ROYALTY PURCHASE AGREEMENT
AMPHASTAR PHARMACEUTICALS, INC.
DRUG ROYALTY USA, INC.
|1.3||Number and Gender||1|
|1.5||Applicable Law and Attornment||1|
|ARTICLE 2||INVESTMENT AND ROYALTY INTEREST||2|
|2.2||Payment of Royalty Interest||2|
|2.4||Additional DRC Default Rights||4|
|ARTICLE 3||REPRESENTATIONS AND WARRANTIES||5|
|3.1||Representations and Warranties of Amphastar||5|
|3.1.2||The Financial Statements||5|
|3.1.4||Absence of Changes||6|
|3.1.6||Absence of Conflicting Agreements||7|
|3.1.7||Consents and Approvals||8|
|3.1.8||Compliance with Applicable Law||8|
|3.1.15||Supply and Manufacture of API||9|
|3.2||Representations and Warranties of DRC||10|
|3.2.2||Absence of Conflicting Agreements||10|
|3.2.3||Consents, Approvals, Etc||11|
|3.5||Survival of Representations and Warranties||11|
|3.6||Meaning of Knowledge Qualification||11|
|4.1||Covenants During the Term||12|
|5.2||Deliveries by DRC||16|
|5.3||Deliveries by Amphastar||16|
|5.7||Failure to Satisfy Conditions||17|
|6.1||Mutual Indemnifications for Breaches of Warranty, etc||17|
|6.2||Third Party Claims||18|
|6.3||Agency for Representatives||18|
|7.2||Remedies Cumulative and Waivers||19|
|7.3||Performance on Holidays||19|
|7.4||Financial Reporting Standards||19|
|7.14||Third Party Beneficiary||22|
|7.18||Waiver of Jury||22|
|7.19||Service of Process||22|
THIS AGREEMENT is made and entered into as of the 5th day of August, 2003 by and between AMPHASTAR PHARMACEUTICALS, INC., a subsisting California corporation ("Amphastar"), and DRUG ROYALTY USA, INC., a subsisting Nevada corporation ("DRC").
NOW, THEREFORE, in consideration of the premises, the mutual covenants in this Agreement and of other good and valuable consideration (the receipt and sufficiency of which are hereby acknowledged), the Parties agree as follows:
All defined terms denoted by a capital letter have the meanings ascribed to them as set forth in Schedule A hereto.
The division of this Agreement into Articles, Sections, Subsections and Schedules and the insertion of headings are for convenience of reference only and shall not affect the construction or interpretation of this Agreement. The Article, Section, Subsection and Schedule headings in this Agreement are not intended to be full or precise descriptions of the text to which they refer and are not to be considered part of this Agreement.
1.3 Number and Gender
In this Agreement, words in the singular include the plural and vice-versa and words in one gender include all genders.
1.4 Entire Agreement
This Agreement, together with the Closing Documents, constitute the entire agreement between the Parties pertaining to the subject matter hereof and supersede all prior agreements, negotiations, discussions and understandings, written or oral including the Confidentiality Agreement. There are no representations, warranties, conditions, other agreements or acknowledgements, whether direct or collateral, or express or implied, that form part of or affect this Agreement, or which induce any Party to enter into this Agreement or on which reliance is placed by any Party, except as specifically set forth in this Agreement or in the Closing Documents.
1.5 Applicable Law and Attornment
The validity, interpretation and enforcement of this Agreement shall be governed by the laws of the State of New York without giving effect to conflict of law principles. The Parties irrevocably attorn and submit to the non-exclusive jurisdiction of the courts of the State of New York with respect to any matter arising hereunder or related hereto.
Each Party irrevocably waives:
Each Party agrees that a final judgment in any litigation commenced in any court of the State of New York shall be conclusive and may be enforced in any other jurisdiction by suit on the judgment or in any other manner provided by law.
Unless specified otherwise, all statements of or references to monetary amounts in this Agreement are to US Dollars.
The following Schedules form part of this Agreement:
||Description of Schedule
|C||Representations and WarrantiesDisclosure|
|D||Form of Security Agreement|
Neither Party shall be or be deemed to be the drafter of this Agreement for the purposes of construing this Agreement against one Part or the other.
INVESTMENT AND ROYALTY INTEREST
2.1 DRC Investment
Subject to the provisions of this Agreement and to Closing, Amphastar agrees to pay to DRC the Royalty Interest in accordance with the terms hereof and such other amounts as provided herein in consideration of the payment of $8 million by DRC to Amphastar on Closing (the "Invested Amount").
2.2 Payment of Royalty Interest
(collectively, the "Royalty Interest"). Subject to Section 2.2(g) and Section 2.4, for avoidance of doubt, no royalty shall be paid to DRC in respect of any Net Sales of Cortrosyn in excess of $7.5 million per Quarter.
2.4 Additional DRC Default Rights
In the event that Amphastar fails to pay Organon the balance of the purchase price of $12,000,000 when due in accordance with Section 4.1(b) and (c) of the Sale Agreement and DRC pays to Organon the amount of purchase price not paid by Amphastar (the "Additional Invested Amount") then in addition to and not in substitution for any rights and remedies of DRC under this Agreement, the Security Agreement, at law or in equity:
REPRESENTATIONS AND WARRANTIES
3.1 Representations and Warranties of Amphastar
Amphastar represents and warrants to DRC as of the date of this Agreement as follows and acknowledges that DRC is relying on such representations and warranties in entering into this Agreement:
3.1.1 Corporate Matters
3.1.2 The Financial Statements
The Financial Statements:
As at the date hereof, Amphastar is not aware of any information that would render the Financial Statements incomplete or inaccurate in any material respect.
3.1.3 Undisclosed Liabilities
Amphastar and its Affiliates have no material liabilities of any kind except:
3.1.4 Absence of Changes
Since December 31, 2002:
3.1.5 Material Contracts
3.1.6 Absence of Conflicting Agreements
None of the execution and delivery of, or the observance and performance by Amphastar of, any covenant or obligation under this Agreement or any Closing Document to which it is a party or the consummation of any of the transactions contemplated thereby:
No consent, approval, license, order or authorization, registration, declaration or filing with or of any Governmental Agency or other Person is required by Amphastar or its Affiliates, in connection with:
3.1.8 Compliance with Applicable Law
Each of Amphastar and each of its Affiliates has conducted and is conducting its business in compliance with all Applicable Laws, and not in breach of any Applicable Laws. Each of Amphastar and each of its Affiliates is in good standing in all jurisdictions where it is required to be registered, licensed or otherwise qualified due to the nature, location or character of its business and assets (including the Purchased Assets), including in each state, district, commonwealth and territory of the United States of America.
Except as disclosed in the Financial Statements, there is no claim, demand, suit, action, cause of action, dispute, proceeding, litigation, investigation, grievance, arbitration, governmental proceeding or other proceeding including appeals and applications for review, in progress against or affecting Amphastar or any of its Affiliates which could reasonably be expected to result in any Material Adverse Financial Change of Amphastar and its Affiliates taken as a whole or relating to Cortrosyn or any of the Product Rights or Intellectual Property, nor are any of the same pending or, to the best of Amphastar's knowledge, threatened. There is not presently outstanding against Amphastar or any of its Affiliates any judgment, decree, injunction, rule, order or award of any court, Governmental Agency or arbitrator that may adversely affect Amphastar or any of its Affiliates or Amphastar's right or ability to manufacture, market, sell or distribute Cortrosyn or the ownership or rights of Amphastar to any of the Product Rights or Intellectual Property.
3.1.10 Purchased Assets
Amphastar is the owner of the Purchased Assets including the Product Rights and Intellectual Property, with good and marketable title thereto, free and clear of all Encumbrances other than the security granted to Organon under the Organon Security Agreement and to DRC under the Security Agreement.
3.1.11 Royalty Interest
Amphastar is entitled to grant and pay the Royalty Interest to DRC as herein contemplated. There has been no sale, conveyance, assignment or granting of any license or any royalties or similar rights to or the creation of any Encumbrance on or in respect of the Royalty Interest, the Product Rights, Intellectual Property, the Acquisition Agreements or the Collateral as defined in and under the Security Agreement in favor of any other Person except for the Royalty Interest to DRC contemplated by this Agreement; the security granted to Organon under the Organon Security Agreement and as set forth in Schedule C.
3.1.12 No Options
No Person other than Organon, by virtue of the Organon Security Agreement and DRC has any agreement, option, warrant or right, or any right capable of becoming any of the foregoing, for the purchase of all or any of Amphastar's right, title or interest in Cortrosyn or any of the Acquisition Agreements, the Product Rights or Intellectual Property.
Amphastar has no current proposal or intention to abandon or delay the marketing, sales and distribution of Cortrosyn nor is it aware of any existing circumstance, event or condition which could have a material adverse effect on the marketing, sales and distribution of Cortrosyn.
3.1.14 Intellectual Property
3.1.15 Supply and Manufacture of API
Organon has agreed to cause Diosynth Inc. or its affiliates to supply to Amphastar and its affiliates or any other party designated by Amphastar the API for the manufacture and sale of the Product (as
such term is defined in the Acquisition Agreements) at a price of $180.00 per gram for a period of five (5) years beginning on June 26,2003 in accordance with the terms of the Acquisition Agreements. Organon has agreed to manufacture the Product for Amphastar at a price of $2.70 per vial (subject to adjustment) for a period of three (3) years beginning on June 26, 2003 in accordance with the terms of the Acquisition Agreements. Pursuant to the Acquisition Agreements, Organon has agreed not to sell any Product to any party (other than Amphastar, its affiliates and designates) in the Territory or to any party outside the Territory for sale, distribution or delivery into the Territory.
No representation or warranty made by Amphastar in this Agreement contains any untrue statement of a material fact or omits to state any material fact necessary to make any such representation or warranty not misleading to a prospective investor seeking full information as to Amphastar, Cortrosyn and the Intellectual Property.
3.2 Representations and Warranties of DRC
DRC represents and warrants to Amphastar as of the date of this Agreement as follows and acknowledges that Amphastar is relying on such representations and warranties in entering into this Agreement:
3.2.1 Corporate Matters
3.2.2 Absence of Conflicting Agreements
None of the execution and delivery of, or the observance and performance by DRC of, any covenant or obligation under this Agreement or any Closing Document to which it is a party or the consummation of the transactions contemplated thereby contravenes or results in, or will contravene or result in, a violation of or a default under (with or without the giving of notice or lapse of time, or both) or in the acceleration of any obligation under:
3.2.3 Consents, Approvals, Etc.
No consent, approval, license, order or authorization, registration, declaration or filing with or of any Governmental Agency or other Person is required by DRC, in connection with:
Each Party represents and warrants to the other that the other Party will not be liable for any brokerage commission, finder's fee or other like payment in connection with the transactions contemplated hereby because of any action taken by, or agreement or understanding reached by, that Party.
No investigations made by or on behalf of DRC at any time shall waive, diminish the scope of or otherwise affect any representation or warranty made by Amphastar herein or pursuant hereto. The acceptance by DRC of any payment in respect of the Royalty Interest shall be deemed not to be a waiver of any of its rights hereunder.
3.5 Survival of Representations and Warranties
All representations and warranties, made by any Party in this Agreement or in any Closing Document shall survive the Closing, until the expiration of the Term. After such period, neither Party shall have any further liability hereunder with respect to such representations and warranties except with respect to Claims properly made within such period.
3.6 Meaning of Knowledge Qualification
Where any representation or warranty contained in this Agreement is expressly qualified by reference to the "knowledge of Amphastar" or to the "best of the knowledge and belief of Amphastar", it shall be deemed to refer to the knowledge of any director or responsible senior officer of Amphastar and the knowledge which Amphastar would have had if it had conducted a diligent inquiry into the relevant subject matter. Amphastar confirms to DRC that at least one responsible senior officer of Amphastar has made due and diligent inquiry of such Persons as he or she reasonably considers necessary as to the matters that are the subject of such representations and warranties.
4.1 Covenants During the Term
Amphastar covenants and agrees with DRC that, subject to Closing, during the Term, Amphastar shall, at its own expense, act as follows:
If so requested by DRC, senior officers of Amphastar shall, up to four times annually (but not more than once in any Quarter) meet with representatives of DRC at a mutually convenient time and place. At such meetings, Amphastar shall be prepared to discuss matters relating to Cortrosyn and the Intellectual Property (and if requested by DRC provide copies of the relevant documentation), including, if any, product development plans, business plans, budget, expansion activities, comparison to forecast, financial results and projections, patent filings, licensing agreements, co-promotion agreements, distribution agreements, sales agreements, purchase orders, sales and marketing activities pertaining to Cortrosyn and the Intellectual Property. Amphastar shall also provide DRC with timely information pertaining to Cortrosyn with respect to all correspondence with or from the FDA.
Amphastar shall provide to DRC:
Amphastar acknowledges and agrees that all financial statements shall be prepared in accordance with GAAP and that the information and materials provided to DRC under clause (i), (ii), (iii) and (iv) may be disclosed or provided to DRC's secured lenders and investors provided such secured lenders and investors enter into a confidentiality agreement pertaining to such information and materials.
If so requested by DRC, DRC shall annually have the right, but not the obligation, to audit Amphastar's books and records and other supporting documentation pertaining to Net Sales of Cortrosyn for any calendar year not previously audited by DRC. Such audit shall be conducted by a recognized accounting firm of DRC's choice. DRC shall give Amphastar reasonable notice prior to having such an audit performed and such audit shall be conducted
during regular working hours at Amphastar. Such audit shall be for DRC's account unless the Royalty Interest paid in such period is less than 97% of the royalties due to DRC as calculated pursuant to the audit, in which case Amphastar shall pay for the out-of-pocket cost of the audit. Any shortfall in royalties payable to DRC that is discovered as a result of such audit shall be included in the Royalty Interest, and shall be payable to DRC within 3 Business Days of such audit.
Amphastar shall on or before Closing execute and deliver a security agreement, substantially in the form of security agreement attached at Schedule D hereto, in favor of DRC as general continuing collateral security for all present and future obligations of Amphastar under this Agreement (the "Security Agreement"), all on the terms set forth in the Security Agreement. Amphastar shall on or before Closing register on behalf of DRC a financing statement in respect of the Security Agreement under the Uniform Commercial Code.
Amphastar shall and shall cause its Affiliates to comply with all Applicable Law in connection with the ownership and rights in and the use of the Intellectual Property and with respect to carrying on its business including in particular the manufacture, marketing, sale and distribution of Cortrosyn. Amphastar shall and shall cause its Affiliates to make all filings, renewals, extensions and take all necessary or desirable actions to maintain in good standing ownership and all rights to the Intellectual Property and Product Rights, including the timely filing of all required notices, supplemental applications and annual and other reports with the FDA which are required to maintain the NDA in good standing.
Amphastar shall maintain comprehensive product liability insurance in respect of Cortrosyn and in respect of any product liability claims in an amount per claim of not less than $5 million. Maintenance of such insurance coverage will not relieve Amphastar of any responsibility under this Agreement for damage in excess of insurance limits or otherwise. Amphastar shall indemnify, defend and save harmless DRC and its Representatives and from and against any and all Claims which may be made or brought against any such indemnified party as a result of, in respect of or arising out of Cortrosyn or the use of Cortrosyn or any of the Intellectual Property infringing a patent, trade mark, copyright or other intellectual property right or any other right of a third party. Amphastar shall provide DRC with a certificate evidencing such insurance coverage and the insurer's agreement to notify DRC at least sixty (60) days in advance of any cancellation or modification of such insurance.
Amphastar shall perform, fulfill, comply and discharge all of its obligations under and in accordance with the terms of the Acquisition Agreements and all sales agreements for Cortrosyn.
Amphastar shall maintain at its usual place of business in Rancho Cucamonga, California, up-to-date records, reports, accounts, books and files which shall accurately reflect all particulars known to or under the control of Amphastar which pertain to Cortrosyn and the operation of its business generally.
Amphastar shall promptly notify DRC in writing of any material adverse change in its business (including, any material adverse event in respect of any contract with respect to Cortrosyn (including any notice of default, suspension, waiver, termination or claim under any of the Acquisition Agreements, any notice of a recall of Cortrosyn, or notice with respect to the NDA including any notice of market withdrawal, suspension or revocation) and any Material Adverse Financial Change (including any material adverse change in a budget or sales projections most recently provided to DRC» or the commencement of any litigation against Amphastar, any of its Affiliates or in respect of Cortrosyn or any of the Product Rights or Intellectual Property claiming in excess of $500,000 and each such notification shall contain full particulars of the event or events described therein.
Amphastar will not allow any Intellectual Property to lapse or become abandoned nor settle any claim by a third party in respect of Amphastar's or its Affiliates' rights in Cortrosyn, any Intellectual Property or Product Rights or the Acquisition Agreements without 60 days' prior written notification to DRC and in the case of such a settlement proposal, without the prior written approval of DRC. If Amphastar or an Affiliate decides not to defend, enforce or pursue any of its rights with respect to Cortrosyn, the Acquisition Agreements, the Product Rights or the Intellectual Property, DRC shall have the right but not the obligation, at its sole expense, to defend, enforce or pursue such rights for and in the name of Amphastar or the applicable Affiliate and any money or non-monetary consideration received or recovered by Amphastar as a result thereof or in connection or non-monetary consideration therewith shall be held in trust for the sole benefit of DRC and paid by Amphastar in full to DRC (and in the case of any non-monetary consideration, assigned to DRC free and clear of any and all Encumbrances) forthwith after receipt thereof by Amphastar or such Affiliate without deduction, set-off or counterclaim. The amount of such proceeds paid to (and any non-monetary consideration received by) DRC shall be in addition to and not included in the Royalty Interest. Amphastar shall (and shall cause its applicable Affiliate(s) to) co-operate in all reasonable respects with DRC's defense, enforcement or pursuit of such rights but at the expense of DRC (including, if required to obtain standing in any such action, appearing in the pleadings or legal proceedings at the direction of DRC and its counsel, at the cost of DRC). Amphastar shall provide to DRC, in confidence, all files, books, records and other information in its possession or control which may be relevant to assist DRC in the defense, enforcement or pursuit of such rights.
Amphastar hereby appoints DRC as its attorney-in-fact, with full authority in the place and stead of Amphastar and in the name of Amphastar, or otherwise, from time to time in DRC's discretion to take any action and to execute any instrument consistent with the terms of this Agreement, which DRC may deem necessary or advisable for the purpose of exercising any rights granted to DRC pursuant to Section 4.1 (j) hereof. The foregoing grant of authority is a power of attorney coupled with an interest and such appointment shall be irrevocable. Amphastar hereby ratifies all that such attorney shall lawfully do or cause to be done by virtue hereof.
Amphastar shall use all commercially reasonable efforts to maximize the Royalty Interest in the Territory, including through selling, manufacturing, marketing, promoting, producing and obtaining regulatory approvals for Cortrosyn, obtaining and maintaining all Registrations for Cortrosyn and maintaining, protecting, pursuing and defending its rights under the Intellectual
Property. Amphastar agrees to act in good faith and to avoid structuring its business and affairs in a manner which would allow it to avoid having to fulfill the spirit of this Agreement.
Without the prior written consent of DRC, Amphastar shall not and shall cause its Affiliates not to (i) sell, assign, transfer, license, deliver or otherwise dispose (each a "disposition"), other than the assignment by way of security of certain collateral granted to Organon under the Organon Security Agreement, of any of the Intellectual Property or Product Rights, its ownership or rights in Cortrosyn or any of its rights in and benefits under the Acquisition Agreements; (ii) waive expressly or by course of conduct, amend, cancel or terminate, or exercise any of Amphastar's rights under the Acquisition Agreements; (iii) create or permit to exist any Encumbrance on the Collateral as defined in and under the Security Agreement other than the Organon Security Agreement; (iv) fail to f1l1fill its obligations under the Acquisition Agreements; (v) consent to any assignment of any of the Acquisition Agreements by Organon; (vi) agree to do any of the foregoing; or (vii) take such other action, if such action would or is reasonably likely to reduce or otherwise adversely affect the Royalty Interest or cause any representation or warranty set forth in Section 3.1 or Section 3 of the Security Agreement to become untrue as of the date of such action. For avoidance of doubt, any disposition referred to in clause (i) above shall be subject to DRC's rights under this Agreement and the Security Agreement and shall only be made by Amphastar or its Affiliates with the prior written consent of DRC.
Amphastar shall not, without the prior written consent of DRC, accept or solicit any non-monetary consideration in respect of the sale of Cortrosyn.
Forthwith upon payment in full to Organon of the balance of the purchase price as set forth in the Sale Agreement; Amphastar shall obtain a release and discharge from Organon of all Encumbrances held by Organon and shall ensure that all registrations and filings necessary or desirable to effect or record the release and discharge are made including a UCC-3 financing statement.
Subject to this Article 5, the payment of the Invested Amount shall be completed (the "Closing") at 4:00 PM, on August 5, 2003 or at such other time or date as the parties may agree (such date being herein referred to as the "Closing Date").
5.2 Deliveries by DRC
DRC hereby agrees to deliver to Amphastar at the Closing a wire transfer to an account designated by Amphastar in writing prior to Closing in the sum of $8 million, representing payment of the Invested Amount in full by wire transfer to the following account:
|Beneficiary Bank Name:||Cathay Bank|
|Beneficiary Bank ABA No.:||122203950|
|Beneficiary Bank Address:||777 North Broadway, Los Angeles, CA 90012|
|Beneficiary Name:||Amphastar Pharmaceuticals, Inc.|
|Beneficiary Account No.:||14012529|
|Beneficiary Address:||11570 6th Street, Rancho Cucamonga, CA 91730|
5.3 Deliveries by Amphastar
Amphastar covenants and agrees to deliver to DRC, each in fonn satisfactory to DRC:
5.4 DRC's Conditions
The obligation of DRC to pay the Invested Amount and to consummate the transactions otherwise contemplated by this Agreement shall be subject to the satisfaction of, or compliance with, at or before the Closing Date, each of the following conditions precedent (each of which is hereby acknowledged to be inserted for the exclusive benefit of DRC and may be waived by it in whole or in part):
Amphastar shall have observed or performed in all respects, all of its obligations, covenants and agreements and fulfilled all of its conditions hereunder to be observed, performed or fulfilled at or before the time of Closing.
Amphastar shall have executed and delivered all of the Closing Documents and made such other deliveries as contemplated in Section 5.3.
The board of directors of DRC shall have authorized the execution and delivery of this Agreement by DRC, the completion of the transactions contemplated in this Agreement and the performance of its obligations hereunder.
DRC shall be satisfied in all material respects, in its sole discretion, with the results of its due diligence with respect to Cortrosyn, Amphastar, including its capability to manufacture, sell and distribute Cortrosyn, the Intellectual Property, the Acquisition and all financial and technical information with respect thereto.
Amphastar shall have obtained all requisite third-party consents and approvals to enable Amphastar to complete the transactions contemplated by this Agreement, to perform its obligations hereunder and to perfect its security interest in the Collateral as defined in and under the Security Agreement including the consent of Organon to the cure right as contemplated in Section 5.3(d).
The obligation of Amphastar to complete the transactions contemplated by this Agreement shall be subject to the satisfaction of, or compliance with, at or before the Closing Date, each of the following conditions precedent (each of which is hereby acknowledged to be inserted for the exclusive benefit of Amphastar and may be waived by it in whole or in part):
DRC shall have observed or performed in all respects, all of its obligations, covenants and agreements and fulfilled all of its conditions hereunder to be observed, performed or fulfilled by it at or before the time of Closing.
DRC shall have executed and delivered all of the Closing Documents and paid the Invested Amount as contemplated in Section 2.1.
Any Party may waive, by notice to the other Parties, any condition set forth in this Article 5 which is for its benefit. No waiver by a Party of any condition, in whole or in part, shall operate as a waiver of any other condition.
5.7 Failure to Satisfy Conditions
If any condition set forth in Section 5.4 or 5.5 is not satisfied on or before the time of Closing, the Party entitled to the benefit of such condition (the "First Party") may terminate this Agreement by notice in writing to the other Party. Upon such notice being given, the First Party shall be released from all obligations hereunder. If the First Party can show that the condition or conditions which have not been satisfied and for which the First Party has terminated this Agreement (a) are, or were during the period between the date hereof and the Closing Date, reasonably capable of being performed or caused to be performed by the other Party or (b) have not been satisfied by reason of a default by the other Party hereunder, the other Party shall be in breach of its obligations hereunder; otherwise the other Party shall also be released from all obligations hereunder.
6.1 Mutual Indemnifications for Breaches of Warranty, etc.
Amphastar agrees with DRC and DRC agrees with Amphastar (the Party agreeing to indemnify another Party, its Representatives and their respective heirs, legal representatives, successors and assigns being called the "Indemnifying Party" and the Party including its Representatives and their respective heirs, legal representatives, successors and assigns to be indemnified being called collectively, the "Indemnified Party") to indemnify and save harmless the Indemnified Party, effective as and from the date hereof, from and against any claims, demands, actions, causes of action, damage, loss, cost, liability or expense (excluding those of an indirect or consequential nature) (the "Claims") which may be made or brought against the Indemnified Party or which it may suffer or incur as a result of, in respect of, or arising out of any non-fulfillment of any covenant or agreement on the part of the Indemnifying Party under this Agreement or any incorrectness in or breach of any representation or warranty of the Indemnifying Party contained herein. Any amount which an Indemnifying Party is liable to pay to an Indemnified Party pursuant to this Section shall bear interest at a rate per annum equal to the Prime Rate plus 5% per annum, calculated and payable monthly, both before and after judgment,
with interest on overdue interest at the same rate, from the date the Indemnified Party disbursed funds, suffered damages or losses or incurred a loss, liability or expense in respect of a Claim, to the date of payment by the Indemnifying Party to the Indemnified Party. Any amount which an Indemnifying Party is required to pay to an Indemnified Party pursuant to this Section or pursuant to Section 6.2 (including interest thereon) is called an "Indemnified Loss". The foregoing obligation of indemnification in respect of such Claims shall be subject to the limitation set forth in Section 3.5 hereof respecting the survival of the representations and warranties of the Parties. The Indemnified Party shall use reasonable commercial efforts to minimize the amount of the Indemnified Loss.
6.2 Third Party Claims
If a Claim is made against an Indemnified Party by a third party for which the Indemnified Party may be entitled to indemnification under Section 6.1, the Indemnified Party shall give notice (the "Indemnity Notice") to the Indemnifying Party specifying the particulars of such claim within 30 days after it receives notification of the Claim. Failure to give such notice within such time period shall not prejudice the rights of an Indemnified Party except to the extent that the failure to give such notice materially adversely affects the ability of the Indemnifying Party to defend the Claim or to cure the breach or incorrectness of the representation, warranty, covenant or agreement giving rise to the Claim. The Indemnifying Party shall have the right to participate in any negotiations or proceedings with respect to such Claim at its own expense. The Indemnified Party shall not settle or compromise any such Claim without the prior written consent of the Indemnifying Party, unless the Indemnifying Party has not, within 15 Business Days after the giving of the Indemnity Notice, given notice to the Indemnified Party that it wishes to dispute such Claim. If the Indemnifying Party does give such a notice,
The Indemnified Party shall provide to the Indemnifying Party, in confidence, all files, books, records and other information in its possession or control which may be relevant to the defense of such Claim. The Indemnified Party shall co-operate in all reasonable respects in the defense of such Claim but at the expense of the Indemnifying Party. If the Indemnifying party fails, after the giving of such notice, diligently and reasonably to defend such Claim throughout the period that such Claim exists, its right to defend the Claim shall terminate and the Indemnified Party may assume the defense of such Claim at the sole expense of the Indemnifying Party. In such event, the Indemnified Party may compromise or settle such Claim, without the consent of the Indemnifying Party.
6.3 Agency for Representatives
Each Party agrees that it accepts the indemnity under this Agreement in favor of any of its Representatives as agent and trustee of that Representative. Each Party agrees that the Indemnified Party may enforce an indemnity in favor of any of its Representatives on behalf of that Representative.
This Agreement may be amended or supplemented only by a written agreement signed by each Party.
7.2 Remedies Cumulative and Waivers
The rights and remedies of DRC under this Agreement and the Security Agreement and under any other document or instrument executed pursuant hereto or thereto are cumulative and are in addition to and not in substitution for any rights or remedies provided by law or by equity. Any waiver of, or consent to depart from, the requirements of any provision of this Agreement shall be effective only if it is in writing and signed by the Party giving it, and only in the specific instance and for the specific purp0se for which it has been given. No failure on the part of any Party to exercise, and no delay in exercising, any right under this Agreement shall operate as a waiver of such right. No single or partial exercise of any such right shall preclude any other or further exercise of such right or the exercise of any other right.
7.3 Performance on Holidays
If any action is required to be taken pursuant to this Agreement on or by a specified date which is not a Business Day, then such action shall be valid if taken on or by the next succeeding Business Day.
7.4 Financial Reporting Standards
All accounting and financial terms used herein and the treatment of any accounting matter contemplated herein, unless specifically provided to the contrary, shall be interpreted and applied in accordance with GAAP.
Each Party shall pay all expenses it incurs in authorizing, preparing, executing and performing this Agreement and the transactions contemplated hereunder, whether or not the Closing occurs, including all fees and expenses of its legal counsel, bankers, investment bankers, brokers, accountants or other representatives or consultants. Notwithstanding the foregoing, Amphastar shall pay DRC forthwith on demand by DRC for all expenses it incurs in connection with maintaining, protecting, realizing, disposing or enforcing its security under the Security Agreement including all reasonable fees and expenses of its legal counsel, other representatives or consultants.
Time is of the essence of this Agreement and each of its provisions.
Any notice, demand or other communication (in this Section, a "notice") required or permitted to be given or made hereunder shall be in writing and shall be sufficiently given or made if:
in the case of a notice to Amphastar at:
11570 6th Street
Chief Financial Officer
Fax No.: (909) 980-6139
and in the case of a notice to DRC at:
Royalty USA, Inc.
Bank of America Center
101 Convention Center Drive
Suite 850, P.O. Box 50401
Las Vegas, Nevada 89109
Fax No.: (702) 598-3651
with a copy to Fasken Martineau DuMoulin LLP at:
Wellington Street West
Suite 4200, Toronto Dominion Bank
Tower Box 20, Toronto-Dominion Centre
Fax No.: (416) 364-7813
Any notice so given shall be deemed to have been given and to have been received on the day of delivery, if so delivered, on the fifth Business Day (excluding each day during which there exists any interruption of postal services due to strike, lockout or other cause) following the mailing thereof, if so mailed, and on the day following the day notice was sent by Federal Express courier or by Transmission, provided such day is a Business Day and if not, on the first Business Day thereafter. Addresses for notice may be changed by giving notice in accordance with this Section.
This Agreement or any or all of the rights or obligations hereunder may not be assigned by either Amphastar or DRC without the prior written consent of the other, provided that (i) Amphastar, without such consent, may assign the entire Agreement and its rights and obligations hereunder to an arm's length bona fide third party in connection with the transfer or sale of all or substantially all of its assets or business, or in the event of its merger or consolidation or change in control or similar transaction and provided that such assignment includes the Security Agreement and the Acquisition Agreements and the assignee assumes the obligations of Amphastar hereunder and thereunder, and
(ii) DRC may assign this Agreement in whole or in part by way of security to a financial institution or other lender and/or to an Affiliate of DRC and/or as part of a sale of a material part of DRC whether by way of a reorganization or otherwise, without the consent of Amphastar, provided DRC gives written notice of such assignment to Amphastar. This Agreement shall enure to the benefit of and be binding upon the Parties and their respective successors (including any successor by reason of amalgamation or statutory arrangement of any Party) and permitted assigns.
7.9 Further Assurances
Each Party shall do such acts and shall execute such further documents, conveyances, deeds, assignments, transfers and the like, and will cause the doing of such acts and will cause the execution of such further documents as are within its power as any other Party may in writing at any time and from time to time reasonably request be done and/or executed, in order to give full effect to the provisions of this Agreement and the Closing Documents. Without limiting the generality of the foregoing, DRC and Amphastar agree to co-operate on any applicable accounting or tax issues arising from the transaction contemplated hereby.
7.10 Independent Parties
Nothing contained in this Agreement shall in any way or for any purpose constitute any Party a partner of any other Party in the conduct of any business or otherwise or a member of a joint venture or joint enterprise or create any fiduciary relationship among them. Except as set forth in Sections 4.1 (j) and 4.1 (k), neither of Amphastar on the one hand or DRC on the other shall have any authority to act for or to assume any obligation or responsibility on behalf of the other and neither of Amphastar on the one hand or DRC on the other shall have any authority to bind the other to act or to undertake any obligation or responsibility whatsoever.
7.11 Public Announcements
The Parties agree to discuss and co-ordinate all public announcements concerning the transactions contemplated herein except as may be necessary, in the opinion of counsel to the Party making such disclosure, to comply with the requirements of any Applicable Law. If any such public statement or release is so required, the Party making such disclosure shall, where practicable, consult with the other Party prior to making such statement or release and shall use reasonable efforts acting in good faith, to agree upon a text for such statement or release which is satisfactory to both Parties. Subject to the Closing, Amphastar and DRC will discuss and agree on the appropriate method for making a joint announcement about such Closing.
If any covenant, obligation or provision of this Agreement or the application thereof to any Person or circumstance shall, to any extent, be invalid or unenforceable, the remainder of this Agreement or the application of such covenant, obligation or agreement to Persons or circumstances other than those as to which it is held invalid or unenforceable shall not be affected thereby and each covenant, obligation and provision of this Agreement shall be separately valid and enforceable to the fullest extent permitted by Applicable Law.
7.13 Specific Performance
Each of the Parties hereto acknowledges that the other Party may have no adequate remedy at law if it fails to perform any of its obligations under this Agreement. In such event, each of the Parties agrees that the other Party shall have the right, in addition to any other rights it may have (whether at law or in equity), to equitable remedies such as injunction and specific performance of this Agreement.
7.14 Third Party Beneficiary
Nothing in this Agreement or in any agreement entered into pursuant hereto or in connection herewith is intended expressly or by implication to, or shall, confer upon any person other than the Parties and their respective Representatives, any rights or remedies of any kind.
This Agreement may be executed in any number of counterparts and by facsimile transmission. Each executed counterpart shall be deemed to be an original. All executed counterparts taken together shall constitute one agreement.
7.16 Facsimile Execution
To evidence the fact that it has executed this Agreement, a Party may send a copy of its executed counterpart to the other Party by facsimile transmission. That Party shall be deemed to have executed this Agreement on the date it sent such facsimile transmission. In such event, such Party shall forthwith deliver to the other Party the counterpart of this Agreement executed by such Party.
All information furnished by DRC to Amphastar or by Amphastar to DRC in connection with this Agreement and the transactions contemplated hereby, as well as the terms, conditions and provisions of this Agreement, shall be kept confidential by Amphastar and DRC and shall be used by Amphastar and DRC only in connection with this Agreement and the transactions contemplated hereby, except in connection with the enforcement of rights or exercise of remedies under this Agreement and the Security Agreement and except to the extent that such information (i) is already known by the party to whom the information is disclosed or in the public domain at the time the information is disclosed, (ii) thereafter becomes lawfully obtainable from other sources, (iii) is required to be disclosed in any document to be filed with any federal, state, provincial, municipal or other governmental department, commission, board, bureau, agency or instrumentality, domestic or foreign or (iv) is required to be disclosed under securities laws or regulations applicable to DRC or its affiliates, or by court order. Notwithstanding the foregoing, either Party may disclose such information to its Affiliates, directors, officers, investors, bankers, advisors, trustees and representatives, provided that such Persons shall be informed of the confidential nature of such information and shall be obligated to keep such information confidential pursuant to the terms of this Section 7.17.
7.18 WAIVER OF JURY
FOR THE PURPOSES OF ANY LITIGATION COMMENCED IN THE UNITED STATES, EACH PARTY IRREVOCABLY WAIVES TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, ANY RIGHT IT MAY HAVE TO A TRIAL BY JURY IN ANY LITIGATION (A) TO ENFORCE OR DEFEND ANY RIGHTS UNDER OR IN CONNECTION WITH OR RELATING TO THIS AGREEMENT; OR (B) ARISING FROM OR RELATING TO ANY RELATIONSHIP EXISTING IN CONNECTION WITH THIS AGREEMENT; AND AGREES THAT ANY SUCH LITIGATION SHALL BE TRIED BEFORE A COURT AND NOT BEFORE A JURY. EACH PARTY HEREBY ACKNOWLEDGES THAT THE OTHER PARTY HAS BEEN INDUCED TO ENTER INTO THIS AGREEMENT BY, AMONG OTHER THINGS, THE WAIVERS IN THIS SECTION 7.18.
7.19 Service of Process
Each Party irrevocably consents to the service of process out of the courts of the State of New York in accordance with the local rules of civil procedure or by mailing a copy thereof, by registered mail, postage prepaid to such Party at the address of such Party, or by sending a copy thereof by facsimile or by email in pdf format to such Party at the facsimile number or email address of such Party determined under Section 7.7.
[signature page to follow]
TO WITNESS THEIR AGREEMENT, the Parties have duly executed this Agreement as of the date first above written.
|AMPHASTAR PHARMACEUTICALS, INC.|
|By:||/s/ DAVID W. NASSIF
Name: David W. Nassif
Title: Chief Financial Officer
|DRUG ROYALTY USA, INC.|
|By:||/s/ BEHZAD KHOSROWSHAHI
Name: Behzad Khosrowshahi
Title: President and CEO
"Acquisition" has the meaning ascribed thereto in recital B to this Agreement.
"Acquisition Agreements" has the meaning ascribed thereto in subsection 3.1.5(a).
"Active Pharmaceutical Ingredient" or "API" means the drug substance cosyntropin, and any analog, derivative, improvement or variation of such active pharmaceutical ingredient.
"Affiliate" means a Person which, directly or indirectly, controls, is controlled by or is under common control with another.
"Agreement" means this agreement, all attached schedules and any agreement, or schedule supplementing or amending this agreement. All uses of the words "hereto", "herein," "hereof," "hereby" and "hereunder" and similar expressions refer to this Agreement and not to any particular section or portion of it. References to an Article, Section, Subsection, or Schedule refer to the applicable article, section, subsection, or schedule of this Agreement.
"Applicable Law" means, in respect of any Person, property, transaction or event, any statute, law, ordinance, rule, regulation, regulatory policy, by-law, order, judgment, decree or restriction of any kind whatever applicable to that Person, property, transaction or event.
"Business Day" means any day of the week other than a Saturday, Sunday or statutory or civic holiday observed in each of Toronto, Ontario and Rancho Cucamonga, California.
"Claim" has the meaning ascribed thereto in Article 6.
"Closing" and "Closing Date" have the respective meanings ascribed thereto in Section 5.1.
"Closing Document" means any document, instrument, undertaking or agreement made or delivered pursuant to or in connection with this Agreement.
"Confidentiality Agreement" means that certain confidentiality agreement entered into by and between Amphastar and DRC dated November 7, 2002.
"Control" (including, with correlative meanings, the terms "controlled by" and "under common control with") means the possession of the power, in law or in fact, to direct or cause the direction of the management and policies of a Person, whether through legal and beneficial ownership of a majority of voting securities or other equity interests, by agreement or otherwise.
"Cortrosyn" means a pharmaceutical preparation containing the Active Pharmaceutical Ingredient, in all doses, for all indications and diseases, whether approved by a Governmental Agency or not, using any delivery mechanism and including any improvement, variation, any minor chemical alteration, new generation or product line extensions, and any product or combination of products with a chemical or biological formulation that contains the Active Pharmaceutical Ingredient, manufactured and/or sold by or on behalf of Amphastar, its Affiliates, licensees, distributors or agents under the Trade Mark or any other name.
"Encumbrance" means any encumbrance of any kind whatsoever, actual or contingent, fixed or floating, including any security interest, mortgage, lien, pledge, assignment, charge, trust or deemed trust (whether contractual, statutory or otherwise arising).
"Excess Cash Flow" for any month means the sum (without duplication) of the gross receipts of Amphastar from all sources minus (i) all cash operating costs of Amphastar actually incurred in the ordinary course of business including all interest expense and scheduled repayments of bank indebtedness, capital lease obligations and other liabilities which in accordance with GAAP would be classified upon the balance sheet of Amphastar as long term debt that was either existing at the time of
payment by DRC of the Additional Invested Amount (and the scheduled repayments thereof have not, without the prior written consent of DRC, been amended or otherwise modified or altered) or was actually incurred subsequently by Amphastar in accordance with an annual budget prepared by Amphastar and approved in writing by DRC or otherwise with the prior written consent of DRC; minus (ii) any cash expenditure that, in conformity with GAAP, would be required to be classified as a capital expenditure and was actually incurred by Amphastar in accordance with an annual budget prepared by Amphastar and approved in writing by DRC or otherwise with the prior written consent of DRC.
"FDA" means the U.S. Food and Drug Administration.
"Financial Statements" means the audited consolidated financial statements of Amphastar for the twelve-month period ending as at December 31,2001 and 2002 and the unaudited consolidated financial statements for the 3 month period ended March 31, 2003.
"GAAP" means U.S. generally accepted accounting principles, unless specifically provided to the contrary herein, from time to time approved by the Financial Accounting Standards Board, or any successor institute, applicable as at the date on which any calculation or determination is required to be made in accordance with generally accepted accounting principles.
"Governmental Agency" means any domestic or foreign government whether federal, state, provincial or municipal and any governmental agency, governmental authority, regulatory authority, governmental tribunal or governmental commission of any kind whatever including the FDA.
"Including", when used herein or in any Closing Document, means "including without limitation" and shall not be construed to limit any general statement which it follows to the specific or similar items or matters immediately following it.
"Indemnified Party" has the meaning ascribed thereto in Article 7.
"Indemnifying Party" has the meaning ascribed thereto in Article 7.
"Indemnity Notice" has the meaning ascribed thereto in Article 7.
"Invested Amount" has the meaning ascribed thereto in Section 2.1.
"Intellectual Property" means all of Amphastar's existing or hereafter acquired right, title and interest in the Territory in and to the Patent Rights, Trade Marks, Trade Secrets, domain names and internet addresses, know-how and other intellectual property relating to, associated with, covering or embodying Cortrosyn or the Active Pharmaceutical Ingredient.
"Material Adverse Financial Change" means any change, event, occurrence or change in the state of facts that has or could be expected to have a material adverse effect on the financial condition of Amphastar.
"NDA" means the application (U.S. NDA Number 16-750) for Cortrosyn prepared pursuant to applicable FDA regulations and filed by Organon with the FDA for authorization to market Cortrosyn within the United States, including all additions, supplements, extensions and modifications thereto made prior to or during the Term; and transferred by Organon to Amphastar pursuant to the Sale Agreement.
"Net Sales of Cortrosyn" means (a) gross revenues from sales of Cortrosyn in the Territory by Amphastar, its Affiliates, licensees, distributors and agents to a purchaser (including, a wholesaler or group purchasing organization and any licensee under Bankruptcy Code Section 365(n)(2)) less deductions actually allowed or specifically allocated to Cortrosyn by such vendor in accordance with GAAP for:
but without any other deduction, including for withholding taxes, other taxes, bad debts, allowance for doubtful accounts, co-management fees, development expenses, educational and promotional expenses or any other expenses, but in no event shall such deductions in aggregate exceed 17.4% of gross revenues from sales of Cortrosyn in the Territory; and (b) all amounts recovered by or paid to Amphastar pursuant to a settlement, order or judgment in respect of any claim or legal proceeding relating to Cortrosyn or any of the Product Rights or Intellectual Property or any right of Amphastar to manufacture, market, sell or distribute Cortrosyn or the ownership or rights of Amphastar to any of the Product Rights or Intellectual Property. For the purposes hereof, "gross revenues" shall mean units shipped times (a) the purchase price in the case of indirect sales through wholesalers and (b) the contract price in the case of direct sales to customers and shall be determined in accordance with GAAP, consistently applied.
"Parties" means Amphastar and DRC, collectively, and "Party" means each of them.
"Patent Rights" means all of Amphastar's existing or hereafter acquired right, title and interest in the Territory to the patents and patent applications claiming, relating to or associated with Cortrosyn or the Active Pharmaceutical Ingredient and all improvements thereto made by Amphastar or its Affiliates, including, all divisions, continuations, partial continuations, extensions, substitutions, confirmations, registrations, revalidations, additions or reissues of or to any of the patents or patent applications.
"Person" includes an individual, body corporate, partnership, joint venture, co-operative, trust or unincorporated organization, Governmental Agency or any agency or instrumentality thereof, or any other entity recognized by law.
"Prime Rate" for any day means the rate of interest expressed as a rate per annum that JP Morgan Chase establishes at its head office in the city of New York, as a reference rate of interest that it will charge on that day for US Dollar demand loans to its corporate customers in the United States and which it at present refers to as its prime rate.
"Product Rights" means all of the rights to Cortrosyn acquired by Amphastar under the Acquisition Agreements including the NDA, copies of all FDA files, regulatory files and formulae for Cortrosyn and the most recent master batch record for Cortrosyn.
"Purchased Assets" has the meaning ascribed thereto in the Sale Agreement and includes the Product Rights and Intellectual Property.
"Quarter" means a calendar quarter ending on March 31, June 30, September 30 and December 31 in each calendar year.
"Registration" means the obtaining of all approvals and authorizations under Applicable Law to legally manufacture, package, market, distribute, promote, offer for sale and sell Cortrosyn to end users in the Territory.
"Representative" means each Affiliate of a Party and the respective directors, officers, employees and agents of such Party and its Affiliates.
"Royalty Interest" has the meaning assigned thereto in subsection 2.2(a).
"Security Agreement" has the meaning assigned thereto in subsection 4.1(d).
"Tax Returns" means all reports, returns and other documents filed or required to be filed by Amphastar and its Affiliates in respect of Taxes or in respect of or pursuant to any Applicable Law.
"Taxes" means all national, federal, provincial, state, municipal, local, foreign or other taxes, imposts, levies, assessments and government fees, charges or dues, lawfully levied, assessed or imposed and all interest and penalties thereon.
"Term" has the meaning assigned thereto in Section 2.3.
"Territory" means the United States of America and its respective territories and possessions.
"Trade Mark" means the United States trade mark Cortrosyn® registration number 779366 any and all United States trade marks, service marks or symbols, trade devices, certification marks, trade names and applications therefor in respect of, associated with or relating to Cortrosyn now or hereafter filed by or issued, licensed or assigned to or under the control of or owned under common law by Amphastar or its Affiliates in the Territory and including all reissues, extensions, continuations, renewals, supplements or amendments thereto.
"Trade Secrets" means all information, technical data, experimental procedure, scientific and medical information invented, developed, controlled or acquired prior to or during the Term by or on behalf of Amphastar or its Affiliates in the Territory relating to the development, manufacturing, distributing, marketing, promoting, offering for sale or sale of Cortrosyn, the Active Pharmaceutical Ingredient or the Product Rights, including all information contained in health and marketing registration applications filed by or on behalf of Amphastar or its Affiliates or Organon or its Affiliates relating to Cortrosyn, and all pre-clinical and clinical data, product forms, specifications and manufacturing data relating to Cortrosyn, the Active Pharmaceutical Ingredient or the Product Rights, including all Technical Information (as such term is defined in the Sale Agreement).
"Transmission" means any electronic means of sending messages, including facsimile transmission and email which produces a paper record.