Full Press Release Details
NORDISK BIOPHARM LIMITED
| 1. | Definitions and interpretation | 4 |
| 2. | Transfer of Joint Ownership Interest and Grant of Rights | 15 |
| 3. | Governance | 17 |
| 4. | Development | 20 |
| 5. | Supply | 25 |
| 6. | Commercialization | 26 |
| 7. | Financial. | 30 |
| 8. | Trademarks | 34 |
| 9. | Intellectual Property (except Trademarks) | 35 |
| 10. | Confidentiality | 37 |
| 11. | Representations, Warranties and Covenants | 39 |
| 12. | Indemnity and insurance cover | 43 |
| 13. | Duration and termination of the agreement | 46 |
| 14. | Assignment/Succession | 51 |
| 15. | Governing law and disputes | 52 |
| 16. | Miscellaneous | 52 |
Budget (currently awaiting finalization at JSC)
Amendment Agreement is dated 16 November 2020
cooperation incorporated under the laws of Germany, ("AZ")
its principal place of business at
Frankfurt am Main Germany;
Nordisk Biopharm Limited
corporation incorporated under the laws of Ireland, ("NNBL")
its registered address at
One, Sir John Rogerson's Quay,
and NNBL sometimes being referred to in this Agreement as a "Party" or together the "Parties".
| 1. | Strongbridge Ireland Limited and AZ entered into a License and Assignment Agreement, dated as of January 16, 2018 ("Original Agreement" and the January 16, 2018 effective date of the Original Agreement is the "Original Agreement Effective Date") and Novo Nordisk Health Care AG, the parent company of NNBL, acquired the shares of Strongbridge in December 2018 and subsequently changed the name of Strongbridge Ireland Limited to Novo Nordisk Biopharm Limited. |
| 2. | NNBL and AZ desire to partly amend the Original Agreement on the terms and conditions herein, to, among others (i) reflect the updated supply agreement between the Parties relating to the supply of the API Macimorelin acetate, (ii) grant NNBL a joint ownership interest in the AZ Patent Rights and AZ Trademarks (both as defined below) (iii) amend responsibility between the Parties for the paediatric clinical trial for the Paediatric Indication, (iv) make a payment to AZ and (v) modify the future payment obligations. |
| 3. | Any rights and obligations set forth in the Original Agreement that are not explicitly modified by this Agreement shall remain valid and continue to be in force. |
| 4. | AZ owns or has the exclusive right to certain technology, intellectual property rights, regulatory files and confidential and/or proprietary information relating to the Product (as defined below). |
| 5. | AZ has assigned the ownership of the Product Registrations under the Original Agreement (as defined above) and is now interested in granting a joint ownership interest under the AZ Patent Rights and the AZ Trademarks to NNBL to carry out development, manufacturing, registration and commercialization of the Product in the Territory (as defined below). |
Parties now agree as follows:
of the Effective Date, Section 1 of the Original Agreement shall be amended and replaced by the following definitions:
Indication" means assessing GHD in adults.
means an entity that has a relationship directly or indirectly with another entity such that either entity is Controlled by, Controlling,
has the power to Control, or under common Control with the other entity, or a third party Controls, or has the power to Control,
both of the entities, where "Control" means possession, directly or indirectly, of the power to direct or cause
the direction of the activities, management and policies of the relevant entity and in the case of a corporate entity shall include
but not be limited to the holding of more than fifty percent (50%) of the share capital of the entity or the equivalent power
or authority to elect more than fifty percent (50%) of the board of directors of such entity or the equivalent management body.
The Parties acknowledge that in the case of certain entities organized under the Laws of certain countries outside of the EU,
the maximum percentage ownership permitted by Law for a foreign investor may be less than fifty percent (50%), and that in such
case such lower percentage shall be substituted in the preceding sentence, provided that such foreign investor has the power to
direct the management and policies of such entity.
means this Amendment Agreement together with its attached Schedules.
Law" means the US Foreign Corrupt Practices Act, UK Bribery Act 2010 and any other applicable Law, rule, regulation,
or other legally binding measure of any jurisdiction that relates to bribery, corruption, or, for purposes of U.S. Law, transfers
of value to licensed healthcare providers.
means the active pharmaceutical ingredient macimorelin acetate, and any metabolite, salt, ester, hydrate, solvate, isomer, enantiomer,
free acid form, free base form, crystalline form, co-crystalline form, amorphous form, pro-drug, racemate, polymorph, chelate,
stereoisomer, tautomer, or optically active form of any of the foregoing.
IPR Package" means the intellectual property and other rights Controlled by AZ or its Affiliates relating to the Product
(with the exception of AZ Materials, Controlled at any time during the Term) including but not limited to:
| a) | Know How | |
| b) | Dossiers; and | |
| c) | the Commercial Information in relation to the Territory. |
Patent Rights" means the Patent Rights set out in Schedule 1 as well as those Patent Rights Controlled by AZ at any
time during the Term of this Agreement in the countries of the Territory containing claims covering the existing product Macrilen
60 mg granules for oral solution for the Existing Indications.
Trademark" means the Macrilen trademark registered in the Territory and any accompanying logos, trade names, trade dress
and/or other indicia relating to the Product Controlled by AZ.
Event" means, with respect to either Party:
| a) | a notice having been issued to convene any meeting for the purpose of passing a resolution or seeking a petition to wind up or liquidate that Party, or to seek bankruptcy or official administration, or such a resolution having been passed or such a petition having been issued, including a petition under title 11 of the United States Code or any similar statute, Law or regulation (except in relation to a solvent reconstruction or reorganization of that Party); | |
| b) | an involuntary petition in an insolvency proceeding or any proceeding seeking reorganization, arrangement composition, readjustment, liquidation or similar relief under any statute, Law or regulation, is filed against a Party and is not dismissed or stayed within ninety (90) days of the filing thereof or that Party admits or accepts; | |
| c) | a trustee in bankruptcy, receiver, administrative receiver, receiver and manager, court appointed receiver, interim receiver, custodian, sequestrator or similar officer is appointed in respect of that Party or over any part of that Party's assets or any third party takes steps to appoint such an officer in respect of that Party and is not dismissed, vacated or stayed within ninety (90) days of the appointment thereof and if stayed, is not dismissed or vacated within ninety (90) days of the such stay; | |
| d) | a Party takes any step, (including starting negotiations), with a view to readjustment, rescheduling or deferral of any part of that Party's indebtedness including a moratorium with creditors, or proposes or makes any general assignment, composition or arrangement with or for the benefit of all or some of that Party's creditors or makes or suspends or threatens to suspend making payments to all or some of that Party's creditors or the Party submits to any type of voluntary arrangement with creditors; or | |
| e) | a Party takes any step, (including starting negotiations), to file a petition or answer seeking for that Party any reorganization, arrangement, composition, conservatorship, winding up, readjustment, liquidation or similar relief under any statute, Law or regulation. |
Day" means between 9.00 am and 5.00 pm local time on a day other than a Saturday, Sunday, bank or other public holiday
in Germany or any State in the USA.
Quarter" means each period of three months ending on 31 March, 30 June, 30 September or 31 December.
Year" means each successive period of twelve calendar (12) months commencing on 1 January.
means persons 18 years of age or younger including neonates, infants and adolescents.
Trial" means the administration of the Product to humans for purposes of generating data on characteristics of the Product
including, without limitation, any study carried out in order to obtain or maintain a Regulatory Approval in any country of the
means a Person that conducts contract manufacture on behalf of another Person.
Information" means information which is Controlled and relates to the pricing, reimbursement, marketing, promotion and
selling of the Product including but not limited to (i) commercialization plans; and (ii) pharmaco-economic studies justifying
pricing; and (iii) analysis of competitive products and environment including market research reports; and (iv) product positioning
strategies and promotional strategies (including Promotional Materials); and (v) Pricing Approval; and (vi) virtual product approaches
and techniques via web page; and (vii) medical education strategies; and (viii) analysis of market sales and prescription data;.
or "Commercialization" means any and all activities directed to commercialization, including marketing, promoting,
detailing, importing, distributing, warehousing, offering for sale, having sold and/or selling a pharmaceutical product, including
market research, pre-launch marketing and educational activities, and sampling.
Reasonable Efforts" means, in respect of a Party, efforts and resources commonly used by a pharmaceutical company of
a similar size to that Party, based on market capitalization, to Commercialize (or where the phrase Commercially Reasonable
Efforts' is used in this Agreement in a context other than relating to Commercialization, to perform such other act as the
operative language of this Agreement states) a product owned by such a company or to which it has rights, which product is at
a similar stage in its development or product life and is of similar market potential to the Product, in each case taking into
account issues of safety and efficacy, product profile, the proprietary position, the then-current competitive environment for
such product and the likely timing of such product's entry into the market, the regulatory environment and status of such
product, and other relevant scientific, technical and commercial factors, in each case as measured by the facts and circumstances
at the time such efforts are due and in relation to the country or countries to which such efforts pertain.
Information" means, subject to the relevant carve-outs set forth in Section 11:
| a) | the terms and conditions of this Agreement, for which each Party will be considered a Disclosing Party and a Recipient Party; | |
| b) | the Dossier, Know How and Commercial Information within AZ IPR Package for which AZ will be considered the Disclosing Party and NNBL shall be the Recipient Party; | |
| c) | information within NNBL IPR Package in relation to which NNBL will be considered the Disclosing Party and AZ the Recipient Party; and | |
| d) | any other non-public information, whether or not patentable, disclosed or provided by one Party to the other Party in connection with this Agreement, including, without limitation, information regarding such Party's strategy, business plans, objectives, research, technology, products, business affairs or finances including any non-public data relating to Commercialization of any product and other information of the type that is customarily considered to be confidential information by parties engaged in activities that are substantially similar to the activities being engaged in by the Parties under this Agreement, for which the Party making such disclosure will be considered the Disclosing Party and the receiver will be the Recipient Party. |
(including variations such as "Controlled" and except as used in the definition of Affiliates')
means with respect to any intellectual property or other rights, possession of the right, whether directly or indirectly, and
whether by ownership, license or otherwise, to assign, or grant a license, sub-license or other right to or under, such intellectual
property or other rights without violating the terms of any agreement or other arrangement with any Third Party.
of Manufacture" means the amounts paid or payable by the relevant Party to the CMOs in respect of relevant Products
or Materials supplied.
Format" means the format of a common technical document recommended by ICH or adopted by any Governmental Authority
in the Territory responsible for marketing authorization or monitoring the marketing of the Product that are formatting requirements
or methods for the submission of other or supplemental information or data to such Government Authority and as may be updated
shall mean Product in a form suitable for administration to humans in a Clinical Trial manufactured in accordance with the specifications
and GMP and as required by any IND appropriately packaged and labelled.
(and the corresponding verb "to Develop") means all development and regulatory activities regarding the Product
and the API in the Territory, including:
| a) | carrying out the PCT or any other pediatric study required to obtain Regulatory Approval for the Product for the Pediatric Indication in any country in the Territory; and | |
| b) | preparing, submitting, reviewing or developing data or information necessary for the purpose of submission to a Regulatory Authority to obtain or maintain and/or expand Regulatory Approval of the Product in the Territory including data management, statistical designs and studies, document preparation, and other related administrative costs. |
Costs" means the direct and indirect costs of the PCT as set forth in the PCT Budget.
Plan" means the plan for carrying out the PCT attached in Schedule 2, as such plan may be amended in accordance with
the terms of this Agreement.
Party" means the Party which discloses Confidential Information to the other Party.
means analyses, books, CD-ROM, charts, comments, computations, designs, discs, diskettes, files, graphs, ledgers, notebooks, paper,
photographs, plans, records, recordings, reports, research notes, tapes, web pages and websites, and any other graphic or written
data or other media on which Know How is made available, communicated, or use whether permanently stored or available temporarily
through other means, and advertising and Promotional Materials of any nature whatsoever including preparatory materials for the
means the information and data for the Product in a country in CTD Format (or otherwise) and as registered with a Regulatory Authority
for the Regulatory Approval containing the administrative, safety, efficacy, quality, non-clinical and clinical data, chemistry
and manufacturing control data and communications with the Regulatory Authority for the Product as it may change from time to
means the European Medicines Agency.
means the countries of the European Union from time to time which are currently Austria, Belgium, Bulgaria, Cyprus, Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands,
Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and includes the United Kingdom regardless of future treaty or common
relationships with the other countries in the EU or Europe.