General Terms and Conditions of Purchase (hereinafter ...€¦ · est and shall expressly alert BI...

Version 01 – Status: March 13, 2020

General Terms and Conditions of Purchase (hereinafter referred to as "GTC-P")

of

Boehringer Ingelheim Pharma GmbH & Co. KG, Boehringer Ingelheim GmbH

and Affiliates of the Boehringer Ingelheim Group (hereinafter referred to as "BI")

Preamble

These GTC-P consist of General Terms and Conditions (Part I) and Special Terms and Conditions (Part II – IV).

Part I contains the General Terms and Conditions applicable to all (purchase) orders (hereinafter collectively

referred to as "Order" or "Orders"). The General Terms and Conditions (Part I) also provide supplementary rules

on Orders for items of moveable property and production of work [“Werkleistungen”].

The Special Terms and Conditions in Parts II–IV contain supplementary rules on services (Part II), design

agreements [“Gestaltungsverträge”] (Part III) and IT software licences (Part IV).

Should there be any conflicts or inconsistencies between the provisions of the Special Terms and Conditions (Part

II, III or IV) and those of the General Terms and Conditions (Part I), then the provisions in the Special Terms and

Conditions (Part II, III or IV) shall take precedence over those in the General Terms and Conditions (Part I).

Boehringer Ingelheim Page - 2 -

Part I:

General Terms and Conditions

1. Scope, deviating/overriding agreements

1.1 All Orders submitted by the BI entity stated on

the Order shall be based exclusively on the

GTC-P set forth below. These GTC-P shall

constitute an integral element of any Order. BI

does not accept any terms and conditions of

the Contractor that conflict with or deviate

from these GTC-P. BI's GTC-P shall apply

even if BI unconditionally accepts or pays for

goods or services despite having knowledge of

the Contractor’s terms and conditions which

conflict with or deviate from its own GTC-P.

1.2 These GTC-P shall apply exclusively in the

context of commercial transactions with “busi-

ness persons” [“Unternehmer”] as defined in

Sec. 14 German Civil Code [Bürgerliches Ge-

setzbuch], sovereign legal entities [“juris-

tischen Personen des öffentlichen Rechts”] or

special funds organised under public law

[“öffentlich-rechtliches Sondervermögen”].

They shall also apply to all future transactions

with the same Contractor as amended at the

time the contract was concluded/the Order was

placed.

1.3 Individual agreements with the Contractor (in-

cluding individual subsidiary agreements, ad-

denda and amendments) shall always take

precedence over these GTC-P. The same shall

apply for conditions stipulated in Orders from

BI that deviate from these GTC-P.

2. Conclusion of contract, written form re-

quirements

2.1 In its offer and service description, the

Contractor shall adhere precisely to BI's requ-

est and shall expressly alert BI in writing in the

event that there are any deviations from BI's

request.

2.2 Orders and notices of acceptance, amend-

ments, and other agreements existing before or

at the time the contract is concluded must be in

writing to have legal effect (letter, fax, e-mail

– hereinafter referred to as "in writing").

2.3 The Contractor hereby undertakes to examine

the Order without delay for any obvious errors,

ambiguities, gaps, or unsuitability in the spe-

cifications selected by BI for their intended use

and to inform BI without delay of any necessa-

ry changes to or elaborations on its Order.

2.4 Offers shall be provided free of charge to BI

and shall not constitute any obligations on BI’s

part. No compensation shall be payable for the

preparation of cost estimates except by spe-

cific agreement. Sec. 632 (3) German Civil

Code shall apply. Written documents including

offers, offers for contractual addenda, confir-

mations and commercial correspondence must

be addressed to the correct purchasing depart-

ment at BI. Contractors shall fully note all Or-

der-specific details in all written documents


(letters, invoices, consignment notes,

waybills).

2.5 The Contractor shall fulfil its contractual obli-

gations personally or within its own company.

The Contractor's employees must possess the

qualifications required by the laws of the Fe-

deral Republic of Germany.

3. Subcontractors

3.1 The enlistment of subcontractors by the Con-

tractor to render services or partial services re-

quires the prior written consent of BI. BI has

the right to deny the use of individual employ-

ees and subcontractors for cause.

3.2 The Contractor may only contract services to

competent, capable, and reliable subcontrac-

tors. Such subcontractors must also fulfil their

legal obligations to pay taxes and make social

insurance payments, as well as meet the re-

quirements under trade law. Prior to enlist-

ment, the Contractor shall notify BI in writing

of the type and scope of service being con-

tracted, as well as the name, address, and em-

ployers' liability insurance association (includ-

ing member number) of the intended subcon-

tractor. Furthermore, BI is entitled to require

evidence of the competency, capability, and re-

liability of the intended subcontractor.

3.3 The Contractor shall keep BI informed of en-

listed subcontractors and the contracts con-

cluded with them provided such notification

does not conflict with the Contractor's or sub-

contractor's legitimate interests or is not sub-

ject to non-disclosure.

3.4 Should the Contractor enlist subcontractors for

services the Contractor itself provides, BI shall

be entitled to set a reasonable deadline for re-

medial action and declare that the Order shall

be rescinded if the deadline passes without

success should the enlisted subcontractors not

be competent, capable, or reliable, or the Con-

tractor fails to provide evidence of compliance

with this requirement at BI's request within the

set period of time.

3.5 In respect of tasks assumed by subcontractors,

the Contractor shall impose on any approved

subcontractors all obligations it has assumed

vis-á-vis BI and ensure that those obligations

are fulfilled. The Contractor may not prevent

its subcontractors from entering into contracts

with BI for other goods and/or services. In par-

ticular, exclusivity agreements with third par-

ties that prevent the Contractor or subcontrac-

tor from procuring goods or services which the

Contractor or the subcontractor requires to ful-

fil Orders of this kind are prohibited.

4. Delivery and performance deadlines, peri-

ods, early and partial deliveries/services, de-

layed delivery/service, contractual penalties

4.1 The delivery period stated in the Order shall be

binding.

4.2 Early and partial deliveries/services shall only

be permitted with BI's consent and shall be

identified as such in the shipping documents.

4.3 The Contractor shall without delay notify BI in

writing when circumstances arise or become

apparent which make it clear that the Contrac-

tor will be unable to adhere to the agreed de-


livery period. Whenever it provides such no-

tice, the Contractor shall indicate the reasons

for the delay and the anticipated duration

thereof.

4.4 Where the delay is due to a lack of documents

or materials to be provided by BI, the Contrac-

tor shall be entitled to rely on this fact only if it

has previously issued a written reminder to BI

and the documents or materials are not provid-

ed to the Contractor within a reasonable time.

4.5 The Contractor shall be liable to BI for any and

all damages for performance delay [“Verzug”]

to the extent provided by law unless it proves

that the actual damages were not caused by its

delay. BI's acceptance of any belated delivery

of goods or services shall not constitute a

waiver of its claims for compensatory damag-

es.

4.6 If, for reasons that are within the Contractor’s

sphere of responsibility, the delivery does not

occur within agreed delivery period, then upon

expiry of such reasonable grace period as BI

shall set and without prejudice to BI’s further

statutory claims, BI shall be entitled at its op-

tion to demand compensatory damages in lieu

of performance of the contract or to procure

contractual cover from a third party. BI's right

of rescission shall remain unaffected thereby.

4.7 Any contractual penalty [“Vertragsstrafe”] for

a delay in delivery of goods or services which

may be agreed upon by the parties shall remain

unaffected by the foregoing pursuant to Sec.

340 (2) German Civil Code. BI may assert

contractual penalties until such a time as the

final payment falls due without the need to ex-

press any reservation pursuant to Sec. 341 (3)

German Civil Code. Contractual penalties shall

be credited against any claims for damages.

5. Withholding and set-off by the Contractor

The Contractor may only assert a right to

withhold the provision of goods and services

based on claims from the same contractual re-

lationship that are beyond dispute, adjudicata-

ble, or legally established. The Contractor may

only resort to set-off if its counterclaim is be-

yond dispute, adjudicatable, or legally estab-

lished.

6. Prices/terms of payment, invoicing, no as-

signment

6.1 The price specified in the Order is binding and

fixed. Unless otherwise stipulated, the price

includes all expenditures in relation to the de-

liveries and services ordered from the Contrac-

tor, including but not limited to the costs for

any testing, acceptance, documentation, and

creation of technical documents, packaging,

transportation, customs clearance fees, and in-

surance.

6.2 Prices must not include VAT. VAT must be

specified separately.

6.3 BI shall make prepayments only if the Con-

tractor produces an unconditional, first-rate

guarantee issued by a German commercial

bank or savings and loan bank in accordance

with banking industry standard and only with

the express prior agreement of both parties.

Any guarantee commission fees shall be borne

by the Contractor.


6.4 Payments shall be made within net thirty (30)

days of delivery (or, if stipulated, acceptance)

and receipt of a contractually compliant in-

voice. BI may reject any invoices that do not

meet the requirements of subsection 6.5. Re-

garding payment, the stipulated deliv-

ery/performance date shall apply in the event

of early delivery/performance.

6.5 At the time of invoicing, the Contractor's in-

voice must comply with tax regulations as

amended. The following mandatory details are

required in every invoice:

Name and address of the Contractor

Name and address of the legal entity of the

Boehringer Ingelheim Group designated in

the Order as the "customer"

Date of invoice

Order number

Amount and currency of invoice.

Invoices for main orders and any subsidiary,

follow-up, or change orders must be submitted

by the Contractor separately. BI may reject in-

voices containing incomplete or miss-

ing/unverifiable information/documents. In the

event an invoice is reissued, the due date for

payment shall be determined by the date of re-

ceipt of the second, compliant invoice.

6.6 In the event of a delay in payment, default in-

terest shall be charged at a rate of five (5) per-

cent above the base rate of the central bank of

Germany, the Deutsche Bundesbank (sec. 247

and Sec. 288 (2) German Civil Code), as of the

date the payment default occurred. The date of

the bank transfer order shall be considered the

date of payment.

6.7 The Contractor is not entitled to assign or have

collected by third parties its claims against BI

without BI's prior written consent. This shall

not apply if the Contractor grants its supplier

an extended retention of title in the proper

course of business. Sec. 354 (a) German

Commercial Code [Handelsgesetzbuch] shall

remain unaffected.

7. Taxes

7.1 All payments stated shall be inclusive of any

taxes and each party shall be responsible for

and shall bear its own taxes assessed by a tax

or other authority except as otherwise set forth

in the contract. “Taxes” shall mean all forms of

preliminary or finally imposed taxation, do-

mestic and foreign taxes, fees, levies, duties

and other assessments or charges of whatever

kind (including but not limited to sales, use,

excise, stamp, transfer, property, value added,

goods and services, withholding and franchise

taxes) together with any interest, penalties or

additions payable in connection therewith.

7.2 The price is understood to be exclusive of val-

ue added tax (VAT) or comparable indirect

taxes (e.g. goods and service tax, etc.). VAT

and comparable indirect taxes must be paid

additionally as required by law.

7.3 As far as expenses are reimbursed the VAT on

any reimbursed expenses may only be reim-

bursed by BI provided the Contractor cannot

deduct VAT and such inability is not due to

default (e.g. delay) on the part of the Contrac-

tor.


7.4 Should applicable laws or regulations require

BI to withhold taxes on licences or other pay-

ments made under this contract, these taxes

shall be deducted by BI from the taxable li-

cences or payments as required by law and

paid by BI to the proper tax authorities on be-

half of the Contractor. Official receipts of

payment of any withholding tax shall be se-

cured and sent to the Contractor as evidence of

such payment only upon the Contractor´s re-

quest. The parties shall use their best endeav-

ours to ensure that the withholding taxes in-

curred in accordance with the terms of the ap-

plicable double tax treaty are reduced as much

as possible.

8. Transfer of risk/ place of performance/

goods labelling/ transport insurance/ pack-

aging/ shipping list/ acceptance

8.1 Unless otherwise stipulated, risk shall transfer

to BI pursuant to the international Incoterms

clause "DAP" (Incoterms 2020) at the time of

delivery to the BI place of receipt stated in the

Order. This shall also be the place of perfor-

mance. If the Order does not contain a delivery

location, the place of performance shall be the

main office of the BI company that placed the

Order. Should acceptance be stipulated, e.g.

for contracts to produce a work, such ac-

ceptance shall be authoritative for the transfer

of risk; in such case, the German law on con-

tracts to produce a work [“Werkvertrags-

recht”] shall apply mutatis mutandis. Default

of acceptance on the part of BI shall constitute

transfer/acceptance.

8.2 For technical equipment, systems, and machin-

ery, risk shall not be transferred until the corre-

sponding formal acceptance inspection [“Ab-

nahme”] and functional testing have been

completed, and BI has confirmed the function-

ality of the delivery at BI's place of perfor-

mance listed in subsection 8.1. Subsection 10.5

shall apply to functional testing.

8.3 For deliveries requiring assembly and/or instal-

lation by the Contractor, risk shall not be trans-

ferred nor delivery completed until assembly

and/or installation is completed and document-

ed in a written protocol. For legally required or

stipulated acceptance, risk shall not be trans-

ferred nor service rendered until the service

has been rendered in accordance with the con-

tract and accepted; failure on the part of BI to

accept when legally required to do so shall

constitute acceptance. Unless otherwise stipu-

lated, BI must provide legally required or stip-

ulated acceptance of the performed service

within fifteen (15) days of completion.

8.4 Goods shall be properly and appropriately

packaged and labelled as instructed by BI.

Should the Contractor be required to retrieve

transport packaging under the German Packag-

ing Ordinance [Verpackungsverordnung] or

foreign provisions, it must retrieve the packag-

ing at the place of performance (subsection

8.1) at its own cost.

8.5 A shipping list containing BI's Order number,

the contents of the delivery itemised by the

Contractor's item number(s) (if specified in the

Order), and the type and quantity of items is

required for every goods delivery.

8.6 The parties hereby agree that the use of wood

products, including but not limited to pallets,


which have been treated with or come into

contact with substances likely to have an ad-

verse impact on the quality of the goods being

supplied/processed, including but not limited

to halogenated phenolic preservatives, is pro-

hibited across the entire supply chain. The

Contractor shall impose corresponding obliga-

tions in favour of BI upon its suppliers and/or

permitted subcontractors and ensure fulfilment

of such obligations. The imposition of such ob-

ligations shall have no effect on the Contrac-

tor's liability to BI.

8.7 For any transport services purchased from the

Contractor by BI under these GTC-P, BI here-

by expressly waives any and all transport in-

surance offered by the shipper or carrier on

behalf of and at cost to BI. The Contractor's

obligation to insure its commercial liability

under the law and under specific agreements

with BI shall remain unaffected.

Should BI and the Contractor specifically con-

clude a delivery agreement under which BI as-

sumes (even part) of the transport risk in dero-

gation of subsection 8.1, BI hereby also ex-

pressly waives any and all transport insurance.

The provisions of the previous Section shall

then apply mutatis mutandis.

9. Transfer of title, processing of delivered

goods before transfer of title

Should a retention of title be specifically stipu-

lated for the delivered goods, title shall be

transferred to BI no later than upon payment

for said goods. In the course of ordinary busi-

ness, BI is entitled to process, sell, or other-

wise dispose of delivered goods even before

transfer of title.

10. Inspection for defects/ liability for defects/

warranty/ statutes of limitation

10.1 BI shall inspect goods for defects without de-

lay after they are received. Such inspections

shall encompass inspections only in respect to

externally visible damage and defects, and ex-

ternally visible deviations in terms of identity

of the goods and quantity. Such defects shall

be reported immediately. BI reserves the right

to conduct more in-depth goods receiving in-

spections during the normal course of business.

Defects which become apparent in the course

of such inspection and which are not covered

under sentence 2 hereof shall be the subject of

an immediate notice of defect. With respect to

these defects, the Contractor hereby waives the

defence of belated notice of defect. Where BI

ascertains the presence of defects, BI shall be

entitled to return the entire delivery. Notices of

defect found at a later point in time shall be

deemed timely pursuant to Sec. 377 (3) Ger-

man Commercial Code and submitted "without

undue delay" [“unverzüglich”] as defined in

this subsection 10.1 if submitted within five

(5) business days from the date of discovery.

In respect of whether a notice of defect was

reasonably forwarded to the Contractor, the

date on which the notice was dispatched shall

be authoritative.

10.2 Payments made on the stipulated price or ac-

ceptance of goods by BI's representative at the

Contractor's location shall not constitute

recognition of a lack of defects in the goods

and shall not release the Contractor from its li-

ability for defects.


10.3 The Contractor warrants that all goods sup-

plied by it and all services rendered by it shall

conform, as of the date of the transfer of risk,

to the terms and conditions of this contract, as

well as to generally accepted engineering

standards, relevant provisions of law, and the

regulations and guidance of public authorities,

employers' liability insurance associations, and

trade associations, and that the Contractor is

unaware of any pending amendments thereto.

The Contractor shall notify BI without undue

delay of any pending amendments of which it

is aware. Where departures from these regula-

tions become necessary, the Contractor must

obtain BI's written consent thereto. Any such

consent shall not affect the Contractor’s re-

maining obligations under purchase contracts

or contracts to produce a work [“kauf- oder

werkvertraglichen Verpflichtungen”], includ-

ing any guarantees on the quality of the goods

or the works [“Beschaffenheitsgarantie”].

10.4 The Contractor also remains solely responsible

for the goods and services even in the event

that BI approves any drawings, computations,

or other documents, or participates in technical

or official controls, inspections, or acceptance

procedures. The same shall apply in the event

BI accepts any suggestions or recommenda-

tions by the Contractor.

10.5 Unless otherwise stipulated, functional testing

of the technical equipment, systems, and ma-

chinery listed in subsection 8.2 shall be con-

ducted within fourteen (14) days of receipt of

notice of readiness. Subsection 10.1 sentences

5 through 8 shall apply mutatis mutandis.

10.6 To the extent at least two partial deliveries un-

der the same Order with the same Contractor

have been deficient/defective in whole or in

part, BI shall be entitled, following a reasona-

ble grace period without remedy, to cancel the

contract and demand compensation for the

damage caused by the deficient performance

and/or cancellation.

10.7 Unless otherwise expressly stipulated, the stat-

ute of limitations shall apply to warranty

claims from the time of the transfer of risk.

The Contractor shall remedy defects in

goods/services for which BI has given notice

within the statute of limitations by, at BI's dis-

cretion, repairing or replacing the defective

parts, or in case of contracts to produce a work

by refurnishing deficient works at no charge,

including all incidentals. The Contractor's

rights under Sections 275, 439 (3), and 636 (3)

German Civil Code shall remain unaffected.

10.8 The Contractor shall remedy defects, replace

defective goods, or refurnish works without

undue delay. The statutory circumstances of

inhibition and interruption shall apply. For re-

furnishing and replacement, the statute of limi-

tations for warranty claims shall recommence

upon completion of supplementary perfor-

mance [“Nacherfüllungspflicht”] provided

such supplementary performance entails ex-

press or implied recognition of a duty to reme-

dy defects [“Mängelbeseitigungspflicht”]. For

repairing within supplementary performance,

the statute of limitations for warranty claims

shall restart upon completion of supplementary

performance, provided such defect has already

been repaired or in case of deficiencies of re-

pairing and such supplementary performance


entails express or implied recognition of a duty

to remedy defects.

10.9 To the extent the Contractor has guaranteed the

quality or durability of goods, claims pertain-

ing thereto may be asserted independently of

statutory warranty claims. In such an event, the

Contractor shall be liable without fault and re-

gardless of whether the defect existed at the

time of transfer of risk.

10.10 The Contractor's statutory warranty shall also

cover the goods or works of any subcontractors

involved.

10.11 The defective goods or works shall remain in

the possession of BI after BI has given notice

of the defect until such time as an appropriate

replacement is delivered to BI and BI may, if

necessary, make use of them. By such use BI is

not constituting a waiver of warranty rights.

10.12 All further and other claims on the part of BI,

in particular BI's right of rescission [“Rück-

trittsrecht”], right to reduce the purchase price

[“Minderungsrecht”], and its claims for com-

pensation of damages, including damages in

lieu of specific performance, shall remain un-

affected by the foregoing.

10.13 To the extent that the Contractor fails to meet

its obligation of supplementary performance

within such reasonable time as BI shall set, BI

shall be entitled to take the necessary action it-

self at the Contractor's cost and risk, or engage

a third party to take the necessary action (sub-

stitute performance [“Ersatzvornahme”]).

Should a demand for supplementary perfor-

mance from the Contractor with deadline not

be possible due to special urgency, Contractor

unavailability, or impending, unreasonably

high damages, BI shall be entitled without

prejudice to statutory claims to render or have

rendered substitute performance, and demand

compensation from the Contractor for the nec-

essary costs. BI shall notify the Contractor of

such action where possible. The principle of

proportionality pursuant to Sections 439 (3)

and 636 (3) German Civil Code shall be ob-

served with regard to any substitute perfor-

mance.

11. Observance of legal regulations and guid-

ance, compliance, safety regulations, notifi-

cation requirements

11.1 The Contractor shall observe all applicable na-

tional, European, and international regulations

on delivery and other services, specifically in

regard to environmental protection including

energy, health and safety at work, anti-

corruption, anti-terrorism, human rights, prod-

uct safety, and data protection, as amended,

and at its own cost.

11.2 In particular, the Contractor shall, at its own

costs, comply and ensure that its subcontrac-

tors and suppliers comply with the applicable

legal requirements for the use of dangerous

goods, including without limitation those set

forth by the then current EU Directive

2011/65/EU ("RoHS") and its national imple-

mentations, and of the Regulation (EC) No

1907/2006 of the European Parliament and of

the Council of 18 December 2006 concerning

the Registration, Evaluation, Authorization and

Restriction of Chemicals as it may be amended

over time (hereinafter “REACH”). Contractor


guarantees that Product delivered is and con-

tinues to be marketable under REACH.

This obligation includes without limitation

(pre-)registration and approval of any chemical

substances and intermediates which constitute

a product, are contained in such product, or are

required for the manufacture of product, in

particular without limitation when substances

of very high concern as stipulated by the

REACH Regulation and its annexes are in-

volved.

Contractor shall specify a dedicated contact for

all REACH related matters and shall provide to

BI relevant information and documentation

(such as safety data sheets, copy of registration

confirmation issued by the European Chemi-

cals Agency, etc.) upon BI's request.

Upon conclusion of this contract/Order and

whenever an opportunity thereafter, Contractor

shall contact BI for both parties to align which

and how planned applications should be regis-

tered jointly/in tandem.

11.3 The Contractor shall provide BI all infor-

mation on compliance with ICH Q3D (Guide-

line for Elemental Impurities) and chapters 232

and 233 of the United States Pharmacopeia

(Elemental Impurities – Limits) with regard to

any delivered substances intended for use in

BI's chemical pharmaceutical production.

11.4 BI is committed to the fundamental principles

of corporate responsibility and integrity, hu-

man rights, working standards and anti-

corruption laws as set forth in the "Supplier

Code of Conduct" available online at

https://www.boehringer-ingelheim.de/ueber-

uns/geschaeftspartner/dokumente. The Con-

tractor hereby acknowledges these fundamen-

tal principles.

11.5 The performance of the foregoing obligations

in this subsection 11 shall be the Contractor's

primary obligation. Failure by the Contractor

to meet its obligations pursuant to this subsec-

tion 11 and to remedy such a breach within a

reasonable period as set by BI shall entitle BI

to cancel the contract/Order. Further claims for

damages on the part of BI shall remain unaf-

fected.

12. German Minimum Wage Act

[Mindestlohngesetz], German Posted

Workers Act [Arbeitnehmerentsendegesetz]

12.1 The Contractor hereby warrants fulfilment of

all relevant duties pursuant to the German

Minimum Wage Act in the provision of ser-

vices, specifically that the Contractor pays its

employees working in the Federal Republic of

Germany no less than the minimum wage (pur-

suant to Sec. 1 German Minimum Wage Act)

no later than the respective due date. This and

all subsequent regulations for subcontractors

shall apply mutatis mutandis for any chain of

subcontractors.

12.2 The Contractor shall notify BI without undue

delay of any claim asserted under the German

Minimum Wage Act by any employee – re-

gardless whether of the Contractor or a sub-

contractor – engaged for the performance of

the contract or of any proceedings initiated

against the Contractor or a subcontractor for a

https://www.boehringer-ingelheim.de/ueber-uns/geschaeftspartner/dokumente

https://www.boehringer-ingelheim.de/ueber-uns/geschaeftspartner/dokumente


violation or violations pursuant to Sec. 21

German Minimum Wage Act.

12.3 Should BI be held liable pursuant to Sec. 13

German Minimum Wage Act or should pro-

ceedings for a fine pursuant to Sec. 21 (2)

German Minimum Wage Act be initiated, the

Contractor shall indemnify BI against any and

all related costs (including reasonable legal de-

fence costs and any imposed monetary fines).

12.4 Insofar as the German Posted Workers Act is

relevant, subsections 12.1 to 12.3 shall apply

mutatis mutandis.

13. Product liability, right of recourse, recalls

13.1 To the extent that third-party claims are assert-

ed against BI pursuant to the German Product

Liability Act [Produkthaftungsgesetz], the

German Medicinal Products Act [Arzneimit-

telgesetz], the German Environmental Liability

Act [Umwelthaftungsgesetz], German tort law

[Deliktsrecht], or comparable domestic or for-

eign law, the Contractor shall indemnify BI

against all third-party claims in which the Con-

tractor is itself responsible for the damage, the

cause of which was within the Contractor's

control, and the Contractor is itself liable to the

third party. Such indemnification shall include

all expenses necessarily incurred by BI in rela-

tion to such a third-party claim, specifically for

legal defence.

13.2 The Contractor shall indemnify BI against all

third-party claims asserted against BI for the

Contractor's infringement of obligations pursu-

ant to subsection 11.2 (REACH). Such indem-

nification shall include all expenses necessarily

incurred by BI from or in relation to such

third-party claims, specifically for legal de-

fence and all costs associated with procuring

necessary replacement.

13.3 Furthermore, the Contractor shall indemnify

BI against all third-party claims of violation of

patents, copyrights, design rights, trademarks,

name rights, and other industrial property

rights or applications for the same (hereinafter

referred to as "Property Rights") arising from

the contractual use of the delivery or work, un-

less the Contractor informed BI in writing up-

on conclusion of the contract of the possibility

that use of the delivery or work could consti-

tute a violation of Property Rights, or the Con-

tractor is not responsible for the violation on

other grounds.

Such indemnification shall include all expens-

es necessarily incurred by BI in relation to

such a third-party claim, specifically for legal

defence.

Furthermore, BI shall be entitled at its discre-

tion either to procure a licence of use of the

supplied goods from the holder of the right at

the Contractor’s cost and expense, or to cancel

the contract.

Should the Contractor be liable pursuant to this

subsection 13.3, it shall be responsible for all

consequential damages incurred by BI, specifi-

cally as a result of supply bottlenecks and pro-

duction stoppages.


13.4 Other rights arising from Property Rights vio-

lations on the part of the Contractor shall re-

main unaffected.

13.5 In the event of a necessary and/or officially or-

dered recall or other action required to avoid

risks to persons or third-party property, the

Contractor shall be liable for any and all ex-

penses, costs, and damages incurred by BI due

to the recall or other action, and shall indemni-

fy BI against corresponding third-party claims

insofar as the recall or other action is due to

the fact that the delivered goods and/or pack-

aging or work is in breach of contract, specifi-

cally that the stipulated specifications were not

observed or contractual assurances were not

met, or there exist product defects, unless the

Contractor is not responsible for the aforemen-

tioned. Further claims by BI shall remain unaf-

fected.

BI shall, to the extent feasible and reasonable,

inform the Contractor as to the substance and

scope of any recalls to be carried out and af-

ford it an opportunity to comment.

13.6 Further obligations notwithstanding, the Con-

tractor shall notify BI without undue delay if it

becomes aware of any specific circumstances

pertaining to the delivered goods or rendered

services that would make it necessary for BI or

the Contractor to conduct a recall or other ac-

tion pursuant to the aforementioned provision

in subsection 13.5 and/or create a relevant risk

of product liability cases. Any legal reporting

requirements to which the parties are subject

shall remain unaffected.

14. Statute of limitations on right of recourse

To the extent BI's customers assert claims

against BI and such claims are for defects in

the goods supplied by the Contractor, BI's

claims for recourse shall be valid for a period

of five (5) years from the date of delivery by

the Contractor to BI.

15. Employers' liability and product liability in-

surance

The Contractor shall take out a policy of com-

prehensive general liability and product liabil-

ity insurance, at its own cost and expense, and

for the duration of its contract with BI, and the

cover must be customary in the market and ap-

propriate to the risk, but shall be no less than a

lump sum of five (5) million euros for personal

injury and damage to property per insured

event, including cover for indirect damages,

covering such losses as are caused by the Con-

tractor, or its employees or representatives as a

result of services rendered, works supplied or

goods delivered. BI shall be entitled to demand

that the Contractor furnish an appropriate con-

firmation of insurance cover from the Contrac-

tor's insurance provider. The Contractor shall

furnish such evidence of insurance cover with-

out undue delay upon BI's request. Any further

claims to which BI is entitled shall remain un-

affected.

16. Good manufacturing practice, requirements

for quality, packaging, and transport of ac-

tive ingredients and excipients

16.1 Should the products ordered by BI be used to

manufacture medicinal products and/or medi-


cal devices and/or cosmetics and/or food, the

World Health Organisation's "Requirements on

the Quality, Packaging and Transport of Active

Ingredients and Excipients for the Pharmaceu-

tical Industry" as amended, as well as the ap-

plicable GxP guidelines in the product's coun-

try of manufacture/origin shall be observed.

16.2 Each delivery should, wherever possible, orig-

inate from a single batch, i.e. constitute a ho-

mogeneous unit. The batch number shall be

marked on each packaging unit as well as on

the consignment note. Should the delivery con-

sist of two or more batches of the same prod-

uct, all batch numbers shall be marked on the

packing units and the shipping list.

16.3 In all cases of continuous manufacturing pro-

cesses in which it is not possible to record

products by batch, the Contractor shall ensure

that quality conforms to specifications. Each

unit of packaging shall be labelled in a perma-

nent and clear fashion, containing the product

name, net weight, tare, batch number, and any

possible risks and storage information.

16.4 The Contractor shall be liable for losses and

costs resulting from any failure to comply with

these rules, including on the part of its subcon-

tractors.

16.5 Goods shall be inspected for compliance with

the rules under subsections 16.1 to 16.4 imme-

diately upon receipt. Goods shall only be in-

spected for externally visible damage and de-

fects in regard to the rules under subsections

16.1 to 16.4. Such defects shall be reported

immediately. BI is entitled to refuse ac-

ceptance of and reject the delivery in the event

the rules under subsections 16.1 to 16.4 are not

observed. BI reserves the right to conduct

more in-depth goods receiving inspections for

compliance with the rules under subsections

16.1 to 16.4 during the normal course of busi-

ness. Defects which become apparent in the

course of such inspection shall be reported

immediately. With respect to these defects, the

Contractor hereby waives the defence of belat-

ed notice of defect. Where BI ascertains the

presence of defects, BI shall be entitled to re-

turn the entire delivery. The rules in subsection

10.1 otherwise apply mutatis mutandis.

17. Anti-corruption

17.1 The Contractor represents and warrants that it,

its owners, directors, officers, employees, sub-

contractors and agents will act in full compli-

ance with any applicable anti-corruption laws

and regulations, including the FCPA, UK

Bribery Act, German Criminal Code, etc. and

industry and professional codes of practice.

Without limiting the generality of the forego-

ing, the Contractor represents and warrants in

particular that the Contractor, its owners, di-

rectors, officers, employees, subcontractors

and agents will not directly or indirectly in

connection with the business of BI or with this

contract:

(i) offer, promise, pay or arrange for pay-

ment or giving of a bribe or any benefit,

advantage or anything of value to any

Public Official, individual, entity or any

other third party in exchange for an im-

proper advantage in any form either di-

rectly or indirectly in order to fulfil, ob-

tain or retain (a) regulatory requirements,


(b) any kind of business including any

commercial transaction to which BI is a

party, or which is otherwise in connec-

tion with this contract or (c) any other

improper advantage;

(ii) transfer anything of value to a Public Of-

ficial without the prior approval of the BI

contact person, regardless of whether or

not such transfer might constitute a bribe;

(iii) transfer anything of value to subcontrac-

tors, agents or any third party for the

purpose of offering, promising, paying,

receiving, soliciting, or arranging for the

payment of, or reimbursing anyone for

payment of, a bribe or a transaction of

anything of value to a Public Official;

(iv) or request, accept a promise of or receive

any payment, benefit or advantage from

any individual or entity for oneself or for

a third party in return for giving another

person or entity unfair preferences in the

procurement of goods or commercial or

other services in connection with this

contract.

17.2 For the purpose of this contract, “Public Offi-

cial” means any officer or employee of a local

or foreign government or any department,

agency, political party, institution, or instru-

mentality thereof (including officers and em-

ployees of government controlled entities), or

of a public international organisation as well as

any person acting in an official capacity for or

on behalf of any such government, department,

agency, institution or instrumentality, or for or

on behalf of any such public international or-

ganisation as well healthcare professionals,

working in healthcare institutions, in which the

central, regional or local government owns an

interest or has control or which are paid partly

or as a whole by the government.

17.3 The Contractor shall report any suspicion of

past, current or potential violations of this Sec.

17 to the BI contact person. If the Contractor is

in doubt whether a certain act violates its obli-

gations under this Sec. 17, the Contractor shall

contact the BI contact person and shall delay

the decision before taking the action.

17.4 The Contractor shall ensure that its directors,

officers, employees, subcontractors and agents

receive appropriate anti-corruption training.

17.5 The Contractor agrees that BI shall have the

right, at its cost, at any time upon reasonable

prior notice, to audit Contractor’s records to

ensure its compliance with the provisions of

this contract and applicable laws and regula-

tions by ensuring high level of confidentiality.

In addition, upon BI‘s request from time to

time, the Contractor agrees to certify compli-

ance with the foregoing in a form suitable for

BI.

17.6 Any violation of this Sec. 17 constitutes a ma-

terial breach of this contract. In addition to any

other sanction provided by law and/or this con-

tract, BI may terminate this contract for cause

and with immediate effect, if the Contractor

violates its obligations under this Sec. 17.

17.7 The Contractor is aware of and acknowledges

that BI will exclude any potential contractual

partners who engage in bribery, collusive prac-


tices or any other form of corruption or fraud

from bids for tenders and future contracting.

17.8 The Contractor shall indemnify and hold BI

harmless for any loss or damage resulting of a

breach by the Contractor, its directors, officers,

employees, subcontractors and agents of this

Sec. 17 or of any applicable laws and regula-

tions.

18. Export control clause

18.1 The Contractor understands and agrees that the

items including goods, software, technology

(specific technical information necessary for

the development, production, or use of a prod-

uct) and technical services provided to BI un-

der this contract may be subject to internation-

al, U.S. and any other applicable export control

laws and regulations (hereinafter “Laws”) re-

stricting exports, re-exports, transfers or dis-

closures, regardless of the mode of provision

(hereinafter “Transactions”). The Contractor

shall comply with all such Laws. The Contrac-

tor shall determine whether an item is con-

trolled under the Laws and identify the specific

export control status of the item. If the item is

subject to any restrictions or license require-

ments under the Laws, the Contractor shall no-

tify BI about these restrictions prior to provid-

ing the item to BI, including information on

where the controlled item is listed (e.g. U.S.

Commerce Control List). The Contractor shall

cooperate with BI by providing upon request

information and other assistance necessary for

the classification (e.g. on the US Export Con-

trol List), export documentation, license de-

termination, export licensing, etc. of items

provided to BI under this contract.

18.2 The Contractor confirms that it is neither a

sanctioned party (i.e. sanctioned by any sanc-

tioned party list) nor controlled by a sanctioned

party to 50% or more. The Contractor shall no-

tify BI without undue delay in case of any

changes in this status.

18.3 The Contractor shall cooperate fully with BI in

any official or unofficial audit or inspection re-

lated to this contract in connection with the

Laws.

18.4 The following shall apply in the event BI pro-

vides the Contractor with items pursuant to this

contract:

a) The Contractor shall not, without first ob-

taining permission to do so from the ap-

propriate authorities, perform any further

Transactions of items provided by BI un-

der this contract should (i) the item be

controlled under the Laws; (ii) the Trans-

action be to any country, person or other

party that is ineligible to receive such

item, i.e. sanctioned by any sanctioned

party list (hereinafter: “Sanctioned Party”)

or embargo under the Laws; or (iii) the

Transaction be to a person or other party

if the Contractor knows or has reason to

assume that such person or party intends

to provide the item to any such country,

person or party, or intends to use or allow

others to use the item for activities related

to military or otherwise restricted use.

b) BI will only perform any Transaction of

items if the Transaction is not restricted

by the Laws. BI is not obliged to perform

any Transaction of items if the required


licenses or other documents have not been

received.

c) The Contractor shall indemnify and hold

BI harmless against any third party claims

arising from or in connection with any of

the provisions of this Section including

any violations by the Contractor`s em-

ployees, consultants, agents, or customers.

19. Changes to products or processes

The Contractor shall inform BI without undue

delay, in writing, and in advance of any in-

tended changes to products and/or manufactur-

ing processes or analysis methods. Changes to

products refers e.g. to changes in product qual-

ity, quality and source of raw materials, syn-

thesis route, including chemicals used, size and

type of production lines, production sites, sig-

nificant increases in batch size (more than thir-

ty (30) percent), and outsourcing of production

stages and/or analysis work.

20. Confidentiality of and title to information

20.1 The Contractor shall hold in strict confidence

all visual, verbal, written, and/or electronic in-

formation, data, material, or know-how, as

well as samples and specimens pertaining

thereto (hereinafter collectively referred to as

"Confidential Information") either designated

confidential or for which it should be assumed

that they should be handled as confidential,

and which is disclosed during ordering or ob-

tained during execution of the Order for the

duration as well as after the conclusion of the

Order, and accordingly to refrain from disclos-

ing Confidential Information to third parties

without the prior written consent of BI except

to execute the Order, from making any com-

mercial use of Confidential Information what-

soever, and from engaging in any other activity

in relation to disclosed and obtained Confiden-

tial Information.

20.2 The parties shall protect Confidential Infor-

mation (specifically of a proprietary, scientific,

or technical nature) against unauthorised ac-

cess by third parties. To the extent Confiden-

tial Information is communicated via the Inter-

net, the use of encryption technology shall be

required (for direct communication between

the parties, BI shall provide suitable technolo-

gy free of charge at http://guides.boehringer-

ingelheim.com).

20.3 The Contractor shall not decompile, reassem-

ble, reverse engineer or otherwise analyse any

part of the Confidential Information of BI

without BI´s explicit written consent.

20.4 Requirements on the confidentiality and non-

use of Confidential Information shall not apply

to the extent such Confidential Information (a)

was known to the Contractor prior to disclo-

sure by BI, (b) was or will be generally known

through lawful publication or other lawful

means without the Contractor's involvement,

(c) was otherwise (i.e. without directly or indi-

rectly originating from BI) demonstrably dis-

closed to the Contractor without violation of a

duty of confidentiality, or (d) must be dis-

closed by law. Information that can only be ob-

tained by compiling isolated, publicly availa-

ble pieces of information shall not be consid-

ered generally known.

http://guides.boehringer-ingelheim.com/

http://guides.boehringer-ingelheim.com/


20.5 To the extent employees of the Contractor or

third party (including subcontractors) require

access to Confidential Information in order to

perform the contract, the Contractor shall con-

tractually impose upon them the same obliga-

tions specified in subsection 20. The Contrac-

tor shall verify such to BI in writing upon re-

quest.

20.6 The Contractor shall, at BI's discretion, return

to BI or destroy or erase all Confidential In-

formation received and/or obtained upon com-

pletion of the Order and without retaining any

copies or data. To the extent required by law,

the Contractor shall retain a copy for documen-

tation purposes.

20.7 All Confidential Information BI has provided

to the Contractor for purposes of its perfor-

mance of the contract and the documents the

Contractor has prepared to BI’s specific direc-

tions shall remain the property of BI, and the

Contractor may not use them, reproduce them,

or provide them to third parties for any other

purpose. BI hereby expressly reserves its intel-

lectual property rights to all Confidential In-

formation provided to the Contractor. To the

extent that BI incurs losses as a result of a

breach of any of these obligations, the Con-

tractor shall be liable to BI.

20.8 The provisions of this subsection 20 shall ex-

tend for ten (10) years beyond the mutual

completion of the Order, subject to any legal

confidentiality requirements beyond this peri-

od.

21. Data protection

The Contractor shall comply with applicable

data protection laws. To the extent that the

Contractor collects, processes or uses personal

data on behalf of BI when rendering the work

(“Processing”) according to Article 28 of the

EU General Data Protection Regulation

2016/679, the Contractor shall, upon BI’s re-

quest, enter into any additional contractual ar-

rangement which is, in BI’s reasonable opin-

ion, required by applicable law, especially in

case of transfers of personal data to recipients

outside the European Union. Such contractual

arrangements may include (i) BI’s standard

contract for Processing, and/or (ii) the Europe-

an Union’s Standard Contractual Clauses for

the transfer of personal data to processors

and/or (iii) any other agreement that competent

data protection authorities have declared to be

compulsory or acceptable to comply with data

protection law obligations.

22. Rights to results and publication

22.1 All data, materials, documents, experience

(know-how), and all other results (hereinafter

referred to as "Results") obtained in the course

of providing the deliverable are the exclusive

property of BI. The Contractor hereby assigns

to BI any and all rights to the Results, includ-

ing but not limited to all copyrights, personali-

ty rights, and trademarks, as well as any and all

associated rights, including all conceivable le-

gal rights to designs (technical designs, drafts,

concepts). BI shall be exclusively entitled to

exploit the Results in any place at any time

without restriction.


22.2 BI shall also acquire exclusive title to all cor-

poreal items of property and data storage me-

dia created by the Contractor or at the Contrac-

tor's direction in connection with the delivera-

bles and performance provided to BI.

22.3 The Contractor shall notify BI without undue

delay of any protectable inventions resulting

from the work performed by the Contractor. At

BI's request, the Contractor shall assert an un-

restricted claim to the inventions vis-à-vis the

inventors and shall thereupon unconditionally

transfer these rights to such inventions to BI

without further compensation.

22.4 BI shall have the sole right to apply for proper-

ty rights globally, with reference to the inven-

tor(s), in its own name and at its own cost, and

likewise to use the invention exclusively and

without restriction. To the extent necessary,

the Contractor shall support the granting and

maintaining of these property rights by provid-

ing such declarations as BI may request from

time to time. The Contractor guarantees that

the inventor(s) shall be made available to BI at

no charge in a timely manner and to a reasona-

ble extent to assist with the patent applica-

tion(s), and submit any declarations necessary

for the granting and maintaining of the pa-

tent(s).

22.5 The Contractor guarantees that appropriate

agreements have been or shall be concluded

before the start of performance with all third

parties involved in the deliverables and per-

formance, including but not limited to its em-

ployees and/or subcontractors that permit the

Contractor to possess the rights specified in

this subsection 22 to the extent described here-

in.

22.6 All rights of publication shall lie exclusively

with BI. Any publication that is planned by the

Contractor, its employees, or third parties en-

gaged by the Contractor must be forwarded in

manuscript or photocopy to BI in advance for

its written consent. BI shall render a decision

in this respect within six (6) weeks.

22.7 The Contractor shall provide the deliverables

(services and items) of the contract or Order

free of any and all third-party rights. Insofar

the Contractor hereby warrants that it is the

exclusive copyright holder of the deliverables

(services and items) of the contract or Order,

and has made no dispositions in conflict with

the transfer of these rights to BI. Where this is

not certain with respect to specific (partial)

works resulting from the provided deliverables

and performance, the Contractor shall inform

BI in writing and furnish BI with all known

facts.

22.8 The Contractor further warrants that it shall

grant all copyright and related rights holders

involved in providing the deliverables (ser-

vices and items) of the contract or Order an

appropriate stake in the resulting earnings as

required by law, including but not limited to

the German Copyright Act [Gesetz über Ur-

heberrecht und verwandte Schutzrechte].

22.9 The Contractor shall fully indemnify BI

against third party claims asserted against BI

pursuant to Sec. 32 (a) German Copyright Act.


22.10 Furthermore, the Contractor shall fully indem-

nify BI against all third party claims asserted

on the basis of any infringement of industrial

property rights or copyright as a result of the

Contractor's contractual provision of the deliv-

erables and performance.

23. Title to provisions

23.1 Unless otherwise stipulated, all patterns, mod-

els, tools, films, materials, raw materials, etc.

which BI has produced/procured for the Con-

tractor to execute the Order or provided for the

Contractor to perform the contract, including

associated documentation (hereinafter collec-

tively referred to as "Provisions"), shall be-

come the property of BI, even where they re-

main in the possession of the Contractor (con-

structive possession of chattels by agreement

[“Besitzmittlungsverhältnis”], Sec. 930 Ger-

man Civil Code).

23.2 The Provisions may only be used to perform

the contract for BI, and may only be repro-

duced as required by operations and in compli-

ance with copyright provisions, and only inso-

far as absolutely necessary to perform the con-

tract.

23.3 The Contractor shall label the Provisions

"Property of Boehringer Ingelheim", store

them with due care at its own cost separately

from the Contractor's property for the duration

of the contract, handle them with care, main-

tain them at its own cost, and insure them

against loss. Provisions may not be removed,

sold, assigned by way of collateral, pledged,

etc. from the location specified in the Order,

without the prior consent of BI. The Contractor

shall bear the risk of loss and damage regard-

ing the Provisions, however not of normal

wear.

23.4 The Provisions, including any duplicates, shall

be returned to BI without undue delay follow-

ing performance of the contract.

24. Delivery of documents

The Contractor shall deliver to BI all docu-

ments required by BI to use, set up, assemble,

process, store, operate, maintain, inspect, ser-

vice, and repair the delivered item promptly,

without solicitation, and at no cost. The stand-

ards and guidelines specified by BI shall apply

as amended.

25. Property of Contractor

BI shall not be liable for the accidental loss,

damage or other deterioration of property

brought by the Contractor or its employees on-

to BI’s premises for purposes of assembly,

servicing, inspection, maintenance, etc.

26. No exploitation of business relationship for

advertising purposes

The Contractor is not permitted to refer to the

business relationship it has with BI in any in-

formational or advertising material, or to use

the name, corporate logo or trademarks of BI

and/or BI Affiliates and/or partner companies

of BI for advertising purposes without BI's

prior written consent.


27. Health and safety rules and regulations

27.1 The Contractor shall strictly adhere to envi-

ronmental health and safety rules and regula-

tions pursuant to the code of conduct for BI's

partner companies and their employees. This

code of conduct shall be applicable to all con-

tractors, constituting an integral part of the

contract, and Contractors shall likewise impose

a binding obligation on their BI-approved sub-

contractors. The Contractor shall verify such to

BI in writing upon request.

The text of the code of conduct for BI partner

companies and their employees as amended

can be found online at

https://partners.boehringer-

ingelheim.com/index.php?lang=en

All environmental (including energy), health

and safety orientation and training sessions

will be provided at the time the contract is

awarded at no cost to the Contractor.

27.2 In the event that the Contractor violates the

code of conduct or established protections de-

spite warning and a reasonable period for re-

mediation, BI shall be entitled to terminate the

contractual relationship without notice and

demand compensation for the resulting damag-

es. In addition, the Contractor may be (tempo-

rarily) excluded from further business relation-

ships with BI.

27.3 The health and safety training under the code

of conduct referenced in subsection 27.1 shall

be deemed a condition precedent to any grant

of access to BI's plant. BI shall furnish binding

training documentation in respect thereof. That

training documentation as amended can be

found online at

https://partners.boehringer-

ingelheim.com/index.php?lang=en

The Contractor shall register its employees

with the BI liaison by using the registration

form which may be downloaded off the Inter-

net, wherever possible five (5) days prior to the

commencement of work. Submission of a reg-

istration form shall be deemed to constitute

confirmation by the Contractor that it has in-

structed its employees on BI's code of conduct

for BI partner companies. The Contractor shall

likewise satisfy this pre-registration obligation

with respect to the employees of its approved

(sub)contractors. At such time as the job

comes to an end and/or access authorisation

expires, the Contractor shall ensure that the

plant access IDs are returned to BI.

28. Further provisions

28.1 The Contractor is not entitled to assign rights

or delegate duties under the Order to third par-

ties in whole or in part without BI's prior writ-

ten consent.

28.2 The parties hereby agree that BI may assign all

rights or delegate all duties pursuant to this

contract to any BI Affiliate, and that any of

BI's rights or obligations pursuant to this con-

tract may be exercised by one of its Affiliates.

28.3 “Affiliate” means any entity which directly or

indirectly Controls, is Controlled by, or is un-

der common Control with a Party. “Control”

means direct or indirect ownership or control

of more than 50% (fifty percent) of the voting

https://partners.boehringer-ingelheim.com/index.php?lang=en





interests of the Party or the power to direct or

cause the direction of the management and pol-

icies of such Party whether by contract,

through majority ownership of voting capital

stock or otherwise. “Controlled” shall be inter-

preted accordingly.

28.4 In the event that portions of the Order, includ-

ing but not limited to portions of the contractu-

al object, are performed by the Contractor in

close collaboration with a BI Affiliate, BI shall

inform the Contractor. In such cases, the Con-

tractor shall issue its invoice directly to that

Affiliate. The invoice shall refer to each im-

putable deliverable pursuant to the contractual

object using the information provided by BI.

However, BI shall remain liable for the proper

payment of the invoice pursuant to the Order

by the respective Affiliate. All payments made

by the appropriate Affiliate shall satisfy BI's

obligations under that Order.

28.5 Neither party may be held liable for defaults or

delays in performing their contractual obliga-

tions where such are attributable to force

majeure such as war, fire, flood, civil unrest,

strikes, government actions or controls, and for

other reasons beyond the control of the party in

question (hereinafter referred to as "Force

Majeure Situations"). The party affected by

force majeure shall make every effort to coun-

teract the incident and shall coordinate with the

other party as to emergency measures. Where

the Force Majeure Situation persists for more

than one (1) month, the party unaffected by

force majeure shall be entitled to exceptional

termination at any time.

28.6 The partial or complete failure to assert, or a

delay in asserting any right by any party shall

not be deemed a waiver or abandonment of

such a right. Waivers of a right by a party may

be made only in writing signed by that party.

29. Governing law

The contract is subject solely to German law.

The UN Convention on the International Sale

of Goods (CISG) and conflict of laws shall not

apply.

30. Jurisdiction and venue

Exclusive jurisdiction and venue for all dis-

putes shall be the competent court in Mainz,

Germany. This shall also apply to any litiga-

tion on bills of exchange and cheques.

31. Severability clause

Should any individual provisions of these

GTC-P be deemed invalid in whole or in part,

the validity of the remaining provisions shall

remain unaffected.

32. Precedence of German version of GTC-P

The native language for BI is German. This

English version of the GTC-P is a translation

based on the German version of BI’s General

Terms and Conditions of Purchase [“Allge-

meine Einkaufsbedingungen” – “AEB”]. In

case of any inconsistencies between the con-

tent of this English translation and the content

of the German AEB, the content of the Ger-

man AEB shall prevail.


Part II:

Special Terms and Conditions for Services

33. Object of the Order

33.1 The Special Terms and Conditions for Services

set forth below shall apply to services of all

kinds, such as any and all consulting, market-

ing, market research, testing, maintenance, or

cleaning services, but shall also refer to per-

formance-based services, such as laboratory

services, sample logistics, or method develop-

ment (hereinafter collectively referred to as

"Service" or “Project”) which do not constitute

construction, engineering, or planning services,

to which BI's Terms and Conditions of Con-

tract for Construction Services [“Vertragsbed-

ingungen für Bauleistungen”] shall apply ex-

clusively.

The object of the Order shall be the Contrac-

tor’s performance of the Service or Project de-

scribed in the specification of services or pro-

ject description contained in the Order (as well

as in BI’s invitation to tender and the Contrac-

tor's offer).

33.2 Changes to the Service as described in the

specification of services shall require BI's prior

written consent. Regarding changes that could

have an impact on the costs, quality, or sched-

ule of the Service/Project, the parties shall

agree on a change to the Order. Otherwise, the

Contractor shall not be entitled to demand any

compensation for such changes. The Contrac-

tor shall notify BI in writing and without un-

due delay of any changes as soon as they be-

come apparent.

34. Principles of the contract

34.1 BI shall appoint a coordinator to handle all

substantive questions in connection with this

Order.

34.2 The Contractor shall appoint a coordinator for

coordinating the Service/Project (hereinafter

referred to as "Coordinator") who shall be au-

thorised to accept instructions and individual

orders from BI. The Coordinator shall also re-

main available to BI as its contact on all tech-

nical and commercial queries. The Contractor

shall notify BI in writing of the identity of the

Coordinator. The Contractor shall ensure that

the Coordinator's duties generally are not as-

signed to any other person. Should such an as-

signment or delegation take place for legiti-

mate reasons and/or is requested by BI, the

Contractor shall without undue delay inform

BI of the identity and qualifications of the new

Coordinator. BI shall then have the right, with-

in a reasonable period, to refuse or consent to

the reassignment.

34.3 The parties shall appoint one deputy each for

these Coordinators.

35. Obligations of the Contractor

35.1 The Contractor shall take all steps necessary to

perform the Service/Project pursuant to the

specification of services, and shall inform BI

regularly of the progress of the work.


35.2 The Contractor shall promptly submit the full

and detailed Results as agreed in the specifica-

tions of services for BI's review and approval.

At BI's request, the Contractor shall make all

reasonable changes to the Results to be deliv-

ered within one (1) week of receiving BI's

written request.

35.3 The Contractor shall ensure that:

(i) the Service described in the specifications

of services is performed within the stipu-

lated times and in accordance with rele-

vant legal provisions and recommenda-

tions, as well as pursuant to the agree-

ments made in the Order;

(ii) trained and appropriately qualified em-

ployees are scheduled in order to perform

the Service within the planned time frame;

(iii) all data, reports, and other information

provided to BI reflect the latest scientific

knowledge, and have been compiled in

such format as has been agreed with BI;

(iv) to the extent applicable, it complies with

all relevant codes of conduct, including

MRS, ABPI, and ESOMAR (International

European Society for Opinion and Market

Research) in the most current version, as

well as any applicable local codes of con-

duct;

(v) to the extent applicable, it has complied

with the relevant legal provisions and

regulations on collaboration between the

pharmaceutical industry and healthcare

professionals, such as the IFPMA Code of

Marketing Practices, the EFPIA Code of

practice on the promotion of medicines,

and the FSA Code of Conduct on the Col-

laboration with Healthcare Professionals

of the association on collaborating with

Healthcare Professionals ["Freiwillige

Selbstkontrolle für die Arzneimittelindus-

trie e. V.”] (FSA Code on Healthcare Pro-

fessionals) [http://www.fs-

arzneimittelindustrie.de/kodex- fach-

kreise.html].

36. Engagement of healthcare professionals and

healthcare organisations

36.1 The cooperation, including contractual rela-

tionships, between the pharmaceutical industry

and healthcare professionals and healthcare or-

ganisations (the “Covered Recipients”) is sub-

ject to certain laws. These laws are relevant al-

so in case that the Contractor engages a Cov-

ered Recipient when rendering the Services.

Consequently, the Contractor shall include in

its agreements with Covered Recipients any

mandatory provision in accordance with appli-

cable laws. BI shall provide advice to the Con-

tractor with respect to the required approval

process and mandatory provisions.

36.2 Any transfer of value to a Covered Recipient

may be subject to reporting/disclosure re-

quirements under the laws of certain countries

such as the United States and European coun-

tries. As details to be reported/disclosed may

vary depending on the country of origin of the

Covered Recipient BI shall inform the Con-

tractor about relevant details in each case (the

“Mandatory Details”).


36.3 The Contractor shall support BI in meeting its

reporting/disclosure obligations. Before enter-

ing into the agreement with the Covered Re-

cipient the Contractor shall provide BI with the

required details for the approval process for a

fair-market-value-check (if required). BI shall

inform the Contractor about the Mandatory

Details for reporting and shall provide a tem-

plate for the spend reporting (“Spend Capture

Portal Template”). The Contractor shall send

the completed Spend Capture Portal Template

to BI as soon as possible after a payment or

other transfer of value to a Covered Recipient,

however, no later than by 31 December of the

respective year.

36.4 Prior to any transfer of data to BI during the

approval process or the conclusion of the con-

tract between the Contractor and the Covered

Recipient, whichever occurs first, the Contrac-

tor shall inform the Covered Recipient about

BI’s reporting/disclosure obligations and ob-

tain Covered Recipient’s consent for using

Mandatory Details for the general preparation

of the report. If required by applicable data

protection laws, BI shall directly obtain the

Covered Recipient´s consent for the disclosure

of its personal data in the report.

37. Obligations of the Contractor regarding

pharmacovigilance

37.1 As used herein an “Adverse Event” or “AE”

means any undesirable medical occurrence in a

patient (human or animal) or participant in a

clinical study to whom a BI pharmaceutical

product for humans or animals has been ad-

ministered which is not necessarily related to

the respective treatment.

37.2 In order to enable BI to comply with its

world-wide regulatory reporting responsibility,

the Contractor shall forward to BI all infor-

mation received on an AE within one (1) busi-

ness day after the Contractor became aware of:

a) any AE,

b) any report where the embryo or foetus

may have been exposed to the medicinal

product via mother or semen with and

without event and any AEs in conjunction

with breastfeeding;

c) any report of lack of effect, medication er-

ror with/without AE, overdose

with/without AE, abuse with/without AE,

misuse with/without AE, drug-drug or

drug-food interaction, transmission of an

infectious agent via a BI product, off label

use (use outside the approved indication

or contrary to a contraindication)

with/without AE;

d) any report of product complaints or falsi-

fied product associated with an AE;

e) any information where at least adverse

event information after intake of a BI ac-

tive substance/product by patient(s) is

available, and all other information (e.g.

about counterfeits) regarding a BI product

that might lead to a risk for a patient.

37.3 The Contractor shall forward all information in

English translation on AEs on the aforemen-

tioned items a) through e) as it has been re-

ceived, without screening, selection or further

processing, either by fax or secure e-mail to

the following BI PV global indicating the date

of receipt:

Fax: +49 6132-72 90454


E-mail:

PV_global_casemanagement@boehringer-

ingelheim.com

37.4 Upon BI’s request, the Contractor shall pro-

vide BI with further information on the respec-

tive AE report.

37.5 Depending on the scope of Services under this

contract, BI may request the Contractor to

comply with additional PV requirements, in-

cluding but not limited to PV training for the

Contractor’s personnel engaged in the provi-

sion of the Services. The Contractor agrees to

comply with all PV provisions required by ap-

plicable law or BI policies (e.g. SOPs) which

shall be specified in writing for each Order, as

required.

37.6 The Contractor shall apply with all archiving

and record-keeping requirements according to

respective industry standards and applicable

law. With regard to records retention the Con-

tractor shall apply its internal processes and

systems on records retention.

38. Compensation

38.1 As consideration for the contractual perfor-

mance of the Service/Project, the Contractor

shall receive the maximum amount stated in

the Order under "Total net value" plus the stat-

utory VAT where applicable.

38.2 The amount specified in the Order shall be

due each month and shall be charged on an

hourly or daily rate basis. The Contractor shall

append a detailed itemisation to each invoice,

indicating the following information: i) name

of Contractor(s) or staff, ii) qualification level,

iii) date service was provided, iv) brief de-

scription of work and v) number of days of

Service.

OR

The amount specified in the Order is calculated

and stipulated based on the assumptions in the

specification of services. This amount shall

cover all costs and expenses (both internal and

transit costs) arising in connection with the

Contractor's performance of the Ser-

vice/Project excluding travel costs. Transit

costs shall be set at the actual costs, i.e. less

profit, overhead, administrative fees, or sur-

charge. BI shall be entitled to audit compliance

with this clause. Upon request, the Contractor

shall furnish BI with all necessary documents

for such an audit without undue delay.

The applicable mode of compensation shall be

agreed in the respective Order.

38.3 Transit costs and travel costs shall then only be

reimbursable by BI when they (i) were agreed

to by BI in writing and (ii) the Contractor

submits the original receipts. The travel ex-

pense guidelines as amended shall be provided

by BI and shall apply mutatis mutandis.

39. Term and termination

39.1 The contractual relationship shall commence

upon ordering by BI and shall end upon full

performance of the Service/completion of the

Project, however no later than upon conclusion

of a stipulated performance period.

mailto:[email protected]



39.2 The right of both parties to terminate the con-

tract without notice for cause [“Kündigung aus

wichtigem Grund”] shall remain unaffected.

Specifically, a gross breach of contractual ob-

ligations by the other party shall constitute

cause.

39.3 Furthermore, any merger of the other party

with a third party to the extent that it entails a

major change in ownership and control shall

constitute cause. Each party shall inform the

other party without undue delay and in writing

of any such change or of any such merger.

However, this provision shall not apply should

(i) a change of ownership amongst the current

owners/shareholders take place, or (ii) the

change of ownership be effected by way of a

corporate restructuring scheme within the BI

Group.

39.4 BI shall furthermore be entitled to terminate its

Order at any time and with immediate effect.

In such case, however, BI shall be obliged to

compensate the Contractor for all Services it

has hitherto rendered pursuant to the specifica-

tion of services. Costs the Contractor incurs for

obligations the Contractor has already entered

into at the time it received notice of termina-

tion shall likewise be refunded, provided those

obligations comply with the specification of

services and the Contractor is unable to termi-

nate them. The legal consequences under this

subsection 39.4 shall not apply should BI have

terminated its Order pursuant to subsection

39.2 of these Special Terms and Conditions.

39.5 Notice of termination must be given in writing.

39.6 Subsection 22 shall apply to Results made up

to the point at which the contract was termi-

nated.

39.7 In the event of premature termination of the

parties' collaboration, the Contractor shall

without undue delay furnish BI with all Results

it has produced up to the date of termination.


Part III:

Special Terms and Conditions for Design Contracts

40. Bases of agreement

The Contractor shall comply with the relevant

legal provisions on unfair competition, the

German Medical Products Advertising Act

[Heilmittelwerbegesetz], the FSA Code of

Conduct on the Collaboration with Healthcare

Professionals, and Boehringer Ingelheim’s

Guidelines on Corporate Design

https://mybi17.eu.boehringer.com/sites/mybi/c

ompany/Pages/corporate_design.aspx

in performing the contract.

To the extent meetings are held during the per-

formance of the contract, the Contractor shall

record minutes of the meetings, which it shall

send to BI within one (1) week. Minutes shall

be binding insofar as BI does not object to

them within fourteen (14) days of receipt.

The Contractor shall be entitled to employ

third parties to perform the contract following

consultation with BI. In such case, the condi-

tion precedent thereto shall be that the Con-

tractor does not select such third party until it

has procured other offers and consulted BI.

Unless otherwise specifically agreed, the Con-

tractor shall engage such third party in its

name and for its own account. The Contractor

shall be responsible for subsequently review-

ing all third party invoices, and the Contractor

shall claim all discounts, commissions, rebates

etc. and to pass them on to BI in full. The Con-

tractor shall furnish evidence of costs to be

charged on to BI by submitting copies to BI.

41. Ownership rights and intellectual property

41.1 Following payment of the stipulated compen-

sation, any and all ownership rights and rights

to intellectual property (including patents,

trademarks, patterns, copyrights and related

rights, whether protected or not) for all works

prepared or created by the Contractor or by

any employee, representative, or agent of the

Contractor in the course of performing work

pursuant to the Order shall be transferred to BI

at the time of their creation. This shall not ap-

ply to "Background Rights”, i.e. intellectual

property rights or copyrights to intellectual

property of any and all kinds that already were

in existence at the time of ordering. For pur-

poses of clarification, the parties hereby agree

that "representatives" as defined in this clause

shall, without limitation, refer to freelance

workers and any other natural or legal person

performing work pursuant to the Order.

41.2 Regarding services which must be procured

but are not covered by the Order (including

buy-outs, i.e. third party rights of use, defined

by time, location, and substantive scope) and

which are necessary or desirable for the or-

dered work (e.g. buyouts from subcontractors,

models, photographers, composers, speakers,

artists, publishers, and record companies), the

Contractor shall:

a) at the time of proposing certain work and

in no event later than at the time of sub-

https://mybi17.eu.boehringer.com/sites/mybi/company/Pages/corporate_design.aspx

https://mybi17.eu.boehringer.com/sites/mybi/company/Pages/corporate_design.aspx


mitting a project proposal, inform BI of

buy-outs which may be necessary or de-

sirable and which BI should consider;

b) make written enquiries with BI as to

whether there are any internal BI policies

governing the review and, where applica-

ble, timely procurement of such buy-outs;

c) in preparing any project proposal and

when performing the work ordered, strict-

ly comply with these policies;

d) ensure that BI has such buy-outs as are

deemed necessary pursuant to the Con-

tractor's obligations under this subsection

41.2 in a timely manner and in sufficient

quantities, unrestricted in time, location,

and substance; and

e) inform BI in a timely manner prior to the

expiry of any such rights of use so that BI

is able to negotiate further buy-outs if and

as soon as BI should require this.

41.3 With the exception of Background Rights, the

Contractor shall have no claim to any rights on

trademarks, trade names, copyrights, or regis-

tered design rights related to the works sup-

plied.

41.4 Any and all documents the Contractor, its rep-

resentatives, employees, or agents prepare pur-

suant to BI's Order shall be labelled

"Boehringer Ingelheim" along with the year

of their creation.

41.5 The Contractor hereby warrants that all works

created by it or for it shall constitute its own

works, and shall be free of third party rights or

encumbrances, whether in time, location, or

substance, unless the Contractor informs BI

otherwise in writing. The Contractor hereby

warrants that it shall not use or reproduce any

work protected by copyright or other intellec-

tual property right (either in whole or in part)

without having first requested permission to do

so from BI and the owner of such rights. The

Contractor hereby further warrants that its

works, when used, reproduced, modified, pub-

lished, licensed, or otherwise utilised by BI,

shall not infringe on any intellectual property

rights (including trademark and copyright) and

shall not constitute unfair competition.

41.6 With the exception of Background Rights and

upon payment of the stipulated fees, the Con-

tractor hereby transfers to BI in full, exclusive-

ly and without any further compensation, all

rights of ownership and intellectual property

rights (including patents, trademarks, patterns,

copyrights and related rights, whether protect-

ed or not) to works prepared or created by the

Contractor or any employee, representative, or

agent of the Contractor in the course of per-

forming the works ordered, worldwide and un-

limited in time, territory and content. The fore-

going transfer is global and unrestricted in

time, location, or substance. The Contractor

shall ensure that each of its employees, repre-

sentatives and agents fully and irrevocably

waive their rights to such property or intellec-

tual property in favour of BI. BI shall be au-

thorised, without restriction, to license, trans-

fer, or exploit the intellectual property, includ-

ing the right to reproduce it, adapt it, and pub-

lish it, whether in print, by audiovisual means,

electronic means, on the Internet or in other

media.


41.7 In cases in which the Contractor uses in con-

nection with its performance of the contract a

work in which it already held the intellectual

property rights prior to commencing its work

for BI, the Contractor hereby grants and shall

ensure that BI and all BI Affiliates are granted

a licence which is unlimited in time, non-

exclusive, free of charge, sub-licensable, and

transferable, for their unrestricted use, repro-

duction, publication, licensing, and other use.

For purposes of clarification, the parties hereby

agree that the Contractor shall remain the own-

er of such intellectual property rights.

42. Fees

The agreed fee shall be payable as soon as the

contractually defined services have been ren-

dered, delivered to BI and have been formally

accepted as being proper in form and sub-

stance. The fee shall constitute full and final

compensation for all works and services of the

Contractor for ideas, design, texts, repeat runs,

etc., including worldwide rights of use thereto.

Any changes to the works and services and/or

fees/costs shall require BI's prior written con-

sent.

43. Domain names and SSL certificates

Domain names and SSL certificates relating to

BI, its business, or its products shall be regis-

tered/applied for by BI only, not by the Con-

tractor. Any need for domain names/SSL cer-

tificates (registration, purchase, or transfer)

shall be addressed by the Contractor to do-

[email protected] ex-

clusively.




Part IV:

Special Terms and Conditions for IT Software Licences

44. Scope of use of software

44.1 The Contractor hereby grants BI and BI's di-

rect or indirect Affiliates (hereinafter referred

to as the "Boehringer Ingelheim Group") a

non-exclusive, perpetual, global right to use

the software designated in the Order and the

accompanying documentation (pursuant to

ISO/IEC 26514) (hereinafter collectively re-

ferred to as "Software").

44.2 This right of use shall also apply to all compa-

nies, persons, and locations of the Boehringer

Ingelheim Group. Subject to limitations, BI

shall therefore be entitled to make the Software

available to the appropriate users either by

storing it on hard drives of individual computer

systems or by providing access via a network.

44.3 BI shall have the right to make the number of

copies necessary to reliably operate the Soft-

ware for its internal use, including but not lim-

ited to development, testing and quality assur-

ance systems (hereinafter collectively referred

to as "Non-Production Systems"), as well as

for its production systems, including back-up

copies of the Software and related documenta-

tion.

44.4 The Software may be transferred in any form

whatsoever from one computer system to an-

other computer system.

45. Scope of licence

The licence granted hereunder shall permit BI

to use the Software with any model of hard-

ware, system configuration, or platform for

which the Contractor has provided the Soft-

ware. Should BI expand, upgrade, or replace

its hardware models, system configuration, or

working platforms, it shall not be required to

obtain the Contractor's consent. Should use of

the Software be controlled by a software key

which is to be procured from the Contractor,

the Contractor shall furnish the necessary

software keys for further Non-Production Sys-

tems upon BI's request. Insofar as the Contrac-

tor intends to provide Open Source Software as

part of its contractual services, the Contractor

shall, as an essential contractual obligation, in-

form BI in writing without undue delay what

Open Source Software components should be

used and what licensing terms apply. The Con-

tractor shall ensure that the use of Open Source

Software does not restrict BI's contractual or

intended use of the contractual services. Liabil-

ity and warranty for Open Source Software are

based on the provisions of these GTC-P.

46. Transfer of right of use to third parties

BI may permanently transfer to third parties its

rights to use the Software, provided that the

third party acquiring the right of use agrees to

be bound by the further application of these li-

censing terms. In the event of such transfer, BI

shall furnish the third party with all copies of


the Software and shall destroy copies it has not

delivered to the third party. BI's right to use the

Software shall be forfeited upon transfer.

47. Warranty and software maintenance

47.1 The Software shall be considered free of de-

fects provided it performs the stipulated ser-

vice when used in accordance with the con-

tract. To such extent, the Contractor hereby

warrants that the Software is free of defects.

47.2 Should defects be discovered within the statute

of limitations, the Contractor shall remedy

them by creating and installing a new version

of the Software that is free of defects within a

period set by BI. Further claims by BI shall

remain unaffected.

47.3 The installation of a new version of the Soft-

ware shall require BI's prior written consent.

Upon installing the new version of its Soft-

ware, the Contractor shall familiarise BI's em-

ployees with the new Software version by

providing appropriate training.

47.4 The Contractor shall furnish an alternative so-

lution on short notice in the event it is unable

to remedy a defect in the Software in short or-

der. In such an event, the Contractor shall

adapt the program documentation accordingly.

47.5 The Contractor hereby warrants to BI that, as

of the time of delivery, the data storage media

on which the Software was recorded and any

hardware which may have been supplied with

the Software are free of defects.

47.6 The Contractor hereby warrants that the Soft-

ware it has supplied is free of malware such as

viruses, Trojans, worms, etc., however appro-

priate testing of the Software through the use

of a state-of-the-art virus scanning program

shall be deemed sufficient.

47.7 The Contractor shall not be liable for claims

based on the use of the Software together with

programs or data which were not supplied by

or stipulated with the Contractor should the

damage from the use of the Software have

been avoidable had these programs or data not

been used.

47.8 The Contractor shall offer Software mainte-

nance services under standard market condi-

tions (including but not limited to hotline sup-

port and corrective maintenance once the war-

ranty has expired) for a period of at least five

(5) years from delivery.

48. Infringement of third-party rights

The Contractor hereby warrants that use of its

Software does not infringe any third party

rights. In the event that a third party asserts

claims against BI based on an infringement of

rights, the Contractor shall indemnify BI

against such claims. The Contractor shall also

exchange the part deemed an infringement of

property rights or procure full rights of use for

BI without undue delay, however within no

more than twenty (20) calendar days.

***

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