Document:

Exhibit 10.16

 

CONFIDENTIAL TREATMENT REQUESTED

 

INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED IS OMITTED

AND NOTED WITH “****”.

AN UNREDACTED VERSION OF THIS DOCUMENT HAS ALSO BEEN
PROVIDED TO THE

SECURITIES AND EXCHANGE

COMMISSION.

 

DISTRIBUTION AGREEMENT

 

This distribution agreement (this “Agreement”) is
entered into as of October 31, 2001 by and between Bristol-Myers Squibb Pharma
Company, a general partnership organized under the laws of the State of
Delaware (“BMS”) and Medi-Physics Inc., doing business as Amersham Health, a
corporation organized under the laws of the State of Delaware (“NA”).

 

RECITALS:

 

BMS has developed
and is the manufacturer of certain terminally
sterilized Technetium (Tc-99m) generators, Gallium Citrate Ga-67 Injection, and
Xe-133 gas products and possesses certain unique and valuable technology,
know-how and other information relating to the manufacture and sales of such
products.

 

NA is, among other things, presently engaged in the
business of marketing and selling various radiopharmaceutical products and has
substantial experience with respect thereto.

 

BMS desires to grant, and NA desires to obtain,
under the terms and conditions of this Agreement, the right to purchase from
BMS and the non-exclusive right to market, distribute and sell such generators,
Gallium Citrate Ga-67 Injection, Xe-133 gas products and related accessory
products in the territory as hereinafter defined.

 

NOW, THEREFORE, in consideration of the convenants
and agreements hereinafter set forth, the parties hereto agree as follows:

 

ARTICLE 1. Appointment as
Distributor

 

BMS hereby grants, to NA, under the terms and
conditions of this Agreement, the non-exclusive right to market, distribute and
sell the terminally sterilized Technetium (Tc-99m) generators, Gallium Citrate
Ga-67 Injection and Xe-133 gas products and accessory products

 

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hereafter identified on Exhibit A attached hereto (“Products”)
in the ****, to include the ****. In addition BMS agrees to supply to NA
Radiopharmacies in ****, solely for unit dose preparation in ****, those Tc-99m
Generators, Ga-67 and Xe-133 Products listed on Exhibit A. NA Radiopharmacies
in **** are defined as those entities in which NA has at least a ****% ownership
position. In addition, BMS
agrees to supply Products to those NA non-radiopharmacy accounts that are under
contract on the date of this Agreement and listed on Exhibit F, until the
expiration of such contract with the NA non-radiopharmacy account. Hereinafter,
the term “Territory” shall refer to both **** and **** so described above.

 

ARTICLE 2. Supply of
Products

 

2.1           (a)
BMS agrees to manufactures and sell to NA **** of NA’s requirements for
Products and NA agrees to purchase **** of its requirements for Products from
BMS.

 

(b) The parties are aware that BMS utilizes a ****
source for supply of Mo-99, and that BMS is required to purchase ****% of its requirements of Mo-99m from that
source. BMS agrees to use commercially reasonable efforts to find an
established backup sources for Mo-99 in the event BMS’s supplier fails to
provide BMS’s  requirements.

 

2.2           All
orders for purchases of Products by NA shall be submitted on NA’s standard
purchase order form as from time to time in use by NA (“Purchase Order”). A
copy of NA’s current form of Purchase Order is attached hereto as Exhibit B.
The terms of this Agreement shall take precedence over any standard terms of any Purchase Order where in conflict.

 

2.3           Upon
the Effective Date (as defined in Section 9.1 hereof) and no later than **** (****)
days prior to each **** during the term of this Agreement, each **** NA shall
provide BMS with a written forecast of the numbers and type of Products which
NA expects to purchase from BMS during the forthcoming calendar year, as the
case may be (the “Annual Forecast”).

 

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2.4           NA
shall place firm Firm Orders, setting forth the quantities, delivery schedules
and dates, and its shipping instructions on the Wednesday prior to the
following Monday through Saturday shipping cycle. Once placed by NA, such Firm
Orders may be increased or decreased only with prior BMS approval. Subject to NA’s limited right to adjust Firm
Orders set forth in the previous sentence, such Firm Orders shall constitute
binding contractual obligations of NA.

 

2.5           Although
an Annual Forecast or Quarterly Forecast shall not constitute a binding
obligation upon NA to order the quantities specified therein, NA agrees to use
all reasonable efforts to make each Annual Forecast and Quarterly Forecast a
reasonably accurate prediction of the number and mix of Products NA will
actually order for delivery in the relevant period pursuant to its Firm Orders.

 

2.6           BMS
shall use commercially reasonable efforts to ship Products pursuant to NA’s
Firm Orders. Tc-99m generators shall be made available for shipment ****  BMS facility, Billerica, MA each day of
manufacture. Days of manufacture of Tc-99m generators are currently ****, ****,
****, **** and ****. Any BMS initiated, permanent changes in the manufacturing schedule
shall be mutually agreed upon, prior to implementation. Xe-133 gas products
shall be made available for shipment ****  BMS
facility, Billerica, MA each **** calibrated for the following ****. Gallium
Citrate Ga-67 Injection products shall be made available ****, calibrated for
the following ****. In the event BMS is unable to deliver all product
requirements on a given day, BMS will allocate product to Nycomed in proportion
to Nycomed’s share of total demand. In the event that delivery of a Product is
delayed more than **** hours past the agreed upon local delivery time, BMS will
reduce the price NA pays for such Product by ****%. However, after **** (****)
hours delay, NA shall not be required to accept such Product and may make arrangements
with BMS to return unopened Product for **** credit. The foregoing shall not apply to delays caused by Force Majeure events such as  weather conditions, effecting
transportation of components or Products, for which there will be no price
reduction. Following the **** hour period outlined above, in the

 

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event that NA is required to find an alternate source of Product, BMS
shall pay the difference between BMS’s price under this Agreement and the price
NA is required to pay to obtain such Product, up to a limit of ****% of BMS’s
original price.

 

2.7           The
purchase prices to be charged NA for calendar year 2001 are shown in Exhibit Cl
and the mechanism to calculate future pricing for each Product is set forth in
Exhibit C2. Included in the prices of the Products are:

 

(a)   **** (****)
external generator shields per initial generator standing order (A25);

(b)   **** (****)
elution shields per initial generator standing order (A14);

(c)   **** (****)
packs of any combination of saline and evacs (A15, A17 or A3) per each received
generator standing order.

(d)   BMS
assures that the prices charged to NA for each Product shall recognize NA’s
proportion of total BMS volume for each product.

 

2.8           Delivery
of Products to NA hereunder shall be made by BMS via Federal Express, Priority
Overnight Service from BMS’s manufacturing facility located at 331 Treble Cove
Road, North Billerica, Massachusetts. If so requested by NA, BMS will arrange
for alternative shipment of Products in accordance with NA’s shipping
instructions contained in a Firm Order. NA shall reimburse BMS for the
difference between Federal Express and any payments made to such alternative
carriers by BMS on behalf of NA at the actual cost of such payments. BMS shall
incur no liability of any nature whatsoever with respect to its performance of
shipping duties on NA’s behalf other that because of BMS’s gross negligence.

 

2.9           All
payments for Products by NA shall be made within **** (****) days after receipt
of invoice.

 

ARTICLE 3. Distribution
and Sale of Products

 

3.1           NA
shall be responsible for compliance with all federal and state rules and regulations
which relate to the sale, promotion, distribution, use and final disposition of
Products

 

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in the Territory. All communications that NA, its subdistributors,
dealers, agents, or affiliates make about the Products in promotional materials
or otherwise shall be consistent with the New Drug Applications or other
governmental registrations for the Product, fully truthful, based on documented
facts, and fairly balanced. NA, its subdistributors, dealers, agents, and
affiliates shall not under any circumstances state or imply in promotional
materials or otherwise that the Xenon gas vials purchased by NA hereunder can
be used with Xenon gas delivery systems other than those purchased by NA
hereunder. BMS agrees to supply **** **** (****) Xenon gun per new customer.

 

3.2           NA
shall ensure that BMS receives a copy of the license renewals or amendments of
each NA customer to which Products are to be shipped directly by BMS
authorizing their receipt and use of the Products in order to keep current
BMS’s present file of such licenses (other than in cases where the relevant
regulatory authorities permit shipment notwithstanding the failure to supply or
provide such copies). BMS shall not be obligated to ship to such NA customers
and shall, immediately upon receiving the order from NA, verify the NA
customer’s licensed status and notify NA immediately if such inability to ship
exists so NA may take such steps as are available to it to remedy the position.
Such refusal to ship to a customer, whose license file in BMS’s custody is not
current and which defect is not remedied by NA, shall not be deemed an
inability or failure on BMS’s part to deliver Product in a timely fashion in
order to meet NA’s required deadlines.

 

3.3           NA
agrees to provide to BMS copies of NA’s  initial promotional literature related
to Products for BMS to transmit to FDA. BMS will play no role in obtaining
approval of that material other than taking any administrative action necessary
because of BMS’s ownership of the registration.

 

3.4           NA
shall have the sole right to determine the resale price, discount and any other
terms and conditions for NA’s
resale of Products. NA shall have complete control over the manner and methods
of the marketing, distribution and sale of Products, and NA may distribute and
sell Products directly or through subdistributors, dealers, agents or its
affiliates and may hire

 

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or retain marketing or other experts to advise and assist NA in the
distribution and sale of Products. Except as specifically stated herein, BMS shall play no role in NA’s
marketing, distribution and sale of Products.

 

3.5           Prior
to use of any label, labeling, advertising or promotional item related to the
Products (hereinafter referred to collectively as “Product Information”) by NA,
its subdistributors, dealers, agents, or affiliates, including but not limited
to any
package insert, product label, detail aid, direct mail piece,
file card, journal article, or reminder advertisement, NA shall submit a sample
of the Product Information to BMS for review. Provided, however that:

 

(a) NA shall not submit any information about
pricing of Products to BMS. If a sample of Product Information contains pricing
information, NA shall redact that information from the sample prior to
providing it to BMS; and

 

(b) BMS shall review the Product Information solely
for the following purposes: (1) to ensure compliance with the terms of BMS’s
New Drug Applications or other governmental registrations for the Products; (2)
to ensure that the Product Information is within the terms of the labeled
indications for the Products and is otherwise consistent with the approved
package inserts for the Products; and (3) to ensure that the Product
Information is not likely to give rise to any formal or informal action,
complaint or comment by or from the United States FDA or the Canadian HPB
regarding the Product Information or the Products; and

 

(c) Review by BMS of a sample of Product Information
shall not serve as admission, a representation.
or evidence thereof,
by BMS, that the Product Information: (1) is correct, accurate, or complete; or
(2) is within the scope of or consistent with the Product claims made by BMS;
or (3) is in compliance with the terms of this Agreement. Review of Product
Information by BMS shall not in any way alter or affect the indemnity given by
NA pursuant to Section 6.5 hereunder.

 

(d) NA shall provide BMS a sample of all Product
Information and BMS shall have fifteen (15) working days after receiving the
sample within which to review and comment on the Product Information. All
comments made by BMS shall be binding on NA, its

 

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subdistributors, dealers, agents and affiliates; which shall implement
and incorporate into the Product Information all comments made by BMS. If BMS
does not respond within fifteen (15) working days, NA, its subdistributors,
dealers, agents, or affiliates may use the Product Information unchanged.

 

3.6           As
market considerations dictate, BMS and NA will consider the implementation of
depleted Uranium shielded Technetium-99 Generators.

 

ARTICLE
4. Trademarks

 

4.1           BMS
hereby grants to NA and NA hereby accepts the right to resell the Products supplied
by BMS to NA in packages bearing the trademarks listed in Exhibit D
(“Trademarks”) and in promotional materials related to such Products. The
rights granted NA hereunder to use the Trademarks shall in no way affect BMS’s
ownership of such Trademarks. No other right, title or interest in the
Trademarks is established hereby, and nothing herein shall be construed to
grant any right or license to NA to use the BMS logo or the BMS trade name,
other than as specifically set forth herein. The parties agree and understand
that this Section 4.1 does not expand the rights granted to NA under Article 1.

 

4.2           NA
shall not make any use or take any action with respect to the Trademarks to
prejudice or infringe BMS’s rights thereto including the use of any confusingly
similar trademark and shall forthwith, upon objection by BMS, desist from any
use thereof or action therewith which is in violation of this Agreement.

 

4.3           NA
will only market the Products using the relevant Trademarks during the term of
this Agreement. Upon termination or expiration of this Agreement, NA will cease
all use of the Trademarks and the license to use any such Trademarks granted
hereunder shall immediately cease and be deemed canceled.

 

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4.4           NA
will use the Trademarks in strict accordance with the instructions given by BMS,
and shall not make any changes in connection therewith without first obtaining
BMS’s written consent. NA further agrees that at all times the Trademarks shall
be used in accordance with good trademark practice, including notation of the
fact that they are trademarks belonging to BMS and use of the appropriate
notice of registration. BMS reserves the right to unilaterally determine the
adequacy of the use and protection given the Trademarks by NA as set forth
herein.

 

4.5           NA
shall promptly notify BMS, in writing, of any conflicting use of, and applications or
registrations for, any of the Trademarks, or any acts of infringement, or acts
of unfair competition involving the Trademark, after such matters are brought
to its attention or it has knowledge thereof. NA further agrees to assist BMS,
at BMS’s expense, in registering or perfecting BMS’s rights to the Trademarks
in the Territory.

 

4.6           In
the event of any claim or litigation by a third party against NA alleging that
any of the Trademarks imitates or infringes a trademark of such third party or
is invalid, NA shall promptly give notice of such claims or litigation to BMS
and BMS shall assume responsibility for and control of the handling, defense,
or settlement thereof. NA shall cooperate fully with BMS during the pendency of
any such claim or litigation. BMS shall keep NA notified of the current status
of any trademark claim, litigation or infringement of any of the Trademarks and
shall permit NA to assume the handling, defense or settlement thereof if BMS
declines to do so.

 

ARTICLE 5. Quality
Control and Governmental Approvals

 

5.1           All
Products delivered to NA hereunder shall be manufactured in accordance with Current
Good Manufacturing Practices as required by the United States Federal Food,
Drug and Cosmetic Act and pursuant to applicable rules and regulations of the
United States Food and Drug Administration (“FDA”) when applicable. BMS shall
manufacture and supply the Products in accordance with the Quality Document
attached here as Exhibit E. Each product lot of

 

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Products shall be inspected and tested by BMS prior to shipment to NA
or its customers. A certificate of Compliance will be forwarded to NA after
each manufactured lot is completed.

 

5.2           As
further set forth herein; NA shall have the right to replacement of or refund
for Products, up to the expiration date of such Products, if such Products fail
to meet BMS’s specifications as set forth in BMS’s NDA for such Products or are
not of merchantable quality. NA will promptly notify BMS by telephone and
telecopy of NA’s request for replacement or refund. Such notice shall specify
with particularity the nature of the nonconformance and NA will have the
Product returned promptly to.BMS for examination at BMS’s expense. Provided that NA promptly returns
the Products to BMS, BMS will promptly replace the Products in question if
requested by NA, determine any nonconformance of the returned Products and
report back to NA.

 

In the event that BMS disagrees with NA regarding
whether the Products are nonconforming and the parties are unable to resolve
the dispute, the Products or samples thereof will be submitted to a qualified
independent laboratory agreed upon by the parties. The laboratory will analyze
the Products or samples in a manner agreed upon by the parties and the results
of that analysis will be a binding determination of whether the Products were
or were not nonconforming. If it is determined that the Products were
nonconforming, BMS shall bear the cost of the analysis, as well as either
providing a refund or replacement Products to NA. If it is determined that the
Products were not nonconforming NA shall bear the cost of the analysis, shall
not be entitled to any refund on the Products and shall pay BMS for any
replacement Products provided by BMS.

 

5.3           All
materials and components used in the fabrication of Products shall be traceable
by lot number and purchase order invoice number.

 

ARTICLE 6. Warranties.
Indemnities and Insurance

 

6.1           BMS
warrants to NA that all Products purchased by NA under this Agreement:

 

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(a) shall be free and clear of all liens, claims,
encumbrances, pledges, security interests or other adverse interests of third
parties,

 

(b) shall be manufactured, supplied and delivered by
BMS with all necessary skill and expertise using qualified personnel so as to
comply with all applicable regulatory requirements,

 

(c) shall be of good and merchantable quality, and
free from defects in material and workmanship;

 

(d) shall be manufactured in accordance with the
specifications set forth in BMS’s NDA, and

 

(e) shall be manufactured in accordance with the
Current Good Manufacturing Practices and other applicable FDA rules and
regulations.

 

6.2           (a)
BMS shall defend, indemnify and hold NA, its subdistributors, dealers, agents or
affiliates, harmless from any and all demands, claims, actions, suits,
judgments, decrees, proceedings, liabilities, costs, losses, damages and
expenses, including, without limitation, court costs and attorneys’ fees, at
any time resulting to any of them as a result of or in connection with (a) any
Products which were nonconforming, damaged, or defective at time of delivery to
NA whether claimed by or established in favor of any third parties, including
purchasers, and (b) any breach by BMS of the warranties provided for herein.

 

(b) NA shall promptly notify BMS upon receipt by NA
of any claim or demand which NA has determined has given or could give rise to
a right of indemnification under this Agreement. If such claim or demand
relates to a claim or demand asserted by a third party against NA, BMS shall
have the right to employ such counsel as is reasonably acceptable to NA to
defend any such claim or demand asserted against NA, and BMS shall have control
over the conduct of the defense of the claim or demand, provided, however, that
BMS shall not settle such claim or demand without the consent of NA unless such
settlement requires no more than a monetary payment for which NA is fully
indemnified under this Agreement or involves other matters not binding upon NA.
NA shall have the right to participate at its cost in the defense of any said
claim or demand. So long as BMS is defending in good faith any such claim or
demand,

 

10

 

NA shall not settle such claim or demand. NA shall fully cooperate with
BMS during the pendency of the claim or demand and shall make available to BMS
and its representatives all records and other materials reasonably required by
them for their use in contesting any claim or demand asserted by third party
against NA. Whether or not BMS  so elects to defend any such claim
or demand, NA shall not have any obligation to do so and NA shall not waive any
rights it may have against BMS hereunder with respect to any such claim or
demand by electing or failing to elect to defend any such claim or demand. NA’s
subdistributors, dealers, agents or affiliates shall also be bound by this
section.

 

6.3           The
obligation of BMS to indemnify and defend shall not extend to claims or demands
to the extent they are attributable to the independent negligence or
intentional malfeasance of NA, its subdistributors, dealers, agents, or
affiliates, nor to any claims or demands to the extent that they are attributable
to or arising out of statements or actions made by NA, its subdistributors,
dealers, agents or affiliates with respect to the Products. The obligation to
BMS to indemnify and defend shall also not apply to any claims or demands to
the extent that they are attributable to any breach by NA of the terms of this
Agreement.

 

6.4           BMS
represents that it is self-insured for the activities to be carried out under
this Agreement and that it maintains sufficient reserves covering these
activities.

 

6.5           (a)
NA shall defend, indemnify and hold BMS, its directors, officers, agents, affiliates,
and employees, harmless from any and all demands, claims, actions, suits,
judgments, decrees, proceedings, liabilities, costs, losses, damages and
expenses, including, without limitation, court costs and attorneys’ fees, at
any time resulting to any of them, as a result of or in connection with (a) any
negligence or intentional malfeasance by NA, its subdistributors, dealers,
agents, or affiliates, and (b) any representation made or other action taken by
NA, its subdistributors, dealers, agents, or affiliates related to marketing,
selling, or distributing the Products, which are outside the scope of or
inconsistent with any Product claims made by BMS, and (c) any breach by NA of
the terms of this Agreement. This obligation of NA to indemnify

 

11

 

 

and defend shall not apply to the extent that claims are attributable
to the independent negligence or intentional malfeasance of BMS.

 

(b) BMS shall promptly notify NA upon receipt by BMS
of any claim or demand which BMS has determined has given or could give rise to
a right of indemnification under this Agreement. If such claim or demand
relates to a claim or demand asserted by a third party against BMS, NA shall
have the right to employ such counsel as is reasonably acceptable to BMS to
defend any such claim or demand asserted against BMS and NA shall have control
over the conduct of the defense of the claim or demand; provided, however, that
NA shall not settle such claim or demand without the consent of BMS unless such
settlement required no more than a monetary payment for which BMS is fully indemnified
under this Agreement or involves other matters not binding upon BMS. BMS shall
have the right to participate at its costs in the defense of any such claim or
demand. So long as NA is defending in good faith any such claim or demand, BMS
shall not settle such claim or demand. BMS  shall fully cooperate with NA
during the pendency of the claim or demand and shall make available to NA and
its representatives all records and other materials reasonably required by them
for their use in contesting any claim or demand asserted by third party against
BMS. Whether or not NA so elects to defend any such claim or demand, BMS shall
not have any obligation to do so and BMS shall not waive any rights it may have
against NA hereunder with respect to any such claim or demand by electing or
failing to elect to defend any such claim or demand. BMS’s subdistributors,
dealers, agents, or affiliates shall also be bound by this section.

 

(c) NA represents that it is self-insured for the
activities to be carried out under this Agreement and that it maintains
sufficient reserves covering these activities.

 

6.6           NA
will notify BMS of any adverse drug experience associated with the Products of
which NA, its subdistributors, dealers, agents, or affiliates become aware.
Such notifications will be made in writing, in a manner reasonably agreed by
the parties, by means which afford the sender evidence of receipt by BMS within
three (3) working days of initial receipt of the report by NA, its
subdistributor, dealer, agent, or employee. Such means of notification may
include Express Mail, Electronic Mail, courier, or facsimile, but are not
so-limited. Advance notification of any fatal or immediately life-threatening
experience will be given by telephone. NA is

 

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responsible for insuring prompt follow-up, as necessary to provide BMS
with reasonably complete information on each such adverse drug experience, by
the same means and within the same time frame of receipt.

 

Any communication to BMS under the terms of this
Section 6.6 shall be directed to the attention of the following individual or
to his designee or successor:

 

Regulatory Affairs

Bristol-Myers Squibb Pharma Company

331 Treble Cove Road

North Billerica, Massachusetts 01862

Telephone: 978-671-8361

Telecopy: 978-663-6897

 

“Adverse drug experience” shall mean any unfavorable
and/or unintended change in the structure (signs), function (symptoms), or
chemistry (laboratory data) of the body temporally associated with the use of
Product or of a derivative thereof in humans, whether or not considered drug
related, including the following: an adverse experience occurring in the course
of the use of a drug in professional practice, an adverse experience occurring
from drug overdose, whether accidental or intentional, an adverse experience
occurring from drug withdrawal, and any significant failure of expected
pharmacological action. (Failure of a radiopharmaceutical product to localize
as expected is not regarded by BMS as an adverse experience, but rather as a
complaint, which is referred to BMS’s Marketing and Technical Services
personnel for further investigation.)

 

ARTICLE 7. Representation
and Warranties.

 

7.1           BMS
hereby represents and warrants to NA as follows:

 

(a) BMS has the full power, authority and legal
right to enter into this Agreement; this Agreement has been duly authorized,
executed and delivered by BMS; and this Agreement constitutes a legal, valid
and binding obligation of BMS, enforceable against BMS in
accordance with its terms.

 

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(b) BMS has executed no agreement in conflict
herewith.

 

(c) The distribution and sale of the Products by NA
will not infringe the patents or intellectual property rights of any third
party.

 

7.2           NA
hereby represents and warrants to BMS that NA has the full power, authority and
legal right to enter into this Agreement; this Agreement has been duly
authorized, executed and delivered by NA; this Agreement constitutes a legal,
valid and binding obligation or NA enforceable against NA in accordance with
its terms; and NA has executed no agreement in conflict with the terms of this
Agreement.

 

ARTICLE 8. Confidentiality

 

Any and all proprietary information with respect to
the Products or the business affairs and activities of either party hereto
(“Proprietary Information”) which is furnished or disclosed in connection with
the Agreement by such party (“Disclosing Party”) to the other party hereto
(“Receiving Party”), including, without limitation, the specifications for the
Products, shall remain the property of the Disclosing Party and shall be
treated as confidential. Receiving Party shall not use such Proprietary
Information for its own benefit except as specified in this Agreement and shall
not disclose such Proprietary Information to others, except to those of its
employees whose duties so require, in such event taking all precautions which
are reasonably necessary to prevent the unauthorized disclosure of such
Proprietary Information by such persons. Information shall not be deemed to be
Proprietary Information and such restrictions shall not apply to any such
information (i) which is, or subsequently may become, within the knowledge of the general public,
without the fault of the Receiving Party; (ii) which may be known to the
Receiving party at the time of receipt thereof from the Disclosing Party as
shown by competent written records, (iii) which may be proved to have been
developed by the Receiving Party, independently and wholly without resort to
the Proprietary Information of the Disclosing Party, as shown by competent
written records; or (iv) which may subsequently be rightfully obtained from
sources other than the Disclosing Party and without confidential restriction in
favor of such transmitting party. The parties’ respective obligations under
this Article 8 shall continue after the expiration or termination of this
Agreement for any reason.

 

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ARTICLE 9. Term and
Termination

 

9.1           Unless
earlier terminated as provided in this Agreement, the initial term of this Agreement
shall commence as of the Effective Date and conclude on December 31, 2005.
Thereafter, this Agreement will automatically renew for three (3) year periods.
Notwithstanding the foregoing, this Agreement
may  be  terminated at any time by BMS on three (3) years written
notice to NA or by NA on six (6) months written notice to BMS.

 

9.2           Upon
the happening of any of the following .events, either party shall have the right to
terminate this Agreement upon written notice of such termination to the other
party:

 

(a) Any material breach by the other party of this
Agreement, which material breach continues for a period of thirty (30) days
after the non-defaulting party shall have given notice thereof to the
defaulting party, or

 

(b) The other party becomes insolvent, is
adjudicated as bankrupt or otherwise seeks or receives protection under the
bankruptcy laws of the United States, has a receiver or trustee appointed for
all or part of its assets and business, executes and delivers an assignment for
the benefit of its creditors or is liquidated, dissolved or wound-up or

 

(c) The continuance of an event of force majeure
for a period of more than sixty (60) days.

 

9.3           The
objective of this Agreement is to realize in an economical and reasonable way
the interests and requirements of both parties. If at any time during the term
of this Ageement, this objective is no longer met due to: ·

 

(a) regulatory changes(s), or economic
circumstances, which could not have been foreseen at the time of execution of
this Agreement causing undue and prolonged hardship; or

 

(b) any substantial increase in Seller’s direct or
indirect cost relating to Uranium targets or radioactive waste disposal;

 

15

 

(c) changes in the selling price effected by the
entrance into the market of sellers capable of meeting the volume commitments
contemplated under this Agreement; then the parties shall negotiate in good
faith in an effort to modify this Agreement in accordance with any of the
matters described above and such negotiations shall commence within **** (****)
days of one party’s written notice to the other of (a) and/or (b) above. During
any negotiation period, the pricing increments defined in Exhibit C will
continue in effect.

 

In the event the parties are unable to agree upon a
satisfactory modification of this Agreement within **** (****) days of
commencement of negotiations (“negotiation period”), the party requesting the
modification may terminate this Agreement within **** (****) days following
expiry of the negotiation period by providing **** (****) days written notice to
the other party.

 

9.4           The
warranties and indemnities contained in this Agreement shall survive any expiration
or termination hereof, as shall the confidentiality obligations of the parties
pursuant to Article 8 hereof. Otherwise, upon expiration or termination of this
Agreement as provided in this Article 9, except as expressly provided herein,
the parties shall have no further liabilities, duties or obligations under this
Agreement, except for any liabilities, duties or obligations which may have
arisen prior to such expiration or termination.

 

ARTICLE 10. Force Majeure

 

10.1         Neither
party will be liable for any failure to fulfill any term or condition of this
Agreement, nor will such failure constitute a breach of or default under this
Agreement, if fulfillment has been delayed, hindered or prevented by an event
of force majeure, including, without limitation, any war, riot, strike,
lock-out or other industrial dispute, acts of the elements, acts of any
government or agency hereof (including the enactment of any new laws, rules or
regulations), sabotage or industrial accident, plant breakdown or failure of
equipment, inability to obtain equipment, fuel, power, materials or
transportation, or by any similar circumstances beyond its reasonable control.

 

16

 

10.2         Promptly
following the date that any event of force majeure commences, the party
concerned will advise the other party in writing of the date and nature of the
event and the period of time such event is expected to continue. During the
existence of such event, the duties and obligations of the parties under this
Agreement shall be suspended and the parties will take all reasonable action to
assure resumption of normal performance under this Agreement as soon as
possible.

 

ARTICLE 11. Assignment

 

This Agreement and all rights and obligations
arising hereunder may not be assigned or otherwise transferred by either party
whether by operation of law or otherwise, unless the other party has given its
written consent thereto, which consent shall not be unreasonably withheld, and
any such purported assignment or transfer without the other party’s written
consent shall be null and void. Notwithstanding the foregoing, a party hereto
may assign this Agreement and all rights and obligations arising hereunder in
connection with the sale of all or substantially all of its business.

 

ARTICLE 12. General
Provisions

 

12.1         The
relationship of BMS and NA under this Agreement shall be that of independent
seller and purchaser, and nothing contained in this Agreement and no action taken
by either party to this Agreement shall be deemed to constitute either party or
any of such party’s employees, agents or representatives to be an employee,
agents or representative of the other party or shall be deemed to create any
partnership, joint venture, association or syndicate between the parties, or
shall be deemed to confer on either party any express or implied right, power
or authority to enter into any agreement of commitment, express or implied, or
to incur any obligation or liability on behalf of the other party.

 

12.2         Except
as specified in Section 6.6 above, any notice, claim; demand, request or other
communication required or permitted under this Agreement shall be valid and
effective

 

17

 

only if given by written instrument which is personally delivered, sent
by facsimile, courier or registered or certified mail, postage prepaid to the
addressee as follows:

 

If to BMS, to:

 

Bristol-Myers Squibb Pharma Company 

Radiopharmaceutical Division

331 Treble Cove Road

North Billerica, Massachusetts 01862 

Attention: Vice President, Manufacturing

Telecopy: 978-671-9577

 

If to NA, to:

 

Medi-Physics, Inc.

2636 South Clearbrook Drive 

Arlington Heights, Illinois 60005

Attention: President

Telecopy: 708-593-8010

 

Except as specified in Section 6.6 above, any notice,
claim, demand, request or other communication given as provided in this Section
12.2, if given personally, shall be effective upon delivery; if given by facsimile,
shall be effective one (1) day after transmission; and if given by courier,
shall be effective two (2) days after deposit with the courier; and if given by
mail, shall be effective five (5) days after deposit in the mail. Either party
may change the address at which it is to be given notice by giving written
notice to the other party as provided in this Section 12.2.

 

12.3       This
Agreement, together with the Exhibits attached hereto, constitutes the entire
agreement, and supersedes all prior agreements and understanding, both written
and oral, between the parties with respect to the subject matter of this
Agreement; and this Agreement may not be modified or amended except by an
instrument in writing executed by the parties hereto.

 

18

 

12.4         No
waiver, forbearance or failure by either party of its right to enforce any
provision of this Agreement shall constitute a waiver or estoppel of such
party’s right to enforce such provision in the future.

 

12.5         Unless
expressly provided otherwise herein, the remedies set forth in this Agreement
shall not be exclusive but shall be cumulative, and in addition to all other
rights and remedies provided by law.

 

12.6         This
Agreement shall be governed by and construed in accordance with the internal
laws of the State of Delaware, excluding the conflict of law provisions
thereof.

 

12.7         If
any provision of this Agreement shall be found invalid or unenforceable, in
whole or in part, by a court of competent jurisdiction, then such provision
shall be deemed to be modified or restricted to the extent and in the manner
necessary to render the same valid and enforceable, or shall be deemed excised
from this Agreement, as the case may require, and this Agreement shall be
construed and enforced to the maximum extent permitted by law, as if such
provision had been originally incorporated herein as so modified or restricted,
or as if such provision had not been originally incorporated herein, as the
case may be, provided that the basic intent of the parties has not thus been
rendered incapable of achievement.

 

IN WITNESS WHEREOF, the
parties hereto have executed this Agreement as of the day and year first above
written.

 

	
   

  	
  MEDI-PHYSICS, INC.

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  By: 

  	
  /s/ [ILLEGIBLE]

  	
   

  
	
   

  	
   

  
	
   

  	
  Title: 

  	
  Vice President

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  BRISTOL-MYERS SQUIBB PHARMA COMPANY

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  By: 

  	
  /s/ Donald J. Hayden

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  Title: 

  	
  Executive Vice President,
  Health Care Group 

  	
   

  

 

19

 

 

EXHIBIT A

 

PRODUCTS

 

Tc-99M GENERATOR

 

	
ITEM #
  	
 
  	
DESCRIPTION
  
	
 
  	
 
  	
 
  
	
****
  	
 
  	
****mCi UNIT, CALIBRATED @****
  
	
****
  	
 
  	
****mCi UNIT, CALIBRATED @****
  
	
****
  	
 
  	
****mCi UNIT, CALIBRATED @****
  
	
****
  	
 
  	
****mCi UNIT, CALIBRATED @****
  
	
****
  	
 
  	
****mCi UNIT, CALIBRATED @****
  
	
****
  	
 
  	
****mCi UNIT, CALIBRATED @****
  
	
****
  	
 
  	
****mCi UNIT, CALIBRATED @****
  
	
****
  	
 
  	
****mCi UNIT, CALIBRATED @****
  
	
****
  	
 
  	
****mCi UNIT. CALIBRATED @****
  
	
****
  	
 
  	
****mCi UNIT, CALIBRATED @****
  
	
****
  	
 
  	
****mCi UNIT, CALIBRATED @****
  
	
****
  	
 
  	
****mCi UNIT, CALIBRATED @****
  
	
****
  	
 
  	
****mCi UNIT, CALIBRATED @****
  
	
****
  	
 
  	
****mCi UNIT, CALIBRATED @****
  
	
****
  	
 
  	
****mCi UNIT, CALIBRATED @****
  
	
 
  	
 
  	
 
  
	
****
  	
 
  	
SET OF **** ML SALINE ELUANT VIALS
  
	
****
  	
 
  	
SET OF **** ML SALINE ELUANT VIALS
  
	
****
  	
 
  	
SET OF **** ML EVACUATED COLLECTION VIALS
  
	
****
  	
 
  	
LEAD ELUTION SHIELD
  
	
****
  	
 
  	
MOLY CODDLE RADIATION REDUCER
  
	
****
  	
 
  	
ALUMINUM ION INDICATOR KIT
  
	
 
  	
 
  	
 
  
	
XENON-133
  	
 
  	
 
  
	
 
  	
 
  	
 
  
	
****
  	
 
  	
XE-133 **** mCi , **** VIAL TUBE
  
	
****
  	
 
  	
XE-133 **** mCi , **** VIAL TUBE
  
	
****
  	
 
  	
XE-133 **** mCi , **** VIAL TUBE
  
	
****
  	
 
  	
XE-133 **** mCi , **** VIAL TUBE
  

 

20

 

EXHIBIT A (cont’d)

 

PRODUCTS

 

XENON-133

 

	
ITEM #
  	
 
  	
DESCRIPTION
  
	
 
  	
 
  	
 
  
	
****
  	
 
  	
XE-133 ****  mCi , **** VIAL TUBE
  
	
 
  	
 
  	
 
  
	
****
  	
 
  	
XE-133 **** mCi , **** VIAL TUBE
  
	
****
  	
 
  	
XE-133 **** mCi , **** VIAL TUBE
  
	
****
  	
 
  	
XE-133 **** mCi , **** VIAL TUBE
  
	
****
  	
 
  	
XE-133 **** mCi , **** VIAL TUBE
  
	
****
  	
 
  	
XE-133 **** mCi , **** VIAL TUBE
  
	
 
  	
 
  	
 
  
	
XGUN
  	
 
  	
XENON GUN
  
	
 
  	
 
  	
 
  
	
GALLIUM-67
  	
 
  	
 
  
	
 
  	
 
  	
 
  
	
****
  	
 
  	
**** mCi VIAL, CALIBRATED@ 1200 EST. Day Of Calibration
  
	
****
  	
 
  	
**** mCi VIAL, CALIBRATED@ 1200 EST. Day Of Calibration
  
	
****
  	
 
  	
**** mCi VIAL, CALIBRATED@ 1200 EST. Day Of Calibration
  
	
****
  	
 
  	
****mCi VIAL, CALIBRATED@ 1200 EST. Day Of Calibration
  
	
****
  	
 
  	
****mCi VIAL, CALIBRATED@ 1200 EST. Day Of Calibration
  
	
 
  	
 
  	
 
  
	
MHDLG
  	
 
  	
HANDLING CHARGE PER ORDER
  

 

NOTES

 

·                                          DUPONT RESERVES THE RIGHT TO ADD OR DELETE SPECIFIC ITEMS FROM ITS TOTAL PRODUCT PORTFOLIO GIVING **** DAY NOTICE

 

·                                          ****=****, ****=****, ****=****, ****=****, ****=****

 

·                                          GENERATORS ARE CALIBRATED ON ****

 

·                                          GA-67 IS CALIBRATED FOR **** FOLLOWING **** RELEASE

 

·                                          XENON IS CALIBRATED FOR **** FOLLOWING **** RELEASE

 

·                                          MOLY CODDLES ARE ONLY SHIPPED VIA COMMON CARRIER (ROADWAY, ETC)

 

21

 

EXHIBIT B 

 

PURCHASE ORDER FORM

 

Lead Generator and Accessories Order Form

 

	
Customer #
  	
 
  	
 
  
	
 
  	
 
  
	
Customer PQ #
  	
 
  	
 
  
	
 
  	
 
  
	
Customer Name
  	
 
  	
 
  
	
 
  	
 
  
	
Address
  	
 
  	
 
  
	
 
  	
 
  
	
City/State
  	
 
  	
 
  
	
 
  	
 
  
	
Zip Code
  	
 
  	
 
  
				

 

	
New Order:
  	
 
  
	
 
  	
 
  
	
 
  	
Product
  	
 
  	
 
  	
Qty
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  
	
 
  	
1st shipping date
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  
	
 
  	
Sales order #
  	
 
  	
 
  
							

 

	
Cancellation
  	
 
  
	
 
  	
 
  	
 
  
	
 
  	
Product
  	
 
  	
 
  	
Qty
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  
	
 
  	
Last shipping date
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  
	
 
  	
Sales order #
  	
 
  	
 
  
							

 

	
Change
  	
 
  	
 
  
	
 
  	
 
  	
 
  
	
 
  	
Product
  	
 
  	
 
  	
New Qty
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
Product
  	
 
  	
 
  	
New Qty
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
Product
  	
 
  	
 
  	
New Qty
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
New Size
  	
 
  	
 
  
	
 
  	
 
  	
 
  
	
 
  	
1st shipping date
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  
	
 
  	
Sales order #
  	
 
  	
 
  
								

 

	
Comments
  	
 
  	
 
  
	
 
  	
 
  
	
 
  	
 
  
	
 
  	
 
  
	
 
  	
 
  

 

22

 

EXHIBIT Cl

 

PRICING **** THROUGH ****

 

	
Item #
  	
 
  	
PRICE
  	
 
  
	
 
  	
 
  	
 
  	
 
  
	
Tc-99m GENERATOR
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  
	
****
  	
 
  	
$
  	
****
  	
 
  
	
****
  	
 
  	
$
  	
****
  	
 
  
	
****
  	
 
  	
$
  	
****
  	
 
  
	
****
  	
 
  	
$
  	
****
  	
 
  
	
****
  	
 
  	
$
  	
****
  	
 
  
	
****
  	
 
  	
$
  	
****
  	
 
  
	
****
  	
 
  	
$
  	
****
  	
 
  
	
****
  	
 
  	
$
  	
****
  	
 
  
	
****
  	
 
  	
$
  	
****
  	
 
  
	
****
  	
 
  	
$
  	
****
  	
 
  
	
****
  	
 
  	
$
  	
****
  	
 
  
	
****
  	
 
  	
$
  	
****
  	
 
  
	
****
  	
 
  	
$
  	
****
  	
 
  
	
****
  	
 
  	
$
  	
****
  	
 
  
	
****
  	
 
  	
$
  	
****
  	
 
  
	
 
  	
 
  	
 
  	
 
  
	
TC-99m ACCESSORIES
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  
	
****
  	
 
  	
$
  	
****
  	
 
  
	
****
  	
 
  	
$
  	
****
  	
 
  
	
****
  	
 
  	
$
  	
****
  	
 
  
	
****
  	
 
  	
$
  	
****
  	
 
  
	
****
  	
 
  	
$
  	
****
  	
 
  
	
****
  	
 
  	
$
  	
****
  	
 
  
	
 
  	
 
  	
 
  	
 
  
	
XENON-133
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  
	
****
  	
 
  	
$
  	
****
  	
 
  
	
****
  	
 
  	
$
  	
****
  	
 
  
	
****
  	
 
  	
$
  	
****
  	
 
  
	
****
  	
 
  	
$
  	
****
  	
 
  
	
****
  	
 
  	
$
  	
****
  	
 
  
	
 
  	
 
  	
 
  	
 
  
	
****
  	
 
  	
$
  	
****
  	
 
  
	
****
  	
 
  	
$
  	
****
  	
 
  
	
****
  	
 
  	
$
  	
****
  	
 
  
	
****
  	
 
  	
$
  	
****
  	
 
  

 

23

 

EXHIBIT Cl (cont’d)

 

PRICING **** THROUGH ****

 

	
Item #
  	
 
  	
PRICE
  	
 
  
	
 
  	
 
  	
 
  	
 
  
	
XENON-133
  	
 
  	
 
  	
 
  
	
****
  	
 
  	
$
  	
****
  	
 
  
	
 
  	
 
  	
 
  	
 
  
	
XGUN
  	
 
  	
$
  	
****
  	
 
  
	
 
  	
 
  	
 
  	
 
  
	
GALLIUM-67
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  
	
****
  	
 
  	
$
  	
****
  	
 
  
	
****
  	
 
  	
$
  	
****
  	
 
  
	
****
  	
 
  	
$
  	
****
  	
 
  
	
****
  	
 
  	
$
  	
****
  	
 
  
	
****
  	
 
  	
$
  	
****
  	
 
  
	
 
  	
 
  	
 
  	
 
  
	
MISCELLANEOUS
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  
	
MHDLG
  	
 
  	
$
  	
****
  	
 
  

 

24

 

EXHIBIT C2

 

A.                PRICES ARE PER ITEM AS DESCRIBED IN EXHIBIT A

 

B.                  ADDITIONAL FREIGHT CHARGES. WHERE REQUESTED AND APPROVED, WILL BE ADDED TO THE $**** MHLDG ITEM

 

C.                  WHEN NECESSARY TO SUBSTITUTE FOR REQUESTED ITEMS DUE TO INVENTORY SHORTFALL, BMS WILL ADJUST PRICES FOR SUBSTITUTED ITEMS TO REFLECT REQUESTED ITEMS TOTAL COST

 

D.                 **** PRICE ADJUSTMENTS FOR EACH PRODUCT, EXPRESSED AS A PERCENTAGE.  FOR **** COMMENCING ****, AND IMPLEMENTED ON EACH SUBSEQUENT **** WILL BE CALCULATED AS FOLLOWS:

 

1.                        COST, OF MATERIALS PLUS ****% OF ****

2.                        NEW PRICING INCORPORATING THE ABOVE WILL BE COMMUNICATED TO NA ON **** TO ASSIST NA COST FORECASTING, THE **** COMMUNICATION WILL INCLUDE ANTICIPATED BMS TIMING/INCREASE % ON APPLICABLE PRODUCTS FOR THE COMING ****. THIS INFORMATION MUST BE HELD IN THE STRICTEST CONFIDENCE BY NA

FOR EXAMPLE, IN THE EVENT THAT THE **** WAS EQUAL TO ****% AND DUPONT COMMUNICATED TO NA ON OCTOBER 1 THAT THE COST OF MATERIAL FOR MO-99 INCREASED BY ****%, THEN THE **** PRICE ADJUSTMENT FOR MO-99, IMPLEMENTED ON ****, WOULD BE CALCULATED AS FOLLOWS: **** PRICE ADJUSTMENT = ****% + **** X ****% = ****%. AS AN ADDITIONAL EXAMPLE IN THE EVENT THE **** ON **** WAS ****% AND THE COST OF MATERIAL FOR GA-67 INCREASED BY ****%. THEN THE **** PRICE ADJUSTMENT FOR GA-67, IMPLEMENTED ON ****, WOULD BE ****%.

 

E.                   SEPARATE FROM THE **** PRICE ADJUSTMENT DESCRIBED ABOVE BMS WILL PASS THROUGH ADDITIONAL PRICE ADJUSTMENTS WHEN BMS HAS ADJUSTED ARMS-LENGTH UNBUNDLED PRICING TO NON-NA, SEGMENTS FROM THE LEVEL DEVELOPED IN THE **** INCREASE PRICE ADJUSTMENT, AS FOLLOWS:

 

1.                    BMS WILL PROVIDE **** MONTHS DOCUMENTED ASP CHANGE REALIZED ASP CHANGE

2.                    **** DAYS FROM PRESENTATION OF REALIZED ASP CHANGE, NA PRICING WILL BE ADJUSTED

3.                    SUCH ADJUSTMENT WILL BE THE DIFFERENCE BETWEEN THE REALIZED ASP CHANGE AND THE **** PRICE ADJUSTMENT. WHETHER IT BE POSITIVE OR NEGATIVE.

4.                    FOR EXAMPLE, IN THE EVENT THE REALIZED ASP CHANGE FOR MO-99 ON **** WAS ****% AND THE **** PRICE ADJUSTMENT WAS EQUAL TO ****%. THEN THE ADDITIONAL PRICE ADJUSTMENT FOR MO-99 WOULD BE IMPLEMENTED ON **** AND WOULD BE CALCULATED AS FOLLOWS: ADDITIONAL PRICE ADJUSTMENT = ****% - ****% = ****%.

5.                    ASP Calculation will be carried out as follows:

 

25

 

For the purposes of calculating price changes, average selling price (ASP) will be defined separately for each item and separately for the **** and ****. In each case, the ASP for the period in question will be defined as the total realized revenue, less discounts and rebates, divided by the number of units sold. Free product provided to customers in the form of a discount or incentive will count toward the unit number but replacement product, to address product performance or delivery issues, will not. Free or discounted product made available as part of clinical trial support will also not count in the unit number.

 

6.                                       Example

 

BMS provides NA new pricing on **** to be effective the following **** that is based upon a ****% increase in the cost of materials for MO-99, ****% for Gallium-67, and ****% for Xenon-133. The **** is ****%. BMS also provides NA on **** anticipated BMS timing /increase % on MO-99, GA-67 and XE-133 for the coming calendar year as set forth below. The Price Increase as a percentage of last year’s price is as follows:

 

A. **** Communication to NA ****

 

	
 
  	
 
  	
MO-99
  	
 
  	
GA-67
  	
 
  	
XE-133
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
Cost of Materials increase
  	
 
  	
****
  	
%
  	
****
  	
%
  	
****
  	
%
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
****% August 1 ****
  	
 
  	
****
  	
%
  	
****
  	
%
  	
****
  	
%
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
**** Increase
  	
 
  	
****
  	
%
  	
****
  	
%
  	
****
  	
%
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
“Non-NA” Forecast Increase
  	
 
  	
****
  	
%
  	
****
  	
%
  	
****
  	
%
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
Timing
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  	
 
  

 

Assume that the ****month weighted average ASP for MO-99 during the period from **** price increase is a Realized ASP Change of ****%, and that the ****month weighted average ASP for GA-67 and XE-133 from the **** price increase is a Realized ASP Change of ****% and ****% respectively. The off cycle price adjustment as a percentage of the calendar’s year price is as follows:

 

26

 

B. “Off cycle” Communication to NA

 

	
Communication Timing
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  	
 
  
	
Realized “Non NA” ASP Increase
  	
 
  	
****
  	
%
  	
****
  	
%
  	
****
  	
%
  
	
Adj. to NA Pricing
  	
 
  	
****
  	
%
  	
****
  	
%
  	
****
  	
%
  
	
Timing
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  	
 
  

 

27

 

EXHIBIT D

 

TRADEMARKS

 

	
Trademark
  	
 
  	
Country
  	
 
  	
Registration Number
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
TECHNELITE
  	
 
  	
USA
  	
 
  	
1,812,837
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
TECHNELITE
  	
 
  	
Canada
  	
 
  	
424737
  	
 
  

 

28

 

EXHIBIT E

 

QUALITY DOCUMENT

 

1.                                      GUIDING PRINCIPLES

 

Regarding the working relationship between the Quality Departments of NA and BMS Pharmaceuticals (Medical Imaging) for the Product(s) (refer to the Appendix):

 

1.1                                 Unless otherwise specified, NA refers to NA Quality and the Contractor refers to BMS Pharmaceuticals (Medical Imaging) Quality.

 

1.2                                 The Contractor has the responsibility to evaluate/monitor any new U.S. NDA requirements and notify NA of any changes in requirements in a timely manner.

 

1.3                                 The Contractor has responsibility to operate within the Product registration documentation and shall provide Product that meets all criteria throughout its shelf life.

 

1.4                                 The Appendix of this document specifies the Product(s) currently covered by this Agreement. This Agreement may be amended as new products are added or deleted.

 

2.                                      MAINTENANCE OF COMPLIANCE BETWEEN THE PRODUCT REGISTRATION AND THE PROCESS

 

2.1                               Technical Changes

 

2.1.1                        The Contractor is responsible for maintaining a change control system that will:

 

2.1.1.1               review and approve all changes;

 

2.1.1.2               evaluate the impact of changes on validation status;

 

29

 

2.1.1.3               evaluate the impact of changes on product registration, and

 

2.1.1.4               evaluate the impact of changes on product safety and efficacy.

 

2.1.2                        The Contractor is responsible for maintaining a system to implement compendial changes.

 

2.2                               Other Changes

 

2.2.1                        All parties, prior to implementation, must approve proposed changes in the storage and/or shipping of the Product.

 

3.                                      BATCH RELEASE

 

3.1                                 The Contractor will manufacture and test the Product according to established, approved procedures and current Good Manufacturing Practices.

 

3.2                                 Batch review and release of the Product and all of its components will be the sole responsibility of the Contractor.

 

3.3                                 The Contractor will have a formal retest policy and procedure in place that is in accordance with applicable regulations.

 

3.4                                 The Contractor will notify NA, within 48 hours, in the event that any test reveals contamination, lack of sterility, or degradation beyond specifications in any batch of Product. The Contractor will file any reports required by the applicable regulations.

 

30

 

4.                                      BATCH DOCUMENTATION

 

4.1                                 Originals of all batch documents will be retained by the Contractor according to regulatory and Contractor requirements; these records will be maintained for a period of one (1) year following the Product lot’s expiration date.

 

5.                                      RETAIN SAMPLES

 

5.1                                 The Contractor shall retain, under proper storage conditions, samples of the Product as required by the regulations for a period of:

 

5.1.1                        At least three (3) months following the Product lot’s expiration date for radioactive products,

 

5.1.2                        At least one (1) year following the Product lot’s expiration date for non-radioactive products.

 

6.                                      STABILITY

 

6.1                                 The Contractor will ensure that a product monitoring (stability testing) program is in place for the Product.

 

6.1.1                        The Contractor is responsible for performing stability testing in accordance with the filed stability schedule. Samples shall be stored and tested at appropriate intervals, as described in the approved stability protocol.

 

6.1.2                        If a confirmed result indicates the Product has failed to remain within specifications, the Contractor is required to notify NA within three business days. Notification will include a discussion of the issues, available data, and a path forward.

 

31

 

6.1.3                        In all cases, the Contractor must investigate any confirmed out of specification (OOS) result. A copy of the completed investigation report shall be sent to NA within thirty business days of the initial confirmation of the OOS.

 

7.                                      COMPLAINTS

 

7.1                                 NA will receive and summarize all customer complaints in accordance with the regulations. Product complaints will be forwarded to the Contractor for evaluation and investigation. The Contractor will provide NA all appropriate and reasonable technical assistance necessary to respond to a complaint. Following investigation, the Contractor will summarize the investigation and provide within 60 days a report to NA. NA will provide a response to the complainant and provide a summary back to the Contractor. Within three working days of receipt, NA will promptly communicate to the Contractor, product complaint reports that may require reporting to the regulatory authorities. The Contractor has sole responsibility for determining when a regulatory authority must be notified of the results of a Product complaint.

 

8.                                      RECALL

 

8.1                                 The Contractor will maintain a procedure for handling product recalls.

 

8.2                                 NA has the responsibility to provide any data or information that could result in Product recall within an appropriate time frame. The Contractor will evaluate all information and has sole responsibility for the decision to recall any Product lot.

 

8.3                                 NA will provide to the Contractor any information required to perform a Product recall.

 

32

 

9.                                      ANNUAL PRODUCT REVIEW

 

9.1                                 Each year the Contractor will conduct an Annual Product Review, which will minimally contain for each Product manufactured:

 

9.1.1                        Total number of batches made, number of batches released, number of batches rejected, and number of batches recalled.

 

9.1.2                        A review and summary of customer complaints.

 

9.1.3                        A listing and discussion of any recalls.

 

9.1.4                        A listing and discussion of any changes.

 

9.1.5                        A listing and discussion of stability data.

 

9.1.6                        Overall discussion, evaluation and conclusions.

 

10.                               AUDITS

 

10.1                           NA may schedule periodic audits of the Contractor’s facilities. If requested, access for additional Product specific audits will be granted.

 

10.2                           NA shall have the right to visit the Contractor’s plant where the Product is manufactured on any business day upon reasonable prior notice to Contractor. During any such visit, NA shall have the right to audit the Contractor’s manufacturing and quality control procedures, records, reports, and facilities as well as any regulatory correspondence applicable to the Product to ensure that the Contractor complies with the Product registration and with Good Manufacturing Practices.

 

11.                               INSPECTIONS/LEGAL ACTIONS

 

11.1                           The Contractor shall notify NA of regulatory agency inspection results and/or legal actions

 

33

 

that impact the Product.

 

12.                               SUPPLIER QUALIFICATIONS

 

12.1                           The Contractor will maintain a formal supplier qualification and management program.

 

13.                               TRAINING

 

13.1                           Each person engaged in the manufacturing, processing, packing, or holding of the drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in current applicable manufacturing regulations as they relate to the employee’s functions. Training in applicable manufacturing regulations shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with requirements applicable to them.

 

14.                               VALIDATIONS

 

14.1                           The Contractor must maintain a formal validation program for:

 

14.1.1                Facilities 

 

14.1.2                Equipment 

 

14.1.3                Methods 

 

14.1.4                Cleaning

 

14.1.5                  Process

 

34

 

14.2                           Validations may be prospective, concurrent or retrospective but in all cases, critical parameters and acceptance criteria will be documented.

 

The following is a listing of BMS Pharmaceuticals, Medical Imaging, Quality Department contacts.

 

·                  Dennis M. Brown, Vice President, Quality, (978) 671-8499

·                  William D. Mann, Director, Quality Assurance (978) 671-8375

 

35

 

EXHIBIT F

 

List of NA Accounts on the Effective Date of This Agreement

 

·                  ****

·                  ****

·                  ****

 

36Exhibit 10.27

 

CONFIDENTIAL TREATMENT REQUESTED

 

INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND NOTED WITH “****”.
 PAGES 26 – 33 IN EXHIBIT 1.1(Q)
 HAVE BEEN OMITTED AND NOTED WITH “****” BASED ON A
 REQUEST FOR CONFIDENTIAL TREATMENT.

AN UNREDACTED VERSION OF THIS DOCUMENT HAS ALSO BEEN PROVIDED TO THE
 SECURITIES AND EXCHANGE COMMISSION.

 

	
CONFIDENTIAL
  	
 
  	
EXECUTION COPY
  

 

MANUFACTURING AND SUPPLY AGREEMENT

 

This Manufacturing and Supply Agreement (this “Agreement”), dated as of April 6, 2009 (the “Effective Date”), is hereby entered into by and between Lantheus Medical Imaging, Inc., a corporation organized and existing under the laws of Delaware with its principal place of business at 331 Treble Cove Road, North Billerica, MA 01862 (“LMI”), and Mallinckrodt Inc., a corporation organized and existing under the laws of Delaware with a place of business at 675 McDonnell Blvd., Hazelwood, MO 63042, and its Affiliates, as applicable (“COV”). LMI and COV are referred to herein individually as a “Party” and collectively as the “Parties”.

 

RECITALS

 

WHEREAS, COV is experienced in the manufacture and supply of contrast imaging agents, including the gadolinium-based contrast agent currently identified by the trademark VasovistTM (the “Base Product”), which has been approved by the FDA (as hereinafter defined) for use in certain indications in the field of magnetic resonance imaging;

 

WHEREAS, LMI has acquired all rights in and to the manufacturing and commercialization of the Product in the Territory (as hereinafter defined) from EPIX Pharmaceuticals, Inc. (“EPIX”);

 

WHEREAS, LMI desires that COV manufacture the Product for and supply the Product to LMI on the terms and conditions set forth in this Agreement; and

 

WHEREAS, COV has experience manufacturing and formulating the Product pursuant to that certain Manufacturing and Supply Agreement, dated June 9, 2000, as amended by the First Amendment to Manufacturing and Supply Agreement, dated as of September 11, 2006, by and between COV and Bayer Schering Pharma AG, a German corporation, which was formerly known as Schering Aktiengesellschaft (such corporation being hereinafter referred to as “Bayer/Schering”); and

 

WHEREAS, COV is willing to manufacture the Product for and supply the Product to LMI on the terms and conditions set forth in this Agreement;

 

NOW, THEREFORE, in consideration of the mutual covenants and agreements contained herein, the Parties, intending to be legally bound, hereby agree as follows:

 

1.                                       DEFINITIONS

 

1.1                                 Defined terms. As used herein, the following terms shall have the following meanings:

 

(a)                                  “Affiliate” means any corporation or other entity which controls, is controlled by, or is under common control with, a Party to this Agreement. A corporation or other entity shall be regarded as in control of another corporation or entity if it owns or

 

 

directly or indirectly controls more than fifty percent (50%) of the voting stock or other ownership interest of the other corporation or entity, or if it possesses, directly or indirectly, the power to direct or cause the direction of the management and policies of the corporation or other entity or the power to elect or appoint fifty percent (50%) or more of the members of the governing body of the corporation or other entity.

 

(b)                                 “Batch” means a specific quantity of Product that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.

 

(c)                                  “cGMPs” means the current good manufacturing practices required by the FDA pursuant to 21 CFR Parts 210 and 211 and ICH Q7, each as amended from time to time.

 

(d)                                 “CMC” means (i) manufacturing process development for Drug Substance, Ligand Excipient and all presentations of Product; (ii) all chemistry, manufacturing and control procedures necessary for the manufacturing, testing and quality control release of Drug Substance, Ligand Excipient and all presentations of the Product; and (iii) sourcing and testing of all raw materials and components used in the production of Drug Substance, Ligand Excipient, and all presentations of Product.

 

(e)                                  “Calendar Quarter” means any period of three consecutive calendar months commencing with the first day of any January, April, July, or October.

 

(f)                                    “DMF” means a Drug Master File as described in 21 CFR 14.420.

 

(g)                                 “Drug Substance” means the pharmacologically active drug substance whose chemical name is ****, and which is also known by the code name MS-32520-R, in bulk chemical form, which can be used to manufacture Unlabeled Vials and Product pursuant to the Product NDA.

 

(h)                                 “FDA” means the United States Food and Drug Administration or any successor entity thereto.

 

(i)                                     “Intellectual Property” means all right, title and interest in or relating to intellectual property, whether protected, created or arising under the laws of the United States or any other jurisdiction in the Territory, including: (i) all patents and applications therefor, including all continuations, divisionals, and continuations-in-part thereof and patents issuing thereon, along with all reissues, reexaminations and extensions thereof (collectively, “Patents”); (ii) all copyrights and all mask work, database and design rights, whether or not registered or published, all registrations and recordations thereof and all applications in connection therewith, along with all reversions, extensions and renewals thereof; (iii) all trade secrets; and (iv) all other intellectual property rights arising from or relating to Technology.

 

(j)                                     “Ligand Excipient” means the excipient whose chemical name is ****, in

 

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bulk chemical form, which can be used to manufacture Unlabeled Vials and Product pursuant to the Product NDA.

 

(k)                                  “Lot” means a Batch, or a specific identified portion of a Batch.

 

(1)                                  “Producer Price Index” or “Index” or “PPI” means the ****, published by the United States Department of Commerce. In the event that publication of the Producer Price Index is discontinued, the Parties will agree on an appropriate substitute index that is substantially similar in substantive coverage.

 

(m)                               “Product” means the final finished dosage form presentations of Vasovist (or such other name as LMI may choose to use in the Territory) manufactured from the Drug Substance and Ligand Excipient pursuant to the Product NDA, tested, released, and suitable for distribution in commerce in the Territory without further processing or packaging. The Product sizes will be 10 mL and 15 mL glass vials.

 

(n)                                 “Product NDA” means the New Drug Application filed with the FDA for the Product pursuant to the federal Food, Drug and Cosmetic Act and the regulations promulgated thereunder, and any amendments or Supplemental New Drug Applications thereto, or documents incorporated by reference.

 

(o)                                 “Quality Agreements” means the agreements described in Section 5.7.

 

(p)                                 “Raw Materials” means ****

 

(q)                                 “Specifications” means the written specifications for the Product, Drug Substance and Ligand Excipient, respectively, attached hereto as Exhibit 1.1(q), as the same may be amended from time-to-time pursuant to the provisions of Section 2.8.

 

(r)                                    “Technology” means, collectively, all information, designs, formulae, algorithms, procedures, methods, techniques, ideas, know-how, research and development, technical data, programs, subroutines, tools, materials, specifications, processes, inventions (whether patentable or unpatentable and whether or not reduced to practice), apparatus, creations, improvements, works of authorship and other similar materials, and all recordings, graphs, drawings, reports, analyses, and other writings, and other tangible embodiments of the foregoing, in any form whether or not specifically listed herein, and all related technology, that are used in, incorporated in, embodied in, displayed by or relate to, or are used in connection with the foregoing.

 

(s)                                  “Territory” means (i) the United States of America, including the states thereof, the District of Columbia and the Commonwealth of Puerto Rico, but excluding each of its other territories, (ii) Canada and (iii) Australia. Additional countries or regions may be added to the Territory upon mutual written agreement of the Parties.

 

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(t)                                    “Term” shall have the meaning set forth in Section 3.1 of this Agreement.

 

(u)                                 “Unlabeled Vials” means the Base Product fully manufactured and packaged into glass vials or other primary glass packaging described in the Product NDA, tested, and released but without commercial or clinical labels or labeling.

 

1.2                                 Interpretation. References in this Agreement to the singular include references to the plural and vice versa. Unless the context otherwise requires, references in this Agreement to Articles, Sections, and Exhibits shall be deemed references to Articles and Sections of, and Exhibits to, this Agreement. Unless the context otherwise requires, the words “hereof”, “hereby” and “herein” and words of similar meaning when used in this Agreement refer to this Agreement in its entirety and not to any particular Article, Section or provision of this Agreement. Any reference to any federal, state or local statute or law shall be deemed also to refer to all rules and regulations promulgated thereunder, unless the context requires otherwise.

 

2.                                       PRODUCT MANUFACTURE: SUPPLY; TERMS

 

2.1                                 Purchase and Sale.

 

(a)                                  COV (or any appropriately licensed and qualified Affiliate, approved in advance by writing by LMI, such approval not to be unreasonably withheld or delayed) shall manufacture, sell and deliver to LMI, and LMI shall purchase from COV, the Product on the terms and conditions and in the quantities set forth in this Agreement.

 

(b)                                 The Parties anticipate that LMI will generally purchase Product, but not Drug Substance or Ligand Excipient, during the Term. If LMI desires at any time during the Term to purchase Drug Substance or Ligand Excipient, it shall notify COV through the forecasting and ordering procedures set forth in Section 2.4(a); provided that any order for Drug Substance or Ligand Excipient (i) for less than **** kg of Drug Substance or Ligand Excipient will require no more than six (6) months’ prior written notice from LMI to COV and (ii) for **** kg or more of Drug Substance or Ligand Excipient will require no more than twelve (12) months prior written notice from LMI to COV. LMI will not order more than **** kg of Drug Substance and Ligand Excipient, in the aggregate, during the Term.

 

2.2                                 Existing Drug Substance and Ligand Excipient at COV. As of the Effective Date, COV has inventories of Drug Substance and Ligand Excipient as set forth on Exhibit 2.2. The following provisions shall apply with respect to these materials:

 

(a)                                  Subject to and upon successful completion of the re-testing contemplated by Section 2.2(c), COV will sell usable Drug Substance and Ligand Excipient as set forth on Exhibit 2.2, which (i) has not yet expired or (ii) has expired but passes re-testing, to LMI, and LMI will  purchase such materials from COV, for the amount of **** Dollars ($****) per kilogram of either Drug Substance or Ligand Excipient. COV will invoice LMI for the amount of the purchase price payable for such Drug Substance and Ligand Excipient and LMI will pay such invoice in accordance with the provisions set forth in Section 2.6 below.

 

4

 

(b)                                 On or before the later of (A) July 1, 2009, and (B) sixty (60) days after receipt by COV from LMI of all required packaging information, artwork and materials (as provided for in Section 2.9), COV will formulate the Drug Substance and Ligand Excipient referred to in Section 2.2(a) and which passed re-testing, into Product for a fee of **** Dollars ($****) per vial, and deliver such resulting Product to LMI. COV will fill approximately **** percent (****%) of this Base Product in 10 mL vials, and **** percent (****%) of this Base Product in 15 mL glass vials. LMI will provide COV with not less than one hundred twenty (120) days prior written notice of any anticipated change in this ratio. COV will invoice LMI concurrent with shipment for the amount payable under this provision and LMI will pay such invoice in accordance with the provisions set forth in Section 2.6 below.

 

(c)                                  LMI acknowledges that the materials set forth on Exhibit 2.2 will require re-testing by COV in order to assess their continuing compliance with applicable Specifications for use in formulating Product. The protocol for such re-testing shall be mutually agreed upon by the Parties. COV will not have any liability or other financial exposure for materials that fail testing under these provisions (it being agreed that LMI will not be obligated to purchase such materials which failed testing), nor will COV have any obligation to manufacture Product in replacement thereof, unless otherwise agreed to by the Parties in writing.

 

2.3                                 Existing Product and Drug Substance at Bayer/ Schering. As of the Effective Date, Bayer/Schering has existing inventories of Base Product and Drug Substance as set forth on Exhibit 2.3 to this Agreement, reflecting Base Product and Drug Substance, respectively, that it previously purchased from COV under the Manufacturing and Supply Agreement referenced in the recitals to this Agreement.

 

(a)                                  Existing Inventory of Base Product. The following provisions shall apply with respect to this existing inventory of Base Product held by Bayer/Schering:

 

(i)                                     LMI will, in its discretion, purchase the existing inventory of Base Product held by Bayer/Schering from Bayer/Schering and will, at LMI’s cost and risk of loss, deliver or cause such Base Product to be delivered to COV at such location as COV directs in writing.

 

(ii)                                  Within thirty (30) business days after receiving the existing inventory of Base Product held by Bayer/Schering from Bayer/Schering, COV will test this Base Product for continuing conformance with the applicable Specifications. The protocol for such testing shall be mutually agreed upon by the Parties. LMI will reimburse COV for such testing in an amount equal to COV’s actual reasonable testing costs (including employee time) plus **** percent (****%). If any  such Base Product fails testing, COV will promptly notify LMI with a description of the basis for such failure. Upon receipt of such notice, LMI will (i) promptly arrange for the disposal of or (ii) request that COV ship to such location as LMI shall designate in writing any Base Product that failed to meet Specifications. COV will not have any liability or other financial exposure for Base Product that fails testing under these provisions, nor will COV have any obligation (i) for the cost and expense of disposal or shipment of such

 

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Base Product or (ii) to manufacture Product in replacement thereof, unless otherwise agreed to by the Parties in writing.

 

(iii)                               On or before the later of (A) July 1, 2009, or (B) sixty (60) days after receipt by COV from LMI of both (1) the Base Product currently held by Bayer/Schering and (2) all required packaging information, artwork and materials (as provided for in Section 2.9), COV will complete labeling, packaging and final release testing for the existing inventory of Base Product acquired from Bayer/Schering, and deliver such resulting Product to LMI, for a fee of **** Dollars ($****) per vial. COV will invoice LMI concurrent with shipment for the amount payable under this provision and LMI will pay such invoice in accordance with the provisions set forth in Section 2.6 below.

 

(iv)                              The Parties acknowledge that any Product and/or Base Product described in this Section 2.3(a) will continue to bear the same shelf life as presently pertains to such Product and/or Base Product (i.e., the existing shelf life of these vials will not change).

 

(b)                                 Existing Inventory of Drug Substance. The following provisions shall apply with respect to this existing inventory of Drug Substance held by Bayer/Schering:

 

(i)                                     Within thirty (30) days after receiving the Drug Substance described on Exhibit 2.3, COV will test this Drug Substance for continuing conformance with the applicable Specifications. The protocol for such testing shall be mutually agreed upon by the Parties. LMI will reimburse COV for such testing in an amount equal to COV’s actual reasonable testing costs plus **** percent (****%). If any such Drug Substance fails testing, COV will promptly notify LMI with a description of the basis for such failure. Upon receipt of such notice, LMI will (i) promptly arrange for the disposal of or (ii) request that COV ship any Drug Substance that failed to meet Specifications to a destination specified by LMI. COV will not have any liability or other financial exposure for Drug Substance that fails testing under these provisions, nor will COV have any obligation (i) for the cost and expense of disposal or shipment of such Drug Substance or (ii) to manufacture Drug Substance in replacement thereof, unless otherwise agreed to by the Parties in writing.

 

(ii)                                  On or before the later of (A) October 1, 2009 or (B) sixty (60) days after receipt by COV from LMI of both (1) the Drug Substance currently held by Bayer/Schering and (2) all required packaging information, artwork and materials (as provided for in Section 2.9), COV will formulate **** percent (****%) of the existing Drug Substance acquired from Bayer/Schering that successfully passes testing, as described above, into Base Product for a fee of **** Dollars ($****) per vial (either 10 mL and/or 15 mL glass vials), and deliver such resulting Base Product to LMI. On or before the later of (A) December 31, 2009 or (B) sixty (60) days after receipt by COV from LMI of both (1) the Drug Substance currently held by Bayer/Schering and (2) all required packaging information, artwork and materials (as provided for in Section 2.9), COV shall formulate the remaining **** percent (****%) of the existing Drug Substance acquired from Bayer/Schering that successfully passes testing, as described

 

6

 

above, into Base Product for a fee of **** Dollars ($****) per vial (either 10 mL and/or 15 mL glass vials), and deliver such resulting Base Product to LMI. In each instance, COV will fill approximately **** percent (****%) of this Base Product in 10 mL vials, and **** percent (****%)  of this Base Product in 15 mL glass vials. LMI will provide COV with not less than one hundred twenty (l20) days prior written notice of any anticipated change in this ratio. COV will invoice LMI concurrent with shipment for the amount payable under this provision and LMI will pay such invoice in accordance with the provisions set forth in Section 2.6 below.

 

2.4                                 Newly-Manufactured Drug Substance, Product and Ligand Excipient. COV will manufacture and supply Drug Substance, Product and Ligand Excipient to LMI, and LMI will purchase Drug Substance, Product and Ligand Excipient, in accordance with the schedule attached hereto as Exhibit 2.4. The following provisions shall apply with respect to these materials:

 

(a)                                  Forecasts; Orders. (i) As soon as practicable following the execution of this Agreement, but no later than the submission of LMI’s initial purchase order for newly-manufactured product pursuant to Section 2.4(b), LMI shall send to COV LMI’s initial forecast by Calendar Quarter of the volume of Product (indicating the presentation desired), and for Drug Substance and/or Ligand Excipient (if any), which LMI expects to have delivered from COV during the four (4) Calendar Quarters commencing July 1, 2010. Each forecast submitted by LMI must reflect not less than the Minimum Volumes of Product as shown for each Calendar Quarter on Exhibit 2.4 to this Agreement. LMI shall thereafter update each such forecast on a quarterly basis, providing COV with a rolling **** (****) month forecast of its requirements for Product, and for Drug Substance and/or Ligand Excipient (if any). It is understood that, except for the first Calendar Quarter of each forecast and subject to LMI’s obligation to purchase the Minimum Volumes of Product for each Calendar Quarter as described in Section 2.4(c), this forecast will not be binding on the Parties. In addition, and having regard for the forecast hereinabove referred to and the Minimum Volume obligation described in Section 2.4(c), at least three (3) months prior to the beginning of each Calendar Quarter, commencing with the Calendar Quarter beginning July 1, 2010, LMI will furnish COV with purchase orders for the volume of Product (including the presentations desired), and for Drug Substance and /or Ligand Excipient (if any), which LMI shall purchase, and which COV shall deliver, during such quarter. The Parties anticipate that LMI will place orders for Product at a ratio of **** percent (****%) for 10 mL vials and **** percent (****%) for 15 mL vials, which percentages will be confirmed for each individual purchase order. LMI will provide COV with not less than one hundred twenty (120) days prior written notice of any anticipated change in this ratio.

 

(b)                                 Initial Order. LMI will submit its initial purchase order for newly-manufactured Product (which shall comply with LMI’s Minimum Volume purchase requirement as described in Section 2.4(c)), Drug Substance and/or Ligand Excipient (if any) to COV, in writing, not later than January 1, 2010. LMI shall provide all applicable artwork and labeling with respect to the initial order of Product, as provided for in Section 2.9, to COV not later than March 31, 2010.

 

7

 

(c)                                  Minimum Purchase Requirement. Notwithstanding anything to the contrary set forth in this Agreement, each forecast and purchase order submitted by LMI must not be less than the Minimum Volumes of Product as shown for each Calendar Quarter on Exhibit 2.4 to this Agreement. COV will use commercially reasonable efforts to accommodate any increase in quantities of Product ordered by LMI; provided, that LMI will communicate any such increased orders to COV not less than six (6) months prior to the Calendar Quarter in which delivery of such additional Product is requested.

 

(d)                                 Rejection of Orders. COV shall use commercially reasonable efforts to accept each purchase order and confirm the date of shipment within ten (10) business days of receipt thereof; provided, however, that COV may refuse confirmation of a purchase order and/or the requested delivery date if and to the extent that:

 

(i)                                     the purchase order is for quantities of Product for which an appropriate forecast and order were not submitted in accordance with the foregoing provisions of this Section 2.4;

 

(ii)                                  the purchase order otherwise fails to comply with the terms and conditions of this Agreement; or

 

(iii)                               COV cannot meet the requested delivery date as a result of a Force Majeure Event.

 

(e)                                  Prices. Pricing for Drug Substance, Product and Ligand Excipient supplied by COV under this Section 2.4 shall be as follows:

 

·                       Drug Substance: $**** / kg

·                       Ligand Excipient: $**** / kg

·                       Product (10 mL vial): $****/vial for 2010, $ **** for 2011 and 2012

·                       Product (15 mL vial): $****/vial for 2010, $ **** for 2011 and 2012

 

On each (anniversary of the Effective Date (“Measurement Date”), COV shall invoice LMI for the amount, if any, by which the aggregate cost of the Raw Materials utilized by COV in manufacturing Drug Substance, Ligand Excipient and Product under this Agreement during the 12-month period then ending has increased by a percentage that exceeds the increase in the Producer Price Index for the same time period. The calculation of the increase of the Producer Price Index shall be based on the difference between the most recently available Producer Price Index on the Effective Date and on each Measurement Date thereafter for the duration of the Term. LMI will pay any invoice submitted by COV under this provision within **** (****) days of receipt.

 

(f)                                    Pre-payment of Cost of Intermediates. Effective as of the first day of each Calendar Quarter beginning April 1, 2010, and continuing for the remainder of the Term, LMI will pay COV an amount equal to (i) $**** / kg multiplied by (ii) the quantity of Drug Substance and Ligand Excipient required to be used by COV in the formulation of Product that is scheduled for delivery in the next following Calendar

 

8

 

Quarter. For purposes of example only, the amount owed by LMI on April 1, 2010, would be determined by reference to the quantity of Product scheduled for delivery by COV to LMI in the Calendar Quarter beginning July 1, 2010. The amount of each pre-payment will be deducted from the amount payable by LMI upon actual delivery of the corresponding Product.

 

(g)                                 Superiority of Agreement. The terms of this Agreement and of the Quality Agreements shall prevail over any inconsistent terms in any purchase order, acknowledgment or invoice, and no additional terms other than those set forth in this Agreement and the Quality Agreements or allowed pursuant to the terms of this Section 2.4 in a purchase order, acknowledgement or invoice shall be binding on either Party.

 

2.5                                 Delivery.

 

(a)                                  Schedule; Quantities. COV  will ship, and LMI will take delivery, of all newly-manufactured Drug Substance, Product and Ligand Excipient on or about the first business day of the corresponding Calendar Quarter for which delivery is specified in Exhibit 2.4. Product provided for in Sections 2.2 and 2.3 of this Agreement will be delivered at the times specified in such Sections. Volumes supplied by COV will have a variance of plus or minus five percent (5%); invoices will reflect actual quantities delivered. COV agrees to provide LMI with thirty (30) days advance notice in the event COV is unable to supply the volumes of Drug Substance, Product and Ligand Excipient as specified in this Agreement or in each relevant purchase order.

 

(b)                                 Terms of Delivery. Delivery terms shall be ****’s manufacturing facility (which shall be either **** in **** or ****), at which time risk of loss and responsibility for Product, Drug Substance and/or Ligand Excipient will transfer to LMI, but not in the event of deliveries between COV facilities. COV shall ship the Product, Drug Substance or Ligand Excipient using COV’s designated carrier in accordance with LMI’s instructions regarding destination, delivery date, temperature control and such other factors as LMI reasonably believes are relevant for purposes of the delivery. COV shall ship all Product, Drug Substance or Ligand Excipient to one location designated by LMI.

 

2.6                                 Payment Terms.

 

(a)                                  Terms. All payments to be made by LMI or credits to be issued to LMI under this Agreement shall be made within **** (****) days after the date of receipt of the corresponding invoice. Such payments shall be made in U.S. dollars by wire transfer as designated by COV or LMI, as applicable, or by such other method as COV or LMI shall reasonably designate from time to time. In no event shall LMI be responsible for any payments related to Drug Substance, Ligand Excipient and Product for which COV was unable to satisfy its obligations under this Agreement, whether by Force Majeure Event or otherwise.

 

(b)                                 Late Payment. Interest shall be payable on all amounts not paid on the due date at a rate of 1% for each whole or partial month the amounts remain unpaid.

 

9

 

(c)                                  Taxes. LMI will reimburse COV for all tariffs, duties and excise, sales or use, value added or other taxes or levies (collectively, “Taxes”) that may be paid by COV with respect to the sale to LMI of Drug Substance, Ligand Excipient and Product under this Agreement. The parties shall work together to minimize any such Taxes. For the avoidance of doubt, LMI will have no reimbursement obligations under this Section to the extent that Taxes are based on COV’s net income.

 

2.7                                 Technology Transfer. During the Term, LMI shall have the right to qualify itself, or an Affiliate or third party as a manufacturer of Drug Substance, Ligand Excipient or Product, and to seek and obtain regulatory approval of such manufacturing site or sites. If LMI desires to exercise its rights in this Section 2.7, LMI shall notify COV of such decision in writing, specifying the Technology to be transferred (“Technology Transfer Notice”). Upon receipt of such Technology Transfer Notice, the Parties will agree in good faith upon a schedule for commencement and completion of the Technology transfer, which in no event will continue for a period of more than **** (****) months. COV shall only be required on one occasion during the Term to make a Technology transfer for each component or process hereunder (e.g., Drug Substance manufacture, Product formulation, Product packaging, etc.). Any transfer of Technology under this provision will be pursuant to a protocol established by LMI and shall include the delivery of all documents required to carry out the Technology transfer. Subject to the immediately preceding limitations, at the reasonable request of LMI, COV will provide LMI with reasonable assistance in effecting a Technology transfer (including laboratory methods) at the rate of **** Dollars ($****) per employee hour, plus reimbursement of COV’s out-of-pocket costs. No in-field work will be required of COV personnel in connection with a Technology transfer.

 

2.8                                 Specifications Ex-United States; Change in Specifications.

 

(a)                                  Ex-United States. Before placing purchase orders for any Drug Substance, Ligand Excipient and/or Product for sale or distribution in any country within the Territory other than the United States, LMI will ensure that the Specifications in such country are identical to the Specifications as are then in effect in the United States.

 

(b)                                 Changes. LMI shall have the right (subject to obtaining approval of the FDA and any other applicable regulatory authority), to change, on a country-by-country basis, with COV’s consent, which shall not be unreasonably withheld and upon six (6) months’ advance written notice to COV, the Specifications and/or the package size, packaging configuration, label design and content in which or with which it chooses to have COV deliver the Product; provided, however, that (i) any change which COV is reasonably able to implement in less than six (6) months shall be implemented within the time period agreed upon by the Parties, and (ii) any such change occasioned by the requirements of law, safety considerations, or the request of FDA or other applicable regulatory authority, shall be implemented as soon as possible. In the event of any change described above, (A) COV shall assist LMI in accomplishing the same; (B) inventory of obsolete materials and reasonable disposal costs thereof shall be charged to LMI, (C) funding for capital improvements specifically required by the change (and which COV would not undertake

 

10

 

 

but for the change in Specifications), subject to
LMI’s prior approval therefor, shall be provided by LMI, and (D) any other
incremental cost incurred as a consequence of such change shall be for the
account LMI. The Parties acknowledge that any change in Specifications will
result in a corresponding delay in the delivery by COV of Product under this
Agreement.

 

2.9          Packaging Information. LMI shall provide COV with all packaging
and labeling information and designs, including without limitation, all art work
and pharmacological information, usage instructions and warnings to be applied
to each Product at least sixty (60) days in advance of any requirement that
Product be delivered in packaged form to enable COV to obtain the necessary
packaging materials and meet such delivery requirements. LMI will be fully
responsible and liable for the content and format of all labeling and artwork
used in connection with the supply of Product hereunder. COV shall be solely
responsible for ensuring that the content and format of all labeling and
artwork used in connection with the supply of the Product, Drug Substance or
Ligand Excipient, as provided by LMI, are accurately and consistently produced
in accordance with the Specifications. The Parties shall cooperate to ensure
that all packaging and labeling information and materials are compatible with
COV’s equipment and specifications. LMI will reimburse COV for COV’s
out-of-pocket costs in obtaining plates and related supplies necessary for the
printing of packaging information as described herein, and upon termination
hereof, such plates shall become the property of LMI. LMI agrees to reimburse
COV to the extent COV incurs additional costs and expenses arising from any
changes requested by LMI to the packaging, labeling information and designs to
be applied to each Product as necessary for the distribution of the Product in
Canada, Australia or any additional countries as the Parties mutually agree.

 

2.10        Changes in
Manufacturing Processes. COV reserves the right to implement reasonable process changes and
improvements during the Term but in all instances subject to LMI’s prior
written approval. COV agrees to notify LMI promptly of any such change or
improvement. If any such change or improvement requires, in COV’s reasonable
judgment, regulatory approval, COV will provide drafts of the proposed
filing(s) to LMI for review and LMI will provide its approval or comments
within thirty (30) days from the date of receipt. LMI will in all events
reasonably cooperate with COV in effecting any process changes or improvements
reasonably requested by COV.

 

3.           TERM; TERMINATION

 

3.1          Term; Renewal. This Agreement shall commence on the
Effective Date and unless terminated sooner in accordance with the terms and
conditions hereof shall continue in effect until September 30, 2012 (such
period being referred to in this Agreement as the “Term”). This Agreement may
be extended for an additional term only in accordance with the mutual written
agreement of the Parties.

 

3.2          Termination by Mutual Agreement.
This Agreement
may be terminated by mutual written agreement of COV and LMI at any time.

 

3.3          Termination for Cause. This Agreement may be terminated by a
Party as follows:

 

11

 

(a)           If a Party institutes for
its protection or is made a defendant in any proceeding under bankruptcy,
insolvency, reorganization or receivership law, or such Party is placed in
receivership, makes an assignment for benefit of creditors or is unable to meet
its debts in the regular course of business, the other Party may elect to
terminate this Agreement immediately by written notice to the first Party
without prejudice to any right or remedy the other Party may have, including
damages for breach.

 

(b)           In the event that a Party
materially defaults under or materially breaches any of the provisions of this
Agreement or the Quality Agreements, the other Party shall have the right to
terminate this Agreement upon sixty (60) days’ prior written notice, unless
such material default or breach is cured during such sixty (60) day period (or
in the event any breach is incapable of being cured in such time period, the
other Party presents a plan to attempt cure of such breach and prevent similar
breaches, which plan is reasonably acceptable to the terminating Party), in
which event this Agreement shall continue in full force and effect.

 

(c)           If LMI is the Party with the
right to terminate this Agreement in accordance with Sections 3.3(b) due
to the uncured material breach of COV, LMI shall have the option to delay the
termination and continue to have COV supply LMI under this Agreement upon
written notice to COV detailing the same, until such time as the Technology
transfer described in Section 2.7 is complete and LMI has qualified and
obtained regulatory approval for itself, an Affiliate or a third party as
manufacturer of Drug Substance, Ligand Excipient and Product. COV shall be
responsible for any costs or expenses reasonably incurred by LMI as a result of
COV’s breach.

 

(d)           If COV is the Party with the
right to terminate this Agreement in accordance with Section 3.3(b) due to
an uncured material breach of LMI, LMI shall continue to make all payments
associated with the Minimum Volume purchase requirements for the remainder of
the Term.

 

3.4          Effect of Expiration or
Termination; Accrued Rights; Surviving Obligations. Upon any
expiration or termination of this Agreement:

 

(a)           Product
and Intermediates on Hand. COV shall notify LMI of the
amount of Product, Drug Substance, Ligand Excipient and intermediates it has on
hand as of the effective date of any termination or expiration as a result of
purchase orders placed by LMI, and LMI shall purchase such Product, Drug
Substance, Ligand Excipient and intermediates at the applicable price as set
forth in this Agreement (or at COV’s cost with respect to intermediates), but
LMI shall not be required to purchase any Product, Drug Substance, Ligand
Excipient or intermediates (i) that fails to meet Specifications, (ii) for
which COV is unable to provide the certificates of analysis specified in
Section 5.4 of this Agreement, (iii) for which COV is unable to
provide the certificates of manufacturing compliance specified in Section 5.5,
or (iv) that is appropriately rejected by LMI pursuant to Section 5.6.

 

(b)           Regulatory
Information. On and as of the effective date of any termination
or expiration, or such earlier date as LMI may reasonably request prior to an
upcoming

 

12

 

termination or expiration, COV shall, promptly
transfer to LMI or its nominee all information and Technology in COV’s
possession and used in connection with the manufacture of the Product, Drug
Substance and Ligand Excipient, all information and Technology relevant to
specific methods of Product, Drug Substance and Ligand Excipient manufacture or
Product characterization, all information relevant to obtaining an FDA
regulatory approval and any other applicable regulatory approval of the
Product, all information contained in COV’s regulatory submissions in
connection with the development and approval of the Product, and all other
information relating to the manufacture of the Product, Drug Substance and
Ligand Excipient, which is useful to enable LMI or a third party to manufacture
and obtain regulatory approval for the Product for commercial sale. LMI and its
nominees may only use any information or Technology received pursuant to this
Section 3.4(b) in connection with the Product.

 

(c)           Orders in
Progress. In the event of any termination or expiration of
this Agreement, COV shall, unless such termination has occurred because of a
material uncured default by LMI under this Agreement, notwithstanding the
effective date of any termination or expiration, complete any purchase orders
for Product, Drug Substance or Ligand Excipient that were placed by LMI and
accepted by COV prior to such date and LMI shall pay COV for any Product, Drug
Substance or Ligand Excipient produced in accordance with such purchase orders
at the applicable price as set forth in this Agreement.

 

(d)           Post-Termination
Acceptance of Orders. Any acceptance by COV of any purchase order
from LMI or the sale of any Products by COV to LMI after the delivery of notice
of termination or after the expiration or termination of the Term shall not be
construed as a renewal or extension of this Agreement or as a waiver of
termination thereof.

 

(e)           Prior
Obligations. Termination or expiration of this Agreement, in
whole or in part, for any reason shall be without prejudice to any rights which
shall have accrued to the benefit of either Party prior to such termination or
expiration, and such termination or expiration shall not relieve either Party
from obligations which are expressly indicated to survive termination or
expiration of the Term.

 

4.             REGULATORY
ISSUES.

 

4.1          Regulatory Obligations. All obligations
relating to the Product NDA and DMF shall, at all times during the Term, remain
with LMI, including without limitation (A) the obligation to prepare and
make any updates or amendments to the Product NDA, DMF or CMC, (B) to pay
any fees or other costs associated with such filings or otherwise relating to
the Product, or (C) to collect, investigate and report to the FDA and
other appropriate regulatory authorities any Product-related adverse drug
experience reports, quality reports, and complaint reports. COV shall provide
LMI with access to any such information reasonably required to enable LMI to
comply with its obligations under this Section 4.1. COV shall remain
solely responsible at its expense during the Term for compliance with (A) cGMPs
(including any comparable requirements imposed by foreign authorities, but
limited to those jurisdictions that are within the Territory as set forth in
any amendment to this Agreement); (B) obtaining or

 

13

 

maintaining establishment registrations and all other required permits
and licenses for all relevant facilities; and (C) the preparation and
submission of all records and reports required by FDA and other appropriate
regulatory authorities in connection with the manufacture and sale to LMI of
the Drug Substance, Ligand Excipient and Product.

 

4.2          Product Recalls.

 

(a)           If either Party reasonably decides or is required by
any government authority or court of competent jurisdiction, to initiate a
product recall, withdrawal or field correction with respect to, or if there is
any governmental seizure of, the Product, the Party initiating or required to
initiate such action will notify the other Party promptly of the details
regarding such action, including providing copies of all relevant documentation
concerning such action. The Parties will assist each other in investigating any
such situation and all regulatory contacts that are made and all activities concerning
seizure, recall, withdrawal or field correction will be jointly coordinated by
COV and LMI.

 

(b)           If any such recall, withdrawal, field correction or
seizure occurs due solely to (i) failure of any Product produced by COV
hereunder to conform to Specifications (including, without limitation, being
adulterated or misbranded) or any warranty or other requirement set forth in
this Agreement, (ii) the failure of COV to comply in all material respects
with any applicable law, rule, regulation, standard, court order or decree or
(iii) the negligent or intentional wrongful act or omission of COV in
connection with the production of Product hereunder, then COV shall bear the
full cost and expense of any such seizure, recall, withdrawal or field
correction and shall reimburse LMI for any purchase price payments made to COV
and related taxes to the extent related to such Product. If any such recall,
withdrawal, field correction or seizure occurs solely for any reason other than
that set forth in the immediately preceding sentence, then LMI shall bear the
full cost and expense of any such seizure, recall, withdrawal or field
correction. If both COV and LMI contribute to the cause of a seizure, recall,
withdrawal or field correction, the cost and expense thereof will be shared in
proportion to each Party’s contribution to the problem. For the purposes of
this Agreement, the expenses of any recall, withdrawal, field correction or
seizure shall include, without limitation, the out-of-pocket expenses of
notification and destruction or return of the recalled Product and all other
out-of-pocket costs incurred in connection with such recall, but shall not
include lost profits of either Party under any circumstances or any
administrative or overhead charge.

 

4.3          Sharing of Information. Each Party
shall promptly advise the other Party of any information of which it obtains
knowledge that may affect the safety, efficacy or labelling of the Products and
any actions in response to such information.

 

5.             WARRANTIES AND
QUALITY ASSURANCE

 

5.1          COV Warranties. COV warrants
that all Drug Substance, Ligand Excipient and Product delivered to LMI: (a) will
have been manufactured, packaged, labeled, tested and/or re-tested in
compliance with applicable provisions of the Federal Food, Drug and Cosmetic
Act (the “Act”), regulations thereunder, and any other comparable laws and
regulations applicable in the Territory, relating to manufacture and supply
under this Agreement, and in compliance with the

 

14

 

specific U.S. or other applicable regulatory approvals regarding the
Drug Substance, Ligand Excipient and/or Product; (b) shall conform to the
Specifications; and (c) will, at the time of such delivery, not be
adulterated within the meaning of the Act or other applicable law, as such Act
or law is constituted and effective at the time of delivery, and will not be an
article which may not, under the provisions of such Act, be introduced into
interstate commerce. Except for Product and/or Base Product described in Section 2.3(a),
at the time of delivery, the Product shall have a minimum shelf life of **** (****)
months.

 

5.2          LMI Warranties. LMI warrants
that the marketing, distribution and sale of the Products in the Territory
shall at all times comply with the Act and all other applicable laws, rules and
regulations.

 

5.3          DISCLAIMER
OF ALL OTHER WARRANTIES. THE WARRANTIES SET FORTH IN
THIS AGREEMENT ARE THE PARTIES’ ONLY WARRANTIES WITH RESPECT TO THE SUBJECT
MATTER OF THIS AGREEMENT AND ARE MADE EXPRESSLY IN LIEU OF ALL OTHER
WARRANTIES, EXPRESS OR IMPLIED, WHICH ARE HEREBY DISCLAIMED, INCLUDING ANY
IMPLIED WARRANTIES OF FITNESS FOR A PARTICULAR PURPOSE, MERCHANTABILITY, OR
OTHERWISE.

 

5.4          Certificates of Analysis. COV shall
perform, or cause to be performed, sample tests on each Lot or Batch of Drug
Substance, Ligand Excipient or Product supplied pursuant to this Agreement
before delivery to LMI, and shall produce a test report setting forth the
results of such testing. Each test report shall set forth, for each Lot or
Batch of Drug Substance, Ligand Excipient or Product delivered hereunder, the
items tested, specifications and test results in a certificate of analysis,
containing the types of information reasonably agreed upon by COV and LMI. COV
shall send such certificates to LMI concurrent with delivery of each Lot or
Batch of Drug Substance. In addition, if LMI orders Ligand Excipient or
Product, COV shall send such certificates to LMI concurrent with delivery of
these items.

 

5.5          Certificates
of Manufacturing Compliance. COV shall provide or cause
to be provided for each Lot or Batch of Drug Substance, Ligand Excipient or
Product purchased under this Agreement a certificate of manufacturing
compliance, containing the type of information reasonably agreed upon by COV
and LMI, which will certify that the Lot or Batch of Drug Substance, Ligand
Excipient or Product was manufactured in accordance with the Specifications and
cGMP, including without limitation 21 CFR 210 and 211 and ICH Q7, as the same
may be amended from time to time. COV agrees that it shall maintain all of the
facilities used for the manufacture of the Drug Substance, Ligand Excipient or
Product in accordance with all applicable FDA, state, local, and federal laws
and regulations and shall permit the FDA to inspect the manufacturing
facilities used for the manufacture of the Drug Substance, Ligand Excipient or
Product whenever deemed necessary by such regulatory agency. COV shall advise
LMI immediately if an authorized agent of the FDA visits any of COV’s
facilities where the Drug Substance, Ligand Excipient or Product is being
manufactured, or where any component of the Drug Substance, Ligand Excipient or
Product is manufactured, processed or controlled, or of any official contact
concerning the Drug Substance, Ligand Excipient or Product. COV shall furnish
to LMI the report by such agency of such visit to the extent that such report
relates to the Drug Substance, Ligand Excipient or Product, within (i) forty
eight (48) hours of COV’s receipt of such report if such report relates to
urgent matters such as Product recall, facility shutdown or

 

15

 

similar events (“Urgent Incident”) and (ii) five (5) business days
after COV’s receipt of such report for other matters. Upon reasonable advance
notice to COV, COV shall allow LMI and its consultants reasonable access during
normal business hours throughout the Term to any of COV’s facilities where the
Drug Substance, Ligand Excipient or Product is being manufactured, or where any
component of the Drug Substance, Ligand Excipient or Product is manufactured,
processed or controlled to verify compliance with COV’s obligations under this
Agreement; provided that such access shall be limited to once during any
consecutive twelve (12) months, except in the event of an Urgent Incident, in
which event COV shall allow LMI and its consultants reasonable access during
normal business hours as necessary to allow LMI to evaluate COV’s planned
response to the Urgent Incident.

 

5.6          Acceptance.

 

(a)           LMI shall have **** (****) days from the date of
receipt of both the shipment of Drug Substance, Ligand Excipient or Product and
the corresponding certificate of manufacturing compliance to confirm
conformance with the Specifications and to claim any shortage in quantity of
any shipment of the Drug Substance, Ligand Excipient or Product. Any notice of
rejection or shortage of any shipment of Drug Substance, Ligand Excipient or
Product must be given in writing, must contain a report of the reason for such
rejection or shortage and be received by COV within said **** (****) day period
or such shipment will be deemed to have been accepted; provided, however that
this limitation shall not apply to hidden defects, it being understood that in
that case LMI shall have **** (****) days from the date it becomes aware or reasonably
should have become aware of any hidden defect to reject any Drug Substance,
Ligand Excipient or Product in accordance with applicable terms and conditions
hereof. COV shall assist in necessary analytical Technology transfers to
accomplish such testing by LMI.

 

(b)           In the event of a rejection or shortage as set forth
in Section 5.6(a) above, upon LMI’s request, COV shall replace such
Drug Substance, Ligand Excipient or Product as soon as commercially
practicable, but in no event later than the following Calendar Quarter,
provided that if COV is unable to replace the rejected Drug Substance, Ligand
Excipient or Product within such time period, then LMI shall have the right to
recover such damages from COV as may be provided by law (subject to the
provisions of Section 9.6). COV shall make arrangements with LMI for the
return or disposal of any rejected Product, Drug Substance or Ligand Excipient,
such return shipping or disposal charges to be paid by COV.

 

5.7          Quality
Agreements. The Parties agree that they will enter into one or
more separate Quality Agreements that will cover arrangements for quality
control, testing documentation, quality assurance and other related matters no
later than thirty (30) days after the Effective Date. The Parties acknowledge
that stability testing for Product manufactured during the Term will continue
after termination or expiration of the Agreement for the Product’s remaining
shelf life, unless LMI decides in its sole discretion to undertake such
stability testing or to assign such responsibilities to a third party. LMI will
reimburse COV for such post-termination or post-expiration stability testing in
an amount equal to COV’s actual reasonable testing costs (including employee
time) plus **** percent (****%).

 

16

 

6.             INTELLECTUAL
PROPERTY; NONDISCLOSURE; CONFIDENTIALITY

 

6.1          Intellectual Property.

 

(a)           As between the Parties,
subject to the licenses granted under Section 6.1(b) below, each
Party retains all right, title and interest in and to the Intellectual Property
and Technology that each Party currently owns and/or uses to the extent related
to the purposes of this Agreement (“Pre-Existing Intellectual Property and
Technology”). Under no circumstances will the licenses granted in Section 6.1(b) below
be construed as a sale of any of the Pre-Existing Intellectual Property and
Technology by either Party. As between the Parties, each Party shall, subject
to the licenses granted in Section 6.1(b) below, own all right, title
and interest in and to any modifications, derivative works, enhancements or
improvements of or to any of the Pre-Existing Intellectual Property and
Technology related to this Agreement (“Improvements”) that such Party creates,
develops, discovers, conceives and/or reduces to practice during the Term. The
Parties shall jointly own all inventions and developments, whether
modifications, derivative works, enhancements or improvements to any
Intellectual Property and/or Technology related to this Agreement, which are
jointly created or developed during the Term.

 

(b)           COV grants to LMT as of the
date of receipt by COV of the Technology Transfer Notice, a non-exclusive,
perpetual, irrevocable and royalty-free license, with right to sublicense, in
and to all COV-owned (i) Pre-Existing Intellectual Property and Technology
and (ii) Improvements for use solely in connection with the Product. This
license shall survive any expiration or termination of the Agreement and shall
be included within the scope of the Technology transfer set forth in Section 2.7.

 

6.2          Nondisclosure Obligations.

 

(a)           Except as otherwise
specifically contemplated by Section 2.7 or as provided in this Article 6,
during the Term of this Agreement and for a period of five (5) years
thereafter, both Parties shall maintain in confidence (i.e., not disclose to any third party)
and use only for purposes specifically authorized under this Agreement
confidential information and data received from the other Party, whether such
information is contained in a written or electronic document, whether it is
oral or whether it is disclosed by means of inspection.

 

(b)           For purposes of this Article 6,
information and data described in clause (a) shall be referred to as
“Information.” To the extent it is reasonably necessary or appropriate to
fulfill its obligations or exercise its rights under this Agreement, a Party
may disclose Information it is otherwise obligated under this Section not
to disclose, to its Affiliates, employees, officers, directors, lenders,
sublicensees, consultants, outside contractors and clinical investigators on a
need-to-know basis and on condition that such entities or persons agree in
writing to keep the Information confidential for the same time periods and to
the same extent as such Party is required to keep the Information confidential;
notwithstanding the foregoing the Party so disclosing Information will be
liable to the other Party hereunder for any misuse or improper disclosure of
any such Information by any such firms or individuals. A Party or its
sublicensees may disclose such Information to government or other regulatory
authorities to the extent that such disclosure is reasonably necessary to obtain
patents or authorizations to conduct clinical

 

17

 

trials of, and to commercially market, the Product.
The obligation not to disclose Information shall not apply to any part of such
Information that (i) is or becomes part of the public domain other than by
unauthorized acts of the Party obligated not to disclose such Information or
its Affiliates or sublicensees, (ii) can be shown by written documents to
have been disclosed to the receiving Party or its Affiliates or sublicensees by
a third party, provided such Information was not obtained by such third party
directly or indirectly from the other Party under this Agreement pursuant to a
confidentiality agreement, (iii) prior to disclosure under this Agreement
can be shown by written documents to have been already in the possession of the
receiving Party or its Affiliates or sublicensees, provided such Information
was not obtained directly or indirectly from the other Party under this
Agreement pursuant to a confidentiality agreement, (iv) can be shown by
written documents to have been independently developed by the receiving Party
or its Affiliates without breach of any of the provisions of this Agreement, or
(v) is disclosed by the receiving Party pursuant to oral questions,
interrogatories, requests for information or documents, subpoena, civil
investigative demand of a court or governmental agency, provided that the
receiving Party notifies the other Party immediately upon receipt of any such
official requests (and provided that the disclosing Party furnishes only that
portion of the Information which is legally required). The Party asserting the
applicability of one of the exclusions set forth in the immediately preceding
sentence shall have the burden of proving the applicability of any such
exclusion in any particular circumstance.

 

6.3          Terms of this Agreement.

 

(a)           LMI and COV each agree not
to disclose, whether by press release or in any other manner, the existence of
this Agreement or any terms or conditions of this Agreement, to any third party
without the prior written consent of the other Party or except as required by
applicable law. Notwithstanding the foregoing, however, each Party may disclose
the terms and conditions of this Agreement to a lender or third party to which
it is considering transferring all or substantially all of its interest in the
assets to which this Agreement relates; provided, however, that such lender or
third party executes a confidentiality agreement by which such lender or third
party is bound to hold the disclosed information in confidence.

 

(b)           The Parties shall agree in
good faith upon the substance of Information that can be used as a routine
reference in the usual course of business to describe the terms of this
transaction and each of them may disclose such Information, as modified by
mutual agreement from time to time, without the other Party’s consent.

 

6.4          Injunctive Relief. The Parties
hereto understand and agree that remedies at law may be inadequate to protect
against any breach of any of the provisions of this Article 6 by a Party
or its employees, agents, officers or directors or any other person acting in
concert with it or on its behalf. Accordingly, each Party shall be entitled to
seek injunctive relief or any other equitable relief appropriate under the
circumstances by a court of competent jurisdiction against or with respect to
any action that constitutes any such breach of this Article 6.

 

18

 

7.             INDEMNIFICATION;
INSURANCE.

 

7.1          By COV. COV  will indemnify
and hold LMI and its Affiliates, their directors, officers, agents and
employees harmless against any and all liability, damages, losses, costs or
expenses, including without limitation, reasonable fees and disbursement of
attorneys (collectively, “Liability”) resulting from any third party claims
made or suits brought against them to the extent such Liability arises from (i) COV’s
negligence or willful misconduct in the manufacture, storage, packaging,
labeling, handling or shipping of the Drug Substance, Ligand Excipient or
Product or (ii) COV’s  breach of any warranty set forth
in Section 5.1.

 

7.2          By LMI. LMI will
indemnify and hold COV and its Affiliates, their directors, officers, agents
and employees harmless against any and all Liability resulting from (i) any
packaging or labeling of any Product to the extent that such packaging or
labeling has been supplied by or at the direction of LMI and applied in
accordance with instructions from LMI, (ii) any third party claims made or
suits brought against COV to the extent such Liability arises from LMI’s
negligence or willful misconduct in the storage, packaging, labeling, handling,
shipping, use, marketing, distribution or sale of the Drug Substance, Ligand
Excipient or Product, (iii) any third party claims made or suits brought
against COV for bodily injury, death or property damage arising out of or in
connection with the use of any Product supplied under this Agreement except to
the extent such damage arises from COV’s negligence or willful misconduct in
the manufacture, storage, handling or shipping of the Product or COV’s breach
of any express warranty set forth in Section 5.1, or (iv) a breach of
a representation or warranty made by LMI to its customers or users with respect
to the Drug Substance, Ligand Excipient or Product other than the
representations or warranties contained in Section 5.2 above.

 

7.3          Conditions of Indemnification. A Party or any
of its Affiliates or their respective directors, officers, employees or agents
(the “Indemnitee”) that intends to claim indemnification under this Article 7
shall promptly notify the other Party (the “Indemnitor”) of any Liability in
respect of which the Indemnitee intends to claim such indemnification
reasonably promptly after the Indemnitee is aware thereof, and the Indemnitor
shall assume the defense of any related third party action, suit or proceeding
with counsel mutually satisfactory to the Parties; provided, however, that an
Indemnitee shall have the right to retain its own counsel and participate in
the defense thereof at its own cost and expense. The indemnity agreement in
this Article 7 shall not apply to amounts paid in settlement of any claim,
loss, damage or expense if such settlement is effected without the consent of
the Indemnitor, which consent shall not be withheld unreasonably. The failure
of an Indemnitee to deliver notice to the Indemnitor within a reasonable time
after becoming aware of any such matter, if prejudicial to the Indemnitor’s
ability to defend such action, shall relieve the Indemnitor of any liability to
the Indemnitee under this Article 7. The Indemnitee under this Article 7
and its directors, officers, employees and agents shall cooperate fully with
the Indemnitor and its legal representatives in the investigation and defense
of any matter covered by this indemnification.

 

7.4          Insurance. LMI and COV
will each, at its own cost and expense, obtain and maintain in full force and
effect, during the term of this Agreement and for a period of one year
following the expiration or other termination of this Agreement, commercial
general liability insurance either through self-insurance or with an insurance
carrier generally acceptable to the other Party, with limits of liability,
including excess coverage, of not less than $20,000,000  combined single
limit bodily injury and property damage covering its duties and obligations
under the Agreement.

 

19

 

8.             ALTERNATIVE
DISPUTE RESOLUTION.

 

(a)           The Parties will attempt in
good faith to resolve any controversy, claim or dispute (“Dispute”) arising out
of or relating to this Agreement promptly by negotiations. Any such Dispute
which is not settled by the Parties within thirty (30) days after notice of such
Dispute is given by one Party to the other in writing shall be referred to a
senior executive of LMI and a senior executive of COV who are authorized to
settle such Disputes on behalf of their respective companies (“Senior
Executives”). If the Dispute has not been resolved within thirty (30) days
after the end of the thirty (30) day negotiation period referred to above
(which period may be extended by mutual agreement), subject to any rights to
injunctive relief and unless otherwise specifically provided for herein, any
Dispute may be settled by binding arbitration as described in subsection (b) below,
if the Parties so choose. However, unless the Parties agree to submit any such
Dispute to binding arbitration, they shall have the right to seek any relief available
at law or equity from court of competent jurisdiction for resolution of any
such Dispute.

 

(b)           Any Dispute which is not
resolved by the Parties within the time period described in subsection (a) and
which the Parties agree to submit to arbitration shall be settled by final and
binding arbitration to be conducted by a three person arbitration panel in
Chicago, Illinois, pursuant to the then-existing Commercial Rules of
the American Arbitration Association. The decision or award of the arbitration
panel shall be final, and judgment upon such decision or award may be entered
in any competent court or application may be made to any competent court for
judicial acceptance of such decision or award and an order of enforcement. The
arbitration panel shall allocate the costs of the arbitration to one or both of
the Parties as it sees fit.

 

(c)           Nothing contained in this
Section or any other provision of this Agreement shall be construed to
limit or preclude a Party from bringing an action in any court of competent
jurisdiction for injunctive or other provisional relief to compel the other
Party to comply with its obligations hereunder before or during the pendency of
mediation or arbitration proceedings.

 

9.             MISCELLANEOUS.

 

9.1          Relationship of the Parties. In making and
performing this Agreement, the Parties are acting, and intend to be treated, as
independent entities and nothing contained in this Agreement shall be construed
or implied to create an agency, partnership, joint venture, or employer and
employee relationship between LMI and COV. Each Party shall retain the
exclusive right of control with respect to its employees and agents, and shall
be responsible for all taxes, withholdings, and other statutory or contractual
obligations of any sort in respect of its employees and agents providing
Products and services hereunder including, but not limited to, workers’
compensation insurance. Except as otherwise provided herein, neither Party may
make any representation, warranty or commitment, whether express or implied, on
behalf of or incur

 

20

 

 

any charges or expenses for or in the name of the other Party. No Party
shall be liable for the act of any other Party unless such act is expressly
authorized in writing by both Parties hereto.

 

9.2          Expenses.  Except as
specifically provided herein, each Party shall each pay its own expenses
(including the fees and expenses of their respective agents, representatives,
counsel and accountants) incidental to the preparation, negotiation, and
consummation of this Agreement and the transactions contemplated hereby.

 

9.3          Survival. The following
provisions shall survive the termination or expiration of this Agreement for
any reason in accordance with their respective terms:

 

Article 1 (Definitions)

Section 3.4
(Effect of Expiration or Termination; Accrued Rights; Surviving Obligations) 

Article 4
(Regulatory Issues)

Article 5
(Warranties and Quality Assurance)

Article 6
(Intellectual Property; Nondisclosure; Confidentiality)

Article 7
(Indemnification)

Article 8
(Alternative Dispute Resolution)

Article 9
(Miscellaneous)

 

9.4          Notices.
All notices, demands and other communications to be given or delivered under
or by reason of the provisions of this Agreement shall be in writing and shall
be deemed to have been given (a) when personally delivered or sent by
confirmed telecopy (with hard copy to follow); (b) one (1) business
day after sent by reputable overnight express courier (charges prepaid); or (c) five
(5) business days following mailing by certified or registered mail,
postage prepaid and return receipt requested. Unless another address is
specified in writing, notices, demands and communications to LMI and COV shall
be sent to the addresses indicated below:

 

Notices to LMI:

 

Lantheus Medical Imaging, Inc.

331 Treble Cove Road

North Billerica, Massachusetts 01862 

Attn: Michael Duffy, Esq.

Facsimile: (978) 671-8724

 

Notices to COV:

 

Mallinckrodt Inc.

675 McDonnell Blvd.

Hazelwood, MO 63042

Attn: President, Mallinckrodt Imaging Solutions 

Facsimile: 314-654-3440

 

with a copy to:

 

Mallinckrodt Inc.

 

21

 

675 McDonnell Blvd.

Hazelwood, MO 63042

Attn: Mallinckrodt Imaging Solutions, Vice President/Chief
Corporate Counsel

Facsimile: 314-654-

 

9.5          Force
Majeure. If the performance of any obligation under this
Agreement by either Party is prevented, restricted, interfered with or delayed
by reason of natural disaster, casualty, acts of God, riots, acts of terrorism
or such other event of similar nature (“Force Majeure Event”), the Party so
affected shall, upon giving prompt written notice to the other Party (including
a full description of particulars), be excused from such performance to the
extent of such prevention, restriction, interference or delay; provided that
the affected Party shall use its reasonable commercial efforts to avoid or
remove such causes of non-performance and shall continue performance whenever
such causes are removed.

 

9.6
         LIMITATIONS
ON LIABILITY. IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE
OTHER PARTY OR TO ANY THIRD PARTY FOR ANY INDIRECT, INCIDENTAL, SPECIAL,
PUNITIVE, EXEMPLARY, OR CONSEQUENTIAL DAMAGES ARISING FROM THIS AGREEMENT OR
FOR ANY AMOUNTS REPRESENTING LOSS OF PROFITS OR LOSS OF BUSINESS, WHETHER THE
BASIS OF THE LIABILITY IS BREACH OF CONTRACT, TORT, STATUTES, OR ANY OTHER
LEGAL THEORY, EXCEPT TO THE EXTENT SUCH LIABILITY ARISES FROM COV’S OR LMI’S
(AS THE CASE MAY BE) WILLFUL MISCONDUCT, AND WHETHER SUCH FIRST PARTY HAS
BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES OR NOT.

 

9.7          Successors
and Assigns; Assignment. This Agreement shall be binding upon and inure
to the benefit of the Parties and their respective successors and permitted
assigns. This Agreement or any part thereof, may not be assigned, in whole or
in part, without the prior written consent of the other Party, which consent
may be withheld in the sole discretion of the other Party; provided,
however, that either Party may assign this Agreement without the consent of
the other Party, (i) in whole or in part to any Affiliate of such Party,
it being agreed that no such assignment to a Party’s Affiliate shall release
the assigning Party from its obligations hereunder, or (ii) in connection
with the direct or indirect (x) transfer and sale of all or substantially
all of the assets or business of such Party or any of its Affiliates or (y) the
transfer and sale of all or substantially all of the assets or business of the
specific business line, division or unit of such Party or any of its Affiliates
to which this Agreement relates.

 

9.8          Entire
Agreement; Modification. This Agreement supersedes all prior
agreements and understandings between the Parties or any of their respective
Affiliates (written or oral) relating to the subject matter hereof, including
any term sheets, and this Agreement is the entire and complete statement of the
terms of the agreement between the Parties with respect to the subject matter
hereof. This Agreement may be amended, modified, or supplemented only in a
writing signed by LMI and COV.

 

9.9          EPIX and
Bayer/Schering. For the avoidance of doubt, the Parties hereby agree
that LMI shall have no liability arising from or related to COV’s past and
current relationship and contractual arrangements with EPIX and/or
Bayer/Schering.

 

22

 

9.10        Waivers. The failure of a
Party at any time or times to require performance of any provision hereof shall
in no manner affect its right at a later time to enforce the same. No waiver by
a Party of any condition or of any breach of any term, covenant, representation
or warranty contained in this Agreement shall be effective unless in writing,
and no waiver in any one or more instances shall be deemed to be a further or
continuing waiver of any such condition or breach in other instances or a
waiver of any other condition or breach of any other term, covenant,
representation or warranty.

 

9.10        Section and
Other Headings. The section and other headings contained in this
Agreement are for reference purposes only and shall not in any way affect the
meaning or interpretation of this Agreement.

 

9.11        Governing
Law. This Agreement shall be exclusively interpreted in accordance with and
governed by the laws of New York, without regard to the conflicts of law rules thereof.

 

9.12        Severability.
Any provision of this Agreement which is prohibited or unenforceable in
any jurisdiction shall, as to such jurisdiction, be ineffective to the extent
of such prohibition or unenforceability without invalidating the remaining
provisions hereof, and any such prohibition and unenforceability in any jurisdiction
shall not invalidate or render unenforceable such provision in any other
jurisdiction.

 

9.13        No Third
Party Beneficiaries. Neither this Agreement nor any provision
hereof is intended to confer upon any person (other than the Parties hereto)
any rights or remedies hereunder.

 

9.14        Construction.
The Parties have participated jointly in the negotiation and drafting
of this Agreement. In the event an ambiguity or question of intent or
interpretation arises, this Agreement shall be construed as if drafted jointly
by the Parties and no presumption or burden of proof shall arise favoring or
disfavoring any Party by virtue of the authorship of any of the provisions of
this Agreement.

 

9.15        Counterparts.
This Agreement may be executed in two or more counterparts, each of
which shall be deemed to be an original, and such counterparts shall together
constitute one and the same instrument. A facsimile transmission of an executed
counterpart signature page shall be deemed an original.

 

IN WITNESS WHEREOF, the Parties have caused this
Agreement to be executed by their respective duly authorized representatives as
of the date first above written.

 

	
  LANTHEUS MEDICAL IMAGING, INC.

  	
   

  
	
   

  	
   

  
	
   

  	
   

  
	
  By:

  	
   

  	
   

  
	
   

  	
  Name:

  	
   

  
	
   

  	
  Title:

  	
   

  

 

23

 

IN WITNESS WHEREOF the Parties have caused this
Agreement to be executed by their respective duly authorized representatives as
of the date first above written.

 

 

	
   

  	
  LANTHEUS MEDICAL IMAGING, INC

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  By:

  	
  /s/ Michael P. Duffy

  
	
   

  	
   

  	
  Name: Michael P. Duffy

  
	
   

  	
   

  	
  Title: Secretary

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  MALLINCKRODI INC

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  By:

  	
   

  
	
   

  	
   

  	
  Name: Timothy R. Wright

  
	
   

  	
   

  	
  Title: President, Imaging
  Solutions and Pharmaceutical Products

  

 

 

Signature Page to
Manufacturing and Supply Agreement

 

 

	
   

  	
  MALLINCKRODT INC.

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  By:

  	
  /s/ Matthew J. Kraus

  	
   

  
	
  

  	
   

  	
  Name: Matthew J. Kraus

  	
   

  
	
   

  	
  Title: Vice President, Business Development

  	
   

  
	
   

  	
   

  	
   

  

 

24

 

Exhibit 1.1(q)

 

Specifications

 

****

 

 

Exhibit 2.2

 

Existing Drug Substance and Ligand Excipient at COV

 

Covidien MS 325 Product Inventory

March-09

 

	
 
  	
 
  	
Code
  	
 
  	
Batch Number
  	
 
  	
Lot Number
  	
 
  	
Expiry Date
  	
 
  	
Kg available
  	
 
  	
 
  	
 
  	
 
  
	
Hazelwood:
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
MS-32503
  	
 
  	
8263
  	
 
  	
B01 - 2008
  	
 
  	
P03083
  	
 
  	
03/2009
  	
 
  	
67.75
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B03
  	
 
  	
P03084
  	
 
  	
03/2009
  	
 
  	
64.50
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B04
  	
 
  	
P03085
  	
 
  	
03/2009
  	
 
  	
67.00
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B05
  	
 
  	
P03086
  	
 
  	
03/2009
  	
 
  	
61.00
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B06
  	
 
  	
P03087
  	
 
  	
03/2009
  	
 
  	
64.60
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B07
  	
 
  	
P03088
  	
 
  	
03/2009
  	
 
  	
64.60
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B08
  	
 
  	
P03089
  	
 
  	
03/2009
  	
 
  	
67.00
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B10
  	
 
  	
P03091
  	
 
  	
03/2009
  	
 
  	
61.30
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B11
  	
 
  	
P03092
  	
 
  	
03/2009
  	
 
  	
62.60
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B12
  	
 
  	
P03093
  	
 
  	
03/2009
  	
 
  	
64.70
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B13
  	
 
  	
P04567
  	
 
  	
03/2009
  	
 
  	
58.10
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B14
  	
 
  	
P04568
  	
 
  	
03/2009
  	
 
  	
66.10
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B15
  	
 
  	
P04569
  	
 
  	
03/2009
  	
 
  	
63.30
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B16
  	
 
  	
P04570
  	
 
  	
03/2009
  	
 
  	
63.00
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B17
  	
 
  	
P04571
  	
 
  	
03/2009
  	
 
  	
63.60
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B18
  	
 
  	
P04572
  	
 
  	
03/2009
  	
 
  	
61.70
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B19
  	
 
  	
P04573
  	
 
  	
03/2009
  	
 
  	
64.30
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B20
  	
 
  	
P04574
  	
 
  	
03/2009
  	
 
  	
64.50
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B21
  	
 
  	
P04575
  	
 
  	
03/2009
  	
 
  	
65.80
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B22
  	
 
  	
P04576
  	
 
  	
03/2009
  	
 
  	
64.50
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B23
  	
 
  	
P04577
  	
 
  	
03/2009
  	
 
  	
61.90
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B24
  	
 
  	
P05607
  	
 
  	
04/2009
  	
 
  	
64.40
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B25
  	
 
  	
P05608
  	
 
  	
04/2009
  	
 
  	
62.30
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B26
  	
 
  	
P05609
  	
 
  	
04/2009
  	
 
  	
63.50
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B27
  	
 
  	
P06000
  	
 
  	
04/2009
  	
 
  	
60.90
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B28
  	
 
  	
P05898
  	
 
  	
05/2009
  	
 
  	
65.00
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B29
  	
 
  	
P05899
  	
 
  	
05/2009
  	
 
  	
61.10
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B30
  	
 
  	
P05900
  	
 
  	
05/2009
  	
 
  	
68.00
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B31
  	
 
  	
P05901
  	
 
  	
05/2009
  	
 
  	
60.10
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B32
  	
 
  	
P05902
  	
 
  	
05/2009
  	
 
  	
63.90
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B33
  	
 
  	
P05903
  	
 
  	
05/2009
  	
 
  	
62.40
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B34
  	
 
  	
P05904
  	
 
  	
05/2009
  	
 
  	
63.00
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B35
  	
 
  	
P05905
  	
 
  	
05/2009
  	
 
  	
63.30
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B36
  	
 
  	
P05906
  	
 
  	
05/2009
  	
 
  	
62.70
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B37
  	
 
  	
P05907
  	
 
  	
05/2009
  	
 
  	
63.40
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B38
  	
 
  	
P05908
  	
 
  	
05/2009
  	
 
  	
62.00
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B39
  	
 
  	
P05909
  	
 
  	
05/2009
  	
 
  	
69.00
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B40
  	
 
  	
P05910
  	
 
  	
05/2009
  	
 
  	
65.70
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B41
  	
 
  	
P05911
  	
 
  	
06/2009
  	
 
  	
63.30
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B42
  	
 
  	
P05912
  	
 
  	
06/2009
  	
 
  	
69.20
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B43
  	
 
  	
P06688
  	
 
  	
06/2009
  	
 
  	
60.60
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B44
  	
 
  	
P06690
  	
 
  	
06/2009
  	
 
  	
65.6
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B45
  	
 
  	
P06691
  	
 
  	
06/2009
  	
 
  	
59.9
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B46
  	
 
  	
P06692
  	
 
  	
06/2009
  	
 
  	
60.1
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B6 - 2004
  	
 
  	
H10679
  	
 
  	
04/2006
  	
 
  	
8.8
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B17 - 2004
  	
 
  	
H12216
  	
 
  	
05/2006
  	
 
  	
63.1
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B09 - 2008
  	
 
  	
P03090
  	
 
  	
03/2008
  	
 
  	
50.4
  	
 
  	
Rejected
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
Total:
  	
2,891.25
  	
 
  

 

	
 
  	
 
  	
Code
  	
 
  	
Batch Number
  	
 
  	
Lot Number
  	
 
  	
Expiry Date
  	
 
  	
Kg available
  	
 
  	
 
  	
 
  	
 
  
	
Hazelwood:
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
MS-32506
  	
 
  	
8200
  	
 
  	
B18 - 2005
  	
 
  	
J05977
  	
 
  	
06/2007
  	
 
  	
6.2
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
Total:
  	
5.20
  	
 
  

 

	
 
  	
 
  	
Code
  	
 
  	
Batch Number
  	
 
  	
Lot Number
  	
 
  	
Expiry Date
  	
 
  	
Kg available
  	
 
  	
 
  	
 
  	
 
  
	
Hazelwood:
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
MS-32509
  	
 
  	
7878
  	
 
  	
B27 - 2005
  	
 
  	
J01275
  	
 
  	
02/2007
  	
 
  	
13.3
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B28 - 2005
  	
 
  	
J01276
  	
 
  	
02/2007
  	
 
  	
36.4
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
Total:
  	
49.70
  	
 
  

 

	
 
  	
 
  	
Code
  	
 
  	
Batch Number
  	
 
  	
Lot Number
  	
 
  	
Expiry Date
  	
 
  	
Kg available
  	
 
  	
 
  	
 
  	
 
  
	
Hazelwood:
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
MS-32507
  	
 
  	
7249
  	
 
  	
 
  	
 
  	
E12468
  	
 
  	
09/2004
  	
 
  	
51.6
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
St Louis Plant:
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
MS-32507
  	
 
  	
7249
  	
 
  	
 
  	
 
  	
J06829
  	
 
  	
05/2006
  	
 
  	
509.2
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
J06830
  	
 
  	
08/2006
  	
 
  	
689.1
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
J06831
  	
 
  	
08/2006
  	
 
  	
504.4
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
J06832
  	
 
  	
08/2006
  	
 
  	
430.8
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
J07851
  	
 
  	
08/2006
  	
 
  	
544.9
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
Total:
  	
2,630.00
  	
 
  

 

	
 
  	
 
  	
Code
  	
 
  	
Batch Number
  	
 
  	
Lot Number
  	
 
  	
Expiry Date
  	
 
  	
Kg available
  	
 
  	
 
  	
 
  	
 
  
	
Hazelwood:
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
MS-32516
  	
 
  	
2690
  	
 
  	
B01 - 07/08
  	
 
  	
M02644
  	
 
  	
02/2010
  	
 
  	
0.476
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B02
  	
 
  	
M02645
  	
 
  	
02/2010
  	
 
  	
0.6164
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B03
  	
 
  	
M02646
  	
 
  	
02/2010
  	
 
  	
0.6796
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B04
  	
 
  	
M04338
  	
 
  	
03/2010
  	
 
  	
0.6658
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B06
  	
 
  	
M11463
  	
 
  	
10/2010
  	
 
  	
0.731
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B07
  	
 
  	
M11465
  	
 
  	
10/2010
  	
 
  	
0.9426
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B08
  	
 
  	
M11466
  	
 
  	
10/2010
  	
 
  	
0.9265
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B09
  	
 
  	
M12015
  	
 
  	
10/2010
  	
 
  	
0.9416
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B10
  	
 
  	
M12430
  	
 
  	
11/2010
  	
 
  	
0.8856
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B11
  	
 
  	
M12431
  	
 
  	
11/2010
  	
 
  	
0.8388
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B13
  	
 
  	
P00432
  	
 
  	
12/2010
  	
 
  	
0.787
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
2004 TIG lot
  	
 
  	
 
  	
 
  	
B3 - 2004
  	
 
  	
J09509
  	
 
  	
4/2007
  	
 
  	
0.2613
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
MS-32516
  	
 
  	
3516
  	
 
  	
B1 - 2004
  	
 
  	
E16990
  	
 
  	
12/2006
  	
 
  	
0.8200
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B6 - 2004
  	
 
  	
H00896
  	
 
  	
01/2007
  	
 
  	
0.1970
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
Raleigh:
  	
 
  	
 
  	
 
  	
 
  	
 
  	
L0720400010
  	
 
  	
12/28/2010
  	
 
  	
0.10896
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
Total:
  	
9.77
  	
 
  

 

	
 
  	
 
  	
Code
  	
 
  	
Batch Number
  	
 
  	
Lot Number
  	
 
  	
Retest Date
  	
 
  	
Kg available
  	
 
  	
 
  	
 
  	
 
  
	
Hazelwood:
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
MS-32520
  	
 
  	
6485
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B23
  	
 
  	
M11458
  	
 
  	
11/2010
  	
 
  	
44.5
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B24
  	
 
  	
M11459
  	
 
  	
11/2010
  	
 
  	
38.5
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B32
  	
 
  	
P00429
  	
 
  	
12/2010
  	
 
  	
38.0
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B34
  	
 
  	
P01308
  	
 
  	
1/2011
  	
 
  	
39.1
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B26
  	
 
  	
M12391
  	
 
  	
11/2010
  	
 
  	
31
  	
 
  	
Rejected but can be reworked
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
Raleigh:
  	
 
  	
 
  	
 
  	
 
  	
 
  	
L0720400011
  	
 
  	
2/28/2010
  	
 
  	
10.5
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
L0720400008
  	
 
  	
3/31/2010
  	
 
  	
6.8
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
L0633800027
  	
 
  	
10/31/2008
  	
 
  	
12.2
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
L0720400012
  	
 
  	
11/30/2008
  	
 
  	
9.3
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
Total:
  	
229.95
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
Grand Total:
  	
5,815.87
  	
 
  

 

26

 

Exhibit 2.3

 

Existing Product and Drug Substance at Bayer/Schering

 

3262789 Bulk purchased

from Covidien

 

	
 
  	
 
  	
Stocks in
 vials
  	
 
  	
Date of Production
 (ALP)
  	
 
  	
Covidien
 Batch #
  	
 
  	
Comments
  
	
Batch 73014
  	
 
  	
8359
  	
 
  	
****
  	
 
  	
M292B
  	
 
  	
 
  
	
Batch 74015
  	
 
  	
17539
  	
 
  	
****
  	
 
  	
M292B
  	
 
  	
 
  
	
Batch 74016
  	
 
  	
5472
  	
 
  	
****
  	
 
  	
M480B
  	
 
  	
 
  
	
available stocks
  	
 
  	
33430
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  

 

	
available API 3313194
 Gadofosveset in Berlin 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  

 

	
Batch#
  	
 
  	
Stocks in kg
  	
 
  	
Date of Production
 (ALP)
  	
 
  	
Covidien
 Batch #
  	
 
  	
Comments
  
	
63074499
  	
 
  	
32
  	
 
  	
****
  	
 
  	
M02405
  	
 
  	
 
  
	
63074500
  	
 
  	
31.6
  	
 
  	
****
  	
 
  	
M02740
  	
 
  	
 
  
	
63074501
  	
 
  	
34.77
  	
 
  	
****
  	
 
  	
M02741
  	
 
  	
 
  
	
63074502
  	
 
  	
29.57
  	
 
  	
****
  	
 
  	
M02742
  	
 
  	
 
  
	
63074503
  	
 
  	
16.97
  	
 
  	
****
  	
 
  	
M02744
  	
 
  	
 
  
	
63074504
  	
 
  	
39.1
  	
 
  	
****
  	
 
  	
M02747
  	
 
  	
300I batches
  
	
63074505
  	
 
  	
46.9
  	
 
  	
****
  	
 
  	
M04333
  	
 
  	
 
  
	
63074507
  	
 
  	
46.7
  	
 
  	
****
  	
 
  	
M04334
  	
 
  	
**** only batch (before variations)
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
SV00008H
  	
 
  	
27.39
  	
 
  	
****
  	
 
  	
M09797
  	
 
  	
 
  
	
SV00008J
  	
 
  	
36.24
  	
 
  	
****
  	
 
  	
M09798
  	
 
  	
 
  
	
SV00008K
  	
 
  	
45.01
  	
 
  	
****
  	
 
  	
M11455
  	
 
  	
 
  
	
SV00008L
  	
 
  	
44.48
  	
 
  	
****
  	
 
  	
M11456
  	
 
  	
 
  
	
SV00008N
  	
 
  	
39.16
  	
 
  	
****
  	
 
  	
M11457
  	
 
  	
 
  
	
SV00008P
  	
 
  	
34.76
  	
 
  	
****
  	
 
  	
M12390
  	
 
  	
 
  
	
SV00008S
  	
 
  	
25.33
  	
 
  	
****
  	
 
  	
P00424
  	
 
  	
 
  
	
SV00008T
  	
 
  	
52.4
  	
 
  	
****
  	
 
  	
P00425
  	
 
  	
 
  
	
SV00008U
  	
 
  	
46.46
  	
 
  	
****
  	
 
  	
P00426
  	
 
  	
 
  
	
SV00008V
  	
 
  	
38.66
  	
 
  	
****
  	
 
  	
P00427
  	
 
  	
 
  
	
SV00008W
  	
 
  	
23.55
  	
 
  	
****
  	
 
  	
P00428
  	
 
  	
 
  
	
SV00008X
  	
 
  	
29.02
  	
 
  	
****
  	
 
  	
P01307
  	
 
  	
 
  
	
SV000090
  	
 
  	
40.87
  	
 
  	
****
  	
 
  	
P01309
  	
 
  	
 
  
	
SV000091
  	
 
  	
17.16
  	
 
  	
****
  	
 
  	
P01310
  	
 
  	
 
  
	
SV00008R
  	
 
  	
31.3
  	
 
  	
****
  	
 
  	
M02746
  	
 
  	
 
  
	
63074497
  	
 
  	
0.672
  	
 
  	
****
  	
 
  	
M00606
  	
 
  	
 
  
	
63074499
  	
 
  	
11.6
  	
 
  	
****
  	
 
  	
M02405
  	
 
  	
 
  
	
available API
  	
 
  	
821.672
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  

 

27

 

	
 
  	
 
  	
Code
  	
 
  	
Batch Number
  	
 
  	
Lot Number
  	
 
  	
Retest Date
  	
 
  	
Kg available
  	
 
  	
Status
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
MS-32516
  	
 
  	
2590
  	
 
  	
B01 - 07/08
  	
 
  	
M02644
  	
 
  	
02/20100
  	
 
  	
.476
  	
 
  	
Released
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B02
  	
 
  	
M02645
  	
 
  	
02/2010
  	
 
  	
0.6164
  	
 
  	
Released
  	
 
  	
B03
  
	
 
  	
 
  	
 
  	
 
  	
M02646
  	
 
  	
02/2010
  	
 
  	
0.6796
  	
 
  	
Released
  	
 
  	
B04
  	
 
  	
M04338
  
	
 
  	
 
  	
 
  	
 
  	
03/2010
  	
 
  	
0.6558
  	
 
  	
Released
  	
 
  	
B05
  	
 
  	
M11463
  	
 
  	
10/2010
  
	
 
  	
 
  	
 
  	
 
  	
0.731
  	
 
  	
Released
  	
 
  	
B07
  	
 
  	
M11465
  	
 
  	
10/2010
  	
 
  	
0.9426
  
	
 
  	
 
  	
 
  	
 
  	
Released
  	
 
  	
B08
  	
 
  	
M11466
  	
 
  	
10/2010
  	
 
  	
0.9265
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
Released
  	
 
  	
B09
  	
 
  	
M12015
  	
 
  	
10/2010
  	
 
  	
0.8416
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
Released
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B10
  	
 
  	
M12430
  	
 
  	
11/2010
  	
 
  	
0.8856
  	
 
  	
Released
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
B11
  	
 
  	
M12431
  	
 
  	
11/2010
  	
 
  	
0.8388
  	
 
  	
Released
  	
 
  	
B13
  
	
 
  	
 
  	
 
  	
 
  	
P00432
  	
 
  	
12/2010
  	
 
  	
0.787
  	
 
  	
Released
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
Total: 8.38
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
2004 TIG lot retest date
  	
 
  	
 
  	
 
  	
2590 B3 – 2004
  	
 
  	
J09509
  	
 
  	
4/2007
  	
 
  	
0.2613
  	
 
  	
Quarantine
  	
 
  	
Past
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
Grand Total 8.64
  	
 
  	
 
  

 

28

 

Exhibit 2.4

 

Supply Schedule for Newly Manufactured Product

 

Volume Requirements per Calendar Quarter:

 

	
Minimum Volumes*
  	
 
  	
Target Volumes**
  	
 
  	
Calendar Quarter
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
****
  	
 
  	
 
  	
 
  	
3Q10
  	
 
  
	
****
  	
 
  	
 
  	
 
  	
4Q10
  	
 
  
	
****
  	
 
  	
****
  	
 
  	
1Q11
  	
 
  
	
****
  	
 
  	
****
  	
 
  	
2Q11
  	
 
  
	
****
  	
 
  	
****
  	
 
  	
3Q11
  	
 
  
	
****
  	
 
  	
****
  	
 
  	
4Q11
  	
 
  
	
****
  	
 
  	
****
  	
 
  	
1Q12
  	
 
  
	
****
  	
 
  	
****
  	
 
  	
2Q12
  	
 
  
	
****
  	
 
  	
****
  	
 
  	
3Q12
  	
 
  

 

* These quantities reflect the minimum committed volumes (in kgs.) specified in Section 2.4(c) to be shipped in the corresponding Calendar Quarter. Not later than ****, LMI will notify COV whether LMI will increase the Minimum Volumes for the 1st, 2nd and 3rd Calendar Quarters of 2012 to **** kg. If LMI elects to increase its Minimum Volumes for such periods, COV will agree to accept orders for such volumes.

** LMI has estimated that it will require the Target Volumes for the Calendar Quarters as indicated. COV will use commercially reasonable efforts to meet the Target Volumes, to the extent such Target Volumes are reflected in the forecasts and purchase orders actually submitted by LMI pursuant to the terms of the Agreement; provided that COV will not bear liability to LMI in the event COV is unable to accept one or more orders reflecting the Target Volumes to the extent such Target Volumes exceed Minimum Volumes.

 

29

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00182-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00182-of-00352.parquet"}]]