S/ Recommendation to include in
N agreement from Quality Operations
01 IL-YANG” warrants that the ready to
fill bulk vaccine supplied by it shall
meet the requirements referred as
technical specifications and
requirements of current British
Pharmacopoeia.
02 In case of recall of finished products of
POPULAR by the regulatory authority
and the reason for such recall is due to
ready to fill bulk supplied by IL-
YANG, IL-YANG shall replace the
said ready to fill bulk with new ones
and reimburse purchaser (POPULAR)
all the costs involved in such recall.
03 IL-YANG shall indemnify and hold
harmless the purchaser (POPULAR)
against any loss and damage resulting
from manufacturing deficiencies in the
ready to fill bulk vaccine.
Clause covers the Statement in agreement
recommendation
As Influenza Vaccine
included in British
Pharmacopeia,
manufacturer will
provide all required
documents as per BP
specifications.
Clause 7.4, 11.4, 16. 7.4.: If the test result is not found
satisfactory or any kind of defect,
IL-YANG will replace the total
quantities.
11.4: IL-Yang shall indemnify to
POPULAR for any loss incurred
by POPULAR due to any issue
from the Korean Regulatory
authority having any impact on
the final ready to fill (RTF) bulk
supplied by IL-YANG or
POPULAR’s finished product
manufactured with the supplied
final ready to fill (RTF) bulk from
IL-YANG”.
16: If any of the Products or any
part of a Product is found not to
be in compliance with the quality
standards, IL-YANG shall supply
POPULAR free of charge the
replacement for the Products or
the part of a Product not meeting
the quality standards, and/or shall
indemnify POPULAR against any
loss and damaged suffered by
POPULAR.
Clause 11.4 At the same time, IL-YANG
should indemnify if the root cause
of the problem is related with the
ready-to-fill (RTF) final bulk,
within 30 days of the receipt of
the product.
04 Purchaser (POPULAR) shall conduct
analysis and tests, as may be necessary
and inform IL-YANG within thirty
days of receipt of the ready to fill bulk
vaccine of any testing deficiencies or
variation in the test results with respect
to the specifications and COA of ready
to fill bulk vaccine provided by IL-
YANG
05 Supplier (IL-YANG) will provide
reference standards required for the
analysis of ready to fill bulk and
finished product
Clause 16 POPULAR shall compare the
actual quantity of the Product
received to the order quantity and
notify to IL-YANG immediately
upon the receipt of the Product in
case of a shortage. POPULAR
shall conduct full chemical and
physical analysis and/or National
Inspection (if necessary) of the
Product within thirty (30) days
from release of the products by
Bureau of Custom in the
Territory.
Clause 7.4 IL-YANG will send Reference
Standard in adequate quantity to
perform the quality control test
for finished product as well as
Bulk materials also.