sufficient time prior to filing thereof, and IDEC shall (i) in the United States
consider in good faith SCHERING's reasonable comments related thereto and (ii)
in the Licensed Territory take into account SCHERING's reasonable comments
related thereto. All reasonable costs related to preparing, filing, prosecuting,
maintaining and extending IDEC Patents and Joint Patents shall be paid by IDEC
for activities within the United States and reimbursed by SCHERING to IDEC for
activities within the Licensed Territory, provided that such Patents are
necessary to properly commercialize the Licensed Product in the Licensed
Territory. Such reimbursement shall be paid to IDEC within 30 days after receipt
of an invoice therefor by SCHERING.
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(c) If SCHERING, prior or subsequent to filing any SCHERING
Patents, elects not to file, prosecute or maintain such Patents or certain
claims encompassed by such Patents, SCHERING shall give IDEC notice thereof
within a reasonable period prior to allowing such Patents or certain claims
encompassed by such Patents to lapse or become abandoned or unenforceable, and
IDEC shall thereafter have the right, at its sole expense, to prepare, file,
prosecute and maintain Patents or certain claims encompassed by such Patents
concerning all such inventions and discoveries in countries of its choice
throughout the world. If IDEC, prior or subsequent to filing IDEC Patents,
elects not to file, prosecute or maintain such Patents or certain claims
encompassed by such Patents, IDEC shall give SCHERING notice thereof within a
reasonable period prior to allowing such Patents or certain claims encompassed
by such Patents to lapse or become abandoned or unenforceable, and SCHERING
shall thereafter have the right, at its sole expense, to prepare, file prosecute
and maintain such Patents or certain claims encompassed by such Patents
concerning all such inventions and discoveries in countries of its choice
throughout the world.
(d) The Party filing Joint Patents shall do so in the name
of and on behalf of both SCHERING and IDEC. Each of IDEC and SCHERING shall hold
all information it presently knows or acquires under this Paragraph which is
related to all such Patents as confidential subject to the provisions of Article
10 of the Collaboration Agreement.
11.6 WAIVER.
(a) IDEC on behalf of itself and its directors, employees,
officers, shareholders, agents, successors and assigns hereby waives any and all
actions and causes of action, claims and demands whatsoever, in law or equity of
any kind it or they may have against SCHERING, its officers, directors,
employees, shareholders, agents, successors and assigns, which may arise in any
way except as a result of SCHERING's gross negligence, recklessness, or willful
misconduct in performance of its rights or obligations under Section 11.5 of the
Collaboration Agreement.
(b) SCHERING on behalf of itself and its directors,
employees, officers, shareholders, agents successors and assigns hereby waives
any and all actions and causes of action, claims and demands whatsoever, in law
or equity of any kind it or they may have against IDEC, its officers, directors,
employees, shareholders, agents, successors and assigns, which may arise in any
way except as a result of IDEC's gross negligence, recklessness, or willful
misconduct in performance of its rights or obligations under Section 11.5 of the
Collaboration Agreement.
11.7 FURTHER ASSURANCES. Notwithstanding the provisions of Section
11.5 of the Collaboration Agreement, each Party shall, at its own expense,
provide reasonable assistance to the other Party to facilitate filing of all
Patents covering inventions referred to in Section 11.3 of the Collaboration
Agreement and shall execute all documents deemed necessary or desirable
therefor.
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11.8 INITIAL FILINGS. The Parties agree to use reasonable efforts to
ensure that any IDEC Patent, SCHERING Patent or Joint Patent filed outside of
the United States prior to a U.S. filing will be in a form sufficient to
establish the date of original filing as a priority date for the purposes of a
subsequent U.S. filing and that the requisite foreign filing license will be
obtained. The Parties agree to use reasonable efforts to ensure that any IDEC
Patent, SCHERING Patent or Joint Patent filed in the United States prior to a
non-U.S. filing will be in a form sufficient to establish the date of original
filing as a priority date for the purposes of a subsequent non-U.S. filing and
that the requisite United States filing license will be obtained.
11.9 PATENT ENFORCEMENT.
(a) In the event that IDEC or SCHERING becomes aware of
actual or threatened infringement of a Patent related to the Licensed Product,
anywhere in the world, that Party shall promptly notify the other Party in
writing. IDEC shall have the first right but not the obligation to bring an
infringement action or file any other appropriate action or claim directly
related to infringement of an IDEC Patent or Joint Patent, wherein such
infringement relates to the Licensed Product, against any Third Party and to use
SCHERING's name in connection therewith. The costs of Patent enforcement and
related recoveries associated with the United States incurred by IDEC shall be
borne by IDEC. Such Patent enforcement costs in the Licensed Territory shall be
borne by IDEC. If IDEC does not commence a particular infringement action in a
country within the Licensed Territory within ninety (90) days after it received
such written notice, SCHERING, after notifying IDEC in writing, shall be
entitled to bring such infringement action or any other appropriate action or
claim at its own expense. The Party conducting such action shall consider in
good faith the other Party's comments on the conduct of such action. Recovery
from any settlement or judgment from such action in the Licensed Territory shall
go first to reimburse the expenses of the Parties and the remainder shall be
shared by the Parties in proportion to their respective economic interests. In
any event, IDEC and SCHERING shall assist one another and reasonably cooperate
in any such litigation at the other's request without expense to the requesting
Party.
(b) SCHERING shall have the first right but not the
obligation to bring an infringement action or file any other appropriate action
or claim directly related to infringement of a SCHERING Patent, wherein such
infringement relates to the Licensed Product, against any Third Party and to use
IDEC's name in connection therewith. The costs of Patent enforcement and related
recoveries associated with the United States incurred by SCHERING shall be borne
by SCHERING. Such Patent enforcement costs in the Licensed Territory shall be
borne by SCHERING. Recovery from any settlement or judgment from such action in
the Licensed Territory shall go first to reimburse the expenses of the Parties
and the remainder shall be shared by the Parties in proportion to their
respective economic interests. In any event, IDEC and SCHERING shall assist one
another and reasonably cooperate in any such litigation at the other's request
without expense to the requesting Party.
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11.10 INFRINGEMENT DEFENSE. Subject to Section 11.11 below, if a Third
Party asserts that a Patent or other right owned by it is infringed by the
Licensed Product, IDEC will be solely responsible for defending against any such
assertions at its cost and expense but no settlement may be entered into with
regard to Patents in the Licensed Territory or, with regard to Patents in the
United States if such settlement would result in an increase in the amounts
payable by IDEC to SCHERING hereunder, without the written consent of SCHERING,
which shall not be unreasonably withheld. If any Third Party is successful in
such claim, and SCHERING is ordered to make any payments to such Third Party in
connection therewith, any such payments will be dealt with in the manner set out
in Section 6.3 above.
*_____*.
ARTICLE 12.
REPRESENTATIONS AND WARRANTIES
12.1 REPRESENTATIONS AND WARRANTIES.
(a) Each of the Parties hereby represents and warrants as
follows:
(i) The Collaboration Agreement is a legal and valid
obligation binding upon such Party and enforceable in accordance with its terms.
The execution, delivery and performance of the Collaboration Agreement by such
Party does not conflict with any agreement, instrument or understanding, oral or
written, to which it is a Party or by which it is bound, nor violate any law or
regulation of any court, governmental body or administrative or other agency
having jurisdiction over it.
(ii) Such Party has not, and during the term of the
Collaboration Agreement will not, grant any right to any Third Party relating to
its respective Patents and Know-how in the Field which would conflict with the
rights granted to the other Party hereunder.
(b) IDEC represents, warrants and undertakes that:
(i) It has the right to grant the licenses granted
herein.
(ii) Except as set forth on EXHIBIT D hereto, it is
not obligated under any agreement as of the Effective Date to pay any Third
Party royalties with respect to Licensed Product.
(iii) *_____*.
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*_____* Indicates that material has been omitted and confidential treatment has
been requested therefor. All such omitted material has been filed separately
with Secretary of the Commission in the Company's Application Requesting
Confidential Treatment pursuant to Rule 24b-2 under the Securities Exchange Act
of 1934, as amended.
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(iv) It has provided to SCHERING all material
information in its possession or control or of which it is aware as of the
Effective Date, concerning efficacy, side effects, injury, toxicity or
sensitivity reaction and incidents of severity thereof, associated with any
clinical use, studies, investigations or tests with the Licensed Product (animal
or human), whether or not determined to be attributable to the Licensed Product.
(v) It has conducted or has caused its contractors
or consultants to conduct, and will in the future conduct, the preclinical and
clinical studies of the Licensed Product in accordance with applicable United
States law, known or published standards of the FDA and has made good faith
efforts to comply with EMEA standards.
(vi) It has employed and will in the future employ
individuals of appropriate education, knowledge and experience to conduct or
oversee the conduct of IDEC's clinical and preclinical studies of the Licensed
Product.
(vii) It has not employed (and, to the best of its
knowledge, has not used a contractor or consultant that has employed) and in the
future will not employ (or, to the best of its knowledge, use any contractor or
consultant that employs) any individual or entity debarred by the FDA (or
subject to a similar sanction of EMEA) or, to the best knowledge of IDEC, any
individual who or entity which is the subject of an FDA debarment investigation
or proceeding (or similar proceeding of EMEA), in the conduct of preclinical or
clinical studies of the Licensed Product.
(viii) In the course of developing the Licensed
Product, it has not knowingly conducted, and during the course of the
Collaboration Agreement it will not knowingly conduct, any development
activities in violation of applicable GCPs, GLPs or GMPs.
(ix) As of the Effective Date, except as it may have
previously disclosed to SCHERING in writing or directly discussed with SCHERING,
it has not received any notices of infringement or any written communications
relating in any way to a possible infringement with respect to the Licensed
Product, and that it is not aware that the development, manufacture, use,
importation or sale of the Licensed Product infringes any Third Party Patent
rights.
(x) As of the Effective Date, it is not aware of any
prior act or any fact which causes it to conclude that any IDEC Patent is
invalid or unenforceable in whole or in part.
(xi) It has complied in all material respects with
each license listed on EXHIBIT C hereto, and during the term hereof will comply
in all material respects, and use all reasonable efforts to keep in full force
and effect each such license; neither the Collaboration Agreement nor any of the
transactions contemplated hereby will, with the giving of notice or the
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lapse of time, or both, constitute a default or breach of any such license.
(xii) It has obtained all right, title and interest in
and to all rights to the Licensed Product and the IDEC Patents and IDEC Know-how
free and clear of any liens, encumbrances or rights to repurchase.
(xiii) During the term of the Collaboration Agreement,
it will not xxxxx x xxxx on the Collaboration Agreement or on any of IDEC's
rights or obligations hereunder or on the IDEC Patents or IDEC Know-how related
to the Licensed Product.
12.2 PERFORMANCE BY AFFILIATES. The Parties recognize that each may
perform some or all of its obligations under the Collaboration Agreement through
Affiliates, provided, however, that each Party shall remain responsible and be
guarantor of the performance by its Affiliates and shall cause its Affiliates to
comply with the provisions of the Collaboration Agreement in connection with
such performance.
ARTICLE 13.
INFORMATION AND REPORTS
13.1 INFORMATION. With respect to the Drug Approval Applications
required for Regulatory Approval for the Initial Indication in the United States
and the corresponding Drug Approval Applications in the Licensed Territory,
SCHERING and IDEC will disclose and make available to each other all
preclinical, clinical, regulatory, commercial and other information, including
without limitation all Information relevant to Licensed Product, developed by
SCHERING or IDEC at any time during the term of the Collaboration Agreement.
Each Party will use Commercially Reasonable and Diligent efforts to disclose to
the other Party all significant Information promptly after it is learned or its
significance is appreciated. Each Party shall own and maintain its own database
of clinical trial data accumulated from all clinical trials of the Licensed
Product for which it was responsible and of adverse drug event information for
the Licensed Product. At the option of the requesting Party, such data shall be
provided in a computer readable format by the providing Party, to the extent
available, which shall also assist in the transfer and validation of such data
to the receiving Party.
13.2 COMPLAINTS. Each Party shall maintain a record of all complaints
it receives with respect to the Licensed Product. Each Party shall notify the
other of any complaint received by it in writing and sufficient detail and
within five (5) Business Days after the event, and in any event in sufficient
time to allow the responsible Party to comply with any and all regulatory
requirements imposed upon it in any country.
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13.3 ADVERSE DRUG EVENTS. The Parties recognize that the holder of a
Drug Approval Application or Regulatory Approval may be required to submit
information and file reports to various governmental agencies on compounds under
clinical investigation, compounds proposed for marketing, or marketed drugs.
Information must be submitted at the time of initial filing for investigational
use in humans and at the time of a request for market approval of a new drug. In
addition, supplemental information must be provided on compounds at periodic
intervals and adverse drug experiences must be reported at more frequent
intervals depending on the severity of the experience. Consequently, each Party
agrees to:
(a) Provide to the other for initial and/or periodic
submission to government agencies significant information on the Licensed
Product from preclinical laboratory, animal toxicology and pharmacology studies,
as well as adverse drug experience reports from clinical trials and commercial
experiences with the compound;
(b) In connection with investigational drugs, report to the
other within three (3) days of the initial receipt of a report of any unexpected
or serious experience with the Licensed Product, or sooner if required for
either Party to comply with regulatory requirements; and
(c) In connection with marketed Licensed Product, report to
the other within five (5) Business Days of the initial receipt of a report of
any adverse experience with the Licensed Product that is serious and unexpected
or sooner if required for either Party to comply with regulatory requirements.
Serious adverse experiences are defined in the Collaboration Agreement to
correspond with the relevant ICH classification from time to time applicable.
Each Party also agrees that if it contracts with a Third Party for research to
be performed by such Third Party on the Licensed Product, that Party agrees to
require such Third Party to report to the contracting Party the information set
forth in subparagraphs (a), (b) and (c) above.
13.4 PUBLICITY REVIEW. The Parties agree that the public announcement
of the execution of the Collaboration Agreement shall be in the form of a press
release to be agreed upon on or before the Effective Date and thereafter each
Party shall be entitled to make or publish any public statement consistent with
the contents thereof. Thereafter, IDEC and SCHERING will jointly discuss and
agree, based on the principles of this Section 13.4, on any statement to the
public regarding the Collaboration Agreement or any aspect of the Collaboration
Agreement subject in each case to disclosure otherwise required by law or
regulation as determined in good faith by each Party. The principles to be
observed by IDEC and SCHERING in such public disclosures will be: accuracy, the
requirements for confidentiality under Article 10, the advantage a competitor of
IDEC or SCHERING may gain from any public statements under this Section 13.4,
and the standards and customs in the biotechnology and pharmaceutical industries
for such disclosures by companies comparable to IDEC and SCHERING. The terms of
the Collaboration Agreement may also be disclosed to (i) government agencies
where required by law, or (ii) Third Parties with the prior written consent of
the other Party, which consent shall not be unreasonably withheld, so long as
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such disclosure is made under a binder of confidentiality and so long as highly
sensitive terms and conditions such as financial terms are extracted from the
Collaboration Agreement or not disclosed upon the request of the other Party.
ARTICLE 14.
TERM AND TERMINATION
14.1 TERM. The Collaboration Agreement shall commence as of the
Effective Date. The Parties have specifically provided elsewhere in the
Collaboration Agreement the term during which certain rights and obligations
hereunder shall apply. Unless sooner terminated as provided herein, and except
as provided in Section 14.6 below, the remaining provisions of the Collaboration
Agreement relating to activities in the Licensed Territory shall continue in
effect on a country-by-country basis until the date on which SCHERING is no
longer paying a royalty on Net Sales in the Licensed Territory. Those provisions
shall govern the term of the rights and obligations specifically covered
thereby. Upon the expiration of the term of the Collaboration Agreement or its
termination by SCHERING under Section 14.2 and limited by Sections 14.5 and
14.6, all licenses granted to SCHERING hereunder shall become fully paid up and
irrevocable.
14.2 TERMINATION BY SCHERING.
(a) SCHERING shall have the right to terminate the
Collaboration Agreement (i) if IDEC elects to discontinue funding of the
development of Licensed Product *_____* such termination to be effective after
*_____* written notice to IDEC and *_____* or (ii) *_____* effective *_____*
days from written notice to IDEC.
(b) Upon any termination under this Section 14.2, the
Parties shall have no further rights or obligations under the Collaboration
Agreement except as set forth in Sections 14.5 and 14.6.
14.3 TERMINATION BY IDEC
(a) IDEC shall have the right to terminate the Collaboration
Agreement, in each case on a country-by-country basis (i) *_____* such
termination to be effective after *_____* written notice *_____* and *_____*
(ii) if SCHERING fails to *_____* such termination to be effective *_____* to
SCHERING, provided that (1) *_____* (2) SCHERING *_____* or (3) such failure
*_____* or (iii) if *_____*.
----------
*_____* Indicates that material has been omitted and confidential treatment has
been requested therefor. All such omitted material has been filed separately
with Secretary of the Commission in the Company's Application Requesting
Confidential Treatment pursuant to Rule 24b-2 under the Securities Exchange Act
of 1934, as amended.
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(b) If SCHERING fails to make sales *_____* and provided
that the reason for the failure is not *_____* IDEC shall be entitled to
terminate SCHERING's rights under the Collaboration Agreement *_____*.
(c) Upon any termination under this Section 14.3, the
Parties shall have no further rights or obligations under the Collaboration
Agreement except as set forth in Sections 14.5 and 14.6 and all licenses are
terminated and the rights revert to IDEC.
14.4 TERMINATION FOR BREACH. If either Party materially breaches the
Collaboration Agreement at any time, which breach is not cured within *_____* of
written notice thereof from the non-breaching Party (or if such breach is not
susceptible of cure within such period but provided it is capable of cure, the
breaching Party is not making diligent good faith efforts to cure such breach),
the non-breaching Party shall have the right to terminate the Collaboration
Agreement. Upon such termination, the Parties shall have no further rights or
obligations under the Collaboration Agreement except as set forth in Sections
14.5 and 14.6. The Parties acknowledge and agree that failure to exercise any
right or option with respect to the Licensed Product or to take any action
expressly within the discretion of a Party shall not be deemed to be material
breach hereunder. *_____*.
14.5 RIGHTS AND OBLIGATIONS UPON TERMINATION.
(a) In the event of termination by SCHERING pursuant to
Section 14.2(a)(ii) or by IDEC pursuant to Section 14.3 (a) or by IDEC pursuant
to Section 14.4 due to SCHERING's material breach, SCHERING shall (i) make its
personnel and other resources reasonably available to IDEC as necessary to
effect an orderly transition of development and/or commercialization
responsibilities, with the cost of such personnel and resources to be borne by
IDEC after the effective date of termination; (ii) grant IDEC a non-revocable,
royalty free license under Section 8.2, provided that IDEC reimburse SCHERING
for all royalties it must pay to Third Parties on account of the development,
use, manufacture or sale of Licensed Product in Licensed Territory.
(b) In the event of termination by SCHERING pursuant to
Section 14.2(a)(i), IDEC shall (i) remain responsible for (A) its share of
Development Costs for Licensed Product in the United States and (B) its supply
obligations under the Supply Agreement; until, in the case of both (A) and (B),
IDEC has fully transferred, and enabled SCHERING to perform, all of IDEC's
responsibilities under the Collaboration Agreement and the Supply Agreement,
including, but not limited to, supplying SCHERING's requirements for Licensed
Product for a reasonable period of time to allow SCHERING to find an alternate
source of supply; (ii) make its personnel and other resources reasonably
available to SCHERING as necessary to effect an orderly transition of
development and/or commercialization responsibilities, with the cost of such
personnel and resources to be borne by SCHERING after the effective date of
termination; and (iii) transfer to SCHERING all of IDEC's right, title, and
interest in and to the Licensed Product in the United
----------
*_____* Indicates that material has been omitted and confidential treatment has
been requested therefor. All such omitted material has been filed separately
with Secretary of the Commission in the Company's Application Requesting
Confidential Treatment pursuant to Rule 24b-2 under the Securities Exchange Act
of 1934, as amended.
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States and the United States shall become part of the Licensed Territory. In
addition, SCHERING shall pay, in lieu of any payments including royalties it
would otherwise owe IDEC pursuant to the terms of the Collaboration Agreement,
*_____*.
(c) In the event of termination by SCHERING pursuant to
Section 14.4 due to IDEC's material breach, IDEC shall (i) remain responsible
for (A) its marketing of Licensed Product in the United States and (B) its
supply obligations under the Supply Agreement; until , in the case of (B), IDEC
has fully transferred, and enabled SCHERING to perform, all of IDEC's
responsibilities under the Supply Agreement, including, but not limited to,
supplying SCHERING's requirements for Licensed Product for a reasonable period
of time to allow SCHERING to find an alternate source of supply; (ii) make its
personnel and other resources reasonably available to SCHERING as necessary to
effect an orderly transition of product supply responsibilities, with the cost
of such personnel and resources to be borne by SCHERING after the effective date
of termination; and (iii) transfer to SCHERING all of IDEC's right, title, and
interest in and to the Licensed Product in the Licensed Territory. *_____*.
(d) In the event of termination by SCHERING pursuant to
Sections 14.2 (a)(i) or 14.4, SCHERING shall not be obliged to make any payments
falling due pursuant to Section 2.1(c) where such payments fall due after the
date of service by SCHERING of notice of termination pursuant to such sections
and if the agreement is terminated pursuant to such notice.
14.6 ACCRUED RIGHTS, SURVIVING OBLIGATIONS. Termination,
relinquishment or expiration of the Collaboration Agreement for any reason shall
be without prejudice to any rights which shall have accrued to the benefit of
either party prior to such termination, relinquishment or expiration, including
paid up irrevocable licenses and including damages arising from any breach
hereunder. Such termination, relinquishment or expiration shall not relieve
either Party from obligations under Articles 10, 11, 14.5, 14.6, 15, 16 and 17
herein, and any other obligations which are expressly indicated to survive
termination or expiration of the Collaboration Agreement.
----------
*_____* Indicates that material has been omitted and confidential treatment has
been requested therefor. All such omitted material has been filed separately
with Secretary of the Commission in the Company's Application Requesting
Confidential Treatment pursuant to Rule 24b-2 under the Securities Exchange Act
of 1934, as amended.
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ARTICLE 15.
INDEMNIFICATION
15.1 INDEMNIFICATION BY SCHERING.
(a) SCHERING hereby agrees to save, defend and hold IDEC and
its agents and employees harmless from and against any and all Third Party
suits, claims, actions, demands, liabilities, expenses and/or loss, including
reasonable legal expense and attorneys' fees ("Losses") resulting directly from
the manufacture, use, handling, storage, sale or other disposition of chemical
agents or Licensed Product sold or used in the Licensed Territory by SCHERING,
its Affiliates, agents, or sublicensees, but only to the extent such Losses
result from the negligence or willful misconduct of SCHERING.
(b) In the event that IDEC is seeking indemnification under
Section 15.1(a), it shall inform SCHERING of a claim as soon as reasonably
practicable after it receives notice of the claim, shall permit SCHERING to
assume direction and control of the defense of the claim (including the right to
settle the claim solely for monetary consideration), and shall cooperate as
requested (at the expense of SCHERING) in the defense of the claim.
15.2 INDEMNIFICATION BY IDEC.
(a) IDEC hereby agrees to save, defend and hold SCHERING and
its agents and employees harmless from and against any and all Losses resulting
directly or indirectly from the manufacture, supply, use, handling, storage,
sale or other disposition of chemical agents or Licensed Product sold or used in
the Licensed Territory or the United States but only to the extent such Losses
do not result from the negligence or willful misconduct of SCHERING or its
employees and agents, as described in Section 15.1(a).
(b) In the event that either Party receives notice of a
claim with respect to a Licensed Product in the United States or in the Licensed
Territory, such Party shall inform the other Party as soon as reasonably
practicable.
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ARTICLE 16.
DISPUTE RESOLUTION
16.1 DISPUTES. The Parties recognize that disputes as to certain
matters may from time to time arise during the term of the Collaboration
Agreement which relate to either Party's rights and/or obligations hereunder. It
is the objective of the Parties to establish procedures to facilitate the
resolution of disputes arising under the Collaboration Agreement in an expedient
manner by mutual cooperation and without resort to litigation. To accomplish
this objective, the Parties agree to follow the procedures set forth in this
Article 16, if and when a dispute arises under the Collaboration Agreement.
Unless otherwise specifically recited in the Collaboration Agreement,
disputes among members of the Steering Committee will be resolved as recited in
this Article 16. If the Steering Committee is unable to resolve a dispute among
its members, any Party may, by written notice to the other, have such dispute
referred to their respective chief operating officers, for attempted resolution
by good faith negotiations within *_____* after such notice is received. In the
event the designated operating officers are not able to resolve such dispute,
either Party may at anytime after the *_____* invoke the provisions of Section
16.2.
16.2 MEDIATION AND ARBITRATION. The parties agree that any dispute,
controversy or claim (except as to any issue relating to intellectual property
owned in whole or in part by IDEC or SCHERING) arising out of or relating to the
Collaboration Agreement, or the breach, termination, or invalidity thereof,
shall be resolved through negotiation, mediation and/or binding arbitration. If
a dispute arises between the parties, and if said dispute cannot be resolved
pursuant to Section 16.1, the Parties agree to first try in good faith to
resolve such dispute by mediation administered by the American Arbitration
Association in accordance with its Commercial Mediation Rules. If efforts at
mediation are unsuccessful within *_____* any unresolved controversy or claim
between the parties shall be resolved by binding arbitration in accordance with
the Commercial Arbitration Rules of the American Arbitration Association, except
as modified herein. IDEC and SCHERING shall each select one arbitrator and the
two arbitrators so selected shall choose a third arbitrator to resolve the
dispute. The arbitration decision shall be rendered within six months of
conclusion of mediation and shall be binding and not be appealable to any court
in any jurisdiction. The prevailing Party may enter such decision in any court
having competent jurisdiction. The mediation or arbitration proceeding shall be
conducted at the location of the Party not originally requesting the resolution
of the dispute and interlocutory relief may be granted by the arbitrator. The
parties agree that they shall share equally the cost of the
mediation/arbitration filing and hearing fees, and the cost of the
mediator/arbitrator. Each Party must bear its own attorney's fees and associated
costs and expenses.
----------
*_____* Indicates that material has been omitted and confidential treatment has
been requested therefor. All such omitted material has been filed separately
with Secretary of the Commission in the Company's Application Requesting
Confidential Treatment pursuant to Rule 24b-2 under the Securities Exchange Act
of 1934, as amended.
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16.3 JURISDICTION. For the purposes of this Article 16, the Parties
agree to accept the jurisdiction of the federal courts located in the *_____*
for the purposes of enforcing awards entered pursuant to this Article and for
enforcing the agreements reflected in this Article.
16.4 DETERMINATION OF PATENTS AND OTHER INTELLECTUAL PROPERTY. Any
dispute relating to the determination of validity of a Party's Patents or other
issues relating solely to a Party's intellectual property shall be submitted
exclusively to the federal court (or equivalent) located in the location of the
defendant, and the Parties hereby consent to the jurisdiction and venue of such
court.
ARTICLE 17.
MISCELLANEOUS
17.1 ASSIGNMENT.
(a) Either Party may assign any of its rights under the
Collaboration Agreement in any country to any Affiliates and, with the prior
written consent of the other Party, may delegate its obligations under the
Collaboration Agreement in any country to any Affiliates; provided, however,
that such assignment shall not relieve the assigning Party of its
responsibilities for performance of its obligations under the Collaboration
Agreement.
(b) Either Party may assign, without consent of the other
Party, all of its rights and obligations under the Collaboration Agreement in
connection with a merger or similar reorganization or the sale of all or
substantially all of its assets, or otherwise with the prior written consent of
the other Party. The Collaboration Agreement shall survive any such merger or
reorganization of either Party with or into, or such sale of assets to, another
party and no consent for such merger, reorganization or sale shall be required
hereunder.
(c) The Collaboration Agreement shall be binding upon and
inure to the benefit of the successors and permitted assigns of the Parties. Any
assignment not in accordance with the Collaboration Agreement shall be void.
17.2 NON-SOLICITATION. The Parties recognize that each Party has a
substantial interest in preserving and maintaining confidential its Confidential
Information hereunder. Each Party recognizes that certain of the other Party's
employees, including those engaged in development, marketing and sale of any
Licensed Product, may have access to such Confidential Information of the other
Party. The Parties therefore agree not to solicit or otherwise induce or attempt
to induce for purposes of employment, any employees from the other Party
involved in the development, marketing or sales of any Licensed Product during
the period in which any Party is developing or commercializing a Licensed
Product hereunder and for a period of two years thereafter.
----------
*_____* Indicates that material has been omitted and confidential treatment has
been requested therefor. All such omitted material has been filed separately
with Secretary of the Commission in the Company's Application Requesting
Confidential Treatment pursuant to Rule 24b-2 under the Securities Exchange Act
of 1934, as amended.
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17.3 HEADINGS. The headings used in the Collaboration Agreement are
for convenience only and shall not affect or be used in the interpretation of
the Sections or Articles.
17.4 RETAINED RIGHTS. Nothing in the Collaboration Agreement shall
limit in any respect the right of either Party to conduct research and
development with respect to and market products outside the Field using such
Party's technology.
17.5 FORCE MAJEURE. Neither Party shall lose any rights hereunder or
be liable to the other Party for damages or losses on account of failure of
performance by the defaulting Party if the failure is occasioned by government
action, war, fire, earthquake, explosion, flood, viral, bacterial, or mycoplasm
contamination of Licensed Product with no assignable cause for any such
contamination after FDA mandated inspection by IDEC, strike, lockout, embargo,
act of God, or any other cause beyond the control of the defaulting Party,
whether or not of the kind listed in the foregoing examples, provided that the
Party claiming force majeure has exerted all reasonable efforts to avoid or
remedy such force majeure; provided, however, that in no event shall a Party be
required to settle any labor dispute or disturbance.
17.6 FURTHER ACTIONS. Each Party agrees to execute, acknowledge and
deliver such further instruments, and to do all such other acts, as may be
necessary or appropriate in order to carry out the purposes and intent of the
Collaboration Agreement.
17.7 NO RIGHT TO USE NAMES. Except as otherwise provided herein, no
right, express or implied, is granted by the Agreement to use in any manner the
name "IDEC," "SCHERING" or any other trade name or trademark of the other Party
or its Affiliates in connection with the performance of the Agreement.
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17.8 NOTICES. All notices hereunder shall be in writing and shall be
deemed given if delivered personally or by facsimile transmission (receipt
verified), telexed, mailed by registered or certified mail (return receipt
requested), postage prepaid, or sent by express courier service, to the Parties
at the following addresses (or at such other address for a party as shall be
specified by like notice; provided, that notices of a change of address shall be
effective only upon receipt thereof).
IF TO IDEC,
ADDRESSED TO: IDEC PHARMACEUTICALS CORPORATION
00000 Xxxxxxxxx Xxxx
Xxx Xxxxx, XX 00000
XXX
Attention: Corporate Secretary
Telephone: 000 (000) 000-0000
Fax: 000 (000) 000-0000
IF TO SCHERING,
ADDRESSED TO: SCHERING X.X.
00000 Xxxxxx, Xxxxxxx
Attention: Legal Department
Telephone: 000 00 00 0000 0000
Fax: 000 00 00 0000 0000
17.9 WAIVER. Except as specifically provided for herein, the waiver
from time to time by either of the Parties of any of their rights or their
failure to exercise any remedy shall not operate or be construed as a continuing
waiver of same or of any other of such Party's rights or remedies provided in
the Collaboration Agreement.
17.10 SEVERABILITY. If any term, covenant or condition of the
Collaboration Agreement or the application thereof to any Party or circumstance
shall, to any extent, be held to be invalid or unenforceable, then (i) the
remainder of the Collaboration Agreement, or the application of such term,
covenant or condition to Parties or circumstances other than those as to which
it is held invalid or unenforceable, shall not be affected thereby and each
term, covenant or condition of the Collaboration Agreement shall be valid and be
enforced to the fullest extent permitted by law; and (ii) the Parties hereto
covenant and agree to renegotiate any such term, covenant or application thereof
in good faith in order to provide a reasonably acceptable alternative to the
term, covenant or condition of the Collaboration Agreement or the application
thereof that is invalid or unenforceable, it being the intent of the Parties
that the basic purposes of the Collaboration Agreement are to be effectuated.
17.11 GOVERNING LAW. The Collaboration Agreement shall be governed by
and construed in accordance with the laws of the *_____* without giving effect
to principles of conflict of laws.
----------
*_____* Indicates that material has been omitted and confidential treatment has
been requested therefor. All such omitted material has been filed separately
with Secretary of the Commission in the Company's Application Requesting
Confidential Treatment pursuant to Rule 24b-2 under the Securities Exchange Act
of 1934, as amended.
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17.12 AMBIGUITIES. Ambiguities, if any, in the Collaboration Agreement
shall not be construed against any Party, irrespective of which Party may be
deemed to have authored the ambiguous provision.
17.13 COUNTERPARTS. The Collaboration Agreement may be executed in two
or more counterparts, each of which shall be deemed an original, but all of
which together shall constitute one and the same instrument.
17.14 ENTIRE AGREEMENT. The Collaboration Agreement, including all
Exhibits attached hereto which are hereby incorporated herein by reference and
the Supply Agreement, set forth all the covenants, promises, agreements,
warranties, representations, conditions and understandings between the Parties
hereto and supersede and terminate all prior agreements and understandings
between the Parties. There are no covenants, promises, agreements, warranties,
representations, conditions or understandings, either oral or written, between
the Parties other than as set forth herein and therein. No subsequent
alteration, amendment, change or addition to the Collaboration Agreement shall
be binding upon the Parties hereto unless reduced to writing and signed by the
respective authorized officers of the Parties.
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IN WITNESS WHEREOF, the Parties have executed the Collaboration
Agreement in duplicate originals by their proper officers as of the date and
year first above written.
IDEC PHARMACEUTICALS SCHERING AKTIENGESELLSCHAFT
CORPORATION
By: /s/ Xxxxxxx X. Xxxx By: /s/ Hubertus Erlen
------------------------------------- -------------------------------------
Xxxxxxx X. Xxxx Hubertus Erlen
Chief Operating Officer and Senior Member of Board
Title: Vice President, Commercial Operations Title: of Executive Directors
------------------------------------- -------------------------------------
Date: June 9, 1999 Date: June 9, 1999
------------------------------------- -------------------------------------
By: /s/ Joachim-Xxxxxxxxx Xxxx
-------------------------------------
Head of Strategic Business
Title: Unit Therapeutics
-------------------------------------
Joachim-Xxxxxxxxx Xxxx
Date: June 9, 1999
-------------------------------------
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EXHIBITS
EXHIBIT A: DEVELOPMENT PLAN
EXHIBIT B: Y2B8/IN2B8 KIT SPECIFICATIONS
EXHIBIT C: LIST OF LICENSES
EXHIBIT D: ANTIBODY MANUFACTURING COSTS
EXHIBIT E: *_____*
EXHIBIT F: ROYALTIES PAYABLE UPON MANUFACTURING IN U.S.
EXHIBIT G: FTE RATES
----------
*_____* Indicates that material has been omitted and confidential treatment has
been requested therefor. All such omitted material has been filed separately
with Secretary of the Commission in the Company's Application Requesting
Confidential Treatment pursuant to Rule 24b-2 under the Securities Exchange Act
of 1934, as amended.
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EXHIBIT A
DEVELOPMENT PLAN
*_____*
----------
*_____* Indicates that material has been omitted and confidential treatment has
been requested therefor. All such omitted material has been filed separately
with Secretary of the Commission in the Company's Application Requesting
Confidential Treatment pursuant to Rule 24b-2 under the Securities Exchange Act
of 1934, as amended.
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EXHIBIT B
Y2B8/IN2B8 KIT SPECIFICATIONS
*_____*
----------
*_____* Indicates that material has been omitted and confidential treatment has
been requested therefor. All such omitted material has been filed separately
with Secretary of the Commission in the Company's Application Requesting
Confidential Treatment pursuant to Rule 24b-2 under the Securities Exchange Act
of 1934, as amended.
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EXHIBIT C
LIST OF LICENSES
*_____*
----------
*_____* Indicates that material has been omitted and confidential treatment has
been requested therefor. All such omitted material has been filed separately
with Secretary of the Commission in the Company's Application Requesting
Confidential Treatment pursuant to Rule 24b-2 under the Securities Exchange Act
of 1934, as amended.
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EXHIBIT D
ANTIBODY MANUFACTURING COSTS
*_____*
----------
*_____* Indicates that material has been omitted and confidential treatment has
been requested therefor. All such omitted material has been filed separately
with Secretary of the Commission in the Company's Application Requesting
Confidential Treatment pursuant to Rule 24b-2 under the Securities Exchange Act
of 1934, as amended.
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EXHIBIT E
*_____*
----------
*_____* Indicates that material has been omitted and confidential treatment has
been requested therefor. All such omitted material has been filed separately
with Secretary of the Commission in the Company's Application Requesting
Confidential Treatment pursuant to Rule 24b-2 under the Securities Exchange Act
of 1934, as amended.
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EXHIBIT F
ROYALTIES PAYABLE UPON MANUFACTURING IN U.S.
*_____*
----------
*_____* Indicates that material has been omitted and confidential treatment has
been requested therefor. All such omitted material has been filed separately
with Secretary of the Commission in the Company's Application Requesting
Confidential Treatment pursuant to Rule 24b-2 under the Securities Exchange Act
of 1934, as amended.
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EXHIBIT G
FTE RATES
*_____*
----------
*_____* Indicates that material has been omitted and confidential treatment has
been requested therefor. All such omitted material has been filed separately
with Secretary of the Commission in the Company's Application Requesting
Confidential Treatment pursuant to Rule 24b-2 under the Securities Exchange Act
of 1934, as amended.
44
