Exhibit 10.1
Confidential Materials
omitted and filed separately with the
Securities and Exchange
Commission. Asterisks denote omissions.
EXECUTION COPY
TERMINATION AND TRANSITION
AGREEMENT
This Termination
and Transition Agreement (the “ Agreement ”) is
effective as of 1 st July 2007 (the “ Effective
Date ”) by and between THE MEDICINES COMPANY, a Delaware
corporation having offices at 8 Campus Drive, Parsippany, New
Jersey 07054 (“ TMC ”), NYCOMED DANMARK
ApS, P.O. Box 88, Langebjerg 1 DK-4000 Roskilde, Denmark, a company
duly organized and existing under the laws of the Kingdom of
Denmark (“ Nycomed” ), and NYCOMED HOLDING ApS,
P.O. Box 88, Langebjerg 1 DK-4000 Roskilde, Denmark, a company duly
organized and existing under the laws of the Kingdom of Denmark
(“ Nycomed Parent ”).
TMC and Nycomed
shall be referred to individually as a “ Party ”
and collectively as the “ Parties ”.
WITNESSETH:
WHEREAS, TMC is in
the business of developing, manufacturing and marketing
pharmaceutical products; and
WHEREAS, Nycomed
is engaged in, among other things, the distribution, promotion and
marketing of pharmaceutical products; and
WHEREAS, TMC and
Nycomed are parties to that certain Sales, Marketing and
Distribution Agreement dated as of March 25, 2002, as amended on
May 28, 2003 (the “ Former Distribution Agreement
”), pursuant to which, among other things:
•
TMC appointed Nycomed as
its exclusive distributor in the Territory (for purposes of these
Recitals, as defined in the Former Distribution Agreement) for the
Product (as defined below);
•
TMC, as the market
authorization holder in certain countries of such Territory, agreed
to manufacture and supply the Product to Nycomed for distribution
by Nycomed in such Territory; and
•
Nycomed agreed to promote,
market and distribute the Product in such Territory; and
WHEREAS, TMC
desires to terminate and reacquire the rights it granted to Nycomed
under the Former Distribution Agreement on the terms and conditions
contained herein, and Nycomed desires to terminate and transfer its
rights in the Product under the Former Distribution Agreement back
to TMC on the terms and conditions set forth herein, whereby, among
other things:
1
•
The Former Distribution
Agreement and the Parties’ rights and obligations thereunder
shall terminate, except to the extent otherwise provided by this
Agreement, and simultaneously therewith, the Parties and Nycomed
Parent shall enter into a New Distribution Agreement (as defined
below) and a Services Agreement (as defined below) and shall
perform pursuant to such agreements through the Transition Period
(as defined below), unless such agreements are terminated earlier
in accordance with their terms;
•
TMC shall make certain
payments to Nycomed as provided herein; and
•
The Parties shall
cooperate to effect the transfer from Nycomed to TMC or TMC’s
designee of Regulatory Filings (as defined below), Approvals (as
defined below) and data generated to support the foregoing, as well
as all Know-How (as defined below), intellectual property,
marketing, sales and customer data and certain contracts that
relate to the Product, either on the Effective Date or during the
Transition Period, as provided below;
NOW THEREFORE, in
consideration of the mutual agreements set forth herein, TMC and
Nycomed hereby agree as follows:
1.
DEFINITIONS
All capitalized
terms used in this Agreement not otherwise defined shall have the
meanings and definitions ascribed to them as listed
below.
1.1.
“ ACUITY Trial” has the meaning set forth in
Section 8.3.
1.2.
“ ADONIS Agreement ” means the [**] dated as of
[**].
1.3.
“Affiliate” means any corporation, company,
joint venture, partnership or other entity which, directly or
indirectly, controls, is controlled by, or is under common control
with a Party to this Agreement. “Control” means the
ownership of at least 50% of the issued share capital or business
assets of another entity, the power to exercise at least 50% of the
voting rights of another entity, or the power to appoint more than
50% of the Board of Directors of another entity.
1.4.
“Approvals” means and includes all approvals,
registrations, permits, licenses and authorizations related to the
Product that are made with or obtained from any Governmental
Authority for the importation, sale, marketing and promotion of the
Product in the Territory or any part thereof, including primarily,
but without limitation, authorizations of medicinal products for
human use and approval of related labels and packaging, as well as
pricing and social health system reimbursement approvals.
1.5.
“ Assigned Contract ” has the meaning set forth
in Section 6.8.
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1.6.
“ Assigned Copyrightable Materials ” has the
meaning set forth in Section 5.3.
1.7.
“Assigned Domain Names ” has the meaning set
forth in Section 5.2.
1.8.
“ Assigned Know-How ” has the meaning set forth
in Section 5.4.
1.9.
“ Assigned Intellectual Property ” has the
meaning set forth in Section 5.4.
1.10.
“Assigned Trademark Registrations ” has the
meaning set forth in Section 5.1.
1.11.
“ Assignment Date ” has the meaning set forth in
Section 3.1.8.
1.12.
“ Business Day ” means any day on which the
banks in the Kingdom of Denmark are open for business.
1.13.
“Claims” means claims, demands, rights, causes
of action, protests, suits, or disputes of any kind.
1.14.
“ Damages” means liabilities, claims, damages,
losses, costs, expenses, demands, suits and actions (including
without limitation attorneys’ fees, expenses and settlement
costs).
1.15.
“ Domain Name ” means any domain name which
incorporates any of the words “Angiomax,”
“Angiox,” “Angionax,” or “The
Medicines Company” or the Marks (as defined in the New
Distribution Agreement) or any variations thereof.
1.16.
“ Effective Date ” has the meaning set forth in
the Recitals.
1.17.
“ Existing Inventory ” means all labeled
and unlabeled vials of Product held by Nycomed or Nycomed’s
Affiliates in inventory on the Effective Date until sold or
supplied by Nycomed pursuant to Section 9 of the New Distribution
Agreement.
1.18.
“ Former Distribution Agreement ” has the
meaning set forth in the Recitals.
1.19.
“Governmental Authority” means and includes all
governmental and regulatory bodies, agencies, departments or
entities, whether or not located in the Territory, which regulate,
direct or control commerce in or with the Territory, including
Approvals.
1.20.
“Improvements” means authorized, updated or
modified manufacturing processes for the Product or its component
substances, additional dosage unit sizes or other similar
authorized modifications to the production and delivery of the
Product as part of an Approval for the Product.
1.21.
“Inventory Purchase Price ” has the meaning set
forth in Section 6.10.1.
1.22.
“ ISAR Agreements ” has the meaning set forth in
the New Distribution Agreement.
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1.23.
“ Know-How ” means all scientific and technical
data, instructions, processes, formulae, specifications, ingredient
sources, manufacturing procedures, methods, market research and
other information relating to the design, composition, formulation,
pre-clinical evaluation, clinical evaluation, manufacture, use,
sale, packaging, formulation or administration of the Product,
including, but not limited to, pharmacological, toxicological,
analytical, stability and clinical data, specifications and drug
master files and/or health registration dossiers and any other
premarket application or registration.
1.24.
“ Licensed Know-How ” has the meaning set forth
in Section 5.4.
1.25.
“ New Agreements ” means, collectively, the New
Distribution Agreement and the Services Agreement.
1.26.
“ New Distribution Agreement” means the
Distribution Agreement between TMC, Nycomed and Nycomed Parent
dated as of the Effective Date.
1.27.
“ New Inventory ” has the meaning set forth in
the New Distribution Agreement.
1.28.
“ Non-Released Claims against Nycomed ” has the
meaning set forth in Section 4.2.2.
1.29.
“ Non-Released Claims against TMC ” has the
meaning set forth in Section 4.2.1.
1.30.
“Nycomed Release Parties” means Nycomed, and its
present/and or past predecessors, successors, assigns, Affiliates,
directors, officers, agents, employees and representatives.
1.31.
“ Ongoing Clinical Trials ” has the meaning set
forth in Section 3.1.6.
1.32.
“ Out-of-Pocket Costs ” has the meaning set
forth in Section 8.4.1.
1.33.
“ PhV Agreements” means the Pharmacovigilance
Agreement and the Pharmacovigilance QP Agreement (each as defined
in the Services Agreement).
1.34.
“Product” means Bivalirudin, being a highly
specific and reversible direct thrombin inhibitor, which operates
by specific binding to both the catalytic site and to the
anion-binding exosite of circulating and clot-bound thrombin. The
active substance is a synthetic, twenty (20)-amino acid peptide,
whose chemical name is
D-phenylalanyl-Lprolyl-Larginyl-L-prolyl-glycyl-glycyl-glycyl-glycyl-L-asparagyl-glycyl-L-aspartly-L-phenylalanyl-L-glutamyl-L-glutamyl-isoleucyl-L-prolyl-L-glutamyl-L-glutamyl-L-tyrosyl-L-leucine-trifluoracetate
(salt) hydrate. Its molecular weight is 218.19 daltons (anhydrous
free base peptide). Product shall also include Improvements.
1.35.
“ Product Documents and Records ” has the
meaning set forth in Section 6.3.
1.36.
“ Product Transition Committee” or “
PTC ” have the meaning set forth in Section 6.1.
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1.37.
“ QA Agreements ” means, collectively, the
AQRPA, the Release Agreement and the Packaging Agreement (each as
defined in the New Distribution Agreement).
1.38.
“ Quality Agreements ” means, collectively, the
QA Agreements and the PhV Agreements. For the sake of clarity, with
respect to each Quality Agreement, all references to such Quality
Agreement with respect to activities pursuant to the Former
Distribution Agreement (i.e., prior to the Effective Date) shall
mean such Quality Agreement unamended by the Transaction
Agreements, and all references to such Quality Agreement with
respect to activities on or after the Effective Date shall mean
such Quality Agreement as amended by the Transaction
Agreements.
1.39.
“ Regulatory Filings ” means all applications,
filings, materials, studies, data and documents of any nature
whatsoever filed with, prepared in connection with or necessary to
support any Approval process in any country or territory, including
any of the foregoing with respect to a clinical trial conducted
with the Product.
1.40.
“ Services Agreement” means the Services
Agreement between TMC, Nycomed and Nycomed Parent dated as of the
Effective Date.
1.41.
“ Territory ” has the meaning set forth in the
New Distribution Agreement.
1.42.
“TMC Release Parties” means TMC, and its present
and/or past predecessors, successors, assigns, Affiliates,
directors, officers, agents, employees and representatives.
1.43.
“ Trademarks ” has the meaning set forth in
Section 3.1.14.
1.44.
“ Transaction Agreements ” means, collectively,
this Agreement and the New Agreements.
1.45.
“ Transition Date ” means (a) the first
anniversary of the Effective Date, (b) such date earlier than the
first anniversary of the Effective Date as TMC may notify Nycomed
upon at least 30 calendar days prior written notice, but in no
event effective before December 31, 2007 or (c) such date later
than the first anniversary of the Effective Date as TMC may, at
TMC’s option, notify Nycomed upon at least 30 calendar days
prior written notice in the event that, notwithstanding the use of
commercially reasonable efforts to do so, TMC has not obtained any
Approvals necessary to perform services and functions performed by
Nycomed under the New Agreements or Quality Agreements by the first
anniversary of the Effective Date; provided , however
, that in no event shall the Transition Date be later than 18
months after the Effective Date. For clarity, the Transition Date
shall not limit TMC’s right to terminate the New Distribution
Agreement or Services Agreement, in whole or in part, prior to the
Transition Date to the extent permitted by such agreements.
1.46.
“ Transition Period ” means the period
commencing on Effective Date and ending on the Transition
Date.
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1.47.
“ Up-Front Payment ” has the meaning set forth
in Section 8.1.
1.48.
“Vials of Remaining Inventory ” has the
meaning set forth in Section 6.10.1.
2.
DELIVERIES UPON EXECUTION; AFFILIATES
2.1.
Deliveries by Nycomed. Contemporaneously with the execution
of this Agreement, Nycomed shall:
(a)
execute and deliver the New Agreements;
(b)
execute and deliver the Trademark Assignment assigning the Assigned
Trademark Registrations to TMC or TMC’s designee
substantially in the form attached hereto as Exhibit A ;
and
(c)
execute and deliver the Bill of Sale assigning the Assigned
Intellectual Property (excluding the Assigned Trademark
Registrations) to TMC or TMC’s designee substantially in the
form attached hereto as Exhibit B .
2.2.
Deliveries by TMC. Contemporaneously with the execution of
this Agreement, TMC
shall:
(a)
execute and deliver the New Agreements; and
(b)
in the event the Effective Date is a day that is both a Business
Day and a day on which the banks in the Commonwealth of
Massachusetts are open for business, deliver the Up-Front Payment
by wire transfer in accordance with the wiring instructions set
forth on Schedule 2.2; provided , however , that in
the event the Effective Date is not a day that is both a Business
Day and a day on which the banks in the Commonwealth of
Massachusetts are open for business, then the Up-Front Payment
shall be made on the next following day that is both a Business Day
and a day on which the banks in the Commonwealth of Massachusetts
are open for business.
2.3.
Application to Affiliates .
2.3.1. The
Parties agree and acknowledge that Nycomed has performed certain of
its obligations under the Former Distribution Agreement through
Nycomed’s Affiliates and that Nycomed may perform certain of
its obligations under the Transaction Agreements and the Quality
Agreements, as well as any of its obligations that may survive
termination under the Former Distribution Agreement, through
Nycomed’s Affiliates. Nycomed shall cause its Affiliates to
comply with all of Nycomed’s obligations under the
Transaction Agreements, the Quality Agreements and any of
Nycomed’s obligations that may survive termination under the
Former Distribution Agreement to the same extent that Nycomed is
itself obligated to perform
6
hereunder or thereunder
and Nycomed shall be responsible for any failure by any Affiliate
to do so. Except as otherwise expressly stated herein, any
references to Nycomed in the Transaction Agreements shall also
apply to Nycomed’s Affiliates to the extent such Affiliates
have performed or will perform Nycomed obligations hereunder or
thereunder.
2.3.2. TMC
shall cause its Affiliates to comply with all of TMC’s
obligations under the Transaction Agreements, the Quality
Agreements and any of TMC’s obligations that may survive
termination under the Former Distribution Agreement to the same
extent that TMC is itself obligated to perform hereunder or
thereunder and TMC shall be responsible for any failure by any
Affiliate to do so.
3.
REPRESENTATIONS, WARRANTIES AND CERTAIN COVENANTS
3.1.
Nycomed Representations, Warranties and Certain Covenants .
Nycomed hereby represents, warrants and covenants to TMC that:
3.1.1.
Corporate Power . Nycomed has the corporate power and
authority to execute and deliver the Transaction Agreements and to
perform the Transaction Agreements and the Quality Agreements. The
execution and delivery of the Transaction Agreements and the
performance of the Transaction Agreements and the Quality
Agreements by Nycomed have been duly authorized by all necessary
corporate action of Nycomed.
3.1.2.
Validity . Each of the Transaction Agreements, when executed
and delivered by Nycomed, shall be, and each of the Quality
Agreements is, the legal, valid and binding obligation of Nycomed,
enforceable against Nycomed in accordance with its terms, except as
such enforceability may be limited by bankruptcy law and other
similar laws affecting creditors’ rights generally and by
general principles of equity.
3.1.3.
Non-Contravention . The execution and delivery of the
Transaction Agreements and the performance of the Transaction
Agreements and the Quality Agreements by Nycomed do not and will
not (i) conflict with, or constitute a breach or default under, or
require the consent of any third party under, Nycomed’s
charter documents or any material license, loan or other agreement,
contract, commitment or instrument to which Nycomed is a party or
any of its assets are bound, (ii) violate any provision of law,
statute, rule or regulation or any ruling, writ, injunction, order,
judgment or decree of any court, administrative agency or other
governmental body, or (iii) require the consent, approval or
authorization of, or notice, declaration, filing or registration
with, any third party or any governmental or regulatory
authority.
3.1.4.
No Litigation . Except as set forth on Schedule 3.1.4(a),
there is no action or proceeding pending or, in so far as Nycomed
knows, threatened against Nycomed before any court, administrative
agency or other tribunal which could impact upon Nycomed’s
right, power and authority to enter into any of the Transaction
Agreements or to carry out
7
its
obligations under any of the Transaction Agreements or Quality
Agreements. Except as set forth in Schedule 3.1.4(b), to its
knowledge, Nycomed has not received written notice of any Claims by
third parties that would result in Non-Released Claims Against
TMC.
3.1.5.
Distribution Rights . Nycomed has not, directly or
indirectly, appointed any third party as a subdistributor of the
Product in the Territory pursuant to the Former Distribution
Agreement.
3.1.6.
Clinical Trials .
(a)
Except as set forth on Schedule 3.1.6: Nycomed is not currently
conducting, funding, supplying Product with respect to, sponsoring
or otherwise engaged in, either itself or through any
subcontractor, any clinical trials or studies with respect to the
Product, and has not committed to do any of the foregoing. The
clinical trials set forth on Schedule 3.1.6 shall be referred to
herein as the “ Ongoing Clinical Trials. ”
For purposes of the foregoing, any clinical trial shall be deemed
ongoing through the completion of data analysis, lock and transfer.
With respect to each such clinical trial, Schedule 3.1.6 sets forth
a description of the clinical trial, its current status (e.g., not
yet started, enrollment phase, treatment phase, data
analysis/transfer phase), a description of any contract(s) Nycomed
has entered into with third parties with respect to the performance
of such clinical trials, a description of any Nycomed payment
obligations with respect thereto that will or may arise after the
Effective Date, and a description of any Nycomed obligations to
supply Product with respect thereto that will or may arise after
the Effective Date. For the avoidance of doubt, Nycomed agrees
that, beginning on the Effective Date, it shall not conduct, fund,
supply Product with respect to, sponsor or otherwise engage in, any
additional clinical trials or studies with respect to the Product,
or commit to do any of the foregoing, without the express written
consent of TMC.
(b)
The Parties acknowledge that with respect to certain Ongoing
Clinical Trials, the agreements between Nycomed and third parties
with respect thereto are Assigned Contracts hereunder and that TMC
or TMC’s designee shall therefore, in accordance with Section
6.8, obtain any rights Nycomed may have thereunder to receive
information, results or data from such third parties with respect
to such Ongoing Clinical Trials. With respect to those Ongoing
Clinical Trials which are not the subject of Assigned Contracts,
Nycomed shall, promptly upon Nycomed’s receipt thereof,
provide TMC with any information, results or data that Nycomed may
receive with respect to such Ongoing Clinical Trials. For the
avoidance of doubt, Nycomed’s obligation to provide such
information, results and data to TMC shall survive the termination
or expiration of this Agreement.
3.1.7.
Contracts . As of the Effective Date, except for (a)
agreements pertaining to the Ongoing Clinical Trials that are
described in Schedule 3.1.6 and (b) agreements between
8
Nycomed and third parties committing Nycomed to
the activities that are to be performed by Nycomed pursuant to
Schedule 2.1(b) of the Services Agreement, Nycomed has not,
directly or indirectly, entered into any agreement, whether oral or
written, with any third party that pertains exclusively or
primarily to the Product or exclusively or primarily to the
activities of Nycomed conducted under the Former Distribution
Agreement or Quality Agreements (each, a “
Product-Specific Contract ”) to the extent any such
Product-Specific Contract is material to the marketing, sale and
distribution of the Product in the Territory. As promptly after the
Effective Date as practicable, but in no event later than 60 days
after the Effective Date, Nycomed shall deliver to TMC a Schedule
3.1.7 that sets forth a true and complete list of all
Product-Specific Contracts, whether or not material to the
marketing, sale and distribution of the Product in the Territory.
With respect to each Product-Specific Contract that may be included
on Schedule 3.1.7 by Nycomed after the Effective Date, TMC may, at
its option, add such contract to Schedule 6.8 such that it will be
deemed an Assigned Contract hereunder. To the knowledge of Nycomed,
as of the Effective Date, there are no Product-Specific Contracts
other than (x) agreements pertaining to the Ongoing Clinical Trials
that are described in Schedule 3.1.6 and (y) agreements between
Nycomed and third parties committing Nycomed to the activities that
are to be performed by Nycomed pursuant to Schedule 2.1(b) of the
Services Agreement. With respect to each Product-Specific Contract,
Schedule 3.1.7 will set forth the names of the contracting parties,
a general description of the agreement and a description of any
Nycomed financial obligations with respect thereto that will or may
arise thereunder. Nycomed agrees that, beginning on the Effective
Date, it shall not enter into additional agreements with third
parties with respect to the Product, or with respect to the
activities of Nycomed conducted under the Transaction Agreements or
Quality Agreements, without the express written consent of
TMC.
3.1.8.
Assigned Contracts . As of the date such Assigned Contract
is assigned to TMC or TMC’s designee hereunder (the
“Assignment Date” ), to the knowledge of
Nycomed, each Assigned Contract is valid and enforceable by Nycomed
against the other parties thereto, in each case in accordance with
its terms, except as enforcement may be limited by applicable
bankruptcy, insolvency, reorganization, moratorium and other laws
affecting enforcement of creditors’ rights generally and
except insofar as the availability of equitable remedies may be
limited by applicable law. As of the relevant Assignment Date,
neither Nycomed or, to the knowledge of Nycomed, any other party to
any Assigned Contract, is in material breach of such Assigned
Contract to which it is a party, nor has it received written notice
or, to the knowledge of Nycomed, oral notice of any material breach
under such Assigned Contract and, to the knowledge of Nycomed,
there does not exist any event, condition or omission that would
constitute such a material breach (whether by lapse of time or
notice or both). Nycomed has provided TMC with a complete and
accurate copy of each Assigned Contract.
9
3.1.9.
Approvals and Filings . Except as set forth on Schedule
3.1.9, Nycomed does not hold any marketing authorizations, and has
not applied for any marketing authorizations, that pertain
exclusively or primarily to the Product. As promptly after the
Effective Date as practicable, but in no event later than 60 days
after the Effective Date, Nycomed shall deliver to TMC an updated
Schedule 3.1.9 that sets forth a true and complete list of all
Approvals held by Nycomed, and all Regulatory Filings made by
Nycomed, that pertain exclusively or primarily to the Product or to
the activities of Nycomed conducted under the Former Distribution
Agreement or Quality Agreements. With respect to each Approval or
Regulatory Filing that may be included on Schedule 3.1.9 by Nycomed
after the Effective Date, TMC may, at its option, add such Approval
or Regulatory Filing to Schedule 6.4 such that it will be
transferred to TMC or TMC’s designee hereunder. With respect
to each such marketing authorization or application therefor, or
(if applicable) each Approval or Regulatory Filing, Schedule 3.1.9
sets forth (or, if applicable, shall set forth): (i) the holder or
applicant of each item, as applicable, (ii) the jurisdiction(s) in
which the item is issued or registered or in which an application
for issuance or registration has been filed, (iii) the issuance,
registration or application numbers and date of filing, issuance or
registration, as applicable and (iv) the expiration date, if
applicable. For the avoidance of doubt, Nycomed agrees that,
beginning on the Effective Date, it shall not make additional
Regulatory Filings or seek additional Approvals without the express
written consent of TMC.
3.1.10. Ownership
Rights. Nycomed owns the Assigned Intellectual Property to be
transferred to TMC or TMC’s designee on the Effective Date
pursuant to Section 5, as well as the Regulatory Filings and
Approvals to be transferred to TMC or TMC’s designee during
the Transition Period pursuant to Section 6, free and clear of any
liens, encumbrances, license, security interest or other rights of
third parties of any kind; provided , however , that
certain authors of Assigned Copyrightable Materials or Assigned
Know-How may not have waived the moral rights granted to authors by
applicable law.
3.1.11. Existing
Inventory . Schedule 3.1.11 sets forth a true, complete and
correct statement of (i) the number of vials of Existing Inventory,
(ii) the number of vials of Existing Inventory which are labeled
and/or packaged and (iii) the number of vials of Existing Inventory
which are unlabeled, in each case, as of June 15, 2007. Within five
Business Days after the Effective Date, Nycomed shall deliver to
TMC an updated Schedule 3.1.11 that sets forth the foregoing
information as of June 30, 2007. All Existing Inventory is and,
until Nycomed sells or supplies the Existing Inventory in
accordance with Section 9 of the New Distribution Agreement shall
be, housed and maintained by Nycomed, at Nycomed’s expense,
at a facility(ies) owned or controlled by Nycomed and has been or,
promptly after the Effective Date, will be segregated and marked as
Existing Inventory.
10
3.1.12. No
Patents . Nycomed does not own and has not applied for any
patent covering the making, using or selling of the Product.
Nycomed agrees that, beginning on the Effective Date, it shall not
apply for any such patents.
3.1.13. No Registered
Copyrights . Nycomed does not own and has not applied for any
registered copyright with respect to copyrightable materials
relating to the Product, including without limitation marketing
materials and translations thereof. Nycomed agrees that, beginning
on the Effective Date, it shall not apply for any such registered
copyrights.
3.1.14.
Trademarks . Except as set forth on Schedule 3.1.14, Nycomed
does not own and has not applied for or registered any trademarks,
service marks, trade names, logos or other proprietary symbols that
are used in connection with the Product, including the performance
of activities directed to obtaining Approvals, marketing,
promoting, distributing, importing or selling the Product (“
Trademarks ”). With respect to each Trademark,
Schedule 3.1.14 sets forth (i) the holder of the registration or
current applicant(s) of each item, as applicable; (ii) the
jurisdictions in which the item is issued or registered or in which
an application for issuance or registration has been filed; and
(iii) the issuance, registration or application numbers and date of
filing, issuance or registration, as applicable. For the avoidance
of doubt, Nycomed agrees that, beginning on the Effective Date, it
shall not apply for or register any additional Trademarks.
3.1.15. Domain
Names . As of the Effective Date, Schedule 3.1.15 sets forth
certain Domain Names which have been registered by Nycomed. As
promptly after the Effective Date as practicable, but in no event
later than 60 days after the Effective Date, Nycomed shall deliver
to TMC an updated Schedule 3.1.15 that sets forth a true and
complete list of all Domain Names which have been registered, or
applied for, by Nycomed. With respect to each Domain Name, Schedule
3.1.15 sets forth (or, if applicable, shall set forth): (i) the
owner(s) or current applicant(s) of the Domain Name, as applicable;
(ii) the entity with which the Domain Name has been registered or
with which an application for registration has been filed; and
(iii) the registration or application numbers and date of filing or
registration, as applicable. For the avoidance of doubt, Nycomed
agrees that, beginning on the Effective Date, it shall not apply
for any additional Domain Names.
3.1.16. No
Infringement Proceedings . Nycomed has not instituted any
proceedings against any infringement or threatened infringement by
a third party of the Patents (as defined in the Former Distribution
Agreement) as permitted by Section 15 of the Former Distribution
Agreement.
3.1.17. Trademark
Licenses . Nycomed has not granted a sublicense to any third
party to use any Trademarks (as defined in the New Distribution
Agreement). For the avoidance
11
of
doubt, Nycomed agrees that, beginning on the Effective Date, it
shall not grant any additional such sublicenses to third
parties.
3.2.
TMC Representations, Warranties and Certain Covenants . TMC
hereby represents, warrants and covenants to Nycomed that:
3.2.1.
Corporate Power . TMC has the corporate power and authority
to execute and deliver the Transaction Agreements and to perform
the Transaction Agreements and the Quality Agreements. The
execution and delivery of the Transaction Agreements and the
performance of the Transaction Agreements and the Quality
Agreements by TMC have been duly authorized by all necessary
corporate action of TMC.
3.2.2.
Validity . Each of the Transaction Agreements, when executed
and delivered by TMC, shall be and each of the Quality Agreements
is the legal, valid and binding obligation of TMC, enforceable
against TMC in accordance with its terms, except as such
enforceability may be limited by bankruptcy law and other similar
laws affecting creditors’ rights generally and by general
principles of equity.
3.2.3.
Non-Contravention . The execution and delivery of the
Transaction Agreements and the performance of the Transaction
Agreements and the Quality Agreements by TMC do not and will not
(i) conflict with, or constitute a breach or default under, or
require the consent of any third party under, TMC’s charter
documents or any material license, loan or other agreement,
contract, commitment or instrument to which TMC is a party or any
of its assets are bound, (ii) violate any provision of law,
statute, rule or regulation or any ruling, writ, injunction, order,
judgment or decree of any court, administrative agency or other
governmental body, or (iii) require the consent, approval or
authorization of, or notice, declaration, filing or registration
with, any third party or any governmental or regulatory
authority.
3.2.4.
No Litigation . There is no action or proceeding pending or,
in so far as TMC knows, threatened against TMC or any of its
Affiliates before any court, administrative agency or other
tribunal which could impact upon TMC’s right, power and
authority to enter into any of the Transaction Agreements or to
carry out its obligations under any of the Transaction Agreements
or the Quality Agreements. Except as set forth in Schedule 3.2.4,
to its knowledge, TMC has not received written notice of any Claims
by third parties that would result in Non-Released Claims Against
Nycomed.
3.3.
Knowledge. Where a representation or warranty contained in
this Section 3 is stated to be to a Party’s knowledge, this
shall mean to the actual knowledge of all of the officers and
appropriate key personnel of such Party or its Affiliates, after
reasonable inquiry.
3.4.
No Other Warranties. EXCEPT FOR THE EXPRESS WARRANTIES
CONTAINED IN THIS AGREEMENT, THE NEW AGREEMENTS AND THE QUALITY
AGREEMENTS,
12
(a) NEITHER
TMC NOR NYCOMED MAKES ANY WARRANTIES OR REPRESENTATIONS, EXPRESS OR
IMPLIED, IN FACT OR IN LAW, INCLUDING ANY IMPLIED WARRANTIES OF
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR
NON-INFRINGEMENT AND (b) WITHOUT LIMITING THE GENERALITY OF THE
FOREGOING, NYCOMED PROVIDES THE ASSIGNED INTELLECTUAL PROPERTY AND
ASSIGNED CONTRACTS ON AN “AS-IS” BASIS.
3.5.
Survival of Warranties. The provisions of this Section 3
shall survive the expiration or sooner termination of this
Agreement without limit.
4.
TERMINATION OF FORMER DISTRIBUTION AGREEMENT; RELEASE OF CERTAIN
CLAIMS; CONTINUATION OF QUALITY AGREEMENTS
4.1.
Termination of Former Distribution Agreement .
4.1.1.
Effective on the Effective Date, the Former Distribution Agreement
shall terminate and, except for those rights and obligations of any
party under the Former Distribution Agreement that expressly
survive the termination of such agreement pursuant to the terms of
such agreement (as modified by this Agreement), all rights and
obligations of any party under the Former Distribution Agreement
shall cease to be of further effect; provided ,
however , that the Parties agree that any obligation of
Nycomed to report information to TMC pertaining to any period of
time prior to the Effective Date shall survive the termination of
the Former Distribution Agreement and such reports shall be due on
the same dates as they would have otherwise been due pursuant to
the Former Distribution Agreement.
4.1.2. As
to those rights and obligations of any party under the Former
Distribution Agreement that do expressly survive the termination
thereof, the Parties agree that they shall be modified as
follows: notwithstanding Section 20.7 of the Former
Distribution Agreement, Section 13 (Collection of Information on
Adverse and Serious Adverse Events/Reporting on Medical
Safety/Recalls) and Section 17 (Confidential Information) shall
terminate upon the termination of the Former Distribution
Agreement. For the avoidance of doubt, simultaneously with the
termination of the Former Distribution Agreement, the New
Agreements and this Agreement shall become effective.
4.2.
Release of Certain Claims .
4.2.1.
Nycomed, on behalf of the Nycomed Release Parties, hereby forever
compromises, settles, waives, releases, and discharges with
prejudice (on the terms and conditions set forth in this Agreement)
the TMC Release Parties from any and all Claims that the Nycomed
Release Parties have against the TMC Release Parties to the extent
such Claims (a) arise out of any events, occurrences, actions or
any failures to act preceding the Effective Date and (b) relate to
(or are in any way connected with) the Former Distribution
Agreement or any Quality Agreement, whether known or unknown,
accrued or not accrued, foreseen or
13
unforeseen, or matured
or not matured (the “ Release By Nycomed ”);
provided , however , that the Release By Nycomed
shall not extend to:
(i)
any Claim by any Nycomed
Release Party against any TMC Release Party that arises out of or
relates to a Claim of a third party against such Nycomed Release
Party (A) for which such Nycomed Release Party is entitled to seek
indemnification under the Former Distribution Agreement or (B) that
arises out of or relates to TMC’s breach or alleged breach of
any of its obligations under the Former Distribution Agreement or
Quality Agreements (the “ Non-Released Claims Against
TMC ”) or
(ii)
any Claim by any Nycomed
Release Party against any TMC Release Party with respect to (A) any
payment obligation of TMC under the Former Distribution Agreement
or any Quality Agreement or (B) for the avoidance of doubt, any
obligation of TMC to perform under the Former Distribution
Agreement (to the extent such obligation survives termination
thereof either pursuant to the terms thereof or pursuant to this
Agreement) or any Quality Agreement, in each case to the extent
such obligation to perform arises on or after the Effective
Date.
4.2.2. TMC,
on behalf of the TMC Release Parties, hereby forever compromises,
settles, waives, releases, and discharges with prejudice (on the
terms and conditions set forth in this Agreement) the Nycomed
Release Parties from any and all Claims that the TMC Release
Parties have against the Nycomed Release Parties to the extent such
Claims (a) arise out of any events, occurrences, actions or any
failures to act preceding the Effective Date and (b) relate to (or
are in any way connected with) the Former Distribution Agreement or
any Quality Agreement, whether known or unknown, accrued or not
accrued, foreseen or unforeseen, or matured or not matured (the
“ Release By TMC ”); provided ,
however , that the Release By TMC shall not extend to
(i)
any Claim by any TMC
Release Party against any Nycomed Release Party that arises out of
or relates to a Claim of a third party against such TMC Release
Party (A) for which such TMC Release Party is entitled to seek
indemnification under the Former Distribution Agreement or (B) that
arises out of or relates to Nycomed’s breach or alleged
breach of any of its obligations under the Former Distribution
Agreement or Quality Agreements (the “ Non-Released Claims
Against Nycomed ”) or
(ii)
any Claim by any TMC
Release Party against any Nycomed Release Party with respect to (A)
any payment obligation of Nycomed under the Former Distribution
Agreement or any Quality Agreement or (B) for the avoidance of
doubt, any obligation of Nycomed to perform under the Former
Distribution Agreement (to the extent such obligation survives
termination thereof either pursuant to the
14
terms thereof or pursuant to this Agreement) or
any Quality Agreement, in each case to the extent such obligation
to perform arises on or after the Effective Date.
4.2.3.
Nycomed hereby agrees to indemnify and hold harmless the TMC
Release Parties from all Damages arising out of the Non-Released
Claims Against Nycomed and Nycomed shall pay promptly to TMC any
Damages to which the foregoing indemnification relates as they are
incurred; provided, however, that Nycomed shall not be obligated to
indemnify the TMC Release Parties with respect to the French
Proceeding Amount (as defined in the Services Agreement). For the
sake of clarity, Nycomed retains any obligation to pay or, if
applicable, to indemnify the applicable TMC Release Party with
respect to, the amount of any fine or penalty imposed with respect
to the French Proceedings (as defined in the Services Agreement)
beyond the French Proceeding Amount. TMC hereby agrees to indemnify
and hold harmless the Nycomed Release Parties from all Damages
arising out of the Non-Released Claims Against TMC and TMC shall
pay promptly to Nycomed any Damages to which the foregoing
indemnification relates as they are incurred. The indemnification
procedures set forth in Section 12.4 of this Agreement shall apply
to any claims for indemnification brought under this Section 4.2.3;
provided, however, that, with respect to the conduct of the French
Proceedings, the provisions of Section C of Schedule 2.1(b) of the
Services Agreement shall apply and, to the extent inconsistent with
Section 12.4 of this Agreement, the provisions of such Section C
shall apply.
4.3.
Continuation of Quality Agreements . For the avoidance of
doubt, as of the Effective Date, the Quality Agreements shall
remain in full force and effect, as amended by the New Agreements,
unless and until terminated in accordance with their respective
terms or in accordance with the New Agreements.
5.
ASSIGNMENTS, LICENSES AND TRANSFERS AS OF THE EFFECTIVE
DATE
5.1.
Trademarks . Effective as of the Effective Date, Nycomed
shall and hereby does assign and transfer to TMC or TMC’s
designee all of Nycomed’s right, title and interest in and to
the registrations and applications for the Trademarks set forth on
Schedule 3.1.14, together with the goodwill symbolized by them, and
the right to sue and recover for past infringement of such
Trademarks (the “ Assigned Trademark Registrations
”).
5.2.
Domain Names . Effective as of the Effective Date, or as
promptly after the Effective Date as practicable, Nycomed shall and
hereby does assign and transfer to TMC or TMC’s designee all
of Nycomed’s right, title and interest in and to the domain
names set forth (or to be set forth) on Schedule 3.1.15, together
with all registrations or applications therefore (the “
Assigned Domain Names ”).
5.3.
Copyrightable Materials . Effective as of the Effective
Date, Nycomed shall and hereby does assign and transfer to TMC or
TMC’s designee all of Nycomed’s right, title and
interest in
15
and to all
copyrightable materials relating to the Product, including without
limitation marketing materials and translations thereof, whether
existing as of the Effective Date or whether created, developed or
acquired by Nycomed during the Transition Period (the “
Assigned Copyrightable Materials
”).
5.4.
Know-How .
5.4.1.
Effective as of the Effective Date, Nycomed shall and hereby does
assign and transfer to TMC or TMC’s designee all of
Nycomed’s right, title and interest in and to all Know-How,
including all clinical and other data, analyses and reports, that
relates exclusively or primarily to the Product, whether existing
as of the Effective Date or whether created, developed or acquired
by Nycomed during the Transition Period (the “ Assigned
Know-How ” and, together with the Assigned Trademark
Registrations, Assigned Domain Names, Assigned Copyrightable
Materials, the “ Assigned Intellectual Property
”).
5.4.2.
Effective as of the Effective Date, Nycomed shall and hereby does
grant to TMC or TMC’s designee a worldwide, fully paid-up,
royalty-free, non-exclusive, perpetual, irrevocable, sublicensable
license to use any Know-How owned by Nycomed and that relates to
the Product (but that does not exclusively or primarily relate to
the Product), whether existing as of the Effective Date or whether
created, developed or acquired by Nycomed during the Transition
Period (“ Licensed Know-How ”).
5.4.3.
Nothing in this Section 5.4 shall be interpreted as creating an
obligation for Nycomed to generate translations or new data,
analyses or reports.
5.5.
Further Assurances . As of the Effective Date, or as
promptly thereafter as practicable, Nycomed will prepare, execute
and deliver to TMC (and where required by law, TMC will execute and
deliver to Nycomed) such additional documents and take such other
action as may be reasonably necessary or desirable to transfer the
Assigned Intellectual Property to TMC or TMC’s designee, as
applicable.
6.
OBLIGATIONS DURING THE TRANSITION PERIOD
6.1.
Transition Managers; Product Transition Committee .
6.1.1.
Transition Managers . Each Party shall appoint a senior
representative who possesses a full understanding of the relevant
operational, regulatory, commercial and legal issues to act as its
Transition Manager (each, a “ TM ” or “
Transition Manager ”). The initial Transition Manager
for each Party is set forth on Schedule 6.1. Any replacements or
proxies for the foregoing persons shall be equivalently senior
personnel. Each Party’s Transition Manager will be the
primary contact with the other Party in connection with the
ongoing, day-to-day implementation of this Agreement, the New
Agreements and the Quality Agreements, and for obtaining any
consents or approvals of the other Party required hereby. The TMs
shall be
16
responsible for: (a)
seeking consensus (both internally, within his/her respective
Party’s organization, as well as between the Parties)
regarding key transition issues that arise under this Agreement,
the New Agreements and the Quality Agreements; (b) identifying and
raising issues to the PTC in a timely manner; (c) assisting the PTC
co-chairs in setting appropriate meeting agendas, attending PTC
meetings and preparing meeting minutes, as appropriate, in a format
agreed upon with the PTC; and (d) in collaboration with the other
TM, drafting and revising on a regular basis a monthly executive
summary of the status of the transition hereunder, in a format
agreed upon with the PTC, and providing such summary to the
PTC.
6.1.2.
Product Transition Committee . The Parties hereby establish
a Product Transition Committee (“ PTC ”) which
shall remain in place during the Transition Period and which shall
be responsible for the smooth and effective implementation of the
activities contemplated by this Agreement, the New Agreements and
the Quality Agreements, for developing and executing a plan to
effect the transfers to take place pursuant to this Section 6 and
for overseeing the implementation of this Agreement, the New
Agreements and the Quality Agreements. The PTC shall consist of
[**] voting members, comprising [**] representatives of TMC and
[**] representatives of Nycomed (which representatives may also
serve as the TMs). The PTC shall have two co-chairs, one from each
Party. The initial representatives on the PTC for each Party are
set forth on Schedule 6.1. TMC’s appointees to the PTC shall
be determined by TMC. Nycomed’s appointees to the PTC shall
be determined by Nycomed and shall include appropriate
representation from its [**] and, if appropriate, its [**]. Any
replacements or proxies for the foregoing persons shall be
equivalently senior personnel. The PTC shall meet at least [**] (in
person or by telephone, as mutually agreed by the Parties) at such
time and, with respect to in-person meetings, place as mutually
agreed upon by the Parties, and at such other dates as may be
agreed upon by the Parties. In addition, the Parties shall cause
their respective members of the PTC to make themselves available,
in person or by telephone, as reasonably necessary to carry out
such implementation. Should the Parties mutually agree to do so,
additional, non-voting members may be appointed to the PTC and
operating subcommittees and project teams may be appointed by and
report to the PTC.
6.1.3. In
the event that a consensus decision cannot be reached by the PTC,
then, except to the extent inconsistent with any provision of this
Agreement, the New Agreements or the Quality Agreements, TMC shall
have final authority for all decisions with respect to the Product,
other than in respect of pricing in each country in the Territory
during the term of the New Distribution Agreement with respect to
such country; provided , however , that (a) the
foregoing shall not be interpreted to require Nycomed to allocate
personnel resources to the performance of the Services (as defined
in the Services Agreement) beyond the then-current Commitment (as
defined in the Services Agreement); (b) Nycomed shall have no
obligation to act in accordance with TMC’s directions if
doing so would violate any applicable provision of law, statute,
rule or regulation, as determined by Nycomed in good faith, or
would cause Nycomed to breach any obligation owed to a third party
under an agreement entered into by Nycomed in good faith; (c)
Nycomed shall perform and fund the activities specified to be
17
performed and funded,
respectively, by Nycomed in Schedule 2.1(b) of the Services
Agreement and TMC shall perform and fund the activities specified
to be performed and funded, respectively, by TMC in Schedule 2.1(b)
of the Services Agreement; and (d) the foregoing shall not be
interpreted as giving TMC any authority to amend any provision of
any Transaction Agreement.
6.2.
Transition of Activities in General . The Parties, via the
PTC, will agree upon procedures to ensure a smooth transition from
Nycomed to TMC on or before the Transition Date of the activities
required to be undertaken by the holder of the Approvals for the
Product, including without limitation adverse experience reporting,
quarterly and annual reports with Governmental Authorities,
complaint and sample tracking, product recalls and communication
with health care professionals and customers. Without limiting the
generality of the foregoing, the Parties will cooperate with each
other in a commercially reasonable manner to notify relevant key
opinion leaders and other relevant parties interested in the
Product of the transition contemplated by this Agreement.
6.3.
Provision of Reports, Documents and Access .
6.3.1.
During the Transition Period, Nycomed shall provide TMC and any
third party that may potentially or actually subsequently perform
services and functions performed by Nycomed under the New
Agreements or Quality Agreements (the “ New
Distributors ”), with reasonable access to all
information, documents, records and facilities and, subject to
clause (iii) below, all personnel, contractors and agents, in each
case as reasonably necessary (a) to complete a reasonable review
and analysis of activities performed by Nycomed with respect to the
Product (including activities directed to obtaining Approvals,
marketing, promoting, distributing, importing or selling the
Product) as customary to evaluate the scope and nature of the
services and functions to be performed by TMC or the New
Distributor and (b) to reasonably assist TMC in TMC’s efforts
to build its commercial operations with respect to the Product,
including without limitation TMC’s efforts to obtain for TMC
or for any New Distributor any Approvals necessary to perform
services and functions performed by Nycomed under the New
Agreements or Quality Agreements. Without limiting the generality
of the foregoing:
(i)
During the Transition
Period, Nycomed will provide TMC with frequent and complete ongoing
reports with respect to all activities performed by Nycomed under
the Transaction Agreements and Quality Agreements, including
registration efforts and other regulatory matters, and activities
in connection with the marketing, promotion, distribution,
importation and sale the Product. To the extent applicable, the
format of such reports shall be consistent with past practice and
shall contain at least as much detail as in similar reports
generated by Nycomed under the Former Distribution
Agreement.
(ii)
On or before the
Transition Date, or with respect to any item below, on such earlier
date as is reasonably practicable following notice by TMC to
Nycomed,
18
Nycomed shall provide to TMC or any New
Distributor all documents and records related to the Product within
the possession or control of Nycomed, in each case whether existing
as of the Effective Date or whether created, developed or acquired
by Nycomed during the Transition Period (the “ Product
Documents and Records ”), including without
limitation:
(A)
documents and records
related to Regulatory Filings and Approvals (including documents
and records relating to clinical trials and adverse events) and any
withdrawals or rejections of applications for Approvals, including
without limitation all documents, files and databases with respect
to the clinical trials set forth on Schedule 6.3.1;
(B)
documents (and
conversation logs) of communications with Governmental Authorities
(excluding communications with respect to registrations and
applications for the Assigned Trademark Registrations, which are
separately addressed by clause (D) below);
(C)
marketing, pricing, sales
and customer information, data and materials, including without
limitation: customer lists, marketing, distribution and sales
plans, methods and systems, sales figures and sales projections,
training materials and promotional and advertising materials, and
all translations of the foregoing; and
(D)
registrations and
applications for the Assigned Trademark Registrations and Assigned
Domain Names, Nycomed’s file with respect to any pending
applications for the Assigned Trademark Registrations, and the
contact information for the law firms or other agents Nycomed has
used with respect to filing and maintaining the registrations and
applications for the Assigned Trademark Registrations.
All
Product Documents and Records shall be provided in a timely manner
and Nycomed shall deliver such information in electronic (if
existing) or hard copy versions, as TMC may reasonably request.
Nycomed may retain one archival copy of the Product Documents and
Records solely for purposes of performing its obligations under
this Agreement, the New Agreements and the Quality Agreements (for
so long as they remain in effect), interpreting and enforcing its
rights under the Transaction Agreements and Quality Agreements or
as necessary to comply with applicable law. Nycomed may and shall
modify the Product Documents and Records provided to TMC pursuant
to the foregoing to remove any individually identifiable
information to the extent required to comply with applicable law.
Nycomed may also redact the Product Documents and Records provided
to TMC pursuant to the foregoing to the extent required to comply
with
19
any
applicable law or any Nycomed contractual obligation of
confidentiality to a third party that exists as of the Effective
Date.
Notwithstanding any provision of this Agreement
that may require Nycomed to provide such Product Documents and
Records to TMC earlier, to the extent Nycomed requires continued
access to any Product Documents and Records in order to perform
under this Agreement, the New Agreements and the Quality
Agreements, and to the extent that retention by Nycomed of a copy
of such Product Documents and Records for such purpose or
Nycomed’s right of access and right of reference provided for
in Section 6.7 are not sufficient for Nycomed to do so, Nycomed
shall be permitted to retain any such Product Documents and Records
for so long as reasonably necessary for such performance, provided
that, during such timeframe, TMC shall have a right of access
(including the right to make copies of records) and right of
reference to all such Product Documents and Records.
(iii)
Upon reasonable advance
notice to the Nycomed TM, Nycomed shall provide TMC or any New
Distributor with reasonable access to: (A) personnel and
contractors (if any) responsible for obtaining and maintaining
Approvals for marketing, promoting, distributing, importing or
selling the Product and (B) any other personnel engaged in
activities under the Transaction Agreements and Quality Agreements,
including promotional, marketing, sales, detailing and distribution
activities. Any such access shall be scheduled during normal
business hours; and
(iv)
As reasonably requested by
TMC, Nycomed shall provide access to facilities owned or operated
by Nycomed (or its subcontractors, if any) used for the
distribution of Product.
6.3.2.
During the Transition Period, Nycomed shall give TMC at least seven
to ten Business Days prior written notice of (or such shorter
notice as is practicable in light of the amount of notice Nycomed
itself receives of the meeting), and grant TMC and any New
Distributor reasonable access to, and the right to participate in,
(a) meetings and any other communications with any third parties
(other than Governmental Authorities, which meetings shall be
governed by Section 6.6) and (b) material scheduled internal
meetings, in each case regarding clinical trials and registration
efforts (in each case, to the extent Nycomed is expressly
authorized to engage in such activities by TMC hereunder) and
promotional, marketing, sales, detailing and distribution
activities relating to the Product.
6.4.
Transfer of Regulatory Filings and Approvals . The Parties
shall use commercially reasonable efforts to complete the transfer
of all Regulatory Filings set forth on Schedule 6.4
(including Approvals that may result therefrom during the
Transition Period) and Approvals set forth on Schedule 6.4 to TMC
or TMC’s designee on the Transition Date or, with respect to
any
20
given
Regulatory Filing or Approval, upon such earlier date as TMC may
request, provided that such earlier date is reasonably practicable.
To the extent that TMC expressly authorizes Nycomed to make
additional Regulatory Filings during the Transition Period, the
Parties shall update Schedule 6.4 accordingly.
6.5.
Maintenance and Registration Efforts . During the Transition
Period, Nycomed shall continue to maintain the Approvals set forth
on Schedule 6.4 and any Approvals that may result from the
Regulatory Filings set forth on Schedule 6.4 until such time as
such Approvals and Regulatory Filings are transferred to TMC or
TMC’s designee pursuant to Section 6.4. As of the Effective
Date, Nycomed shall no longer be obligated or have the right to
pursue new Approvals with respect to the Product other than in
support of Regulatory Filings set forth on Schedule 6.4;
provided , however , that TMC may, at any time during
the Transition Period, direct Nycomed to withdraw or, if practical,
to cease to actively pursue, any such Regulatory Filing(s) pending
further instruction from TMC. Subject to the foregoing and subject
to Section 6.6, during the Transition Period, Nycomed shall
continue to use commercially reasonable efforts to seek Approvals
with respect to such Regulatory Filings, except to the extent that
the applicable Regulatory Filing is transferred to TMC or a TMC
designee in accordance with Section 6.4, in which event TMC or such
designee shall be responsible for the conduct of any such
activities. In the event TMC or a TMC designee assumes such
responsibility, Nycomed shall assist TMC or such designee in
seeking such Approvals by supplying TMC or such designee with
copies of all relevant documents and communications, and informing
TMC or such designee of the status of the applicable Regulatory
Filings. The Parties agree that during the Transition Period, or
until such earlier time as TMC or a TMC designee may assume
responsibility for such activities, Nycomed’s activities with
respect to seeking the foregoing Approvals shall be subject to
reasonable coordination with TMC; provided , however
, that Nycomed shall not be required to take any action that
Nycomed determines in good faith would jeopardize its standing and
reputation with any Governmental Authority or violate any
applicable provision of law, statute, rule or regulation.
6.6.
Communications with Governmental Authorities .
6.6.1. In
addition to its obligations under the New Agreements and the
Quality Agreements, during the Transition Period:
(a)
Nycomed shall give TMC at least seven to ten Business Days prior
written notice and the right to attend any meeting between Nycomed
and any Governmental Authority relating to the Product, or such
shorter notice as is practicable in light of the amount of notice
Nycomed itself receives of the meeting.
(b)
Nycomed shall provide TMC with a copy of each proposed
communication that will be made between Nycomed and any
Governmental Authority that relates to the Product and the right to
review such communication with as much advance notice as
practicable. Nycomed shall follow the instructions and comments of
TMC with respect
21
to any such proposed
communication; provided , however , that Nycomed
shall not be required to take any action that Nycomed determines in
good faith would jeopardize its standing and reputation with any
Governmental Authority or violate any applicable provision of law,
statute, rule or regulation. Nycomed shall permit TMC to
participate in any response to any such communication.
(c)
Nycomed shall be responsible for making presentations to any
Governmental Authority that relate to Approvals and Regulatory
Filings in Nycomed’s name during any joint meetings and for
responding to questions and comments from such Governmental
Authority with respect to its Approvals and Regulatory Filings, but
shall solicit and follow the instructions of TMC prior to making
such a presentation or response; provided , however ,
that Nycomed shall not be required to take any action that Nycomed
determines in good faith would jeopardize its standing and
reputation with any Governmental Authority or violate any
applicable provision of law, statute, rule or regulation.
(d)
Nycomed shall, within five Business Days, provide TMC with a copy
of each written communication Nycomed receives from any
Governmental Authority related to the Product. Nycomed shall,
within five Business Days, provide TMC with notes from any
in-person or teleconference meeting with any Governmental Authority
related to the Product at which TMC is not present.
6.6.2.
Notwithstanding the foregoing, upon a transfer in accordance with
Section 6.4 of an Approval or Regulatory Filing prior to the
Transition Date, (i) TMC shall assume all responsibility for
presentations to and communications with the relevant Governmental
Authority that relate to the Product and (ii) Nycomed shall be
relieved of any responsibility therefor. For the avoidance of
doubt, this Section 6.6 pertains only to Approvals and Regulatory
Filings (including Approvals that may result therefrom during the
Transition Period) that exist as of the Effective Date and is not
intended to grant any authority to Nycomed to file or seek new
Approvals or Regulatory Filings.
6.7.
Delivery of Know How and Clinical Data. As promptly as
possible after the Effective Date (or, if applicable, as promptly
as possible after the creation, development or acquisition of any
such item), and in any event no later than the Transition Date,
Nycomed shall provide to TMC or TMC’s designee the physical
embodiments of all Assigned Know-How and copies of the physical
embodiments of all Licensed Know-How; provided ,
however , that (i) to the extent Nycomed requires access to
Assigned Know-How to comply with applicable legal requirements
pertaining to Nycomed’s performance under the New Agreements,
Quality Agreements or this Agreement, subject to Section 11
(Confidential Information), TMC or TMC’s designee, as
applicable, shall allow Nycomed a right of access (including the
right to make copies of records) and right of reference to all such
Assigned Know-How, (ii) Nycomed may retain one archival copy of
each such item of Assigned Know-How solely for purposes of
interpreting and enforcing its rights under the Transaction
Agreements and Quality Agreements or as necessary
22
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