Supply Agreement on Paclitaxel OC between Oncocorp GmbH and Resolute Oncology
GmbH
Dated May 1st, 2013

 
SUPPLY AGREEMENT

--------------------------------------------------------------------------------

Made and effective on June 1st 2013 by and between

 
Resolute Oncology GmbH, 6, Röntgenstraße 6, 82362 Weilheim, Germany (hereafter
"ROG")

 
and

 
             Oncocorp GmbH, Röntgenstraße 6, 82362 Weilheim, Germany (hereafter
"ONCO"),

(Hereinafter also individually referred to as “Party” and jointly as “Parties”),

Whereas ONCO is MAH of Paclitaxel OC  Paclitaxel 6mg/ml solution for injection
in vials of 30mg/5ml, 100mg/16,7ml, 150mg/25ml, 300mg/50ml (hereafter
"Product"),

Whereas Onco grants thereafter the selling right of Product to ROG for Territory
for the period from May 1st through December 31. 2013,

Whereas ONCO is willing to supply the Product for Territory to ROG according to
the terms herein,

Whereas ROG is interested to acquire the marketing authorisation  upon December
31st 2013 and the rights of use of Product’s dossier and then sell the
registered Product in Germany (hereafter "Territory") under its own trademark,
respecting the underlying Contract between ONCO and Stragen SA Switzerland.

Now therefore the Parties hereto agree as follows:

1. Supply
 
ROG acts as an independent company and therefore buys and sells Product in its
own name and for its own account. ROG will exercise all reasonable efforts to
support sales of Product in Territory. ROG undertakes to purchase all its
requirements of Product in Territory during the term of this Agreement
exclusively from ONCO.
 
ONCO delivers all existing product in the stock to ROG.
 
ONCO shall put its best endeavors in ensuring that the delivery of Product will
be secured.
 
The Product is contract manufactured by Haupt Pharma Wolfratshausen GmbH,
Pfaffenrieder Strasse 5, 82515 Wolfratshausen, Germany, for the account and on
behalf of ONCO under a separate agreement between ONCO and Stragen, Switzerland.
 

2. Health Registration

Product’ application dossier and all documentation necessary for obtaining the
German registration of Product in Territory (Zul.Nr. 81177.00.00) (hereafter
"Marketing Authorization" or “MA”) is referred to as "Dossier".

ONCO has obtained in the Territory a marketing authorisation (Zul.Nr.
81177.00.00).

Page 1 of 6
 

--------------------------------------------------------------------------------

 
 
Supply Agreement on Paclitaxel OC between Oncocorp GmbH and Resolute Oncology
GmbH
Dated May 1st, 2013
 

 
Notwithstanding any event which may affect the validity or maintenance of the
present Agreement, ONCO, as long as it is MA holder in Territory, shall take all
measures necessary to maintain the MA and to keep it valid. Fees for
modifications/updates to initially granted MA which can be considered to be in
the nature of a medicinal product’s life cycle as
 
­  
submission of PSURs and

­  
renewal, but also

­  
variations updating Quality (Module 3) to current status of scientific knowledge

 
(as for instance change in shelf life of finished product, DMF or CEP updates
etc,) as well as for

­  
variations imposed by Health Authorities as for instance an Article 30 procedure
to harmonise SmPC, PIL and labelling,

shall be borne by ONCO.
 
Fees related to changes/variations to the MA made upon request from ONCO or from
the Health Authorities in the Territory, as e.g. change in Product or company
name, additional pack size and/or packaging/batch release site, or
pharmacovigilance system approval, shall entirely be entirely borne by ONCO.
 
Costs and fees for variation(s) initiated by ROG and affecting Product in or
outside the Territory (as for example increase of batch size, change of
manufacturing process,…) shall be entirely borne by ROG.
 
Upon termination of the present Agreement, provided  ROG has refused to finally
acquire product, this agreement will end and ONCO shall be reinstated in all
rights to product.

3. Price

For distribution rights in Territory, ONCO will receive the following monthly
payments immediately upon receipt of the corresponding invoices for sold
product:

-  
cogs of product sold + mandatory rebate + (netsales-cogs)*0,1;

quarterly Onco will invoice according the following formula:

-  
(netsales-cogs)*0,25 – prepaid monthly profits (e.g. (netsales-cogs)*0,1)

Netsales is defined as sales minus mandatory rebates, minus skonto to
pharmacies.

If ROL or ROG decides to acquire product from ONCO, ONCO will do everything in
order to convince Stragen to switch MA from ONCO to ROG/ROL. If this is
successful the price for Product is 150.000 €.

Remaining product in Stock will be evaluated at cogs. Onco will herefor provide
an invoice which is du within 6 month without any deductions.
 
4. Quality

In the event that any supplied Product shall be found defective in Quality
("Quality" means hereafter in conformity with the EU-GMP and with the current
approved MA Dossier), it shall be reported in writing together with reasonable
evidence of such defect to ONCO within:

-  
ten (10) working days for visible defects (i.e.: a defect visible at reception
of the goods by a non expert person, as for example a defect in packaging) from
the date of delivery to ROG or

-  
during Product’s shelf life for latent defects (i.e. a defect that only appears
when the Product is used being understood that such defect may appear during the
whole shelf life of the Product, as for example a defect in vials or the Product
itself)  (within fifteen (15) days from occurrence or discovery),

 
 
 
Page 2 of 6
 

--------------------------------------------------------------------------------

 
 
Supply Agreement on Paclitaxel OC between Oncocorp GmbH and Resolute Oncology
GmbH
Dated May 1st, 2013
 

 
Upon ROG’s request, ONCO shall replace such presumed defective Product within a
reasonable time period not to exceed seventy (70) days delivered DDP ROG.
 
5. Pharmacovigilance

ONCO as Marketing Authorization Holder is solely responsible for
pharmacovigilance in Territory and all related duties in accordance with the
applicable regulations.
If ROG is aware of an adverse event which shall be processed by ONCO, ROG shall
immediately forward such information to ONCO and in any case within one (1)
working-day.

6. Duration

This Agreement will commence May 1st 2013 and remain in force till as from the
date of ONCO’s first commercial order of Product and ends automatically at
December 31st 2013.

Upon expiry of this agreement further to the terms of the hereabove article 8,
the MA shall remain in the undisputed ownership of ONCO.

9. Termination

This Agreement may be terminated at any time:

(a) by either Party upon registered written notice to the other Party in case of
breach of any of its obligations hereunder not have been remedied within thirty
(30) days after receiving written notice requiring such breach to be remedied;
or

(b) forthwith by either Party if the other Party goes into liquidation, is
bankrupt or insolvent; or

(c) by ROG by written notice to ONCO in case of breach by ONCO of the
non-competition obligation set forth in Article 1 here above.
 
One month before this Agreement ends, the parties start the process of changing
the MA from ONCO to ROG under participation of Stragen.

No claims for indemnity or compensation can be lodged under the law of this
Agreement by reason of the termination of the present Agreement, save where
these claims are based on breach of contract by one of the Parties hereto.

Orders placed by ONCO and confirmed by ROG prior to the date of termination, and
the manufacture of which has begun prior to the said date, shall remain valid.
 
10. Non-Assignability

ONCO undertakes during the term of this Agreement not to transfer the MA and the
present Agreement to any third party without the prior written consent of ROG.
 
11. Law of Contract / Jurisdiction

This Agreement shall be exclusively governed by and construed in all respects by
and in accordance with the German Law without regard to conflict of law
provisions.

In the event of any dispute arising out of or in connection with the execution
or interpretation of this Agreement, the President or Managing Director of both
Parties shall meet and seek to resolve in good faith such dispute amicably
between themselves within a period of sixty (60) days.
 
 
 
Page 3 of 6
 

--------------------------------------------------------------------------------

 
 
Supply Agreement on Paclitaxel OC between Oncocorp GmbH and Resolute Oncology
GmbH
Dated May 1st, 2013
 
 

It is expressly agreed between the Parties that if no settlement can be found
between them within these sixty (60) days, and in any case no later than two (2)
months following the receipt by one Party of the written claim of the other
Party, such dispute shall be finally and exclusively settled by arbitration in
accordance with the Swiss Rules of International Arbitration of the Swiss
Chambers of Commerce in force on the date when the Notice of Arbitration is
submitted in accordance with these Rules. The number of arbitrators shall be one
(1). The seat of the arbitration shall be in Geneva (Chamber of Commerce) and
the proceedings shall be conducted in English language.
 
13. Indemnification

ONCO undertakes to indemnify ROG and hold it harmless from and against any
liability, claims, damages, lawsuits, costs (including reasonable attorney's
fees) or judgments arising out of (i) a defect in manufacturing the Product or
(ii) being a result of any breach by ONCO of any of its obligations under this
Agreement. ROG’s liability is limited to the amounts specified within RONCO’s
product liability insurance. A copy of this product liability insurance will be
provided to ROG on first demand.

ROG undertakes to indemnify ONCO and hold it harmless from and against any
liability, claims, damages, lawsuits, costs (including reasonable attorney's
fees) or judgments arising out of (i) ROG's negligent distribution, storage or
sale of Product or (ii) any claim of failure by ROG to comply with local
governmental requirements relating to the supplied Product in the Territory or
(iii) being a result of any breach by ROG of any of its obligations under this
Agreement. ONCO’s liability is limited to the amounts specified within ROG’
product liability insurance. A copy of this product liability insurance will be
provided to ONCO on first demand.

14. Final provision

This Agreement contains the entire agreement between the Parties concerning the
subject matter and supersedes all prior agreements and understandings relating
to the subject matter hereof.

This Agreement will be binding upon and inure to the benefit of any affiliates,
subsidiaries, successors and/or assignees of a Party hereto.

No supplement, modification or waiver of any provision of this Agreement shall
be valid unless in writing signed by both Parties hereto.

In case of one or more of the provisions contained hereto is invalid, illegal or
unenforceable in any respect, the validity of the remaining provisions hereto
shall not be affected or impaired thereby, except to the extend necessary to
avoid an unjust or inequitable result.

IN WITNESS WHEREOF the Parties hereto have caused this Agreement in duplicate
originals to be entered into by their duly authorized representatives as of the
day and year first above written.
 
 
 

For Oncocorp GmbH For Resolute Oncology GmbH         By : /s/Eva Gotzler By :
/s/Peter Gotzler Name  Mrs. Eva Gotzier Name  Mr. Peter Gotzler Title 
Geschäftsführerin Title Geschäftsführer Date  Weilheim, the Date  Weilheim, the

 
 
 
Page 4 of 6
 

--------------------------------------------------------------------------------

 

Supply Agreement on Paclitaxel OC between Oncocorp GmbH and Resolute Oncology
GmbH
Dated May 1st, 2013

Appendix Nr. 1

--------------------------------------------------------------------------------

Attached to and forming part of the Supply Agreement dated September 14th 2011
by and between

ROG Pharma SA, 3, Chemin du Pré-Fleuri, 1228 Plan-Les-Ouates, Switzerland
and
ONCO GmbH, Am Weidenbach 6, 82362 Weilheim, Germany

PRODUCT
Paclitaxel 6mg/ml solution for injection in vials of 30mg/5ml

 
Paclitaxel 6mg/ml solution for injection in vials of 100mg/16,7ml

 
Paclitaxel 6mg/ml solution for injection in vials of 150mg/25ml

 
Paclitaxel 6mg/ml solution for injection in vials of 300mg/50ml

 
                   In finished packs of 1 vial (vial type 1 clear glass with
flip-off cap, label and box in 2 colors, leaflet 1 color)

TERMS OF DELIVERY                    Storage Resolute Oncology GmbH, Alpenstraße
6, Weilheim,
 

PRODUCT PRICE vial of 30mg/5ml : € 11,45   vial of 100mg/16,7ml : € 29,00   vial
of 150mg/25ml € 44,00   vial 300mg/50ml : € 88,00

 
TERMS OF PAYMENT                    At 30 days net from date of invoice

For Oncocorp GmbH For Resolute Oncology GmbH         By : /s/Eva Gotzler By :
/s/Peter Gotzler Name Mrs. Eva Gotzier Name Mr. Peter Gotzler Title
Geschäftsführerin Title Geschäftsführer Date Weilheim, the Date Weilheim, the

 

Page 5 of 6
 
 

--------------------------------------------------------------------------------

 
Supply Agreement on Paclitaxel OC between Oncocorp  GmbH and Resolute Oncology
GmbH
Dated May 1st, 2013

Appendix Nr. 2

TECHNICAL AGREEMENT

--------------------------------------------------------------------------------

Oncocorp GmbH and Resolute Oncology GmbH agree upon that Oncocorp GmbH is the
sole responsible party for all technical questions concerning Product and that
the Technical Agreemant between Oncocorp Gmbh and Stragen SA covers all relevant
issues, including pharmacovigilance.

Oncocorp GmbH Resolute Oncology GmbH          /s/Eva Gotzler /s/Peter Gotzler
Eva Gotzier Peter Gotzler

 

Page  6 of 6