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Development and Licence Agreement

Development Agreement

Development and Licence Agreement | Document Parties: ONYX PHARMACEUTICALS INC | BTG International Limited You are currently viewing:
This Development Agreement involves

ONYX PHARMACEUTICALS INC | BTG International Limited

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Title: Development and Licence Agreement
Governing Law: Delaware     Date: 2/25/2009
Industry: Biotechnology and Drugs     Sector: Healthcare

Development and Licence Agreement, Parties: onyx pharmaceuticals inc , btg international limited
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Exhibit 10.27

 

 

 

[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

DATED 6 NOVEMBER 2008

(1) BTG International Limited

- and -

(2) Onyx Pharmaceuticals Inc.

 

Development and Licence Agreement

 

 


 

THIS AGREEMENT is made the 6 th day of November 2008

BETWEEN:-

(1)

 

BTG International Limited a company incorporated under the laws of England with company registration number 02664412 and whose registered office is at 10 Fleet Place, Limeburner Lane, London EC4M 7SB (“BTG”); and

 

(2)

 

Onyx Pharmaceuticals Inc. a corporation incorporated under the laws of the State of Delaware whose principal office is at 2100 Powell Street, Emeryville, CA 94608 (“Onyx”).

BACKGROUND:-

(A)

 

BTG has acquired and commenced the development of a technology comprising a product known as BGC-0945 which, subject to further development, is intended to be used in the field of oncology.

 

(B)

 

Onyx is in the business of developing and commercializing anticancer therapies.

 

(C)

 

BTG is willing to grant to Onyx, and Onyx wishes to receive, a worldwide, sub-licensable, royalty-bearing, licence to develop, make, have made, use, import, sell, distribute, have sold and offer for sale products in accordance with and subject to the provisions set out in this Agreement.

THE PARTIES AGREE AS FOLLOWS:-

1.

 

DEFINITIONS

 

 

 

In this Agreement the following words and expressions shall have the following meanings:-

 

 

 

 

 

1.1

 

“Affiliate”

 

any entity that directly or indirectly controls, is controlled by, or is under common control with another entity, for so long as such control exists. In the case of companies and corporations “control” and “controlled” means beneficial ownership of more than fifty percent of the voting stock, shares, interest or equity in an entity. In the case of any other legal entity, “control” and “controlled” shall exist through the ability to directly or indirectly control the management and/or business of the legal entity;

 

 

 

 

 

1.2

 

“BGC-0945”

 

[ * ] (the structure of which is shown in Schedule 6) or any salts, esters, racemates, stereoisomers, crystalline polymorphs, hydrates, solvates, or other acids thereof.

 

 

 

 

 

1.3

 

“Combination Product”

 

shall have the meaning given to it in Clause 1.33;

 

 

 

 

 

1.4

 

“Commencement Date”

 

the date first above written;

 

 

 

 

 

1.5

 

“Commercially Reasonable Endeavours”

 

[ * ];

 

 

 

 

 

1.6

 

“Confidential Material”

 

shall have the meaning given to it in Clauses 11.1 and 11.2;

 

[ * ]

 

= Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

1


 

 

 

 

 

 

1.7

 

“Damages”

 

shall have the meaning given to it in Clause 16.6;

 

 

 

 

 

1.8

 

“Deductions”

 

shall have the meaning given to it in Clause 1.33;

 

 

 

 

 

1.9

 

“Detailed Development Plan”

 

the detailed development plan to be prepared by Onyx pursuant to Clause 9.3;

 

 

 

 

 

1.10

 

“Disclosing Party”

 

shall have the meaning given to it in Clause 11.1;

 

 

 

 

 

1.11

 

“EU”

 

member states of the European Union as it is constituted from time to time;

 

 

 

 

 

1.12

 

“FDA”

 

United States Food and Drug Administration, or any successor entity thereto;

 

 

 

 

 

1.13

 

“ICR”

 

shall have the meaning given to it in Clause 11.9;

 

 

 

 

 

1.14

 

“IND”

 

investigational new drug application as defined by FDA;

 

 

 

 

 

1.15

 

“Infringement”

 

any infringement of any of the Licensed Rights;

 

 

 

 

 

1.16

 

“Infringer”

 

a third party that commits, or is alleged to have committed, an Infringement;

 

 

 

 

 

1.17

 

“International Accounting Standards”

 

the international accounting standards within the meaning of Regulation (EC) No. 1606/2002 of the European Parliament and of the Council of 19 July 2002, adopted from time to time by the European Commission in accordance with the Regulation;

 

 

 

 

 

1.18

 

“Licensed Know-How”

 

the know-how, data, trade secrets, manufacturing processes and proprietary information that is owned or controlled by BTG as of the Commencement Date as set out in Schedule 2;

 

 

 

 

 

1.19

 

“Licensed Patents”

 

means:-
(a) the Patent Applications;

(b) any patents granted in respect of the Patent Applications;

(c) the granted patents listed in Schedule 1; and

(d) in relation to any patents falling within (b) or (c) above, any re-issues, renewals, re-examinations, extensions, confirmations, continuations, continuations-in-part or divisionals thereof, and any Patent Term Extensions granted in connection with such patents; and

(e) any foreign counterparts of the foregoing patents and patent applications.

 

 

 

 

 

1.20

 

“Licensed Products”

 

BGC-0945 and any other product, the research, development, manufacture, import, marketing, use, sale or supply of which would (a) use or incorporate (or has used or incorporated) any Licensed Know-How; or (b) but for the Licence, would infringe the Licensed Patents;

 

 

 

 

 

1.21

 

“Licensed Rights”

 

the Licensed Patents and the Licensed Know-How;

 

 

 

 

 

1.22

 

“Licensed Technology”

 

the technology claimed by the Licensed Patents and/or included in the Licensed Know-How;

 

[ * ]

 

= Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

2


 

 

 

 

 

 

1.23

 

“Licences”

 

the licences granted under Clause 2.1;

 

 

 

 

 

1.24

 

“Major European Country”

 

the [ * ];

 

 

 

 

 

1.25

 

“Major Markets”

 

the [ * ];

 

 

 

 

 

1.26

 

“Materials”

 

the quantities of bulk intermediates, active pharmaceutical ingredients and formulated Licensed Products, listed in Schedule 3;

 

 

 

 

 

1.27

 

“Materials Payment”

 

shall have the meaning given to it in Clause 5.2;

 

 

 

 

 

1.28

 

“MHRA”

 

Medicines and Healthcare products Regulations Agency (or any successor entity thereto);

 

 

 

 

 

1.29

 

“Milestone Events”

 

the milestone events set out in Clause 5.3;

 

 

 

 

 

1.30

 

“Milestone Payments”

 

the milestone payments set out in Clause 5.3;

 

 

 

 

 

1.31

 

“NDA”

 

shall mean a new drug application (as more fully defined in 21 Code of Federal Regulations section 314.5 et seq);

 

 

 

 

 

1.32

 

“Net Receipts”

 

(a) all royalties, profit shares or other amounts received by Onyx or any Affiliate of Onyx from a Sub-licensee or its Affiliates (other than an Affiliate of Onyx), or any subsequent sub-licensees thereof, relating to sales of Licensed Products (it being understood that this definition excludes [ * ], but includes [ * ]) and (b) solely in the event that the commercialization of the Licensed Products in [ * ] is being carried out or is to be carried out by a Non-Affiliate Sub-licensee, any milestones or other payments received by Onyx or any Affiliate of Onyx from such Sub-licensee as a result of (i) the [ * ] or (ii) the [ * ];

 

 

 

 

 

1.33

 

“Net Sales Value”

 

the amount billed or invoiced by Onyx Suppliers to third parties in respect of supplies of the Licensed Products (in fully formulated, final form packed for ultimate consumer use) less the following items as indicated on the relevant invoice (but only to the extent relating to the Licensed Product and actually paid or allowed and not reimbursed by any third party and provided that no deductions shall be allowed for any advertising, promotional or sales force expenses): (i) tariffs, duties, excises and sales taxes, (ii) costs of delivery, including transportation and insurance charges, (iii) customary trade or quantity discounts actually granted, (iv) amounts actually repaid or credited by reason of rejections, defects, recalls or returns or because of adjustments, billing errors, or trial prescriptions, (vi) amounts that are recorded in the sellers audited accounts as written off as bad debts, uncollectible in accordance with the applicable seller’s accounting policies for the general provision of doubtful debts, as consistently applied and as allowed by United States Generally Accepted Accounting Principles or International Accounting Standards (as the case may be), (vii)

 

[ * ]

 

= Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

3


 

 

 

 

 

 

 

 

 

 

allowances or credits to customers on account of price reductions affecting the Licensed Products, and (viii) rebates and discounts actually paid or credited to any governmental agency (or branch of government) (the “Deductions”); provided that where:

 

 

 

 

 

(a) the Licensed Products are sold other than in an arm’s-length sale; or
(b) the consideration for the Licensed Product includes any non-cash element other than customary rights that are typically granted to customers in contracts with cash customers (for the avoidance of doubt such customary rights shall not include equity, stock or any other form of securities or any loan arrangement otherwise than on normal commercial terms); or

(c) the Licensed Product is transferred in any manner other than an invoiced order,

the Net Sales Value applicable to such transaction shall be deemed to be the amount billed or invoiced by Onyx Suppliers to independent third parties in respect of supplies of the Licensed Products (in fully formulated, final form packed for ultimate consumer use) that would have been billed or invoiced for that Licensed Product in the country where the transaction was effective had (a), (b) and/or (c) not been the case, less the Deductions (where such Deductions relate to the Licensed Product and are actually paid or allowed and not reimbursed by any third party and provided that no Deductions shall be allowed for any advertising, promotional or sales force expenses) that would have been applicable for that Licensed Product in the country where the transaction was effective had (a), (b) and/or (c) not been the case. Such hypothetical Net Sales Value shall be agreed by the parties acting in good faith or, failing such agreement, as determined by a reputable independent auditor appointed by agreement between the parties (or failing such agreement, the Chairman for the time being of the Institute of Chartered Accountants of England and Wales), with the decision of such auditor being final and binding on the parties and with the auditor acting as an expert and not an arbitrator. If the price determined by the auditor is equal to or lower than that proposed by Onyx then BTG shall be responsible for the costs of the appointment of the auditor. If the price determined by the auditor is greater than that proposed by Onyx then Onyx shall be responsible for the costs of such appointment;

provided, further that if a Licensed Product is sold in the form of a combination product containing both a Licensed Product and one or more active pharmaceutical ingredients or devices that are not Licensed Products (for the purpose of this Agreement, a “Combination Product”), the Net Sales Value of such Licensed Product for the purpose of calculating royalties owed by Onyx under this Agreement for sales of such Licensed Product, shall be determined as follows: first, Onyx shall determine the actual

 

[ * ]

 

= Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

4


 

 

 

 

 

 

 

 

 

 

Net Sales Value of such Combination Product (using the above provisions) and then such amount shall be multiplied by the fraction A/(A+B), where A is the invoice price of the Licensed Product, if sold separately, and B is the total invoice price of any other active pharmaceutical ingredient or device in the combination if sold separately. If, the other active pharmaceutical ingredient or device in the combination are not sold separately, Net Sales Value of the Licensed Product in question shall be calculated by multiplying actual Net Sales Value of such Combination Product (calculated using the above provisions) by a fraction A/C where A is the invoice price of the Licensed Product if sold separately, and C is the invoice price of the Combination Product where the maximum value of the fraction A/C equals one (1). If, neither the Licensed Product nor the other active pharmaceutical ingredient or device in the Combination Product is sold separately, the adjustment to Net Sales Value shall be determined by the parties in good faith to reasonably reflect the fair value of the contribution of the Licensed Product in the Combination Product to the total market value of such product;

 

 

 

 

 

1.34

 

Non-Affiliate
Sublicensee

 

a Sublicensee that is not also an Affiliate of Onyx;

 

 

 

 

 

1.35

 

“Onyx Suppliers”

 

Onyx, its Affiliates, its Sub-licensees and the Affiliates of the Sub-licensees;

 

 

 

 

 

1.36

 

“Outline Development Plan”

 

the outline development plan relating to the development and commercialisation of Licensed Products as agreed between the parties and set out in Schedule 5;

 

 

 

 

 

1.37

 

“Patent Applications”

 

the patent applications listed in Schedule 1 and any continuation applications, continuation-in-part applications, divisional applications, national or international patent applications anywhere in the world in each case that claim priority solely from the patent applications listed in Schedule 1 and/or any of their priority filings;

 

 

 

 

 

1.38

 

“Patent Term Extension”

 

any patent term extensions, including extensions granted under the US Drug Price Competition and Patent Term Restoration Act 1984 and the EC Supplementary Protection Certificate Regulation (Council Regulation (EEC) No. 1768/92) and any legislation, amending, replacing or implementing the foregoing;

 

 

 

 

 

1.39

 

“Personnel”

 

officers, employees, consultants, agents, representatives, contractors and advisers;

 

 

 

 

 

1.40

 

“Phase I Clinical Trial

 

“a human clinical trial, the principal purpose of which is to determine the metabolic and pharmacologic actions of a drug and its safety, the side effects associated with increasing doses and, if possible, to gain early evidence of its effectiveness;

 

 

 

 

 

1.41

 

“Phase II Clinical Trial”

 

a human clinical trial, the principal purpose of which is to evaluate the effectiveness of a drug for a particular indication in patients with a disease and to determine the common short-term side effects and risks associated with the drug;

 

[ * ]

 

= Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

5


 

 

 

 

 

 

1.42

 

“Phase III Clinical Trial”

 

an expanded controlled or uncontrolled human clinical trial of a drug in a randomized study (with endpoints agreed upon by a regulatory body for Product Approval for example, without limitation, as evidenced in the minutes of an end of Phase II Clinical meeting with a competent regulatory authority in the United States of America or the EU) which is intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of such drug and to provide an adequate basis for physician labelling;

 

 

 

 

 

1.43

 

“Product Approval”

 

in relation to a country, the grant of all governmental, regulatory and pricing approvals required to sell a Licensed Product in that country;

 

 

 

 

 

1.44

 

“Quarter”

 

the quarterly periods in each Year of the Term ending 31 March, 30 June, 30 September and 31 December with the exception of the first Quarter of this Agreement, which shall be the period of time from the Commencement Date to 31 December 2008;

 

 

 

 

 

1.45

 

“Reasonable Revisions”

 

such revisions by Onyx as may be reasonably necessary (in good faith and having regard to Onyx’s obligations in Clause 9) after the Commencement Date to adjust development of Licensed Products in response to changed external circumstances comprising material [ * ] problems arising regarding the Licensed Product but not [ * ];

 

 

 

 

 

1.46

 

“Receiving Party”

 

shall have the meaning given to it in Clause 11.1;

 

 

 

 

 

1.47

 

“Revocation Proceedings”

 

“any proceedings where the validity of any of the Licensed Patents is at issue including opposition proceedings in respect of European patents and interference proceedings in respect of US patents;

 

 

 

 

 

1.48

 

“Signing Fee”

 

shall have the meaning given to it in Clause 5.1

 

 

 

 

 

1.49

 

“Sub-licence Agreement”

 

any agreement between Onyx and a Sub-licensee relating to this Agreement or any of the Licensed Rights;

 

 

 

 

 

1.50

 

“Sub-licensee”

 

a third party (including an Affiliate of Onyx) to whom Onyx and/or any of its Affiliates has sub-licensed, sub-contracted or otherwise transferred any of Onyx’s rights and/or obligations under this Agreement including, a third party with whom Onyx and/or any of its Affiliates has agreed not to assert the Licensed Rights and/or has otherwise waived the Licensed Rights (unless such waiver or non-assert has been given with the prior written consent of BTG), it being understood that a failure to bring or maintain an infringement suit against an alleged infringer shall not, by itself, constitute a waiver for the purpose of this definition unless Onyx and/or any of its Affiliates are receiving consideration of any form from, or otherwise supplying a Licensed Product to, the alleged infringer or its Affiliates;

 

 

 

 

 

1.51

 

“Term”

 

shall have the meaning given to it in Clause 18.1;

 

[ * ]

 

= Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

6


 

 

 

 

 

 

1.52

 

“Termination Milestone”

 

Shall have the meaning given to it in Clause 19.3;

 

 

 

 

 

1.53

 

“Third Party Claims”

 

shall have the meaning given to it in Clause 5.11;

 

 

 

 

 

1.54

 

“Third Party Royalty”

 

shall have the meaning given to it in Clause 5.11;

 

 

 

 

 

1.55

 

“United States Generally Accepted Accounting Standards”

 

means the generally accepted accounting principles as established by the United States of America Financial Accounting Standards Board from time to time;

 

 

 

 

 

1.56

 

“Valid Claim”

 

an issued claim of any unexpired patent or claim of any pending patent application, which has not been held unenforceable, unpatentable or invalid by a court or governmental body of competent jurisdiction, unappealable through disclaimer or otherwise, and which has not been lost through an interference proceeding or abandoned; provided, however, that if a claim of a pending patent application has been pending for more than [ * ] years from the Commencement Date or, if applied for after the Commencement Date, has been pending for more than [ * ] years from its application date, such claim will not constitute a Valid Claim for the purposes of this Agreement from the end of that [ * ] period (as applicable) unless and until such claim issues and otherwise satisfies the above requirements at which time the claim shall be deemed a Valid Claim [ * ] for the purposes of, inter alia , calculating any royalty obligation from Onyx to BTG (subject to Clause 5.7); and

 

 

 

 

 

1.57

 

“Year”

 

a calendar year;

 

2.

 

GRANT OF LICENCES

2.1.

 

With effect from the Commencement Date and subject to the provisions of this Agreement, BTG grants to Onyx, an exclusive, worldwide, sub-licensable, royalty-bearing, licence under the Licensed Rights to develop, make, have made, use, import, sell, distribute, have sold and offer for sale Licensed Products for all applications and for all uses.

 

2.2.

 

Promptly following the Commencement Date (but in any event no later than thirty (30) days thereafter), BTG shall transfer to Onyx all Licensed Know-How, to the extent such Licensed Know-How is not already in Onyx’s possession. All costs and expenses of any such transfer by BTG shall be borne by BTG. Subject to Clause 19.2.2 all media supplied by BTG to Onyx in which Licensed Know-How is recorded shall be thereafter owned by Onyx.

 

2.3.

 

If, following the Commencement Date, BTG discovers know-how or information that was in the possession of, and owned or controlled by, BTG prior to the Commencement Date that is necessary or (in [ * ]’s opinion) reasonably useful for the development, manufacture, or commercialization of BGC-0945 or any other molecule claimed in the Licensed Patents and that [ * ] from BTG’s development of BGC-0945 prior to the Commencement Date, which is not set out in Schedule 2, BTG shall, upon discovery, subject to [ * ], provide such know-how or information to Onyx. Such know-how or information shall become, for the purposes of this Agreement, Licensed Know-How provided that [ * ].

 

[ * ]

 

= Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

7


 

2.4.

 

If, following the Commencement Date, BTG discovers patent(s) or patent application(s) that were in the possession of, and owned or controlled by, BTG prior to the Commencement Date that are necessary or (in [ * ]’s opinion) reasonably useful for the development, manufacture, or commercialization of BGC-0945 or any other molecule claimed in the Licensed Patents (as defined on the Commencement Date without regard to the rest of this Section 2.4) and that [ * ] from BTG’s development of BGC-0945 prior to the Commencement Date, which is not set out in Schedule 1, BTG shall, upon discovery, subject to [ * ], provide such patent(s) and/or patent application(s) to Onyx. Such patent(s) and/or patent application(s) shall become, for the purposes of this Agreement, Licensed Patents (and shall be deemed to be included on Schedule 1), provided that [ * ].

 

2.5.

 

In no event shall Onyx be responsible for any payments owed by BTG or its Affiliates under any agreements between a third party and BTG or its Affiliates related to the Licensed Products or Licensed Technology, as a result of the grant of the Licences or the exploitation of the Licences by Onyx, its Affiliates, or its Sub-licensees.

 

2.6.

 

In no event shall BTG be responsible for any payments owed by Onyx or its Sub-licensees or their respective Affiliates under any agreements between a third party and Onyx or its Sub-licensees or their respective Affiliates related to the Licensed Products or Licensed Technology, as a result of the grant of the Licenses or the exploitation of the Licenses by Onyx, its Affiliates, or its Sub-licensees or their Affiliates. For the avoidance of doubt, this Clause 2.6 shall not affect the operation of the royalty reduction provision in Clause 5.11.

 

3.

 

DURATION OF THE LICENCES

 

3.1

 

Unless terminated earlier in accordance with Clause 18 of this Agreement, the Licences shall commence on the Commencement Date and shall automatically expire on a country by country basis on the last to occur of the following:-

 

3.1.1

 

the date on which no Valid Claim of a Licensed Patent remains in force in the country concerned; or

 

 

3.1.2

 

ten (10) years from the date of the first commercial sale of the relevant Licensed Product in the country concerned.

 

3.2

 

Following expiry of the Licences in a country, Onyx’s obligation to pay further royalties pursuant to Clause 5.5 and 5.6 in respect of Net Sales Value of Licensed Products in such country (unless the Licensed Products sold in such country are manufactured in a country where a Valid Claim subsists) shall terminate and Onyx shall have a fully paid up, royalty-free (subject to Onyx’s obligation to pay royalties on Net Sales Value of Licensed Products sold in such country but manufactured in a country where a Valid Claim subsists), perpetual, exclusive licence under the Licensed Know-How to make, have made, use, import, promote, distribute, sell, offer for sale and otherwise exploit the Licensed Products in that country.

 

4.

 

SUBLICENSING AND SUBCONTRACTING

 

4.1

 

Onyx may sub-licence and/or subcontract its rights under this Agreement provided it complies with this Clause 4.

 

[*] 

 = 

Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

8


 

4.2

 

Onyx shall enter into a written agreement with each Sub-licensee (provided that this obligation to enter into a written agreement shall not apply where, and for so long as, the Sub-licensee is an Affiliate) and shall ensure that:-

 

4.2.1

 

the provisions of the Sub-licence Agreement are entirely consistent with the provisions of this Agreement;

 

 

4.2.2

 

the Sub-licence Agreement is [ * ] and [ * ] the [ * ] from [ * ] the [ * ] without the prior written consent of BTG, not to be unreasonably withheld;

 

 

4.2.3

 

the Sub-licence Agreement prohibits the Sub-licensee and its Affiliates from [ * ] or otherwise [ * ] in each case without the prior written consent of BTG, not to be unreasonably withheld;

 

 

4.2.4

 

the Sub-licence Agreement sets out all the terms agreed between the parties including, in particular, all terms as to remuneration;

 

 

4.2.5

 

the Sub-licence Agreement imposes obligations of confidentiality on the Sub-licensee in respect of any Confidential Material disclosed by BTG and/or its Affiliates which are no less onerous than those set out in Clause 11;

 

 

4.2.6

 

the Sub-licence Agreement shall terminate automatically if (1) this Agreement expires or is terminated (subject to Clause 4.7) or (2) the Sub-licensee or its Affiliates [ * ] or otherwise assist any third party to [ * ], the [ * ] of any of the [ * ] including the [ * ] of any of the [ * ] of the [ * ];

 

 

4.2.7

 

the Sub-licence Agreement imposes an obligation on the Sub-licensee to (a) keep and provide financial statements and other such information as is reasonably required to allow Onyx to document and verify payments required to be made to BTG under this Agreement and otherwise to comply with all of its obligations under this Agreement (including, without limitation, the provision of the royalty statement as set out in Schedule 4), and on Onyx’s request, (b) allow an independent professional accountant appointed by Onyx to be given access to and be permitted to examine and copy the books, accounts and records of the Sub-licensee (and the Sub-licensee’s Affiliates, to the extent relevant) upon [ * ] days notice having been given by Onyx and at all reasonable times on business days for the purpose of certifying to Onyx that the monies calculated by the Sub-licensee as being due to Onyx under the relevant Sub-licence Agreement during any Year and the sale of Licensed Products in any Year were each correctly calculated, true and accurate; and (c) oblige the Sub-licensee to make available its Personnel on [ * ] days advance notice and during normal business working hours, to answer queries on all accounts, books and records required for the purpose of the above certification;

 

 

4.2.8

 

the Sub-licence Agreement imposes an obligation on the Sub-licensee to, on termination of the Sub-licence Agreement (but, for the avoidance of doubt, excluding any expiration of the Sub-license Agreement following which the Sub-licensee retains the right to sell and distribute the Product), transfer to Onyx all Product Approvals for the Licensed Products that are owned by the applicable Sub-licensee or its Affiliates as well as all technical information or data generated by or on behalf of the Sub-licensee or its Affiliates pursuant to activities conducted under the Sub- license Agreement, including without limitation, market research so generated to support the sale and distribution of the Licensed Product; and

 

[*] 

 = 

Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

9


 

 

4.2.9

 

the Sub-licensee shall be required by the Sub-license Agreement to include on the packaging of each Licensed Product and in the information leaflet supplied with each Licensed Product the notice set out at Clause 10.2 (subject to any limitations imposed by applicable law).

4.3

 

Onyx shall procure that each Sub-licensee complies fully at all times with the provisions of its Sub-licence Agreement.

 

4.4

 

Any acts and omissions of a Sub-licensee that, if committed by Onyx, would constitute a breach of any of the provisions of this Agreement, shall be deemed to be a breach of this Agreement by Onyx.

 

4.5

 

Onyx shall promptly notify BTG of the details of any material breach of a Sub-licensee of which it becomes aware to the extent that such material breach would reasonably be expected to cause Onyx to be in breach of its obligations under this Agreement.

 

4.6

 

Onyx shall provide BTG with a true and complete copy of any Sub-licence Agreement promptly following its execution; provided, however, that Onyx may redact any portions of such Sub-licence Agreement that are confidential or proprietary (other than any portions relating to payments or other consideration payable by Sub-licensees with respect to the Licensed Products and any other provisions that are necessary for BTG to verify Onyx’s compliance with the terms of this Agreement).

 

4.7

 

At Onyx’s request and on a case-by-case basis, unless termination is due to acts or omissions of a Sub-licensee or the relevant Sub-licensee is otherwise in breach of the terms of the Sub-licence, BTG shall in good faith consider amending this Agreement to allow the rights granted by Onyx to a particular Sub-licensee to continue (i.e., as a direct licence from BTG) following termination of this Agreement.

 

5.

 

PAYMENTS

Signing Fee

5.1

 

Onyx shall pay to BTG on the Commencement Date a one-time, non-refundable signing fee of [ * ] (the “Signing Fee”).

Payment for the Materials

5.2

 

Onyx shall pay to BTG on the Commencement Date a non-refundable payment of [ * ] in respect of the transfer of the Materials (the “Materials Payment”).

Milestone Payments

5.3

 

Onyx shall pay to BTG the following non-refundable Milestone Payments on the attainment of the corresponding Milestone Event by an Onyx Supplier:

 

[*] 

 = 

Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

10


 

 

 

 

Milestone Event

 

Milestone Payments

Development Milestone Event

 

Development Milestone Payment

[ * ]

 

US$[ * ]

[ * ]

 

US$[ * ]

[ * ]

 

US$[ * ]

[ * ]

 

US$[ * ]

[ * ]

 

US$[ * ]

[ * ]

 

US$[ * ]

[ * ]

 

US$[ * ]

[ * ]

 

US$[ * ]

[ * ]

 

US$[ * ]

[ * ]

 

US$[ * ]

Sales Milestone Event

 

Sales Milestone Payment

[ * ]

 

US$[ * ]

[ * ]

 

US$[ * ]

[ * ]

 

US$[ * ]

[ * ]

 

US$[ * ]

 

5.4

 

No Milestone Payments shall be payable more than once and all Milestone Payments are non-refundable in any circumstances.

Royalties

Sales by Onyx and its Affiliates

5.5

 

Onyx shall pay to BTG a royalty at the applicable incremental rate(s) set out below on the Net Sales Value of all Licensed Products sold by Onyx and/or its Affiliates and manufactured or sold in a country where there exists, at the time of manufacture or sale, one or more Valid Claims of the Licensed Patents that, but for the Licence, would be infringed by such manufacture or sale:

 

 

 

 

 

 

 

Portion of Cumulative Worldwide Net Sales Value

 

 

Tier

 

of Licensed Products Supplied During the Year

 

Royalty Rate

Tier 1

 

US$[ * ]

 

[ * ]%

Tier 2

 

US$[ * ]

 

[ * ]%

Tier 3

 

US$[ * ] and over

 

[ * ]%

 

 

 

For the avoidance of doubt, each of the royalty rates set forth in this Clause 5.5 shall apply only to that portion of the Net Sales Value during a Year that falls within the applicable range for such royalty rate. For example, [ * ].

 

5.6

 

Onyx shall pay to BTG a royalty at the applicable rate set out below on the Net Sales Value of all Licensed Products sold by Onyx and/or its Affiliates where such Licensed Product was manufactured in a country and sold in a country where, at the time of manufacture and at the time of sale, no Valid Claim of a Licensed Patent exists in such country/countries that, but for the Licence, would be infringed by such manufacture or sale (as applicable), provided that at least one of the following is true:

 

[*] 

 = 

Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

11


 

 

5.6.1

 

had the Licensed Product concerned been [ * ] (as applicable) in [ * ] in which a Valid Claim of a Licensed Patent exists that, but for the Licence, would be infringed by such [ * ] (as applicable), such [ * ] would have infringed that Valid Claim;

 

 

5.6.2

 

had such Licensed Product concerned been [ * ] (as applicable) [ * ] in the county/countries in which it was [ * ], such [ * ] would have infringed a Valid Claim of a Licensed Patent which, but for the Licence, would have been infringed by such [ * ] (as applicable);

 

 

5.6.3

 

the Licensed Product is [ * ]; or

 

 

5.6.4

 

such Licensed Product [ * ] (or has [ * ] or [ * ], or the Product Approval for such Licensed Product was [ * ], in each case [ * ], [ * ].

 

 

 

 

 

 

 

Culmulative Worldwide Net Sales Value of Licensed

 

 

Tier

 

Products Supplied During the Year

 

Royalty Rate

Tier 1

 

US$[ * ]

 

[ * ]%

Tier 2

 

US$[ * ]

 

[ * ]%

Tier 3

 

US$[ * ] and over

 

[ * ]%

 

 

 

For the avoidance of doubt, each of the royalty rates set forth in this Clause 5.6 shall apply only to that portion of the Net Sales Value during a Year that falls within the applicable range for such royalty rate. Additionally, if in a particular Quarter there are sales of a Licensed Product in a country to which Clause 5.5 applies and sales of a Licensed Product in a country to which Clause 5.6 applies, then the royalties shall be calculated by determining the percentage of the total Net Sales Value in such Quarter to which Clause 5.5 or Clause 5.6 applies and multiplying that percentage to each royalty tier to determine which portion of such amount should bear royalties at rates set forth in Clause 5.5 or Clause 5.6, respectively. By way of example, [ * ].

 

5.7

 

[ * ].

Sales by Sub-licensees

5.8

 

Onyx shall pay to BTG whichever is the greater of (i) [ * ]% of all Net Receipts received by Onyx or its Affiliates from any Sub-licensee or its Affiliates; or (ii) a royalty of [ * ]% of the Net Sales Value of all Licensed Products sold by Non-Affiliate Sub-licensees or their Affiliates or any subsequent sub-licensee thereof.

 

5.9

 

In the event that the royalty payment calculated by a Non-Affiliate Sub-licensee of Onyx or a Sub-licensee of any Affiliate of Onyx, or any subsequent sub-licensees thereof, as being due to Onyx under the relevant Sub-licence Agreement during any Year prove, following verification carried out by Onyx or an independent professional accountant appointed by

 

[*] 

 = 

Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

12


 

 

 

Onyx for the purpose of calculating that the monies paid to Onyx were correctly calculated and accurate, to be inaccurate (and, therefore, the monies paid to BTG in accordance with Clause 5.8 are inaccurate) Onyx shall either (as applicable):

 

5.9.1

 

within [ * ] days of the end of the month in which such verification was carried out, pay to BTG the balance of the monies due; or

 

 

5.9.2

 

within [ * ] days of receipt of written notification from Onyx that Onyx has paid more than was due, BTG shall reimburse Onyx for such sum. Such notification shall include sufficient evidence to enable BTG to verify the accuracy of such notification.

 

5.10

 

Onyx’s obligations to pay royalties in accordance with Clauses 5.5 and 5.6 shall terminate in accordance with the provisions of Clause 3.2. Onyx’s obligations to make payments under Clause 5.8 shall terminate at the end of the Term.

Infringement of Third Party Patents

5.11

 

If it is not reasonably possible to sell and/or have sold a Licensed Product, or to manufacture a Licensed Product for sale, in one or more countries without infringing one or more Valid Claims of third party patents that apply to or cover the inventions claimed in the Licensed Patents in such countries (“Third Party Claims”) and as a consequence Onyx is required to make and does make royalty payments or licence fees to a non-Affiliate independent third party in respect of such one or more Third Party Claims in order to sell a Licensed Product, or to manufacture a Licensed Product for sale, in such countries then, subject to the provisions of Clause 5.12, Onyx may deduct from the royalties that are otherwise due to BTG as provided in Clause 5.5 and 5.6 in respect of the Licensed Product that is sold or manufactured (as the case may be) in the countries covered by the Third Party Claims, [ * ]% of the royalty payments or license fees paid by Onyx to Third Parties in respect of that Licensed Product in the countries covered by the Third Party Claims (“Third Party Royalty”). For the avoidance of doubt, Onyx may only make deductions from royalties pursuant to this Clause 5.11 to the extent that the royalty payments or licence fees made to the third party concerned relate solely to Third Party Claims applying to or covering the inventions claimed in the Licensed Patents.

 

5.12

 

In the event that Onyx is unable to deduct from a particular royalty payment the full deduction in respect of Third Party Royalties that is permitted by Section 5.11, the unrealized portion such deduction will be carried over to subsequent royalty payments.

 

5.13

 

In no circumstances shall any provisions of this Agreement (including Clauses 5.11, 5.12 and the provision in Clause 1.33 setting out the manner in which Net Sales Value shall be calculated where a Licensed Product is sold as a Combination Product) operate to reduce the effective royalty on Net Sales Value payable by Onyx under Clause 5.5 to less than [ * ]% or under Clause 5.6 to less than [ * ]%.

 

5.14

 

The provisions of (a) Clauses 5.11 and 5.12 and the provisions of (c) Clause 1.33 which sets out the manner in which Net Sales Value shall be calculated where a Licensed Product is sold as a Combination Product, cannot both be applied to the same sale of a Licensed Product.

 

[*] 

 = 

Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

13


 

5.15

 

For the avoidance of doubt, Clause 5.11 and 5.12 shall not apply to payments under Clause 5.8.

 

6.

 

PAYMENT TERMS

 

6.1

 

Onyx shall notify BTG within [ * ] days of any of the Milestone Events being reached.

 

6.2

 

Once a Milestone Event has been reached Onyx shall pay to BTG the relevant Milestone Payment within [ * ] days of reaching the Milestone Event. After receipt of such Milestone Payment, BTG shall issue to Onyx a receipted invoice for such Milestone Payment.

 

6.3

 

Within [ * ] days of the end of each Quarter, Onyx shall provide BTG with a royalty statement for that Quarter setting out the information listed in Schedule 4.

 

6.4

 

Onyx shall pay to BTG the royalties due under Clauses 5.5 and 5.6 in respect of the Net Sales Values generated during any Quarter, within [ * ] days of the end of such Quarter. After receipt of such royalties, BTG shall issue to Onyx a receipted invoice for such royalties. Onyx shall pay to BTG the sums due under Clause 5.8 in respect of Net Receipts received by Onyx and its Affiliates during any Quarter, within [ * ] days of the end of such Quarter. After receipt of such sums, BTG shall issue to Onyx a receipted invoice for such sums.

 

6.5

 

All sums payable under this Agreement:-

 

6.5.1

 

shall be paid in United States dollars to the credit of the following bank account of BTG (or to such other account as BTG may, from time to time, notify to Onyx):

National Westminster Bank plc
Westminster Branch
P.O. Box 3038
57 Victoria Street
London
SW1H 0HN

US Dollar payments:
Account number: [ * ]
Sort Code: [ * ]
IBAN BIC [ * ]

 

6.5.2

 

shall be paid in full without any deductions or withholdings (including deductions or withholdings in respect of items such as income tax, corporation tax, or other taxes, charges or duties) except insofar as Onyx is required by law to deduct withholding tax from sums payable to BTG in which case Onyx shall:

 

6.5.2.1

 

ensure that the deduction or withholding does not exceed the minimum amount legally required;

 

[*] 

 = 

Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

14


 

 

6.5.2.2

 

account to the relevant taxation or other authorities within the period for payment permitted by the applicable law the full amount of the deduction or withholding; and

 

 

6.5.2.3

 

provide to BTG within the period for payment permitted by the relevant law either an official receipt of the relevant taxation authorities involved in respect of all amounts so deducted or withheld or if such receipts are not issued by the taxation authorities concerned a certificate of deduction or equivalent evidence of the relevant deduction or withholding sufficient to establish the fact that such amount was remitted to such taxation authorities, for the purpose of enabling BTG to obtain credit for the tax deducted or to claim relief from double taxation under any relevant double taxation treaty;

 

 

6.5.3

 

shall be paid by the due date for payment as specified in this Agreement. If Onyx fails to pay any sum due under this Agreement in whole or part, any outstanding royalties or other payments due under this Agreement shall bear interest (calculated on a daily basis) from the date on which they fell due until payment at a per annum rate of [ * ] and [ * ], following such failure to pay. The payment of such interest shall be made in United States dollars. It shall not foreclose BTG from exercising any other right it may have as a consequence of the failure of Onyx to make any payment when due.

6.6

 

The parties shall co-operate to ensure that all sums payable under this Agreement can be lawfully paid without deduction of withholding tax, where this is reasonably possible under the laws of the relevant jurisdiction. Such co-operation shall include, at the reasonable request of a party, the provision by the other party of any information required to enable payments to be made without deduction of tax pursuant to section 911 of the Income Tax Act 2007 (or to any equivalent provision under the laws of the United States of America or any other relevant jurisdiction) and the prompt completion and filing of any relevant forms and other documents with the relevant tax authorities.

 

6.7

 

If Licensed Products are sold or supplied by Onyx or its Sub-licensees in a currency other than United States dollars, the royalties payable in respect of such sales under this Agreement shall be first determined in the currency of the country in which such sales took place and then converted into United States dollars at the rate of exchange as shown in the Financial Times (www.ft.com) on the last business day of the Quarter in which such sales took place.

 

6.8

 

If the Net Receipts received by Onyx or its Affiliates are in a currency other than United States dollars, the monies payable in respect of such Net Receipts under this Agreement shall be converted into United States dollars at the rate of exchange shown in the Financial Times (www.ft.com) on the last business day of the Quarter in which the Net Receipts were received by Onyx or its Affiliates.

 

7.

 

RECORDS, INSPECTIONS AND STATEMENTS

Maintenance of Records

 

[*] 

 = 

Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

15


 

7.1

 

During the term of this Agreement and for a period of [ * ] years thereafter, Onyx shall, and shall procure that Onyx’s Affiliates shall, keep at their normal place of business detailed, accurate and up to date records and books of account showing the quantity, description and value of all Licensed Products supplied by Onyx Supplier in each country, all sums paid to Onyx Supplier in connection with such supply, and all Net Receipts, in each case during the previous [ * ] years. Onyx shall ensure that such records and books of accounts are sufficiently complete and detailed to permit the verification of the royalties due to BTG under this Agreement.

Inspections

7.2

 

Onyx shall, and shall procure that Onyx’s Affiliates shall, make available the records and books described in Clause 7.1 for inspection during normal business hours by a qualified accountant of BTG for the purpose of verifying the accuracy of any statement provided by Onyx to BTG pursuant to Clause 6.3. BTG’s accountant shall be entitled to obtain such records and books solely for the purposes of carrying out the verification.

 

7.3

 

BTG shall be entitled to have inspections carried out pursuant to Clause 7.2 no more frequently than once every Year (and once following termination or expiry of this Agreement) on giving Onyx or its Affiliates [ * ] days’ written notice prior to each inspection. BTG shall not be permitted to have such inspections carried out more than once with respect to books and records covering a particular time period unless such re-inspection is reasonably necessary in order to resolve a discrepancy or concern that [ * ].

 

 
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