As originally asked by Korina Fischer.

Ada Melanie Galbiati
Corporate Regulatory Affairs Manager Medical Devices Presso SOL Group
Do you mean a commercial agreement or a Quality one? Cause usually they are managed separately.

Korina Fischer
VP Healthcare at Optel Group
We are focusing on the Canadian and US markets. I am just trying to get some insight into the main clauses we will need to prepare with our legal team.
Thanks,
Korina

Bruce Wang
Vice President at Microport Scientific Corp
Hello Korina, I could not offer you a specific template since each company and/or country may have specific requirements as Ravi and Michelle pointed out. But I can list key components of a distribution contract here for your reference since over the last few years, I have signed quite a few distribution contracts in Asia countries by working with my legal team closely. Here they are:

1. Contract date and parties
2. Definitions of terms
3. Appointment
4. Forecast, POs, Supply terms, Shipping terms, Order changes, acceptance of products, Payment terms, Taxes, Prices (normally details in Annex) and currency.
5. Storage and handling of the products
6. Distributors covenants and representations (for example: Regulatory responsibilities and inventory transfer if there are any)
7. Marketing
8. Training
9. Warranty; Disclaimer
10. Confidentiality
11. Indemnification; Limitation of Liability
12. Insurance
13. License and Intellectual Property Rights Ownership
14. Term and Termination
15. Consequences of Expiration or Termination
16. Miscellaneous, i.e. governing laws – which country?
17. Annex – covering territories, price list, subcontract appointment request form, business conduct guidelines, AdvaMed Code of Ethics, US Foreign Corrupt Practices Act, and etc…

Hope this helps.
Bruce

Debra Pollock
🌎 MedCepts Independent Network↔★Top Linked ★ | ✔ 30+ Yrs Healthcare | Medical | Sales & Marketing ★ Recruiter Network
Korina, I have to presume you are merely looking for a little insight in preparation for discussions with your team’s legal representative. It’s not only important to know the governing laws of the intended distribution, but more specifics of the type of DME product. It is also important to establish a relationship with an attorney who not only understands the applicable laws, but also has extensive experience with how the sales and distribution business works particularly with the ever changing landscape for legal matters.

We have thousands of different distribution/independent rep agreements from various manufacturers and suppliers on file, primarily USA/Canada – each tailored to specific needs. A few of the USA distribution / product variances, I can think of quickly, depend on the following, but certainly not limited to:

Stocking
Non-stocking
Exclusivity
Single / Multiple Contracted distributors
Rep teams, Managed Rep groups, Independent Reps
Branding/co-branding
Repair / Maintenance
Rentals / Lease
Reimbursable
Governing Laws – International, USA (as mentioned by Michelle and Ravi)
Sales Targets – providers/DME suppliers
Certification / Licensure requirements

Another rather quick thought, not only should one consider aligning with a legal representative knowledgeable with preparing medical product distribution agreements for manufacturers/vendors/suppliers but it may also be beneficial to explore further with a legal representative for distributors with vast experience handling unjustified terminations and territorial incursions by manufacturers, as well as recovering unpaid commissions. Food for thought only.

Lian Zhang
Technical Documentation Assessor for Medical Devices, MDD 93/42/EEC; MDR 2017/745
China could be very interesting.

Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
Korina, are you targeting specific countries?

Share more information here and I bet a group member can assist you directly.

Michelle Bonn
President, Guideline Medical
Korina,

Distribution agreements will vary depending upon where your products will be sold.
I recommend you find an attorney that has experience with international sales and some background with FDA/Health Canada and other country standards. Within these contracts, It will be critical to outline specific product registration requirements, labeling requirements and product recall parameters with your chosen distributors. If issues like these aren’t defined in your contracts, you can run into serious and expensive legal problems. It’s issues like these that are often absent from “template style” contracts.

Ravi Soni
Co-Founder & CEO at Madison Ortho Inc.
Korina, distribution agreements are generally specific to a country and of course built around the commercial terms and product categories. You may like to specify which country you want the template for. In any case, due to different laws in different states and countries, I would suggest that these be vetted by your in-country lawyer. Cheers!