Confidential Materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote omissions. Supply Agreement
Exhibit 10.3
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
Securities and Exchange Commission. Asterisks denote omissions.
This Supply Agreement (the “Agreement”) is made as of the 7th day of July,
2008 (the “Effective Date”) by and between Biodel Inc., a Delaware corporation (“Biodel”), with its
principal office and place of business at 000 Xxx Xxxx Xxxx, Xxxxxxx, XX 00000, U.S.A., and N.V.
Organon, a Dutch company (“Organon”) with its principal office and place of business at
Xxxxxxxxxxxxxx 0, 0000 XX XXX, Xxx Xxxxxxxxxxx (each of Biodel and Organon, a “Party” and together,
the “Parties”).
RECITALS
Whereas, Biodel is a development stage specialty biopharmaceutical company focused on the
development and commercialization of innovative treatments for endocrine disorders, such as
diabetes;
Whereas, Organon is in the business of manufacturing and supplying active
pharmaceutical ingredients, including the Product (as defined below);
Whereas, Biodel and Organon now desire to enter into this Agreement to provide the
terms and conditions upon which Organon shall manufacture for and supply to Biodel the Product.
Agreement
Now Therefore, in consideration for the covenants set forth below, and for other good
and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the
Parties agree as set forth below.
1. Certain Definitions.
1.1 “Additional Quantities” means any quantities for which Biodel has issued a Purchase Order
in accordance with § 4.2.
1.2 “Affiliate” means, with respect to any Party, another entity or person which directly or
indirectly, is controlled by, or controls, or is under common control with such Party, where, for
purposes of this definition, the term “control” means ownership, directly or indirectly, of more
than 50% of the shares of stock entitled to vote for the election of directors, in the case of a
corporation, or more than 50% of the equity interests in the case of any other type of legal
entity, status as a general partner in any partnership, or any other arrangement whereby a Party
controls or has the right to control the Board of Directors or equivalent governing body of a
corporation or other entity, or if such level of ownership or control is prohibited in any country,
any entity owning or controlling at the maximum control or ownership right permitted in the country
where such entity exists.
1.3 “Technical Change” means, with respect to the Product, any change, including without
limitation to the Specifications, the manufacturing process, the manufacturing facility and
equipment etc., that requires a notification by either or both of the Parties to, or approval from,
the relevant authorities with respect to the End Product(s).
1.4 “Confidentiality Agreement” means the confidentiality agreement between the Parties as
executed concurrent with this Agreement and attached hereto as Exhibit C.
1.5 “Confidential Information” means any confidential or proprietary information of a Party
disclosed to the other Party or generated in the course of this Agreement, including inventions,
know-how, works of authorship, software, data, software tools, designs, schematics, plans or other
information relating to any work in process, future development, engineering, manufacturing,
marketing or business plan, or financial or personnel matters relating to either Party, its present
or future products, sales, suppliers, customers, employees, investors or business, however
excluding any such information disclosed by Organon to Biodel under the Confidentiality Agreement,
which is and remains governed thereby.
1.6 “CPR” means the International Institute for Conflict Prevention & Resolution.
1.7 “End Product(s)” means Biodel’s proprietary VIAdel™ insulin formulations, as developed by
Biodel and used, distributed and/or sold solely in the Territory.
1.8 “Excluded Countries” means Australia, Bangladesh, Bhutan, Brunei, Burma, Cambodia, China
P.R., Hong Kong, India, Indonesia, Israel, Laos, Malaysia, Maldive Islands, New Zealand, Pakistan,
Philippines, Poland, Singapore, South Korea, Sri Lanka, Taiwan, Thailand and Vietnam.
1.9 “Fixed Quarterly Quantities” means the fixed quantities of Product, measured in kilograms,
that are described in § 4.1.
1.10 “Current Good Manufacturing Practice” or “cGMP” means the methods to be used in, and the
facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug
to assure that such drug meets the regulatory requirements of the United States Food and Drug
Administration and as further defined in 21 C.F.R. Parts 210 and 211 and the guidance of the Center
for Drug Evaluation and Research (“CDER”) and the Center for Biologics Evaluation and Research
(“CBER”), and the European Commission Directive 2003/94/EC of October 8, 2003.
1.11 “Intellectual Property Rights” means any and all rights in and to discoveries, concepts,
ideas, technical information, developments, specifications, methods, drawings, designs, flow
charts, diagrams, models, formulae, procedures, processes, schematics, specifications, algorithms,
apparatus, inventions, ideas, know- how, materials, techniques, methodologies, modifications,
improvements, works of authorship and data (whether or not protectable under patent, copyright,
trade secrecy or similar laws), including patents, utility models, and registered and unregistered
designs, including mask works, copyrights, trade secrets, design history, manufacturing
documentation, and any other form of protection afforded by law to inventions, models, designs,
works of authorship, databases or technical information and applications and registrations with
respect thereto.
1.12 “Material Change to Organon’s Current Manufacturing Operations” means a change or
modification to the form, fit, function, method or process of manufacture or production of the
Product hereunder which (x) would reasonably be expected to require any new regulatory filing(s)
with respect to the Product and/or Organon’s other customer’s end products
- 2 -
or (y) could affect the safety, efficacy or quality of the Product and/or Organon’s other
customer’s end products.
1.13 “Non-conforming Product” means Product that does not conform to the Specifications, the
Quality Agreement, or is not free and clear of all liens, claims and encumbrances upon delivery.
1.14 “Product” means Recombinant Human Insulin manufactured for and supplied to Biodel under
this Agreement for use in its manufacturing process of the End Product(s).
1.15 “Purchase Order” means a purchase order that is issued by, and binding on, Biodel and to
be accepted by Organon for the purpose of obtaining the Product under this Agreement, all in
accordance with § 4.3.
1.16 “Quality Agreement” means a separate agreement, executed in accordance with § 8.3 of the
Agreement, between the Parties which shall be incorporated herein by reference, and following its
execution shall be attached hereto and made a part hereof as Exhibit B, and which sets forth, among
other things, the quality control and quality assurance terms for the Product. In case of a
discrepancy between this Agreement and the Quality Agreement, as to quality matters the terms of
the Quality Agreement shall govern; otherwise the provisions of this Agreement shall prevail.
1.17 “Specifications” means the technical specifications for the Product, as further described
in Exhibit A.
1.18 “Territory” means all countries in the world except the Excluded Countries.
2. Performance Obligations
2.1 Supply.
(a) Performance. Organon shall manufacture and supply the Product in accordance with the
Specifications, Quality Agreement, and all applicable laws and regulations. Organon shall perform
its activities in accordance with professional standards and practices, including, but not limited
to, cGMP. Organon shall provide cGMP facilities as well as resources for such services, including,
but not limited to, testing, release, storage, and manufacture of the Product. Biodel shall
provide, upon request and only for use in accordance with the terms of this Agreement, Organon with
any information that Organon reasonably requires to perform its obligations under this Agreement.
(b) Subcontracting. Notwithstanding § 13.1, neither Party shall delegate or subcontract the
performance of activities under this Agreement to third party subcontractors without the prior
written consent of the other Party, provided (i) that such consent shall not be required to the
extent Organon is entitled, without Biodel’s consent, to delegate or subcontract pursuant to the
Quality Agreement, and (ii) that such consent shall not be unreasonably withheld if (a) the
delegating or sub-contracting Party controls the performance of such activities and remains fully
responsible to Organon for the performance of such activities and any breach of this Agreement by
such third party subcontractor, and (b) the third party subcontractor agrees in
- 3 -
writing to comply with confidentiality restrictions at least as stringent as those set forth
in this Agreement.
2.2 Regular Communication. Both Parties shall (i) be available for a reasonable number of
telephone and written consultations on a schedule to be determined by mutual arrangement between
the Parties, and (ii) shall respond to all telephone and written (e.g. letters, e-mail, fax)
communications from the other Party within ten (10) business days or as otherwise reasonably
requested.
2.3 Regulatory Approval.
(a) Applications for Approval. Up until [**] from termination or expiry of this
Agreement, the Parties shall cooperate diligently and in good faith to obtain any and all necessary
approvals and permits for the Product and/or the End Product(s) in the Territory, provided that,
with respect to all End Product(s) other than (i) Biodel’s proprietary insulin formulation known as
VIAject™ and/or (ii), with respect to the US and the EU only, any second proprietary insulin
formulation as requested by Biodel prior to the termination or expiry of this Agreement, and
subsequently approved by Organon, which approval shall not be unreasonably withheld, Organon shall
only be obligated to support Biodel in its efforts to obtain such approvals and permits for
clinical trials up to and including clinical Phase 2. Biodel shall inform Organon timely of its
intention to perform clinical trials or obtain marketing approval anywhere in the Territory, as to
reasonably enable Organon to fulfill its obligations set out above.
(b) Maintenance. Organon shall, with respect to VIAject™ and/or any second
formulation as approved by Organon in accordance with the foregoing, cooperate diligently and in
good faith support Biodel in maintaining any marketing approval that (a) has been accepted for
review by the relevant regulatory authority prior to the date that lies [**] from termination or
expiry of this Agreement and/or (b) is obtained prior to the date that lies [**] from termination
or expiry of this Agreement.
(c) Costs. Each Party shall bear all costs incurred by it and shall pay all costs,
consistent with industry practice, associated with obtaining such approvals or permits for the
Product and/or End Product(s).
(d) Drug Master File for the Product. Without detracting from Biodel’s sole
responsibility for any regulatory and other filings with respect to the End Product(s) anywhere in
the Territory, including without limitation in the EU, unless mutually agreed to between the
Parties in good faith, (i) in connection with applications for End Product(s) in the Territory
other than the EU, Organon shall, subject to the limitations set forth in this § 2.3 and to the
extent required by applicable laws and regulations, file and maintain the drug master file(s) for
the Product, and (ii) in connection with applications for End Product(s) in the EU, Organon shall
subject to the limitations set forth in this § 2.3 and pursuant to the Confidentiality Agreement,
provide such information to Biodel as is necessary to prepare and maintain the ‘Drug Substance
Quality Section’ of the ‘Common Technical Documents’ that form part of such application(s).
(e) Inspections. Subject to the limitations set forth in this § 2.3, Organon shall
provide access to the manufacturing facility and pertinent information to inspectors from
- 4 -
regulatory agencies conducting inspections in connection with applications and permits
relating to End Product(s).
2.4 Regulatory Compliance. In performing its obligations hereunder each Party shall comply
with all applicable federal, state, municipal, or local laws, rules, regulations, orders, decisions
or permits of any relevant jurisdiction relating to matters including, but not limited to
employment, safety, health, environmental standards and requirements, non-discrimination, equal
employment opportunity, import/export and privacy protection.
3. Ownership Rights
3.1 Ownership Rights. Each Party shall retain ownership and control of their respective works
of authorship, inventions, know-how, information, data, and all Intellectual Property Rights
therein that were in existence as of the Effective Date or are created hereafter, whether or not in
the course of the performance of its obligations under this Agreement. The Parties hereby
acknowledge that neither Party has, nor shall it acquire, any interest in any of the other party’s
Intellectual Property unless otherwise expressly agreed to in writing.
3.2 Reservation of Rights. Except for the rights expressly provided in this Agreement, no
other rights are granted by either Party to the other Party. Notwithstanding anything to the
contrary, no rights or licenses are granted under this Agreement by either Party to the other for
the use of any trade names, trademarks, and service marks.
4. Sale and Purchase Terms
4.1 Purchase.
(a) Fixed Quarterly Quantities. Subject to the other provisions of this Agreement and
unless otherwise agreed upon by the Parties, Organon shall sell and deliver to Biodel and its
Affiliates, and Biodel and its Affiliates shall purchase from Organon, for use only in Biodel’s End
Product(s), one hundred percent (100%) of the Fixed Quarterly Quantities for the Product as
provided in the table below.
| Calendar Quarter | Fixed Quarterly Quantities | Shelf Life Left | ||
Q3 2008
|
[**] | [**] | ||
Q4 2008
|
[**] | [**] | ||
Total 2008
|
[**] | |||
Q1 2009
|
[**] | [**] | ||
Q2 2009
|
[**] | [**] | ||
Q3 2009
|
[**] | [**] | ||
Q4 2009
|
[**] | [**] | ||
Total 2009
|
[**] | |||
Q1 2010
|
[**] | [**] | ||
Q2 2010
|
[**] | [**] | ||
Q3 2010
|
[**] | [**] | ||
Q4 2010
|
[**] | [**] | ||
Total 2010
|
[**] |
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The ‘Shelf Life Left calculation’ using the percentages set forth above will be based upon the
shelf life for the Product as stated in the Drug Master File as filed with the FDA on the Effective
Date (“Shelf Life”) and as measured at the time of shipment of the Product to Biodel (“Shelf Life
Left”). The Parties acknowledge that the Shelf Life at the Effective Date is [**], and the Parties
affirm that they have no knowledge of facts or circumstances that are likely to result in the Shelf
Life being reduced. Notwithstanding the foregoing, if at any time Organon notifies Biodel that the
Shelf Life Left of the Product will be less than [**], then Biodel shall have the option, within
[**] of the date of receipt of such notice, of either (i) reducing, in accordance with Section
4.l(b), the Product ordered by Biodel, or (ii) terminating the Agreement pursuant to Section
11.2(a) with immediate effect; provided further than in either instance Biodel shall not be
obligated to pay the reduction fee contemplated in Section 4.1(b) or the termination fee
contemplated in Section 11.3, as applicable. Under no circumstances, however, will Product be
delivered to Biodel with less than [**] Shelf Life Left.
(b) Voluntary Reduction by Biodel. Notwithstanding § 4.1(a), Biodel may, at its
discretion, in writing request Organon to reduce any individual Fixed Quarterly Quantities for
which Biodel at the date of such request had not issued a Purchase Order, or not yet had to issue a
Purchase Order for in accordance with § 4.3, and Organon shall approve of such request, provided
that (i) Biodel may only make such request [**] per calendar year, (ii) such reduction, with
respect to any individual Fixed Quarterly Quantities, is limited to a total of [**] percent ([**]%)
of the corresponding Fixed Quarterly Quantities as originally included in the table above, and
(iii) Biodel shall, with respect to the [**] consecutive Purchase Orders that it in accordance with
§ 4.3 must issue following its request to reduce Fixed Quarterly Quantities, concurrent with its
respective payments in accordance with § 7.2 for such reduced amount, pay Organon a reduction fee
in the amount of [**] percent ([**]%) of the purchase price, as determined in accordance with §
7.1, that Biodel would have had to pay to Organon for the reduced part(s) of the Fixed Quarterly
Quantities if Biodel had not requested to reduce. Notwithstanding the foregoing, Biodel shall not
be required to pay any reduction fee if the reduction request is related to a Technical Change
referred to under § 5.4(A) as required by any regulatory authority, and the Technical Change
significantly affects the US and/or EU market for the End Product(s); provided, however, that any
disagreement between the Parties with respect to whether a reduction fee should not be due pursuant
to this sentence shall be subject to mediation in accordance with the second paragraph of § 13.12.
As an illustration of the reduction fee: If X was the last calendar
quarter for which a Purchase Order was issued; calendar quarters Y
and Z are next in line with Fixed Quarterly Quantities of [**].
Reduction fee is payable and due concurrent with payment for the,
then reduced, Fixed Quarterly Quantities for both Y and Z,
respectively. Irrespective of the number of reduction requests,
Fixed Quarterly Quantities for Y and Z can never be reduced to less
than [**] (Y) and [**] (Z).
(c) Reduction for Failure to Complete Enzyme Development Work. In the event that the
results of the enzyme development work as set forth on Exhibit D cannot be included in the
application for marketing approval for Biodel’s End Product_known as VIAject™, which
application is set to be filed no earlier than [**] and no later than [**], Biodel shall have the
right to reduce, in whole or in part, the Fixed Quarterly Quantities for those quarters for which
Biodel then had not issued a Purchase Order, or not yet had to issue a Purchase Order for in
accordance with § 4.3.
- 6 -
4.2 Additional Quantity. At any time Organon may, at its discretion, submit a binding offer
to Biodel for any Additional Quantity of Product it would be willing to supply to Biodel in
addition to the Fixed Quarterly Quantities. Biodel has the right to accept such binding offer
within [**] of its receipt thereof by submitting a Purchase Order in accordance with § 4.3, after
which period the offer is no longer binding upon Organon.
4.3 Purchase Orders. Biodel shall order Fixed Quarterly Quantities [**] calendar quarters in
advance, and Biodel shall order Additional Quantities in accordance with Organon’s offer referred
to in § 4.2, provided that Biodel shall issue Purchase orders with respect to Q3 and Q4 2008 and Q1
2009 within [**] of the Effective Date. All orders shall be evidenced by specific and separate
Purchase Orders issued by Biodel to Organon pursuant to this § 4.3. Purchase Orders for Product
may be submitted by Biodel to Organon in writing, or electronically pursuant to a mutually agreed
upon process. All Purchase Orders shall contain: (a) the corresponding Fixed Quarterly
Quantities; (b) the purchase price for Product ordered, in accordance with § 7.1; (c) mutually
agreed to delivery dates, whereby Parties shall initially be bound to a delivery date that lies
within the corresponding calendar quarter; and (d) shipping/installation instructions. If Biodel
issues any such Purchase Orders, Organon shall inform Biodel in writing of its acceptance or
rejection thereof. Upon Organon’s acceptance of a Purchase Order, which Organon shall not refuse
to accept on the basis of arguments that detract from Biodel’s rights under §4.1, § 4.2 and/or §
7.1, such Purchase Order shall be deemed to be a transaction issued under the terms of this
Agreement between the Parties. No additional or inconsistent terms in any Purchase Orders or
Purchase Order acknowledgements shall have any legal effect.
4.4 Limits on Production of the Product. Without detracting from Organon’s obligation to
accept properly issued Purchase Orders, if Organon, becomes aware, that it will be technically or
practically unable (for example as a result of supply chain issues or technical failures) to fill
any Purchase Order or Fixed Quarter Quantity which may become subject to a Purchase Order, then
Organon shall inform Biodel in writing with at least a [**] notice of any reduced capacity, and
Organon shall use commercially reasonable efforts to resolve the condition that caused the need to
reduce such capacity. Organon shall, taking into account customer specific technical limitations
(for example: specific specifications and/or packaging requirements), allocate its available
Recombinant Human Insulin between Biodel and Organon’s other customers proportionally in accordance
with the amount of Recombinant Human Insulin supplied thereto during the twelve (12) months prior
to the condition that caused the need to reduce such capacity.
5. Manufacture
5.1 Raw Materials. Organon shall be responsible for obtaining, and shall store at no cost to
Biodel, any and all materials required for the manufacture of the Product, in reasonable quantities
consistent with Biodel’s forecasts and orders for the Product.
5.2 Manufacture of Product. Organon shall manufacture Product in accordance with § 2.1, §
2.4, and any applicable regulations with respect to the transportation, storage, use, handling and
disposal of hazardous materials. If and to the extent such is not addressed by the Quality
Agreement, each Party shall promptly notify the other of any new instructions or
- 7 -
specifications with respect to the Product required under any applicable laws and shall confer
with each other with respect to the best means to comply with such requirements. Organon
represents and warrants to Biodel that it has, and shall maintain during the term of this
Agreement, all government permits, including without limitation health, safety and environmental
permits, necessary for the conduct of the actions and procedures that it undertakes pursuant to
this Agreement.
5.3 Product Specifications; Testing. Product supplied hereunder shall conform to the
Specification as set forth in Exhibit A and the warranty set forth in § 8.2. Organon shall perform
quality control testing and quality oversight on the Product to be delivered to Biodel or its
designee hereunder.
5.4 Technical Changes. If throughout the duration of this Agreement any controlling
regulatory authority requires, or any Party voluntarily requests, a Technical Change, the Parties
shall discuss in good faith the consequences thereof, including amending any of the terms of this
Agreement. Without detracting from each Party’s right to assess and decide with respect to any
such Technical Change,
(A) if such Technical Change, whether required by any controlling regulatory authority or
voluntarily requested by Biodel, is uniquely related to the use of the Product in the End
Product(s), Organon shall in no event be required to implement such Technical Change to the extent
that this would (i) adversely affect Organon’s ability to manufacture Recombinant Human Insulin for
its other customers or (y) necessitate a Material Change to Organon’s Current Manufacturing
Operations, while
(B) if such Technical Change is required by any controlling regulatory authority or voluntarily
requested by Organon, Biodel shall not be required to implement such Technical Change if such
Technical Change is (i) not required for use of the Product in the End Product(s) and (ii) would
affect the safety, efficacy or quality of the End Product(s), and (iii) would require significant
regulatory filings or new development work.
If the Parties, following good faith negotiations, fail to mutually agree on the consequences of
such required or voluntarily requested Technical Change (including, without limitation, the
allocation of the costs and expenses associated therewith, taking into account, without limitation,
to what extent the relevant Technical Change is specifically related to the use of the Product in
the End Product(s)), then the Parties shall attempt to resolve the matter through mediation in
accordance with § 13.9 and § 13.12. Notwithstanding the foregoing, with respect to a Technical
Change requested by Organon that is not required for the use of the Product in the End Product,
Biodel shall not be required to accept price increases associated with such Technical Change,
unless Biodel agrees with the proposed Technical Change.
6. Delivery and Acceptance
6.1 Time and Place of Delivery. Organon shall ship the Product to Biodel’s Danbury,
Connecticut facility or to such other, or additional, U.S. location(s) as Biodel shall designate
from time to time, to arrive on the scheduled date, or within the timeframe specified, as set forth
in the Purchase Orders as accepted by Organon in accordance with § 4.3. Any deviation
- 8 -
from an agreed upon scheduled delivery date for Product shall occur only upon approval by the
Parties. Organon shall retain samples of each batch as described in the Quality Agreement. In
case Biodel, in a single Purchase Order, requires other than standard packaging and/or packaging
quantities and/or multiple deliveries to one ore more U.S locations, Organon may charge Biodel with
a reasonable fee to cover costs resulting from such requirements.
During the term of this Agreement no Product shall be delivered to Biodel with less Shelf Life
Left than that specified in § 4.1 (a), provided that if as a result of any mutually agreed to
delivery postponements such required level of Shelf Life Left can no longer be met, such required
level shall be reduced by the duration of any such postponement.
6.2 Risk of Loss. Organon shall bear the risk of loss for the Product until delivery to such
designated facility at which time title to the Product and the risk of loss shall pass to Biodel.
6.3 Documents. Each shipment of the Product shall be accompanied by accurate and complete
documents including, but not limited to relevant certificates of analysis, certificates of
compliance and a copy of the invoice.
6.4 Inspection, Acceptance, and Rejection. Biodel shall have the right to inspect the Product
as follows:
(a) Initial Inspection. Biodel shall, without limitation, have the option to audit, inspect,
review, and document, at Organon’s facility, any activities related to the manufacture, including,
but not limited to processing, process testing, and final laboratory release testing to determine
whether the Product is acceptable to Biodel, complies with the Specifications, and is not a
Non-conforming Product. Any participation or presence by Biodel personnel does not waive Organon’s
responsibilities to provide the agreed upon quantity of the Product, on the time of delivery, and
in conformance with the Specifications.
(b) Delivery Inspection. Within [**] from delivery at the facility designated in accordance
with §6.1, Biodel shall perform further testing to determine whether the Product is acceptable to
Biodel, and is not a Non-conforming Product. If Biodel determines that a batch of Product does not
conform to the Specifications based on Biodel’s analysis performed on the Product, or is for any
other reason to be considered a Non-conforming Product, Biodel shall notify Organon thereof in
writing within [**] following delivery. In the event the batch of Product does not conform to
Specifications, or for any other reason is confirmed to be Non-conforming Product, Organon shall at
Biodel’s option either (i) replace such Product free of charge as soon as reasonably possible, but
no later than [**], or (ii) issue a credit note on the basis of the purchase price paid in
accordance with § 7 for such Non-conforming Product. If Biodel requests replacement of
Non-conforming Product and Organon determines that replacement of such Product in a timely manner
is not commercially reasonable, then it shall notify Biodel within a reasonable time, issue a
credit note as described in (ii) above, and the Parties shall discuss in good faith a reasonable
plan, including timeframes, to address any material delivery shortfall created by such
Non-conforming Product. If Biodel does not notify Organon that any batch of Product is a
Non-conforming Product within [**] following delivery of such Product at Biodel’s facility, or does
not reject any Non-conforming Product in accordance with the procedure described above, such
batches of Product shall be deemed to have
- 9 -
been accepted by Biodel; provided, however, that in the case of any batch of Product having
latent defects that could not have been discovered by Biodel within the applicable period described
above despite reasonable inspection by Biodel, Biodel may reject such batch of Product by giving
written notice to Organon of Biodel’s rejection of such batch of Product within [**] following
discovery of such latent defects.
6.5 Expert. If the Parties fail to agree on whether a batch of the Product does not conform
to the Specifications or for any other reason is to be considered a Non-conforming Product or on
the responsibility therefore the matter shall be finally determined by an expert to be nominated by
agreement between the Parties, or failing agreement, by an expert, to be nominated by the CPR. The
expert shall act as an expert and not as an arbitrator, but his opinion shall be binding upon the
parties and his fees and expenses shall be borne by the party against which the expert’s opinion is
rendered.
In no event shall Product, whether Non-conforming or not, be returned to Organon without its
prior written consent. In case it is established in accordance with the terms of this Agreement
that Product is Non-Conforming, Biodel shall at the instruction and cost of Organon either return
or destroy such Product.
7. Pricing; Payment
7.1 Purchase Price. The purchase price of the Product purchased from and delivered by Organon
in any given calendar year pursuant to § 4 and § 6 shall be €[**] Euros) per gram for all
Product delivered.
Within one month of each anniversary date of the Agreement, Organon may adjust the purchase
price in accordance with any unadjusted percentage change in the Chemical Industry Wage Index for
the previous 12 months period, as published by the Central Bureau of Statistics in the Netherlands
by a maximum of [**] percent ([**]%) per adjustment.
7.2 Payment. Biodel shall pay Organon for the Product within [**] of delivery of Product in
accordance with § 6.1, for which Organon shall submit an invoice to Biodel, Attention: Accounts
Payable, 000 Xxx Xxxx Xxxx, Xxxxxxx, XX 00000. If it in good faith disputes any portion of an
invoice, then Biodel shall pay the undisputed amounts and the Parties shall use good faith efforts
to reconcile the disputed amount as soon as practicable, in accordance with the terms of this
Agreement. Organon shall not suspend work or seek to terminate this Agreement or any Purchase
Order on account of Biodel’s failure to pay any invoiced amount which is the subject of a good
xxxxx xxxx fide dispute, provided that Biodel pays all undisputed amounts. In the event Organon
has a good faith belief that Biodel may not meet it’s financial obligations under this Agreement
then Organon shall notify Biodel, in writing, within a reasonable time, not to exceed [**] of such
concerns. The Parties shall discuss, and meet as necessary, to negotiate a good faith resolution
to such concerns, may refer the matter to their respective senior management, or attempt to resolve
through mediation in accordance with § 13.12. If Biodel fails to pay any undisputed amount when
due, then, without prejudice to any other rights Organon may have, but only after having in good
faith consulted Biodel, Organon may provide notice to the immediate effect that:
- 10 -
(i) default interest shall be due on the amount outstanding at the rate of one percent (1%)
per month;
(ii) all costs, including judicial, made in order to obtain payment by Biodel of the amount(s)
due, shall be for account of Biodel;
(iii) Organon shall, notwithstanding its obligation to consult in good faith with Biodel, at
its discretion be entitled to demand adequate security to cover arrears, to demand prepayment of
further deliveries as the terms thereof shall be reasonably discussed with Biodel, or to suspend
further deliveries.
7.3 Taxes. Unless otherwise provided on the Purchase Order, in addition to the price stated
on the face of the invoice, Biodel shall pay costs for all sales, use, or excise taxes, assessments
or other charges attributable to the sale, use, shipment transportation, or delivery of the goods.
In the event that any such charges can be waived or Biodel is entitled to a refund, Organon will
reasonably cooperate with Biodel and reasonably assist Biodel in obtaining such waiver or refund.
8. Representations And Warranties; Covenants
8.1 General Representations and Warranties. Each Party represents and warrants:
(a) Corporate Power and Authorization. It is duly organized and validly existing under the
laws of the state of its incorporation, and has full corporate power and authority to execute and
deliver this Agreement and to perform all of its obligations hereunder; and
(b) Binding Agreement. This Agreement is a legal and valid obligation binding upon it and
enforceable in accordance with its
terms; and
terms; and
(c) No Conflict. The execution, delivery and performance of this Agreement by such Party does
not conflict with any agreement, instrument or understanding, oral or written, to which it is a
Party or by which it may be bound, nor violate any law or regulation of any court, governmental
body, or administrative or other agency having jurisdiction over it; and
(d) Resources. It has adequate resources, both financial and otherwise, to perform its duties
hereunder.
8.2 Warranty. Organon represents and expressly warrants that the Product provided hereunder
shall conform to the Specifications shall be in compliance with all applicable laws and
regulations, and free from defect, claim, encumbrance or lien, and, subject to § 4.3, shall be
delivered according to the terms of the relevant Purchase Order. Organon represents and expressly
warrants that it has and shall at all times throughout the term of this Agreement has, whether by
right, title, interest, including by license or otherwise, the Intellectual Property Rights that
are required to use, manufacture, market, offer to sell, sell, import and export the Product in
accordance with the terms of this Agreement and that neither this Agreement nor the act of any
Party pursuant hereto shall infringe any third party rights. Biodel warrants that it shall only
use the Product for the sole purpose of the use, manufacture, marketing, sale and distribution of
the
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End Product(s) in the Territory only. EXCEPT AS EXPRESSLY PROVIDED HEREIN, ORGANON MAKES NO
OTHER WARRANTIES, EXPRESS OR IMPLIED, AS TO THE QUALITY OR FITNESS FOR PURPOSE OF THE PRODUCT
SUPPLIED TO BIODEL.
8.3 Covenants. Contemporaneous with the Effective Date, the Parties hereby agree to negotiate
in good faith the execution of a Quality Agreement. Such Quality Agreement shall be mutually
agreed to in writing prior to the first delivery of Product under this Agreement.
9. Indemnification And Liability
9.1 Mutual Indemnification. Each Party (the “Indemnifying Party”) shall defend, indemnify and
hold harmless the other Party and its Affiliates, and their respective directors, employees,
consultants and agents (the “Indemnified Parties”) from and against any and all liabilities,
losses, damages, costs, and other expenses (including reasonable attorneys’ and expert witnesses’
costs and fees) (“Losses”) incurred by the Indemnified Parties as a result of any claim, demand,
action or proceeding by any third party (a “Claim”) to the extent arising from or relating to (i)
any material breach of any representation, warranty, covenant, or obligation of the Indemnifying
Party under this Agreement or any intentional misconduct or negligence by the Indemnifying Party or
any of its employees, agents, or subcontractors, or (ii) the manufacture, sale and/or use of End
Product(s) by or on behalf of Biodel, except, in each case, to the extent such Losses result from
the intentional misconduct or negligence of, any of the Indemnified Parties.
9.2 Indemnification Procedures. In the event of any Claim for which any Indemnified Party is
or may be entitled to indemnification hereunder, the Indemnified Party may, at its option, require
the Indemnifying Party to defend such Claim at the Indemnifying Party’s sole expense. Indemnifying
Party may not agree to settle any such Claim without the Indemnified Party’s express prior written
consent.
9.3 Failure to Defend or Settle. If the Indemnifying Party fails or wrongfully refuses to
defend or settle any Claims, then the Indemnified Party shall, upon written notice to the
Indemnifying Party, have the right to defend or settle (and control the defense of) such Claims.
In such case, the Indemnifying Party shall cooperate, at its own expense, with the Indemnified
Party and its counsel in the defense and settlement of such Claims, and shall pay, as they become
due, all costs, damages, and reasonable legal fees incurred therefore.
9.4 Liability. IN NO EVENT OTHER THAN IN CASE OF INTENTIONAL MISCONDUCT OR GROSS NEGLIGENCE
WILL EITHER OF THE PARTIES BE LIABLE TO THE OTHER FOR ANY INDIRECT OR CONSEQUENTIAL LOSS OR DAMAGES
OR LOSS OF PROFITS IN RELATION TO, OR ARISING OUT OF THE OPERATION OR TERMINATION OF THIS
AGREEMENT. EACH PARTY’S LIABILITY TO THE OTHER PARTY UNDER THIS AGREEMENT, REGARDLESS OF THE CAUSE
OF ACTION, IS LIMITED TO THE TOTAL VALUE AMOUNT OF INVOICES PAID OR PAYABLE BY BIODEL UNDER THIS
AGREEMENT AND/OR THE SUPPLY AGREEMENT BETWEEN THE PARTIES OF 4 APRIL, 2004 WITHIN THE 12 MONTHS
IMMEDIATELY PRECEDING SUCH CLAIM.
- 12 -
10. Insurance Protection. Each Party shall obtain and maintain during the term of
this Agreement liability, comprehensive, and workers’ compensation insurance with a reputable
insurance company to help protect against those insurable risks that such Party may incur in
connection with the performance of its obligations under this Agreement. Each Party shall provide,
upon request, to the other Party any such policies of such insurance, and the premium receipt(s)
and insurance certificate(s) therefore.
11. Term; Termination
11.1 Term. This Agreement shall begin on the Effective Date and, unless terminated sooner as
provided in § 11.2, end December 31st 2010.
11.2 Termination Events
(a) At Will. Biodel may terminate this Agreement with immediate effect upon written notice to
Organon.
(b) For Cause. Organon shall have the right to terminate this Agreement for cause with
immediate effect if Biodel materially breaches this Agreement and fails to cure such material
breach within [**] after receiving written notice that specifies the particulars of such breach.
(c) Force Majeure. Organon shall have a right to terminate this Agreement in accordance with
§ 13.13.
(d) Business Circumstances. Organon shall have the right to terminate this Agreement with
immediate effect in the event of Biodel’s liquidation, bankruptcy or state of insolvency.
(e) Manufacturing Decisions. Organon may terminate this Agreement upon a ten (10) business
days written notice to Biodel if the Parties fail to reach agreement after any mediation conducted
in accordance with § 5.4.
11.3 Effects of Termination. Upon the expiration or termination of this Agreement, (a) Biodel
shall pay to Organon all amounts due to Organon under this Agreement; (b) Organon shall deliver to
Biodel all Product for which a delivery date under a Purchase Order has passed; and (c) subject to
the Confidentiality Agreement, each Party shall return to the other Party, upon the other Party’s
request, all tangible items of the other Party in its possession or under its control evidencing
the Confidential Information of the other Party. The expiration or earlier termination of this
Agreement shall not affect any rights or claims of a Party hereunder that accrued prior to the date
of such expiration or earlier termination.
In the event the Agreement is terminated (i) by Biodel pursuant to § 11.2(a), or (ii) by
Organon pursuant to § 11.2(e) following the Parties’ failure to reach agreement after any mediation
conducted in accordance with § 5.4 with respect to any Technical Change referred to under § 5.4(A),
then Biodel has the option, within [**] of sending or receiving a termination notice, to request
delivery of all Product for which, on or before the date of termination of this
- 13 -
Agreement, a Purchase Order was issued in accordance with § 4.3 but no delivery date has
passed and Organon shall accept and perform such Purchase Orders, and Biodel shall subsequently
take delivery and pay for the Product, all in accordance with the terms of this Agreement; provided
that in the event that Biodel does not timely make use of such option, Organon is entitled to, and
Biodel will within [**] sending or receiving such termination notice pay to Organon a termination
fee to the amount of (a) seventy-five percent (75%) of the purchase price, as to be determined in
accordance with §4.1 and § 7.1, of all the Fixed Quarterly Quantities corresponding with the said
Purchase Orders, plus (b) fifty percent (50%) of the purchase price, as to be determined in
accordance with §4.1 and § 7.1, of the Fixed Quarterly Quantity corresponding to the calendar
quarter for which Biodel, but for the termination of this Agreement, would have had to issue a
Purchase Order for first.
11.4 Survival. Sections (§) § 1, § 2.3, § 3, § 7.2 and § 7.3, § 8, § 9, § 10, § 11.3 and §
11.4, § 12, and § 13 shall survive the expiration or termination of this Agreement.
12. Confidential Information
12.1 Confidentiality Obligations. Each Party shall at all times, and notwithstanding any
termination or expiration of this Agreement, hold in confidence and not disclose to any third party
Confidential Information of the other Party, except as approved in writing by the other Party to
this Agreement, and shall use the Confidential Information for no purpose other than the purposes
expressly permitted by this Agreement. Each Party shall only permit access to Confidential
Information of the other Party to those of its employees, consultants, agents, and attorneys having
a need to know and who are bound by confidentiality obligations at least as restrictive as those
contained herein. The obligations in this § 12.1 shall terminate [**] years from the date of
expiration or termination of this Agreement in accordance with §11.
12.2 Exceptions to Confidentiality Obligations. A Party’s obligations under this Agreement
with respect to any portion of the other Party’s Confidential Information shall terminate when the
Party that is subject to such obligations can document in writing that such information: (a)
entered the public domain through no fault of such Party; (b) it was in such Party’s possession
free of any obligation of confidence at the time it was communicated to such Party by the other
Party; (c) it was rightfully communicated to such Party free of any obligation of confidence
subsequent to the time it was communicated to such Party by the other Party; or (d) it was
developed by employees or agents of such Party independently of and without reference to any
information communicated to such Party by the other Party.
12.3 Authorized Disclosure. Notwithstanding anything to the contrary, a Party shall not be in
violation of § 12.1 with regard to a disclosure of the other Party’s Confidential Information that
is in response to a valid order by a court or other governmental body or necessary to comply with
applicable law or governmental regulations, provided that if such Party is required to make any
such disclosure of the other Party’s Confidential Information it shall to the extent practicable
give reasonable advance notice to the other Party of such disclosure requirement in order to permit
the other Party to seek confidential treatment of or to limit the Confidential Information required
to be disclosed.
- 14 -
12.4 Separate Confidential Disclosure Agreements. Any prior confidential disclosure
agreements between the Parties are incorporated by reference to this Agreement, except for the
Confidentiality Agreement. In case of a discrepancy between the terms of this Agreement and such
prior agreements, the terms of this Agreement shall prevail; in case of a discrepancy between the
terms of this Agreement and the Confidentiality Agreement, the terms of the Confidentiality
Agreement shall prevail. Notwithstanding the foregoing, the Parties from time to time may execute
additional confidential disclosure agreements, as required by their respective SOPs, for the
limited and specific purpose of conducting audits.
13. Miscellaneous
13.1 Assignment. Except as expressly provided hereunder, and subject to the Confidentiality
Agreement, neither this Agreement nor any rights or obligations hereunder may be assigned or
otherwise transferred by either Party without the prior written consent of the other (which consent
shall not be unreasonably withheld); provided, however, that either Party may assign this Agreement
and its rights and obligations hereunder without the other Party’s consent, to any Affiliate or to
any successor in title to the whole or part of that part of a Party’s business to which this
Agreement pertains. Notwithstanding the foregoing, any such assignment to an Affiliate or
successor in title shall not relieve the assigning Party of its responsibilities for performance of
its obligations under this Agreement. The rights and obligations of the Parties under this
Agreement shall be binding upon and inure to the benefit of the successors and permitted assigns of
the Parties. Any assignment not in accordance with this Agreement shall be void.
In the event a prospective successor in title to the whole or part of that part of a Party’s
business to which this Agreement pertains desires to review information that is subject to the
Confidentiality Agreement, Organon shall reasonably cooperate in arranging a supervised, read-only
review (e.g. no notes or copies) at Organon’s facilities in Oss, The Netherlands.
13.2 Relationship of the Parties. It is expressly agreed that Organon and Biodel shall be
independent contractors and that the relationship between the Parties shall not constitute a
partnership, joint venture or agency of any kind. Neither Party shall have the authority to make
any statements, representations or commitments of any kind, or to take any action, which shall be
binding on the other Party, without the prior written consent of the other Party.
13.3 Amendment. Unless otherwise provided herein, this Agreement may not be changed, waived,
discharged, or terminated orally, but instead only by a written document that is signed by the duly
authorized officers of both Parties.
13.4 Waiver. No failure or delay by either Party in exercising any right, power, or privilege
under this Agreement shall operate as a waiver thereof, nor shall any single or partial waiver
thereof include any other or further exercise thereof or the exercise of any other right, power, or
privilege.
13.5 Severability. Whenever possible, each provision of the Agreement shall be interpreted in
such manner as to be effective and valid under applicable law, but if any term or provision of this
Agreement is held to be prohibited by or invalid under applicable law, such
- 15 -
provision shall be ineffective only to the extent of such prohibition or invalidity, without
invalidating the remainder of the Agreement and this Agreement shall be interpreted and construed
as if such provision had never been contained herein.
13.6 Notices. All notices and statements to be given (which shall be in writing) and all
payments to be made hereunder shall be given or made at the respective addresses of the Parties as
set forth above, unless notification of a change of address is given. All notices, payments and
statements to be made hereunder shall be mailed by certified or registered mail, return receipt
requested, or sent by overnight courier, or by facsimile or other electronic means. Any notice
given pursuant to this Agreement by mail shall be considered effective three (3) business days
after mailing. Any notice sent by overnight courier shall be considered effective one day after
mailing. The date of transmission of any notice sent by electronic means shall be deemed to be the
date the notice or statement is transmitted.
13.7 Construction. The section headings of this Agreement are inserted only for ease of
reference only, and shall not be used to interpret, define, construe, or describe the scope or
extent of any aspect of this Agreement. Unless otherwise expressly stated, when used in this
Agreement the word “including” means “including but not limited to.” Each Party represents that it
has had the opportunity to participate in the preparation of this Agreement and hence the Parties
agree that the rule of construction that ambiguities be resolved against the drafting Party shall
not apply to this Agreement.
13.8 No Third Party Beneficiaries. Unless expressly provided, no provisions of this Agreement
are intended or shall be construed to confer upon or give to any person other than Biodel and
Organon any rights, remedies, or other benefits under or by reason of this Agreement.
13.9 Dispute Resolution. If a dispute arises under this Agreement, the Parties shall use
reasonable efforts to attempt to resolve such dispute, including escalation of discussions to the
appropriate level of management, as provided in § 13.12, prior to commencing an action against the
other Party. Notwithstanding the foregoing, either Party may at any time seek equitable relief
under § 13.10 without first attempting to resolve a dispute under this § 13.9 provided, however,
that such Party notifies the other Party promptly after it files any such action.
13.10 Equitable Relief. Each Party acknowledges and agrees that any breaches of this
Agreement (included without limitation violations of §3 and/or §12) may cause the non-breaching
Party irreparable damage for which the award of monetary damages would be inadequate.
Consequently, the non-breaching Party may seek to enjoin the breaching Party from any and all acts
in violation of any such provisions, which remedy shall be cumulative and not exclusive, and a
Party may seek the entry of an injunction enjoining any breach or threatened breach of such
provisions, in addition to any other relief to which the non-breaching Party may be entitled at law
or in equity.
13.11 Governing Law. This Agreement shall be governed by and interpreted under the laws of
the State of New York without regard to its conflict or choice of law provisions. The United
Nations Convention on Contracts for the International Sale of Goods shall not apply to this
Agreement.
- 16 -
13.12 Alternative Dispute Resolution. The Parties shall attempt by direct good faith
negotiations to resolve promptly any dispute arising out of or relating to this Agreement. If the
matter cannot be resolved in the normal course of business either Party shall give the other Party
written notice (the “Dispute Notice”) of any such dispute not resolved at which time the dispute
shall be referred to the senior management of the respective Parties who shall likewise attempt to
resolve the dispute.
If the dispute has not been resolved by negotiation as detailed above, or if the Parties fail
to meet, within thirty (30) business days of the Dispute Notice, then the Parties shall endeavor to
settle the dispute by mediation under the supervision of and in accordance with the CPR Model
Mediation Procedure for Business Disputes in Europe. Unless otherwise agreed, both parties or each
individual party may request the CPR to appoint an independent mediator. The language of the
mediation shall be in English and the seat of mediation shall be agreed upon by both parties or, in
the event the parties do not timely agree, the seat will be determined by the mediator.
If the dispute has not been resolved by mediation as detailed above within ninety (90) days of
the Dispute Notice, either party may submit the dispute to arbitration for resolution in accordance
with the CPR Arbitration Rules. A single, impartial arbitrator mutually acceptable to the Parties
shall conduct the arbitration. In the event the Parties cannot agree on an arbitrator within
twenty (20) business days of the submission of the dispute to arbitration, either Party may request
the CPR to appoint an arbitrator.
The seat of the arbitration shall be in London, United Kingdom, unless the Parties agree
otherwise. As a condition of appointment of the arbitrator, said arbitrator shall agree to use
her/his best efforts to conclude the proceeding within ninety (90) business days. Said arbitrator
shall have the authority to limit the volume of evidence and documents to be submitted by the
Parties. Any court having jurisdiction thereof may enter judgment upon the award rendered by the
arbitrator. This § 13.12 shall, however, not be construed to limit or to preclude the rights of
either Party under § 13.10 from bringing any action in any court of competent jurisdiction for
injunctive or other provisional relief as necessary or appropriate.
13.13 Force Majeure. Neither Party shall be liable to the other for any failure or delay in
the performance of any of its obligations under this Agreement arising out of any event or
circumstance beyond its reasonable control, including war, rebellion, terrorism, civil commotion,
strikes, lock-outs or industrial disputes; fire, explosion, earthquake, acts of God, flood or
drought; or requisitioning or other act or order by any government, council, or constituted body.
If such failure or delay occurs, then the affected Party shall give the other Party notice of the
circumstances causing such failure or delay, and such Party shall be excused from the performance
of such of its obligations that it is thereby disabled from performing for so long as it is
disabled and for thirty (30) days thereafter; provided, however, that such affected Party commences
and continues to take reasonable and diligent actions to cure such failure or delay.
Notwithstanding the foregoing, if a Party is disabled from the performance of any material
obligation under this Agreement for a period of ninety (90) days or more, then the other Party
shall have the right to terminate this Agreement upon written notice to the other Party, in which
event the provisions of § 11.3 shall apply.
- 17 -
13.14 Attorneys’ Fees. If any claim, action, or dispute arises between the Parties with
respect to any matter covered by this Agreement that leads to a proceeding before a court of
competent jurisdiction to resolve such claim, the Prevailing Party in such proceeding shall be
entitled to receive from the other Party its reasonable attorneys’ fees, expert witness fees, court
costs and other out-of-pocket costs incurred in connection with such proceeding, in addition to any
other relief that it may be awarded. For purposes of this § 13.14, the term “Prevailing Party”
means that Party in whose favor any monetary or equitable award is made or in whose favor any
dispute is resolved, regardless of any settlement offers.
13.15 Publicity. Neither Party shall disclose the fact that they are conducting business
together or the existence of, or the provisions of, this Agreement to any other party unless such
disclosure is in response to a valid order by a court or other governmental body or necessary to
comply with applicable governmental law or regulations provided. Notwithstanding the foregoing,
each Party shall have the right to issue from time to time press releases that disclose the
relationship of the Parties under this Agreement upon the agreement of the Parties, which agreement
shall not be unreasonably withheld, delayed, or conditioned. Any press releases that are to be
issued by either Party shall be in a form and substance as may be mutually agreed upon by the
Parties.
13.16 Entire Agreement. This Agreement includes all exhibits attached hereto (subject to §
8.3 with regard to the Quality Agreement) and any Specifications that are executed by authorized
representatives of the Parties, and constitutes the entire Agreement by and between the Parties as
to the subject matter hereof. Subject to § 12.4, this Agreement supersedes and replaces in its
entirety all prior agreements, understandings, letters of intent, and memoranda of understanding by
and between the Parties hereto, in either written or oral form, including without limitation the
supply agreement between the Parties of 4 April, 2005. No amendment or modification of this
Agreement shall be valid unless set forth in writing referencing this Agreement and executed by
authorized representatives of both Parties.
13.17 English Language. This Agreement has been prepared in the English language and the
English language shall control its interpretation. In addition, all notices required or permitted
to be given hereunder, and all written, electronic, oral or other communications between the
Parties regarding this Agreement, or delivered pursuant to the terms of this Agreement, shall be in
the English language. Any proceedings related to dispute resolution including, but not limited to
legal, equitable, or alternative dispute resolution, shall be conducted in the English language.
- 18 -
In Witness Whereof, the Parties hereto have this day caused this Agreement to be
executed by their duly authorized officers.
| N.V. Organon | Biodel Inc. | |||||||||
By:
|
/s/ Xxxxxxx Xxxxxxx | By: | /s/ Xxxxxxx X. Xxxxxxx | |||||||
| Title: VP API/BT Global Supply Chain | Title: President & Chief Executive Officer | |||||||||
| Date: 10-July-2008 | Date: 7-July-2008 | |||||||||
| N.V. Organon | ||||||||||
By: |
/s/ K.S. Xxxxxxxx | |||||||||
| Name: K.S. Xxxxxxxx | ||||||||||
| Title: Managing Director | ||||||||||
| Date: 10-July-2008 | ||||||||||
- 19 -
Exhibit A
SPECIFICATIONS
SPECIFICATIONS
Product shall be delivered with a Certificate of Analysis following the most recent version of
the European Pharmacopeia (EP) or the United States Pharmacopeia (USP), respectively, whereby the
A-21 desamido levels of all batches of Product delivered in a calendar quarter shall be at or below
[**] percent ([**]%).
- 20 -
Exhibit B
QUALITY AGREEMENT
QUALITY AGREEMENT
To be provided
- 21 -
Exhibit C
CONFIDENTIALITY AGREEMENT
CONFIDENTIALITY AGREEMENT
- 22 -
CONFIDENTIALITY AGREEMENT
THIS CONFIDENTIALITY AGREEMENT (The “Agreement”) is made this 7th day of July 2008 by and
between
N.V. Organon, a limited liability company incorporated under Dutch law having its
registered office at Xxxxxxxxxxxxxx 0, 0000 XX Xxx, xxx Xxxxxxxxxxx (“Organon”),
and
Biodel Inc., a Delaware corporation, with its principal office and place of business at
having its offices at 000, Xxx Xxxx Xxxx, Xxxxxxx XX 00000, X.X.X., (“Biodel”),
each a “Party”, and when collectively referred to, “Parties”
WITNESSETH:
WHEREAS, Organon (through its predecessor organization Diosynth B.V.) and Biodel have
previously entered into a supply agreement, dated the 4th day of April 2005 regarding
the supply to Biodel of recombinant human insulin (rHI) (the “Product”) by Organon in respect of
Biodel’s proprietary formulations of insulin (the “End Product(s)”; the “Old Supply Agreement”);
WHEREAS, Organon and Biodel have in good faith negotiated the terms and conditions of a new
supply agreement for the manufacture for and supply to Biodel of the Product for the End
Product(s), which new supply agreement is executed concurrent with this Agreement and replaces the
Old Supply Agreement (the “New Supply Agreement”);
WHEREAS, Biodel has requested Organon to grant access to Biodel of Organon’s certain
proprietary information with respect to the Product (“Confidential Information”) as is necessary
for the purpose of preparing and maintaining the ‘Drug Substance Quality Section’ of the ‘Common
Technical Documents’ that form part of Biodel’s application for a marketing authorization for its
End Product VIAject® (the “Marketing Authorization”) with the relevant regulatory bodies in the
European Union (the “EMEA”) (the “Purpose”); and
WHEREAS, in consideration of the foregoing, which forms part of this Agreement, the Parties
agree to the terms and conditions as set out below;
IT IS HEREBY AGREED AS FOLLOWS:
| 1. | Upon execution of this Agreement by the Parties, Organon shall, solely for the Purpose and only to the extent required therefore and subject to the final sentence of this Article 1, discuss, Confidential Information with the following Representatives (as defined below) of Biodel only: | |
| • [**] | ||
| (jointly, the “Designated Persons”), |
1 - 9
| who will, prior to the aforementioned discussion of Confidential Information, co-sign this Agreement as an acknowledgement of having reviewed this Agreement with Biodel’s General Counsel with the purpose of understanding Biodel’s obligations hereunder. The Parties agree that the Designated Persons shall also be Representatives of Biodel Europe (as defined in Article 10 hereof). For the avoidance of doubt, (i) physical access to and disclosure of the Confidential Information to the Designated Persons shall only be granted by Organon as of the date that lies [**] before the date of submission of an application for the Marketing Authorization with the EMEA, provided that the terms of this Agreement shall fully apply thereto, and (ii) any other proprietary and confidential information than the Confidential Information (e.g. proprietary and confidential information that Organon also discloses to Biodel with respect to regulatory filings in other countries and/or jurisdictions in the Territory than the European Union), or any other proprietary and confidential information shall be governed by the confidentiality terms under the New Supply Agreement. | ||
| 2. | For purposes of this Agreement, the term Confidential Information shall not include information which, as adequately substantiated by documentation, (i) is or becomes publicly available other than as a result of a disclosure by Biodel or any of its directors, officers, employees, affiliates, or other representatives (with regard to Biodel or Organon, respectively, the “Representatives”, in the case of Biodel including without limitation the Designated Persons) in violation of this Agreement or other obligation of confidentiality or (ii) is or becomes available to Biodel or its Representatives on a non-confidential basis from a source (other than Organon or its Representatives) not known by Biodel or its Representatives to be prohibited from disclosing such Confidential Information to Biodel or its Representatives by a legal, contractual or fiduciary obligation. | |
| 3. | Biodel agrees to keep secret and confidential all Confidential Information and to use the Confidential Information solely for the Purpose. In that respect, and subject to the other terms of this Agreement, Biodel, solely through its Designated Persons, is entitled to provide the Confidential Information to, and to liaise with, the EMEA only. The Designated Persons shall keep a detailed log of the dealings and correspondence with the EMEA regarding the Confidential Information and Biodel shall at least quarterly provide Organon with an update of any permitted use, as described in the Purpose, of Confidential Information, including copies of the aforementioned dealings and correspondence. Unless Biodel has obtained Organon’s prior written approval thereto, (i) Biodel shall not in any way amend or modify (e.g. change, delete, add to) the Confidential Information, or parts thereof, (ii) nor shall Biodel respond to any questions by the EMEA if and to the extent the response directly or indirectly requires or results in the use of or the reference to, or is otherwise related to, the Confidential Information. | |
| 4. | Except as explicitly provided for in Articles 3 and 10 hereof, Biodel shall not, and shall cause the Designated Persons not to, (i) disclose any of the Confidential Information to any other person (without limitation including Biodel’s Representatives other than the Designated Persons), and/or (ii) make copies of, and/or prepare analyses, compilations, forecasts, studies, or other documents based in whole or in part on, or otherwise containing or reflecting any of, the Confidential Information. |
2 - 9
| 5. | Biodel agrees to assume liability for any breach of this Agreement resulting from the act or omission of any of its Representatives, and Biodel shall guarantee the respecting of all obligations under this Agreement by it or its Representatives. Biodel hereby represents and warrants that it has entered into confidentiality agreements with each of its Representatives that will enable Biodel to meet its obligations hereunder. | |
| 6. | In the event that Biodel or its Representatives are requested pursuant to, or required by, applicable law, regulation or legal process to disclose any of the Confidential Information, whether or not such disclosure is or would be in accordance with the Purpose, Biodel will notify Organon promptly so that it may take appropriate action or direct Biodel to take such action, including but not limited to, seeking an appropriate protective order, or, in Organon’s sole discretion, waive compliance with the terms of this Agreement (and Biodel will provide such cooperation as Organon shall reasonably request). In the event that (i) despite Organon’s and Biodel’s mutual efforts to take appropriate action to protect the Confidential Information from disclosure Biodel or its Representatives are nonetheless legally compelled to disclose such Confidential Information, or (ii) Organon waives compliance with the terms of this Agreement, Biodel or its Representatives, as the case may be, will furnish only that portion of the Confidential Information which they are advised in writing by counsel is legally required and will give Organon written notice (unless prohibited by law) of the Confidential Information to be disclosed as far in advance as practicable and exercise all reasonable efforts to obtain reliable assurance that confidential treatment will be accorded the Confidential Information. | |
| 7. | If, for whatever reason, (i) Biodel has not submitted an application for the Marketing Authorization with the EMEA prior to [**], (ii) Biodel has not obtained approval from the EMEA with respect to the Marketing Authorization prior to [**], and/or (iii) Biodel intends to assign or otherwise transfer the Marketing Authorization, or any of its rights thereunder, to any third party or affiliate (other than to Biodel Europe in accordance with Article 10 hereof), then Biodel shall timely inform Organon thereof and, subsequently, if and to the extent requested by Organon, return and/or deliver to Organon, at Biodel’s expense, any and all copies of the Confidential Information, and no copy thereof will be retained by Biodel or its Representatives; provided that any orally disclosed Confidential Information will continue to be subject to the terms of this Agreement, and provided further that Biodel may retain one complete archival copy of the Confidential Information, with an independent third party mutually agreed to in writing between the Parties, in accordance with professional standards of practice for the sole purpose of meeting its regulatory obligations. With respect to the foregoing, in the event of the occurrence of a circumstance referred to under (i) or (ii) above, Organon shall only request such return of the Confidential Information if good faith discussions with Biodel have not lead to amendment of the dates mentioned in (i) and/or (ii); in the event of the occurrence of a circumstance referred to under (iii), Organon shall only request such return of the Confidential Information if the (prospective) transferee party, at the time of such transfer, is active in the manufacturing of recombinant human insulin API market, or can reasonably be expected to become active therein within [**]. By way of example with respect to the occurrence of a circumstance referred to under (ii) above, Organon shall reasonably agree to an amendment of the date mentioned in (ii) above if EMEA |
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| requests the performance of additional clinical development work which would reasonably be expected to delay receipt of approval for the Marketing Authorization beyond the date specified in (ii) above. If Organon for any reason did not make use of its rights hereunder with respect to a particular event as referred to above, such does not preclude Organon from exercising such rights with respect to such other previous, simultaneous or subsequent events. | ||
| 8. | Biodel acknowledges that remedies at law may be inadequate to protect Organon against any actual or threatened breach of this Agreement by it or any of its Representatives, and, without prejudice to any other rights and remedies otherwise available to Organon, Biodel agrees that Organon may seek to enjoin Biodel from any and all acts in violation of any such provisions, which remedy shall be cumulative and not exclusive, and Organon may seek the entry of an injunction enjoining Biodel from any breach or threatened breach of such provisions, in addition to any other relief to which Organon may be entitled at law or in equity, without proof of actual damages. In the event of litigation relating to this Agreement, if a court of competent jurisdiction determines in a final, non-appealable order that this Agreement has been breached by Biodel and/or its Representatives, then Biodel will reimburse Organon for its costs and expenses (including, without limitation, reasonable legal fees and expenses) incurred in connection with all such litigation to the extent a judgment is actually obtained. | |
| 9. | No failure or delay by Organon in exercising any right hereunder will operate as a waiver thereof, nor will any single or partial exercise thereof preclude any other or further exercise thereof or the exercise of any right hereunder. | |
| 10. | Neither this Agreement nor any rights or obligations hereunder may be assigned or otherwise transferred by Biodel without the prior written consent of Organon; provided, however, that Biodel may assign this Agreement and its rights and obligations hereunder (including, without limitation, the transfer of Confidential Information through Designated Persons) without Organon’s consent to any corporation or other business entity which (i) is based in a member state of the European Union (other than an Excluded Country, as defined in the New Supply Agreement), and (ii) is wholly owned and controlled by Biodel. Notwithstanding the foregoing, any such assignment shall not relieve Biodel of its responsibilities for performance of its obligations under this Agreement. The rights and obligations of the Parties under this Agreement shall be binding upon and inure to the benefit of the successors and permitted assigns of the Parties. Any assignment not in accordance with this Agreement shall be void. | |
| 11. | This Agreement will be governed by, construed in accordance with and enforceable under the laws of The Netherlands. Each party consents and submits to personal jurisdiction in The Netherlands, to settle any dispute concerning the conclusion, validity, interpretation or performance of this Agreement. Biodel and the Designated Persons agree that they may be served with process at the address set forth on the first page hereof. | |
| 12. | This Agreement contains the entire agreement between Biodel and Organon concerning the Confidential Information, and as such prevails over the Confidentiality Agreement of |
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| 11 April 2007, and no provision of this Agreement may be waived, amended or modified, in whole or in part, nor any consent given, unless beforehand approved in writing by duly authorized Representatives of Organon and Biodel respectively, which writing specifically refers to this Agreement and the provision so amended or modified or for which such waiver or consent is given. In the event that any provision of this Agreement is deemed invalid, illegal or unenforceable, the validity, legality and enforceability of the remaining provisions of this Agreement will not in any way be affected or impaired thereby. | ||
| 13. | Neither this Agreement nor any disclosure of Confidential Information shall be deemed by implication or otherwise to vest in Biodel any present or future rights in any patents, trade secrets or property belonging to or controlled by Organon and no license is granted except as explicitly stated in this Agreement. Biodel further acknowledges and agrees that this Agreement does not, by implication or otherwise, purport in any way to an obligation on the part of Organon (i) to supply Biodel with the Product, other than agreed to in the New Supply Agreement, or (ii) to expand the scope of the Purpose. | |
| 14. | This Agreement is and remains valid until the date of termination or expiry of the New Supply Agreement or, if applicable, of any written supply arrangement following the New Supply Agreement; provided that the obligations of confidentiality and non-use set forth in this Agreement expire [**] years from such date. | |
| AS AGREED upon and signed in duplicate by authorised representatives of each party |
| N.V. Organon | Biodel Inc. | |||||
| /s/ Xxxxxxx Xxxxxxx | /s/ Xxxxxxx X. Xxxxxxx | |||||
By: Xxxxxxx Xxxxxxx
|
By: | Xxxxxxx X. Xxxxxxx, Pd.D | ||||
Title: VP
API/BT Global Supply Chain
|
Title: | President and CEO | ||||
Date: 10-6-08
|
Date: | 7 July 2008 | ||||
Place:
|
Place: | Danbury, CT USA | ||||
N.V. Organon |
||||||
/s/ K.
S.
Xxxxxxxx |
||||||
Title: Managing
Director |
||||||
Date: 00-0-00 |
||||||
Xxxxx: |
||||||
Pursuant to Article 1 of this Agreement, the Designated Persons indicate by their signature
below that they acknowledge having reviewed this Agreement with Biodel’s General Counsel for the
sole purpose of understanding Biodel’s obligations hereunder. The Parties agree that the
Designated Individuals shall not become individually liable as a result of signing below.
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| /s/ [**] |
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By:
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[**] | |||||
Title:
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[**] | |||||
Date: |
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Place: |
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| /s/ [**] | ||||
By:
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[**] | |||
Title:
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Date: |
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Place: |
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| /s/ [**] | ||||
By:
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[**] | |||
Title:
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Date: |
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Place: |
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Title: |
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Date: |
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Place: |
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Title: |
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Place: |
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Title: |
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Exhibit D
ENZYME DEVELOPMENT WORK PLAN
ENZYME DEVELOPMENT WORK PLAN
Confidential
Materials omitted and filed separately with the Securities and
Exchange Commission.
A total of 6 pages have been omitted.
[**]
A total of 6 pages have been omitted.
[**]
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