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As Of Filer Filing For·On·As Docs:Size 5/02/19 Dyadic International Inc 8-K:1,8,9 4/26/19 4:911K |
Document/Exhibit Description Pages Size 1: 8-K Current Report HTML 23K 2: EX-10.1 Material Contract HTML 187K 3: EX-10.2 Material Contract HTML 249K 4: EX-99.1 Miscellaneous Exhibit HTML 15K
Exhibit |
1 | Definitions and interpretation | 1 |
2 | Grant of rights | 8 |
3 | Sub-licensing | 8 |
4 | Payment Obligations | 9 |
5 | Records
and audits | 10 |
6 | Further obligations of the parties | 11 |
7 | Further development and regulatory matters | 14 |
8 | Term and termination | 15 |
9 | Improvements | 17 |
10 | Prosecution
and enforcement of Patent Rights | 19 |
11 | Warranties | 20 |
12 | Liabilities and indemnities | 20 |
13 | Insurance | 22 |
14 | Confidentiality and media releases | 23 |
15 | Dispute
resolution | 25 |
16 | GST | 26 |
17 | Miscellaneous | 27 |
Schedule 1 - Royalties | 31 | |
Schedule 2 - Patent Rights | 32 | |
Schedule 3 - Know-How | 33 | |
1 | Dyadic International (USA), Inc of 140 Intracoastal Pointe Drive, Suite 404, Jupiter FL 33477-5094,
United States (Dyadic) |
2 | Luina Bio Pty Ltd ACN 074 656 509 of 2806 Ipswich Road, Darra, Brisbane 4076 Queensland, Australia (Luina) |
3 | Novovet Pty Ltd ACN 631 032 749 of 2806 Ipswich Road, Darra, Brisbane 4076 Queensland, Australia
(Novovet) |
A | Dyadic owns or has been granted rights under certain Patent Rights and Know-How from Danisco US, Inc. relating to the Sub-Licensed IP. |
B | Luina is an experienced contract manufacturing and development company with experience in manufacturing animal health products. |
C | Luina
wishes to Commercialise the Sub-Licensed IP within the Field and Territory. |
D | Luina and Dyadic have agreed that they will work together to Commercialise the Sub-Licensed IP and have agreed to establish Novovet for the purposes of achieving this objective. |
E | In consideration of the mutual promises and consideration set out in this document, Dyadic has agreed to grant to Novovet a licence to the Sub-Licensed IP on the terms of this document. |
1 | Definitions and interpretation |
1.1 | Definitions |
(a) | a corporation that is related to a party as defined in the Corporations
Act 2001 (Cth); or |
(b) | any individual who, or any corporation or other form of business organisation which, in any country directly or indirectly (including through intermediaries), is Controlled by, or is under common Control with, or Controls, a party. |
(a) | in relation to a Product, to make, have made, use, sell, have sold, offer for sale, import and export the Product; and |
(b) | in
relation to an Intellectual Property Right, the exercise of the rights granted to the holder of such Intellectual Property Right by the laws of the jurisdiction in which the Intellectual Property Right subsists, including the right to grant sub‑licences in accordance with clause 3. |
(a) | is by its nature confidential; |
(b) | is
designated as confidential; or |
(c) | the Recipient knows or ought to reasonably know is confidential, |
(a) | information comprised in or relating to the Sub-Licensed IP; |
(b) | information relating to the business and financial affairs of the
Discloser; |
(a) | is in or comes into the public domain otherwise than by disclosure in breach of this document or other duty of confidentiality owed to the Discloser; |
(b) | had been independently developed by the Recipient prior to obtaining it from the Discloser; or |
(c) | is
received by the Recipient from a third party who has the right to provide that information without breach of any legal obligation. |
(a) | the ability to cast or control the casting of more than 50% of the maximum number of votes that might be cast at any general meeting (or equivalent) of an entity; |
(b) | the holding of more than 50% of the issued ordinary share capital, the equity, or other ownership interest, in the entity, or the holding of the maximum ownership interest permitted in the country where the entity exists; or |
(c) | the ability of a person or persons to direct, or share equally in the direction of, the composition of the board of directors (or equivalent) of the entity, or to manage the entity pursuant to an agreement. |
(a) | a person is or states that the person is unable to pay from the person’s own money all the person’s debts as and when they become due and payable; |
(b) | a person is taken
or must be presumed to be insolvent or unable to pay the person’s debts under any applicable legislation; |
(c) | an application order is made for the winding up or dissolution or a resolution is passed or any steps are taken to pass a resolution for the winding up or dissolution of a corporation and the application or resolution is not stayed, withdrawn or dismissed within seven days; |
(d) | an administrator, provisional liquidator, liquidator or person having a similar or analogous function under the laws of any relevant jurisdiction
is appointed in respect of a corporation or any action is taken to appoint any such person and the action is not stayed, withdrawn or dismissed within seven days; |
(e) | a controlled is appointed in respect of any property of a corporation; |
(f) | a corporation is deregistered under the Corporations Act or notice of its proposed deregistration is given to the corporation and the notice is not stayed, withdrawn or dismissed within seven days; |
(g) |
a distress, attachment or execution is levied or becomes enforceable against any property of a person; |
(h) | a person enters into or takes any action to enter into an arrangement (including a scheme of arrangement or deed of company arrangement), composition or compromise with, or assignment for the benefit of, all or any class of the person’s creditors or members or a moratorium involving any of them; or |
(i) | anything
analogous to or of a similar effect to anything described above under the law of any relevant jurisdiction occurs in respect of a person. |
(a) | cash,
trade or quantity discounts; |
(b) | value-added, sales, use, tariff, import/export duties or other excise taxes imposed on particular sales (except for income taxes); and |
(c) | transportation charges if not paid by the customer. |
(a) | the party’s employees, agents, students, contractors, directors, officers; and |
(b) | the employees, agents, students, contractors, directors and officers of that party’s Associates. |
(a) | [***]; |
(b) | [***]; |
(c) | [***]; |
(d) | [***]; |
(e) | [***];
and |
(f) | [***] |
1.2 | Rules
for interpreting this document |
(a) | A reference to: |
(i) | legislation (including subordinate legislation) is to that legislation as amended, re-enacted or replaced, and includes any subordinate legislation issued under it; |
(ii) | a
document (including this document) or agreement, or a provision of a document (including this document) or agreement, is to that document, agreement or provision as amended, supplemented, replaced or novated; |
(iii) | a party to this document or to any other document or agreement includes a permitted substitute or a permitted assign of that party; |
(iv) | a
person includes any type of body of persons, whether or not it is incorporated or has a separate legal identity, and any executor, administrator or successor in law of that person; and |
(v) | anything (including a right, obligation or concept) includes each part of it. |
(b) | A singular word includes the plural, and vice versa. |
(c) | A
word which suggests one gender includes all other genders. |
(d) | If a word or phrase is defined, any other grammatical form of that word or phrase has a corresponding meaning. |
(e) | If an example is given of anything (including a right, obligation or concept), such as by saying it includes something else, the example does not limit the scope of that thing. |
(f) | A
reference to dollars and $ is to Australian currency. |
(g) | The word agreement includes an undertaking or other binding arrangement or understanding, whether or not in writing. |
(h) | The expression this document includes the agreement, arrangement, understanding or transaction recorded in this document. |
(i) | The
expressions subsidiary, holding company and related body corporate each have the same meaning as in the Corporations Act. |
1.3 | Business Days |
(a) | if the act involves a payment that is due on demand, the person must do I ton or by the next Business
Day; and |
(b) | in any other case, the person must do it on or by the previous Business Day. |
1.4 | Multiple parties |
(a) | an obligation of those
persons is several; |
(b) | a right of those persons is held by each of them severally; and |
(c) | any other reference to that party or that term is a reference to each of those persons separately, so that (for example) a representation, warranty or undertaking relates to each of them separately. |
2 | Grant
of rights |
2.1 | Grant |
(a) | the Patent Rights; and |
(b) | the Know-How, |
2.2 | Exclusivity |
2.3 | Acknowledgments |
(a) | sell or otherwise dispose of Products outside of the Territory or Field or to a customer that it knows or has reason to believe intends to use or resupply the Products outside of the Territory or Field, unless Dyadic has given its prior written approval; and |
(b) | use any of the Sub-Licensed IP other than for bona fide Commercialisation of the Products in accordance with this agreement. |
3 | Sub-licensing |
3.1 | Consent
required |
(a) | Novovet is not permitted to sub-license the Sub-Licensed IP to any Affiliate or Third Party unless Dyadic has given its prior written consent. |
(b) | Dyadic will not unreasonably withhold its consent where the proposed Sub-Licensee is an Affiliate of Novovet and has adequate resources to enable it to fulfil its obligations under the proposed sub-licence. |
(c) | Novovet
remains solely liable for the performance of its obligations under this agreement, notwithstanding the grant of any sub-licence or sub-contract. |
3.2 | Conditions of sub-licence |
(a) | prohibit the grant of further sub-licences unless Dyadic has given its prior written consent
(which consent may be granted, whether or not subject to conditions, or withheld in Dyadic’s sole discretion); |
(b) | contain provisions no less onerous than those set out in clauses 6.7 (Branding), 6.12 (Personnel), 7.3 (Adverse Event Reporting), 7.4 (Recalls, Market Withdrawals or Corrective Action) , 13 (Insurance) and |
(c) | will automatically terminate if Novovet exercises its right of termination under clause 8.5; and |
(d) | will, at Dyadic’s option, either terminate or be novated to Dyadic on termination of this agreement (other than termination by Novovet under clause 8.5). |
3.3 | Contract
Manufacture |
3.4 | Related party services |
4 | Payment Obligations |
4.1 | Payments by Novovet |
(a) | pay Dyadic the Upfront Sub-Licence Fee by way of the issue of ordinary shares (credited as fully paid) equal to 20% of the equity in Novovet in accordance with the terms of the Shareholders’ Agreement; and |
(b) | pay to Dyadic any Royalties on Net Sales and Non-Sales Revenue in accordance with Schedule 1. |
4.2 | Timing
of Royalty Payments |
(a) | Payments of Royalties are to be made by Novovet to Dyadic within 30 days after the end of each Quarter and are to be calculated by reference to Net Sales and Non-Sales Revenue made during that Quarter. |
(b) | Each payment must be accompanied by a statement signed by an authorised officer of Novovet containing a detailed summary of: |
(i) | Products
sold, delivered or otherwise disposed of during the relevant Quarter; |
(ii) | the calculation of the Net Sales, Non-Sales Revenue and Royalties payable in respect of, the relevant Quarter; and |
(iii) | sales, marketing, training and other activities relating to the Commercialisation of the Product, provided that after Launch such reports only need to be made annually. |
4.3 | Currency |
4.4 | Payment |
4.5 | Interest on overdue payments |
4.6 | Withholding tax |
(a) | If
any laws, rules or regulations require the withholding or deduction of amounts of income or other taxes or other amounts from payments made by a party to the other under this agreement, the party making the payment will make such withholding payments as required. |
(b) | The recipient will, provided it has received proof of payment of the withholding taxes, sign such documentation as the paying party reasonably requires in order for it to obtain credits or rebates under any applicable double taxation treaties. |
5 | Records
and audits |
5.1 | Records |
5.2 | Right of audit |
(a) | Novovet
agrees at all reasonable times to permit Dyadic’s auditor to access, inspect and review the accounts, books and records referred to in clause 5.1. |
(b) | Novovet further agrees to permit those books of accounts and records to be examined at Dyadic’s expense by an independent accountant, and to permit that accountant to take copies of or extracts from the accounts, books and records. Such audits may not be conducted more than once each calendar year. |
(c) | Novovet agrees to give Dyadic’s representatives reasonable assistance,
access and facilities to enable them to verify such accounts, books and |
(d) | If an audit conducted in accordance with clause 5.2(b) identifies a deviation of more than 5% from the amounts identified as payable in statements provided by Novovet pursuant to clause 4.2 in any consecutive period of four Quarters, the costs of the audit are to be reimbursed to Dyadic by Novovet on
demand. |
(e) | Dyadic’s rights under this clause 5.2 apply during the Term and for seven years thereafter. |
(f) | Novovet agrees to permit Dyadic’s representative to inspect Novovet’s manufacturing facilities and those of any permitted sub-contract manufacturers in order to verify {Novovet]’s compliance with this agreement (including under clause 6.6). At least ten Business Days’ notice of any such inspection will be given. |
6 | Further
obligations of the parties |
6.1 | Technology transfer and assistance |
(a) | Dyadic will disclose the Sub-Licensed IP to Novovet, including providing Novovet with electronic copies of the Know-How, within 60 days of the Commencement Date. All documents will be provided in English. |
(b) | Dyadic will use
all reasonable endeavours to provide updated versions of the Know-How on a timely basis. Novovet is solely responsible for the cost of modifying or translating any materials supplied by Dyadic, or developing its own materials, as may be necessary or desirable for the Territory. |
(c) | Dyadic will provide such technical advice and assistance as Novovet may reasonably require, via telephone and email, for a maximum of [***]. Any additional assistance will be at Dyadic’s discretion and on its standard consulting terms. |
(d) | Any
site visits by Dyadic’s Personnel will be at Dyadic’s discretion and sole expense unless such site visit(s) are requested by Novovet. If Novovet requests such a site(s) visits then all travel, hotel, meal and other costs and expenses along with the then current Dyadic or its Collaborators FTE daily rate will be at the sole expense of Novovet. |
6.2 | Prosecution and maintain Sub-Licensed IP |
6.3 | Registration Costs |
6.4 | Commercialisation efforts |
(a) | Novovet is to use reasonable and diligent efforts to develop and Commercialise the Sub-Licensed IP and Products throughout the Territory within the Field as soon as practicable, consistent with sound business practices and judgement. |
(b) | Without limiting the generality of the foregoing, Novovet agrees to sell, distribute, market and promote Products in the Territory, including the provision of customer support, logistics,
inventory, pharmacovigilance and related activities so as to maximise sales of Products in the Territory. |
6.5 | Commercialisation progress |
(a) | extend the deadline for performance; |
(b) | convert
Novovet’s exclusive rights to non-exclusive in all or part of the Field and Territory by giving five Business Days’ notice; or |
(c) | terminate this agreement by giving 60 days’ written notice, |
6.6 | Care and skill |
6.7 | Branding |
6.8 | Patent
marking |
6.9 | Recording licence |
6.10 | Diligence Report |
6.11 | Review
meetings |
6.12 | Personnel |
(a) | agree
in writing, prior to beginning work, to assign to Novovet or Dyadic, as the case may be, all Intellectual Property Rights that may be created by such Personnel in connection with this agreement; and |
(b) | have not been debarred by any Regulatory Authority. |
6.13 | Non-Solicitation |
7 | Further development and regulatory matters |
7.1 | Regulatory approvals |
(a) | is
solely responsible for obtaining all Regulatory Approvals needed to Commercialise Products in the Field in the Territory; |
(b) | must keep Dyadic informed of all material correspondence with, or investigations by, Regulatory Authorities; and |
(c) | notify Dyadic in writing immediately if it becomes aware that it, its Affiliates or Sub-Licensees, contract manufacturer or any Third Party involved in the Commercialisation of Products or
their respective Personnel is subject to a debarment investigation by a Regulatory Authority or if any action, suit, claim, investigation, or proceeding relating to the foregoing is pending or threatened. |
7.2 | Clinical trial data |
(a) | Each party agrees to share with the other all results and data resulting from or generated in the course of any pre-clinical studies or clinical trials of the Product conducted by it, or its Affiliates (Data). |
(b) | Each
party will have the right to use any and all Data in the conduct of its obligations and exercise of its rights under this agreement. |
(c) | Dyadic has the non-exclusive, royalty-free, irrevocable and perpetual right to use Data supplied by Novovet: |
(i) | outside the Field; and |
(ii) | within the Territory;
and |
(iii) | in the event that this agreement is terminated by Dyadic for any reason or by Dyadic under clause 8.5, within the Field and within the Territory. |
(d) | Any use of Data supplied by the other party in support of a patent application or a filing to obtain a Regulatory Approval (other than as required by law in connection with Dyadic’s fulfilling its obligations as a publicly traded company) may only be made with the other party’s prior written consent which will not be unreasonably withheld. |
7.3 | Adverse
event reporting |
(a) | Novovet will be responsible for Adverse Event (as defined below) reporting to applicable authorities in the Territory and complying with other pharmacovigilance obligations under applicable laws. |
(b) | Novovet must promptly (and in any event within three Business Days) report and provide details to Dyadic of any Adverse Event. Adverse Events must be reported in as much detail as possible, whether or not there is proof of a causal connection between events and use of Products. |
(c) | Each
party must promptly notify the other if such party becomes aware of any information or circumstance that is likely to have a material adverse effect on the safety of animals using the Products. |
(d) | For the purposes of this clause, Adverse Event means any side effect, injury, toxicity, sensitivity reaction, or other unintended harmful effect, or any unexpected incident, and the severity thereof, which are or may possibly be attributable to the Products. |
7.4 | Recalls,
Market Withdrawals or Corrective Action |
(a) | In the event that any Regulatory Authority issues or requests a recall or takes a similar action in connection with the Products in the Territory, or in the event either party determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal in the Territory, the party notified of such recall or similar action, or the party that desires such recall or similar action, must within 24 hours, advise the other party by telephone (with written confirmation notice to follow) or by facsimile or email to the address specified in clause 17.1. |
(b) | Novovet,
in consultation with [Dyadic], will decide whether to conduct any recall of Products in the Territory (except in the case of a Regulatory Authority mandated recall, in which case either party may act without such advance notice but, will notify the other party as soon as possible) and the manner in which any such recall will be conducted. |
(c) | Novovet must bear the sole expense of any recall of Products in the Territory. |
8 | Term and termination |
8.1 | Term |
(a) | This
agreement commences on the Commencement Date and, unless this agreement is terminated earlier in accordance with its terms, will continue in each country in the Territory until the later of: |
(i) | [***]; |
(ii) | [***]; or |
(iii) | [***]. |
(b) | On
expiry or termination of this agreement in a country, Novovet will have a fully paid-up, perpetual, irrevocable, non-exclusive, non-transferrable licence to use the Know-How in that in a country, except in the event of termination by Dyadic for any reason or by Novovet pursuant to clause 8.5. |
8.2 | Termination for insolvency |
8.3 | Termination
for breach |
(a) | the other party is in breach of any of its material obligations under this agreement; and |
(b) | the party in breach has failed to remedy the breach within 60 days of receipt
of written notice from the other party describing the breach and calling for it to be remedied. |
8.4 | Termination by Dyadic |
(a) | if Novovet or its Affiliates challenge or assist any Third Party to challenge the validity of the Patent Rights; or |
(b) | there
is a change in the Control of Novovet, in respect of which Dyadic has not given its prior approval in accordance with the Shareholders’ Agreement. |
8.5 | Termination by Novovet |
8.6 | Consequences
of termination |
(a) | the licences granted in clause 2.1 terminate (other than any ongoing rights under clause 8.1(b)); |
(b) | Novovet, its Affiliates and Sub-Licensees if any must cease all use of the C1 Expression Platform, the Sub-Licensed IP and all research and development efforts in any way related to the C1 expression Platform and the Development, Registration, Manufacturing and Commercialisation of the Target Indicators
Products; |
(c) | each party must return to the other party all documents and other materials in any form in its possession or under its control which contain or refer to any Confidential Information of the other party; |
(d) | Novovet must do such things as may be required to transfer all pending and granted Regulatory Approvals in respect of the Products to Dyadic or its nominee (except where this agreement is terminated by Novovet pursuant to clause 8.5). |
8.7 | Survival |
8.8 | Conversion to non-exclusive rights |
9 | Improvements |
9.1 | Relevant definitions |
9.2 | Novovet Improvements |
(a) | [***]. |
(b) | [***]. |
(c) | Novovet
hereby grants Dyadic a non-exclusive, perpetual, irrevocable royalty free licence of all Novovet Non-Sub-Licensed IP Improvements outside of the Field and within the Territory. |
(d) | In the event Dyadic terminates this agreement for any reason or Novovet terminates this agreement pursuant to clause 8.5, with effect from such termination Novovet hereby grants Dyadic a non-exclusive, perpetual, irrevocable royalty free licence of all Novovet Non-Sub-Licensed IP Improvements within the Field and within the Territory. |
(e) | In
the event Dyadic terminates this agreement under clause 8.3 or 8.4 with effect from such termination Novovet hereby assigns to Dyadic all right, title and interest in all Novovet Licensed IP Improvements and agrees to take all steps as Dyadic may reasonable require in order to give effect to such assignment and enable it to have the benefit of such Novovet Licensed IP Improvements. |
9.3 | Financial terms |
(a) | No royalties or other payments are required to be made by Dyadic for the licenses of Novovet Improvements in clause
9.2 or for the assignment of Novovet Licensed IP Improvements in clause 9.2(e). |
(b) | If the provisions of clause 9.3(a) are prohibited or unenforceable under the laws of a country within the Territory, the parties agree to negotiate financial terms for the assignment or licence in good faith. |
9.4 | Obligations in respect to Novovet Improvements |
(a) | Novovet must give Dyadic details of all Novovet Improvements and do so promptly after their creation or acquisition, and in any event at least Quarterly. |
(b) | Novovet must not transfer, use, license a Third Party to use or otherwise Commercialise the Novovet Improvements, in violation of the terms & conditions of the Pharma License Agreement or if such use or Commercialisation depends on the use of or would otherwise infringe any Sub-Licensed IP or other Intellectual Property Rights of Dyadic or its Affiliates,
Dyadic’s contract research collaborators unless Dyadic has given its prior written consent, which must be done only by Dyadic’s CEO. |
10 | Prosecution and enforcement of Patent Rights |
10.1 | Notice of suspected infringement |
(a) | any claim or allegations that the exercise of the rights under this agreement constitute an infringement of the rights of any Third Party, including an attack on the grant or validity of any of the Sub-Licensed IP; |
(b) | any Third Party’s infringement or threatened infringement of the Sub-Licensed IP. |
10.2 | Action
by Dyadic |
(a) | will retain damages or other amounts recovered by it; and |
(b) | Novovet must, at Dyadic’s and/or Danisco US, Inc’s expense, do all acts and execute such documents
as may be necessary or desirable to enable Dyadic and/or Danisco US, Inc. to institute and prosecute those proceedings. |
10.3 | Action by Novovet |
(a) | Novovet
may institute and prosecute enforcement proceedings in its own name or, if required under local law, by joining Dyadic and/or Danisco US, Inc. if permitted under the Pharma License Agreement to such proceedings; |
(b) | Dyadic must, at Novovet’s expense, do all acts and execute such documents as may be necessary or desirable to enable Novovet to institute and prosecute those proceedings; |
(c) | Novovet must ensure that it does not perform any acts or omissions that in anyway adversely affect the validity of the Sub-Licensed
IP and the reputation of Dyadic and/or Danisco US, Inc. the owners or Licensee of the Sub-Licensed IP; |
(d) | Novovet must indemnify Dyadic and/or Danisco US, Inc. against all actions, claims, loss, damage, costs, expenses and awards arising out of or in connection with those proceedings; |
(e) | Novovet must regularly keep Dyadic and/or Danisco US, Inc. advised of the progress of such proceedings and provide copies of all material correspondence and documents; and |
(f) | Novovet
must remit 50% of all damages. accounts of profits, settlements or other amounts recovered in respect of the proceedings, after deduction of all |
10.4 | Notice of claims |
(a) | Novovet must immediately notify Dyadic and provide Dyadic with details of the claim or proceedings; and |
(b) | Novovet and its Affiliates are to be solely responsible for the defence of proceedings against them, and Dyadic must, at Novovet’s expense, do all acts and execute such documents as may be necessary or desirable to enable Novovet to institute and prosecute those proceedings. |
11 | Warranties |
11.1 | Mutual
warranties |
(a) | it has the power and authority to enter into and perform its obligations under this agreement and that the execution of this agreement by it has been duly and validly authorised by all necessary corporate action; |
(b) | its obligations under this agreement are valid and binding and enforceable against it in accordance with their terms. |
11.2 | Dyadic’s
warranties |
(a) | Dyadic warrants that, as far as its directors are aware, the Sub-Licensed IP is owned or licensed by Dyadic and it is entitled to grant the licences under clause 2.1 to Novovet. |
(b) | In addition to the exclusions set out in clause 12.1, Dyadic does not warrant that any Patent Rights are or will be valid, or that the Commercialisation of the Sub-Licensed IP is not or will not be an infringement of the rights of Third Parties. |
11.3 | Novovet’s
warranties |
12 | liabilities and indemnities |
12.1 | Dyadic’s exclusions |
(a) | Dyadic excludes all liability to Novovet in respect of
the prospects of, or the suitability of the Sub-Licensed IP for the Commercialisation of the Sub-Licensed IP, the quality or performance of any Product, the fitness for purpose of any advice provided under this agreement or the claims of Third Parties arising from the Commercialisation of the Sub-Licensed IP. |
(b) | Any clinical or scientific information provided as part of the Know-How is provided for Novovet’s information only, and it must obtain its own |
12.2 | Prescribed Terms |
(a) | Except as required by any Prescribed Terms, all conditions, warranties, terms, and obligations expressed or implied by law or otherwise relating to the performance of Dyadic’s obligations under, or any other services supplied by Dyadic in connection with, this agreement are excluded. |
(b) | Where
any Prescribed Terms apply, the liability of Dyadic to Novovet for a breach of a Prescribed Term implied into this agreement is limited to the re-supply of services or the payment of the cost of re-supplying services (at Dyadic’s option). |
(c) | For the avoidance of doubt, any Prescribed Term relating to the completeness, effectiveness or fitness for purpose of any Sub-Licensed IP is limited to the use of the Sub-Licensed IP solely for the purposes expressly contemplated by this agreement or otherwise agreed in writing by the parties. |
(d) | For
the purposes of this clause, Prescribed Terms mean terms, conditions and warranties implied by law into some contracts for the supply of goods or services or for the license of Intellectual Property Rights and which the law expressly provides may not be excluded, restricted or modified or may be excluded, restricted or modified only to a limited extent. |
12.3 | Novovet’s indemnity |
(a) | a breach of Novovet’s warranties or obligations contained in this agreement; or |
(b) | the Commercialisation of the Sub-Licensed IP or Products by or
on behalf of Novovet, |
12.4 | Consequential loss |
12.5 | Cap on liability |
(a) | arising out of any one act, omission or event and any one series of related acts, omissions or events will not under any circumstance exceed the amounts paid by Novovet to Dyadic under this agreement in
the 12 month period prior to the act, omission or event or the first in the series of acts, omissions or events; and |
(b) | arising out of all acts, omissions and events whenever occurring will not under any circumstance exceed the total amounts paid by Novovet to Dyadic under this agreement. |
13 | Insurance |
13.1 | Novovet
and Sub-Licensees to maintain insurance |
(a) | a comprehensive commercial general liability and products liability policy to cover all sums which it may become legally liable to pay as compensation consequent upon: |
(i) | death of, or bodily injury (including disease
or illness) to, any person; and |
(ii) | loss of, or damage to, property, |
(b) | clinical trial liability insurance in respect of all clinical trials; |
(c) | insurance
in respect of all claims and liabilities arising, whether at common law or under statute relating to workers compensation or employer’s liability, from any accident or injury to any person employed in connection with the Commercialisation of Products, in compliance with applicable local; and |
(d) | any other insurance required by law. |
13.2 | Dyadic to be noted |
13.3 | Evidence
of currency |
13.4 | Cancellation and changes |
13.5 | Potential
claims |
(a) | notify Dyadic as soon as reasonably practicable but in any event within five Business Days of the occurrence of that event; and |
(b) | ensure that Dyadic is kept fully informed of any subsequent actions and developments concerning the relevant claim. |
14 | Confidentiality
and media releases |
14.1 | Permitted use and disclosure |
(a) | A party may disclose Confidential Information of the other party if legally compelled to do so by any judicial or administrative body, provided that the party required to make such disclosure must promptly inform the other party and cooperate (at the other party’s expense) with the other party’s efforts to take reasonably available legal measures to avoid or limit the extent of such disclosure. |
1.1. | Either
party may disclose the terms of this agreement as to its auditors, and other advisors and as required by the SEC, a share listing exchange or other such regulatory or governmental agencies and to a Third Party who |
(b) | is evaluating whether or not to acquire or invest in that party, where that Third Party is acting in good faith and is subject to a binding obligation of confidence. |
14.2 | Protection of Confidential Information |
(a) | not use, and ensure that its Personnel do not use, any Confidential Information for any purpose other than compliance with its obligations or exercise of its rights under this agreement; |
(b) | take reasonable action necessary to maintain the confidential nature of the Confidential Information, including keeping all records of the Confidential Information under the same degree of protection that such party uses for its own Confidential Information of a similar nature; |
(c) | not
disclose any of the Confidential Information to any person other than those Personnel of the party or an Affiliate who need to have access to the Confidential Information for the purposes of this agreement provided: |
(i) | such person has been made aware of the requirements of this clause and is subject to a legally enforceable undertaking of confidence on terms substantially equivalent to those in this agreement; and |
(ii) | enforce the terms of that obligation of confidence at its own expense, on the request of the party
that disclosed the Confidential Information; and |
(d) | return all documents and other materials in any medium in its possession, power or control which contain or refer to any Confidential Information, on the earlier of demand by the other party or the time the documents and other material are no longer required for the purposes of this agreement, except |
14.3 | Publications |
(a) | Novovet
must provide Dyadic with the opportunity to review any proposed publications, manuscripts or summaries of presentations in respect of the Product at least 45 days prior to publication, submission or being presented. |
(b) | Dyadic will respond promptly and in no event later than 21 days after receipt of the proposed material with either approval of the proposed material or a specific statement of concern, based upon either the need to seek patent protection for any Improvement owned by Dyadic or concern regarding protection of its Confidential Information. |
(c) | In
the event of concern, Novovet agrees not to submit such publication or to make such presentation that contains such information until Dyadic is given a reasonable period of time (not to exceed 90 days) to seek patent protection for any material in such publication or presentation that it believes is patentable or to resolve any other issues, and Novovet must remove any Confidential Information of Dyadic from such proposed publication as requested. |
14.4 | Media and stock exchange releases |
(a) | A party may not make press or
other announcements or releases relating to this agreement and the matters the subject of this agreement without the prior approval of the other party. Each party acknowledges that the other party has a proprietary interest in its legal and business name and reputation. Therefore, each party agrees not to make reference to or otherwise use the other party’s name or mention or describe this agreement or its relationship with the other party and its Affiliates in any advertising, marketing and/or promotional materials or other publications or materials (except as required or permitted by this agreement) without first obtaining the prior written approval of the other party. |
(b) | Notwithstanding clause 14.4(a), if a party is required by law to disclose
any information relating to this agreement or the identity of the other party (including filing a copy of this agreement with relevant authorities in the Territory or statements required to be made by either party to a relevant stock exchanges), it may do so to the extent required by law, provided that it: |
(i) | gives notice to the other party, including a copy of the proposed release containing the information, as soon as practicable after it becomes aware of the need for the release; and |
(ii) | minimises, to the extent
permitted by law, the extent of the disclosure. |
15 | Dispute resolution |
15.1 | Notice of dispute |
15.2 | Dispute resolution procedure |
(a) | If a dispute arises a party may not commence any court or arbitration proceedings relating to the dispute unless it has complied with this clause 15.2, except where the party seeks urgent interlocutory relief. |
(b) | A
party claiming that a dispute has arisen must give notice to the other party specifying the nature of the dispute. |
(c) | On receipt of that notice by that other party, senior executives of both parties must endeavour in good faith to resolve the dispute expeditiously by negotiation or using informal dispute resolution techniques such as mediation, expert evaluation or determination or similar techniques agreed by them. |
(d) | If the dispute has not been resolved or parties have not agreed within 30 days of receipt of the notice
(or such further period as agreed in writing by them) as to: |
(i) | the dispute resolution technique and procedures to be adopted; |
(ii) | the timetable for all steps in those procedures; and |
(iii) | the selection and compensation of the independent person required for such technique, |
15.3 | Expert determination |
(a) | If this clause 15.3 applies, an independent chartered accountant with at least 10 years’ experience in valuing technology must be appointed as a valuer (Independent Expert) to determine the proportion of the value of a Third Party Transaction that is attributable to Target Indicators Products within the Field (Apportionment) in accordance with this clause 15.3. |
(b) | If
there is failure to agree on an independent chartered accountant, the Independent Expert will be appointed by the President for the time being of the Institute of Chartered Accountants in England and Wales. |
(c) | Neither the Independent Expert, nor any firm or company of which the Independent Expert is an employee, partner, director or consultant, must have had any business dealings with either party in the two years before the date of appointment. |
(d) | The Independent Expert will have a right of access at all reasonable
times to the accounting records and other records of Dyadic, Luina and Novovet and its affiliates and is entitled to require from any officer of Dyadic, Luina, Novovet and its affiliates such information and explanation as the Independent Expert requires to determine the Apportionment. |
(e) | The Independent Expert will be instructed to make a determination as soon as practicable and in any event within 30 Business Days after receiving instructions. |
(f) | The
parties agree that, in determining the Apportionment, the Independent Expert: |
(i) | will act as an expert and not as an arbitrator; |
(ii) | may obtain or refer to any documents, information or material and undertake any inspections or enquiries as he or she determines appropriate; |
(iii) | must provide
the parties with a draft of his or her determination and must give the parties an opportunity to comment on the draft determination before it is finalised; and |
(iv) | may engage such assistance as or she reasonably believes is appropriate or necessary to make a determination. |
(g) | The Independent Expert’s determination will be final and binding on the parties. |
(h) | The
parties will equally pay the costs and expenses of the Independent Expert. |
16 | GST |
16.1 | GST pass on |
(a) | the
consideration otherwise provided for that supply under this document is increased by the amount of that GST; and |
(b) | the recipient must make payment of the increase as and when the consideration otherwise provided for, or relevant part of it, must be paid or provided or, if the consideration has already been paid or provided, within seven days of receiving a written demand from the supplier. |
16.2 | Tax Invoice |
16.3 | Consideration exclusive of GST |
16.4 | Adjustments |
(a) | may recover from the recipient the amount by which the amount of GST on the supply exceeds the amount already recovered by giving seven days written notice; or |
(b) | must
refund to the recipient the amount by which the amount already recovered exceeds the amount of GST on the supply to the extent that the supplier is entitled to a refund or credit from the Commissioner of Taxation; and |
(c) | must issue an adjustment note or tax invoice reflecting the adjustment event in relation to the supply to the recipient within 28 days of the adjustment event except where the recipient is required to issue an adjustment note or tax invoice in relation to the supply. |
16.5 | Reimbursements |
17 | Miscellaneous |
17.1 | Notices |
(a) | must be in in writing and signed by the send or by a person duly authorised by the sender; |
(b) | must be delivered to the intended recipient by prepaid post (if posted to an address in another country, by registered airmail) or by hand or email to the address or email address below or the address or email address last notified by the intended recipient to the sender after the date of this document: |
(i) to Dyadic: | Address: 140 Intracoastal Pointe Drive, Suite #404 Jupiter, Florida USA 33477 Attention: Mark Emalfarb Email: memalfarb@dyadic.com |
(ii) to Luina: | Address:
2806 Ipswich Road, Darra, Brisbane 4076 Queensland, Australia Attention: [***] Email: [***] |
(iii) to Novovet: | Address: 2806 Ipswich Road, Darra, Brisbane 4076 Queensland, Australia Attention: Chris Burrell Email: chris.burrell@novovet.com |
(c) | will be conclusively
taken to be duly given or made: |
(i) | in the case of delivery in person, when delivered; or |
(ii) | in the case of delivery by post, two Business Days after the date of posting (if posted to an address in the same country) or seven Business Days after the date of posting (if posted to an address in another country) and |
(iii) | in
the case of email, the earlier of: |
(A) | the time that the sender receives an automated message from the recipient’s information system confirming delivery of the email; or |
(B) | the time that the email is first opened or read by the recipient, or an employee or officer of the recipient, |
17.2 | No waiver |
17.3 | Amendment |
17.4 | Assignment |
17.5 | Further assurances |
17.6 | Costs
and duty |
17.7 | Severability of provisions |
17.8 | Variation
of rights |
17.9 | No merger |
17.10 | Entire
agreement |
17.11 | Governing law and jurisdiction |
17.12 | Counterparts |
17.13 | Authorised
signatories |
1 | Royalties on Net Sales of Products |
Total
Net Sales per country (AUD) | Royalty Rate (%) of Net Sales) |
A. Countries in which Patent Rights exist | |
$0 - $10 million | [***]% |
Over $10 million | [***]% |
B. Countries in which Patent Rights have expired or abandoned, or do not exist | |
$0 - $10 million | [***]% |
Over
$10 million | [***]% |
2 | Royalties on Non-Sales Revenue |
1 | Know-How |
(a) | Strains
and constructs: |
(i) | [***]. |
(ii) | [***]. |
(iii) | [***]. |
(b) | Dyadic
SOPs: |
(i) | [***] |
(ii) | [***] |
(iii) | [***] |
(iv) | [***]
|
(v) | [***] |
(vi) | [***] |
(vii) | [***] |
(viii) | [***]
|
(ix) | [***] |
(c) | [***] |
Signed by Dyadic International (USA), Inc by | |
sign here ► | |
print
name ► | Mark A. Emalfarb |
Sign here ► | |
print name ► |
Signed by Luina Bio Pty Ltd by | |
sign here ► | |
print
name ► | _Chris Burrell_______________________ |
Sign here ► | /s/ Robbie White________________________ Company Secretary |
print name ► | Robbie White_______________________ |
Signed by Novovet Pty Ltd by | |
sign here ► | |
print name ► | _Chris Burrell_______________________ |
Sign here ► | /s/ Robbie White________________________ Company Secretary |
print name ► | Robbie
White_______________________ |
As Of Filer Filing For·On·As Docs:Size Issuer Filing Agent 3/29/23 Dyadic International Inc. 10-K 12/31/22 58:5.9M RDG Filings/FA 3/29/22 Dyadic International Inc. 10-K 12/31/21 58:5.9M RDG Filings/FA 7/27/21 Dyadic International Inc. 10-K/A 12/31/20 16:370K RDG Filings/FA 3/30/21 Dyadic International Inc. 10-K 12/31/20 57:5.8M RDG Filings/FA |