xxiii. Risks

xxiv. Confidentiality

xxv. Amendments

xxvi. Closing, signature, date and place

xxvii. Date of effectiveness

6.5.3 MoU

MoU (Memorandum of Understanding) is also known as commitment letter or letter

of intent.

It is used:

i. At the start of license negotiations and it has mutual conditions as specified by

both the parties.

ii. When receiving party is showing serious intention to sign a license with another

party.

iii. To motivate and speed up the transfer process.

iv. It is a non-binding document and has no legal obligations. However, may have

legal obligations some time in case of:

• Binding by default status

• Indicating binding/not binding status.

Requirements of MoU

1. State the overall aim of the MoU: Many MoUs begin with a short description of the

overall aim/goal of the parties. MoUs should have clearly stated clauses that

accurately reflect the intentions of parties involved.

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2. The parties: The next clause in an MoU describes the details about the parties to the

agreement.

3. The period: It is essential to specify a period for the partnership with dates.

4. Assignments/responsibilities: This important section of the MoU describes the duties

and responsibilities of each party. It is generally more effective to describe each

organization’s responsibilities separately, the organization’s sole responsibility, each

group’s sole responsibilities, shared responsibilities, etc.

5. Disclaimers: While drafting, MOUs must contain one or more disclaimers for

different conditions, e.g. guarantee, attestation, declaration, etc.

6. Financial arrangements: Financial implications should be described in detail

including what to pay and to whom.

7. Risk sharing: It is essential to mention in MoU that who will bear the risk of a

mishap.

8. Signatures: A representative from each partner with authority should sign the MoU.

And retain a copy of the signed agreement.

6.5.4 Legal Issues

The technology transfer process should be per the legal framework and jurisdiction of

the concerned country. Issues like tax, intellectual property rights, infringement of

contract, failure to comply with regulatory guidelines come under legal issues.

Mentioning of recommended law and jurisdiction in case of breach of conditions in

the agreement should be there in the technology transfer agreement.

Checklist for the technology transfer agreement is as follows:

Preliminary statements

i. Identification of the parties

ii. Purpose

iii. Effective date of the agreement

iv. Whereas clauses (recitals, preamble)

v. Licensor representations

vi. Licensee representations

vii. Background of the agreement

viii. Definition of terms

Subject matter of the license

i. The license grant

ii. Patent rights

iii. Exclusivity

iv. Territory

v. Rights conferred

vi. Limitations

vii. Maintenance and prosecution of the patents

viii. Infringement

ix. Patent marking

x. Know-how/trade secrets/confidential information

xi. Technical assistance

xii. Plant visits and training

xiii. Direct assistance.

104 Industrial Pharmacy II

xiv. Consultation

xv. Improvements

xvi. Sublicense rights

xvii. Initial payment

xviii.Royalties

xix. Separate payments for patents and know-how

xx. Acquisition of machinery

xxi. Technical services

xxii. Term of the license agreement

“Boilerplate” Provisions

i. Termination of the agreement

ii. Best efforts

iii. Most favoured licensee

iv. Warranty and identification

v. Export control

vi. Arbitration and applicable law

vii. General provisions