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DEVELOPMENT AND MANUFACTURING AGREEMENT

Manufacturing Agreement

DEVELOPMENT AND MANUFACTURING AGREEMENT | Document Parties: Dragon Pharmaceutical, Inc You are currently viewing:
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Dragon Pharmaceutical, Inc

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Title: DEVELOPMENT AND MANUFACTURING AGREEMENT
Governing Law: Florida     Date: 3/2/2005
Industry: Biotechnology and Drugs     Sector: Healthcare

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Exhibit 10.20

Portions redacted

* Certain information on this page has been

omitted and filed separately with the

Securities and Exchange Commission.

Confidential treatment has been requested

with respect to the omitted portions.

DEVELOPMENT AND MANUFACTURING AGREEMENT

THIS AGREEMENT is made as of October 31, 2003.

BETWEEN:

Dragon Pharmaceutical, Inc., a corporation duly incorporated under the laws

of the state of Florida, USA, having an office at 1900-1055 West Hastings

St., Vancouver, British Colombia, Canada, and duly licensed to do business

there.

("Dragon")

AND:

Polymun Scientific lmmunbiologische Forschung GmbH, a corporation duly

incorporated under the laws of the Republic of Austria having its principal

place of business at Nussdorfer Laende 11, 1190 Vienna, Austria, and duly

licensed to do business there.

("Polymun")

WHEREAS:

(A) Dragon does not presently have either the technical Know-How or

manufacturing capacity for manufacturing therapeutic cytokines for European and

international markets, and has commercial interest in developing both technology

and capacity that will enable it to do so.

(B) Polymun has both technical Know-How and manufacturing capacity for

development and manufacture of therapeutic biopharmaceuticals.

NOW THEREFORE, in furtherance of and in consideration of the premises and the

mutual covenants, terms and conditions contained herein and for other good and

valuable consideration, the receipt and adequacy of which are acknowledged, the

Parties hereby agree as follows:

PART 1

DEFINITIONS AND INTERPRETATION

Definitions

1.1 In this Agreement, except as otherwise expressly provided or as the context

otherwise requires:

(a) "Additional Taxes" has the meaning as set out in Section 3.2(b).

(b) "Affiliate(s)" means any entity that directly or indirectly owns, is

owned by or is under common ownership with, a Party to this Agreement,

where "Own" or "Ownership" means direct or indirect possession of at least

fifty percent (50%) of the outstanding voting securities of a corporation

or a comparable ownership in any other type of entity,

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PROVIDED, HOWEVER, that if the law of the jurisdiction in which such entity

operates does not allow fifty percent (50%) or greater ownership by a Party

to this Agreement, such ownership interest shall be the direct or indirect

ownership by a Party of the maximum amount permitted by the law of such

jurisdiction of outstanding voting securities of such entity.

(c) "Business Information" means any and all information belonging to

either Party concerning the methods of manufacturing EPO, as well as steps

taken for its subsequent commercialization.

(d) "CGMP" means current good manufacturing practices as determined by and

promulgated as guidance by the International Conference on Harmonization

(ICH).

(e) "CHO" has the meaning as set out in Section 2.1(a).

(f) "CMC" has the meaning as set out in Section 2.3(a).

(g) "Commercial EPO Availability Date" means the date when Polymun

successfully produces the * * * consistent batch of EPO at industrial scale

and under CGMP conditions.

(h) "Commercially Reasonable Efforts" shall mean efforts and resources

commonly used in the pharmaceutical industry, taking into consideration

safety and efficacy, cost of development, availability of funds to carry

out operations, the relative competitive positions of parties as a result

of alternative products, proprietary positions) the likelihood of

regulatory approval and all other relevant factors that go into making

reasonable, informed business decisions.

(i) "Confidential Information" has the meaning as set out in Section 5.1.

(j) "EPO" means recombinant human erythropoietin, in bulk purified form.

(k) "Exclusive License" has the meaning as set out in Section 2.1(b).

(1) "Exclusive Period" means the period from signing of this Agreement

until the end of the first 3-year period subsequent to the Commercial EPO

Availability Date, during which Dragon is granted the Exclusive License

under Section 2.1.

(m) "Financial Information" means any and all information concerning costs,

prices, royalties, payments and any other commercial information relevant

in the context of this Agreement.

(n) "FOB" has the meaning as set out in Section 3.2(a).

(o) "Improvement," as used in this Agreement, refers to an improvement that

is new, useful and unobvious over the subject matter of the first patent.

(p) "Know-How" shall mean any and all technical, scientific and other

Know-How and information, Trade Secrets, knowledge, technology, means,

methods, processes, practices, formulae, instructions, skills, techniques,

procedures, experiences, ideas, technical assistance, designs, drawings,

assembly procedures, computer programs apparatuses, specifications, data,

results and other material, including clinical data, patient data,

improvements and/or Technical Information.

* * * CONFIDENTIAL MATERIAL REDACTED AND SEPARATELY FILED WITH THE COMMISSION.

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(q) "Licensed Cell Line" has the meaning as set out in Section 2.1(a).

(r) "Licensed Intellectual Properly" has the meaning as set out in Section

2.1 (b).

(s) "Manufacturing Orders" has the meaning as set out in Section 3.4.

(t) "Market Area" means all countries of the world excluding only * * *.

(u) "Master Cell Bank" or "MCB" means a collection of vials containing

copies of the Licensed Cell Line.

(v) "3-Month-Period" has the meaning as set out in Section 3.6.

(w) "Most Favored Pricing" is the euro price per gram, subject to the terms

and conditions set forth in Annex C hereto and made a part hereof.

(x) "Net Sales" means the invoice price, net of sales tax discount and

rebate, of EPO products made incorporating or developed by using the

Licensed Intellectual Property sold by Dragon or its Affiliates to any

party in the Market Area. A sale to an Affiliate that is an end-user is

included in the ambit of Net Sales. Notwithstanding anything to the

contrary, no deduction against the invoice price shall be given for

commission, stocking allowance or marketing and promotional expenses.

(y) "Non-Competition List" has the meaning as set out in Section 5.11(a).

(z) "Non-Exclusive License" has the meaning as set out in Section 2.3(a).

(aa) "Non-Exclusive Period" means the four (4) year period after the expiry

of the Exclusive Period, during which Dragon is granted the Non-Exclusive

License under Section 2.1.

(bb) "Non-Signers" has the meaning as set out in Section 5.8.

(cc) "Notice" has the meaning as set out in Section 9.9.

(dd) "Party" or "Parties" refers to either Dragon or Polymun or both as

required by the context.

(ee) "Prior Agreement" has the meaning as set out in Section 5.9.

(ff) "Process" has the meaning as set out in Section 8.3.

(gg) "Product Specifications" means the minimum passing specifications for

EPO in bulk purified form as described in the European Pharmacopoeia

version 4.2, * * *.

(hh) "Reasonable Efforts," as used herein, means a lower standard than that

of Commercially Reasonable Efforts, but it implies that Parties will try to

do what is necessary to comply with the provisions of this Agreement where

such a standard is called for and in no way act in an unreasonable fashion.

(ii) "Recipient(s)" has the meaning as set out in Section 5.2.

 

* * * CONFIDENTIAL MATERIAL REDACTED AND SEPARATELY FILED WITH THE COMMISSION.

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(jj) "Royalty Reporting Period" has the meaning set out in Annex B Section

2.

(kk) "Scope of Work" has the meaning set out in Section 7 .3(b).

(ll) "Semi.Exclusive License" has the meaning set out in Annex B Section 1

(a).

(mm) "Technical Information" means any and all information relevant for

CHO-technology platform as used to manufacture EPO.

(nn) "Term" has the meaning as set out in Section 7 .1.

(oo) "Trade Secrets" means that secret compilation (the secrecy of which is

guarded by Polymun) of information that Polymun has to develop a CHO cell

line suitably transfected with the human erythropoietin gene and adapted

for use in cell culture for the manufacture of EPO in industrial quantities

and enables the optimization of both cell culture and downstream

purification processes for the manufacture of EPO. But for the grant of a

license to use the Trade Secrets, it would take an immense amount of time,

effort and money for others to innocently acquire the information that

gives Polymun an advantage over competitors who do not possess the Trade

Secrets.

(pp) "Transferred Technology" has the meaning as set out in Section 2.4(a).

(qq) "Therapeutically Equivalent Recombinant Proteins" means recombinant

proteins having molecular structure, bio-activity, and method of

manufacture significantly similar to like innovator recombinant drug

products currently under patent and marketed by other companies.

Interpretation

1.2 In this Agreement, except as otherwise expressly provided or as the context

otherwise requires,

(a) "this Agreement" means this agreement as from time to time supplemented

or amended by one or more agreements entered into pursuant to the

applicable provisions of this Agreement,

(b) a reference to a "Part" is to a Part of this Agreement, and the word

"Section" followed by a number or some combination of numbers and letters

refers to the section, paragraph, subparagraph, clause or subclause of this

Agreement so designated,

(c) headings are solely for convenience of reference and are not intended

to be complete or accurate descriptions of content or to be guides to

interpretation of this Agreement or any part of it)

(d) an accounting term not otherwise defined herein has the meaning

assigned to it, and every calculation to be made hereunder is to be made,

in accordance ,with accounting principles generally accepted in the United

States applied on a consistent basis,

(e) a reference to currency means European Union Euros,

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(f) a reference to a statute includes all regulations made thereunder, all

amendments to the statute or regulations in force from time to time, and

every statute or regulation that supplements or supersedes such statute or

regulations unless otherwise indicated,

(g) a reference to an entity includes any successor to that entity, whether

by merger, acquisition, or any other means by which the entity may be

succeeded by another

(h) a word importing the masculine gender includes the feminine and neuter,

a word in the singular includes the plural, a word importing a corporate

entity includes an individual, and vice versa, and

(i) a reference to "approval", "authorization" or "consent" means written

approval, authorization or consent.

PART 2

SCOPE OF WORK

2.1 Development of EPO Cell Line and downstream process by Polymun and Dragon

(a) Subject to the terms of this Agreement, Polymun undertakes the

development of a Chinese Hamster Ovary (CHO) cell line suitably transfected

with the human erythropoietin gene and adapted for use in cell culture for

the manufacture of EPO in industrial quantities (the "Licensed Cell Line").

This Licensed Cell Line shall be developed in compliance with ICH

guidelines for cell substrate safety. This Licensed Cell Line as well as

associated manufacturing processes shall be clearly and distinctly

different from any previous cell line developed by Polymun for any other

client, and in that respect it is not subject to any claim of ownership by

any third party in connection with making, using, selling, offering to

sell, importing and/or exporting EPO.

(b) Polymun hereby grants to Dragon an exclusive, royalty bearing license,

to the Licensed Cell Line, Know-How, Technical Information and Trade

Secrets associated with the cell culture and downstream purification

processes for EPO (the "Licensed Intellectual Property") to make, use,

sell, offer to sell, import and/or export EPO in the Market Area during the

Exclusive period ("Exclusive License"). At the expiration of the Exclusive

Period Polymun hereby grants Dragon a non-exclusive license for the

Non-Exclusive period subject to the terms and conditions set forth

hereinafter to the Licensed Intellectual Property (the "Non-Exclusive

License"). During the Non-Exclusive Period, Polymun grants Dragon the Most

Favored Pricing and Polymun agrees to abide by the non-competition

provisions set forth in Sections 5.10, 5.11 and 5.12.

(c) Polymun will develop and optimize both cell culture and downstream

purification processes for the manufacture of EPO. Polymun shall integrate

selected technical staff from Dragon or its Affiliates into the process of

optimizing and finalizing the downstream purification process and establish

a manufacturing technology in a bioreactor scale of up to * * * in volume

that shall be satisfactory to fulfil the following technical

specifications:

(i) Manufacture not less than * * * EPO per litre of raw supernatant

using Polymun's proprietary low cost serum-free cultivation &

production medium.

* * * CONFIDENTIAL MATERIAL REDACTED AND SEPARATELY FILED WITH THE COMMISSION.

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(ii) Apply a downstream processing procedure for purification of raw

supernatant leading to a yield of not less than * * */litre of bulk

purified EPO meeting or surpassing Product Specifications.

(iii) Transfer to Dragon not less than * * * of bulk purified EPO

manufactured during the pilot manufacture process.

(d) Dragon will pay Polymun for development work milestones has undertaken

according to the schedule set forth in Annex A, within thirty (30) days of

having been informed by Polymun that the milestone has been met and Dragon

has informed Polymun in writing that the milestone is acceptable, and

acknowledges that it satisfies the criteria stated in the Agreement. Dragon

shall have the right to audit records and inspect the work and determine

completion to its satisfaction prior to its acceptance of the milestone

being met. Payment will be by wire transfer to accounts specified by

Polymun.

(e) Upon Polymun's receipt of all the milestone payment as per Annex A,

Dragon may use the Licensed Cell Line for manufacturing directly executed

by Dragon and its Affiliates using its own cell culture media and

processes. Polymun will also make available any and all Licensed Cell Line

development documentation needed for regulatory filings to any regulatory

body to which Dragon may apply for registration of EPO.

2.2 Polymun to manufacture EPO for Dragon

(a) During the Term of this Agreement, Polymun shall manufacture EPO for

Dragon in Polymun's Austrian-certified facilities in accordance with

Section 2 of this Agreement. Polymun will manufacture the BPO under CGMP

conditions and bear the costs of batch releases, tests and assays to be

undertaken in accordance with the Product Specifications.

For and in consideration of Dragon entering into this Agreement) Dragon's

price per gram is in accordance with the terms and conditions set forth in

Annex C.

(b) During the Term of this Agreement, Polymun shall reserve and Dragon

shall purchase CGMP manufacturing capacity to manufacture a minimum of * *

* grams and a maximum of * * * grams of bulk purified EPO per year in

ccordance with the Product Specifications in the Agreement.

(c) During the Exclusive Period of the Term of this Agreement, Dragon shall

have the exclusive right to be supplied by Polymun, in the Market Area with

EPO which will be used by Dragon in accordance with the rights granted

hercunder in the Market Area. Dragon agrees that it will purchase the

minimum quantities of EPO manufactured by Polymun for Dragon during the

Exclusive Period and Non Exclusive Period as follows:

- * * * of EPO for the first twelve (12)-month after the Commercial

EPO Availability Date,

- * * * of EPO for the second twelve (12)-month after the

Commercial EPO Availability Date,

- * * * of EPO for the third twelve (12) month after the Commercial

EPO Availability Date.

* * * CONFIDENTIAL MATERIAL REDACTED AND SEPARATELY FILED WITH THE

COMMISSION.

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- * * * grams of EPO for each year of the Non-exclusive Period

until its expiry.

(d) During the Non-Exclusive Period of the Term of this Agreement, Polymun

is free to sell and market its EPO to any customers in the Market Area,

other than * * * subject to the terms and conditions set forth herein,

including but not limited to, the Most Favored Pricing and the

non-competition clause in Section 5 of this Agreement.

2.3 Polymun to provide documentation and technical advice to Dragon

(a) Polymun will provide Dragon with all necessary documentation in its

custody and control required by regulatory authorities in a chemical

manufacturing controls (CMC) documentation for the registration of the

Licensed Cell Line and the associated EPO. No obligation is established to

provide data with respect to toxicology, experiences in human application

or any other data beyond the ICH-specifications. In the event that this

documentation contains information proprietary to Polymun, such information

shall be transmitted at Dragon's request to relevant regulatory authorities

for submission as a "closed part" of a submission for registration and

approval. Costs for provision of this documentation are to be borne by

Polymun.

(b) Polymun, by virtue of its prior experience of developing drugs and

biological products from recombinant proteins, will provide advisory

assistance to Dragon during the time Polymun is developing the EPO

manufactured at its own facilities. Such advisory assistance shall apply to

issues of outsourcing of tests and assays for protein characterization and

preclinical studies. Polymun will provide this advice at no cost to Dragon,

PROVIDED, HOWEVER, it will do so on a basis whereby Polymun's qualified

expert staff members do not encounter disruption of their normal duties.

2.4 Transfer of Technology from Polymun to Dragon

(a) Subject to the conditions set forth in Annex B, Dragon, in its sole

discretion, can pay Polymun, as specified in Annex B, to transfer to Dragon

the Polymun-developed cell culture and downstream processes for the

manufacture of EPO with the Licensed Cell Line for manufacture in any

facility designated by Dragon ("Transferred Technology"). Polymun agrees to

render any and all assistance necessary in the localization of the

Transferred Technology in the Dragon-designated facility, PROVIDED,

HOWEVER, Dragon pays Polymun's fees and expenses for rendering the

aforesaid assistance, should Polymun's fees and expenses exceed

(euro)200,000 (TWO HUNDRED THOUSAND EUROS) in the case of Dragon's exercise

rights described in Annex B:1.(a) or (euro)50,000 (FIFTY THOUSAND EUROS) in

the case of Dragon's exercise of rights described in Annex B:1.(b). Polymun

shall advise Dragon of the amount of these fees in writing within a

reasonable time after Polymun's fees and/or expenses exceed the amounts

enumerated above and Dragon shall remit payment to Polymun within thirty

(30) days.

(b) Limitation on Dragon's usage of Polymun technology and its products

(i) If Dragon obtains the Transferred Technology in accordance with

Section 2.4(a), immediately preceding this section, it is agreed that

Dragon will not make, use, offer to sell, sell, import and/or export

the Transferred Technology in, to, or from * * *. With this exception

Dragon's rights pertaining to the Transferred Technology apply in the

remainder of the Market Area.

 

* * * CONFIDENTIAL MATERIAL REDACTED AND SEPARATELY FILED WITH THE COMMISSION.

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2.5 Both parties to share unilaterally developed information

(a) Polymun will, under the provisions set forth in Section 2.1 through 2.4

disclose to Dragon all improvements and/or developments to the process

applicable to the Licensed Cell Line, cell culture and downstream

purification process for manufacturing and/or producing EPO. The results of

such technology Improvements will be immediately disclosed to Dragon and

made available for its use at no cost, however, these will be owned by

Polymun and its Affiliates and Dragon agrees that it will not transfer any

such Improvements and/or developments to any third parties.

(b) Dragon acknowledges Polymun's intent to sell certain amounts of EPO in

* * * and will support this effort by providing any data concerning

preclinical and clinical development of the EPO into a therapeutic drug to

* * * regulatory authorities via Polymun. Subject to this Section 2.5(b)

this information otherwise remains Dragon's exclusive property.

2.6 Option of First Information

(a) Polymun hereby grants to Dragon an option to obtain information

pertinent to the making, using, offering to sell, selling, importing and/or

exporting and subsequent commercialization of additional Therapeutically

Equivalent Recombinant Proteins, subject to obligations of confidentiality

imposed upon Polymun by third parties, if any. Such subsequent

commercialization shall be the subject of a separate development and

manufacturing agreement.

2.7 Nothing in this Agreement confers on Dragon any additional interest,

license, or right in respect of either the Licensed Cell Line or the Licensed

Intellectual Property, other than as set out in Sections 2.1 through 2.6, and

Annexes A-C.

PART 3

PRICING, ORDERS AND PAYMENT

Price of EPO Manufactured by Polymun for Dragon

3.1 Polymun will sell the manufactured EPO to Dragon at the prices set out in

Annex C, such prices to be in effect for the entire seven (7)-year period of the

agreement.

3.2 (a) Prices are FOB (* * * International Airport) exclusive of sales tax and

import duties, or any other taxes and duties now existing or hereinafter imposed

by national authorities or those of any political subdivision thereof upon the

sale of EPO by Polymun to Dragon, which are to be paid by Dragon, along with

costs of transportation and insurance to cover the risk of loss.

3.2 (b) Prices as set forth in Annex C are also exclusive of customs fees,

excise and sales taxes in the importing country, and other taxes in the

importing country in the nature of a sales tax, now existing or hereinafter

imposed by national authorities or those of any political subdivision thereof

upon the sale of EPO by Polymun to Dragon. In the event any such fee or tax is

imposed on, or assessed against, Polymun as a result of the sale and delivery of

EPO hereunder, (the "Additional Taxes"), Polymun shall separately itemize such

Additional Taxes on the applicable invoices and Dragon shall pay the Additional

Taxes within thirty (30) days after receiving such invoices from Polymun.

 

 

* * * CONFIDENTIAL MATERIAL REDACTED AND SEPARATELY FILED WITH THE COMMISSION.

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3.3 Notwithstanding any change in the EPO pricing set out in Annex C, no price

change will effect the price of any EPO for which a Manufacturing Order, as

defined in Section 3.4 hereinafter, has been issued and accepted.

Manufacturing Orders

3.4 Dragon will prepare Manufacturing Orders for all EPO and each such order

will specify the quantity of EPO and any other information that either Party

considers necessary ("Manufacturing Orders"). Such Manufacturing Orders cannot

be amended without the consent of Dragon.

3.5 Polymun will acknowledge receipt of all Manufacturing Orders by a facsimile

sent within five business days after receipt of the Manufacturing Order from

Dragon.

Delivery Times

3.6 Polymun will start the production of EPO within a 3-month period of

receiving a Manufacturing Order from Dragon (the "3-Month-Period"). Thereafter,

depending upon Polymun's available capacity, it will at minimum fulfil

Manufacturing Orders received from Dragon up to the first * * * within six

(6)-months from the 3-Month-Period and within 12-months for any additional

amount over * * *, not to exceed * * *. If Polymun is able to deliver the EPO in

a shorter period of time than specified in the Manufacturing Order, PROVIDED,

the Manufacturing Order takes the foregoing time periods into consideration, it

will notify Dragon of such earlier delivery date.

3.7 Notwithstanding Section 3.6, if Polymun for any reason canno meet the

delivery times in a Manufacturing Order, it will notify Dragon of the expected

delivery date when it confirms the Manufacturing Order pursuant to Section 3.5.

Upon receipt of Polymun's notice of the expected delivery date, Dragon may, on

notice delivered to Polymun within five business days of Dragon's receipt of

Polymun's confirmation of the Manufacturing Order, withdraw the Manufacturing

Order. If the Manufacturing Order is not withdrawn, the delivery times in

Section 3.6 will be deemed to be amended to the time set out in Polymun's

confirmation of the Manufacturing Order.

Payment

3.8 Dragon will make full payment for EPO shipped to it by Polymun on or before

sixty (60) days after the date of shipment provided that Dragon has received

from Polymun the following documents:

(a) Pol


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