Document:

QuickLinks
 -- Click here to rapidly navigate through this document
  

 
 

Exhibit 4.6    
    

 
 

AKELA PHARMA INC.
  LOCK-UP AGREEMENT    
    

            , 2007  

 LAZARD CAPITAL MARKETS LLC  

c/o
Lazard Capital Markets LLC

30 Rockefeller Plaza

New York, NY 10020 

Ladies
and Gentlemen: 

        This
Lock-Up Agreement is being delivered to you in connection with the proposed Underwriting Agreement (the "Underwriting
Agreement") to be entered into by Akela Pharma Inc., a corporation organized under the laws of Canada (the "Company"),
and Lazard Capital Markets LLC ("Lazard") and the other underwriters named in Schedule I to the Underwriting Agreement, with respect to the
public offering (the "Offering") of common shares, without par value, of the Company (the "Stock"). 

        In
order to induce you to enter into the Underwriting Agreement, the undersigned agrees that, for a period (the "Lock-Up
Period") beginning on the date hereof and ending on, and including, the date that is 180 days after the date of the final prospectus relating to the Offering, without
the prior written consent of Lazard (which consent may be withheld in Lazard's sole discretion), the undersigned will not (i) sell, offer to sell, contract or agree to sell, hypothecate,
pledge, grant any option to purchase or otherwise dispose of or agree to dispose of, directly or indirectly, or file (or participate in the filing of) a registration statement with the Securities and
Exchange Commission (the "Commission") in respect of, or establish or increase a put equivalent position or liquidate or decrease a call equivalent
position within the meaning of Section 16 of the Securities Exchange Act of 1934, as amended, and the rules and regulations of the Commission promulgated thereunder (the
"Exchange Act") with respect to, any Stock or any securities convertible into or exercisable or exchangeable for Stock, or warrants or other rights to
purchase Stock or any such securities, (ii) enter into any swap or other arrangement that transfers to another, in whole or in part, any of the economic consequences of ownership of Stock or
any securities convertible into or exercisable or exchangeable for Stock, or warrants or other rights to purchase Stock or any such securities, whether any such transaction is to be settled by
delivery of Stock or such other securities, in cash or otherwise, or (iii) publicly announce an intention to effect any transaction specified in clause (i) or (ii). The foregoing
sentence shall not apply to (a) the registration of or sale to the Underwriters (as defined in the Underwriting Agreement) of any Stock pursuant to the Offering and the Underwriting Agreement,
(b) bona fide gifts, (c) dispositions to any trust for the direct or indirect benefit of the undersigned and/or the immediate family of the undersigned, (d) transfers occurring by
bequest by will, operation of law, such as rules of descent and distribution, or statutes governing the effects of merger or qualified domestic order, (e) transfers by the undersigned between
or among any of its affiliates, and, if a limited partnership, limited liability company or corporation, to any limited or general partner, member or corporate subsidiary, or (f) transactions
relating to shares of Stock or other securities acquired in open market transactions after the completion of the Offering; provided, that in the case of
any transfer pursuant to clauses (b) through (f) above, each transferee agrees in writing with the Underwriters to be bound by the terms of this Lock-Up Agreement and no
filing by any party (transferor or transferee) under the Exchange Act shall be required or shall be voluntarily made during the Lock-Up Period in connection with such transfer. For
purposes of this paragraph, "immediate family" shall mean the undersigned and the spouse, any lineal descendent, father, mother, brother or sister of the undersigned. 

1

 

        For
the avoidance of doubt, nothing shall prevent the undersigned from, or restrict the ability of the undersigned to exercise any options or other convertible securities granted under
any benefit plan of the Company. 

        In
addition, the undersigned hereby waives any and all preemptive rights, participation rights, resale rights, rights of first refusal and similar rights that the undersigned may have in
connection with the Offering or with any issuance or sale by the Company of any equity or other securities before the Offering, except for any such rights as have been heretofore duly exercised. The
undersigned also hereby waives any rights the undersigned may have to require registration of Stock in connection with the filing of a registration statement relating to the Offering. The undersigned
further agrees that, for the Lock-Up Period, the undersigned will not, without the prior written consent of Lazard, make any demand for, or exercise any right with respect to, the
registration of Stock or any securities convertible into or exercisable or exchangeable for Stock, or warrants or other rights to purchase Stock or any such securities. 

        Notwithstanding
the above, if (a) during the period that begins on the date that is fifteen (15) calendar days plus three (3) business days before the last day of
the Lock-Up Period and ends on the last day of the Lock-Up Period, the Company issues an earnings release or material news or a material event relating to the Company occurs;
or (b) prior to the expiration of the Lock-Up Period, the Company announces that it will release earnings results during the sixteen (16) day period beginning on the last day
of the Lock-Up Period, then the restrictions imposed by this Lock-Up Agreement shall continue to apply until the expiration of the date that is fifteen (15) calendar
days plus three (3) business days after the date on which the issuance of the earnings release or the material news or material event occurs. 

        The
undersigned hereby acknowledges and agrees that written notice of any extension of the Lock-Up Period pursuant to the previous paragraph will be delivered by Lazard to
the Company (in accordance with the Underwriting Agreement) and that any such notice properly delivered will be deemed to have been given to, and received by, the undersigned. The undersigned further
agrees that, prior to engaging in any transaction or taking any other action that is subject to the terms of this Lock-Up Agreement during the period from the date of this
Lock-Up Agreement to and including the 34th day following the expiration of the initial Lock-Up Period, it will give notice thereof to the Company and will not
consummate such transaction or take any such action unless it has received written confirmation from the Company that the Lock-Up Period (as may have been extended pursuant to the previous
paragraph) has expired. 

        The
undersigned hereby agrees and consents to the entry of stop transfer instructions with the Company's transfer agent against the transfer of securities of the Company held by the
undersigned except in compliance with this Lock-Up Agreement. 

        If
(i) the Company notifies Lazard in writing that it does not intend to proceed with the Offering or (ii) the registration statement filed with the Commission with respect
to the Offering is withdrawn, this Lock-Up Agreement shall be terminated as of the date of such notice or withdrawal and the undersigned shall be released from its obligations hereunder. 

        The
undersigned hereby confirms that the undersigned has not, directly or indirectly, taken, and hereby covenants that the undersigned will not, directly or indirectly, take, any action
designed, or which has constituted or will constitute or might reasonably be expected to cause or result in, under the Exchange Act or otherwise, the stabilization or manipulation of the price of any
security of the Company to facilitate the sale or resale of shares of Stock. 

        The
undersigned hereby represents and warrants that the undersigned has full power and authority to enter into this Lock-Up Agreement. This Lock-Up Agreement is
irrevocable and all authority herein conferred or agreed to be conferred shall survive the death or incapacity of the undersigned and any obligations of the undersigned shall be binding upon the
heirs, personal representatives, successors and assigns of the undersigned. This Lock-Up Agreement shall be governed by and construed in accordance with the laws of
the State of New York.

[Signature Page Follows]

2

        IN WITNESS WHEREOF, the undersigned has executed this Lock-Up Agreement as of the    day of            , 2007. 

Very
truly yours, 

Printed
Name: 

Capacity:

(Indicate
capacity of person signing if signing as

custodian or trustee or on behalf of an entity) 

Address: 

[Signature Page to Lock-Up Agreement]

QuickLinks

Exhibit 4.6

AKELA PHARMA INC. LOCK-UP AGREEMENTQuickLinks
 -- Click here to rapidly navigate through this document

 
 

Exhibit 10.1    
    

        Redactions marked with '*' 

 
 

DEVELOPMENT AND MANUFACTURING AGREEMENT    
    
    between    
    
    PERLOS Oyj    
    
    and    
    
    FOCUS INHALATION Oy    
    

 

INDEX 

	1.	 	DEFINITIONS	 	3
	

2.	
 	

MANUFACTURING OF AGREEMENT COMPONENTS	
 	

4
	

3.	
 	

MANUFACTURING	
 	

4
	

4.	
 	

PRICE AND PAYMENT	
 	

4
	

5.	
 	

FOCUS' PROPERTY	
 	

5
	

6.	
 	

DEVELOPMENT OF AGREEMENT PRODUCTS	
 	

6
	

7.	
 	

DISCLOSURE OF INFORMATION AND SECRECY	
 	

6
	

8.	
 	

PRIMARY SOURCE OF SUPPLY	
 	

7
	

9.	
 	

PERMISSIONS AND LICENCES	
 	

7
	

10.	
 	

IPR WARRANTY	
 	

7
	

11.	
 	

LIABILITY FOR DEFECTS, LIMITATION OF LIABILITY	
 	

7
	

12.	
 	

LIQUIDATED DAMAGES	
 	

8
	

13.	
 	

PRODUCT LIABILITY	
 	

9
	

14.	
 	

TERM AND TERMINATION	
 	

9
	

15.	
 	

CONSEQUENSES OF TERMINATION	
 	

9
	

16.	
 	

FORCE MAJEURE	
 	

9
	

17.	
 	

MISCELLANEOUS	
 	

10

2

   
        THIS DEVELOPMENT AND MANUFACTURING AGREEMENT is entered into on this date January 20, 2003, by and between 

Focus Inhalation Oy, whose registered office is at Biolinja 12, P.O. Box 980, 20101 Turku and registration number Y1629116-4
(hereinafter referred to as "Focus"), 

and 

Perlos Oyj Pharma, whose registered office is at Äyritie 12 C, P.O. Box 178, 01511 Vantaa and registration number Y
1067837-6 (hereinafter referred to as "Perlos"). 

        This
Agreement is comprised of this document and the attached Appendices. In case of any inconsistency between this document and any of the Appendices, they shall take precedence in the
following order: 

	1.
	This
document;

	2.
	Appendices
in the order they are numbered. 

        WHEREAS,
Perlos and Focus are willing to establish a commercial relation, where Perlos would develop and manufacture certain components as well as assemble and pack certain products for
Focus as more closely defined in the Agreement. 

        WHEREAS,
the parties hereby document the reciprocal rights and obligations. 

        WHEREAS
it is the intention of the parties that Perlos shall remain as the main supplier of the Agreement Components and that Focus shall use only one second source supplier. 

NOW
THEREFORE THE PARTIES AGREE AS FOLLOWS: 

1.     DEFINITIONS  

        In this Agreement the following expressions will have the following meanings unless otherwise expressly provided or unless the context clearly indicates
otherwise. In case this Agreement is used for more than one product the appendices will be identified and grouped by numbers. 

	1.1
	The
"Agreement Product" means TAIFUN® inhalator closer specified in Appendix B.

	1.2
	The
"Agreement Components" means components manufactured by Perlos for the Agreement Product.

	1.3
	"Specifications"
means the Specifications for the Agreement Components and the Agreement Products, enclosed to Appendix B of this Agreement.

	1.4
	"Perlos
Services" shall mean product development & industrialisation service, injection moulding, sub-assembly, filling, assembly and packing of the Agreement
Products as more closely specified in Appendix B and C.

	1.5
	"Focus
IPR" means intellectual property rights relating to the Agreement Products.

	1.6
	"Perlos
IPR" means intellectual property rights relating to the manufacturing process of the Agreement Components and the assembly process of the Agreement Products created by Perlos
such as 3D files prepared by Perlos (design data for tools and assembling lines), specification of manufacturing equipment, validation plans and data, manufacturing process (injection moulding,
assembly) documentation, process control instructions and data, functional test working instructions and data, measuring methods and related programs, test jig design data, tool and automation design
data, including software for line controls and data banks and DMF type III. 

3

 

	1.7
	"Development
Results" shall mean any invention, discovery, design, computer program, chip topography, or copyright work and any documentation or any other material devised, invented,
discovered, made, originated, or created by either of the Parties or jointly by the Parties under this Agreement. 

2.     MANUFACTURING OF AGREEMENT COMPONENTS

	2.1
	Perlos
undertakes to manufacture the Agreement Components and to supply them to Focus. Manufacture shall be performed in accordance with the specifications attached hereto under
Appendix B. Any modification to such specifications shall be agreed by the parties' in writing. 

It
is understood that the word "manufacture" as used in this Agreement shall include the manufacturing process, quality control and assurance. Unless otherwise agreed in writing Perlos may not supply
the Agreement Components to any third party. 

	2.2
	Focus
will provide Perlos with forecasts estimating Focus' need for the Agreement Components and place orders for delivery in accordance with the routines agreed in Appendix D.

	2.3
	Perlos
will deliver the Agreement Components DDP Focus' plant Turku. Prices of the Agreement Components and the terms of payment are agreed in Appendix A. 

3.     MANUFACTURING

	3.1
	Perlos
shall assemble the Agreement Products, fill them and pack them as more closely specified in Appendix B and C.

	3.2
	Perlos
injection moulding and subassembly services will be performed by Perlos in Kontiolahti, or at an alternative location agreed by the Parties in writing.

	3.3
	Perlos
filling, assembling and packing Services will be performed by Perlos in Focus' premises in Turku under Focus' supervision, or at an alternative location agreed by the Parties
in writing.

	3.4
	The
Parties plan to invest, subject to separate agreement in writing, jointly in Tools for Agreement Components, and Automation Machinery for the sub-assembly, filling and
assembly of the Agreement Products. The Automation Machinery, its financing and other terms and conditions relating to the investment shall be specified in an Investment Agreement that will be
appended to this Development and Manufacturing Agreement (Appendix G). 

4.     PRICE AND PAYMENT

	4.1
	Focus
will pay the prices for the Agreement Components and the Perlos Services as set forth in Appendix A. 

The
prices are based on specifications of the Agreement Components and Perlos Services on the date of signature hereof. In case of future amendments or variations, the parties shall agree in writing
the effect of such variations or amendments on the prices and other terms and conditions hereof. 

	4.2
	Prices
may be amended once a year for delivery scheduled during the ensuing calendar year by mutual agreement between the parties. Price changes will be based on corresponding changes
in Perlos' costs for the delivery of the Agreement Components and the Perlos Services. 

Prices
for each calendar year shall be discussed and agreed in October the preceding year. If a price for any calendar year has not been agreed by the end of the preceding year, either party 

4

 

may
terminate the Agreement by giving at least six (6) months' written notice. During the notice period the last agreed prices will prevail. 

	4.3
	Without
prejudice to the above, should Perlos' costs for Perlos' supplies and services under this Agreement increase by more than * per cent  * from the level of the latest price agreement, Perlos may request a
renegotiation of the price. In such case, Focus is entitled to verify the increase
of Perlos' cost by obtaining a break down of Perlos' cost structure, including past and present cost. 

The
parties will meet within thirty (30) days from such request and negotiate in good faith a revision of the price. If the parties fail to agree on a revised price within thirty
(30) days from the beginning of such good faith negotiations, the price will be increased by * * percent of the proven increase of the raw material costs, such revised price to be valid for the
remainder of the current calendar year. 

5.     FOCUS' PROPERTY

	5.1
	Any
production tools, machines or other property of Focus situated in Perlos' premises and put by Focus at Perlos' disposal for the purposes of this Agreement are to be listed in
Appendix E ("Focus' Property").

	5.2
	The
right of ownership to any property that is procured or purchased by Perlos on Focus' behalf will pass over to Focus when such property has been fully paid by Focus.

	5.3
	Perlos
is only entitled to use Focus' Property and any property contenplated under section 5.2 for the purposes of this Agreement and may not in any way dispose over it in a
way that may jeopardise or otherwise affect Focus' rights thereto. Perlos shall at all times keep the Focus' Property marked in a way that clearly indicates to a third party that it is the property of
Focus and clearly distinguishes it from the property of others.

	5.4
	Perlos
undertakes to insure the Focus Property and any property contenplated under section 5.2 against loss, destruction or damage while the Focus Property is in the possession
of Perlos.

	5.5
	Perlos
undertakes to keep Focus informed of discovered changes in the condition and status of the Focus Property and any property contenplated under section 5.2 as well as of
the need for repairs, replacement or substitution of any individual machine, mould or tool in order to keep up with or improve forecasted production quantities and quality. The parties shall
separately agree in writing upon necessary actions and the division of costs resulting from such actions.

	5.6
	Focus
shall bear the costs connected with the removal of the Focus Property to Perlos plant and any possible refurbishment cost of the transferred tools. Focus shall bear the costs
connected with the removal of the Focus Property and any property contenplated under section 5.2 from Perlos' plant.

	5.7
	Perlos
agrees to maintain the Focus Property and any property contenplated under section 5.2 in working condition, safe, secure and in conditions which are suitable for such
equipment and adequate to prevent any deterioration. Perlos further agrees to carry out the day-to-day maintenance according to the instruction manual developed by the supplier
of the machinery and the instructions of Focus, and in any case, at least to same level of care as Perlos takes of its own capital equipment and tooling as required to fulfil its obligations under
this Agreement. 

Perlos
undertakes at its cost to repair or replace items of the Focus Property to the extent necessary for the performance of this Agreement where the loss or damage is caused by the negligent act or
omission of Perlos. Otherwise any reparation of damages and spare parts for Focus Property shall be to Focus' account. 

5

   6.     DEVELOPMENT OF AGREEMENT PRODUCTS

	6.1
	Perlos
and Focus will conduct possible future development work concerning the Agreement Components and other products and manufacturing processes in the field of inhalation
technology. The development work shall be carried out according to separate Project Agreements that will be signed from time to time between the parties and attached hereto as appendixes starting with
Appendix F 1.

	6.2
	If
not otherwise agreed the costs of such joint development projects shall be borne by Focus.

	6.3
	All
rights in and to the development results related to such joint development projects carried out jointly by the Parties or by a Party under any Project Agreement shall be agreed
upon separately in the respective Project Agreement. The principle being that the Party who bears the cost of the development work owns the rights to the results.

	6.4
	All
rights in and to the development results other than mentioned above shall be jointly owned by the Parties, both of the Parties having a right to freely exploit, including a right
to grant licenses to third parties, such development results without obtaining any consent from the other Party. 

7.     DISCLOSURE OF INFORMATION AND SECRECY

	7.1
	Perlos
will make available to Focus all information relating to the Agreement Products in its possession and necessary in registration matters for Focus to be able to make the
intended use of the Agreement Products.

	7.2
	Any
information relating to the Agreement Products and/or to the manufacture and quality control of the Agreement Products including information relating to Focus IPR or Perlos IPR
disclosed by either party to the other, and information regarding a party's products, production, development work, research and other business secrets disclosed by or on behalf of a party to the
other party under this Agreement or under any previous agreement with confidentiality obligations, whether oral, in writing or in any other way, will be treated in the strictest confidence by the
receiving party and will not be disclosed or used to another purpose than set forth in this Agreement without prior written consent from the other party during the term of this Agreement and for ten
(10) years thereafter.

	7.3
	The
provision of Article 7.2 shall not apply to:

	(a)
	information
which before the date of this Agreement is in the public domain;

	(b)
	information
which after the date of this Agreement becomes part of the public domain by publication or otherwise except by breach of this Agreement;

	(c)
	information
which was in the possession of the receiving party at the date of this Agreement and was not acquired directly or indirectly from the disclosing party;

	(d)
	information
which is disclosed by a third party, provided that such information was not obtained, directly or indirectly, from the disclosing party;

	(e)
	information
which is independently developed by a party without the benefit of information disclosed by the other party;

	(f)
	information
which Focus needs to disclose to national and international authorities for the purposes described in Article 7.1. Focus will, however, endeavour to maintain the
confidentiality as far as possible. 

6

 

8.     PRIMARY SOURCE OF SUPPLY

	8.1
	Perlos
will be the Primary Supplier of the Agreement Components. Primary Supplier shall mean that Focus will order from the Primary Supplier the following share of its yearly
demand:

    •    when the annual volume is less than    •    pieces

    •    when the annual volume is over    •    pieces

(The annual volume = the aggregate ordered volumes during a calendar year)

	8.2
	To
ensure competitive cost structure Perlos will utilise transparency in price calculations and offer an additional manufacturing location if needed in order to ensure volumes in all
circumstances. If an additional Perlos manufacturing location is used, and the annual manufacturing volumes of the Agreement Components are
from                  components, the price level of the
Agreement Components will be determined according to annual manufacturing volumes of                  components. For annual manufacturing volumes of
1 million components or more, the prices
will be based on actual volumes.

	8.3
	Focus
will have the right to maintain or establish a second supplier for the Agreement Components for the purpose of risk management, and to ensure competitive pricing. The volumes
allocated to such a second supplier shall not affect Perlos' rights under clause 8.1. 

        However
in case Perlos cannot deliver in the agreed timeframe the volumes specified in 8.1 forecasted by Focus reasonably in advance according to Appendix D, Focus shall not be
bound to the limitations agreed in 8.1 above for as long as such an inability lasts. 

	8.4
	Should
such an alternative second supplier, as defined above, need a license to use Perlos IPR in connection with manufacturing of components for the Agreement Products, Perlos will
grant the license for such a limited use under Perlos customary conditions. In consideration of the license Focus shall pay to Perlos    •    EUR and shall compensate
Perlos' project costs associated therewith up to the maximum of    •    million EUR. 

9.     PERMISSIONS AND LICENCES

	9.1
	Focus
shall be responsible for obtaining and maintaining all manufacturing and other licences, permissions, and approvals by relevant authorities necessary for the manufacturing,
sales and distribution of the Agreement Products.

	9.2
	Perlos
and Focus shall keep each other informed of market conditions, Government regulations, and appropriate developments relating to the Agreement Product. 

10.   IPR WARRANTY

	10.1
	According
to Perlos' knowledge it has valid right to use the Perlos IPR. To the knowledge of Perlos (without making any specific enquiries thereof), Perlos IPR does not interfere
with and does not infringe any patent, copyright, trademark or other intellectual property right of any other person.

	10.2
	According
to Focus' knowledge it has valid right to use the Focus IPR. To the knowledge of Focus (without making any specific enquiries thereof), Focus IPR does not interfere with
and does not infringe any patent, copyright, trademark or other intellectual property right of any other person. 

11.   LIABILITY FOR DEFECTS, LIMITATION OF LIABILITY

	11.1
	All
Agreement Components delivered to Focus will have been subject to production and quality control in accordance with the documents in Appendix B. In the event that any 

7

 

Agreement
Components are found not to conform with the Product Specification included in Appendix B due to reasons for which Perlos is responsible, Perlos will replace the defective Agreement
Components. 

	11.2
	Perlos
Services will be performed in conformity with the specifications in Appendices B and C. Perlos shall not be responsible for materials or components supplied by Focus, defects
resulting from Focus' specifications or the design of the Agreement Products or any other defects not caused by Perlos. Perlos assumes no liability for the performance, accuracy, specifications or
defects of or due to tooling supplied by Focus, designs or instructions produced or supplied by Focus and Focus shall be liable for costs expenses incurred by Perlos related thereto. In the event that
Perlos Services shall not be in conformity with the specifications in Appendices B and C, Perlos shall at Perlos' option, either credit Focus for any such nonconformity (not exceeding the price
paid by Focus for Perlos Services in respect of such defective Agreement Products) or, at Perlos' expense, replace, repair or correct the respective defective Agreement Product.

	11.3
	The
foregoing constitute Focus' sole remedy for claims based on defects in the Agreement components or the Agreement Products. In any and all cases, except in cases of gross
negligence or intentional misconduct, the liability of Perlos for any defect or non-conformity in Perlos' Services, the Agreement Components or Agreement Products, including any losses,
damages or costs arising out of or in connection with such defects shall be limited:

	(a)
	regarding
Agreement Products being defective due the same technical or another ground, to the amount charged by Perlos from Focus for the Agreement Components and Perlos Services
during the two (2) calendar months preceding the month when the defect was first noticed, and

	(b)
	notwithstanding
the limitation set forth in point (a) above, for claims arising during any single calendar year, in the aggregate to 50% of the amount charged by Perlos from
Focus for Agreement Components and Perlos Services during the previous calendar year.

	11.4
	Perlos
shall not be liable to Focus for any indirect or consequential loss or damage regardless of its cause, unless due to gross negligence or intentional misconduct. 

12.   LIQUIDATED DAMAGES  

	12.1
	If
the supply by Perlos of the Agreement. Components is delayed due to reasons solely attributable to Perlos and if Focus has not granted Perlos an extension to the delivery time
Focus shall be entitled to claim liquidated damages calculated on the basis of the price of the delayed Agreement Components at the rate of    •    per cent
    •    per each full delayed week up to a maximum of    •    per cent    •    of the price of the
delayed Agreement Components.

	12.2
	The
liquidated damages determined in accordance with Article 12.1 shall mean the full and final compensation by Perlos to Focus in respect of delays in delivery under this
Agreement except as ruled by applicable laws. Focus shall definitively forfeit its right to claim liquidated damages if it has not claimed such damages in writing within
    •        •        •    from the date the Agreement Components in question should have been
delivered in accordance with the original delivery date.

	12.3
	Perlos
shall not be responsible for the delays in the performance of Perlos Services unless such delay is solely due to Perlos' intentional misconduct or gross negligence. 

8

 

13.   PRODUCT LIABILITY  

	13.1
	As
the owner of all product based IPR. Focus is alone responsible for product liability connected with the Agreement Products. Perlos is not liable to pay any punitive damages or any
other damages of punitive nature, any fines or penalties or any other fee(s) under public law unless such damages arise out of or are attributable to gross negligence or intentional misconduct on the
part of Perlos.

	13.2
	In
any and all cases the liability of Perlos regarding product liability and/or product safety is limited to maximum of EUR 1 million in the aggregate concerning occurrences
during each individual calendar year.

	13.3
	Focus
agrees to indemnify and hold Perlos harmless against all consequences (including without limitation attorney's fees and other legal costs) of any and all claims, suits, actions
or demands asserted against Perlos directly or indirectly, which claims, suits, actions or demands concern(s) or relate(s) to product liability and/or product safety which exceed the amounts mentioned
above in 13.2 

14.   TERM AND TERMINATION

	14.1
	This
Agreement is valid from and including the January 20, 2003 ("Effective Date") and may be terminated by either party by giving not less than twelve (12) months
prior written notice.

	14.2
	Articles
6.4; 7.2; 7.3; 10; 11; 13; 15 and 17.2 shall survive the termination of this Agreement.

	14.3
	Upon
the failure of either party to keep or perform any of its obligations hereunder and the continuation of such default, for thirty (30) days after the defaulting party has
been notified by the non-defaulting party, the non-defaulting party may, at its sole option and in addition and without prejudice, to its other rights and remedies, terminate
this Agreement forthwith upon notice to the defaulting party. 

The
insolvency of, or stoppage of payment by, either party or the commencement of a bankruptcy, insolvency or receivership or any similar proceeding against either party, or levy of any distress,
execution or attachment upon the property of either party shall be deemed a default for purposes of this Article 14.3. 

15.   CONSEQUENSES OF TERMINATION

	15.1
	Upon
termination of this Agreement for whatever reason, Perlos and Focus respectively shall without delay return to the other party all written know- how, data and
information provided by that party, and all copies thereof, and shall not use such know-how, data and information for any purpose. Focus and Perlos may, however, retain one copy of such
information in their respective confidential files solely for compliance purposes.

	15.2
	Upon
termination or expiry of this Agreement for whatever reason Focus shall be entitled and obliged to purchase from Perlos all Agreement Components in Perlos' stock for the
purchase price then in force and delivery to be made the first working day after termination or expiry of this Agreement on the delivery terms in force at that time. Focus is also obliged to pay
Perlos all remaining share of the non-amortised part of the investments. 

16.   FORCE MAJEURE

	16.1
	Neither
of the parties shall be liable on any account for any failure to fulfil any terms of this Agreement if such fulfilment has been frustrated or made unreasonably onerous by
Force Majeure including strikes, riots, lockouts, civil commotion, war, governmental regulations, shortage of transport, general shortage of materials, restrictions or: disturbances in the
supply 

9

 

of
energy or communications, defects or delays in deliveries by sub-contractors caused by any such Force Majeure circumstance, or any other unforeseeable event beyond the control of the
affected party. 

	16.2
	If
a party is unable, wholly or in part, to fulfil any term of this Agreement due to a Force Majeure situation for a total period of three (3) months, the other party may
terminate this Agreement with immediate effect. 

17.   MISCELLANEOUS

	17.1
	The
obligations of Perlos may, at Perlos' sole discretion, be performed by a subcontractor or subcontractors appointed by Perlos.

	17.2
	This
Agreement will be governed and construed in accordance with the laws of Finland. Any dispute or controversy arising out of or relating to this Agreement shall be settled by
arbitration. Such arbitration shall be conducted in Helsinki in accordance with the Rules of the Arbitration Institute of the Central Chamber of Commerce in Helsinki by one sole arbitrator appointed
jointly by Focus and Perlos. If Focus and Perlos cannot agree upon the person of the arbitrator within two (2) weeks the arbitrator shall be appointed by the Arbitration Institute of the
Central Chamber of Commerce in Helsinki.

	17.3
	This
Agreement embodies all the terms and conditions and obligations of the contract between the parties hereto and supersedes and cancels all previous agreements and understandings,
whether oral or in writing, in respect of the subject matter hereof and may not be amended, or modified except by an express declaration in writing signed on behalf of Focus and Perlos by a duly
authorised officer and referring specifically to this Agreement. 

IN
WITNESS WHEREOF, the parties have caused this Agreement to be duly executed in duplicate. 

	Date:	 	 	Date:	 
	 	
	 	 	

	

For and behalf of

FOCUS INHALATION OY	
 	

For and behalf of

PERLOS OYJ PHARMA
	

Signed by:	

 	
 	

Signed by:	

 
	 	
	 	 	

	

Name:	

 	
 	

Name:	

 
	 	
	 	 	

	

Title:	

 	
 	

Title:	

 
	 	
	 	 	

Enclosures

	Appendix A	 	Prices and terms of payment
	Appendix B	 	Quality Assurance Agreement
	Appendix C	 	Specification for the sub-assembly, filling, assembly and packing services
	Appendix D	 	Forecasts and orders of the Agreement Components
	Appendix E	 	Focus' Property
	Appendix F	 	Development Project Agreements
	Appendix G	 	Investment Agreement

10

APPENDIX A to

Development and Manufacturing Agreement 

        Prices
and terms of payment 

*
* * 

 
 

Appendix B to
  Development and Manufacturing Agreement:    
    

 
  Quality Assurance Agreement    
    

Table of contents:  

	1.    PURPOSE OF AGREEMENT	 	2
	

2.    ADMINISTRATIVE DATA	
 	

2
	

3.    PRODUCT DEFINITION	
 	

2
	

4.    MANUFACTURING REQUIREMENTS	
 	

2
	 	
 4.1    FACILITIES AND EQUIPMENT	
 	

2
	 	4.2    GMP STANDARDS	 	3
	 	4.3    MATERIALS	 	3
	 	4.4    DOCUMENTATION	 	3
	 	4.5    BATCH NUMBERING	 	4
	 	4.6    BATCH RECORD	 	4
	 	4.7    DEVIATIONS	 	4
	 	4.8    PRODUCT STORAGE	 	4
	 	4.9    PRODUCT PACKAGING AND TRANSPORT	 	5
	

5.    QUALITY ASSURANCE REQUIREMENTS	
 	

5
	 	
 5.1    SAMPLING	
 	

5
	 	5.2    TESTING	 	5
	 	5.3    SAMPLE RETENTION	 	5
	 	5.4    PRODUCT RELEASE	 	6
	 	5.5    REJECTION OF PRODUCT BY PURCHASER AND PRODUCT COMPLAINTS	 	6
	

6.    RIGHT TO AUDIT	
 	

7
	

7.    CHANGE CONTROL	
 	

7
	

8.    PROCESS VALIDATION	
 	

7
	

9.    CONTINUOUS IMPROVEMENT	
 	

7
	

10.  CONTRACTUAL AGREEMENT	
 	

8

       

List of Appendices:  

	Appendix 1.	 	Product Specification
	Appendix 2:	 	AQL Specification (to appended later)
	Appendix 3:	 	List of Approved Suppliers
	Appendix 4:	 	Transit Packaging Specification
	Appendix 5:	 	Customer Complaint Form
	Appendix 6:	 	Certificate of Analysis Sample
	Appendix 7:	 	List of Contact Personnel
	Appendix 8:	 	Sampling

   1.     PURPOSE OF AGREEMENT  

The
purpose of this Agreement is to identify and document the general quality standards which are to be applied and adhered to by the Manufacturer (Perlos) in the manufacturing, testing, packaging,
quality assurance, and release of the Product. 

2.     ADMINISTRATIVE DATA  

	Purchaser:	 	Focus Inhalation Oy

Biolinja 12

P.O. Box 980

FIN-20101 Turku

Finland
	

Manufacturer:	
 	

Perlos Oyj

Äyritie 12 C

P.O. Box 178

FIN-01511 Vantaa

Finland

3.     PRODUCT DEFINITION  

The
Product covered under this agreement is the TAIFUN® dry powder inhaler device. The Product definition shall include and be applicable to the individual components, any and all device
subassemblies. The definition, for purposes of this document, is relevant to the current as well as future TAIFUN® designs. 

4.     MANUFACTURING REQUIREMENTS  

4.1   Facilities and Equipment

4.1.1.    The
Manufacturer shall produce components for the Products at its Kontiolahti, Finland manufacturing site. 

4.1.2.    The
Manufacturer will not transfer any of the manufacturing, testing, or packaging operations for the Product to another site or to a third party without the prior and written
approval of the Purchaser. 

4.1.3.    The
premises and equipment used for the manufacture, assembly, packaging, sampling and testing of the Product must be in compliance with relevant GMP's, cGMP's, current regulatory
guidelines, EN46001 (Quality Systems for Medical Devices) applicable to the manufacture of plastic medical devices and pharmaceutical packaging components. 

4.1.4.    The
moulding and assembly premises and operations shall be maintained according to standard ISO14644-1 Class 8 or better. The Manufacturer will conduct
microbiological measurements on personnel, air and surfaces in accordance with the Manufacturer's standard procedures. In general, moulding, assembly and packaging areas for the Product are to be
maintained clean, orderly and under line clearance procedures. 

4.1.5.    Manufacturer
will conduct microbiological measurements on Product according to the Purchaser's requirements. Microbiological contamination of the Products shall not exceed 100 CFU
per 20 units. 

4.1.6.    The
Manufacturer will implement and keep up to date appropriate equipment maintenance and will institute and keep active a calibration program and a validation program to ensure
all equipment subject to such requirements is complaint. 

2

 

4.1.7.    The
Manufacturer may only produce the Product under properly validated process conditions on validated production equipment and may only utilize validated test methods for the
release of Product against specifications. 

4.2   GMP Standards  

4.2.1.    The
Manufacturer shall ensure all manufacturing is conducted under quality standards according to the following standards: EC Directive 93/42, ISO 9001, EN 46001, and the US cGMP
Guideline for Medical Devices (21 CFR Part 820: Quality System Regulation, cGMP for Medical Devices). 

4.2.2.    The
Manufacturer will prepare and maintain current a Type III Drug Master File according to the requirements of the FDA. The Parties will agree separately on the payment of the
costs for preparation and maintenance of the Drug Master File. 

4.3   Materials  

4.3.1.    Materials
for manufacture of the Product shall be procured only from material suppliers approved by the Purchaser Appendix 3 "Approved Suppliers and Materials". The
Manufacturer is responsible for
ensuring all materials procured for use in the Product are in full compliance with the specifications given on Appendix 1, "Product Specification of TAIFUN® Dry Powder Inhaler". 

4.3.2.    The
Manufacturer will store the raw materials under the conditions specified or recommended by the raw material supplier and will regulate the raw material stock to ensure its
utilisation within the supplier recommended shelf life. Expired stock may not be used. 

4.3.3.    Only
food grade materials and lubricants may be used for the construction and maintenance of production equipment on any surfaces that contact or may contact Product components
during the manufacturing process. The name and technical data for such materials and lubricants must be kept on file and submitted to the Purchaser on request. 

4.3.4.    The
Manufacturer shall conduct regular quality and GMP audits of the important goods and services providers. 

4.4   Documentation  

4.4.1.    The
Purchaser is responsible for generating and maintaining all the specifications required to define the Product and test its functionality including design and tolerances,
materials of construction, functional and performance tests. The Purchaser is responsible for the specification of all transit packaging requirements for the Product, see Appendix 4, "Transit
Packaging Specification". 

4.4.2.    The
Purchaser is responsible for providing updates to specifications to the Manufacturer via an established Change Control Procedures. 

4.4.3.    The
Manufacturer is responsible for generating and maintaining all the specifications, standard operating procedures, batch records, maintenance logs, change control documents,
validation records, training records, and general manufacturing documents as required to manufacture, control, test and release the Product against the specifications provided by the Purchaser and as
required to ensure compliance of the entire manufacturing operation with applicable current GMP's. 

4.4.4.    The
Manufacturer is responsible for maintaining all product specifications current and up to date based on the information provided by the Purchaser. 

3

 

4.4.5.    The
Manufacturer will utilize a Certificate of Analysis (Appendix 6), signed by a qualified representative of the manufacturer's Quality Department, to guarantee each batch
is in conformance with the relevant specifications as defined in this agreement. This certificate will also contain any agreed functional and dimensional data. This certificate will become a part of
the batch record and as such will be included with each batch delivered to the Purchaser and a copy will also be retained as part of the Manufacturer's batch record. 

4.4.6.    The
Manufacturer commits to providing a full document package for any batch of the product within two working days of notification by the Purchaser in case of a request by a
Regulatory Agency or an internal need of the Purchaser. 

4.4.7.    The
Manufacturer shall maintain and safeguard batch records for each manufactured batch of the product for a period of no less than 12 (twelve) years from the date of product
release to the Purchaser. After the agreed period handling of the records shall be mutually negotiated and agreed by the Parties. 

4.5   Batch Numbering  

4.5.1.    A
batch shall consist of units of Product (moulded components or sub-assembled components,) of a single type, grade, class, size, and composition, manufactured under
essentially the same conditions and essentially at the same time. 

4.5.2.    The
Manufacturer's standard batch numbering system will be used for numbering each batch of the Product. The number assigned to each batch will be unique and will appear on all
documents relating to that particular batch. 

4.5.3.    Batch
numbering will be applied and controlled so as to provide traceability through the entire manufacturing process. 

4.6   Batch Record  

4.6.1.    A
batch record must include all information required to provide full traceability of the Product of each of the materials, components, methods, equipment, personnel and analytical
results (including statistical data and analysis) utilized in the manufacturing process and testing of each batch of Product. 

4.6.2.    Batch
record traceability extends to all data and information obtained from external suppliers of materials and components used in the manufacture of the Product. 

4.7   Deviations  

4.7.1.    The
Manufacturer will record, within the batch record documentation, any deviation from the validated manufacturing process of the Product. The Manufacturer is responsible for
conducting an investigation as to the cause of the deviation and take corrective action to prevent its reoccurrence. 

4.7.2.    The
Manufacturer is responsible for investigating any test result, which yields an out of specification result, and for taking corrective and preventive action in accordance with
the Manufacturer's standard operating procedure. 

4.8   Product Storage  

Product
shall be stored by the Manufacturer prior to shipment according to the requirements of the Product Specification (ambient temperature to be between 8 degrees and 35 degrees Centigrade) in a
controlled access warehouse. The Manufacturer will store the raw materials, work 

4

 

in
progress and final Product so as to ensure there is no possibility of deterioration, contamination, moistening, damage or admixture. 

4.9   Product Packaging and Transport  

The
Manufacturer will package and identify all batches of Product per the requirements listed in the Packaging specification for TAIFUN Components, Sub-assemblies, and Devices, reference
Appendix 4, "Transit Packaging Specification". 

5.     QUALITY ASSURANCE REQUIREMENTS  

5.1   Sampling  

5.1.1.    The
Manufacturer will utilise one of the following recognised sampling standards, ISO 2859-1, Mil Spec 105D, or ANSI Z1.4 as appropriate for the size of batch being
sampled. This is applicable to batches of raw materials, additives, purchased goods and Product. 

5.1.2.    The
sampling and inspection switching rules for the selected sampling standard shall apply for the relaxation or tightening of inspection level and sample size. 

5.1.3.    The
Manufacturer shall collect and supply to the Purchaser samples from each batch of product to be used by the Purchaser for incoming inspection purposes according to
Appendix 8 and as amended from time to time. These samples shall be packaged separately and labelled according to the requirements of Appendix 4 in a separate sample box that is also
labelled as containing samples. 

5.2   Testing  

5.2.1.    The
Purchaser is responsible for providing the Manufacturer with a comprehensive listing of all the dimensions, attributes and functions that will be verified by the Manufacturer
via incoming inspection, in-process testing and/or batch release testing to ensure the Product's compliance with specification. 

5.2.2.    The
Manufacturer will conduct inspection/testing on all in-coming material batches to ensure compliance with specification. 

5.2.3.    The
Purchaser is responsible for setting the Acceptable Quality Limits for each product release attribute. Reference Appendix 2, "AQL Specification for TAIFUN Dry Powder
Inhaler Device Attributes." 

5.2.4.    The
Manufacturer is responsible for ensuring that all in-process testing and batch release testing is conducted according to the requirements of Appendix 2 and
documented. 

5.2.5.    The
Manufacturer will reject product batches, which do not meet the specified AQL for any of the inspection criteria. 

5.2.6.
The Manufacturer will reject product batches, which do not meet the Product specification requirement for any of the inspection criteria given in the Product specification. 

5.2.7.    Concessions
may be granted at the Purchaser's discretion to release batches, which have been rejected by the Manufacturer. 

5.3   Sample Retention  

5.3.1.    The
Manufacturer will retain, properly identify, and store sufficient samples in accordance with the Manufacturer's standard procedures. 

5

 

5.4   Product Release  

5.4.1.    The
release of each batch of Product by the Manufacturer will require a full review of all manufacturing and analytical documentation, as documented by the batch record, for the
batch by a qualified representative of the Manufacturer's Quality Department. 

5.4.2.    The
Manufacturer may only release those batches of Product, which are in full compliance with the Product specifications and have been manufactured under the approved, validated
process conditions. The Purchaser may, at its discretion when requested by the Manufacturer, allow batch release against a concession. 

5.4.3.    Each
batch of Product shipped to the Purchaser will be accompanied by a Certificate of Analysis (Appendix 6) signed by a qualified representative of the Manufacturer's
Quality Department. The Certificate of Analysis will serve as written guarantee by the Manufacturer that the product was manufactured and tested according to specifications and methods and meets all
agreed specifications for the product. 

5.5   Rejection of Product by Purchaser and Product Complaints  

5.5.1.    All
Product batches received by the Purchaser will be subjected to Incoming Inspection to verify each of the cosmetic attributes, dimensional specifications and functional
requirements given in Appendix 1, "Product Specification of TAIFUN® Dry Powder Inhalation Device". The Purchaser may reject batches that do not meet the AQL or the Product
specification requirement for any of the inspection criteria and issue a complaint to the Manufacturer. 

5.5.2.    The
Manufacturer shall inform the Purchaser of any quality problems which may affect on time delivery or could potentially be representative of a repetitive problem which could
affect several batches of Product. 

5.5.3.    Quality
problems identified during final assembly of the Product at the Purchaser's facility or field complaints, which are indicative of out of specification components or
sub-assemblies, may also result in batch rejection. 

5.5.4.    The
Manufacturer will be advised immediately of any Product rejection via the Purchaser's standard complaint form, see Appendix 5 "Customer Complaint
Form—TAIFUN® Dry Powder Inhaler Device". The Purchaser shall supply with the complaint, as a minimum, the following information: reason for the rejection, quantity of affected
Product, batch number, and representative samples. 

5.5.5.    All
complaints will be logged and handled through the Manufacturer's Customer Complaint Procedure. 

5.5.6.    Upon
notification of a batch rejection, the Manufacturer must initiate corrective actions so as to prevent the compromise of any additional batches of product and retest as
necessary to ensure the suspected or identified cause of failure is not present in other batches of the Product. 

5.5.7.    A
complaint arising from the identification of a critical defect may result in the stoppage of all deliveries until corrective actions and/or additional testing have been completed
to the satisfaction of the Purchaser. 

5.5.8.    A
complaint arising from the identification of defects other than critical will result in the joint determination of the seriousness of the defect and the need to stop deliveries
until corrective measures have been implemented. 

6

  

5.5.9.    A
complaint arising from the identification of a previously unclassified defect which the Purchaser considers to be detrimental to the quality or safety of the Product shall be
discussed and negotiated with the Manufacturer as to its disposition and corrective action. 

6.     RIGHT TO AUDIT  

6.1.    The
Manufacturer will allow representatives from the Purchaser access to their manufacturing, warehousing and laboratory facilities (and all records and documentation of these
operations related to the Product) during working hours and with reasonable prior notification for the purposes of conducting quality and GMP audits. The frequency of the audits will depend on the
Product quality trends, the result of previous audits and the Purchaser's current auditing policies. 

6.2.    The
Manufacturer will also extend the right to audit their facilities to representatives of third parties, which utilise or may be considering the use of the Product as supplied by
the Purchaser. 

7.     CHANGE CONTROL  

7.1.    The
Manufacturer will not deviate from any of the approved product manufacturing and testing specifications, sampling plans, acceptable quality levels, and packaging specifications
without prior written authorisation from the Purchaser. 

7.2.    The
Purchaser will use change control to notify the manufacturer of all Product specification updates, test method revisions, and other critical document revisions. 

7.3.    The
Manufacturer must inform the Purchaser of significant changes in the Quality organisation or the Quality Practices that may affect the quality of the Products. 

8.     PROCESS VALIDATION  

8.1.    The
Manufacturer must conduct formal validation with at least three production-size batches to prove that all manufacturing processes are capable of consistently and
repeatedly producing the Product within specifications. 

8.2.    The
Manufacturer is responsible for ensuring the manufacturing processes, utilities, tooling, equipment, and test methods are properly validated and in compliance with appropriate
GMP guidelines. 

8.3.    The
Manufacturer will provide copies of the validation plan to the Purchaser for comment prior to initiation of the validation process. 

8.4.    All
validation will be maintained current. Change control procedure must be utilised to ensure that all significant modifications are subjected to validation review. 

8.5.    The
Manufacturer must utilise cleaning procedures and line clearance procedures according to GMP's as necessary to prevent cross contamination in production and packaging areas and
on machines utilised for multiple products. 

9.     CONTINUOUS IMPROVEMENT  

9.1.    Statistical
techniques will be utilised by the Manufacturer to monitor, understand and adjust the manufacturing processes. 

9.2.    Continuous
Improvement philosophy shall be jointly applied by the manufacturer and the purchaser to the design, manufacturing, and testing of the product. 

7

 

10.   CONTRACTUAL AGREEMENT  

10.1.    All
inquiries, remarks, claims, and communications concerning the Quality Agreement shall be made in writing to the addresses listed in Clause 1.0. The contact persons of the
Parties are as listed in Appendix 7 "List of Contact Personnel". 

10.2.    The
assignment of the rights and responsibilities given in this Agreement cannot be assigned by the Manufacturer without the prior written consent of the Purchaser. 

10.3.    The
Quality Agreement is binding to both Parties upon acceptance via signing by the designated officer of the company. The Quality Agreement becomes effective upon approval by both
Parties of the Development and Manufacturing Agreement. 

10.4.    Changes
to the Quality Agreement are valid only in writing and are effective once signed by both parties. 

10.5.    The
Quality Agreement is valid only in conjunction with the Development and Manufacturing Agreement. The Quality Agreement can only be rescinded via termination of the Development
and Manufacturing Agreement. 

10.6.    The
formal review period for the Quality Agreement shall be once every year on or about the anniversary date of its approval. 

10.7.    Two
master copies of the Quality Agreement will exist and will be attached to the Development and Manufacturing Agreement. One will reside with the Manufacturer and the other with
the Purchaser. 

10.8.    The
responsibilities of the Manufacturer and of the Purchaser for the assurance of Product quality are as identified and defined by the Development and Manufacturing Agreement, its
Appendix B and this document 

8

 
APPENDIX 1 to

Quality Assurance Agreement  

Product Specification of TAIFUN® Dry Powder Inhaler:  

        Following product specifications are appended to this Appendix 1 of the Quality Assurance Agreement. Product Specifications are agreed by the Parties to be
updated and added when needed via an established Change Control Procedure. 

*
* * 

9

 
APPENDIX 2 to

Quality Assurance Agreement  

AQL Specification for TAIFUN® Dry Powder Inhaler Device Attributes:  

        AQL Specifications are agreed by the Parties to be updated and added when needed via an established Change Control Procedure. 

10

 
APPENDIX 3 to

Quality Assurance Agreement  

Approved Suppliers and Materials of TAIFUN®:  

*
* * 

11

 
APPENDIX 4 to

Quality Assurance Agreement  

Transit Packaging Specification:  

Labeling and Packaging  

1.     Labeling  

The
following information shall be printed on each label. 

	1.
	Product
name

	2.
	Focus
code

	3.
	Drawing
number(s)

	4.
	Focus
order number

	5.
	Batch
number

	6.
	Date
of manufacturing (dd/mm/yy)

	7.
	Quantity
of Products 

2.     Packaging  

*
* * 

12

  

 
 

APPENDIX 5 to
  Quality Assurance Agreement    
    

Customer Complaint Form—TAIFUN® Dry Powder Inhaler Device:  

FOCUS iNHALATiON  

CUSTOMER COMPLAINT FORM  

Rejected batch information 

	Product name / Material	 	:	 	 	 	Focus item code:
	Focus batch number	 	:	 	 	 	 
	

Vendor	
 	

:	
 	

 	
 	

Vendor item code:
	Vendor batch number	 	:	 	 	 	 
	

Order number	
 	

:	
 	

 	
 	

 
	Quantity received	 	:	 	 	 	 
	Date of delivery:	 	 	 	 	 	 

Defect information 

	Defect noticed in:	 	o Quality Assurance

o Production

o Material storage	 	 
	

Reason for rejection	
 	

: Specification:	
 	

Result:
	 	 	  Specification:	 	Result:
	 	 	  Specification:	 	Result:
	 	 	: Description of the defect:	 	 

         

  

	Estimated quantity of defective material	 	:
	Amount of rejected material	 	:
	Statement of the defect from quality assurance	 	:
	

Comments to Vendor	
 	

:

	

Signature of QA:	
 	

 	
 	

Date:	
 	

 	
 	

 
	 	 	
	 	 	 	
	 	 

	Sample information	 	Samples sent: o yes o no Date

Number of samples:

Contact information 

	Focus Inhalation Oy	 	Perlos Oyj [Pharma]
	Katri Outinen	 	N.N.
	P.O.Box 980	 	P.O. Box 163
	FIN-20101 TURKU	 	FIN-80101 Joensuu
	Tel: +358 2 333 3430	 	Tel: +358 13 261 2001
	Fax: +358 2 333 3444	 	Fax: +358 13 261 4600

Prepared by 

	Name:	 	 	 	 
	Title:	 	 	 	 
	Place / Date:	 	 	 	 
	Signature:            	 	 	 	 
	 	 	
	 	 

13

  

APPENDIX 6 to

Quality Assurance Agreement  

Certificate of Analysis—Sample:  

Perlos
Oyj

P.O. Box 163

80101 Joensuu 

Certificate of Analysis  

Perlos
Oyj certifies that the products as listed have been manufactured and analysed according to the "QUALITY ASSURANCE AGREEMENT" between Perlos Oyj and Focus Inhalation Oy 

	Product name:	 	    
	 	 
	Focus Inhalation code:	 	    
	 	 
	Order number:	 	    
	 	 
	Batch number:	 	    
	 	 
	Quantity of delivery:	 	    
	 	 
	Date(s) of manufacturing:	 	    
	 	 

	
 Specification
 
	
 	

Results
	
 	

Date of measurement
	
 	

Remarks

	    	 	 	 	 	 	 
	    	 	 	 	 	 	 
	    	 	 	 	 	 	 

Name and date

Quality Manager

Perlos Oyj 

14

 
APPENDIX 7 to

Quality Assurance Agreement  

List of Contact Personnel:  

*    *    * 

15

 
 
 

APPENDIX 8 to
  Quality Assurance Agreement    
    

Sampling:  

*    *    *

16

 
 

APPENDIX C to
  Development and Manufacturing Agreement    
    

Specification for the filling and final assembly services  

1.     Division of responsibilities  

The
parties clearly understand that the co-operation between the two companies is based on the following division of responsibilities: 

	1.1
	Focus 

As
the owner of all product based IPR Focus is alone responsible for product liability connected with the Agreement Products (Taifun inhalers). 

Focus
will also approve each batch in a similar way as it would approve any material supply to its factory. 

Focus
is also responsible for the filling and final assembly processes. 

Focus
(or third parties as the case may be) shall bear the full responsibility relating to or in any way connected with the drugs to be incorporated into the Agreement Products. 

	1.2
	Perlos 

Perlos
responsibility, except for those mentioned in Appendix C, is to provide filling and final assembly services to Focus at Focus premises, according to the specifications set by Focus
(Perlos Services). 

The
parties have agreed that Perlos Pharma will as soon as possible manage the manufacturing process of the services including filling and final assembly. At the moment Focus Inhalation is responsible
for all manual assembling and filing operations. The parties will separately agree a time schedule for transferring the performance of each of the said manufacturing process steps from Focus to
Perlos. 

When
Perlos has taken a manufacturing process step over, as described above, Perlos will be responsible for the quality and performance of the manufacturing process/processes as more closely specified
later. 

2.     Quality standards, inspection and auditing  

For
each batch Perlos will deliver Focus a batch release certificate, which states that all inspections are carried out as specified. 

The
parties will together further develop the specifications to maintain the quality standards set by the authorities. The possible effect on the unit price shall be negotiated between the parties in
good faith. 

Focus'
responsibility is to regularly audit the processes and to give Perlos feedback on any possible deviations from the regulatory or customer demands noticed. 

3.     Manufacturing process description  

A
detailed description of the process will be appended later. 

 
 

APPENDIX D to
  Development and Manufacturing Agreement    
    

Forecasts and orders of the Agreement Components  

1.     Purpose  

The
Parties shall in good faith jointly develop and put into practice a Forecast and Order Procedure, which shall be used by Parties to: 

	1.1.
	Format,
organize, and communicate the short-term (monthly, quarterly, yearly) volume demand for the Agreement Components and the production capacity to meet this demand.

	1.2.
	Communicate
and adjust order volumes and delivery schedules required by Focus prior to the issuance of firm orders for the Agreement Components

	1.3.
	Give
visibility to the long term (greater than 12 months) demand for Product so as to provide for the expansion or contraction of manufacturing capacity at Perlos, as may be
appropriate. 

2.     Forecast  

	2.1.
	Focus
shall submit to Perlos 

*
* * 

	2.2.
	In
addition to the above Focus 

*
* * 

	2.3.
	Should
the marketing situation of Focus' product(s) containing the Agreement Components change unexpectedly including but not limited to adverse events caused by such Focus' products
and actions of the authorities, the Parties shall negotiate in good faith on the proceedings to be taken. 

3.     Orders  

	3.1.
	All
deliveries of Agreement Components shall be against written orders placed by Focus. Perlos shall confirm and accept in writing each Focus purchase order for the Agreement
Components within five (5) business days from the receipt of Focus' purchase order, provided that should Perlos fail to confirm Focus' purchase order within such five (5) days period,
then the order shall be deemed confirmed and accepted as of the date of the order. Such separate orders shall also contain delivery schedules and details regarding delivery batches, as set out in
monthly forecasts. Deviations from the forecasts have to be agreed upon by both Parties.

	3.2.
	Perlos
shall promptly notify Focus in writing of any anticipated delay or of any circumstance(s) rendering it unable to Manufacture and/or supply the Agreement Components and the
estimated duration of such delay/circumstances. 

4.     Evaluation of the delivery performance  

Delivery
performance is maintained at a minimum of 90% on time in full against the confirmed and accepted orders agreed by the Parties according to procedure mentioned in Chapter 3.1. of this
Appendix. A review of delivery performance is to be conducted at least once per quarter. Delivery performance will be calculated using the following formulae: Percentage share of on time orders from
all orders. The delivery shall be determined to be on time in case the delivery is available at Focus plant Turku during the week stated in order confirmation by Perlos. 

Table
1 

*
* * 

 

Table
2 

*
* * 

2

 
 

APPENDIX E to
  Development and Manufacturing Agreement    
    

Focus Property  

*
* * 

 
 

APPENDIX F1 to
  Development and Manufacturing Agreement    
    

Development Project Agreements  

*
* * 

 
 

Appendix G to
  Development and Manufacturing Agreement    
    

INVESTMENT AGREEMENT  

by
and between 

Focus
Inhalation Oy, whose registered office is at Biolinja 12, P.O. Box 980, 20101 Turku and registration number Y1629116-4 (hereinafter referred to as "Focus"), 

and 

Perlos
Oyj Pharma, whose registered office is at Ayritie 12 C, P.O. Box 178, 01511 Vantaa and registration number Y 1067837-6 (hereinafter referred to
as "Perlos"). 

This
Agreement is comprised of this document and the attached Enclosures. In case of any inconsistency between this document and any of the Enclosures, they shall take precedence in the following
order: 

	1.
	This
document;

	2.
	Enclosures
in the order they are numbered. 

WHEREAS,
the Parties' objective is to start co-operation as more closely defined in the Development and Manufacturing Agreement pursuant to which Perlos would among others, supply certain
Production machinery and tools to Focus for manufacturing of the Agreement Product; 

WHEREAS,
the Parties' objective is that Perlos would provide the financing of such machinery subject to the terms and conditions agreed below 

NOW
THEREFORE THE PARTIES AGREE AS FOLLOWS: 

1.     DEFINITIONS  

In
this Agreement the expressions will have the meanings defined in the Development and Manufacturing Agreement unless otherwise expressly provided or unless the context clearly indicates otherwise. 

The
"Development and Manufacturing Agreement" means the Development and Manufacturing agreement and any amendment thereto entered into between the Parties dated on the date hereof; 

2.     MACHINERY, SPECIFICATIONS AND PURCHASE ORDERS  

Perlos
will sell and deliver to Focus certain machinery and tools (intended to include injection moulding tools, an automated sub-assembly line and one filling and final assembly line) for
the manufacture of the Agreement Product. Perlos will either manufacture and/or assemble the machinery itself or have it manufactured/assembled by a third party. 

The
specifications of the machinery to be purchased and sold hereunder, the price, basic terms of payment and other technical and commercial terms and conditions of sale shall be specified in separate
delivery contracts that will be listed in Enclosure 1. Such machines are hereinafter called the "Relevant Machines". 

All
these above mentioned separate delivery contracts shall be negotiated in good faith in the Steering Committee taking into consideration relevant business conditions and commercial needs for cost
effective production of a forecasted volume of the Agreement Components, evaluated from time to time. The price of any individual piece of Relevant Machinery shall be competitive compared to
commercially available comparable machinery. If any individual piece of Relevant Machinery shall be manufactured and/or assembled by a third party, the purchase price for Focus shall be the same as
invoiced Perlos by the third party. 

 

Under
no circumstances shall the aggregate financing granted by Perlos hereunder exceed * * * * * * . 

Subject
to the terms and conditions of this Financing Agreement, 100 per cent of the contract price of the Relevant Machines will be paid by Focus to Perlos in arrears during a period not exceeding *
years calculated from the date of commissioning of each individual Relevant Machine ("the Credit"). Focus shall pay to Perlos 

	(i)
	the
interest on the Credit;

	(ii)
	amortisation
of the Credit until it has been fully repaid; and

	(iii)
	an
unit based profit element 

all
as more closely specified below. 

Focus
shall, upon commissioning of each individual Relevant Machine issue to Perlos a promissory note covering the respective Credit, interest and collection charges. 

Focus
shall effect all the payments timely and in full without any deduction. 

Overdue
interest is charged at a rate of * per cent per annum from the due date of each payment hereunder until the payment has been credited in full to Perlos bank account. 

Focus
shall not be allowed to exercise any right of set-off against the payments hereunder. 

All
mutually agreed validation costs related to the investment of Relevant Machinery are invoiced by Perlos separately and shall be paid by Focus within thirty (30) days from the date of the
invoice. Any development work related to the Agreement Product is agreed in the Development and Manufacturing Agreement. 

3.     INTEREST  

Interest
on the Credit starts to accrue when half of the delivery time (delivery time means the time between written order and start of manufacturing of the PQ batches) of the Relevant Machine has
passed and shall be calculated on actual capital invested by Perlos as at the end of each month based on the terms of payment defined in relevant Purchase Orders. Interest shall be charged at a rate
of * per cent * per annum. 

Payments
of interest shall be invoiced semi-annually for each calendar half-year and be paid not later than the 15th day of the month succeeding the end of the period. 

4.     PROFIT ELEMENT  

The
Reimbursement of profit element will commence upon starting of the commercial production of the Agreement Product using a Relevant Machine. 

The
profit element payable by Focus to Perlos shall be * € per each unit of the Agreement Product being composed of Agreement Components manufactured by Perlos until the aggregate
credit of all the Relevant Machines together with the agreed interest has been paid off to Perlos in full. 

Thereafter
a sustained profit element of * € per each unit of the Agreement Product being composed of Agreement Components manufactured by Perlos will be applied for the lifetime of
the Relevant Machinery. 

2

 

5.     AMORTISATION  

Focus
shall pay to Perlos as a basic amortisation of the Credit * € per each unit of the Agreement Product being composed of Agreement Components manufactured by Perlos. The
amortisation shall be calculated [semi-annually] and be paid not later than the 15th day of the month succeeding the end of the period. 

*
* * 

*
* * 

6.     COLLATERAL  

Perlos
retains full ownership and title to each Relevant Machine until Focus has paid its purchase price together with accrued interest in full. As long as a Relevant Machine that stands in Focus'
premises remains the property of Perlos, Focus shall mark it so that it is observably separated from Focus' property. 

Focus
shall at its expense establish in favour of Perlos the following collateral to secure the repayment of the Credit, interest and eventual collection charges: establish, and take necessary actions
to allow Perlos to register, with the relevant authorities a right of lien in favour of Perlos on all the patents listed in Enclosure 2. Focus warrants that it has full right, title and
interest to the patents listed in Enclosure 2. 

The
collateral shall be issued before the parties enter into a delivery contract for a Relevant Machine and shall always cover the Credit and interest payable by Focus to Perlos for the Relevant
Machinery. 

As
long as any Credit hereunder is outstanding Focus will not create or permit to subsist any mortgage, charge, pledge, lien or other encumbrance on the collateral without Perlos' previous approval in
writing. Perlos hereby gives its approval to the following: 

	—
	Focus
may at any time free the collateral by paying the remaining part of the Credit

	—
	Focus
may at any time grant licenses to third parties to the patents listed in Enclosure 2 

Perlos
has no right to the above mentioned patents except as defined in article 8. 

Focus
has the right to change the collateral to other securities subject to approval by Perlos, which Perlos may not unreasonably withhold. 

7.     PERLOS OPTION  

Perlos
has an option to use a part of this financing as a strategic investment in Focus under the terms and conditions to be negotiated in good faith. The option is valid until the next financing
round is completed or the end of June 2003, whichever is earlier. 

8.     OTHER CONDITIONS  

Focus
shall within 120 days after the end of each of its fiscal year, furnish to Perlos its audited balance sheet as at the end of such fiscal year and its income statement. 

Focus
shall promptly give notice to Perlos of each event that has or might have a materially adverse effect on its ability to perform its obligations under this Investment Agreement. 

3

 

9.     DEFAULT  

Upon
the occurrence of any of the following events 

	(a)
	Focus
shall fail to pay when due any substantial amount payable hereunder and such failure shall continue for thirty (30) days; or

	(b)
	Focus
shall default in the performance and observance of any other provision contained in this Investment Agreement or the Development and Manufacturing Agreement and such default (if
capable of remedy) remains unremedied for thirty (30) days after written or telefax notice thereof has been given by Perlos to Focus; or

	(c)
	insolvency
of, or stoppage of payment by Focus or the commencement of a bankruptcy, insolvency or receivership or any similar proceeding against Focus, or levy of any distress,
execution or attachment upon the property of Focus; 

then
and in any such event at any time thereafter Perlos shall have the right to declare the Credit immediately due and payable whereupon the same shall become immediately due and payable together
with all interest accrued thereon and all other amounts payable hereunder. 

Perlos
shall have the right to realise the pledged property by voluntary sale without auction or other statutory realisation proceedings. 

10.   TERM AND TERMINATION  

This
Agreement is valid from and including the January 20, 2003 ("Effective Date") and expire when the Credit granted hereunder together with the agreed interest and the profit element has been
paid in full by Focus to Perlos. 

Focus
may terminate for any reason at any time the Investment Agreement by paying the Credit and Interest. 

The
payment obligations relating to the sustained profit element shall survive the termination of this Agreement. 

11.   MISCELLANEOUS  

The
obligations of Perlos related to the manufacture and/or assembly of Relevant Machinery as jointly specified maybe performed by a subcontractor or subcontractors appointed by Perlos. 

This
Agreement will be governed and construed in accordance with the laws of Finland. Any dispute or controversy arising out of or relating to this Agreement shall be settled by arbitration. Such
arbitration shall be conducted in Helsinki in accordance with the Rules of the Arbitration Institute of the Central Chamber of Commerce in Helsinki by one sole arbitrator appointed jointly by Focus
and Perlos. If Focus and Perlos cannot agree upon the person of the arbitrator within two (2) weeks the arbitrator shall be appointed by the Arbitration Institute of the Central Chamber of
Commerce in Helsinki. 

This
Agreement supersedes and cancels all previous agreements and understandings, whether oral or in writing, in respect of the subject matter hereof and may not be amended, or modified except by an
express declaration in writing signed on behalf of Focus and Perlos by a duly authorised officer and referring specifically to this Agreement 

Enclosures

Enclosure
1: The Relevant Machines

Enclosure 2: The patents 

4

 
 
 

ENCLOSURE 1 to
  Investment Agreement    
    

The Relevant Machines  

*
* * 

5

QuickLinks

Exhibit 10.1

DEVELOPMENT AND MANUFACTURING AGREEMENT between PERLOS Oyj and FOCUS INHALATION Oy

Appendix B to Development and Manufacturing Agreement

Quality Assurance Agreement

APPENDIX 5 to Quality Assurance Agreement

APPENDIX 8 to Quality Assurance Agreement

APPENDIX C to Development and Manufacturing Agreement

APPENDIX D to Development and Manufacturing Agreement

APPENDIX E to Development and Manufacturing Agreement

APPENDIX F1 to Development and Manufacturing Agreement

Appendix G to Development and Manufacturing Agreement

ENCLOSURE 1 to Investment Agreement

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00130-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00130-of-00352.parquet"}]]