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EXHIBIT 10.1 - CLINICAL TRIAL MANUFACTURING AGREEMENT

Clinical Trial Agreement

EXHIBIT 10.1 - CLINICAL TRIAL MANUFACTURING AGREEMENT | Document Parties: ORAMED PHARMACEUTICALS INC. | SWISS CAPS AG You are currently viewing:
This Clinical Trial Agreement involves

ORAMED PHARMACEUTICALS INC. | SWISS CAPS AG

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Title: EXHIBIT 10.1 - CLINICAL TRIAL MANUFACTURING AGREEMENT
Date: 11/2/2006

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EXHIBIT 10.1

CLINICAL TRIAL MANUFACTURING AGREEMENT

This Clinical Trial Manufacturing Agreement   ( “Agreement” )   dated this   30th day of October,   2006 (the “Effective Date” ) between:          

 

SWISS CAPS AG , of Husenstr. 35, CH-9533 Kirchberg, Switzerland ( “Swiss Caps” ) – Fax +41 (0)71 931 41 91

And

ORAMED PHARMACEUTICALS, INC. , of 2 Elza Street, Jerusalem, 93706, Israel ( “Oramed” or the “Company” ) –Fax +011 972-2-679-2336

WITNESSES THAT WHEREAS

A.      

Swiss Caps is a manufacturer and business development services partner for the pharmaceutical and healthcare industry;

 

B.      

Oramed is in the business of developing an oral form of insulin; and

 

C.      

Oramed desires to engage the services of Swiss Caps, and Swiss Caps accepts such appointment, to manufacture and deliver the Product (as defined below) to Oramed in accordance with the terms and conditions of this Agreement.

 

NOW THEREFORE, in consideration of the premises and the covenants and agreements set out herein, the receipt and sufficiency of which is hereby acknowledged, the parties agree as follows:

1.      

DEFINITIONS & INTERPRETATION

 

1.1      

All capitalised terms in this Agreement have the following meaning:

 

 

(a)      

Agreement ” means this agreement for services and includes its schedules and any documents incorporated by reference, as amended from time to time in accordance with its terms.

 

 

(b)      

Compensation ” means the compensation for the Services as set out in the Statement of Work.

 

 

(c)      

Force Majeure Event ” means any act of God or act of nature, fire, flood, storm, explosion, sabotage, riot, act of war whether declared or not, act of terrorism, requirement or restriction of governmental authorities, inability or delay in the grant of governmental or other approvals, consents, permits, licenses or authorities or any other like event, any strike, lockout, work stoppage or other industrial dispute of any kind, or any other event or circumstance beyond the reasonable control of the affected party.

 

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(d)      

Intellectual Property ” means all inventions, methods, processes, ideas and concepts, whether patentable or not, all literary and other works and all data and databases, whether or not protected by copyright, all trade-marks, trade names and domain names, industrial designs, integrated circuit topographies, trade secrets, know-how and show-how.

 

(e)      

Intellectual Property Rights ” means all world-wide legal protection provided for Intellectual Property, whether under statute, common law, international treaty or in equity, including all protection granted under laws protecting patent, copyright, trade-mark, industrial design, trade secret or integrated circuit topography rights.

 

(f)      

Loss ” means all costs, loss, damage, liability or expenses (including all reasonable legal costs, fees and expenses).

 

(g)      

Oramed Confidential Information ” means all confidential information of Oramed including all Oramed Materials, all know-how, trade secrets, business ideas and concepts of Oramed, all technical, operational, strategic, marketing, financial and business information relating to Oramed, all Intellectual Property of Oramed and any formulas, reports, notes, medical records, test results, patient information and any other information or data provided to Swiss Caps by Oramed that is designated in writing as confidential or that Swiss Caps ought to be reasonably aware is confidential. Oramed Confidential Information does not include information which is: (i) made public other than by a breach of an obligation of confidentiality, (ii) disclosed to Swiss Caps free of any obligation to keep it confidential, or (iii) independently developed by Swiss Caps without use, directly or indirectly, of Oramed Confidential Information received from Oramed.

 

(h)      

Oramed Materials ” means all materials provided by Oramed to Swiss Caps in order to assist Swiss Caps with the provision of the Services including, without limitation, those listed on Schedule 1 attached to this Agreement.

 

(i)      

Personnel ” means directors, officers, employees, agents, contractors, advisers or representatives of a party.

 

(j)      

Primary Contact ” has the meaning given to that term in Section 4.1 of this Agreement.

 

(k)      

Product ” means the product developed as a result of the provision of the Services in accordance with the Specifications, as detailed in the Statement of Work.

 

(l)      

Representatives ” has the meaning given to that term in Section 15.4(b) of this Agreement.

 

(m)      

Services ” means the services which Swiss Caps has agreed to supply to Oramed as detailed in the Statement of Work.

 

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(n)      

Specifications ” means the technical specifications for the Product, as specified in the Statement of Work.

 

(o)      

Swiss Caps Confidential Information ” means all confidential information of Swiss Caps including all know-how, trade secrets, business ideas and concepts of Swiss Caps, all technical, operational, strategic, marketing, financial and business information relating to Swiss Caps, all Intellectual Property of Swiss Caps and any other information or data provided to Oramed by Swiss Caps that is designated in writing as confidential or that Oramed ought to be reasonably aware is confidential. Swiss Caps Confidential Information does not include information which is: (i) made public other than by a breach of an obligation of confidentiality, (ii) disclosed to Oramed free of any obligation to keep it confidential, or (iii) independently developed by Oramed without use, directly or indirectly, of Swiss Caps Confidential Information received from Swiss Caps.

 

(p)      

Statement of Work ” means the statement of work attached as Schedule 1 to this Agreement, setting out the Services, the Product, the Specifications and the Compensation, as amended by the parties from time-to-time in accordance with the terms of this Agreement.

 

(q)      

Term ” has the meaning given to that term in Section 3.1 of this Agreement.

 

 

1.2      

All references to any Section herein is to the Section in this Agreement unless otherwise specified. All references to a Schedule herein is to a Schedule of this Agreement unless otherwise specified.

 

1.3      

The headings in this Agreement are for reference purposes only and will not be deemed a part of the Agreement.

 

1.4      

The term “including” means including without limitation or prejudice to the generality of any description, definition, term or phrase preceding that word, and the word “include” and its derivatives will be construed accordingly.

 

1.5      

The interpretation of any ambiguities will be construed by the principles of fairness and reasonable business practice, and authorship of this Agreement will have no bearing on the construction of any terms hereof.

 

2.      

APPOINTMENT

 

2.1      

Swiss Caps hereby agrees to perform for Oramed and Oramed hereby engages Swiss Caps to perform the Services in accordance with the terms and conditions of this Agreement.

 

2.2      

The parties agree and acknowledge that:

 

 

(a)      

the manufacturing of the Product under this Agreement is for clinical testing purposes (proof of concept) only; and

 

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(b)      

should Oramed elect to engage Swiss Caps to manufacture the Product for commercial distribution, a separate agreement will be entered into by the parties for such purpose.

 

 

3.      

TERM

 

3.1      

Subject to the express termination rights granted herein, this Agreement will commence on the Effective Date and will remain in full force and effect for a period of six (6) months from the Effective Date (the “ Term ”). The parties may renew this Agreement by mutual consent.

 

4.      

PRIMARY CONTACTS

 

4.1      

Upon execution of this Agreement, each party will designate a primary contact (“ Primary Contact ”) who will have the primary responsibility for that party’s relationship with the other party and will have the authority necessary to make the day-to- day decisions on behalf of that party with respect to the implementation of this Agreement.

 

5.      

SERVICES

 

5.1      

Swiss Caps will perform the Services in accordance with the terms of this Agreement and otherwise in a professional and workmanlike manner in accordance with industry best practices and using only appropriately skilled and experienced personnel exercising due care at all times.

 

5.2      

Swiss Caps will commence performing the Services on the Effective Date and will use best commercial efforts to meet the milestones and target dates (if any) specified in the Statement of Work.

 

5.3      

Oramed will, promptly after the Effective Date, deliver to Swiss Caps the Oramed Materials necessary for Swiss Caps to fulfil its obligations herein.

 

5.4      

Oramed will ship the Oramed Materials to Swiss Caps Delivered Duty Paid (DDP) (Incoterms 2000), and Swiss Caps will be responsible for insuring against loss or damage while the Oramed Materials are in the custody, possession or control of Swiss Caps, as required by Section 13.

 

5.5      

Notwithstanding the above clause, Swiss Caps is responsible to provide, at its cost, all materials necessary to carry out the terms of this Agreement and provide the Services and the Product.

 

5.6      

Swiss Caps will ship the Product, FCA Kirchberg (Incoterms 2000), to Oramed’s nominated address promptly on completion of the Services.

 

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6.      

AMENDMENT TO STATEMENT OF WORK

 

6.1      

If the parties jointly determine that the scope of the Services being provided under the Statement of Work, or the assumptions on which those Services are based, has changed during the course of the engagement, then such changes will be described in a written change order (“ Change Order ”) to be signed by both parties. At the option of Oramed, such additional Services may be addressed in a separate Statement of Work signed by both parties.

 

6.2      

If Oramed wishes at any time to request a change in the Services specified in the Statement of Work, then it will prepare a Change Order. Swiss Caps will evaluate and respond to any change request within 20 business days or such other period as the parties may agree in writing. Swiss Caps’ response will include the amount of any adjustment to the Compensation, if any, and an estimate on any perceived changes to the delivery dates, if applicable, specified for the Product in light of the change to the scope of the Services.

 

 

Upon receiving written authorization from Oramed, Swiss Caps will proceed with Oramed’s requested changes and the Statement of Work will be deemed to be amended accordingly.

 

7.      

ORAMED WARRANTIES

 

7.1      

Oramed represents and warrants that:

 

 

(a)      

it is authorized to enter into this Agreement and be bound by its terms;

 

 

(b)      

it is not bound by the terms of any agreement which would limit, restrict or conflict with its obligations herein; and

 

 

(c)      

it possesses all relevant permissions, consents, authorities and licenses to perform its obligations set out in this Agreement.

 

8.      

SWISS CAPS WARRANTIES

 

8.1      

Swiss Caps represents and warrants that:

 

 

(a)      

it is authorized to enter into this Agreement and be bound by its terms;

 

 

(b)      

it is not bound by the terms of any agreement which would limit, restrict or conflict with its obligations herein;

 

 

(c)      

it possesses all relevant permissions, consents, authorities and licenses to perform its obligations set out in this Agreement;

 

 

(d)      

it will perform its obligations under this Agreement in compliance with all applicable laws, statutes, regulations and codes of conduct;

 

 

(e)      

its method of manufacturing the Product will not infringe the Intellectual Property Rights of any third party; and

 

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          (f)       the Product delivered to Oramed will conform with the Specifications.

9.      

COMPENSATION

 

9.1      

The amount of the Compensation is set out in the Statement of Work.

 

9.2      

Subject to Section 9.3, Oramed will pay the Compensation to Swiss Caps in 2 instalment payments in the amounts set out in the Statement of Work. Swiss Caps will deliver an invoice to Oramed for each instalment payment as follows:

 

 

(a)      

the first such invoice will be delivered to Oramed on or after the date that Swiss Caps confirms in writing to Oramed that it has commenced performance of the Services; and

 

 

(b)      

the second such invoice will be delivered to Oramed on or after the date that Oramed advises Swiss Caps in writing that it has received the Product from Oramed.

 

9.3      

In full satisfaction of its obligation to pay each instalment payment of the Compensation to Swiss Caps, Oramed will issue that number of common shares in its capital stock having an aggregate value equal to the amount of that instalment payment. For the purposes of determining the number of common shares to be issued to Swiss Caps pursuant to an instalment payment, the Oramed common shares will be valued at the current trading price of such shares on the U.S. Over the Counter Bulletin Board on the 10th trading day after the invoice in respect of that instalment payment is delivered to Oramed in accordance with Section 9.2. Oramed will issue the applicable number of common shares to Swiss Caps within 30 days after receipt of such invoice.

 

9.4      

Swiss Caps agrees and acknowledges that Oramed’s obligation to pay the Compensation is subject to Oramed’s determination that: (a) the quantity of Product delivered to Oramed meets the requirements set forth in the Statement of Work; and (b) the Product delivered to Oramed is free from visible defects or damage. Within 5 business days after receipt of the Product, Oramed will either: (c) deliver written notice to Swiss Caps that Oramed accepts the Product as delivered; or (d) deliver written notice to Swiss Caps stating, as applicable: (i) that there is a discrepancy between the number of Product actually delivered and the number of Product specified in the Statement of Work; and/or (ii) that there are visible defects or damage to the Product, and specifying such defect or   damage in reasonable detail. If Oramed fails to deliver a notice under (c) or (d) above in this Section with such 5 business day period, then it will be deemed to have accepted the Product for the purposes of this Section 9.

 

 

 

 

 

 

 

9.5      

Swiss Caps acknowledges that it is receiving the Compensation outside of the United States and warrants, represents and acknowledges the statements and covenants set out in Schedule 2 attached to this Agreement.

 

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10.      

TERMINATION

 

10.1      

Either party may terminate this Agreement (in whole or in part) at any time with immediate effect by giving written notice to the other party (the “ Defaulting Party ”), if:

 

 

(a)      

the Defaulting Party materially breaches any provision of this Agreement that: (i) is not capable of being remedied; or (ii) is capable of being remedied but is not remedied within 15 days after receiving notice from the non-Defaulting Party requiring it to do so;

 

 

(b)      

a Force Majeure Event substantially adversely affects the ability of the Defaulting Party to perform its obligations under this Agreement continuously for a period of not less than 15 days;

 

 

(c)      

any proceeding in bankruptcy, receivership, liquidation or insolvency is commenced against the Defaulting Party or its property and is not dismissed within 30 days; or

 

 

(d)      

the Defaulting Party makes any assignment for the benefit of creditors, becomes insolvent, commits any act of bankruptcy, ceases to do business as a going concern, seeks any arrangement or compromise with its creditors under any statute or otherwise, or is unable to pay its debts as and when they fall due.

 

10.2      

Except as provided in Section 10.1, Swiss Caps will have no right to terminate this Agreement (in whole or in part) during the Term.

 

11.      

CONSEQUENCES OF TERMINATION

 

11.1      

Within 14 days of the expiry of the Term or earlier termination of this Agreement or any part thereof:

 

 

(a)      

Swiss Caps will immediately return to Oramed all Oramed Materials and Oramed Confidential Information which is in the possession, custody or control of Swiss Caps;

 

 

(b)      

Oramed will immediately return to Swiss Caps all Swiss Caps Confidential Information which is in the possession, custody or control of Oramed; and

 

 

(c)      

the parties will use best commercial efforts to co-operate fully with each other in effecting an orderly transition of the Services, if applicable.

 

11.2      

The exercise by Oramed of its right to terminate this Agreement (in whole or in part) under Section 10 will not affect or impair Oramed’s other rights or remedies under this Agreement or otherwise at law or in equity.

 

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12.      

SWISS CAPS INDEMNITY

 

12.1      

Notwithstanding any other term in this Agreement, Swiss Caps hereby covenants and agrees to indemnify and hold Oramed harmless from and against:

 

 

(a)      

all Loss arising from or relating to personal injury or death to the extent that such Loss is caused by a negligent or wilful act or omission or breach of this Agreement by Swiss Caps or any of its Personnel;

 

 

(b)      

all Loss arising from any breach or failure of performance by Swiss Caps of any of its warranties, covenants or material obligations in this Agreement;

 

 

(c)      

any damage to or loss of any tangible property of Or


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