A Pharmaceutical License Agreement is essential when one party wishes to grant rights to another party to develop, manufacture, or commercialize pharmaceutical products or technologies in Austria. This document type is particularly relevant when dealing with pharmaceutical intellectual property rights, manufacturing rights, or distribution rights within the Austrian market, which must comply with both national and EU regulations. The agreement needs to address specific requirements under Austrian pharmaceutical law, including the Arzneimittelgesetz (AMG), while ensuring alignment with EU pharmaceutical directives and regulations. It typically includes detailed provisions on regulatory compliance, quality standards, pharmacovigilance, and specific Austrian market requirements. The document is crucial for pharmaceutical companies, research institutions, or biotechnology firms engaging in licensing transactions in Austria, providing a comprehensive framework for the commercialization of pharmaceutical products while ensuring regulatory compliance.
Your data doesn't train Genie's AI
You keep IP ownership of your information
Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.
OR
Let Ƶ's market-leading legal AI identify missing terms, unusual language, compliance issues and more - in just seconds.
1. Parties: Identification of the licensor and licensee with full legal entity details
2. Background: Context of the agreement, including brief description of the pharmaceutical product and parties' capabilities
3. Definitions: Detailed definitions of technical, legal, and commercial terms used throughout the agreement
4. License Grant: Scope of the license, including territory, exclusivity, and field of use
5. Regulatory Compliance: Obligations regarding regulatory approvals, maintenance, and compliance with pharmaceutical regulations
6. Quality Standards: Requirements for maintaining product quality, GMP compliance, and quality control procedures
7. Intellectual Property Rights: IP ownership, protection, and enforcement provisions
8. Financial Terms: License fees, royalties, milestone payments, and payment terms
9. Record Keeping and Audit Rights: Requirements for maintaining records and audit procedures
10. Representations and Warranties: Standard and specific warranties regarding IP rights, product quality, and regulatory compliance
11. Indemnification: Allocation of risks and responsibilities for product liability and other claims
12. Term and Termination: Duration of the agreement and grounds for termination
13. Confidentiality: Protection of confidential information and trade secrets
14. Governing Law and Dispute Resolution: Choice of law and dispute resolution mechanisms
15. General Provisions: Standard boilerplate clauses including assignment, notices, and entire agreement
1. Development Obligations: Include when the agreement involves ongoing product development or clinical trials
2. Manufacturing and Supply: Include when the license includes manufacturing rights or supply obligations
3. Commercialization Obligations: Include when specific marketing and sales commitments are required
4. Technology Transfer: Include when technical knowledge transfer is part of the agreement
5. Pharmacovigilance: Include when post-market safety monitoring responsibilities need to be allocated
6. Sub-licensing Rights: Include when sub-licensing is permitted
7. Export Control: Include when cross-border activities are involved
8. Data Protection: Include when processing of personal data is involved
9. Competition Law Compliance: Include when specific competition law issues need to be addressed
1. Licensed Patents: List of patents and patent applications covered by the license
2. Licensed Products: Detailed description of licensed pharmaceutical products
3. Technical Information: Specific technical details and know-how related to the licensed products
4. Quality Agreement: Detailed quality control and assurance requirements
5. Development Plan: Timeline and milestones for product development (if applicable)
6. Commercialization Plan: Marketing and sales targets and strategies
7. Territory: Detailed description of licensed territory and any restrictions
8. Royalty Calculations: Detailed methodology for calculating royalties
9. Approved Sub-contractors: List of approved third-party manufacturers or service providers
10. Press Release: Agreed form of public announcement of the license agreement
Relevant legal definitions
Clauses
Relevant Industries
Pharmaceuticals
Biotechnology
Healthcare
Life Sciences
Research & Development
Manufacturing
Medical Devices
Clinical Research
Chemical Industry
Relevant Teams
Legal
Regulatory Affairs
Business Development
Research and Development
Intellectual Property
Quality Assurance
Commercial
Finance
Compliance
Scientific Affairs
Manufacturing
Clinical Development
Relevant Roles
Chief Executive Officer
Chief Legal Officer
Head of Legal
Legal Counsel
Regulatory Affairs Director
Business Development Director
Licensing Manager
Intellectual Property Manager
Quality Assurance Manager
Research and Development Director
Chief Scientific Officer
Commercial Director
Chief Financial Officer
Compliance Officer
Patent Attorney
Technology Transfer Manager
Find the exact document you need
Perpetual Royalty License
An Austrian law-governed perpetual royalty license agreement establishing long-term IP licensing rights with ongoing royalty payment obligations.
find out more
Sub License Agreement
An Austrian law-governed agreement where a licensee grants sublicense rights to a third party to use intellectual property, subject to the main license terms.
find out more
License Agreement Before Settlement
An Austrian law-governed agreement establishing interim licensing terms between parties in an IP dispute pending final settlement.
find out more
Land License Agreement
An Austrian law-governed agreement granting temporary rights to use land or property, subject to specified terms and conditions under Austrian civil code.
find out more
Individual Contributor License Agreement
An Austrian law-governed agreement for managing individual contributions to open source projects, ensuring proper IP rights transfer and GDPR compliance.
find out more
License Back Agreement
An Austrian law agreement allowing an IP transferor to retain or receive usage rights for previously transferred intellectual property.
find out more
Standard Copyright License
An Austrian law-governed copyright license agreement establishing terms for legal use of copyrighted material, compliant with Austrian and EU copyright regulations.
find out more
Software License Agreement
Austrian law-governed Software License Agreement defining terms for software usage, licensing rights, and compliance with Austrian and EU regulations.
find out more
Enterprise License Agreement
An Austrian law-governed agreement establishing enterprise-wide software licensing terms and conditions, including usage rights, maintenance, and regulatory compliance.
find out more
Commercial Licensing Agreement
An Austrian law-governed agreement establishing terms for commercial licensing of intellectual property, technology, or proprietary assets between parties.
find out more
Software License Commercial Use
Austrian law-governed commercial software license agreement establishing terms for business software usage, including license rights, obligations, and compliance requirements.
find out more
Non Commercial Use License
An Austrian law-governed license agreement for non-commercial use of intellectual property, designed to facilitate educational and research purposes while preventing commercial exploitation.
find out more
Patent Agreement
An Austrian law-governed agreement for patent transfer, licensing, or assignment, compliant with national and EU patent regulations.
find out more
Copyright Agreement For Artwork
An Austrian law-governed agreement for artwork copyright transfer or licensing, compliant with local and EU copyright regulations.
find out more
Trademark Agreement
An Austrian law-governed agreement establishing terms for trademark licensing, usage, and protection, compliant with both Austrian and EU regulations.
find out more
Technology License Agreement
An Austrian law-governed agreement for licensing proprietary technology, establishing usage rights, technical specifications, and commercial terms between technology provider and recipient.
find out more
Standard End User License Agreement
Austrian law-governed EULA defining software usage terms and conditions, compliant with local consumer protection and EU regulations.
find out more
Simple License Agreement
An Austrian law-governed agreement establishing terms for intellectual property licensing between a licensor and licensee.
find out more
Short Term License Agreement
An Austrian law-governed agreement granting temporary permission to use specific intellectual property, typically for a period under one year, with defined usage terms and conditions.
find out more
Patent Cross License
An Austrian law-governed agreement establishing mutual patent licensing rights between parties, subject to Austrian Patent Act and EU regulations.
find out more
Open License Agreement
An Austrian law-governed agreement establishing terms for open use, modification, and distribution of intellectual property.
find out more
Open Content License
An Austrian law-compliant Open Content License for sharing and distributing creative works while protecting creators' rights.
find out more
Non Exclusive Patent License
An Austrian law-governed Non-Exclusive Patent License Agreement enabling patent rights licensing while preserving the licensor's right to grant additional licenses.
find out more
Non Exclusive License Agreement
An Austrian law-governed agreement granting non-exclusive rights to use intellectual property while allowing the licensor to license the same rights to others.
find out more
License To Occupy Agreement
An Austrian law-governed agreement granting temporary occupation rights to a property without creating a formal lease relationship.
find out more
Master Use License
An Austrian law-governed agreement establishing terms for licensed use of intellectual property, content, or technology, including usage rights, fees, and compliance requirements.
find out more
Licence Rental Agreement
An Austrian law-governed agreement combining rental of physical space with licensing of associated intellectual property or equipment.
find out more
Master License Agreement
An Austrian law-governed agreement establishing comprehensive terms for software or technology licensing, including usage rights, obligations, and commercial terms.
find out more
Manufacturing License Agreement
An Austrian law-governed agreement granting manufacturing rights and establishing terms for licensed production using proprietary technology and know-how.
find out more
International License Agreement
Austrian law-governed international license agreement for cross-border intellectual property licensing, incorporating Austrian and EU regulatory requirements.
find out more
Intellectual Property License Agreement
An Austrian law-governed agreement for licensing intellectual property rights, establishing terms for IP usage, royalties, and protection under Austrian and EU regulations.
find out more
Equipment License Agreement
Austrian law-governed agreement for equipment licensing, establishing usage rights, maintenance terms, and compliance requirements under Austrian commercial regulations.
find out more
Video Licensing Agreement
An Austrian law-governed agreement for licensing video content, establishing usage rights, technical requirements, and payment terms.
find out more
Trademark Use Agreement
An Austrian law-governed agreement setting out terms for trademark usage, including licensing rights, quality control, and financial arrangements.
find out more
Sync Licensing Contract
An Austrian law-governed synchronization licensing agreement for musical works used in audiovisual content, compliant with EU and Austrian copyright regulations.
find out more
Software Usage Agreement
An Austrian law-governed agreement defining software usage terms, licensing conditions, and user obligations in compliance with EU regulations.
find out more
Permission Agreement
An Austrian-law governed agreement establishing terms for granted permissions, rights, or access between parties.
find out more
Music Licensing Contract
An Austrian law-governed agreement for licensing musical works, establishing rights, permissions, and commercial terms between rights holders and licensees.
find out more
Image Licensing Agreement
An Austrian law-governed agreement establishing terms and conditions for image licensing, usage rights, and copyright protection.
find out more
Content Licensing Agreement
An Austrian law-governed agreement establishing terms for content licensing between parties, including usage rights, restrictions, and payment terms.
find out more
ұԾ’s Security Promise
Genie is the safest place to draft. Here’s how we prioritise your privacy and security.
Your documents are private:
We do not train on your data; ұԾ’s AI improves independently
All data stored on Genie is private to your organisation
Your documents are protected:
Your documents are protected by ultra-secure 256-bit encryption
We are ISO27001 certified, so your data is secure
Organizational security:
You retain IP ownership of your documents and their information
You have full control over your data and who gets to see it
.png)