Exhibit 10.1
Certain identified information in this document has been excluded because it is both (i) not material and (ii) is the type the registrant treats as private or confidential. [***] indicates where such information has been omitted.
(1) FUJIFILM DIOSYNTH BIOTECHNOLOGIES UK LIMITED
(2) FUJIFILM DIOSYNTH BIOTECHNOLOGIES TEXAS, LLC
(3) FUJIFILM DIOSYNTH BIOTECHNOLOGIES U.S.A., INC.
AND
(4) Savara Aps
CONTENTS
1. | Definitions and Interpretation | 1 |
|
|
|
2. | Appointment of Fujifilm | 9 |
|
|
|
3. | Term | 9 |
|
|
|
4. | Performance of Programs | 9 |
|
|
|
5. | Quality AND REGULATORY MATTERS | 10 |
|
|
|
6. | Conforming batches AND NON-CONFORMING BATCHES | 12 |
|
|
|
7. | Delivery, TITLE AND RISK | 14 |
|
|
|
8. | Price and Payment | 15 |
|
|
|
9. | FUJIFILM WARRANTIES | 17 |
|
|
|
10. | Liability | 17 |
|
|
|
11. | Intellectual Property | 21 |
|
|
|
12. | Intellectual Property Indemnity | 21 |
|
|
|
13. | Confidentiality | 22 |
|
|
|
14. | Change | 24 |
|
|
|
15. | DELAY, Cancellation, Termination AND CONSEQUENCES | 25 |
|
|
|
16. | Force Majeure | 29 |
|
|
|
17. | Dispute Resolution | 30 |
|
|
|
18. | Audit & RECORDS | 31 |
|
|
|
19. | Notices | 32 |
|
|
|
20. | Export/IMPORT Controls AND SANCTIONS COMPLIANCE | 34 |
|
|
|
21. | MODERN SLAVERY AND CORRUPTION | 36 |
|
|
|
22. | Assignment AND SUB-CONTRACTING | 36 |
|
|
|
23. | General | 37 |
|
|
|
24. | Governing Law | 38 |
|
|
|
Schedule 1 | Charges | 39 |
|
|
|
Signature Page | 40 |
THIS AGREEMENT is made on the date it is signed by the last signing party.
BETWEEN
BACKGROUND
AGREED TERMS
“Affiliate” | means in relation to an entity, each or any other entity who for the time being, directly, or indirectly through one or more intermediaries, controls, is controlled by, or is under common control with such entity. For the purposes hereof (and clause 15.2), “control” shall mean: (a) holding the majority of the voting rights or share capital of such entity; (b) any power (whether direct or indirect and whether by the ownership of share capital, the possession of voting power, contract, or otherwise) to appoint and/or remove all or such of the members of the board or other governing body of a body corporate as are able to cast the majority of the votes capable of being cast by members of that board or body on all, or substantially all, matters, or (c) otherwise to control or have the power to control the policies, management and affairs of that body corporate; |
|
|
“Ancillary Charges” | has the meaning given to it in clause 8.2; |
|
|
1
“Ancillary Services” | has the meaning given to it in Schedule 1 (Charges); |
|
|
“Applicable Laws” | applicable law (which, for the avoidance of doubt, includes applicable common law), regulations, and binding guidance which applies in the jurisdiction in which the Program is being performed or where Fujifilm Services or Ancillary Services are being performed; |
|
|
“Authorized Third Parties” | has the meaning given to it in clause 13.1.3; |
|
|
“Background IP” | all Intellectual Property Rights controlled, owned or jointly owned by any party (or a third party on its behalf) prior to the Effective Date or developed independently from the Program. Fujifilm’s proprietary manufacturing, expression or purification technologies, including [***]; |
|
|
“Batch” | a quantity of Product that is produced from a run of the Process; |
|
|
“Batch Cancellation Fee” | the Batch Cancellation Fee described in Schedule 1; |
|
|
“Batch Fee” | if the Batch Fee is clearly described in the applicable SoW the Batch Fee for that SoW shall be the Batch Fee described in the SoW, however, if the Batch Fee is not clearly described in the applicable SoW it will be deemed to be, in respect of any Batch under that SoW, all Charges for Fujifilm Services in respect of the Manufacturing Stages carried out in connection with that Batch which are described in the applicable SoW; |
|
|
“Business Day” | a day other than a Saturday, Sunday or a day on which the New York Stock Exchange is closed and, where a notice is being given or obligation performed under this Agreement or a SoW to which FDBK is a party, a public holiday in England; |
|
|
“cGMP” | Represents principles and practices applied to the manufacture of pharmaceutical materials as supported by the following cGMPs for drugs, as applicable to the material being manufactured (e.g. non-sterile bulk API / Drug Substance(s)): (i) the U.S. Federal Register volume 66 No 186 the FDA Regulations 21 CFR Part 11, 210, 211, 600 and 610 and ICH Q7; (ii) the Rules governing medicinal products in the European Union under the EC, EudraLex, Volume 4 – Guidelines for Good Manufacturing Practices for medicinal products for human and veterinary use. Part I – Basic Requirements for Medicinal Products. Part II – Basic Requirements for Active Substances used as Starting Materials, Part III GMP related documents, Annexes and Part IV GMP requirements for Advanced Therapy Medicinal Products, as applicable to the Product manufactured; and (iii) United Kingdom Human Medicines Regulations 2012 (HMR, SI 2012/1916, as amended), Guidelines on Good Manufacturing Practice, Parts and Annexes as EudraLex, Volume 4 above; |
|
|
2
“cGMP Batch” | a Batch identified in a Scope of Work which is intended to be manufactured during a Manufacturing Stage and subject to Disposition in each case in accordance with cGMP; |
|
|
“Change” | has the meaning given to it in clause 14; |
|
|
“Charges” | has the meaning set out in clause 8.2; |
|
|
“Commercially Reasonable Efforts” | with respect to the activities pursuant to a Program, the reasonable efforts and resources used by a reputable biopharmaceutical contract manufacturing organization for Drug Substances of similar nature, complexity and developmental stage in the same or similar circumstances as the Product; |
|
|
“Competitor” | a contract development and/or manufacturing organization in the biopharmaceutical industry; |
|
|
“Confidential Information” | the fact and terms of this Agreement and any Scope of Work, and all information (in whatever form) in respect of the business of each of the parties and each of its Affiliates including any ideas; business methods; finance; prices, business, financial, marketing or development plans; products or services, know-how or other matters connected with products or services manufactured and/or marketed; customer lists or details; computer systems and software; which is (in each case) provided to, or obtained by, one party from the other. For clarity, Confidential Information of Customer includes Customer Background IP and Customer Foreground IP; |
|
|
“Conforming Batch” | a cGMP Batch which has been produced in accordance with cGMP and which meets the Product Specification; |
|
|
“Consumable” | a consumable item used or intended for use in a Program, including PEG, reagents (including analytical reagents), plasmids, raw materials, packaging components, chromatography resins, filters, filtration membranes, media, buffer bags, refold bags, tubing, hoses, disposable analytical test kits, in-process measurement probes, columns (including analytical columns) and disposable containers; |
|
|
“Consumables Delay” | Has the meaning given to it in clause 15.1.2; |
|
|
“Customer Foreground IP” | all Foreground IP that constitutes an improvement or modification or derivative which is specific to, or requires use of, the Customer’s Background IP, Customer’s Confidential Information or Customer’s Materials which have been provided to Fujifilm by the Customer pursuant to the Program in each case, obtained or developed by any party hereto (or any of its subcontractors); |
|
|
“Delay” | has the meaning given to it in clause 15.1.1; |
|
|
3
“Demonstration Batch” | a Batch which is manufactured in a non cGMP R&D facility for demonstration purposes and which is not intended for human use; |
|
|
“Deviation” | a cGMP deviation as detailed in the Quality Agreement; |
|
|
“Disposition” | the Stage during which (i) the Product is tested for compliance versus the Product Specification; (ii) all production instruction and analytical records relating to cGMP manufacture of each cGMP Batch prepared by Fujifilm are reviewed; and (iii) a Fujifilm recommendation for Product release or reject is made; in each case as applicable; |
|
|
“Drug Product” | the final dosage form of product which is, or contains, Product in association with other active or inactive ingredients; |
|
|
“Drug Substance” | any substance or mixture of substances intended to be used in the manufacture of a Drug Product and that, when used in the production of a drug, contains the active ingredient(s) of the Drug Product. Such substances are intended to furnish pharmacological activity or other direct effect on the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body; |
|
|
“Effective Date” | the date of final signature by all parties to this Agreement being the date the last signing party signs this Agreement; |
|
|
“Engineering Batch” | a Batch that is manufactured in a cGMP Facility at scale using the Process but which is not intended for human use; |
|
|
“Facility” | (a) FDBK: Belasis Avenue, Billingham, TS23 1LH, England (b) FDBT: 100 Discovery Drive, Suite 200 College Station, Texas 77845 United States of America; or (c) FDBU: 101 J Morris Commons Lane, Morrisville, North Carolina 27560, United States of America, or such other Fujifilm facility specifically identified and agreed to by Customer in a Scope of Work; |
|
|
“Force Majeure Event” | any event or circumstances outside the reasonable control of a party affecting its ability to perform any of its obligations under this Agreement including act of God, fire, flood, severe weather, epidemic or pandemic, war, revolution, acts of terrorism, riot or civil commotion, acts of government, trade embargo, labor disputes (excluding labor disputes involving the party in question), interruption of utility service, restraints or delays affecting shipping or carriers, inability or delay in obtaining supplies of adequate or suitable materials, inability or delay in obtaining third party services, breakdown or failure in equipment or machinery, cyber-attack, currency restrictions but shall not include the failure of Drug Product in clinical trials or failure of Drug Product to gain regulatory approval; |
|
|
4
“Foreground IP” | all Intellectual Property Rights that arise or are obtained or developed by or on behalf of any party (alone or jointly) in the course of the performance of a Program; |
|
|
“Fujifilm” | FDBK, FDBT and/or FDBU as the context requires in accordance with clause 1.4; |
|
|
“Fujifilm Foreground IP” | all Foreground IP other than Customer Foreground IP; |
|
|
“Fujifilm Services” | the research and development services to be provided by Fujifilm for the Customer during a Program as the same are described in the relevant Scope of Work excluding the Ancillary Services; |
|
|
“Gross Negligence” | a conscious and voluntary disregard of the need to use reasonable care, which is likely to cause foreseeable grave injury or harm to persons, property, or both; |
|
|
“Historic Documents” | any historic contractual documentation which cover the same subject matter as a Program as identified in the relevant SoW; |
|
|
“Indemnify” | on demand to indemnify and hold harmless and keep indemnified, and held harmless, the party to be indemnified and held harmless on an after tax basis; |
|
|
“Intellectual Property Right” | any current and future intellectual property rights and interests including patents, utility models, designs, design rights, copyright (including rights in software), decryption rights, database rights, trade marks, rights pursuant to passing off, service marks, business and trade names, domain names, know-how, results, data, databases, formulations, compounds, rights in biological or chemical materials, rights under data exclusivity laws, rights under unfair competition laws, topography rights, inventions, rights in confidential information (including technical and commercial trade secrets); supplementary protection certificates and image rights, and rights of a similar or corresponding character in any part of the world, in each case whether registered or not and including any application for registration and renewals or extensions of such rights in any country in the world and whether subsisting now or in the future; |
|
|
[***] | [***] |
|
|
“Liabilities” | any (i) liabilities of any nature, whether accrued, absolute, contingent or otherwise and whether in contract, tort (including negligence) or otherwise; (ii) losses, costs (including internal costs/overheads), damages, fines or expenses including reasonable legal fees; and (iii) claim, demand, proceeding, action or cause of action including those by third parties; in each case howsoever arising. “Liability” shall be construed accordingly; |
|
|
5
“Manufacturing Stage” | a Stage of a Program during which production, testing and Disposition (if applicable) of Engineering Batches or cGMP Batches are intended to take place, including pre and post manufacturing activities; Facility change–over, setup, and cleaning before, between and after Batch manufacturing; |
|
|
“Material Review Board” or “MRB” | a cross-functional committee, led by quality assurance, that consists of representation from program management, quality control (as applicable), and manufacturing. Customer representation is required; |
|
|
“Materials” | Has the meaning given to it in clause 7.1; |
|
|
“Modifications” | a modification to a Facility; or equipment (including Process specific qualification and installation of existing equipment), required in order to perform a Process and detailed in the applicable Scope of Work; |
|
|
“Non-Conforming Batch” | a cGMP Batch which has not been produced in accordance with cGMP and/or does not meet the Product Specification; |
|
|
“Non-Manufacturing Stage” | any Stage of a Program, which is not a Manufacturing Stage, including (for clarity) the production and testing of Demonstration Batches; |
|
|
“Process” | the particular process used, or to be used for manufacture of the Product, as set forth in the Process Specification; |
|
|
“Process Specification” | the Process operating parameters and specifications as documented in the regulatory submission and/or a QA Document (including Deviations) which has been agreed by the parties for cGMP Batch production; |
|
|
“Process-Specific Consumable” | a Consumable which is required to operate the Process and which is specific to the Process or a Consumable which is required in such large volumes as would not be possible for Fujifilm to consume during other manufactures and/or within the shelf life of such Consumable; |
|
|
“Process-Specific Equipment” | an item of equipment which is required by Fujifilm to operate the Process and which is specific to the Process in addition to that equipment which Fujifilm uses in its Facilities as at the SoW Effective Date (which existing equipment is not already dedicated to other customer(s) of Fujifilm); |
|
|
“Product” | the particular product or substance (compound, reagent, intermediate or molecule) created during and as a result of performing the Process. The name of the relevant Product is identified in the applicable Scope of Work; |
|
|
“Product Specification” | the Product specification for Product which is documented in a QA Document; |
|
|
6
“Program” | a program of work as set out in the applicable Scope of Work (or more than one Scope of Work, as the case may be) to be carried out by Fujifilm in accordance with the terms of this Agreement; |
|
|
“Program Cancellation Fee” | an amount equal to the sum of: (i) the relevant Batch Cancellation Fee in respect of every cancelled Manufacturing Stage in the Program; and (ii) the amount calculated under clause 15.3.1(b) in respect of cancelled Non-Manufacturing Stages in the Program; |
|
|
“Program Manager” | the Program manager appointed by each of Fujifilm and the Customer under the applicable SoW; |
|
|
“Program Plan” | the Program plan controlled by Fujifilm’s Program Manager and communicated to the Customer regularly including prior to any relevant Program management meetings; |
|
|
“Quality Agreement” | the document agreed by the parties which sets out the mutually agreed quality standards applicable for any cGMP activity under the Program; |
|
|
“QA Documents” | the Quality Agreement and the documents produced and approved in accordance with the Quality Agreement or any cGMP documents agreed by the parties in writing; |
|
|
“Regulatory Authority” | the U.S. Food and Drug Administration, the European Medicines Agency, the Medicines & Healthcare products Regulatory Agency and any successor to any such entities and any other similar regulatory authorities as may be agreed upon in writing by Fujifilm and the Customer; |
|
|
“Scope of Work” or “SoW” | the document setting out the detail of the Fujifilm Services and/or Ancillary Services to be undertaken by Fujifilm for the Customer; |
|
|
“SoW Effective Date” | for each Scope of Work, the date that the Scope of Work is fully signed by all relevant parties; |
|
|
“Special Waste” | waste or effluent which requires special handling including waste or effluent which is required to be collected in a special container (for example by tanker) for external disposal or which requires incineration; |
|
|
“Stage” | a stage of the Program as described in the SoW. For the purposes of clause 10, a sub-stage described in a SoW (for example a Stage that is described by the Stage number and a suffix such as Stage 1A) shall be deemed to be an independent Stage in its own right; |
|
|
“Subcontracted Work” | work subcontracted by Fujifilm under clause 22.3 but excluding any work subcontracted between FDBK, FDBT and/or FDBU; |
|
|
7
“Tax” | any and all taxes, charges, levies, assessments and other fees of any kind imposed by any governmental or other authority (including, but not limited to, value added tax, sales tax or any other similar type of turnover tax); and |
“Willful Misconduct” | a knowing violation of a reasonable and uniformly enforced rule or policy. It means intentionally doing that which should not be done or intentionally failing to do that which should be done, knowing that injury may result or recklessly disregarding the possibility that injury may result. |
8
9
10
5.2.4 The Customer shall have the right and responsibility for determining regulatory strategy, decisions and actions relating to each Program and any Product and/or Drug Product subject to clause 5.2.6 and provided that Fujifilm shall have the right and responsibility for determining regulatory strategy, decisions and actions to the extent relating to:
(each a “Fujifilm Regulatory Responsibility”).
11
12
13
14
together the “Charges”.
15
16
and the dispute shall be dealt with under the dispute resolution process set out in clause 17.
17
18
19
20
21
infringes such third party’s Intellectual Property Rights.
the “Authorized Third Parties”.
22
provided that the Receiving Party shall be entitled to retain copies of the Confidential Information to enable it to monitor its obligations under this Agreement or which is required to be maintained by Applicable Laws or a Regulatory Authority subject always to the obligations of confidence under this Agreement.
23
24
25
26
in the event Customer terminates this Agreement or the Program where there are only Non-Manufacturing Stages contracted, the relevant SoW(s) shall terminate and this clause 15.3.1 shall apply when determining cancellation fees.
27
provided that, in each case, the factor was not known and could not reasonably have been known at the commencement of the applicable Program and provided further that Fujifilm has used Commercially Reasonable Efforts in its attempts to address the factor prior to such termination.
28
29
in each case before three arbitrators. Judgment on the Award may be entered in any court having jurisdiction.
30
31
32
Chief Executive Officer
FUJIFILM Diosynth Biotechnologies
Belasis Avenue
Billingham, TS23 1LH
England
[***]
With a copy to:
General Counsel
FUJIFILM Diosynth Biotechnologies
Belasis Avenue
Billingham, TS23 1LH
England
[***]
Chief Financial and Administrative Officer
Dave Lowrance
1717 Langhorne Newton Rd, Suite 300
Langhorne, Pennsylvania 19047
Email: [***]
With a copy to:
Sr. VP Legal Affairs
Kate McCabe
1717 Langhorne Newton Rd, Suite 300
Langhorne, Pennsylvania 19047
Email: [***]
provided that, (a) where in the case of delivery by hand or transmission by email, such delivery or transmission occurs either after 4.00pm on a Business Day, or on a day other than a Business Day, service will be deemed to occur at 9.00am on the next Business Day and (b) all notices delivered by hand, recorded delivery/registered post or registered airmail must also be sent via email.
33
34
“Authorization” | all consents, licences, authorisations, approvals, permissions, registrations, certificates and clearances and any precondition in any relevant jurisdiction;
|
“Export/Import Laws” | (a) any laws of the United States of America, the United Kingdom, the European Union or of any of its Member States or Japan that relate to the control of (re)export, transfer or import of Products, software or technology and technical data; or (b) any other (re)export, transfer or import controls or restrictions imposed or adopted by any government, state or regulatory authority in a country in which obligations under this Agreement are to be performed; |
“Sanctions” | any economic, financial, trade or other sanction, embargo, import or export ban, prohibition on transfer of funds or assets or on performing services or equivalent measure imposed by any Sanctions Authority or by the laws of any state or any union of states from time to time; |
“Sanctions Authority” | means (a) the Security Council of the United Nations, (b) the Organization for Security and Co-operation in Europe (c) the United Kingdom, (d) the European Union, (e) any Member State of the European Union, (f) the United States of America, (g) Japan (h) the governments and official institutions or agencies of any of paragraphs (a) to (h) above and (i) any other regulatory body imposing or enforcing sanctions legislation in any country or territory from which or into which the Customer is exporting or importing; and |
“Sanctioned Person” | any person who appears on or is owned, operated or controlled by any person who appears on any list issued or maintained by any Sanctions Authority or is referred to in any list or public announcement issued by any Sanctions Authority, in each case as amended, supplemented or substituted from time to time. |
35
36
but not otherwise without written consent of the other parties (such consent not to be unreasonably withheld or delayed) and provided that (a) the assignee agrees in writing to assume all obligations undertaken by its assignor in this Agreement and (b) in relation to assignment in part no such assignment shall relieve the assigning party of responsibility for the performance of any of its obligations under this Agreement.
37
IN WITNESS of the above the parties have signed this Agreement on the dates set out next to their signature.
38
Schedule 1 Charges [Intentionally omitted.]1
1 Omitted schedule to be provided to the Securities and Exchange Commission upon request.
39
Signature Page
SIGNED for and on behalf of FUJIFILM DIOSYNTH BIOTECHNOLOGIES TEXAS, LLC:
Signature: /s/ Vincent Romeo |
|
|
|
Title: Interim Site Head |
|
|
|
Date: 2/12/2024 |
|
SIGNED for and on behalf of FUJIFILM DIOSYNTH BIOTECHNOLOGIES U.S.A., INC:
Signature: /s/ Chris Vannais |
|
|
|
Title: Chief Operating Officer |
|
|
|
Date: 2/12/2024 |
|
SIGNED for and on behalf of FUJIFILM DIOSYNTH BIOTECHNOLOGIES UK LIMITED:
Signature: /s/ Jonathan Haigh |
|
|
|
Title: Head of UK Site |
|
|
|
Date: 2/12/2024 |
|
SIGNED for and on behalf of SAVARA APS:
Signature: /s/ Dave Lowrance | Signature: |
|
|
Title: CFO | Title: |
|
|
Date: 2/13/2024 | Date: |
40