Document:

Exhibit

Exhibit 4.6
DESCRIPTION OF SHARE CAPITAL
The following description of the share capital of Jazz Pharmaceuticals plc, or the Company, is a summary. This summary does not purport to be complete and is qualified in its entirety by reference to the Irish Companies Act 2014 (as amended), or the Companies Act, and the complete text of the Company’s amended and restated memorandum and articles of association, which amended and restated memorandum and articles of association, or the Company’s Constitution, are filed as Exhibit 3.1 to the Company’s Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission, or SEC, on August 9, 2016. You should read those laws and documents carefully. 
Capital Structure
Authorized Share Capital
The authorized share capital of the Company is €40,000 and $30,000, divided into 4,000,000 non-voting euro deferred shares with nominal value of €0.01 per share and 300,000,000 ordinary shares with nominal value of $0.0001 per share.
The Company may issue shares subject to the maximum authorized share capital contained in the Company’s Constitution. The authorized share capital may be increased or reduced (but not below the number of shares then issued and outstanding) by a resolution approved by a simple majority of the votes cast at a general meeting, in person or by proxy, of the Company’s shareholders (referred to under Irish law as an “ordinary resolution”). The shares comprising the Company’s authorized share capital may be divided into shares of such nominal value as the resolution shall prescribe. As a matter of Irish law, the directors of a company may issue new ordinary or preferred shares for cash without shareholder approval once authorized to do so by the memorandum and articles of association or by an ordinary resolution adopted by the shareholders at a general meeting. The authorization may be granted for a maximum period of five years, at which point it must be renewed by the shareholders by an ordinary resolution.
The Company’s board of directors is authorized pursuant to shareholder resolutions passed on August 4, 2016 to issue new ordinary or preferred shares for cash without shareholder approval for a period of five years from the date of the passing of the resolutions.
The rights and restrictions to which ordinary shares are subject are prescribed in the Company’s Constitution. The Company’s Constitution permits it to issue preferred shares once authorized to do so by ordinary resolution. The Company may, by ordinary resolution and without obtaining any vote or consent of the holders of any class or series of shares, unless expressly provided by the terms of that class or series of shares, provide from time to time for the issuance of other classes or series of shares and to establish the characteristics of each class or series, including the number of shares, designations, relative voting rights, dividend rights, liquidation and other rights, redemption, repurchase or exchange rights and any other preferences and relative, participating, optional or other rights and limitations not inconsistent with applicable law.
Irish law does not recognize fractional shares held of record. Accordingly, the Company’s Constitution does not provide for the issuance of fractional shares, and the official Irish register of the Company will not reflect any fractional shares. Whenever an alteration or reorganization of the Company’s share capital would result in any shareholder becoming entitled to fractions of a share, the Company’s board of directors may, on behalf of those shareholders that would become entitled to fractions of a share, sell the shares representing the fractions for the best price reasonably obtainable, to any person and distribute the proceeds of the sale in due proportion among those members.
Issued Share Capital
As of December 31, 2019, 56,140,917 ordinary shares were issued and outstanding. In addition, as of December 31, 2019, 4,000,000 non-voting euro deferred shares were issued and outstanding at that time, which shares are held by nominees in order to satisfy an Irish legislative requirement to maintain a minimum level of issued share capital denominated in euro. The euro deferred shares, which are not listed on any stock exchange and are not the subject of any registration, carry no voting rights and are not entitled to receive any dividend or distribution. On a return of assets, whether on liquidation or otherwise, the euro deferred shares will entitle the 

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holder thereof only to the repayment of the amounts paid up on such shares after repayment of the capital paid up on ordinary shares plus the payment of $5,000,000 on each of the ordinary shares and the holders of the euro deferred shares (as such) will not be entitled to any further participation in the assets or profits of the Company. 
Preemption Rights, Share Warrants and Share Options
Under Irish law, certain statutory preemption rights apply automatically in favor of shareholders where shares are to be issued for cash. However, the Company has opted out of these preemption rights by way of shareholder resolution as permitted under Irish law. Irish law provides that this opt-out expires every five years unless renewed by a resolution approved by not less than 75% of the votes cast at a general meeting, in person or by proxy, of the Company’s shareholders (referred to under Irish law as a “special resolution”) and Parent’s current opt-out will expire on August 4, 2021. If the opt-out is not renewed before then, shares issued for cash must be offered to existing shareholders on a pro rata basis to their existing shareholding before the shares may be issued to any new shareholders. The statutory preemption rights do not apply (i) where shares are issued for non-cash consideration (such as in a stock-for-stock acquisition), (ii) to the issue of non-equity shares (that is, shares that have the right to participate only up to a specified amount in any income or capital distribution) or (iii) where shares are issued pursuant to an employee stock option or similar equity plan.
The Company’s Constitution provides that, subject to any shareholder approval requirement under any laws, regulations or the rules of any stock exchange to which it is subject, the Company’s board of directors is authorized, from time to time, in its discretion, to grant such persons, for such periods and upon such terms as it deems advisable, options to purchase such number of shares of any class or classes or of any series of any class as the Company’s board of directors may deem advisable, and to cause warrants or other appropriate instruments evidencing such options to be issued. The Companies Act provides that, save to the extent the constitution of a company provides otherwise, the directors of a company may issue options. The Company is subject to the rules of The NASDAQ Stock Market LLC and the U.S. Internal Revenue Code of 1986, or the Code, which require shareholder approval of certain equity plan and share issuances. The Company’s board of directors may issue shares upon exercise of validly issued warrants or options without shareholder approval or authorization, except as described above (up to the relevant authorized share capital limit).
Dividends
Under Irish law, dividends and distributions may only be made from distributable reserves. Distributable reserves generally means accumulated realized profits less accumulated realized losses and includes reserves created by way of capital reduction. In addition, no distribution or dividend may be made unless the Company’s net assets are equal to, or in excess of, the aggregate of its called up share capital plus undistributable reserves and the distribution does not reduce its net assets below such aggregate. Undistributable reserves include the share premium account, the par value of shares acquired by Parent and the amount by which Parent’s accumulated unrealized profits, so far as not previously utilized by any capitalization, exceed Parent’s accumulated unrealized losses, so far as not previously written off in a reduction or reorganization of capital.
The determination as to whether or not the Company has sufficient distributable reserves to fund a dividend must be made by reference to its “relevant financial statements.” The “relevant financial statements” are either the last set of unconsolidated annual audited financial statements or other financial statements properly prepared in accordance with the Companies Act, which give a “true and fair view” of the Company’s unconsolidated financial position and accord with accepted accounting practice. The relevant financial statements must be filed in the Companies Registration Office (the official public registry for companies in Ireland).
The Company’s Constitution authorizes the directors to declare dividends without shareholder approval to the extent they appear justified by profits lawfully available for distribution. The Company’s board of directors may also recommend a dividend to be approved and declared by the shareholders at a general meeting. The Company’s board of directors may direct that the payment be made by distribution of assets, shares or cash, and no dividend issued may exceed the amount recommended by the directors. The dividends declared by the directors or shareholders may be paid in the form of cash or non-cash assets and may be paid in dollars or any other currency.
The Company’s board of directors may deduct from any dividend payable to any shareholder any amounts payable by such shareholder to the Company in relation to its shares.
The Company may issue shares with preferred rights to participate in dividends declared by the Company from time to time, as determined by ordinary resolution. The holders of preferred shares may, depending on their terms, 

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rank senior to ordinary shares in terms of dividend rights and/or be entitled to claim arrears of a declared dividend out of subsequently declared dividends in priority to ordinary shareholders.
Share Repurchases, Redemptions and Conversions
Overview
The Company’s Constitution provides that, unless the board specifically determines otherwise, any ordinary share that it has agreed to acquire shall be deemed to be a redeemable share. Accordingly, for Irish law purposes, the repurchase of ordinary shares by the Company may technically be effected as a redemption of those shares as described below under “—Repurchases and Redemptions.” If the Company’s Constitution did not contain such provision, repurchases by the Company would be subject to many of the same rules that apply to purchases of its ordinary shares by subsidiaries described below under “—Purchases by the Company’s Subsidiaries,” including the shareholder approval requirements described below, and the requirement that any purchases on market be effected on a “recognized stock exchange,” which, for purposes of the Companies Act, includes The NASDAQ Global Select Market. Neither Irish law nor any of the Company’s constituent documents places limitations on the right of nonresident or foreign owners to vote or hold its ordinary shares. Except where otherwise noted, references herein to repurchasing or buying back ordinary shares refer to the redemption of ordinary shares by the Company or the purchase of ordinary shares by one of its subsidiaries, in each case in accordance with the Company’s Constitution and Irish law as described below.
Repurchases and Redemptions
Under Irish law, a company may issue redeemable shares and redeem them out of distributable reserves or the proceeds of a new issue of shares for that purpose. Please see also “—Dividends.” The Company may not purchase any of its shares if, as a result of such purchase, the nominal value of its issued share capital which is not redeemable would be less than 10% of the nominal value of its total issued share capital. All redeemable shares must also be fully-paid. Redeemable shares may, upon redemption, be cancelled or held in treasury. Based on the provisions of the Company’s Constitution, shareholder approval will not be required to redeem its shares.
The Company may also be given an additional general authority to purchase its ordinary shares on market by way of ordinary resolution, which would take effect on the same terms and be subject to the same conditions as applicable to purchases by the Company’s subsidiaries as described below.
Repurchased and redeemed shares may be cancelled or held as treasury shares. The nominal value of treasury shares held by the Company at any time must not exceed 10% of the aggregate of the par value and share premium received in respect of the allotment of Parent shares together with the par value of any shares acquired by Parent. The Company may not exercise any voting rights in respect of any shares held as treasury shares.
Treasury shares may be canceled by the Company or re-issued subject to certain conditions.
Purchases by the Company’s Subsidiaries
Under Irish law, an Irish or non-Irish subsidiary of the Company may purchase the Company’s shares either on market or off market. For a subsidiary of the Company to make purchases on market of ordinary shares, the Company’s shareholders must provide general authorization for such purchase by way of ordinary resolution. However, as long as this general authority has been granted, no specific shareholder authority for a particular on market purchase by a subsidiary of ordinary shares is required. For a purchase of ordinary shares by a subsidiary of the Company off market, the proposed purchase contract must be authorized by special resolution of the Company’s shareholders before the contract is entered into. The person whose ordinary shares are to be bought back cannot vote in favor of the special resolution and, from the date of the notice of the meeting at which the resolution approving the contract is proposed, the purchase contract must be on display or must be available for inspection by Parent’s shareholders at the registered office of Parent. 
In order for one of the Company’s subsidiaries to make an on market purchase of its shares, such shares must be purchased on a “recognized stock exchange.” The NASDAQ Global Select Market, on which ordinary shares are currently listed, is specified as a recognized stock exchange for this purpose by Irish law.
The number of shares held by the Company’s subsidiaries at any time will count as treasury shares and will be included in any calculation of the permitted treasury share threshold of 10% of the aggregate of the par value and 

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share premium received in respect of the allotment of Parent shares together with the par value of any shares acquired by Parent. While a subsidiary holds the Company’s shares, it cannot exercise any voting rights in respect of those shares and no dividend or other payment (including any payment in a winding up of the Company) shall be payable in respect of those shares. The acquisition of ordinary shares by a subsidiary must be funded out of distributable reserves of the subsidiary.
Lien on Shares, Calls on Shares and Forfeiture of Shares
The Company’s Constitution provides that it has a first and paramount lien on every share that is not a fully paid up share for all amounts payable at a fixed time or called in respect of that share. Subject to the terms of their allotment, directors may call for any unpaid amounts in respect of any shares to be paid, and if payment is not made, the shares may be forfeited. These provisions are standard inclusions in the memorandum and articles of association of an Irish public company limited by shares such as the Company’s and are only applicable to ordinary shares that have not been fully paid up.
Bonus Shares
Under the Company’s Constitution, the Company’s board of directors may resolve to capitalize any amount for the time being standing to the credit of any of Parent’s reserve accounts or to the credit of the profit and loss account which is not available for distribution through the issuance of fully paid up bonus shares on the same basis of entitlement as would apply in respect of a dividend distribution.
Consolidation and Division; Subdivision
Under the Company’s Constitution, the Company may, by ordinary resolution, consolidate and divide all or any of its share capital into shares of larger nominal value than its existing shares or subdivide its shares into smaller amounts than are fixed by the Company’s Constitution.
Reduction of Share Capital
The Company may, by ordinary resolution, reduce its authorized share capital in any way. The Company also may, by special resolution and subject to confirmation by the Irish High Court, reduce or cancel its issued share capital (which includes share premium) in any manner permitted by the Companies Act.
Annual Meetings of Shareholders
The Company is required to hold an annual general meeting at intervals of no more than 15 months from the previous annual general meeting, provided that an annual general meeting is held in each calendar year following the first annual general meeting and no more than nine months after the Company’s fiscal year-end. Parent’s articles of association provide that shareholder meetings may be held outside of Ireland (subject to compliance with the Companies Act). Where a company holds its annual general meeting or extraordinary general meeting outside of Ireland, the Companies Act requires that the company, at its own expense, make all necessary arrangements to ensure that members can by technological means participate in the meeting without leaving Ireland (unless all of the members entitled to attend and vote at the meeting consent in writing to the meeting being held outside of Ireland).
Notice of an annual general meeting must be given to all of the Company’s shareholders and to its auditors. The Company’s Constitution provides for a minimum notice period of 21 clear days, which is the minimum permitted under Irish law.
The only matters which must, as a matter of Irish law, be transacted at an annual general meeting are the presentation of the annual financial statements and reports of the directors and auditors, a review by the shareholders of the company’s affairs, the appointment of new auditors and the fixing of the auditor’s remuneration (or delegation of same). If no resolution is made in respect of the reappointment of an existing auditor at an annual general meeting, the existing auditor will be deemed to have continued in office.
Extraordinary General Meetings of Shareholders
Extraordinary general meetings may be convened by (i) the Company’s board of directors, (ii) on requisition of the Company’s shareholders holding not less than 10% of its paid up share capital carrying voting rights, (iii) on requisition of the Company’s auditors or (iv) in exceptional cases, by order of the court. Extraordinary general meetings are generally held for the purpose of approving shareholder resolutions as may be required from time to 

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time. At any extraordinary general meeting only such business shall be conducted as is set forth in the notice thereof.
Notice of an extraordinary general meeting must be given to all of the Company’s shareholders and to its auditors. Under Irish law and the Company’s Constitution, the minimum notice periods are 21 clear days’ notice in writing for an extraordinary general meeting to approve a special resolution and 14 clear days’ notice in writing for any other extraordinary general meeting.
In the case of an extraordinary general meeting convened by the Company’s shareholders, the proposed purpose of the meeting must be set out in the requisition notice. Upon receipt of any such valid requisition notice, the Company’s board of directors has 21 days to convene a meeting of its shareholders to vote on the matters set out in the requisition notice. This meeting must be held within two months of the receipt of the requisition notice. If the Company’s board of directors does not convene the meeting within such 21-day period, the requisitioning shareholders, or any of them representing more than one half of the total voting rights of all of them, may themselves convene a meeting, which meeting must be held within three months of the Company’s receipt of the requisition notice.
If the Company’s board of directors becomes aware that its net assets are not greater than half of the amount of the Company’s called-up share capital, it must convene an extraordinary general meeting of its shareholders not later than 28 days from the date that they learn of this fact to consider how to address the situation.
Quorum for General Meetings
The Company’s Constitution provides that no business shall be transacted at any general meeting unless a quorum is present. One or more of the Company’s shareholders present in person or by proxy holding not less than a majority of the Company’s issued and outstanding shares entitled to vote at the meeting in question constitute a quorum.
Voting
At general meetings of the Company, a resolution put to the vote of the meeting is decided on a poll. The Company’s Constitution provides that its board of directors or its chairman may determine the manner in which the poll is to be taken and the manner in which the votes are to be counted.
Each shareholder is entitled to one vote for each ordinary share that he or she holds as of the record date for the meeting. Voting rights may be exercised by shareholders registered in the Company’s share register as of the record date for the meeting or by a duly appointed proxy, which proxy need not be a shareholder. Where interests in shares are held by a nominee trust company, such company may exercise the rights of the beneficial holders on their behalf as their proxy. All proxies must be appointed in the manner prescribed by the Company’s Constitution, which permits shareholders to notify the Company of their proxy appointments electronically in such manner as may be approved by the Company’s board of directors.
In accordance with the Company’s Constitution, it may from time to time be authorized by ordinary resolution to issue preferred shares. These preferred shares may have such voting rights as may be specified in the terms of such preferred shares (e.g., they may carry more votes per share than ordinary shares or may entitle their holders to a class vote on such matters as may be specified in the terms of the preferred shares). Treasury shares or the Company’s shares that are held by its subsidiaries are not entitled to be voted at general meetings of shareholders.
Irish law requires special resolutions of the Company’s shareholders at a general meeting to approve certain matters. Examples of matters requiring special resolutions include:
		
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	amending the objects or memorandum of association of the Company;

		
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	amending the articles of association of the Company;

		
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	approving a change of name of the Company;

		
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	authorizing the entering into of a guarantee or provision of security in connection with a loan, quasi- loan or credit transaction to a director or a person who is deemed to be “connected” to a director for the purposes of the Companies Act;

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	opting out of preemption rights on the issuance of new shares;

		
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	re-registration of the Company from a public limited company to a private company;

		
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	variation of class rights attaching to classes of shares (where the articles of association do not provide otherwise);

		
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	purchase of the Company’s shares off market;

		
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	reduction of issued share capital;

		
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	sanctioning a compromise/scheme of arrangement with creditors or shareholders;

		
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	resolving that the Company be wound up by the Irish courts;

		
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	resolving in favor of a shareholders’ voluntary winding-up; and

		
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	setting the re-issue price of treasury shares.

Unanimous Shareholder Consent to Action Without Meeting
The Companies Act provides that shareholders may approve an ordinary or special resolution of shareholders without a meeting only if (i) all shareholders sign the written resolution and (ii) the company’s articles of association permit written resolutions of shareholders (the Company’s articles of association contain the appropriate authorizations for this purpose).
Variation of Rights Attaching to a Class or Series of Shares
Under the Company’s Constitution and the Companies Act, any variation of class rights attaching to its issued shares must be approved by a special resolution of the Company’s shareholders of the affected class or with the consent in writing of the holders of three-quarters of all the votes of that class of shares.
The provisions of the Company’s Constitution relating to general meetings apply to general meetings of the holders of any class of the Company’s shares except that the necessary quorum is determined in reference to the shares of the holders of the class. Accordingly, for general meetings of holders of a particular class of the Company’s shares, a quorum consists of the holders present in person or by proxy representing at least one half of the issued shares of the class.
Inspection of Books and Records
Under Irish law, shareholders have the right to: (i) receive a copy of the Company’s Constitution and any act of the Irish Government which alters its memorandum; (ii) inspect and obtain copies of the minutes of general meetings and the Company’s resolutions; (iii) inspect and receive a copy of the register of shareholders, register of directors and secretaries, register of directors’ interests and other statutory registers maintained in respect of the ordinary shares; (iv) receive copies of financial statements and directors’ and auditors’ reports which have previously been sent to shareholders prior to an annual general meeting; and (v) receive financial statements of any of the Company’s subsidiaries that have previously been sent to shareholders prior to an annual general meeting for the preceding ten years. The Company’s auditors also have the right to inspect all of the Company’s books, records and vouchers. The auditors’ report must be circulated to the shareholders with the Company’s financial statements prepared in accordance with Irish law 21 clear days before the annual general meeting and must be read to the shareholders at the Company’s annual general meeting.
Acquisitions
An Irish public limited company may be acquired in a number of ways, including:
		
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	a court-approved scheme of arrangement under the Companies Act. A scheme of arrangement with shareholders requires a court order from the Irish High Court and the approval of a majority in number representing 75% in value of the shareholders present and voting in person or by proxy at a meeting called to approve the scheme;

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	through a tender or takeover offer by a third party for all of the Company’s shares. Where the holders of 80% or more of the Company’s shares have accepted an offer for their shares, the remaining shareholders may also be statutorily required to transfer their shares, and if the bidder does not exercise its “squeeze out” right, then the non-accepting shareholders also have a statutory right to require the bidder to acquire their shares on the same terms. If the Company’s shares were to be listed on the main securities market of Euronext Dublin or another main securities market or regulated stock exchange in the European Union, this threshold would be increased to 90%; and

		
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	by way of a merger with an EU-incorporated company under the EU Cross-Border Mergers Directive 2005/56/EC. Such a merger must be approved by a special resolution.

Irish law does not generally require shareholder approval for a sale, lease or exchange of all or substantially all of a company’s property and assets, unless the company is listed on a regulated stock exchange in the European Union.
Appraisal Rights
Generally, under Irish law, shareholders of an Irish company do not have dissenters’ or appraisal rights. Under the European Communities (Cross-Border Mergers) Regulations 2008 governing the merger of an Irish company limited by shares such as the Company and a company incorporated in the European Economic Area (the European Economic Area includes all member states of the European Union and Norway, Iceland and Liechtenstein), a shareholder (i) who voted against the special resolution approving the merger or (ii) of a company in which 90% of the shares are held by the other party to the merger, has the right to request that the company acquire its shares for cash at a price determined in accordance with the share exchange ratio set out in the merger agreement.
Disclosure of Interests in Shares
Under the Companies Act, subject to certain limited exceptions, a person must notify the Company (but not the public) if, as a result of a transaction, such person will become interested in three percent or more of the Company’s voting shares, or if as a result of a transaction a shareholder who was interested in more than three percent of its voting shares ceases to be so interested. Where any person is interested in more than three percent of the Company’s voting shares, such person must notify the Company of any alteration of his or her interest that brings his or her total holding through the nearest whole percentage number, whether an increase or a reduction. The relevant percentage figure is calculated by reference to the aggregate nominal value of the voting shares in which the person is interested as a proportion of the entire nominal value of the Company’s issued share capital (or any such class of share capital in issue). Where the percentage level of the person’s interest does not amount to a whole percentage, this figure may be rounded down to the next whole number. The Company must be notified within five business days of the transaction or alteration of the person’s interests that gave rise to the notification requirement. If a person fails to comply with these notification requirements, such person’s rights in respect of any of the Company’s shares he or she holds will not be enforceable, either directly or indirectly. However, such person may apply to the court to have the rights attaching to such shares reinstated.
In addition to these disclosure requirements, the Company, under the Companies Act, may, by notice in writing, require a person whom the Company knows or has reasonable cause to believe to be, or at any time during the three years immediately preceding the date on which such notice is issued to have been, interested in shares comprised in the Company’s relevant share capital to: (i) indicate whether or not it is the case; and (ii) where such person holds or has during that time held an interest in the Company’s shares, to provide additional information, including the person’s own past or present interests in the Company’s shares. If the recipient of the notice fails to respond within the reasonable time period specified in the notice, the Company may apply to a court for an order directing that the affected shares be subject to certain restrictions, as prescribed by the Companies Act, as follows:
		
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	any transfer of those shares or, in the case of unissued shares, any transfer of the right to be issued with shares and any issue of shares, shall be void;

		
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	no voting rights shall be exercisable in respect of those shares;

		
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	no further shares shall be issued in right of those shares or in pursuance of any offer made to the holder of those shares; and

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	no payment shall be made of any sums due from the Company on those shares, whether in respect of capital or otherwise.

The court may also order that shares subject to any of these restrictions be sold with the restrictions terminating upon the completion of the sale.
In the event the Company is in an offer period pursuant to the Irish takeover rules, as defined below, accelerated disclosure provisions apply for persons holding an interest in the Company’s securities of one percent or more.
Anti-Takeover Provisions
Irish Takeover Rules and Substantial Acquisition Rules
A transaction in which a third party seeks to acquire 30% or more of the voting rights of the Company and certain other acquisitions of the Company’s securities are governed by the Irish Takeover Panel Act 1997 and the Irish Takeover Rules made thereunder, which are referred to herein as the “Irish takeover rules,” and are regulated by the Irish Takeover Panel. The “General Principles” of the Irish takeover rules and certain important aspects of the Irish takeover rules are described below.
General Principles
The Irish takeover rules are built on the following General Principles which will apply to any transaction regulated by the Irish Takeover Panel:
		
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	in the event of an offer, all holders of securities of the target company must be afforded equivalent treatment and, if a person acquires control of a company, the other holders of securities must be protected;

		
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	the holders of securities in the target company must have sufficient time and information to enable them to reach a properly informed decision on the offer; where it advises the holders of securities, the board of directors of the target company must give its views on the effects of the implementation of the offer on employment, employment conditions and the locations of the target company’s place of business;

		
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	a target company’s board of directors must act in the interests of the company as a whole and must not deny the holders of securities the opportunity to decide on the merits of the offer;

		
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	false markets must not be created in the securities of the target company, the bidder or any other company concerned by the offer in such a way that the rise or fall of the prices of the securities becomes artificial and the normal functioning of the markets is distorted;

		
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	a bidder can only announce an offer after ensuring that he or she can pay in full the consideration offered, if such is offered, and after taking all reasonable measures to secure the implementation of any other type of consideration;

		
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	a target company may not be hindered in the conduct of its affairs longer than is reasonable by an offer for its securities (this is a recognition that an offer will disrupt the day-to-day running of a target company, particularly if the offer is hostile and the board of directors of the target company must direct its attention to resisting the offer); and

		
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	an acquisition of securities (whether such acquisition is to be effected by one transaction or a series of transactions) shall take place only at an acceptable speed and shall be subject to adequate and timely disclosure. Specifically, the acquisition of 10% or more of the issued voting shares within a seven day period that would take a shareholder’s holding to or above 15% of the issued voting shares (but less than 30%) is prohibited, subject to certain exemptions.

Mandatory Bid
Under certain circumstances, a person who acquires ordinary shares, or other of the Company’s voting securities, may be required under the Irish takeover rules to make a mandatory cash offer for the remaining issued 

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and outstanding voting securities at a price not less than the highest price paid for the securities by the acquiror, or any parties acting in concert with the acquiror, during the previous 12 months. This mandatory bid requirement is triggered if an acquisition of securities would increase the aggregate holding of an acquiror, including the holdings of any parties acting in concert with the acquiror, to securities representing 30% or more of the voting rights in the Company, unless the Irish Takeover Panel otherwise consents. An acquisition of securities by a person holding, together with its concert parties, securities representing between 30% and 50% of the voting rights in the Company would also trigger the mandatory bid requirement if, after giving effect to the acquisition, the percentage of the voting rights held by that person (together with its concert parties) would increase by 0.05% within a 12-month period. Any person (excluding any parties acting in concert with the holder) holding securities representing more than 50% of the voting rights of a company is not subject to these mandatory offer requirements in purchasing additional securities.
Voluntary bid; Requirements to Make a Cash Offer and Minimum Price Requirements
If a person makes a voluntary offer to acquire the issued and outstanding ordinary shares of the Company and the bidder acquired ordinary shares in the three-month period prior to the commencement of the offer period, the offer price must not be less than the highest price paid for ordinary shares by the bidder or its concert parties during that period. The Irish Takeover Panel has the power to extend the “look back” period to 12 months if the Irish Takeover Panel, taking into account the General Principles, believes it is appropriate to do so.
If the bidder or any of its concert parties has acquired more than 10% of the issued and outstanding ordinary shares (i) during the period of 12 months prior to the commencement of the offer period or (ii) at any time after the commencement of the offer period, the offer must be in cash (or accompanied by a full cash alternative) and the price per ordinary share must not be less than the highest price paid by the bidder or its concert parties during, in the case of (i), the 12-month period prior to the commencement of the offer period or, in the case of (ii), the offer period. The Irish Takeover Panel may apply this rule to a bidder who, together with its concert parties, has acquired less than 10% of the total ordinary shares in the 12-month period prior to the commencement of the offer period if the Irish Takeover Panel, taking into account the General Principles, considers it just and proper to do so.
An offer period will generally commence on the date of the first announcement of the offer or proposed offer.
Substantial Acquisition Rules
The Irish takeover rules also contain rules governing substantial acquisitions of shares and other voting securities which restrict the speed at which a person may increase his or her holding of shares and rights over shares to an aggregate of between 15% and 30% of the voting rights of the Company. Except in certain circumstances, an acquisition or series of acquisitions of shares or rights over shares representing 10% or more of the voting rights of the Company is prohibited, if such acquisition(s), when aggregated with shares or rights already held, would result in the acquirer holding 15% or more but less than 30% of the voting rights of the Company and such acquisitions are made within a period of seven days. These rules also require accelerated disclosure of acquisitions of shares or rights over shares relating to such holdings.
Frustrating Action
Under the Irish takeover rules, the Company’s board of directors is not permitted to take any action that might frustrate an offer for its shares once the Company’s board of directors has received an approach that may lead to an offer or has reason to believe that such an offer is or may be imminent, subject to certain exceptions. Potentially frustrating actions such as (i) the issue of shares, options or convertible securities, (ii) material acquisitions or disposals, (iii) entering into contracts other than in the ordinary course of business or (iv) any action, other than seeking alternative offers, which may result in frustration of an offer, are prohibited during the course of an offer or at any earlier time during which the Company’s board of directors has reason to believe an offer is or may be imminent. Exceptions to this prohibition are available where:
		
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	the action is approved by the Company’s shareholders at a general meeting; or

		
	•
	the Irish Takeover Panel has given its consent, where:

		
	•
	it is satisfied the action would not constitute frustrating action;

		
	•
	the Company’s shareholders holding more than 50% of the voting rights state in writing that they approve the proposed action and would vote in favor of it at a general meeting;

9

		
	•
	the action is taken in accordance with a contract entered into prior to the announcement of the offer (or any earlier time at which the Company’s board of directors considered the offer to be imminent); or

		
	•
	the decision to take such action was made before the announcement of the offer and either has been at least partially implemented or is in the ordinary course of business.

Other Provisions
Certain other provisions of Irish law or the Company’s Constitution may be considered to have anti-takeover effects, including advance notice requirements for director nominations and other shareholder proposals, as well those described under the following captions: “—Capital Structure—Authorized Share Capital” (regarding issuance of preferred shares), “—Preemption Rights, Share Warrants and Share Options,” “—Disclosure of Interests in Shares” and “—Corporate Governance.”
Corporate Governance
The Company’s Constitution delegates the day-to-day management of the Company to the board of directors. The Company’s board of directors may then delegate the management of the Company to committees of the board of directors (consisting of one or more members of the board of directors) or executives; regardless, the Company’s board of directors remains responsible, as a matter of Irish law, for the proper management of the affairs of the company. Committees may meet and adjourn as they determine proper. A vote at any committee meeting will be determined by a majority of votes of the members present.
The Company’s board of directors has a standing audit committee, a compensation committee and a nominating and corporate governance committee, with each committee comprised solely of independent directors, as prescribed by The NASDAQ Global Select Market listing standards and SEC rules and regulations. The Company has adopted corporate governance policies, including a code of conduct and an insider trading policy, as well as an open door reporting policy and a comprehensive compliance program.
The Companies Act require a minimum of two directors. The Company’s Constitution provides that the board may determine the size of the board from time to time.
The Company’s board of directors is divided into three classes, designated Class I, Class II and Class III. The term of the Class I directors will expire on the date of the 2021 annual general meeting; the term of the Class II directors will expire on the date of the 2022 annual general meeting; and the term of the Class III directors will expire on the date of the 2020 annual general meeting. At each annual general meeting of shareholders, successors to the class of directors whose term expires at that annual general meeting are elected for a three-year term. In no case will any decrease in the number of directors shorten the term of any incumbent director. A director may hold office until the annual general meeting of the year in which his or her term expires and until his or her successor is elected and duly qualified, subject to his or her prior death, resignation, retirement, disqualification or removal from office.
Directors are elected by ordinary resolution at a general meeting. Irish law requires majority voting for the election of directors, which could result in the number of directors falling below the prescribed minimum number of directors due to the failure of nominees to be elected. Accordingly, the Company’s Constitution provides that if, at any general meeting of shareholders, the number of directors is reduced below the minimum prescribed by the Constitution due to the failure of any person nominated to be a director to be elected, then, in such circumstances, the nominee or nominees who receive the highest number of votes in favor of election will be elected in order to maintain such prescribed minimum number of directors. Each director elected in this manner will remain a director (subject to the provisions of the Companies Act and the articles of association) only until the conclusion of the next annual general meeting unless he or she is reelected.
Under the Companies Act and notwithstanding anything contained in the Constitution or in any agreement between the Company and a director, the Company’s shareholders may, by an ordinary resolution, remove a director from office before the expiration of his or her term at a meeting held on no less than 28 days’ notice and at which the director is entitled to be heard. The power of removal is without prejudice to any claim for damages for breach of contract (e.g. employment contract) that the director may have against the Company in respect of his removal.
The Company’s Constitution provides that the board of directors may fill any vacancy occurring on the board of directors. If the Company’s board of directors fills a vacancy, the director’s term expires at the next annual 

10

general meeting. A vacancy on the board of directors created by the removal of a director may be filled by the shareholders at the meeting at which such director is removed and, in the absence of such election or appointment, the remaining directors may fill the vacancy.
Legal Name; Formation; Fiscal Year; Registered Office
Jazz Pharmaceuticals Public Limited Company is the Company’s current legal and commercial name. The Company was incorporated in Ireland on March 15, 2005 as a private limited company (registration number 399192) under the name Azur Pharma Limited. Azur Pharma Limited was re-registered as a public limited company named Azur Pharma Public Limited Company effective October 20, 2011, and was subsequently renamed Jazz Pharmaceuticals Public Limited Company on January 16, 2012. The Company’s fiscal year ends on December 31st and its registered address is Fifth Floor, Waterloo Exchange, Waterloo Road, Dublin 4, Ireland D04 E5W7.
Duration; Dissolution; Rights Upon Liquidation
The Company’s duration is unlimited. The Company may be dissolved and wound up at any time by way of a shareholders’ voluntary winding up or a creditors’ winding up. In the case of a shareholders’ voluntary winding up, a special resolution of shareholders is required. The Company may also be dissolved by way of court order on the application of a creditor, or by the Companies Registration Office as an enforcement measure where it has failed to file certain returns.
The Company’s Constitution provides that the ordinary shareholders are entitled to participate pro rata in a winding up, but their right to do so may be subject to the rights of any preferred shareholders to participate under the terms of any series or class of preferred shares.
Certificated Shares
Pursuant to the Companies Act, a shareholder is entitled to be issued a share certificate on request and subject to payment of a nominal fee.
No Sinking Fund
Ordinary shares have no sinking fund provisions.
Stock Exchange Listing
Ordinary shares are listed on The NASDAQ Global Select Market under the trading symbol “JAZZ.” Ordinary shares are not currently intended to be listed on the Irish Stock Exchange.
Transfer and Registration of Shares
The transfer agent and registrar for ordinary shares is Computershare Trust Company, N.A. Its address is 250 Royall Street, Canton, MA 02021. An affiliate of the transfer agent maintains the share register, registration in which is determinative of ownership of ordinary shares. A shareholder who holds shares beneficially is not the holder of record of such shares. Instead, the depository (for example, Cede & Co., as nominee for DTC) or other nominee is the holder of record of those shares. Accordingly, a transfer of shares from a person who holds such shares beneficially to a person who also holds such shares beneficially through a depository or other nominee will not be registered in the Company’s official share register, as the depository or other nominee will remain the record holder of any such shares.
A written instrument of transfer is required under Irish law in order to register on the Company’s official share register any transfer of shares (i) from a person who holds such shares directly to any other person, (ii) from a person who holds such shares beneficially but not directly to a person who holds such shares directly, or (iii) from a person who holds such shares beneficially to another person who holds such shares beneficially where the transfer involves a change in the depository or other nominee that is the record owner of the transferred shares. An instrument of transfer is also required for a shareholder who directly holds shares to transfer those shares into his or her own broker account (or vice versa). Such instruments of transfer may give rise to Irish stamp duty, which must be paid prior to registration of the transfer on the Company’s official Irish share register. However, a shareholder who directly holds shares may transfer those shares into his or her own broker account (or vice versa) without giving rise to Irish stamp duty provided there is no change in the ultimate beneficial ownership of the shares as a result of the transfer and the transfer is not made in contemplation of a sale of the shares.

11

Any transfer of ordinary shares that is subject to Irish stamp duty will not be registered in the name of the buyer unless an instrument of transfer is duly stamped and provided to the transfer agent. The Company, in its absolute discretion and insofar as the Companies Act or any other applicable law permit, may, or may provide that any of its subsidiaries will, pay Irish stamp duty arising on a transfer of ordinary shares on behalf of the transferee of such ordinary shares. If stamp duty resulting from the transfer of ordinary shares which would otherwise be payable by the transferee is paid by the Company or any of its subsidiaries on behalf of the transferee, then in those circumstances, the Company will, on its behalf or on behalf of its subsidiary (as the case may be), be entitled to (i) seek reimbursement of the stamp duty from the transferee, (ii) set-off the stamp duty against any dividends payable to the transferee of those ordinary shares and (iii) to claim a first and permanent lien on ordinary shares on which stamp duty has been paid by the Company or its subsidiary for the amount of stamp duty paid. The Company’s lien shall extend to all dividends paid on those ordinary shares. Parties to a share transfer may assume that any stamp duty arising in respect of a transaction in ordinary shares has been paid unless one or both of such parties is otherwise notified.
The Company’s Constitution delegates to the secretary or assistant secretary of the Company the authority, on behalf of the Company, to execute an instrument of transfer on behalf of a transferring party. Under the Company’s Constitution, the directors can also authorize any person to execute an instrument of transfer on behalf of a transferring party in certain circumstances.
In order to help ensure that the official share register is regularly updated to reflect trading of ordinary shares occurring through normal electronic systems, the Company intends to regularly produce any required instruments of transfer in connection with any transactions for which stamp duty is paid (subject to the reimbursement and set-off rights described above). In the event that the Company notifies one or both of the parties to a share transfer that its believes stamp duty is required to be paid in connection with the transfer and that the Company will not pay the stamp duty, the parties may either themselves arrange for the execution of the required instrument of transfer (and may request a form of instrument of transfer from the Company for this purpose) or request that the Company execute an instrument of transfer on behalf of the transferring party. In either event, if the parties to the share transfer have the instrument of transfer duly stamped (to the extent required) and then provide it to the Company’s transfer agent, the buyer will be registered as the legal owner of the relevant shares on the Company’s official Irish share register (subject to the suspension right described below).
The directors may suspend registration of transfers from time to time, not exceeding 30 days in aggregate each year.
Irish Restrictions on Import and Export of Capital
Except as indicated below, there are no restrictions on non-residents of Ireland dealing in Irish domestic securities, which includes ordinary shares of Irish companies. Except as indicated below, dividends and redemption proceeds also continue to be freely transferable to non-resident holders of such securities.
The Financial Transfers Act, 1992, provides that the Irish Minister for Finance can make provision for the restriction of financial transfers between Ireland and other countries. For the purposes of this Act, “financial transfers” include all transfers which would be movements of capital or payments within the meaning of the treaties governing the European Communities if they had been made between Member States of the Communities. This Act has been used by the Minister for Finance to implement European Council Directives, which provide for the restriction of financial transfers to certain countries, organizations and people including the Al-Qaeda network and the Taliban, Afghanistan, Belarus, Burma (Myanmar), Democratic People’s Republic of Korea, Democratic Republic of Congo, Egypt, Iran, Iraq, Ivory Coast, Lebanon, Liberia, Libya, Republic of Guinea, Somalia, Sudan, and Syria.
Any transfer of, or payment in respect of, a share or interest in a share involving the government of any country that is currently the subject of United Nations sanctions, any person or body controlled by any of the foregoing, or by any person acting on behalf of the foregoing, may be subject to restrictions pursuant to such sanctions as implemented into Irish law.

12Exhibit

	
			
	Execution Version
	 
	Exhibit 10.10

CONTRACT MANUFACTURING AGREEMENT
API AND DRUG PRODUCT
This Agreement is made as of 20 January 2020 (the Effective Date) between
Siegfried AG    
Untere Bruehlstrasse 4, 4800 Zofingen, Switzerland (Siegfried); 
and
Jazz Pharmaceuticals Ireland Limited
5th Floor, Waterloo Exchange, Waterloo Road, Dublin 4, Ireland (Jazz).
Recitals
		
	A.
	Siegfried is engaged in the business of, among other things, providing development and/or manufacturing services with regard to drug substances and drug products for the pharmaceutical industry;

		
	B.
	Jazz is engaged in the business of, among other things, developing, producing, formulating, distributing and commercializing pharmaceutical products;

		
	C.
	Jazz desires to have Siegfried Manufacture and supply to Jazz Product (as defined herein) in commercial quantities; and 

		
	D.
	Siegfried, subject to the terms and conditions of this Agreement, desires to Manufacture and supply Product to Jazz.

Now, therefore, the Parties agree as follows:
		
	1.
	Definitions

Unless elsewhere defined in this Agreement, each of the capitalized terms used in this Agreement (other than the names of the Parties and the headings of the Sections) shall have the meanings indicated below. Such meanings shall apply equally to all forms of such terms, including singular and plural forms, unless otherwise clearly indicated.
		
	1.1
	Active Pharmaceutical Ingredient/API shall mean the active pharmaceutical ingredient(s) set forth in Annex 1.1. 

/s/ Henn        /s/ KG
Siegfried        Jazz

2 / 37

		
	1.2
	Affiliate shall mean with respect to any Party any person or entity Controlling, Controlled by, or under common Control with a Party at any time during the Term of this Agreement. For purposes of this definition, the term Control shall mean the power to direct or cause the direction of the management and policies of an entity, whether through the ownership of voting stock, by contract or otherwise. In the case of a corporation, the term Control shall mean the direct or indirect ownership of at least fifty per cent (50%) of the outstanding voting stock.

		
	1.3
	Agreement shall mean this Contract Manufacturing Agreement, including its Annexes (and appendices, if applicable), and including the Quality Agreement, in each case as may be amended from time to time according to the applicable terms and conditions of this Agreement or the Quality Agreement.

		
	1.4
	Alternative Manufacturer shall have the meaning as set out in Section 12.10.

		
	1.5
	API Manufacturing Site shall mean Siegfried’s facilities located at Untere Bruehlstrasse 4, 4800 Zofingen, Switzerland.

		
	1.6
	Applicable Laws shall mean all laws, rules and regulations applicable to the Manufacturing of API at the API Manufacturing Site or to the Manufacturing of Drug Product at the Drug Product Manufacturing Site, respectively, including without limitation the (i) U.S. Federal Food, Drug and Cosmetic Act, and all rules and regulations thereunder, (ii) EU Commission Directives 2001/83/EC as amended, and 2003/94/EC, and Directive 91/412/EEC, (iii) cGMP Regulations, and (iv) the counterparts to the foregoing in other jurisdictions, to the extent that Siegfried performs any Manufacturing in such jurisdiction. 

		
	1.7
	Arising Intellectual Property Rights means all Intellectual Property Rights which are made, developed or reduced to practice by a Party in the performance of, or in connection with or related to, this Agreement.

		
	1.8
	Batch shall mean a specific quantity of Product or other Material that is intended to have uniform character and quality, within specified limits, and is produced during the same cycle of manufacture.

		
	1.9
	Business Day shall mean a day (not being a Saturday or Sunday) on which banks are open for business in Zurich, Switzerland, Hal-Far, Malta or Dublin, Ireland, as the context requires.

		
	1.10
	cGMP shall mean good manufacturing practices as described in regulations and guidance documents pertaining to manufacturing and quality control practice applicable for respective Product as may be further defined in the Quality Agreement.

		
	1.11
	Change shall mean any change to the Specifications, Master Batch Record, Raw Materials, Consigned Materials, Designated Vendor, API Manufacturing Site or the Drug Product Manufacturing Site, such Change being either (i) a Required Change (as 

/s/ Henn        /s/ KG
Siegfried        Jazz

3 / 37

defined in Section 6.5), (ii) a Customer Change (as defined in Section 6.6), or (iii) a Siegfried Change (as defined in Section 6.7).
		
	1.12
	Chemistry, Manufacturing and Control/CMC shall mean the part of pharmaceutical development that deals with the nature of the API or Drug Product, respectively, the manner in which both are made, and the manner by which the manufacturing process is shown to be in control.

		
	1.13
	Confidential Information shall have the meaning as set out in Section 10.1. 

		
	1.14
	Consigned Materials shall mean the materials that are owned by Jazz or that are to be provided by or on behalf of Jazz to Siegfried for the Manufacture of the API or Drug Product, respectively; including without limitation the Key Material and API (in accordance with Section 5.2).

		
	1.15
	Designated Vendor shall have the meaning as set out in Section 6.4.

		
	1.16
	Delivery Shortfall shall have the meaning as set out in Section 14.2.

		
	1.17
	Drug Product shall mean the drug product containing the API (film-coated tablets in bulk form), as set forth in Annex 1.2.

		
	1.18
	Drug Product Manufacturing Site shall mean Siegfried’s Affiliate (Siegfried Malta Limited) facilities located in HHF070 Hal Far Industrial Estate, Hal Far BBG 3000, Malta.

		
	1.19
	DEA shall mean the United States Drug Enforcement Administration or any successor entity thereto.

		
	1.20
	Effective Date shall have the meaning set forth on the front page of this Agreement.

		
	1.21
	EMA shall mean the European Medicines Agency or any successor entity thereto.

		
	1.22
	Entitled Person shall have the meaning as set out in Section 10.3.

		
	1.23
	Equipment means any equipment used in the Manufacture of a Product by Siegfried hereunder.

		
	1.24
	FDA shall mean the United States Food and Drug Administration or any successor entity thereto.

		
	1.25
	Forecast shall have the meaning as set out in Section 3.2.

		
	1.26
	Force Majeure Event shall have the meaning as set out in Section 16.3.

		
	1.27
	Hidden Defects shall mean a failure of Product to conform to the Specifications upon delivery, such failure not being discoverable by Jazz or its designee upon reasonable physical inspection upon receipt of the Product pursuant to Section 4.3.

/s/ Henn        /s/ KG
Siegfried        Jazz

4 / 37

		
	1.28
	Improvement shall mean any result, data, documentation, invention, improvement,  innovation, development, discovery, computer program, device, trade secret, method, know-how, process, technique or the like, whether or not written or otherwise fixed in any form or medium, regardless of the media on which contained and whether or not patentable or copyrightable.  

		
	1.29
	Initial Period shall have the meaning as set forth in Section 12.1.

		
	1.30
	Intellectual Property Rights shall mean, without limitation, all Improvements, inventions, patent applications, rights in patents, registered or unregistered design rights, copyrights, database rights, trademarks, trade names, know-how, trade secrets and other industrial or intellectual property rights of whatever kind.

		
	1.31
	Key Material shall mean the key starting material as set forth in Annex 1.3. 

		
	1.32
	Losses shall mean all liabilities, claims, demands, actions, suits, losses, damages, costs and expenses (including reasonable attorney's fees) incurred by a Party.

		
	1.33
	Manufacture/Manufacturing/Manufactured shall mean all activities with respect to the manufacturing of the API or Drug Product, respectively, including, without limitation, the purchase of Raw Materials and primary packaging materials, production, quality control, quality assurance, release testing and stability testing, packaging and release of Product for shipment (but excluding, without limitation, (i) release of Drug Product for the market and (ii) shipment). 

		
	1.34
	Manufacturing Site shall mean the API Manufacturing Site, the Drug Product Manufacturing Site, or both of them, as the case may be. 

		
	1.35
	Marketing Authorization/MA shall mean the formal authorization (and associated documentation) granted or issued by a Regulatory Authority necessary for the lawful marketing and sale of the Drug Product in the respective country/countries of the Territory over which such Regulatory Authority has jurisdiction.

		
	1.36
	Master Batch Record shall mean the production Batch record for the Manufacture of the API or Drug Product, developed by Siegfried in part from the Technology, specifying the process, manufacture, deviations and testing of the API or Drug Product, respectively.

		
	1.37
	Materials shall mean Raw Materials and/or Consigned Materials.

		
	1.38
	Non-Conformance Claim shall have the meaning as set out in Section 4.3.

		
	1.39
	Order shall mean a purchase order issued by Jazz for a certain quantity of Product.

		
	1.40
	Order Confirmation shall mean a confirmation issued by Siegfried that an Order posted by Jazz shall be executed.

/s/ Henn        /s/ KG
Siegfried        Jazz

5 / 37

		
	1.41
	Party/Parties shall mean either Jazz or Siegfried, or both, as the context may require.

		
	1.42
	Pre-Existing Intellectual Property Rights of a Party means all Intellectual Property Rights owned, conceived, developed, first reduced to practice or otherwise made or acquired by such Party prior to the Effective Date hereof, including all modifications, adjustments or improvements thereto (to the extent such modifications, adjustments or improvements do not constitute any of the other Party’s Arising Intellectual Property Rights in accordance with Section 11.2 or Section 11.3, as the case may be).

		
	1.43
	Product/Products shall mean the API or the Drug Product or the two of them, as the context may require.

		
	1.44
	Quality Agreement shall mean the quality technical agreement between Jazz and Siegfried which defines the quality assurance responsibilities of each Party in respect of Product quality and compliance under cGMP Regulations, as may be amended from time to time. 

		
	1.45
	Raw Materials shall mean all raw materials, excipients, and processing, filling and packaging components, which are not Product or Consigned Materials and which are necessary to manufacture the API or Drug Product, respectively, as set forth in the relevant Master Batch Record.

		
	1.46
	Recall shall have the meaning as set out in Section 7.6.

		
	1.47
	Regulatory Authority shall mean the governmental authority or authorities, which are responsible for approving the conduct of clinical trials, marketing and sale of pharmaceutical products and shall be EMA and FDA.

		
	1.48
	Specifications shall mean the description of technical requirements the API or Drug Product has to conform to, as set out in detail in the Quality Agreement.

		
	1.49
	Technology shall mean all information, Intellectual Property Rights and data in any form that Jazz has disclosed or will disclose, directly or indirectly, to Siegfried that may be necessary or useful for Manufacture of the API or Drug Product, respectively, as the same may be modified from time to time by Jazz in its sole discretion. All Technology shall constitute Confidential Information of Jazz, subject to Section 10.5. 

		
	1.50
	Term shall have the meaning as set out in Section 12.2.

		
	1.51
	Territory shall mean the United States of America (with its territories, possessions, and protectorates, such as the Commonwealth of Puerto Rico), the member states of the European Union and/or European Economic Area (EU/EEA), Canada, United Kingdom (notwithstanding it being a member of the EU/EEA as of the Effective Date), Switzerland, Turkey, Australia, New Zealand, Brazil, Mexico, and any other country, which the Parties agree in writing to add to this definition of Territory in an amendment to this Agreement. 

/s/ Henn        /s/ KG
Siegfried        Jazz

6 / 37

		
	2.
	Scope of Work

		
	2.1
	Appointment. Jazz hereby appoints Siegfried, and Siegfried accepts such appointment, to (i) Manufacture and supply the Drug Product for or on behalf of Jazz at the Drug Product Manufacturing Site, (ii) Manufacture and supply the API for or on behalf of Jazz at the API Manufacturing Site, whereas the API may be supplied to Jazz or may be used by Siegfried in the Manufacture of the Drug Product and (iii) act as a broker for the transport of the API (owned by Jazz) from the API Manufacturing Site to the Drug Product Manufacturing Site, subject to the terms and conditions set forth in this Agreement. 

		
	2.2
	Siegfried Malta Limited. Siegfried has entered into this Agreement on behalf of itself and its Affiliate, Siegfried Malta Limited, through which Siegfried shall be performing certain activities hereunder. Siegfried shall procure that Siegfried Malta Limited shall be bound by the applicable terms and conditions of this Agreement as if it were a direct Party hereto and shall procure the due performance thereof by Siegfried Malta Limited. Jazz shall only be entitled to engage and communicate directly with Siegfried Malta Limited upon prior consent of Siegfried.

		
	2.3
	Purchase Commitment. Subject to Section 2.3, during the Term, Jazz (and any of its Affiliates, or any transferee or successor in interest to Jazz’s business or Product) shall order and purchase at least sixty percent (60%) of its requirements for the API and forty percent (40%) of its requirements for the Drug Product from Siegfried. 

Subject to this minimum purchase commitment and Section 2.4 below, the Parties further agree on the following pricing mechanism:
		
	a)
	For the API: [ * ]; or 

		
	b)
	For the Drug Product: [ * ]:

/s/ Henn        /s/ KG    
Siegfried        Jazz

7 / 37

		
	c)
	During the Term, but not more often than [ * ], upon reasonable prior written notice to Jazz and to such an extent as will not interfere with the normal operations of Jazz, an independent certified public accountant selected by Siegfried and reasonably acceptable to Jazz will have reasonable access during normal business hours to inspect, at Siegfried’s expense, Jazz’s books of accounts and other records pertaining to the purchase of API and Drug Product as may reasonably be necessary for the purpose of determining Jazz’s compliance with the minimum purchase commitment provided for under this Agreement. Prior to commencing any such inspection and/or audit, the accountant shall enter into a reasonable and customary confidentiality agreement with Jazz which prohibits the disclosure of any information, except as provided in said confidentiality agreement or pursuant to court order, relating to Jazz and/or its Affiliates to any person or entity, including Siegfried, except that such accountant may issue a report to Siegfried, which report shall also be provided to Jazz, the sole purpose of which will be to report to Siegfried on Jazz’s compliance or non-compliance with such minimum purchase commitment. Siegfried shall treat all information received from Jazz and/or its Affiliates and/or the accountant hereunder as Jazz’s Confidential Information. In the event of any dispute between Jazz and Siegfried regarding the findings of any such inspection or audit, the Parties shall initially attempt in good faith to resolve the dispute amicably between themselves. The costs for such an audit shall be borne by Jazz in case of the discovery of any inaccuracies resulting in non-compliance with Jazz’s minimum purchase commitment. 

		
	d)
	In the event (i) Siegfried does not deliver conforming Product as per Sections 3.7 and 14.1 or (ii) Jazz notifies Siegfried in writing that Jazz has reasonable and material quality concerns regarding Siegfried’s Manufacture of the Product (including without limitation due to the occurrence of any major or critical deviations that have not been properly investigated by Siegfried (in Jazz’s reasonable discretion) or any material breach by Siegfried of its obligations under the Quality Agreement that remain uncured after [ * ] as per Section 12.4), the Parties agree that Jazz may, upon written notice to Siegfried, temporally purchase (i) more than forty-percent (40%) of its requirements of API and/or (ii) more than sixty-percent (60%) of its requirements of Drug Product from other suppliers without constituting a breach of its obligations under Section 2.3 and without any penalty, surcharge or Volume Shortfall payment being due or owing (pursuant to Section 2.3a) or 2.3b)). This Section 2.3 c) will apply only to the extent and for so long as Siegfried does not deliver conforming Product as per Sections 3.7 and 14.1 (excluding any Force 

/s/ Henn        /s/ KG
Siegfried        Jazz

8 / 37

Majeure Event or any reason caused due to an act or omission of Jazz); provided, however, that, if Siegfried resumes the capability to deliver (conforming) Product comprising at least eighty percent (80%) of Jazz’s outstanding Product requirements, the requirements of this Section 2.3 shall be deemed to be reinstated (provided, however, that Jazz shall not be liable for any penalty, surcharge or Volume Shortfall payment in respect of any Product orders it committed to with another supplier during the period in which Siegfried did not or could not deliver conforming Product). 
		
	2.4
	Exclusivity. 

Without limiting Siegfried’s other obligations hereunder (including without limitation its obligations under Sections 10 and 11), during the Term of this Agreement, neither Siegfried nor any of Siegfried’s Affiliates engaged by Jazz (or any of Jazz’s Affiliates) within the previous [ * ] shall develop, make, have made, use, sell, have sold, solicit, import or commercialize, or assist any third party in any of the foregoing (other than Jazz or its designee pursuant to this Agreement) with respect to 
		
	(i)
	Product and/or 

		
	(ii)
	any drug product containing the API 

that directly or indirectly uses, relies on, references, incorporates, derives from or relates to in any way, in whole or in part, any of the Technology (except technology that is general knowledge and publicly known or in the public domain), Jazz’s Confidential Information or Jazz’s Intellectual Property Rights (including without limitation Jazz’s Pre-Existing Intellectual Property Rights and Jazz’s Arising Intellectual Property Rights). For the avoidance of doubt, Jazz acknowledges that nothing in this Agreement shall be construed as a representation or inference that Siegfried will not enter into business relationships with other third parties regarding products that are similar to or that may compete with any Product, Technology or process covered by this Agreement subject always to Siegfried’s compliance with its obligations hereunder (including without limitation its obligations under Sections 10 and 11) and provided always that none of Jazz’s Technology, Jazz’s Confidential Information and/or Jazz’s Intellectual Property Rights (including Jazz’s Pre-Existing Intellectual Property Rights and Jazz’s Arising Intellectual Property Rights) shall be used or disclosed in breach of this Agreement.
		
	2.5
	Controlled Substance. The Parties acknowledge that the API (and thus the Drug Product) may become scheduled under the Federal Controlled Substances Act and/or respective laws in other countries of the Territory (collectively, the FCSA). Jazz shall promptly inform Siegfried if the API will be subject to the FCSA, and the Parties will confer and discuss in good faith the necessary activities to be taken as needed to comply with the FCSA, and the allocation of costs therefore, including without limitation, amending this Agreement and obtaining the necessary licenses, authorizations and regulatory requirements. 

		
	2.6
	Relationship Management. Upon execution of this Agreement, each Party shall forthwith appoint one of its employees to be a relationship manager responsible for liaison 

/s/ Henn        /s/ KG
Siegfried        Jazz

9 / 37

between the Parties. Those representatives shall meet periodically as agreed  to review the current status of the business relationship, including, but not limited to, Equipment and facilities updates, current and anticipated need of each Product (current and anticipated inventory (as per Section 5.4), current and anticipated manufacturing capacity, planned work or changes to the Manufacturing Site, supply chain concerns, in particular without limitations, Materials in short supply or vendor performance, and manage any issues that have arisen. [ * ], the Parties shall organize business review meetings to discuss operational and strategic aspects relating to the execution of this Agreement as well as any issues communicated by either Party to the other Party. With the prior agreement of the Parties, the frequency of the meetings may be increased. The meetings may also be organized through media (teleconferences or videoconferences) and each Party shall bear its own costs in relation with all meetings organized under this Section 2.6.
		
	2.7
	Information. Jazz shall provide to Siegfried the Technology and such other information in Jazz's possession relating to the Products, which are useful and necessary for Siegfried in performing its obligations hereunder, in particular any information concerning any potential hazards involved in Manufacturing Product and other Safety, Health and Environment (SHE) requirements related to the handling of the Product or any waste. The Technology provided by Jazz to Siegfried hereunder shall be subject to the terms and conditions set forth in Sections 10 and 11. 

		
	3.
	Ordering, Purchase and Supply of Product

		
	3.1
	Jazz shall submit to Siegfried, upon [ * ] and then [ * ], an estimated (good faith) demand forecast of Jazz’s requirements of each Product for the next [ * ].

		
	3.2
	Jazz shall submit to Siegfried, on a [ * ] basis, [ * ] prior to the beginning of each month, an estimated (good faith) demand forecast of Jazz’s requirements of each Product for the next [ * ], as follows (each, a “Forecast”): 

		
	3.2.1
	Drug Product Forecast: Jazz’s [ * ] forecast for Drug Product shall set forth:

(i)    the placed Orders for the next [ * ], which shall be binding on the Parties with respect to quantities and delivery dates;
(ii)    the estimated forecast for the next [ * ], which shall not be binding. 
		
	3.2.2
	The total lead-time for Manufacture of Drug Product shall be [ * ], provided sufficient quantity of API is available to Drug Product Manufacturing Site at least [ * ] prior to the confirmed delivery date.

/s/ Henn        /s/ KG
Siegfried        Jazz

10 / 37

		
	3.2.3
	API Forecast: Jazz’s [ * ] forecast for API shall set forth:

(i)    the placed Orders for the next [ * ], which shall be binding on the Parties with respect to quantities and delivery dates; 
(ii)    the estimated forecast for the [ * ], which shall not be binding. 
		
	3.2.4
	The total lead-time for Manufacture of API shall be [ * ], provided sufficient quantity of Key Material is available to Siegfried at least [ * ] prior to the confirmed delivery date. In case (i) the Key Material is not available  to Siegfried in sufficient quantity at least [ * ] prior to the confirmed delivery date or (ii) the API ordered by Jazz was not reflected in the [ * ] forecast, the Parties shall jointly agree on the lead time.

		
	3.3
	Siegfried shall use commercially reasonable efforts to supply Jazz, no later than [ * ], with a written summary report of the agreed Consigned Materials, API and Drug Product inventory for such prior month in the form used by Siegfried for its customers, in order that Jazz may properly account for the inventory held by Siegfried (and its Affiliates) pursuant to this Agreement. The Parties may agree that additional specialized reports shall be prepared by Siegfried in accordance with Jazz's reasonable instructions. The costs for such additional reports will be borne by Jazz.

		
	3.4
	Jazz acknowledges that Siegfried will rely on the accuracy of Jazz’s Forecasts in planning its Manufacture, storage and transport of Product as well as its acquisitions of Raw Materials, as set forth in Section 5. If at any time Jazz finds that a Forecast is inaccurate in a material respect, Jazz shall inform Siegfried without delay and the Parties shall confer and discuss without delay how to proceed. 

		
	3.5
	Jazz shall make all purchases of Product hereunder by submitting Orders to Siegfried in accordance with the respective Product Forecast. Each such Order shall be in writing and shall specify (i) the Product ordered, (ii) the quantity ordered), (iii) the price pursuant to Annex 1.4, and (iv) the requested delivery date, giving Siegfried no less than the number of days in advance of requested delivery to Jazz pursuant to Section 3.2 (the Lead Time). Lead Times for Product deliveries for validation campaigns and/or initial requirements of Product for launch in a country of the Territory shall be agreed upon between the Parties in good faith. 

		
	3.6
	In accordance with Section 3.2.3 or 3.2.4, Siegfried shall use commercially reasonable efforts to execute Orders which exceed by [ * ] of the forecasted quantities. Orders exceeding [ * ] of the forecasted quantities shall be discussed between the Parties, but are only binding upon confirmation by Siegfried. Subject to this Section 3, Siegfried shall confirm to Jazz by way of an Order Confirmation that it will meet Jazz’s quantity requirements in accordance with the delivery date(s) within [ * ] from the date of 

/s/ Henn        /s/ KG
Siegfried        Jazz

11 / 37

the receipt of an Order from Jazz, whereupon the Order shall be confirmed, final, and binding on Siegfried. 
		
	3.7
	Siegfried shall promptly and without undue delay notify Jazz in writing of any anticipated delay or of any circumstance rendering it unable to Manufacture and/or supply Product in accordance with the delivery date(s) and the estimated duration of such delay/circumstance(s). Upon such written notice, the Parties will work together to agree upon a revised delivery schedule and the Parties shall proceed in accordance with Section 14.1. 

		
	3.8
	The Product shall be delivered from Siegfried to Jazz [ * ] (Incoterms 2010) API Manufacturing Site or Drug Product Manufacturing Site, and at the price as set out in Annex 1.4. To clarify, Jazz assumes all responsibilities and liability arising out of the shipment, transport, storage, handling and use of the Product after delivery by Siegfried to Jazz in accordance with the agreed [ * ] Incoterms. 

		
	4.
	Product Delivery and Conformance

		
	4.1
	Jazz shall procure the pick-up and shipment of the Product at the agreed delivery date. A storage fee shall apply for Product which is not picked-up and shipped at that agreed delivery date through no fault of Siegfried or upon mutual agreement and thus stored by or on behalf of Siegfried for more than [ * ] from the agreed delivery date, such storage fee shall be [ * ]. Upon prior written notice to Jazz, Siegfried shall have the right to ship Product that have been stored more than [ * ] from the agreed delivery date to Jazz or its designee.

		
	4.2
	Siegfried will provide to Jazz the documentation set forth in the Quality Agreement with each shipment of Product. Siegfried acknowledges that Jazz will rely on the accuracy and completeness of such documentation in its determination of conformance of Product with Specifications, cGMP, the Quality Agreement and Applicable Law.

		
	4.3
	Upon delivery of Product to Jazz (or its designee), Jazz shall carry out a reasonable physical inspection, or shall procure a designee to carry out a reasonable physical inspection, of the Product within [ * ] in order to determine compliance with the Specifications, the Quality Agreement, Applicable Law and cGMP at the time of delivery and all stages of Manufacture prior thereto. If, in either Party's opinion or determination, any Product Manufactured does not comply with the Specifications, the Quality Agreement, Applicable Law or cGMP upon delivery or at any stage of Manufacture prior thereto, then such Party shall promptly notify the other Party in writing thereof (which may include email notification) (Non-Conformance Claim). If Jazz does not notify Siegfried within [ * ] after delivery of the Product, then the Product is deemed accepted, provided that Jazz retains the right to reject the Product at a later time in the case of Hidden Defects as set out in Section 4.4.

/s/ Henn        /s/ KG
Siegfried        Jazz

12 / 37

		
	4.4
	Jazz retains the right to reject Product for a period of [ * ] after delivery to Jazz (or its designee) in case of Hidden Defects (which may include, without limitation, a Hidden Defect caused by or arising due to a material error in the documentation supplied by Siegfried under Section 4.2), provided that Jazz notifies Siegfried in writing within [ * ] of discovering the Hidden Defect. 

		
	4.5
	Any Non-Conformance Claim made by Jazz shall specify in reasonable detail the nature and basis for the claim and cite Siegfried’s relevant Batch numbers or other information to enable specific identification of the Product involved. Siegfried shall review any Non-Conformance Claim made by Jazz and provide Jazz with the results of such (interim) review without undue delay and, in any event, within [ * ] of receipt of Jazz’s Non-Conformance Claim, as set forth in the Quality Agreement. If such review by Siegfried confirms that the identified Product did not comply with the Specifications, Applicable Law, the Quality Agreement or cGMP upon delivery or at any stage of Manufacture, then Jazz shall have the right to reject such Product and the Parties shall proceed according to Section 14.1. The nonconforming Product shall be disposed or delivered, at Siegfried’s expense, to such destination as agreed by the Parties, in compliance with applicable environmental laws and regulations. Neither Party shall use or dispose of Product that does not, or of which either Party claims that it does not, conform to the Specifications, the Quality Agreement, Applicable Law and cGMP upon delivery or at any stage of Manufacture thereof, without the other Party's prior written consent.

		
	4.6
	Any Non-Conformance Claim made by Siegfried shall specify in reasonable detail the nature and basis for the claim and cite Siegfried’s relevant Batch numbers or other information to enable specific identification of the Product involved. Jazz shall review any Non-Conformance Claim made by Siegfried and provide Siegfried with the results of such review within [ * ] of receipt of Siegfried’s Non-Conformance Claim. If such review by Jazz confirms that the identified Product did not comply with the Specifications, Applicable Law, the Quality Agreement or cGMP upon delivery or at any stage of Manufacture, then Siegfried shall have the right to reject such Product and the Parties shall proceed according to Section 14.1. The nonconforming Product shall be disposed or delivered, at Siegfried’s expense, to such destination as agreed by the Parties, in compliance with applicable environmental laws and regulations. Neither Party shall use or dispose of Product that does not, or of which either Party claims that it does not, conform to the Specifications, the Quality Agreement, Applicable Law and cGMP upon delivery or at any stage of Manufacture thereof, without the other Party's prior written consent.

		
	4.7
	If the Parties fail to agree as to whether a quantity of Product conforms to the Specifications, Applicable Law, the Quality Agreement or cGMP upon delivery or at any stage of Manufacture, the Parties shall have the Batch in dispute and/or relevant data or information investigated, tested and/or further analyzed by an independent testing laboratory or consultant (if the Parties mutually agree to refer to a consultant) selected by agreement between the Parties. The decision of the independent testing laboratory or 

/s/ Henn        /s/ KG
Siegfried        Jazz

13 / 37

consultant shall be deemed final as to any dispute over Product conformance with Specifications, Applicable Law, the material provisions of the Quality Agreement or cGMP upon delivery or at any stage of Manufacture. Should the laboratory or consultant  determine that the delivered Product does not conform to the Specifications, the Quality Agreement, Applicable Law or cGMP upon delivery or at any stage of Manufacture, then Siegfried shall bear all costs for the independent laboratory or consultant, and all shipment, disposal and other reasonable, direct costs and expenses for conducting the investigations and Jazz shall have the right to reject such Batch of Product and the Parties shall proceed according to Section 14.1. However, in case of wrongful rejection of Drug Product by Jazz, then Jazz shall bear the expenses of returning any rejected Drug Product to Siegfried and shall compensate Siegfried the reasonable, direct costs and expenses for conducting the investigations, including without limitation, related to the shipment of the Product (initial or replacement shipment, as the case may be) and any pending purchase price payment still due as set out in this Agreement.
		
	5.
	Purchase, Storage and Transport of Materials

		
	5.1
	In accordance with Jazz’s Forecast and Orders placed, Siegfried will obtain sufficient quantities of all Raw Materials at Siegfried’s costs and expenses in sufficient quantities and of good quality as necessary to enable Siegfried to Manufacture and supply Product in accordance with Jazz’s requirements. Jazz shall also bear the mutually agreed costs of all material to be used as reference standards or impurity standards in the Manufacture of Products, unless otherwise mutually agreed in writing.

		
	5.2
	Jazz shall obtain all right, title and interest in and to the API upon release by Siegfried, whereupon such (released) API becomes Consigned Materials. Jazz shall cause that the Key Material will be supplied in good quality as necessary to enable Siegfried to Manufacture Product in accordance with Jazz’s Forecast and Orders (see i.a. Section 3.2.4 above), at Jazz’s costs and expenses. Any import duties, taxes or other fees due to governmental authorities regarding Consigned Materials shall be paid by Jazz.

		
	5.3
	Jazz shall solely and exclusively retain all right, title and interest in and to all Consigned Material released by Siegfried and Jazz shall insure such Consigned Material against loss and damage. Siegfried shall be liable for any loss of or damage to such Consigned Material, including destruction and shipping costs, if such loss or damage was caused by Siegfried’s gross negligence or willful misconduct. 

		
	5.4
	Any inventory level of Key Material and Consigned Materials (particularly of consigned API) shall only be established upon mutual agreement and at Jazz’s reasonable cost and expenses. Siegfried shall adopt appropriate warehousing controls to rotate Consigned Materials stock as mutually agreed (based on the First-In/First-Out (FiFo) principle unless otherwise agreed in writing), unless otherwise instructed by Jazz and agreed by Siegfried. 

/s/ Henn        /s/ KG
Siegfried        Jazz

14 / 37

		
	5.5
	Siegfried agrees that, without prior written consent by Jazz, Consigned Materials shall: (i) be used solely for the purpose of the Manufacture and supply of Product; (ii) be used in compliance with all Applicable Laws; and (iii) not be transferred to any third party, except to any Affiliate or subcontractor of Siegfried as agreed in the Quality Agreement or otherwise in writing with Jazz (and Siegfried remains fully and directly responsible for the acts and omissions of such Affiliate or subcontractor, as if performed by Siegfried), unless otherwise agreed by the Parties in writing.

		
	5.6
	Until otherwise notified by Jazz to Siegfried with at least [ * ] prior notice or otherwise agreed by the Parties in writing, Siegfried shall act as a broker with regard to the transport of API owned by Jazz (Consigned Material) from the API Manufacturing Site to the Drug Product Manufacturing Site, at Jazz’s reasonable and prior-agreed cost and expenses, and Siegfried shall appoint a qualified and approved subcontractor, as specified in the Quality Agreement and Jazz may monitor and approve Siegfried’s shipping and freight practices as may be agreed in the Quality Agreement or otherwise in writing between the Parties. Siegfried shall only be responsible for the acts and omissions of all such logistics providers, if due Siegfried’s gross negligence or willful misconduct. 

		
	5.7
	Jazz agrees to reimburse Siegfried all reasonable cost and expenses incurred for the amount of inventory of Materials required to be written off as a result of Jazz requiring a change of Materials, in particular, without limitation, changes to specification or vendors, provided however, that Siegfried shall use commercially reasonable efforts to limit such loss of Materials.  

		
	5.8
	Upon reasonable request of Jazz or expiration or termination of the Agreement, Siegfried will make such Consigned Materials available for collection by or on behalf of Jazz in good and usable condition and Jazz will pick-up such Consigned Materials within [ * ], at Jazz’s cost and expenses. 

		
	6.
	Manufacture of Product

		
	6.1
	The terms of the Quality Agreement shall be deemed incorporated by reference into this Agreement.

		
	6.2
	Siegfried shall maintain the Manufacturing Sites and Equipment in a state of repair and operating efficiency consistent with the requirements of the Applicable Laws, cGMP, Specifications, the Quality Agreement, and Master Batch Record. Further details with regard to the Manufacturing Site shall be set forth in the Quality Agreement.

		
	6.3
	Siegfried shall obtain sufficient quantities of all Raw Materials to Manufacture and supply Product in accordance with Jazz’s Forecast and shall ensure that such Raw Materials comply with the Specifications. Jazz shall reimburse Siegfried all costs and expenses reasonably incurred as a result of a change in the Specifications of such Raw Materials.

/s/ Henn        /s/ KG
Siegfried        Jazz

15 / 37

		
	6.4
	If Jazz, in its sole discretion, designates certain Raw Material or any other vendors, other than Siegfried or its Affiliates (each a Designated Vendor), then Siegfried shall obtain respective Raw Material(s) only from such Designated Vendors. Jazz shall reimburse Siegfried all costs and expenses reasonably incurred as a result from appointing or changing a Designated Vendor. Siegfried shall not be liable or responsible for any acts or omissions of such Designated Vendor, including without limitation, a delayed delivery, delivery of non-conforming Raw Material or other supply failure (unless and to the extent any such acts or omissions of such Designated Vendor arise as a result of Siegfried’s negligence or wilful misconduct or any breach by Siegfried of its obligations hereunder).

		
	6.5
	In the event that either Party becomes aware and notifies the other Party that any Change is mandated by Applicable Laws (including, without limitation cGMP Regulations) or by a competent Regulatory Authority (Required Change), then Siegfried shall promptly (i) advise Jazz as to any quality assurance effect scheduling and, if applicable, Product price adjustments, which may reasonably and necessarily result therefrom, and (ii) make any necessary Required Change. Prior to implementation of such Required Change, the Parties shall negotiate in good faith on: (a) the allocation of the implementation costs with regard to the Product and any other products, (b) if applicable, the new Product price after the Required Change has been implemented; and (c) any other amendments to this Agreement which may be necessitated by such Required Change; provided always that all costs associated with Required Changes directly related to the Manufacturing Site that are not required solely to permit Siegfried to Manufacture the Product, or a group of products including the Product, shall be borne by Siegfried. Siegfried and Jazz shall cooperate in making any Required Changes and use commercially reasonable efforts to implement any Required Changes promptly in a manner that minimizes any effect on the supply hereunder to Jazz of the Product meeting Specifications.  

		
	6.6
	In the event Jazz wishes to effect a Change which is not a Required Change (Customer Change), Jazz shall advise Siegfried in writing of such Customer Change as set forth in the Quality Agreement. If Siegfried (acting reasonably and promptly) deems, in its reasonable discretion, such Customer Change as implementable, then Siegfried shall provide (a) if applicable, an estimate of all reasonable, necessary and vouched implementation costs to be borne by Jazz, (b) if applicable, the new proposed Product price after the Customer Change has been implemented (if necessitated by such Customer Change), (c) the timing for implementation and (d) if applicable, an estimated amount of any Raw Materials rendered obsolete as a result of the Customer Change and respective costs to be borne by Jazz. Subject to Jazz’s approval, Siegfried shall implement such Customer Change. Jazz shall bear the approved implementation costs (which include the costs for the Raw Materials rendered obsolete) and the new Product Price, if applicable, shall apply after the implementation. 

		
	6.7
	In the event Siegfried wishes to effect a Change which is not a Required Change (Siegfried Change), Siegfried shall advise Jazz in writing of such Siegfried Change as 

/s/ Henn        /s/ KG
Siegfried        Jazz

16 / 37

set forth in the Quality Agreement. Siegfried Changes will only be implemented following the approval of Jazz (acting reasonably and promptly), such approval not to be unreasonably conditioned, withheld or delayed. Unless otherwise agreed by the Parties, Siegfried’s implementation costs of the Siegfried Changes will be borne by Siegfried. Both Parties shall negotiate in good faith (a) the timing for implementation and (b) an estimated amount of any Raw Material rendered obsolete as a result of the Siegfried Change. In allocating the costs, the Parties should consider whether such Siegfried Change is beneficial to either or both Parties.
		
	7.
	Audits, Notification and Recall

		
	7.1
	Jazz has the right to carry out audits as set forth in the Quality Agreement. While on the Manufacturing Site, Jazz shall comply with all of Siegfried’s applicable policies regarding, safety, health, data protection, confidentiality and the like which Siegfried, in its sole discretion, deems relevant. 

		
	7.2
	Siegfried shall provide Jazz and its designees with reasonable access to its Manufacturing Site and the areas in which Materials or Product is Manufactured, stored, handled or shipped, and Jazz and its designees shall be permitted to review Siegfried’s standard operating procedures related to Manufacture, storage, handling, general facilities, equipment and procedures required for compliance with cGMP. 

		
	7.3
	Siegfried will use commercially reasonable efforts to obtain the right for Jazz to have similar audit rights for Siegfried’s subcontractors, as set forth in the Quality Agreement.

		
	7.4
	Siegfried shall permit any Regulatory Authority to inspect relevant facilities, Equipment and records (including those of its Affiliates) at their request and shall resolve, and procure the resolution by its Affiliates, of all issues raised by a Regulatory Authority, if and to the extent such issues are relevant for the Manufacture of the Product or other cGMP-related obligations under this Agreement. 

		
	7.5
	Each Party shall notify the other Party promptly of any serious or unexpected adverse reaction from the use of the Drug Product, which is reported to it or of which it becomes aware otherwise.

		
	7.6
	In the event either Party believes it may be necessary to conduct a recall or other similar action with respect to the Drug Product (each a Recall), the Parties shall consult with each other as to how best to proceed. If Siegfried reasonably requests a Recall and Jazz declines to act accordingly, Siegfried shall not be liable for any consequences or damages thereafter. Under no circumstances shall Siegfried be prohibited hereunder from taking any action that it is required to take by applicable law.

		
	7.7
	This Section applies to Affiliates of Siegfried and Siegfried shall procure the adherence of its Affiliates hereto and Jazz’s right of audit thereof.

/s/ Henn        /s/ KG
Siegfried        Jazz

17 / 37

		
	8.
	Compensation and Terms of Payment

		
	8.1
	In consideration for the services under the terms of this Agreement, Jazz shall pay Siegfried the prices as specified in, and in accordance with the payment terms set forth in, Annex 1.4.

		
	8.2
	All pricing, payments, credits, allowances or other monetary adjustments under this Agreement shall be in [ * ], as agreed between the Parties and set forth in the Annex 1.4.

		
	8.3
	The Parties may adjust prices upon mutual agreement based on (i) Raw Material price changes, (ii) indices, (iii) exchange rate variations as set forth in the Annex 1.4 or as otherwise agreed in writing. 

		
	8.4
	Invoices shall be issued by Siegfried and sent to Jazz upon release of the Product. 

		
	8.5
	Jazz shall pay such invoices to Siegfried within [ * ] after the date of receipt of such invoice. Each invoice shall, to the extent applicable, identify the Jazz Order number, Product quantities, unit price, freight charges and the total amount to be remitted by Jazz. Notwithstanding the foregoing, Jazz may withhold any amounts invoiced by Siegfried that it disputes in good faith and in writing prior to such [ * ] after the date of receipt of the respective invoice. If Jazz disputes any invoice, Jazz shall within [ * ] after such invoice is furnished to it notify Siegfried in writing that it disputes the accuracy or appropriateness of such invoice and specify the particular respects in which such invoice is inaccurate or inappropriate. The Parties will make good faith efforts to resolve any disputes within [ * ] thereafter. Any amounts that are disputed by Jazz and which the Parties determine are due following resolution of such dispute shall not be due until [ * ] following such resolution.

		
	8.6
	In the event any undisputed sum is not paid when due, then Jazz shall pay interest at a rate of [ * ] on the amount of such undisputed late sum (from the original due date until the date such undisputed late sum is paid). 

		
	9.
	Regulatory Affairs

		
	9.1
	Jazz shall be responsible for all regulatory filings in connection with the Product. 

		
	9.2
	All information, documents and updates with regard to the Manufacture of Product which are in the possession of Siegfried and required by any Regulatory Authority shall, as reasonably requested by Jazz in connection with a submission for such regulatory filings, be as is provided by Siegfried to Jazz, free of charge. 

/s/ Henn        /s/ KG
Siegfried        Jazz

18 / 37

		
	9.3
	Siegfried shall further provide Jazz, at Jazz’s costs and expenses, with reasonable assistance in preparing or reviewing the regulatory filing or formulating responses to any questions and/or inquiries (i.e., deficiency letters) with respect to the above submissions. 

		
	9.4
	Jazz shall provide, and Siegfried shall review, the CMC and other portions of Jazz’s proposed regulatory filings relating to Siegfried’s Manufacturing procedures or otherwise related to Siegfried’s key obligations hereunder before the regulatory filings are submitted with relevant Regulatory Authorities and Jazz shall consider Siegfried’s comments thereto in good faith. 

		
	9.5
	The Parties acknowledge that the ultimate decision of whether any Drug Product will be approved for marketing and sale rests with the Regulatory Authorities of the respective market in the Territory and that Siegfried shall not be liable for the failure of the Regulatory Authorities to issue such Marketing Authorization approval other than due to Siegfried’s gross negligence or willful misconduct or material breach of any of its obligations, warranties or undertakings hereunder. 

		
	9.6
	The Parties acknowledge that the Manufacturing Site and/or the Drug Product Manufacturing Site has the required certifications from the Regulatory Authorities (the FDA, the EMA), which currently allows the Product distribution also in Canada and Australia by GMP certificates mutual recognition. In case a Product launch in other specific countries of Territory would require additional certifications, Parties will discuss in good faith and agree in prior on the plausibility, and costs and timelines associated.

		
	10.
	Confidential Information

		
	10.1
	Confidential Information shall mean any information of whatever kind (including without limitation, data, compilations, formulae, models, patent disclosures, procedures, processes, projections, protocols, results of experimentation and testing, specifications, strategies and techniques), and all tangible and intangible embodiments and oral disclosures thereof of any kind whatsoever, (including without limitation, samples, apparatus, compositions, documents, drawings, machinery, patent applications, records and reports), which has been or will be disclosed by or on behalf of one Party (Disclosing Party) to the other Party (Receiving Party) in connection with this Agreement, and which is confidential or proprietary to the Disclosing Party or an Affiliate thereof, including, without limitation, any and all information pertaining to the Products and information which relates to the business of either Party, including business plans, strategies, operations, policies, procedures, pricing, techniques, accounts, marketing plans, financial plans and status, and personnel of either Party; provided that such information was designated in writing as "Confidential" or "Proprietary" information at the time of the initial disclosure or by confirmation in writing to the Receiving Party within [ * ] of the initial disclosure and further provided always that, notwithstanding the foregoing, information shall be subject to the obligations set forth herein and constitute Confidential Information, even if not identified or marked as confidential or proprietary, if the Receiving Party knows, or in the exercise of reasonable business

/s/ Henn        /s/ KG
Siegfried        Jazz

19 / 37

judgment should know, such information to be confidential or proprietary to the Disclosing Party. 
		
	10.2
	Each Receiving Party agrees to retain in strict confidence any Confidential Information of the Disclosing Party (or its Affiliates or contractors), whether disclosed prior to, or after the Effective Date and not to use any such Confidential Information for any purpose except pursuant to, and in order to carry out, the terms and objectives of this Agreement, and not to disclose, divulge or otherwise communicate any such Confidential Information to any third party. 

		
	10.3
	The Receiving Party may disclose Confidential Information of the Disclosing Party to its Affiliates or its (or its Affiliate's) officers, directors, employees, agents, consultants, licensees, subcontractors or representatives (each an Entitled Person), who, in each case, (i) need to know such information for purposes of the implementation and performance by the Receiving Party of this Agreement, and (ii) are subject to confidentiality and non-use restrictions covering the Confidential Information that are at least as stringent at those contained herein, provided that the Receiving Party shall, nevertheless, remain fully liable for any breach by any of its Entitled Persons of their confidentiality obligations in respect of the Confidential Information. 

		
	10.4
	Each Party agrees to use with respect to Confidential Information of the other Party at least the same standard of care as it uses to protect proprietary or confidential information of its own of comparable sensitivity and to exercise every reasonable precaution to prevent and restrain the unauthorized disclosure of such Confidential Information by any of its Entitled Persons.

		
	10.5
	The provisions of Section 10.1 shall not apply to any Confidential Information disclosed hereunder which (a) was independently developed or independently known by the Receiving Party prior to its disclosure to the Receiving Party by the Disclosing Party, as evidenced by written or electronic records; or (b) was before or after the date of such disclosure in the public domain or lawfully disclosed to the Receiving Party by an independent, unaffiliated third party rightfully in possession of the Confidential Information and not under any confidentiality obligation with regard to such Confidential Information; or (c) is required to be disclosed by the Receiving Party to the officials of a Regulatory Authority or to comply with applicable laws, to defend or prosecute litigation or to comply with Applicable Law, judicial orders or valid subpoenas, provided that the Receiving Party provides prior written notice of such intended disclosure to the Disclosing Party and takes reasonable and lawful actions to avoid and/or minimize the degree of such disclosure. The burden of proof of the foregoing exceptions shall lie with the Receiving Party. Specific information disclosed as part of the Confidential Information shall not be deemed to be in the public domain or in prior possession of the Receiving Party merely because it is included in more general information in the public domain or in the prior possession of the Receiving Party.

/s/ Henn        /s/ KG
Siegfried        Jazz

20 / 37

		
	10.6
	Except as otherwise expressly stated under this Agreement, nothing herein shall be construed as giving either Party any right, title or interest in or ownership of the Confidential Information of the other Party. 

		
	10.7
	Except as may be required by law or regulation (including securities law and related filings), or in response to a valid subpoena or other judicial order, neither Party shall disclose the terms of this Agreement without the prior written consent of the other Party, which consent shall not be unreasonably withheld, except that the Parties may disclose the terms of this Agreement to the Parties' or third parties' accountants and attorneys, provided any such attorney or accountant receiving information concerning the terms of this Agreement is either bound by professional secrecy or agrees to be bound by confidentiality obligations equal to this Section 10 with respect to such information.

		
	10.8
	The Parties acknowledge that any breach of this Section 10 may constitute irreparable harm, and that the non-breaching Party shall be entitled to seek specific performance or injunctive relief to enforce this Section 10 in addition to whatever remedies such Party may otherwise be entitled to at law.

		
	10.9
	Upon termination or expiration of this Agreement (in whole or in part), each Party shall immediately deliver to the other (and cause any of its Entitled Persons to so deliver), at such Party’s expense, all Confidential Information of the other Party (in the case of partial termination, that relates to the Terminated Product), including without limitation any and all copies, duplications, summaries and/or notes thereof or derived thereof, regardless of the format, and all remaining samples of Product (or, in the case of partial termination, Terminated Product), provided however, that both Parties may keep (i) such original documents, copies and samples as required by law or (ii) one set of such information in its legal files or archives for the sole purpose of monitoring its compliance with its obligations hereunder and neither Party shall be required to delete copies made in routine back up of its information technology systems (if access to such material is limited to members of such Party’s information technology department only). Any information retained by a Party pursuant to this Section 10.9 shall be subject to the confidentiality obligations set forth herein.

		
	11.
	Intellectual Property

		
	11.1
	Siegfried acknowledges that Jazz Confidential Information and Jazz’s Pre-Existing Intellectual Property Rights provided to, utilized or observed by Siegfried pursuant to this Agreement shall be and remain the sole and exclusive property of Jazz.  Likewise, Jazz acknowledges that Siegfried Confidential Information and Siegfried’s Pre-Existing Intellectual Property Rights utilized by Siegfried pursuant to this Agreement shall be and remain the sole and exclusive property of Siegfried.

		
	11.2
	All rights, title, and interest in and to any Arising Intellectual Property Rights shall be the sole and exclusive property of Jazz to the extent any such Arising Intellectual Property Rights (i) incorporate, (ii) are derived from or (iii) relate to any of Jazz’s Pre-Existing

/s/ Henn        /s/ KG
Siegfried        Jazz

21 / 37

Intellectual Property Rights, Jazz Product(s) (including without limitation Product development and use, whether patentable or not, Product Manufacture, manufacturing processes and procedures, Product analytical processes, procedures, methods or results and any route(s) of synthesis) and/or Jazz Confidential Information (Jazz Arising Intellectual Property Rights), and Siegfried hereby assigns, and transfers to Jazz its entire right, title and interest in and to any and all Jazz Arising Intellectual Property Rights. Jazz shall have the sole right to file and seek protection for any Jazz Arising Intellectual Property Rights. During the Term of this Agreement and for a period of [ * ] thereafter, upon request by Jazz and at Jazz’s reasonable expense, Siegfried shall, and shall cause its employees and Affiliates and employees of its Affiliates, to promptly take all reasonable acts and things and execute all documents as Jazz may reasonably request, to transfer, assign and vest in Jazz the ownership and registration of Jazz Arising Intellectual Property Rights, and thereafter Jazz shall be responsible for and shall control, at its sole expense, the preparation, prosecution, maintenance and enforcement of all patent applications, resulting patents, and any other forms of Jazz Arising Intellectual Property Rights. In the event Jazz decides to file and prosecute patent applications on any Jazz Arising Intellectual Property Rights, Siegfried shall provide Jazz with reasonable assistance to obtain and defend such Jazz Arising Intellectual Property Rights at Jazz's reasonable cost and expense.
		
	11.3
	Jazz agrees that, as between Siegfried and Jazz, Siegfried shall own all Arising Intellectual Property Rights of a general nature generated or derived by Siegfried in the course of performing its obligations hereunder which (i) do not incorporate, (ii) are not derived from, (iii) are not specific to or dependent upon and (iv) do not relate in any way, either directly or indirectly, in whole or in part, to (a) Jazz’s Pre-Existing Intellectual Property Rights, (b) Jazz Arising Intellectual Property Rights, (c) Jazz Confidential Information and/or (d) Jazz Product(s) (Siegfried Arising Intellectual Property Rights) and Jazz hereby assigns, and transfers to Siegfried its entire right, title and interest in and to any and all Siegfried Arising Intellectual Property Rights. Siegfried hereby grants Jazz a non-exclusive, worldwide, irrevocable, transferable, royalty-free license to use such Siegfried Arising Intellectual Property Rights to the extent that, and limited to, the development, manufacturing, sale, commercialization or any other use of the Product is dependent upon such license.

		
	11.4
	In the event of patent infringement or regulatory litigation or other legal proceedings, involving the Product, Siegfried shall have the right to suspend further supply of the Product to the extent this is required by a court order or arbitral award or order (whether interim or final). Such suspension shall be deemed a temporary suspension of Siegfried’s supply obligations under this Agreement; provided, that if such suspension continues for more than [ * ], the Parties shall jointly attempt in good faith to modify this Agreement to resolve the situation but if they are unable to do so within the following [ * ] either Party may terminate this Agreement by notice to the other Party.

/s/ Henn        /s/ KG
Siegfried        Jazz

22 / 37

		
	12.
	Term and Termination

		
	12.1
	This Agreement shall become effective on the Effective Date and, unless earlier terminated in accordance with this Section 12 or other applicable term of this Agreement, shall continue in full force and effect until December 31, 2024 (Initial Period). 

		
	12.2
	Unless earlier terminated in accordance with any applicable term of this Agreement, this Agreement shall automatically renew for consecutive periods of one (1) year each unless one of the Parties notifies the other of its election not to renew the Agreement, either in whole or in part, at least eighteen (18) months prior to the end of the Initial Period or the renewal term then in effect, in which case this Agreement shall terminate, either in whole or in part (as the case may be), upon the expiration of such term (Term).  

		
	12.3
	Either Party may terminate the Agreement immediately, by providing written notice to the other Party following the occurrence of any of the following events: 

		
	(a)
	the liquidation or dissolution of the other Party, or the commencement of insolvency procedures or any proceeding under any bankruptcy, insolvency or moratorium law, or any other law or laws for the relief of debtors which proceeding is not dismissed within [ * ], or the appointment of any receiver, trustee or assignee to take possession of the properties of the other Party; 

		
	(b)
	the sale, lease or other disposition of at least seventy-five percent (75%) of the other Party’s business or assets, to a person other than an Affiliate of such Party; or

		
	(c)
	the cessation of all or substantially all of the other Party’s business operations.

		
	12.4
	If a Party breaches a material term or condition of this Agreement, the non-breaching Party shall have the right to terminate this Agreement, either in whole or in part, after [ * ] prior written notice to the other Party unless any such breach is cured within said [ * ]. Termination shall be in addition to all other rights and remedies available to the non-breaching Party at law or in equity.

		
	12.5
	This Agreement may be terminated, in whole or in part, by [ * ] written notice given by Jazz to Siegfried, as follows:  

		
	(a)
	If any required license, permit or certificate of Siegfried is not approved or not issued, or is withdrawn or suspended, by any Regulatory Authority; or

		
	(b)
	If Drug Product is withdrawn or deleted by any Regulatory Authority so that there are no remaining markets available;

		
	(c)
	If Jazz decides to permanently cease the commercialisation of Product.

/s/ Henn        /s/ KG
Siegfried        Jazz

23 / 37

		
	12.6
	This Agreement may be terminated, in whole or in part, by [ * ] written notice given by Siegfried to Jazz, as follows:

		
	(a)
	If Jazz does not commercially launch any Drug Product within [ * ] after receipt of approval from any Regulatory Authority;  

		
	(b)
	If Jazz ceases commercial sale of Drug Product after commercial launch; or 

		
	(c)
	If Jazz does not purchase at least the total volume of Drug Product that requires Siegfried to Manufacture [ * ] of API during any [ * ] period after commercial launch of the Drug Product.

		
	12.7
	Any and all references to termination of this Agreement “in part” or “partial termination” throughout this Agreement shall mean that the applicable Party may, subject to and in accordance with the provisions of this Agreement, terminate this Agreement solely in respect of the Manufacture and supply of either (i) the API or (ii) the Drug Product (hereinafter referred to as the “Terminated Product”), in which case:

		
	(a)
	the Agreement shall be terminated solely in respect of the Terminated Product;

		
	(b)
	the Agreement shall continue in full force and effect in respect of the other non-terminated Product(s) (the “Non-Terminated Product”); 

		
	(c)
	the provisions of the Agreement (including, without limitation, all applicable references to “Product”) shall be construed accordingly; and

		
	(d)
	for the avoidance of doubt, the terms of Section 2.3 shall apply accordingly solely in respect of the Non-Terminated Product and Jazz shall have no further obligations pursuant thereto in respect of the Terminated Product.

		
	12.8
	Upon expiration or termination of this Agreement, in whole or in part, Siegfried shall have the right to deliver to Jazz (and Jazz shall have the obligation to take delivery of) all Product (or, in the case of partial termination, all Terminated Product) already Manufactured by Siegfried pursuant to any Order and the remaining Materials that relate to the Terminated Product maintained by Siegfried pursuant to Section 5 and Jazz shall pay the price for such Products or Terminated Product (as the case may be) or Materials, provided however, that Siegfried uses commercially reasonable efforts to limit such loss of Materials.

		
	12.9
	Neither the expiration nor the termination of this Agreement, in whole or in part, shall relieve the Parties of their obligations (in the case of partial termination, as they relate to the Terminated Product) incurred prior to such expiration or termination. All provisions that, by their express or implied terms, are meant to survive termination of the Agreement, in particular all rights and obligations set forth in Sections 8 (Compensation and Terms of Payment), 10 (Confidential Information), 11 (Intellectual Property), 14.1 (Liability and Indemnity), 16 (Miscellaneous) and 17 (Applicable Law and Dispute Resolution) shall continue irrespective of such termination. 

/s/ Henn        /s/ KG
Siegfried        Jazz

24 / 37

		
	12.10
	At all times during the Term, Jazz shall have the right to make Product and to have Product made by an Affiliate or third party manufacturer (Alternative Manufacturer) on its behalf, subject to the terms and conditions of this Agreement, including, without limitation Sections 2.3 (Purchase Commitment), 10 (Confidentiality), and 11 (Intellectual Property). Prior to appointing such an Alternative Manufacturer, Jazz and Siegfried shall, without delay, confer and discuss in good faith if and how any Affiliate of Siegfried may be appointed as alternative manufacturing site.

		
	12.11
	In the event Jazz intends to engage an Alternative Manufacturer at any time (including during the Term or upon termination of this Agreement in whole or in part), Siegfried shall, at the request of Jazz and subject to Jazz’s reasonable cooperation, provide documents already prepared by Siegfried as may be necessary or helpful for the technology transfer of the manufacturing process for Product and the regulatory qualification to Jazz or the Alternative Manufacturer (including all know-how necessary or reasonably useful to enable Jazz or the Alternative Manufacturer to manufacture Product), provided that Siegfried will not be required to (i) prepare, translate or otherwise generate documents, unless otherwise agreed by Siegfried (acting reasonably ) and at Jazz’ reasonable costs and expenses, (ii) provide Siegfried Confidential Information, or (ii) grant licenses to Siegfried Pre-Existing Intellectual Property Rights or Siegfried Arising Intellectual Property Rights to a third party Alternative Manufacturer.

		
	12.12
	In the event of transfer to Jazz or its Affiliate, at the request of Jazz and subject to Jazz’s reasonable cooperation, the Parties shall confer and discuss a technology transfer plan prepared by Jazz and agreed by Siegfried (such agreement not to be unreasonably withheld, conditioned or delayed), including applicable fees (Jazz Technology Transfer Plan). Such Jazz Technology Transfer Plan may, as applicable, provide for reasonable technical assistance regarding the manufacture, testing and supply of Product, including access to technical personnel, as may be helpful for Jazz or its Affiliate to implement such process to manufacture Product. Subject to Siegfried’s approval and consent of the scope of the Jazz Technology Transfer Plan and cost and expenses therefore (such approval and consent not to be unreasonably withheld, conditioned or delayed), Siegfried shall implement the Jazz Technology Transfer Plan and Jazz shall reimburse Siegfried for all reasonable costs and expenses incurred by Siegfried to conduct such technology transfer and technical assistance, unless otherwise mutually agreed in writing.  

		
	13.
	Representations and Warranties

		
	13.1
	Each Party represents and warrants to the other Party (i) that it has the legal power, authority and right to enter into this Agreement and to perform its respective obligations set forth herein, (ii) that this Agreement has been duly executed and delivered by each Party and constitutes the valid and binding obligation of such Party, enforceable against such Party in accordance with its terms, and (iii) the execution, delivery and performance by such Party of this Agreement and its compliance with the terms hereof does not and will not conflict with or result in a breach of any term of, or constitute a 

/s/ Henn        /s/ KG
Siegfried        Jazz

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default under (i) any agreement or instrument binding or affecting it or its property; (ii) its charter documents or bylaws; or (iii) any order, writ, injunction or decree of any court or governmental authority entered against it or by which any of its property is bound. 
		
	13.2
	Siegfried represents, warrants and covenants to Jazz that all Product Manufactured pursuant to this Agreement shall conform with Specifications, Applicable Law and the Master Batch Record upon delivery and all Product has been Manufactured in accordance with cGMP and the material provisions of the Quality Agreement.

		
	13.3
	Jazz represents, warrants and covenants that the Technology and the Consigned Materials provided to Siegfried by or on behalf of Jazz hereunder, and used by Siegfried for the performance of its obligations in accordance with the terms of this Agreement and Jazz’s instructions, does not infringe or misappropriate and, to the best of Jazz’ knowledge, will not infringe or misappropriate the Intellectual Property Rights of any third party.

		
	13.4
	EXCEPT AS EXPRESSLY WARRANTED IN THIS AGREEMENT, NEITHER PARTY EXTENDS ANY OTHER WARRANTIES OR REPRESENTATIONS COVERING THE PRODUCT OR THE TECHNOLOGY, EXPRESS OR IMPLIED, AND EACH PARTY EXPRESSLY DISCLAIMS ALL IMPLIED WARRANTIES, INCLUDING THE WARRANTY OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. EACH PARTY’S LIABILITY UNDER THESE WARRANTY PROVISIONS SHALL BE STRICTLY LIMITED TO THE REMEDIES PROVIDED FOR UNDER THIS AGREEMENT.

		
	14.
	Liability and Indemnity

		
	14.1
	If Siegfried is unable to meet the delivery dates or other agreed time lines regarding the delivery of Product, or in case Product does not comply with Specifications, Applicable Law, cGMP or the Quality Agreement upon delivery and is rejected by Jazz (acting reasonably) in accordance with Section 4, Siegfried shall promptly, at Jazz’s election: (i) for delayed delivery, use all commercially reasonable efforts to deliver the delayed Product as soon as possible after the original delivery date (or such later date as may be agreed by Jazz, acting reasonably), at no additional cost to Jazz and Siegfried shall bear the reasonable and documented transport costs for expedited delivery; (ii) for non-conforming Product, (a) replace any rightfully rejected Product with conforming Product as soon as possible (or such later date as may be as agreed by Jazz, acting reasonably) at no additional cost to Jazz or, if delivery of conforming Product is not possible within reasonable additional time, Siegfried shall refund to or credit Jazz all amounts paid by Jazz to Siegfried for such rightfully rejected Product, and (b) Siegfried shall bear the reasonable and documented transport, packaging, and destruction costs for such non-conforming Product. As agreed by the parties pursuant to Section 2.3, and upon Jazz’ written notification as per Section 2.3, Jazz may temporally purchase (i) more than forty-percent (40%) of its requirements of API and/or (ii) more than sixty-percent (60%) of its requirements of Drug Product from other suppliers without constituting a breach of its 

/s/ Henn        /s/ KG
Siegfried        Jazz

26 / 37

obligations under Section 2.3 and without any penalty, surcharge or Volume Shortfall payment being due or owing (pursuant to Section 2.3a) or 2.3b)). Except in the case of Siegfried’s gross negligence or willful misconduct, and with the exception of the remedy set forth under Section 14.2 below, such delivery, replacement, credit or refund shall be the only remedy available to Jazz in case of late deliveries or non-conforming Product.
		
	14.2
	If Siegfried fails to deliver conforming Drug Product within a grace period of [ * ] after the original delivery date on [ * ] consecutive occasions within [ * ] (excluding, without limitation, due to any Force Majeure Event or any reason caused due to an act or omission of Jazz) (Delivery Shortfall), Jazz shall be entitled to terminate this Agreement, either in whole or in part, upon [ * ] written notice to Siegfried. 

		
	14.3
	Siegfried shall indemnify, defend and hold Jazz, its directors, officers, employees and Affiliates, harmless against all Losses arising out of or in connection with third party claims, suits, actions, demands or judgments to the extent arising out of (i) the breach of any of Siegfried's obligations, warranties or representations under this Agreement, except to the extent such Losses are caused by Jazz’s negligence or willful misconduct. 

		
	14.4
	Jazz shall indemnify, defend and hold Siegfried, its directors, officers, employees and Affiliates harmless against all Losses, arising out of or in connection with third party claims, suits, actions, demands or judgments to the extent arising out of (i) the breach of any of Jazz's obligations, warranties or representations under this Agreement, of (ii) the death of or injury to any person or any damage to property caused by Jazz’ commercialization or use of Product except to the extent such Losses are caused by Siegfried's negligence or willful misconduct.

		
	14.5
	With respect to any indemnification obligation under this Agreement, the following conditions shall be applicable: 

		
	(a)
	The Party seeking to be indemnified shall notify the indemnifying Party promptly in writing of any claim which may give rise to an obligation on the part of the indemnifying Party hereunder; and

		
	(b)
	the indemnifying Party shall be allowed to timely take the sole control of the defense of any such action and claim, including all negotiations for the settlement, or compromise of such claim or action at its sole expense; and

		
	(c)
	the Party to be indemnified shall, at the expense of the indemnifying Party, render reasonable assistance, information, co-operation and authority to permit the indemnifying Party to defend such action; and 

		
	(d)
	no settlement or compromise shall be binding on a Party hereto without its prior written consent, which consent shall not be unreasonably withheld, conditioned or delayed.

/s/ Henn        /s/ KG
Siegfried        Jazz

27 / 37

		
	14.6
	During the Term of this Agreement, Siegfried and Jazz shall each obtain and carry in full force and effect adequate commercial, general liability insurance as common in the industry, including product liability insurance, which shall protect the Parties with respect to liability claims covered by Sections 14.3 and 14.4. Such insurance shall be written by a reputable insurance company and shall be endorsed to include product liability coverage. A Party shall provide another Party on request with a copy of certificates of insurance evidencing the same.

		
	14.7
	NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR SPECIAL, PUNITIVE, INCIDENTAL, INDIRECT (EXCEPT WITH RESPECT TO THE INDEMNIFICATION AGAINST CLAIMS OF THIRD PARTIES UNDER SECTION 14), OR CONSEQUENTIAL DAMAGES OF THE OTHER PARTY OR ANY THIRD PARTY, INCLUDING BUT NOT LIMITED TO CLAIMS BASED ON LOST PROFITS, LOSS OF TIME, LOSS OF OPPORTUNITY OR ANY OTHER ECONOMIC LOSS SUFFERED OR INCURRED AS A RESULT OF THIS AGREEMENT.

		
	14.8
	WITH THE EXCEPTION OF ANY LIABILITY ARISING DUE TO GROSS NEGLIGENCE, FRAUD, WILFUL MISCONDUCT OR BREACH OF SECTION 10 (CONFIDENTIAL INFORMATION) OR SECTION 11 (INTELLECTUAL PROPERTY) HEREOF, AND IF AND TO THE EXTENT PERMITTED BY APPLICABLE LAW, EACH PARTY'S MAXIMUM LIABILITY UNDER THIS AGREEMENT SHALL BE LIMITED TO [ * ]. 

		
	15.
	Anti-Bribery and Anti-Corruption

		
	15.1
	Each Party shall comply fully at all times with all applicable laws and regulations, including without limitation any applicable anti-corruption laws, regulations and standards, of the territories in which Jazz or Siegfried, respectively, conduct business or activities hereunder or which are relevant to the operation of this Agreement (including but not limited to the U.S. Foreign Corrupt Practices Act and the U.K. Bribery Act 2010) (collectively, the Anti-Corruption Laws). Each Party will ensure that its personnel have read, understood and shall comply with the Anti-Corruption Laws.

		
	15.2
	Each Party shall at all times comply with their respective code of conducts. Any non-compliance of the Anti-Corruption Laws or otherwise relevant in connection with this Agreement shall be reported to the other Party without any delay. Siegfried acknowledges that Jazz’s Code of Conduct is available online at www.jazzpharmaceuticals.com or will be handed out as a hard copy upon request. Jazz acknowledges that Siegfried’s Code of Business Conduct is available online at www.siegfried.ch or will be handed out as a hard copy upon request. 

		
	15.3
	Without limiting its obligations under Sections 15.1 and 15.2, each Party agrees that it has not, and covenants that it will not, in connection with the performance of this Agreement, promise, authorize, ratify or offer to make, or take any act in furtherance of any payment or transfer of anything of value, directly or indirectly: (i) to any individual 

/s/ Henn        /s/ KG
Siegfried        Jazz

28 / 37

including Government Officials; or (ii) to an intermediary for payment to any individual including Government Officials; or (iii) to any political party. For the purpose of this Section, “Government Official” means: (a) any officer or employee of a government or any department, agency or instrument of a government: (b) any person acting in an official capacity for or on behalf of a government or any department, agency, or instrument of a government; (c) any officer or employee of a company or business owned in whole or part by a government; (d) any officer or employee of a political party or any person acting in an official capacity on behalf of a political party; and/or (f) any candidate for political office.
		
	15.4
	Without limiting its obligations under Sections 15.1 and 15.2, each Party agrees and covenants that no payments or transfers of value shall be made, promised, authorized, ratified or offered with the purpose or effect of public or commercial bribery, acceptance of or acquiescence in extortion, kickbacks or other unlawful or improper means of securing an improper advantage or obtaining or retaining business.

		
	15.5
	Each Party agrees and covenants that it has not permitted and will not permit anyone acting on its behalf to violate the Anti-Corruption Laws.

		
	16.
	Miscellaneous

		
	16.1
	No set-off. Neither Party shall be entitled to set off any of its rights or obligations under this Agreement against the rights or obligations of another Party without having first obtained the prior written consent of that other Party. 

		
	16.2
	Sub-contracting. Other than laboratory services as is necessary, Siegfried shall not be permitted to subcontract Manufacturing under this Agreement to any third party (other than certain activities hereunder to Siegfried Malta), without Jazz’s prior written consent. If a subcontractor is appointed by Siegfried, Siegfried shall be responsible for all work performed by, and all acts, omissions and breaches of, such subcontractor as if performed or made by itself. 

		
	16.3
	Force Majeure. A Party shall be excused from performing its obligations under this Agreement (other than obligations of payment) to the extent that its performance is delayed or prevented by any cause beyond such Party’s reasonable control, including, but not limited to, act of God (such as extreme weather), fire, (naturally caused) flood, explosion, disease, war, insurrection, civil strike, riots, government action power failure or energy shortages (Force Majeure Event). Performance shall be excused only to the extent of and during the reasonable continuance of such disability. Any deadline or time for performance specified in this Agreement that falls due during or subsequent to the occurrence of any of the disabilities referred to herein shall be automatically extended for a period of time equal to the period of such disability. The prevented Party shall immediately notify the other Party if, by reason of any Force Majeure Event, the prevented Party is unable to meet any deadline or time for performance specified in this Agreement. In the event that such Force Majeure Event cannot be removed or 

/s/ Henn        /s/ KG
Siegfried        Jazz

29 / 37

overcome within [ * ] (or such other period as the Parties jointly shall determine) from the date the Party affected first became affected, then the non-prevented Party may at any time after the expiration of such period, by written notice to the other Party, either (i) suspend this Agreement, in whole or in part, for as long as such Force Majeure Event continues to exist, or (ii) terminate this Agreement, in whole or in part, with immediate effect.
		
	16.4
	Precedence of Agreement. Unless expressly agreed otherwise in writing, the terms outlined in this Agreement shall prevail over any terms and conditions outlined in any Order or Order Confirmation for Product and any general terms and conditions of a Party, and such terms and conditions are hereby expressly excluded. In case of discrepancies between this Agreement and an Annex hereto, the provisions of this Agreement shall prevail.

		
	16.5
	No assignment. This Agreement is binding upon and shall inure to the benefit of the Parties hereto and their successors and permitted assigns. This Agreement and any rights or obligations hereunder may be assigned or delegated only (i) with the consent of the other Party, not to be unreasonably withheld, conditioned or delayed, or (ii) by Jazz to its Affiliates or to the successor to all or substantially all of the business of Jazz (whether by merger, consolidation, asset transfer or similar transaction) to which this Agreement relates. Any other assignment or delegation by either Party without the prior written consent of the other Party is void.

		
	16.6
	No waiver. The failure by either Party at any time to enforce any of the terms, provisions or conditions of this Agreement or to exercise any right hereunder shall not constitute or be construed to constitute a waiver of the same or affect that Party's rights thereafter to enforce or exercise the same. 

		
	16.7
	Independent Parties. Nothing in this Agreement shall be deemed or construed to constitute or create between the Parties hereto a partnership, joint venture, agency, or other relationship other than as expressly set forth herein. Neither Party shall have authority to speak for, represent or obligate the other Party in any way without prior written consent of the other Party.

		
	16.8
	Entire Agreement. This Agreement (together with the Quality Agreement) contains the full understanding of the Parties with respect to the subject matter hereof and supersedes all prior understandings and writings relating thereto (other than, for the avoidance of doubt, the Master Development Services Agreement and any Confidential Disclosure Agreement executed by the Parties and/or their Affiliates, each of which shall remain in full force and effect in accordance with its respective terms). No waiver, alteration or modification of any of the provisions hereof shall be binding unless made in writing and signed by the Parties.

		
	16.9
	Severability. If any portion of this Agreement is held invalid by a court of competent jurisdiction, such portion shall be deemed to be of no force and effect and this Agreement shall be construed as if such portion had not been included herein, provided 

/s/ Henn        /s/ KG
Siegfried        Jazz

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however, if the deletion of such provision materially impairs the commercial value of this Agreement to either Party, the Parties shall attempt to renegotiate such provision in good faith. The fact that any provision of this Agreement shall be prohibited or unenforceable in any jurisdiction shall not invalidate or render unenforceable such provision in any other jurisdiction. To the extent permitted by applicable law, the Parties to this Agreement waive any provision of law that renders any provision of this Agreement prohibited or unenforceable in any respect.
		
	16.10
	Notices. Any notice required under this Agreement shall be effective only if it is in writing and (i) delivered in person or (ii) deposited with a nationally recognized overnight courier service, or (iii) sent by registered mail or (iv) dispatched by e-mail (pdf), in which case such notice is to be confirmed by registered mail within [ * ]; in either case any notice is to be addressed to the applicable address set forth below or any other address as designated by either Party.

	
			
	 
	if to Siegfried
	Siegfried AG 
Untere Brühlstrasse 4, 4800 Zofingen, Switzerland 
Attention: [ * ] 
Email: [ * ]

	 
	with a copy to:
	Siegfried AG 
Untere Brühlstrasse 4, 4800 Zofingen, Switzerland 
Legal Department 
Email: [ * ]

	 
	if to Jazz:
	Jazz Pharmaceuticals Ireland Limited 
Waterloo Exchange, Waterloo Road, Dublin 4, Ireland 
Attention: Legal Department 
Fax/e-mail: [ * ]

Either Party may change the above addresses, but no such change shall have any effect until the other Party has been properly notified with written notice of the change of the address.
		
	16.11
	Compliance with Laws. Each Party shall comply with all Applicable Law governing its performance of the terms of this Agreement, including, but not limited to, those relating to health, safety and the environment, fair labor practices, unlawful discrimination, debarment, supply chain transparency and modern slavery, anti-corruption and anti-bribery laws.

		
	16.12
	Hardship. If during the Term of this Agreement, the performance of the Agreement should lead to unreasonable hardship for the one or the other Party, both Parties shall undertake reasonable endeavors to discuss in good faith a possible amicable resolution or possible amendment to this Agreement in light of the change in circumstances; provided always, however, that (i) neither Party shall have any obligation to amend this Agreement or to waive or modify any of its rights under this Agreement and (ii) 

/s/ Henn        /s/ KG
Siegfried        Jazz

31 / 37

notwithstanding any claim of unreasonable hardship by a Party pursuant to this Section 16.12, each Party shall remain fully liable for the performance of its obligations and duties under this Agreement unless and until, and only to the extent that, the Parties mutually agree in writing to alter or modify such obligations or duties by amending the provisions hereof (which alteration or modification shall only be binding if made in writing and signed by both Parties in accordance with the terms of this Agreement).
		
	17.
	Applicable Law and Dispute Resolution

		
	17.1
	This Agreement shall be governed by German laws without regard to its conflict of laws provisions and the provisions of the UN Convention regarding Contracts on the International Sale of Goods (Vienna Convention). 

		
	17.2
	All disputes arising out of or in connection with this Agreement, including disputes on its conclusion, binding effect, amendment or termination, shall be resolved exclusively by arbitration in accordance with the Arbitration Rules of the German Arbitration Institute (DIS) in force on the date on which the Notice of Arbitration is submitted in accordance with these Rules, agree as follows:

		
	a)
	The number of arbitrators shall be three (3).

		
	b)
	The seat of the arbitration shall be Hannover, Germany.

		
	c)
	The arbitral proceedings shall be conducted in English. 

		
	17.3
	Notwithstanding any other provision of this Agreement, each Party shall still be entitled to access the courts in Hannover, Germany, to obtain appropriate injunctive relief.

[remainder of page intentionally left blank]

/s/ Henn        /s/ KG
Siegfried        Jazz

32 / 37

List of Annexes

	
			
	Annex
	Description
	Content

	1.1
	API
	Description of API

	1.2
	Drug Product
	Description of Drug Product

	1.3
	Key Material
	Description of Key Material

	1.4
	Commercial Terms
	Price, MOQ and other commercial terms

Intending to be bound by the provisions hereof, each of the parties hereto have caused this Agreement to be executed personally or by its duly authorized representative, to be effective as of the Effective Date.

	
				
	Siegfried AG
	 
	 
	 

	 
	 
	 

	   /s/   Luca Parlanti
	   /s/   Marco Henneböhle
	 

	Name / function 
	Name / function
	 

	Dr. Luca Parlanti
	Dr. Marco Henneböhle
	 

	Head of Exclusive Sales
	Director Business Development
	 

	Drug Substance
	Exclusive Synthesis Europe
	 

	Siegfried AG
	Siegfried AG
	 

	 
	 
	 

	 
	 
	 

	Jazz Pharmaceuticals Ireland Limited
	 
	 

	 
	 
	 

	/s/ Kathleen Gibbons
	 
	 

	Name / function
	 
	 

	 
	 
	 

	Kathleen Gibbons
	 
	 

	VP, Finance
	 
	 

/s/ Henn        /s/ KG
Siegfried        Jazz

33 / 37

ANNEX 1.1 - API

[ * ]

/s/ Henn        /s/ KG    
Siegfried        Jazz

34 / 37

ANNEX 1.2 – Drug Product
[ * ]

/s/ Henn        /s/ KG
Siegfried        Jazz

35 / 37

ANNEX 1.3 - Key Material 
[ * ]

/s/ Henn        /s/ KG
Siegfried        Jazz

36 / 37

ANNEX 1.4 – Commercial Terms 
[ * ]

/s/ Henn        /s/ KG
Siegfried        Jazz

37 / 37

[ * ]

/s/ Henn        /s/ KG
Siegfried        Jazz

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